ORCID Profile
0000-0001-7884-6389
Current Organisations
University of Oxford
,
Ysbyty Treforys NHS
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Publisher: British Editorial Society of Bone & Joint Surgery
Date: 02-2015
DOI: 10.1302/0301-620X.97B2.34294
Abstract: We assessed the orientation of the acetabular component in 1070 primary total hip arthroplasties with hard-on-soft, small diameter bearings, aiming to determine the size and site of the target zone that optimises outcome. Outcome measures included complications, dislocations, revisions and ΔOHS (the difference between the Oxford Hip Scores pre-operatively and five years post-operatively). A wide scatter of orientation was observed (2sd 15°). Placing the component within Lewinnek’s zone was not associated withimproved outcome. Of the different zone sizes tested (± 5°, ± 10° and ± 15°), only ± 15° was associated with a decreased rate of dislocation. The dislocation rate with acetabular components inside an inclination/anteversion zone of 40°/15° ± 15° was four times lower than those outside. The only zone size associated with statistically significant and clinically important improvement in OHS was ± 5°. The best outcomes (ΔOHS 26) were achieved with a 45°/25° ± 5° zone. This study demonstrated that with traditional technology surgeons can only reliably achieve a target zone of ±15°. As the optimal zone to diminish the risk of dislocation is also ±15°, surgeons should be able to achieve this. This is the first study to demonstrate that optimal orientation of the acetabular component improves the functional outcome. However, the target zone is small (± 5°) and cannot, with current technology, be consistently achieved. Cite this article: Bone Joint J 2015 -B:164–72.
Publisher: Elsevier BV
Date: 11-1996
Publisher: British Editorial Society of Bone & Joint Surgery
Date: 11-2001
DOI: 10.1302/0301-620X.83B8.0831098
Abstract: We have assessed the effectiveness of reconstruction of the anterior cruciate ligament (ACL) in reducing functional tibial translation (TT). The gait of 11 ACL-deficient patients was studied using Vicon equipment before and after surgery. Measurements of the angle between the patellar tendon and the long axis of the tibia were obtained in order to calculate TT in the sagittal plane relative to the uninjured limb during standing and walking. Before surgery, patients did not show abnormal TT on the injured side, but after surgery significant anterior TT was found in the operated limb for every parameter of gait. Abnormal anterior TT occurring during activity does not seem to be reduced by reconstruction rather, it increases. It may be that the increased translation results from relaxation of excess contraction of the hamstring muscles, since compensatory muscle activity no longer is required in a reconstructed knee. The reduction of TT may not be an appropriate objective in surgery on the ACL.
Publisher: Springer Science and Business Media LLC
Date: 18-09-2023
Publisher: Medical Journals Sweden AB
Date: 13-10-2020
Publisher: Springer Science and Business Media LLC
Date: 29-04-2019
Publisher: Springer Science and Business Media LLC
Date: 11-2013
Publisher: British Editorial Society of Bone & Joint Surgery
Date: 06-2022
DOI: 10.1302/0301-620X.104B6.BJJ-2021-1577.R1
Abstract: Routinely collected patient-reported outcome measures (PROMs) have been useful to quantify and quality-assess provision of total hip arthroplasty (THA) and total knee arthroplasty (TKA) in the UK for the past decade. This study aimed to explore whether the outcome following primary THA and TKA had improved over the past seven years. Secondary data analysis of 277,430 primary THAs and 308,007 primary TKAs from the NHS PROMs programme was undertaken. Outcome measures were: postoperative Oxford Hip/Knee Score (OHS/OKS) proportion of patients achieving a clinically important improvement in joint function (responders) quality of life patient satisfaction perceived success and complication rates. Outcome measures were compared based on year of surgery using multiple linear and logistic regression models. For primary THA, multiple linear regression modelling found that more recent year of surgery was associated with higher postoperative OHS (unstandardized coefficient (B) 0.15 points (95% confidence interval (CI) 0.14 to 0.17) p 0.001) and higher EuroQol five-dimension index (EQ-5D) utility (B 0.002 (95% CI 0.001 to 0.002) p 0.001). The odds of being a responder (odds ratio (OR) 1.02 (95% CI 1.02 to 1.03) p 0.001) and patient satisfaction (OR 1.02 (95% CI 1.01 to 1.03) p 0.001) increased with year of surgery, while the odds of any complication reduced (OR 0.97 (95% CI 0.97 to 0.98) p 0.001). No trend was found for perceived success (p = 0.555). For primary TKA, multiple linear regression modelling found that more recent year of surgery was associated with higher postoperative OKS (B 0.21 points (95% CI 0.19 to 0.22) p 0.001) and higher EQ-5D utility (B 0.002 (95% CI 0.002 to 0.003) p 0.001). The odds of being a responder (OR 1.04 (95% CI 1.03 to 1.04) p 0.001), perceived success (OR 1.02 (95% CI 1.01 to 1.02) p 0.001), and patient satisfaction (OR 1.02 (95% CI 1.01 to 1.02) p 0.001) all increased with year of surgery, while the odds of any complication reduced (OR 0.97 (95% CI 0.97 to 0.97) p 0.001). Nearly all patient-reported outcomes following primary THA/TKA improved by a small amount over the past seven years. Due to the high proportion of patients achieving good outcomes, PROMs following THA and TKA may need to focus on better discrimination of patients achieving high scores to be able to continue to measure improvement in outcomes. Cite this article: Bone Joint J 2022 -B(6):687–695.
Publisher: Elsevier BV
Date: 04-2012
Publisher: F1000 Research Ltd
Date: 30-01-2018
DOI: 10.12688/F1000RESEARCH.12528.2
Abstract: In this paper, we use evidence from our earlier review of surgical randomised controlled trials with a placebo arm to show that blinding in trials of interventional procedures is feasible. We give ex les of ingenious strategies that have been used to simulate the active procedure and to make the placebo control indistinguishable from the active treatment. We discuss why it is important to blind of patients, assessors, and caregivers and what types of bias that may occur in interventional trials. Finally, we describe the benefits of blinding, from the obvious ones such as avoiding bias, as well as less evident benefits such as avoiding patient drop out in the control arm.
Publisher: Elsevier BV
Date: 2019
Publisher: American Physiological Society
Date: 08-2021
DOI: 10.1152/JAPPLPHYSIOL.00180.2021
Abstract: This study presents novel insights into the effect of artificial gravity (AG) on the deterioration of standing balance and anticipatory postural adjustments (APAs) of trunk muscles induced by 60-day strict head-down bed rest. The results indicated severe balance dysfunction and delayed APAs during rapid arm movement. AG partially mitigated the deterioration in standing balance and may thus be considered as a potential countermeasure for future planetary surface explorations. Optimization of AG protocols might enhance effects.
Publisher: Springer Science and Business Media LLC
Date: 2013
Publisher: Wiley
Date: 03-1994
Abstract: Decreased dynamic stability of the knee joint associated with functional disability is a feature of anterior cruciate ligament deficiency (ACLD). The purposes of this study were to examine the between-limbs difference in reflex contraction latency of the hamstring muscles in patients with unilateral ACLD and to investigate its relationship with instability and function. Fifty patients with arthroscopically diagnosed unilateral ACLD were measured bilaterally for reflex hamstring contraction latency (RHCL), and 20 normal volunteers were similarly tested. The subjects were measured in a position of single-limb full weight-bearing with the knee flexed 30 degrees. An anteriorly directed shear force was applied to the tibia, and surface electromyographs (EMGs) recorded the activity of the hamstrings in response to the applied force. The latency of contraction was defined as the time from initial tibial movement, identified by accelerometry, to the onset of increased hamstring EMG activity. Both legs were tested and a between-limbs difference was computed. A significant difference in RHCL was found between the limb with ACLD and the control limb. The mean RHCL of the limb with ACLD was nearly double that of the unaffected limb, for a significant mean between-limbs difference (p < 0.05). The mean between-limbs difference for the control subjects was not statistically significant. The conclusion is that patients with ACLD have an increased RHCL of the injured leg. As the RHCL is dependent on proprioceptive activity around the joint, it can be used as a measure of proprioceptive ability. The loss of the neurophysiological protective reflex involving the anterior cruciate ligament and hamstrings in patients with ACLD is likely to be a contributory factor in the decreased joint stability experienced by these patients.
Publisher: British Editorial Society of Bone & Joint Surgery
Date: 02-2006
DOI: 10.1302/0301-620X.88B2.17055
Abstract: We performed a clinical and radiological study to determine the rate of failure of the Charnley Elite-Plus femoral component. Our aim was to confirm or refute the predictions of a previous roentgen stereophotogrammetric analysis study in which 20% of the Charnley Elite-Plus stems had shown rapid posterior head migration. It was predicted that this device would have a high early rate of failure. We examined 118 patients at a mean of nine years after hip replacement, including the 19 patients from the original roentgen stereophotogrammetric study. The number of revision procedures was recorded and clinical and radiological examinations were performed. The rate of survival of the femoral stems at ten years was 83% when revision alone was considered to be a failure. It decreased to 59% when a radiologically loose stem was also considered to be a failure. All the patients previously shown in the roentgen stereophotogrammetric study to have high posterior head migration went on to failure. There was a highly significant difference (p = 0.002) in posterior head migration measured at two years after operation between failed and non-failed femoral stems, but there was no significant difference in subsidence between these two groups. Our study has shown that the Charnley Elite-Plus femoral component has an unacceptably high rate of failure. It confirms that early evaluation of new components is important and that roentgen stereophotogrammetric is a good tool for this. Our findings have also shown that rapid posterior head migration is predictive of premature loosening and a better predictor than subsidence.
Publisher: Elsevier BV
Date: 06-2023
Publisher: Elsevier BV
Date: 08-2019
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 02-2003
Publisher: British Editorial Society of Bone & Joint Surgery
Date: 04-2015
DOI: 10.1302/0301-620X.97B4.35314
Abstract: The Swansea Morriston Achilles Rupture Treatment (SMART) programme was introduced in 2008. This paper summarises the outcome of this programme. Patients with a rupture of the Achilles tendon treated in our unit follow a comprehensive management protocol that includes a dedicated Achilles clinic, ultrasound examination, the use of functional orthoses, early weight-bearing, an accelerated exercise regime and guidelines for return to work and sport. The choice of conservative or surgical treatment was based on ultrasound findings. The rate of re-rupture, the outcome using the Achilles Tendon Total Rupture Score (ATRS) and the Achilles Tendon Repair Score, (AS), and the complications were recorded. An elementary cost analysis was also performed. Between 2008 and 2014 a total of 273 patients presented with an acute rupture 211 of whom were managed conservatively and 62 had surgical repair. There were three re-ruptures (1.1%). There were 215 men and 58 women with a mean age of 46.5 years (20 to 86). Functional outcome was satisfactory. Mean ATRS and AS at four months was 53.0 (sd 14), 64.9 (sd 15) (n = 135), six months 67.8 (sd 16), 73.8 (sd 15) (n = 103) and nine months (72.4 sd 14) 72.3 (sd 13) (n = 43). The programme realised estimated cost savings exceeding £91 000 per annum. The SMART programme resulted in a low rate of re-rupture, a satisfactory outcome, a reduced rate of surgical intervention and a reduction in healthcare costs. Cite this article: Bone Joint J 2015 97-B:510–15.
Publisher: Elsevier BV
Date: 2018
Publisher: SAGE Publications
Date: 05-2018
Publisher: Wiley
Date: 24-04-2009
DOI: 10.1002/JOR.20880
Abstract: This study's aim was to determine the patterns of osteoarthritis (OA) in both unicompartmental medial and lateral OA of the knee. Forty patients with medial and 20 with lateral unicompartmental knee osteoarthritis were studied to determine the location of full-thickness cartilage lesions. Intraoperatively, the distance between margins of the lesion and reference lines were measured. The femoral measurements were transposed onto lateral radiographs to determine the relationship between the lesion site and knee flexion angles. Both tibial and femoral lesions were significantly (p < 0.01) more posterior in lateral OA than medial OA. In medial OA, the lesion center was, on average, at 11 degrees (SD 3 degrees) of flexion, whereas in lateral OA, it was at 40 degrees (SD 3 degrees). The smallest medial femoral lesions were near full extension and, as they enlarged, they extended posteriorly. The smallest lateral femoral lesions extended from 20 degrees to 60 degrees flexion. As these lesions enlarged, they extended both anteriorly and posteriorly. There was a well-defined relationship between the site of the lesions and their size, suggesting that they develop and progress in a predictable manner. The relationship was different for medial and lateral OA, suggesting that different mechanical factors are important in initiating the different types of OA. The lesions in medial OA occur in extension, perhaps initiated by events occurring at heel strike. The lesions in lateral OA begin at flexion angles above those occurring during the single leg stance phase of the gait cycle, so activities other than gait are likely to induce lateral OA.
Publisher: BMJ
Date: 08-2013
Publisher: British Editorial Society of Bone & Joint Surgery
Date: 11-2005
DOI: 10.1302/0301-620X.87B11.16325
Abstract: Polyethylene particulate wear debris continues to be implicated in the aetiology of aseptic loosening following knee arthroplasty. The Oxford unicompartmental knee arthroplasty employs a spherical femoral component and a fully congruous meniscal bearing to increase contact area and theoretically reduce the potential for polyethylene wear. This study measures the in vivo ten-year linear wear of the device, using a roentgenstereophotogrammetric technique. In this in vivo study, seven medial Oxford unicompartmental prostheses, which had been implanted ten years previously were studied. Stereo pairs of radiographs were acquired for each patient and the films were analysed using a roentgen stereophotogrammetric analysis calibration and a computer-aided design model silhouette-fitting technique. Penetration of the femoral component into the original volume of the bearing was our estimate of linear wear. In addition, eight control patients were examined less than three weeks post-insertion of an Oxford prosthesis, where no wear would be expected. The control group showed no measured wear and suggested a system accuracy of 0.1 mm. At ten years, the mean linear wear rate was 0.02 mm/year. The results from this in vivo study confirm that the device has low ten-year linear wear in clinical practice. This may offer the device a survival advantage in the long term.
Publisher: BMJ
Date: 04-2020
DOI: 10.1136/BMJOPEN-2019-030609
Abstract: The purpose of this study was to analyse the rate of knee arthroplasty in the population of patients with a history of arthroscopic chondroplasty of the knee, in England, over 10 years, with comparison to general population data for patients without a history of chondroplasty. Retrospective cohort study. English Hospital Episode Statistics (HES) data. Patients undergoing arthroscopic chondroplasty in England between 2007/2008 and 2016/2017 were identified. Patients undergoing previous arthroscopic knee surgery or simultaneous cruciate ligament reconstruction or microfracture in the same knee were excluded. Patients subsequently undergoing a knee arthroplasty in the same knee were identified and mortality-adjusted survival analysis was performed (survival without undergoing knee arthroplasty). A Cox proportional hazards model was used to identify factors associated with knee arthroplasty. Relative risk of knee arthroplasty (total or partial) in comparison to the general population was determined. Through 2007 to 2017, 157 730 eligible chondroplasty patients were identified. Within 1 year, 5.91% (7984/135 197 95% CI 5.78 to 6.03) underwent knee arthroplasty and 14.22% (8145/57 267 95% CI 13.94 to 14.51) within 5 years. Patients aged over 30 years with a history of chondroplasty were 17.32 times (risk ratio 95% CI 16.81 to 17.84) more likely to undergo arthroplasty than the general population without a history of chondroplasty. Patients with cartilage lesions of the knee, treated with arthroscopic chondroplasty, are at greater risk of subsequent knee arthroplasty than the general population and for a proportion of patients, there is insufficient benefit to prevent the need for knee arthroplasty within 1 to 5 years. These important new data will inform patients of the anticipated outcomes following this procedure. The risk in comparison to non-operative treatment remains unknown and there is an urgent need for a randomised clinical trial in this population.
Publisher: British Editorial Society of Bone & Joint Surgery
Date: 12-2011
DOI: 10.1302/0301-620X.93B12.27046
Abstract: We obtained pre-operative and six-month post-operative Oxford hip (OHS) and knee scores (OKS) for 1523 patients who underwent total hip replacement and 1784 patients who underwent total knee replacement. They all also completed a six-month satisfaction question. Scatter plots showed no relationship between pre-operative Oxford scores and six-month satisfaction scores. Spearman’s rank correlation coefficients were -0.04 (95% confidence interval (CI) -0.09 to 0.01) between OHS and satisfaction and 0.04 (95% CI -0.01 to 0.08) between OKS and satisfaction. A receiver operating characteristic (ROC) curve analysis was used to identify a cut-off point for the pre-operative OHS/OKS that identifies whether or not a patient is satisfied with surgery. We obtained an area under the ROC curve of 0.51 (95% CI 0.45 to 0.56) for hip replacement and 0.56 (95% CI 0.51 to 0.60) for knee replacement, indicating that pre-operative Oxford scores have no predictive accuracy in distinguishing satisfied from dissatisfied patients. In the NHS widespread attempts are being made to use patient-reported outcome measures (PROMs) data for the purpose of prioritising patients for surgery. Oxford hip and knee scores have no predictive accuracy in relation to post-operative patient satisfaction. This evidence does not support their current use in prioritising access to care.
Publisher: JMIR Publications Inc.
Date: 10-03-2023
Abstract: emote patient-reported outcome measure (PROM) data capture can provide useful insights in research and clinical practice, and deeper insights can be gained by administering assessments more frequently. However, frequent data collection can be limited by the by the burden of multiple, lengthy questionnaires. This burden can be reduced with algorithms that select only the most relevant items from a PROM for an in idual respondent. We developed "Ecological Momentary Computerized Adaptive Testing” (EMCAT), using algorithms to reduce PROM response burden and facilitate high frequency data capture via a smartphone application. o determine the feasibility of EMCAT as a system for remote PROM administration. e enrolled 40 patients with hand trauma or thumb-base arthritis, across 2 sites, between 13th July 2022 and 14th September 2022. We monitored their symptoms with a validated PROM (the Patient Evaluation Measure), via EMCAT, over a 12-week period. Patients were assessed either thrice weekly, once daily, or thrice daily. We additionally administered full-length PROM assessments at 0, 6, and 12 weeks, and the User Engagement Scale (UES) at 12 weeks. he use of EMCAT significantly reduced the length of the PROM (median 2 vs 11 items) and the time taken to complete it (median 8.8 seconds vs 1 minute 14 seconds). Very similar scores were produced when EMCAT was administered concurrently with the full-length PROM, with a mean error of .01 on a logit (z-score) scale. The median response rate in the daily assessment group was 93%. The median Perceived Usability score of the UES was 4.0 (maximum possible score 5.0). MCAT reduces the burden of PROM assessments, enabling acceptable high-frequency, remote PROM data capture. SRCTN19841416
Publisher: Oxford University Press (OUP)
Date: 22-03-2023
DOI: 10.1093/BJS/ZNAD031
Abstract: Surgery for nail bed injuries in children is common. One of the key surgical decisions is whether to replace the nail plate following nail bed repair. The aim of this RCT was to assess the clinical effectiveness and cost-effectiveness of nail bed repair with fingernail replacement/substitution compared with repair without fingernail replacement. A two-arm 1 : 1 parallel-group open multicentre superiority RCT was performed across 20 secondary-care hospitals in the UK. The co-primary outcomes were surgical-site infection at around 7 days after surgery and cosmetic appearance summary score at a minimum of 4 months. Some 451 children presenting with a suspected nail bed injury were recruited between July 2018 and July 2019 224 were allocated to the nail-discarded arm, and 227 to the nail-replaced arm. There was no difference in the number of surgical-site infections at around 7 days between the two interventions or in cosmetic appearance. The mean total healthcare cost over the 4 months after surgery was €84 (95 per cent c.i. 34 to 140) lower for the nail-discarded arm than the nail-replaced arm (P & 0.001). After nail bed repair, discarding the fingernail was associated with similar rates of infection and cosmesis ratings as replacement of the finger nail, but was cost saving. Registration number: ISRCTN44551796 (www.controlled-trials.com).
Publisher: BMJ
Date: 08-2016
Publisher: Informa UK Limited
Date: 12-2011
Publisher: British Editorial Society of Bone & Joint Surgery
Date: 07-2005
DOI: 10.1302/0301-620X.87B7.15716
Abstract: Abnormal sagittal kinematics after total knee replacement (TKR) can adversely affect functional outcome. Two important determinants of knee kinematics are component geometry and the presence or absence of a posterior-stabilising mechanism (cam-post). We investigated the influence of these variables by comparing the kinematics of a TKR with a polyradial femur with a single radius design, both with and without a cam-post mechanism. We assessed 55 patients, sub ided into four groups, who had undergone a TKR one year earlier by using an established fluoroscopy protocol in order to examine their kinematics in vivo. The kinematic profile was obtained by measuring the patellar tendon angle through the functional knee flexion range (0° to 90°) and the results compared with 14 normal knees. All designs of TKR had abnormal sagittal kinematics compared with the normal knee. There was a significant (p 0.05) difference between those of the two TKRs near to full extension. The presence of the cam-post mechanism did not influence the kinematics for either TKR design. These differences suggest that surface geometry is a stronger determinant of kinematics than the presence or absence of a cam-post mechanism for these two designs. This may be because the cam-post mechanism is ineffective.
Publisher: Public Library of Science (PLoS)
Date: 29-08-2022
DOI: 10.1371/JOURNAL.PONE.0273696
Abstract: Implementation of Robotic Assisted Surgery (RAS) is complex as it requires adjustments to associated physical infrastructure, but also changes to processes and behaviours. With the global objective of optimising and improving RAS implementation, this study aimed to: 1) Explore the barriers and enablers to RAS service adoption, incorporating an assessment of behavioural influences 2) Provide an optimised plan for effective RAS implementation, with the incorporation of theory-informed implementation strategies that have been adapted to address the barriers/enablers that affect RAS service adoption. Semi-structured interviews were conducted with RAS personnel and stakeholders, including: surgeons, theatre staff, managers, industry representatives, and policy-makers/commissioners. The Theoretical Domains Framework (TDF) and the Consolidated Framework for Implementation Research (CFIR) was used to identify barriers and enablers that represent in idual behaviours, capabilities, attitudes, beliefs, and external organisational factors that influence the implementation of RAS. Findings suggest that implementation planning has three separate phases–pre-, early, and late implementation. For pre-implementation, barriers and enablers identified included the cost of RAS equipment and issues of economic viability, weak outcome evidence for RAS, a preponderance of an eminence driven model, the clinician/manager relationship, and views around the uptake and expansion of RAS in the future. Early implementation findings revealed role changes for theatre personnel and an enhanced team approach, reliance on industry for training provision, and changes in skill sets and attentional processes. Late implementation factors included equipment maintenance costs, technological limitations, changes to cognition during RAS routine use, and benefits to institutions/healthcare professionals (such as ergonomic improvement). Together, findings suggest the factors that affect RAS implementation are multi-faceted and change across the life-cycle of intervention adoption. Theory-informed strategies are suggested which can optimise implementation of RAS. Optimisation strategies need planning from the outset.
Publisher: Elsevier BV
Date: 10-2004
Publisher: IEEE
Date: 05-2013
Publisher: American Physiological Society
Date: 07-2021
DOI: 10.1152/JAPPLPHYSIOL.00990.2020
Abstract: This study presents novel insights into the morphological adaptations occurring in the lumbar spine after 60-day head-down bed rest and the potential role of artificial gravity (AG) to mitigate them. Results demonstrated no protective effect of AG protocols used in this study. In atrophied paraspinal muscles, the ratio of lipids versus intramuscular water increased in the postural lumbar muscles, which could impair muscle function during upright standing. These findings have relevance for future space explorations.
Publisher: Elsevier BV
Date: 04-2017
Publisher: Springer Science and Business Media LLC
Date: 11-2013
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 08-1997
DOI: 10.3109/03093649709164535
Abstract: There is no central database that records the changing provision of prostheses in the United Kingdom. Experience suggests there have been some shifts in the population, particularly in the past decade. Because the detailed records of these changes are contained in the patients' medical records it is difficult to assess the substance of these data except on an in idual basis the larger picture the sifting of a centre's or many centres' data. This paper describes the analysis of one such set of records at the Oxford Limb Fitting Centre. It relates the profile of the population that attends the centre to the general population, and compares the information with that obtainable from other sources. The possible causes for the findings are discussed.
Publisher: Public Library of Science (PLoS)
Date: 30-03-2023
DOI: 10.1371/JOURNAL.PONE.0283000
Abstract: The introduction of robot-assisted surgery is costly and requires whole system transformation, which makes the assessment of benefits (or drawbacks) complex. To date, there has been little agreement on which outcomes should be used in this regard. The aim of the RoboCOS study was to develop a core outcome set for the evaluation of robot-assisted surgery that would account for its impact on the whole system. Identification of a long-list of potentially relevant outcomes through systematic review of trials and health technology assessments interviews with in iduals from a range of stakeholder groups (surgeons, service managers, policy makers and evaluators) and a focus group with patients and public prioritisation of outcomes via a 2-round online international Delphi survey consensus meeting. 721 outcomes were extracted from the systematic reviews, interviews and focus group which were conceptualised into 83 different outcome domains across four distinct levels (patient, surgeon, organisation and population) for inclusion in the international Delphi prioritisation survey (128 completed both rounds). The consensus meeting led to the agreement of a 10-item core outcome set including outcomes at: patient level (treatment effectiveness overall quality of life disease-specific quality of life complications (including mortality) surgeon level (precision/accuracy visualisation) organisation (equipment failure standardisation of operative quality cost-effectiveness) and population (equity of access). The RoboCOS core outcome set, which includes the outcomes of importance to all stakeholders, is recommended for use in all future evaluations of robot-assisted surgery to ensure relevant and comparable reporting of outcomes.
Publisher: Elsevier BV
Date: 11-2018
Publisher: Springer Science and Business Media LLC
Date: 11-2013
Publisher: Springer Science and Business Media LLC
Date: 11-2013
Publisher: Springer Science and Business Media LLC
Date: 10-2022
DOI: 10.1186/S12874-022-01734-2
Abstract: Assessing the long term effects of many surgical interventions tested in pragmatic RCTs may require extended periods of participant follow-up to assess effectiveness and use patient-reported outcomes that require large s le sizes. Consequently the RCTs are often perceived as being expensive and time-consuming, particularly if the results show the test intervention is not effective. Adaptive, and particularly group sequential, designs have great potential to improve the efficiency and cost of testing new and existing surgical interventions. As a means to assess the potential utility of group sequential designs, we re-analyse data from a number of recent high-profile RCTs and assess whether using such a design would have caused the trial to stop early. Many pragmatic RCTs monitor participants at a number of occasions (e.g. at 6, 12 and 24 months after surgery) during follow-up as a means to assess recovery and also to keep participants engaged with the trial process. Conventionally one of the outcomes is selected as the primary (final) outcome, for clinical reasons, with others designated as either early or late outcomes. In such settings, novel group sequential designs that use data from not only the final outcome but also from early outcomes at interim analyses can be used to inform stopping decisions. We describe data from seven recent surgical RCTs (WAT, DRAFFT, WOLLF, FASHION, CSAW, FIXDT, TOPKAT), and outline possible group sequential designs that could plausibly have been proposed at the design stage. We then simulate how these group sequential designs could have proceeded, by using the observed data and dates to replicate how information could have accumulated and decisions been made for each RCT. The results of the simulated group sequential designs showed that for two of the RCTs it was highly likely that they would have stopped for futility at interim analyses, potentially saving considerable time (15 and 23 months) and costs and avoiding patients being exposed to interventions that were either ineffective or no better than standard care. We discuss the characteristics of RCTs that are important in order to use the methodology we describe, particularly the value of early outcomes and the window of opportunity when early stopping decisions can be made and how it is related to the length of recruitment period and follow-up. The results for five of the RCTs tested showed that group sequential designs using early outcome data would have been feasible and likely to provide designs that were at least as efficient, and possibly more efficient, than the original fixed s le size designs. In general, the amount of information provided by the early outcomes was surprisingly large, due to the strength of correlations with the primary outcome. This suggests that the methods described here are likely to provide benefits more generally across the range of surgical trials and more widely in other application areas where trial designs, outcomes and follow-up patterns are structured and behave similarly.
Publisher: Elsevier BV
Date: 03-1992
Publisher: BMJ
Date: 10-05-2013
Publisher: BMJ
Date: 04-2018
Publisher: Frontiers Media SA
Date: 11-11-2021
DOI: 10.3389/FPHYS.2021.745811
Abstract: Exposure to spaceflight and head-down tilt (HDT) bed rest leads to decreases in the mass of the gluteal muscle. Preliminary results have suggested that interventions, such as artificial gravity (AG), can partially mitigate some of the physiological adaptations induced by HDT bed rest. However, its effect on the gluteal muscles is currently unknown. This study investigated the effects of daily AG on the gluteal muscles during 60-day HDT bed rest. Twenty-four healthy in iduals participated in the study: eight received 30 min of continuous AG eight received 6 × 5 min of AG, interspersed with rest periods eight belonged to a control group. T1-weighted Dixon magnetic resonance imaging of the hip region was conducted at baseline and day 59 of HDT bed rest to establish changes in volumes and intramuscular lipid concentration (ILC). Results showed that, across groups, muscle volumes decreased by 9.2% for gluteus maximus (GMAX), 8.0% for gluteus medius (GMED), and 10.5% for gluteus minimus after 59-day HDT bed rest (all p & 0.005). The ILC increased by 1.3% for GMAX and 0.5% for GMED (both p & 0.05). Neither of the AG protocols mitigated deconditioning of the gluteal muscles. Whereas all gluteal muscles atrophied, the ratio of lipids to intramuscular water increased only in GMAX and GMED muscles. These changes could impair the function of the hip joint and increased the risk of falls. The deconditioning of the gluteal muscles in space may negatively impact the hip joint stability of astronauts when reexpose to terrestrial gravity.
Publisher: Elsevier BV
Date: 10-2019
DOI: 10.1016/J.JOCA.2019.03.009
Abstract: The aim of this study was to determine the proportion of patients undergoing arthroscopic partial meniscectomy (APM) then subsequently receiving a knee arthroplasty within one or two years, with focus on patients over the age of 60 years and regional variation. Patients undergoing APM in England over 20-years (01-April-1997 to 31-March 2017) were identified in the national Hospital Episode Statistics (HES). The proportion of patients undergoing arthroplasty in the same knee within one or two years of APM was determined and trends were analysed over time nationally and by NHS Clinical Commissioning Group (CCG) region. 806,195 APM patients were eligible for analysis with at least one-year of follow up and 746,630 with two-years. The odds of arthroplasty conversion within one year increased over the study period (odds ratio [OR] 3.10 within 1-year in 2014 vs 2000 95% confidence interval [CI] 2.75-3.50). For patients undergoing APM aged 60 years or older in 2015-16, 9.9% (1689/17,043 95% CI 9.5-10.4) underwent arthroplasty within 1-year and, in 2014-15, 16.6% (3100/18,734 95% CI 16.0-17.1) underwent arthroplasty within 2-years. There was greater than 10-fold variation by CCG. Over the study period, the proportion of patients undergoing arthroplasty within one-year of APM increased. In 2015-16, of patients aged 60 years or older who underwent APM, 10% subsequently underwent knee arthroplasty within one year (17% within two years in 2014-15) and there was a high level of regional variation in this outcome. The development and adoption of national treatment guidance is recommended to improve and standardise treatment selection.
Publisher: Elsevier BV
Date: 12-2013
DOI: 10.1016/J.KNEE.2013.05.011
Abstract: Despite the excellent total knee arthroplasty (TKA) results reported using traditional outcome measures, dissatisfaction rates of up to 30% are reported following surgery. Although several preoperative factors have been identified as possible predictors of satisfaction, there is conflicting evidence. Identification of dissatisfaction in the early postoperative assessment may therefore be an alternative consideration. We examined the relationship between 12-month satisfaction, and early post-operative outcomes in a cohort of 486 TKA patients. Preoperative, and postoperative outcome measures at 3- and 12-months (Oxford knee score, pain score, SF12, and knee motion), were analysed and compared between patients who were satisfied and dissatisfied at 12-months following TKA. Mean scores, and postoperative change in scores were calculated. Postoperative outcomes were examined for correlation with satisfaction, and multivariate logistic regression models used to identify potential predictors of dissatisfaction. Overall satisfaction was 77.0%. No preoperative differences were observed between groups. Dissatisfaction was associated with worse postoperative status across all outcome measures (p<0.001), except the 3-month SF12-physical component (p=0.052). Dissatisfied patients demonstrated minimal further improvement or even worsening of outcome scores between 3- and 12-months postoperatively (p<0.02). Both the 3-month OKS (OR=1.15, p<0.001), and knee flexion (OR=1.03, p=0.009) were significant predictors of subsequent 12-month satisfaction. Dissatisfaction following TKA is associated with worse outcomes as early as 3months following surgery, with minimal further improvement subsequently achieved at 12-months. Early postoperative assessment following TKA should therefore be considered, including clinical assessment, to identify those patients at risk of dissatisfaction.
Publisher: BMJ
Date: 06-07-2022
Abstract: To provide clinicians and patients with accurate risk estimates of serious adverse events after common elective shoulder arthroscopic procedures, including reoperation within one year. Population based cohort study. Hospital Episode Statistics for NHS England, including civil registration mortality data from the Office for National Statistics. 288 250 arthroscopic shoulder procedures performed in 261 248 patients aged ≥16 years between 1 April 2009 and 31 March 2017. Elective procedures were grouped into subacromial decompression, rotator cuff repair, acromioclavicular joint excision, glenohumeral stabilisation, and frozen shoulder release. The primary outcomes were rates of serious adverse events (mortality, pulmonary embolism, pneumonia, myocardial infarction, acute kidney injury, stroke, and urinary tract infection) requiring inpatient care within 90 days post-surgery. Secondary outcomes were specific adverse event rates at 90 days, and reoperations (including for deep infection) within one year. The overall rate of complications within 90 days after arthroscopic shoulder surgery (including reoperation) was low at 1.2% (95% confidence interval 1.2% to 1.3%), with one in 81 patients at risk, and varied according to type of procedure, from 0.6% (0.5% to 0.8%) for glenohumeral stabilisation to 1.7% (1.5% to 1.8%) for frozen shoulder release. After adjustment for age, comorbidities, and sex, no effect of procedure type was observed. Pneumonia was the most common adverse event (0.3%, 0.3% to 0.4%), with one in 303 patients at risk. Pulmonary embolic events were rare, at 0.1% (0.1% to 0.1%), with one in 1428 patients at risk. At one year, the overall rate for reoperation was 3.8% (3.8% to 3.9%), with one in 26 patients at risk, ranging from 2.7% (2.5% to 3.0%) for glenohumeral stabilisation to 5.7% (5.4% to 6.1%) for frozen shoulder release. The overall rate of further surgery for deep infection was low, at 0.1% (0.1% to 0.1%), with one in 1111 patients at risk, but was higher after rotator cuff repair (0.2%, 0.2% to 0.2%), with one in 526 patients at risk. Over the study period the number of arthroscopic shoulder procedures increased, except for subacromial decompression, which decreased. The findings of this study suggest that risks of serious adverse events associated with common shoulder arthroscopy procedures are low. Nevertheless, serious complications do occur, and include the risk of reoperation in one in 26 patients within one year. Clinical.Trials.gov NCT03573765 .
Publisher: BMJ
Date: 02-10-2018
DOI: 10.1136/BJSPORTS-2018-099414
Abstract: We investigated trends and regional variation in the rate of arthroscopic knee surgery performed in England from 1997–1998 to 2016–2017. Cross-sectional study of the national hospital episode statistics (HES) for England. All hospital episodes for patients undergoing a knee arthroscopy between 1 April 1997 and 31 March 2017 were extracted from HES by procedure code. Age and sex-standardised rates of surgery were calculated using Office for National Statistic population data as the denominator. Trends in the rate of surgery were analysed by procedure both nationally and by Clinical Commissioning Group (CCG). A total of 1 088 872 arthroscopic partial meniscectomies (APMs), 326 600 diagnostic arthroscopies, 308 618 knee washouts and 252 885 chondroplasties were identified (1 759 467 hospital admissions 1 447 142 patients). The rate of APM increased from a low of 51/100 000 population (95% CI 51 to 52) in 1997–1998 to a peak at 149/100 000 (95% CI 148 to 150) in 2013–2014 then, after 2014–2015, rates declined to 120/100 000 (95% CI 119 to 121) in 2016–2017. Rates of arthroscopic knee washout and diagnostic arthroscopy declined steadily from 50/100 000 (95% CI 49 to 50) and 47/100 000 (95% CI 46 to 47) respectively in 1997–1998, to 4.8/100 000 (95% CI 4.6 to 5.0) and 8.1/100 000 (95% CI 7.9 to 8.3) in 2016–2017. Rates of chondroplasty have increased from a low of 3.2/100 000 (95% CI 3.0 to 3.3) in 1997–1998 to 51/100 000 (95% CI 50.6 to 51.7) in 2016–2017. Substantial regional and age–group variation in practice was detected. In 2016–2017, between 11% (22/207) and 16% (34/207) of CCGs performed at least double the national average rate of each procedure. Over the last 20 years, and likely in response to new evidence, rates of arthroscopic knee washout and diagnostic arthroscopy have declined by up to 90%. APM rates increased about 130% overall but have declined recently. Rates of chondroplasty increased about 15-fold. There is significant variation in practice, but the appropriate population intervention rate for these procedures remains unknown.
Publisher: SAGE Publications
Date: 07-2011
Abstract: Preoperative psychological distress has been reported to predict poor outcome and patient dissatisfaction after total hip arthroplasty (THA). The purpose of this study was to investigate if pre-operative psychological distress was associated with adverse functional outcome after primary THR. We analysed the database of a prospective multi-centre study undertaken between January 1999 and January 2002. We recorded the Oxford Hip Score (OHS) and SF36 score preoperatively and up to five years after surgery for 1055 patients. We dichotomised the patients into the mentally distressed (Mental Health Scale score - MHS ≤56) and the not mentally distressed (MHS ) groups based on their pre-operative MHS of the SF36. 762 (72.22%). Patients (595 not distressed and 167 distressed) were followed up at 5 years. Both pre and post-operative OHS and SF-36 scores were significantly worse in the distressed group (both p .001). However, both groups experienced statistically significant improvement in OHS and MHS, which was maximal at 1 year after surgery and was maintained over the follow up (p=0.00). There was a substantial improvement in mental distress in patients who reported mental distress prior to surgery. The results suggest that pre-operative psychological distress did not adversely compromise functional outcome gain after THA. Despite having worse absolute values both pre and post operatively, patients with mental distress did not have any less functional gain from THA as measured by improvement in OHS.
Publisher: Oxford University Press (OUP)
Date: 14-10-2020
DOI: 10.1002/BJS5.50352
Abstract: Robot-assisted surgery (RAS) has potential panspecialty surgical benefits. High-quality evidence for widespread implementation is lacking. This systematic review aimed to assess the RAS evidence base for the quality of randomized evidence on safety and effectiveness, specialty ‘clustering’, and outcomes for RAS research. A systematic review was undertaken according to PRISMA guidelines. All pathologies and procedures utilizing RAS were included. Studies were limited to RCTs, the English language and publication within the last decade. The main outcomes selected for the review design were safety and efficacy, and study purpose. Secondary outcomes were study characteristics, funding and governance. Searches identified 7142 titles, from which 183 RCTs were identified for data extraction. The commonest specialty was urology (35·0 per cent). There were just 76 unique study populations, indicating significant overlap of publications 103 principal studies were assessed further. Only 64·1 per cent of studies reported a primary outcome measure, with 29·1 per cent matching their registration rotocol. Safety was assessed in 68·9 per cent of trials operative complications were the commonest measure. Forty-eight per cent of trials reported no significant difference in safety between RAS and comparator, and 11 per cent reported RAS to be superior. Efficacy or effectiveness was assessed in 80·6 per cent of trials 43 per cent of trials showed no difference between RAS and comparator, and 24 per cent reported that RAS was superior. Funding was declared in 47·6 per cent of trials. The evidence base for RAS is of limited quality and variable transparency in reporting. No patterns of harm to patients were identified. RAS has potential to be beneficial, but requires continued high-quality evaluation.
Publisher: Springer Science and Business Media LLC
Date: 12-05-2022
DOI: 10.1186/S13063-022-06309-6
Abstract: Rupture of the anterior cruciate ligament (ACL) is a common injury, primarily affecting young, active in iduals. Despite surgical intervention being the more common treatment for patients suffering ACL ruptures, current management is based on limited and generally low-quality evidence. We describe a statistical analysis plan (SAP) for the ACL SNNAP randomised controlled trial, which aims to investigate the necessity of surgical management in patients with ACL injuries. ACL SNNAP is a pragmatic, multi-centre, superiority, parallel-group randomised controlled trial in participants with a symptomatic non-acute ACL deficient knee. Participants are allocated in a 1:1 ratio to either non-surgical management (rehabilitation) or surgical management (reconstruction) with the aim of assessing the efficacy and cost-effectiveness. The primary outcome of the study is the Knee Injury and Osteoarthritis Outcome Score (KOOS4) at 18 months post-randomisation. The KOOS4 score at 18 months will be evaluated using a linear regression model adjusting for recruitment centre and baseline KOOS4 scores, allowing for intra-centre correlation. A secondary analysis of the primary outcome will be carried out using an area under the curve (AUC) approach using treatment estimates obtained from a mixed model using baseline, 6 months, 12 months, and 18 months post-randomisation outcome data. Secondary outcomes will be measured at 18 months and will include return to activity/level of sport participation, intervention-related complications, the EQ-5D-5L questionnaire, all 5 in idual subscales of the KOOS questionnaire, the ACL-QOL score, expectations of return to activity and cost-effectiveness of the interventions. Missing primary outcome data will be investigated through a sensitivity analysis. Full details of the planned methods for the statistical analysis of clinical outcomes are presented in this paper. The study protocol for the ACL SNNAP trial has been published previously. The methods of analysis for the ACL SNNAP trial have been described here to minimise the risk of data-driven results and reporting bias. Any deviations from the analysis methods described in this paper will be described in full and justified in the publications of the trial results. ISRCTN ISRCTN10110685 . Registered on 16 November 2016
Publisher: National Institute for Health and Care Research
Date: 10-2015
DOI: 10.3310/HTA19800
Abstract: Uncertainty exists regarding the best management of patients with degenerative tears of the rotator cuff. To evaluate the clinical effectiveness and cost-effectiveness of arthroscopic and open rotator cuff repair in patients aged ≥ 50 years with degenerative rotator cuff tendon tears. Two parallel-group randomised controlled trial. Nineteen teaching and district general hospitals in the UK. Patients ( n = 273) aged ≥ 50 years with degenerative rotator cuff tendon tears. Arthroscopic surgery and open rotator cuff repair, with surgeons using their usual and preferred method of arthroscopic or open repair. Follow-up was by telephone questionnaire at 2 and 8 weeks after surgery and by postal questionnaire at 8, 12 and 24 months after randomisation. The Oxford Shoulder Score (OSS) at 24 months was the primary outcome measure. Magnetic resonance imaging evaluation of the shoulder was made at 12 months after surgery to assess the integrity of the repair. The mean OSS improved from 26.3 [standard deviation (SD) 8.2] at baseline to 41.7 (SD 7.9) at 24 months for arthroscopic surgery and from 25.0 (SD 8.0) at baseline to 41.5 (SD 7.9) at 24 months for open surgery. When effect sizes are shown for the intervention, a negative sign indicates that an open procedure is favoured. For the intention-to-treat analysis, there was no statistical difference between the groups, the difference in OSS score at 24 months was –0.76 [95% confidence interval (CI) –2.75 to 1.22 p = 0.452] and the CI excluded the predetermined clinically important difference in the OSS of 3 points. There was also no statistical difference when the groups were compared per protocol (difference in OSS score –0.46, 95% CI –5.30 to 4.39 p = 0.854). The questionnaire response rate was 86%. At 8 months, 77% of participants reported that shoulder problems were much or slightly better, and at 24 months this increased to 85%. There were no significant differences in mean cost between the arthroscopic group and the open repair group for any of the component resource-use categories, nor for the total follow-up costs at 24 months. The overall treatment cost at 2 years was £2567 (SD £176) for arthroscopic surgery and £2699 (SD £149) for open surgery, according to intention-to-treat analysis. For the per-protocol analysis there was a significant difference in total initial procedure-related costs between the arthroscopic group and the open repair group, with arthroscopic repair being more costly by £371 (95% CI £135 to £607). Total quality-adjusted life-years accrued at 24 months averaged 1.34 (SD 0.05) in the arthroscopic repair group and 1.35 (SD 0.05) in the open repair group, a non-significant difference of 0.01 (95% CI –0.11 to 0.10). The rate of re-tear was not significantly different across the randomised groups (46.4% and 38.6% for arthroscopic and open surgery, respectively). The participants with tears that were impossible to repair had the lowest OSSs, the participants with re-tears had slightly higher OSSs and the participants with healed repairs had the most improved OSSs. These findings were the same when analysed per protocol. In patients aged 50 years with a degenerative rotator cuff tear there is no difference in clinical effectiveness or cost-effectiveness between open repair and arthroscopic repair at 2 years for the primary outcome (OSS) and all other prespecified secondary outcomes. Future work should explore new methods to improve tendon healing and reduce the high rate of re-tears observed in this trial. Current Controlled Trials ISRCTN97804283. This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment Vol. 19, No. 80. See the NIHR Journals Library website for further project information.
Publisher: British Editorial Society of Bone & Joint Surgery
Date: 07-2020
DOI: 10.1302/0301-620X.102B7.BJJ-2019-0105.R2
Abstract: To assess how the cost-effectiveness of total hip arthroplasty (THA) and total knee arthroplasty (TKA) varies with age, sex, and preoperative Oxford Hip or Knee Score (OHS/OKS) and to identify the patient groups for whom THA/TKA is cost-effective. We conducted a cost-effectiveness analysis using a Markov model from a United Kingdom NHS perspective, informed by published analyses of patient-level data. We assessed the cost-effectiveness of THA and TKA in adults with hip or knee osteoarthritis compared with having no arthroplasty surgery during the ten-year time horizon. THA and TKA cost £7,000 per quality-adjusted life-year (QALY) gained at all preoperative scores below the absolute referral thresholds calculated previously (40 for OHS and 41 for OKS). Furthermore, THA cost £20,000/QALY for patients with OHS of ≤ 45, while TKA was cost-effective for patients with OKS of ≤ 43, since the small improvements in quality of life outweighed the cost of surgery and any subsequent revisions. Probabilistic and one-way sensitivity analyses demonstrated that there is little uncertainty around the conclusions. If society is willing to pay £20,000 per QALY gained, THA and TKA are cost-effective for nearly all patients who currently undergo surgery, including all patients at and above our calculated absolute referral thresholds. Cite this article: Bone Joint J 2020 -B(7):950–958.
Publisher: British Editorial Society of Bone & Joint Surgery
Date: 02-2013
DOI: 10.1302/2046-3758.22.2000137
Abstract: The number of surgical procedures performed each year to treat femoroacetabular impingement (FAI) continues to rise. Although there is evidence that surgery can improve symptoms in the short-term, there is no evidence that it slows the development of osteoarthritis (OA). We performed a feasibility study to determine whether patient and surgeon opinion was permissive for a Randomised Controlled Trial (RCT) comparing operative with non-operative treatment for FAI. Surgeon opinion was obtained using validated questionnaires at a Specialist Hip Meeting (n = 61, 30 of whom stated that they routinely performed FAI surgery) and patient opinion was obtained from clinical patients with a new diagnosis of FAI (n = 31). Clinical equipoise was demonstrated when surgeons were given clinical scenarios and asked whether they would manage a patient operatively or non-operatively. A total of 23 surgeons (77%) who routinely perform FAI surgery were willing to recruit patients into a RCT, and 28 patients (90%) were willing to participate. 75% of responding surgeons believed it was appropriate to randomise patients to non-operative treatment for ≥ 12 months. Conversely, only eight patients (26%) felt this was acceptable, although 29 (94%) were willing to continue non-operative treatment for six months. More patients were concerned about their risk of developing OA than their current symptoms, although most patients felt that the two were of equal importance. We conclude that a RCT comparing operative and non-operative management of FAI is feasible and should be considered a research priority. An important finding for orthopaedic surgical trials is that patients without life-threatening pathology appear willing to trial a treatment for six months without improvement in their symptoms.
Publisher: Elsevier BV
Date: 06-1997
Publisher: SAGE Publications
Date: 05-1994
DOI: 10.1177/036354659402200320
Abstract: A model of the knee in the sagittal plane was used to investigate the ligament forces resulting when an ex ternal load applied to the tibia resisted either extension or flexion of the knee under increasing isometric quad riceps or hamstrings contractions, respectively. An el ementary mechanical analysis showed which ligament, the anterior or posterior cruciate, was loaded at a given flexion angle and known line of action of the external load. Ligament force, as a proportion of the external load, was also calculated. The results serve as guide lines for the design of injury-specific physical therapy techniques for use after cruciate ligament reconstruc tion.
Publisher: British Editorial Society of Bone & Joint Surgery
Date: 2010
DOI: 10.1302/0301-620X.92B1.22654
Abstract: Using the General Practice Research Database, we examined the temporal changes in the rates of primary total hip (THR) and total knee (TKR) replacement, the age at operation and the female-to-male ratio between 1991 and 2006 in the United Kingdom. We identified 27 113 patients with THR and 23 843 with TKR. The rate of performance of THR and TKR had increased significantly (p 0.0001 for both) during the 16-year period and was greater for TKR, especially in the last five years. The mean age at operation was greater for women than for men and had remained stable throughout the period of study. The female-to-male ratio was higher for THR and TKR and had remained stable. The data support the notion that the rate of joint replacement is increasing in the United Kingdom with the rate of TKR rising at the highest rate. The perception that the mean age for TKR has decreased over time is not supported.
Publisher: Public Library of Science (PLoS)
Date: 14-03-2014
Publisher: BMJ
Date: 02-2019
DOI: 10.1136/BMJOPEN-2018-021614
Abstract: To assess a targeted ‘therapy as required’ model of post-discharge outpatient physiotherapy provision. Specifically, we investigated what proportion of patients accessed post-discharge physiotherapy following total hip arthroplasty (THA) and total knee arthroplasty (TKA), whether accessing therapy was associated with post-arthroplasty patient reported outcomes and whether it was possible to predict which patients would access post-discharge physiotherapy from pre-operative data. Prospective, observational, longitudinal cohort study. Single National Health Service orthopaedic teaching hospital in the UK. 1395 patients undergoing total hip arthroplasty and 1374 patients undergoing total knee arthroplasty. Self-reported access of post-discharge physiotherapy, the Oxford Hip or Knee Score, EuroQol 5-dimension questionnaire and post-operative surgical episode satisfaction metric. 662 (48.2%) patients with TKA and 493 (35.3%) patients with THA accessed additional post-discharge physiotherapy. Patient-reported outcomes (p .001) and surgical episode satisfaction (p=0.001) in both THA and TKA were higher in patients that did not participate in post-discharge physiotherapy. Regression models using pre-operative symptom burden and demographic data predicted post-discharge therapy access with an accuracy of only 17% greater than chance in patients with THA and 7% greater than chance in patients with TKA. In a choice-based service model of ‘therapy as required’ following hip and knee arthroplasty only a third of THA and half of TKA patients accessed post-discharge therapy. Patients who did not access physiotherapy reported greater post-operative outcomes. This variation in the need for post-discharge physiotherapy suggests that targeting of rehabilitation may be a cost-effective model, however it was not possible to reliably predict which patients would access post-discharge physiotherapy from pre-operative data.
Publisher: Elsevier BV
Date: 07-1993
Publisher: Springer Science and Business Media LLC
Date: 10-06-2023
DOI: 10.1186/S13063-023-07417-7
Abstract: The use of invasive placebo controls in surgical trials can be challenging. The ASPIRE guidance, published in the Lancet in 2020, provided advice for the design and conduct of surgical trials with an invasive placebo control. Based on a more recent international expert workshop in June 2022, we now provide further insights into this topic. These include the purpose and design of invasive placebo controls, patient information provision and how findings from these trials may be used to inform decision-making.
Publisher: British Editorial Society of Bone & Joint Surgery
Date: 07-1994
DOI: 10.1302/0301-620X.76B4.8027158
Abstract: We performed a prospective, double-blind, randomised, clinical trial to investigate the efficacy of two regimes of rehabilitation for knees with anterior cruciate ligament deficiency (ACLD). Fifty ACLD patients were randomly allocated to one of two treatment groups: a programme of muscle strengthening (T) or a programme designed to enhance proprioception and improve hamstring contraction reflexes (P). An indirect measure of proprioception, the reflex hamstring contraction latency (RHCL), and a functional scoring system were used to record the status of the knee before and after the 12-week course of physiotherapy. Sagittal knee laxity was also measured. There was improvement in mean RHCL and in the mean functional score in both groups after treatment. The improvement in group P was significantly greater than that in group T. There was no significant change in joint laxity after treatment in either group. In both groups there was a positive correlation between improvement in RHCL and functional gain.
Publisher: BMJ
Date: 21-05-2014
DOI: 10.1136/BMJ.G3253
Publisher: Springer Science and Business Media LLC
Date: 20-08-2021
DOI: 10.1186/S40814-021-00899-9
Abstract: A rotator cuff tear is a common disabling shoulder problem. Symptoms include pain, weakness, lack of mobility and sleep disturbance. Many patients require surgery to repair the tear however, there is a high failure rate. There is a pressing need to improve the outcome of rotator cuff surgery. The use of patch augmentation to provide support to the healing process and improve patient outcomes holds new promise. Different materials (e.g. human/animal skin or intestine tissue, and completely synthetic materials) and processes (e.g. woven or a mesh) have been used to produce patches. However, clinical evidence on their use is limited. The patch augmented rotator cuff surgery (PARCS) feasibility study aimed to determine the design of a definitive randomised controlled trial (RCT) assessing the effectiveness and cost-effectiveness of a patch to augment surgical repair of the rotator cuff that is both acceptable to stakeholders and feasible. A mixed methods feasibility study of conducing a subsequent RCT. The project involved six stages: a systematic review of clinical evidence a survey of the British Elbow and Shoulder Society’s (BESS) surgical membership a survey of surgeon trialists focus groups and interviews with stakeholders a two-round Delphi study administered via online questionnaires and a 2-day consensus meeting. The BESS surgeons’ survey identified a variety of patches in use (105 (21%) responses received). Twenty-four surgeons (77%) completed the trialist survey relating to trial design. Four focus groups were conducted involving 24 stakeholders. Twenty-nine (67% of invited) in iduals took part in the Delphi. Differing views were held on a number of aspects including the appropriate patient population for trial participation. Agreement on the key research questions and the outline of two potential RCTs were achieved through the Delphi study and the consensus meeting. Randomised comparisons of on-lay patch use for completed rotator cuff repairs, and bridging patch use for partial rotator cuff repairs were identified as areas for further research. The value of an observational study to assess safety concerns of patch use was also highlighted. The main limitation was that the findings were influenced by the participants, who might not necessarily reflect all stakeholders.
Publisher: No publisher found
Date: 2014
Publisher: SAGE Publications
Date: 2004
Abstract: Factors potentially causing chronic instability after ankle inversion sprains have rarely been examined during the injuring movement. To compare control of ankle movement during quiet stance and after inversion perturbation in chronically unstable ankles (n = 16) with healthy controls (n = 26). Movement control was measured as magnitude of lateral ankle oscillation, using 3SPACE Fastrak during single leg stance (baseline oscillation) in two foot positions, flat and demi-pointe. In both positions, time to resume baseline oscillation after inversion perturbation (perturbation time) of 15 ° for the flat foot and 7.5 ° on demi-pointe was also determined. Baseline oscillation on demi-pointe was significantly smaller (P 0.005) for the sprained group (2.5 ± 0.5 mm) than for controls (4.0 ± 2.3 mm). Perturbation time for the flat foot was significantly longer (P 0.05) for the sprained group (2.2 ± 0.4 seconds) than for controls (1.8 ± 0.5 seconds). However, failure rate was higher (P 0.05) among the sprained group than controls for perturbation with the foot flat and baseline oscillation on demi-pointe. Findings demonstrated altered sensorimotor control in chronically unstable ankles. Those sprainers who successfully completed the tasks minimized oscillation. The impairments in the sprained group may reflect deficits in either movement detection, peroneal muscle response, or both.
Publisher: Elsevier BV
Date: 10-2008
DOI: 10.1016/J.MEDENGPHY.2007.12.011
Abstract: The presence of an intra-articular pump has been proposed as a central mechanism in the process of osteolysis and aseptic loosening of hip arthroplasty. It is not known if this pump exists and its mechanism remains uncharacterised. This study describes a new in vitro model of a cemented femoral stem in which cement/stem interface fluid pressures can be reliably measured under dynamic loads simulating stair climbing. A stem pump mechanism was found that generates both positive and negative clinically significant pressures (mean pressure ranges 5000-17,000 Pa). The timing of pressure peaks on the anterior and posterior aspects of the stem were in anti-phase, giving rise to oscillatory pressure gradients and potentially generating oscillatory fluid flows during the simulated physiological load cycle. The pump mechanism was shown to occur at the interface of a newly implanted polished double-tapered stem and emphasizes the importance of a complete mantle to protect the femoral bone from the raised fluid pressures.
Publisher: British Editorial Society of Bone & Joint Surgery
Date: 04-2013
DOI: 10.1302/0301-620X.95B4.30558
Abstract: We conducted a randomised controlled trial to determine whether active intense pulsed light (IPL) is an effective treatment for patients with chronic mid-body Achilles tendinopathy. A total of 47 patients were randomly assigned to three weekly therapeutic or placebo IPL treatments. The primary outcome measure was the Victorian Institute of Sport Assessment – Achilles (VISA-A) score. Secondary outcomes were a visual analogue scale for pain (VAS) and the Lower Extremity Functional Scale (LEFS). Outcomes were recorded at baseline, six weeks and 12 weeks following treatment. Ultrasound assessment of the thickness of the tendon and neovascularisation were also recorded before and after treatment. There was no significant difference between the groups for any of the outcome scores or ultrasound measurements by 12 weeks, showing no measurable benefit from treatment with IPL in patients with Achilles tendinopathy. Cite this article: Bone Joint J 2013 -B:504–9.
Publisher: Cold Spring Harbor Laboratory
Date: 29-05-2021
DOI: 10.1101/2021.05.26.21257208
Abstract: Shoulder pain is common in primary care but achieving definitive diagnosis is contentious leading to uncertainty in management. To inform optimal primary care for patients with shoulder pain, the study aims to (i) to investigate the short- and long-term outcomes (overall prognosis) of shoulder pain, (ii) estimate costs of care, (iii) develop a prognostic model for predicting in iduals’ level and risk of pain and disability at 6 months, (iv) investigate experiences and opinions of patients and healthcare professionals regarding diagnosis, prognosis, and management of shoulder pain. PANDA-S is a longitudinal clinical cohort with linked qualitative study. At least 400 people presenting to general practice and physiotherapy services in the UK will be recruited. Participants will complete questionnaires at baseline, 3, 6, 12, 24 and 36 months. Short-term data will be collected weekly between baseline and 12 weeks via SMS text or software application (App). Participants will be offered clinical (physiotherapist) and ultrasound (sonographer) assessments at baseline. Qualitative interviews with ≈15 dyads of patients and their healthcare professional (GP or physiotherapist). Short and long-term trajectories of shoulder pain and disability (using SPADI) will be described, using latent class growth analysis. Health economic analysis will estimate direct costs of care and indirect costs related to work absence and productivity losses. Multivariable regression analysis will be used to develop a prognostic model predicting future levels of pain and disability at 6-months using penalisation methods to adjust for overfitting. The added predictive value of pre-specified physical examination tests and ultrasound findings will be examined. For the qualitative interviews an inductive, exploratory framework will be adopted using thematic analysis to investigate decision making and perspectives of patients and clinicians on the importance of diagnostic and prognostic information when negotiating treatment and referral options. The PANDA-S study has ethical approval from Yorkshire and The Humber – Sheffield Research Ethics Committee, UK (18/YH/0346, IRAS Number: 242750). Results will be disseminated through peer-reviewed publications, social and mainstream media, professional conferences, and the patient and public involvement and engagement group supporting this study, and through newsletters, leaflets and posters in participating sites. The PANDA-S Study is registered at ISRCTN Number: 46948079 ▪ This cohort study will offer a detailed characterisation of patients presenting with a new episode of shoulder pain in primary care, including short and long-term outcomes. ▪ Detailed, weekly data collection will offer unique insights into the impact of shoulder pain on everyday activity, mood, and work during the first 3 months after presentation. ▪ Clinical assessment will investigate the added predictive value of physical examination tests and ultrasound scan findings, over and beyond self-reported prognostic information. ▪ The use of ‘dyad’ interviews allows for a rich understanding of the views and experiences of clinicians and patients towards shoulder pain management. ▪ The COVID-19 pandemic has impacted on recruitment and data collection, but the study allows an investigation of the pandemic and related (lockdown) measures restrictions on the experience and management of shoulder pain.
Publisher: Springer Science and Business Media LLC
Date: 11-2013
Publisher: BMJ
Date: 10-05-2013
Publisher: BMJ
Date: 07-2017
Publisher: Medical Journals Sweden AB
Date: 2002
Publisher: Oxford University Press (OUP)
Date: 17-10-2017
DOI: 10.1002/BJS.10673
Abstract: Nail-bed injuries are the most common hand injury in children. Surgical dogma is to replace the nail plate after repairing the nail bed. Recent evidence suggests this might increase infection rates and returns to clinic. The aim of this feasibility trial was to inform the design and conduct of a definitive trial comparing replacing or discarding the nail plate after nail-bed repair. This study recruited participants from four hand units in the UK between April and July 2015. Participants were children under the age of 16 years with a nail-bed injury requiring surgery. They were randomized to either having the nail plate replaced or discarded after nail-bed repair. The follow-up method was also allocated randomly (postal versus clinic). Information was collected on complications at 2 weeks and 30 days, and on nail-plate appearance at 4 months using the Zook classification. Two possible approaches to follow-up were also piloted and compared. During the recruitment phase, there were 156 potentially eligible children. Sixty were randomized in just over 3 months using remote web-based allocation. By 2 weeks, there were two infections, both in children with replaced nail plates. The nail-replaced group also experienced more complications. There was no evidence of a difference in return rates between postal and clinic follow-up. Recruitment was rapid and nail-bed repair appeared to have low complication and infection rates in this pilot trial. The findings have led to revision of the definitive trial protocol, including the mode and timing of follow-up, and modification of the Zook classification.
Publisher: World Scientific Pub Co Pte Ltd
Date: 23-08-2019
DOI: 10.1142/S2424835519500425
Abstract: Background: Electively-managed conditions account for over 100 000 inpatient surgeries a year in the English National Health Service alone, with further procedures in other regions of the UK, or performed on an outpatient basis. To quality assure this care and to conduct research, effective outcome measurement is critical. Traditional surgeon-centric outcome measures correlate poorly with hand function and are seldom important to patients. There has been an advent in the use of patient reported outcome measures (PROMs) in hand surgery although consensus of PROM choice appears to be lacking. This systematic review aimed to describe the use of relevant PROMs in clinical research of electively-managed hand conditions. Methods: A PRISMA-compliant methodology was used. A bespoke search strategy was developed in conjunction with a search strategist, and applied to Medline, EMBASE, CINAHL and PSYCHINFO from 1992 to June 2017. Pre-specified stepwise inclusion criteria were used to identify studies describing adult patients undergoing treatment for electively-managed hand conditions distal to the distal radius, with clinical outcomes measured using one or more PROMs. Results: Of 4554 results, 834 met inclusion criteria. PROMs identified included 9 disease-specific, 8 site-specific and 4 generic quality of life measures. Across all, the Disabilities of the Arm, Shoulder and Hand (DASH) was the most commonly used (overall frequency 41.0%). The most commonly reported disease-specific measure was the Boston Carpal Tunnel Questionnaire (overall frequency 23.0%). The most commonly reported generic quality of life of measure was the SF-36 (overall frequency 4%). Time-analysis demonstrated predominance of site-specific PROMs since the year 2000. Conclusions: Various PROMs have been used to study electively-managed hand conditions, with site-specific PROMs most popular. However, there appears to be limited consensus on choices. A future systematic evaluation of the published psychometric properties of identified PROMs may inform standardisation of measurement.
Publisher: Springer Science and Business Media LLC
Date: 02-10-2014
DOI: 10.1007/S00167-014-3356-Z
Abstract: Early knee OA is a significant problem that can be disabling. The purpose of this study was to understand the symptomatic profile of patients with early knee OA when compared to those with end-stage knee OA. A cross-sectional case control study design was used to compare those with early structural change to those with advanced structural change. In total, 100 consecutive patients with early radiographic knee OA presenting to the knee service outpatient clinic from December 2010 to August 2011 were prospectively identified on the basis of their radiographic changes. All met the symptomatic and radiological diagnostic criteria of early knee OA as defined by Luyten et al. They were compared with 200 knees with full thickness anteromedial knee OA and 200 knees with full thickness tricompartmental knee OA for their demographic, pain and functional profile. Patients with early knee OA were younger than those with full thickness disease. However, 78% of in idual patients with early radiographic OA had pain and function scores equal to in idual patients presenting for UKA, whilst 74% of in idual patients with early radiographic OA had pain and function scores that are equal to or worse than in idual patients presenting for TKA. Patients with early radiographic knee OA demonstrate considerable overlap in the severity of their symptoms with those demonstrating end-stage structural changes within the knee. Patients with early structural changes of arthritis should not be assumed by clinicians to have mild disease. In many cases, their symptoms are as bad as those with end-stage structural changes. This work will help clinicians to identify and categorise those with early arthritis and thereby assist in guiding appropriate treatments.
Publisher: Elsevier BV
Date: 06-2004
Publisher: Elsevier BV
Date: 2007
DOI: 10.1016/J.JBIOMECH.2007.02.016
Abstract: Newer designs of total knee arthroplasty (TKA), through the use of added degrees of constraint, attempt to provide a "guided motion" to restore more normal and predictable kinematics. Two such design philosophies are the posterior stabilised (PS) using a cam-post and the medial pivot (MP) concepts. Knee kinematics of 12 patients with a PS TKA, 13 subjects with a MP TKA and 10 normal subjects were compared. For kinematic assessment, patients underwent fluoroscopic assessment of the knee during a step-up exercise and deep knee bend. Fluoroscopic images were corrected for distortion and assessed using 3D model fitting to determine relative 3D motion, and a 2D method to measure the patellar tendon angle (PTA) as function of knee flexion. For the PS design the cam-post mechanism engaged between 70 degrees and 100 degrees flexion. Between extension and 50 degrees there was forward motion of the contact points. Beyond 60 degrees both condyles rolled moved posteriorly. The majority of the external rotation of the femur occurred between 50 degrees and 80 degrees . The PTA was lower than normal in extension and higher than normal in flexion. The MP exhibited no anterior movement throughout the rage of motion. The medial condyle moved minimally. The lateral contact point moved posteriorly from extension to flexion. The femur rotated externally throughout the range of flexion analysed. The PTA was similar to normal from extension to mid flexion and then higher than normal beyond to high flexion. The PS design fails to fully restrain paradoxical anterior movement and although the cam engages, it does not contribute significantly to overall rollback. The MP knee does not show significant anterior movement, the medial pivot concept appears to achieve near normal kinematics from extension to 50 degrees of knee flexion. However, the results show that at high flexion this design does not achieve normal knee kinematics.
Publisher: Springer Science and Business Media LLC
Date: 2013
Publisher: Public Library of Science (PLoS)
Date: 18-10-2016
Publisher: BMJ
Date: 07-2015
Publisher: Springer Science and Business Media LLC
Date: 06-2011
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 02-08-2022
DOI: 10.1097/J.PAIN.0000000000002432
Abstract: The number of placebo surgical trials on musculoskeletal conditions is increasing, but little is known about the quality of their design and methods. This review aimed to (1) assess the level of placebo fidelity (ie, degree to which the placebo control mimicked the index procedure) in placebo trials of musculoskeletal surgery, (2) describe the trials' methodological features using the adapted Applying Surgical Placebo in Randomised Evaluations (ASPIRE) checklist, and (3) describe each trial's characteristics. We searched 4 electronic databases from inception until February 18, 2021, for randomised trials of surgery that included a placebo control for any musculoskeletal condition. Protocols and full text were used to assess placebo fidelity (categorised as minimal, low, or high fidelity). The adapted 26-item ASPIRE checklist was also completed on each trial. PROSPERO registration number: CRD42021202131. A total of 30,697 studies were identified in the search, and 22 placebo-controlled surgical trials of 2045 patients included. Thirteen trials (59%) included a high-fidelity placebo control, 7 (32%) used low fidelity, and 2 (9%) minimal fidelity. According to the ASPIRE checklist, included trials had good reporting of the “rationale and ethics” (68% overall) and “design” sections (42%), but few provided enough information on the “conduct” (13%) and “interpretation and translation” (11%) of the placebo trials. Most trials sufficiently reported their rationale and ethics, but interpretation and translation are areas for improvement, including greater stakeholder involvement. Most trials used a high-fidelity placebo procedure suggesting an emphasis on blinding and controlling for nonspecific effects.
Publisher: IOP Publishing
Date: 04-2009
DOI: 10.1088/1748-6041/4/2/025018
Abstract: Despite the satisfactory short-term implant survivorship of metal-on-metal hip resurfacing arthroplasty, periprosthetic soft-tissue masses such as pseudotumours are being increasingly reported. Cytotoxic effects of cobalt or chromium have been suggested to play a role in its aetiology. The aim of this study was to investigate the effects of clinically relevant metal nanoparticles and ions on the viability of macrophages in vitro. A RAW 264.7 murine macrophage cell line was cultured in the presence of either: (1) cobalt, chromium and titanium nanoparticles sized 30-35 nm or (2) cobalt sulphate and chromium chloride. Two methods were used to quantify cell viability: Alamar Blue assay and Live/Dead assay. The cytotoxicity was observed only with cobalt. Cobalt nanoparticles and ions demonstrated dose-dependent cytotoxic effects on macrophages in vitro: the cytotoxic concentrations of nanoparticles and ions were 1 x 10(12) particles ml(-1) and 1000 microM, respectively. The high concentration of cobalt nanoparticles required for cytotoxicity of macrophages in vitro suggests that increased production of cobalt nanoparticles in vivo, due to excessive MoM implant wear, may lead to local adverse biological effects. Therefore, cytotoxicity of high concentrations of metal nanoparticles phagocytosed by macrophages located in the periprosthetic tissues may be an important factor in pathogenesis of pseudotumours.
Publisher: Elsevier BV
Date: 08-2012
DOI: 10.1016/J.KNEE.2011.04.008
Abstract: The current rate of day-case anterior cruciate ligament reconstruction (ACLR) in the UK remains low. Although specialised care pathways with standard operating procedures (SOPs) have been effective in reducing length of stay following some surgical procedures, this has not been previously reported for ACLR. We evaluate the effectiveness of SOPs for establishing day-case ACLR in a specialist unit. Fifty patients undergoing ACLR between May and September 2010 were studied prospectively ("study group"). SOPs were designed for pre-operative assessment, anaesthesia, surgical procedure, mobilisation and discharge. We evaluated length of stay, readmission rates, patient satisfaction and compliance to SOPs. A retrospective analysis of 50 patients who underwent ACLR prior to implementation of the day-case pathway was performed ("standard practice group"). Eighty percent of patients in the study group were discharged on the day of surgery (mean length of stay=5.3h) compared to 16% in the standard practice group (mean length of stay=21.6h). This difference was statistically significant (p<0.05, Mann-Whitney U test). All patients were satisfied with the day case pathway. Ninety-two percent of the study group were discharged on the day of surgery when all SOPs were followed and 46% where they were not. High rates of day-case ACLR with excellent patient satisfaction can be achieved with the use of a specialised patient pathway with SOPs.
Publisher: BMJ
Date: 2013
Publisher: Springer Science and Business Media LLC
Date: 30-10-2015
DOI: 10.1007/S00167-015-3788-0
Abstract: In this study, we examined whether the OKS demonstrated a floor or a ceiling effect when used to measure the outcome of knee replacement surgery in a large national cohort. NHS PROMs database, containing pre- to 6 month post-operative OKS on 72,154 patients, mean age 69 (SD 9.4), undergoing knee replacement surgery, was examined to establish the proportion of patients achieving top or bottom OKS values pre- and post-operatively. Pre-operatively, none of patients achieved the maximum/'best' (48) and minimum (0) scores. Post-operatively, no patients (0 %) achieved the minimum/'worst' score, but the percentage achieving the maximum score increased to 2.7 %. Subgroup analyses demonstrated that the highest post-operative overall ceiling percentage was 3 %, in a subgroup of patients between 60 and 79 years of age and 13.7 % in a group of patients who had a pre-operative OKS above 41. Furthermore, 10.8 % of patients achieved the top post-operative OKS-PCS and 4.7 % top post-operative OKS-FCS. Based on NHS PROMs data, the OKS does not exhibit a ceiling or floor effect overall, or for both its pain and function subscales, and remains a valid measure of outcomes for patients undergoing TKA. Large-scale retrospective observations study, Level II.
Publisher: Elsevier BV
Date: 06-2009
DOI: 10.1016/J.ARTH.2008.04.008
Abstract: Femoral neck fracture is an important early complication after hip resurfacing. Our aims were firstly to determine the incidence of fracture in an independent series and secondly, in a case control study, to investigate potential risk factors. Fifteen femoral neck fractures occurred in a series of 842 procedures, representing an incidence of 1.8%. No relationship existed between age, sex, and fracture incidence. Mechanical factors such as notching, femoral neck lengthening, and varus alignment of the femoral component were found to have a similar incidence in both fracture and control groups. The proportion of patients that had at least 1 mechanical risk factor was not different between the 2 groups (fracture group, 50% control group, 41%). Established avascular necrosis of the femoral head was evident in all retrieved femoral heads (n = 9) of patients who sustained postoperative fracture in none of these patients was avascular necrosis the initial diagnosis. This study suggests that in our practice, mechanical factors, such as neck notching, neck lengthening, or varus angulations, are not the primary cause of femoral neck fractures.
Publisher: Springer Science and Business Media LLC
Date: 12-2015
Publisher: Elsevier BV
Date: 03-2020
Publisher: BMJ
Date: 09-2021
DOI: 10.1136/BMJOPEN-2021-052758
Abstract: People presenting with shoulder pain considered to be of musculoskeletal origin is common in primary care but diagnosing the cause of the pain is contentious, leading to uncertainty in management. To inform optimal primary care for patients with shoulder pain, the study aims to (1) to investigate the short-term and long-term outcomes (overall prognosis) of shoulder pain, (2) estimate costs of care, (3) develop a prognostic model for predicting in iduals’ level and risk of pain and disability at 6 months and (4) investigate experiences and opinions of patients and healthcare professionals regarding diagnosis, prognosis and management of shoulder pain. The Prognostic And Diagnostic Assessment of the Shoulder (PANDA-S) study is a longitudinal clinical cohort with linked qualitative study. At least 400 people presenting to general practice and physiotherapy services in the UK will be recruited. Participants will complete questionnaires at baseline, 3, 6, 12, 24 and 36 months. Short-term data will be collected weekly between baseline and 12 weeks via Short Message Serevice (SMS) text or software application. Participants will be offered clinical (physiotherapist) and ultrasound (sonographer) assessments at baseline. Qualitative interviews with ≈15 dyads of patients and their healthcare professional (general practitioner or physiotherapist). Short-term and long-term trajectories of Shoulder Pain and Disability Index (using SPADI) will be described, using latent class growth analysis. Health economic analysis will estimate direct costs of care and indirect costs related to work absence and productivity losses. Multivariable regression analysis will be used to develop a prognostic model predicting future levels of pain and disability at 6 months using penalisation methods to adjust for overfitting. The added predictive value of prespecified physical examination tests and ultrasound findings will be examined. For the qualitative interviews an inductive, exploratory framework will be adopted using thematic analysis to investigate decision making, perspectives of patients and clinicians on the importance of diagnostic and prognostic information when negotiating treatment and referral options. The PANDA-S study has ethical approval from Yorkshire and The Humber-Sheffield Research Ethics Committee, UK (18/YH/0346, IRAS Number: 242750). Results will be disseminated through peer-reviewed publications, social and mainstream media, professional conferences, and the patient and public involvement and engagement group supporting this study, and through newsletters, leaflets and posters in participating sites. ISRCTN46948079 .
Publisher: Springer Science and Business Media LLC
Date: 09-05-2015
Publisher: Wiley
Date: 03-04-2016
Publisher: Elsevier BV
Date: 12-2007
DOI: 10.1016/J.KNEE.2007.08.004
Abstract: As part of the step-wise validation of a new prosthesis (TMK), we previously published the 1 year results of a randomised controlled trial in patients undergoing bilateral knee replacement [Price A., Rees J., Beard D., Juszczak E. et al. A mobile-bearing total knee prosthesis compared with a fixed-bearing prosthesis. JBJS B 2003 -B-1:62-7.]. Forty patients had the new mobile-bearing prosthesis implanted in one knee and an established fixed-bearing device in the other (AGC). We now report the 3 year status of these patients and, in addition, review a separate multi-centre cohort of 172 patients who had undergone unilateral arthroplasty with the TMK. No significant differences were found in outcome (American Knee Society Score and Oxford Knee Score) between the two prostheses. The greater incidence of "clicking" in the mobile-bearing knee, reported in the previous review, persisted (TMK=48%, AGC=30%). The presence of this mechanical noise was found to have no relationship with outcome in either of the prostheses. The unilateral cohort study showed an acceptable complication rate for the new prosthesis, although some patients reported subjective instability. The method of controlled introduction of the TMK, of which this constitutes a further step, has allowed us to assess the significance of a reported problem (clicking) and to provide scientific data from which other surgeons can decide about use of the implant.
Publisher: National Institute for Health and Care Research
Date: 02-2021
DOI: 10.3310/HTA25130
Abstract: A rotator cuff tear is a common, disabling shoulder problem. Symptoms may include pain, weakness, lack of shoulder mobility and sleep disturbance. Many patients require surgery to repair the tear however, there is a high failure rate. There is a need to improve the outcome of rotator cuff surgery, and the use of patch augmentation (on-lay or bridging) to provide support to the healing process and improve patient outcomes holds promise. Patches have been made using different materials (e.g. human/animal skin or tissue and synthetic materials) and processes (e.g. woven or mesh). The aim of the Patch Augmented Rotator Cuff Surgery (PARCS) feasibility study was to determine the design of a definitive randomised controlled trial assessing the clinical effectiveness and cost-effectiveness of a patch to augment surgical repair of the rotator cuff that is both acceptable to stakeholders and feasible. A mixed-methods feasibility study of a randomised controlled trial. MEDLINE, EMBASE and the Cochrane Library databases were searched between April 2006 and August 2018. The project involved six stages: a systematic review of clinical evidence, a survey of the British Elbow and Shoulder Society’s surgical membership, a survey of surgeon triallists, focus groups and interviews with stakeholders, a two-round Delphi study administered via online questionnaires and a 2-day consensus meeting. The various stakeholders (including patients, surgeons and industry representatives) were involved in stages 2–6. The systematic review comprised 52 studies only 15 were comparative and, of these, 11 were observational (search conducted in August 2018). These studies were typically small (median number of participants 26, range 5–152 participants). There was some evidence to support the use of patches, although most comparative studies were at a serious risk of bias. Little to no published clinical evidence was available for a number of patches in clinical use. The membership survey of British Elbow and Shoulder surgeons [105 (21%) responses received] identified a variety of patches in use. Twenty-four surgeons (77%) completed the triallist survey relating to trial design. Four focus groups were conducted, involving 24 stakeholders. Differing views were held on a number of aspects of trial design, including the appropriate patient population (e.g. patient age) to participate. Agreement on the key research questions and the outline of two potential randomised controlled trials were achieved through the Delphi study [29 (67%)] and the consensus meeting that 22 participants attended. The main limitation was that the findings were influenced by the participants, who are not necessarily representative of the views of the relevant stakeholder groups. The need for further clinical studies was clear, particularly given the range and number of different patches available. Randomised comparisons of on-lay patch use for completed rotator cuff repairs and bridging patch use for partial rotator cuff repairs were identified as areas for further research. The value of an observational study to assess safety concerns of patch use was also highlighted. These elements are included in the trial designs proposed in this study. The systematic review is registered as PROSPERO CRD42017057908. This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment Vol. 25, No. 13. See the NIHR Journals Library website for further project information.
Publisher: Elsevier BV
Date: 07-2018
Publisher: Springer Science and Business Media LLC
Date: 14-04-2022
Publisher: AME Publishing Company
Date: 06-2020
DOI: 10.21037/ATM-2020-59
Publisher: Elsevier BV
Date: 08-2010
Publisher: Elsevier BV
Date: 04-2014
Publisher: BMJ
Date: 02-04-2014
DOI: 10.1136/BMJ.G2382
Publisher: Oxford University Press (OUP)
Date: 18-04-2023
DOI: 10.1093/BJS/ZNAD086
Abstract: Every year in the UK, around 10 000 children need to have operations to mend injuries to the bed of their fingernails. Currently, most children have their fingernail placed back on the injured nail bed after the operation. The NINJA trial found that children were slightly less likely to have an infection if the nail was thrown away rather than being put back, but the difference between groups was small and could have be due to chance. This study looked at whether replacing the nail is cost-effective compared with throwing it away. Using data from the NINJA trial, we compared costs, healthcare use, and quality of life and assessed the cost-effectiveness of replacing the nail. It was found that throwing the nail away after surgery would save the National Health Service (NHS) £75 (€85) per operation compared with placing the nail back on the nail bed. Changing clinical practice could save the NHS in England £720 000 (€819 000) per year.
Publisher: British Editorial Society of Bone & Joint Surgery
Date: 2013
DOI: 10.1302/0301-620X.95B1.28061
Abstract: We present a comparison of patient-reported outcomes (PROMs) in relation to patient age, in patients who had received a total (TKR) or unicompartmental knee replacement (UKR). The outcome was evaluated using the Oxford knee score (OKS), EuroQol (EQ-5D) and satisfaction scores. Patients aged 65 to 84 years demonstrated better pre-operative function scores than those aged 65 years (OKS, p = 0.03 EQ-5D, p = 0.048) and those aged ≥ 85 years (OKS, p = 0.03). Post-operative scores were comparable across age groups, but a linear trend for greater post-operative improvement in OKS and EQ-5D was seen with decreasing age (p 0.033). The overall mean satisfaction score at six months was 84.9, but those aged 55 years exhibited a lower mean level of satisfaction (78.3) compared with all other age groups (all p 0.031). The cumulative overall two-year revision rate was 1.3%. This study demonstrates that good early outcomes, as measured by the OKS and EQ-5D, can be anticipated following knee replacement regardless of the patient’s age, although younger patients gain greater improvement. However, the lower satisfaction in those aged 55 years is a concern, and suggests that outcome is not fully encapsulated by the OKS and EQ-5D evaluation, and raises the question whether the OKS alone is an appropriate measure of pain and function in younger, more active in iduals. Cite this article: Bone Joint J 2013 -B:38–44.
Publisher: Oxford University Press (OUP)
Date: 18-03-2020
DOI: 10.1002/BJS.11509
Abstract: Placebo-controlled trials play an important role in the evaluation of healthcare interventions. However, they can be challenging to design and deliver for invasive interventions, including surgery. In-depth understanding of the component parts of the treatment intervention is needed to ascertain what should, and should not, be delivered as part of the placebo. Assessment of risk to patients and strategies to ensure that the placebo effectively mimics the treatment are also required. To date, no guidance exists for the design of invasive placebo interventions. This study aimed to develop a framework to optimize the design and delivery of invasive placebo interventions in RCTs. A preliminary framework was developed using published literature to: expand the scope of an existing typology, which facilitates the deconstruction of invasive interventions and identify placebo optimization strategies. The framework was refined after consultation with key stakeholders in surgical trials, consensus methodology and medical ethics. The resulting DITTO framework consists of five stages: deconstruct treatment intervention into constituent components and co-interventions identify critical surgical element(s) take out the critical element(s) think risk, feasibility and role of placebo in the trial when considering remaining components and optimize placebo to ensure effective blinding of patients and trial personnel. DITTO considers invasive placebo composition systematically, accounting for risk, feasibility and placebo optimization. Use of the framework can support the design of high-quality RCTs, which are needed to underpin delivery of healthcare interventions.
Publisher: Elsevier BV
Date: 05-2019
DOI: 10.1016/J.GAITPOST.2019.03.008
Abstract: Rehabilitation has an established role in the management of a wide range of musculoskeletal conditions. Much of this treatment relies on self-directed exercises at home, where adherence of execution is unknown. Demonstrating treatment fidelity is necessary to draw conclusions about the efficacy of rehabilitation interventions in both clinical and research settings. There is a lack of tools and methods to achieve this. This study aims to evaluate the feasibility of using a single inertial sensor to recognise and classify shoulder rehabilitation activity using supervised machine learning techniques. Twenty patients with shoulder pain were monitored performing five rehabilitation exercises routinely prescribed for their condition. Accelerometer, gyroscope and magnetometer data were collected via a device mounted onto an arm sleeve. Non-specific motion data was included in the analysis. Time and frequency domain features were calculated from labelled data segments and ranked in terms of their predictive importance using the ReliefF algorithm. Selected features were used to train four supervised learning algorithms: decision tree, k-nearest neighbour, support vector machine and random forests. Performance of algorithms in accurately classifying exercise activity was evaluated with ten-fold cross-validation and leave-one-subject-out-validation methods. Optimal predictive accuracies for ten-fold cross-validation (97.2%) and leave-one-subject-out-validation (80.5%) were achieved by support vector machine and random forests algorithms, respectively. Time domain features derived from accelerometer, magnetometer and orientation data streams were shown to have the highest predictive value for classifying rehabilitation activity. Classification models performed well in differentiating patient exercise activity from non-specific movement and identifying specific exercise type using inertial sensor data. A clinically useful account of home rehabilitation activity will help guide treatment strategies and facilitate methods to improve patient engagement. Future work should focus on evaluating the performance of such systems in natural and unsupervised settings.
Publisher: BMJ
Date: 10-05-2013
Publisher: Elsevier BV
Date: 08-2004
DOI: 10.1016/J.ARTH.2003.12.082
Abstract: This study compares in vivo sagittal plane kinematics of the Oxford mobile-bearing unicompartmental knee arthroplasty (UKA) at 1 and 10 years' postsurgery (10 knees) with a fixed-bearing total knee arthroplasty (TKA) (5 knees) and the normal knee (5 knees), using dynamic fluoroscopic measurement of the patellar tendon angle. The Oxford UKA preserved normal changes in patellar tendon angle with flexion, and this was maintained at 10 years. In contrast, an abnormal pattern was seen with the TKA. The results suggest that a normal pattern of sagittal plane knee kinematics exists following Oxford medial UKA and imply that anterior cruciate ligament function is maintained in the long term.
Publisher: Elsevier BV
Date: 12-2012
DOI: 10.1016/J.KNEE.2012.02.001
Abstract: Arthroplasty is an effective intervention for symptomatic knee osteoarthritis refractory to conservative therapy. However, recent data highlights regional variations in service provision unrelated to disease severity and a low, but not insignificant, rate of patient dissatisfaction. The variation in knee arthroplasty provision is in part also due to the clinical decision-making of orthopaedic surgeons. The management of osteoarthritis is an ex le of a preference-sensitive clinical pathway, and possible explanations for poor patient satisfaction include unrealistic expectations and poor perception of potential benefits and risks. In addition to the in idual impact, this represents an inefficient use of resources by healthcare providers during a challenging economic period. Improved shared-decision making between patients and clinicians would potentially address these issues. Patient decision aids provide relevant personalized evidence-based information to facilitate the shared decision-making process. Orthopaedic surgeons are receptive to the use of patient decision aids to support shared decision-making, but there are a number of issues to overcome before they are routinely adopted. The number of decision aids and the literature supporting their effectiveness is growing rapidly. NHS Direct has launched online patient decision support for knee osteoarthritis. The use of patient decision aids in clinical practice is gathering pace and may soon become the ethical and legal standard. This article provides a narrative review of patient decision aids in the context of knee replacement surgery from a UK perspective.
Publisher: Springer Science and Business Media LLC
Date: 11-06-2013
Abstract: Platelet-rich plasma (PRP) is an autologous platelet concentrate. It is prepared by separating the platelet fraction of whole blood from patients and mixing it with an agent to activate the platelets. In a clinical setting, PRP may be reapplied to the patient to improve and hasten the healing of tissue. The therapeutic effect is based on the presence of growth factors stored in the platelets. Current evidence in orthopedics shows that PRP applications can be used to accelerate bone and soft tissue regeneration following tendon injuries and arthroplasty. Outcomes include decreased inflammation, reduced blood loss and post-treatment pain relief. Recent shoulder research indicates there is poor vascularization present in the area around tendinopathies and this possibly prevents full healing capacity post surgery ( Am J Sports Med 36 (6):1171–1178, 2008). Although it is becoming popular in other areas of orthopedics there is little evidence regarding the use of PRP for shoulder pathologies. The application of PRP may help to revascularize the area and consequently promote tendon healing. Such evidence highlights an opportunity to explore the efficacy of PRP use during arthroscopic shoulder surgery for rotator cuff pathologies. PARot is a single center, blinded superiority-type randomized controlled trial assessing the clinical outcomes of PRP applications in patients who undergo shoulder surgery for rotator cuff disease. Patients will be randomized to one of the following treatment groups: arthroscopic subacromial decompression surgery or arthroscopic subacromial decompression surgery with application of PRP. The study will run for 3 years and aims to randomize 40 patients. Recruitment will be for 24 months with final follow-up at 1 year post surgery. The third year will also involve collation and analysis of the data. This study will be funded through the NIHR Biomedical Research Unit at the Oxford University Hospitals NHS Trust. Current Controlled Trials: ISRCTN10464365
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 1998
Publisher: Wiley
Date: 13-04-2012
DOI: 10.1002/LSM.22029
Abstract: Light therapy is a common mode of treatment for musculoskeletal injuries but the depth of penetration of light radiation is controversial. Evidence exists for the efficacy of intense pulsed light (IPL) treatment for the rejuvenation of skin (superficial tissue) but it is not known if the IPL can penetrate deeper. If the IPL can penetrate to the depth of the Achilles tendon it may provide a potential management options in the treatment of a chronic mid-body Achilles tendinopathy. To examine if any optical radiation produced by an IPL transmits to the depth of the Achilles tendon when applied cutaneously to excised s les of human Achilles tissue. A secondary aim was to establish the relative amount of optical radiation that was attenuated within the tendon. Three s les of human Achilles tendon and surrounding tissue were harvested following elective lower limb utation operations. Each s le was irradiated 2-6 cm above the insertion into the calcaneus (area of an Achilles tendinopathy) with IPL (model iPulse Cyden Ltd, Wales, UK) set at a single pulse of 25 millisecond, wavelength range 530-1,110 nm and fluence of 13 J/cm(2). The transmission of light radiation was evaluated using (a) standard SLR digital camera, (b) spectrometer, and (c) an external energy meter. Light radiation was found to have transmitted through each of the three tissue s les by all three instruments. There were observable differences in the color of light detected for the control photo and the IPL irradiated tissue s les photographs. The percentage of fluence that was detected to have transmitted through the tissue s les by the energy meter was 4-8.1% and wavelengths between 645 and 843 nm were detected to have transmitted through the tissue by the spectrometer. In addition, the percentage of light radiation that attenuated with the tendon was 10.2-17.32%. The results of this study provides evidence that IPL penetrates to the depth of the Achilles tendon and attenuates with the tendon. IPL has potential to produce physiological effects in the treatment of patients with a chronic mid-body Achilles tendinopathy.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 22-08-2023
Abstract: The purpose of this study was to investigate patient-relevant outcomes following first revision total knee arthroplasties (rTKAs) performed for different indications. This population-based cohort study utilized data from the United Kingdom National Joint Registry, Hospital Episode Statistics Admitted Patient Care, National Health Service Patient-Reported Outcome Measures, and the Civil Registrations of Death. Patients undergoing a first rTKA between January 1, 2009, and June 30, 2019, were included in our data set. Patient-relevant outcomes included implant survivorship (up to 11 years postoperatively), mortality and serious medical complications (up to 90 days postoperatively), and patient-reported outcome measures (at 6 months postoperatively). A total of 24,540 first rTKAs were analyzed. The patient population was 54% female and 62% White, with a mean age at the first rTKA of 69 years. At 2 years postoperatively, the cumulative incidence of re-revision surgery ranged from 2.7% (95% confidence interval [CI], 1.9% to 3.4%) following rTKA for progressive arthritis to 16.3% (95% CI, 15.2% to 17.4%) following rTKA for infection. The mortality rate at 90 days was highest following rTKA for fracture (3.6% [95% CI, 2.5% to 5.1%]) and for infection (1.8% [95% CI, 1.5% to 2.2%]) but was .5% for other indications. The rate of serious medical complications requiring hospital admission within 90 days was highest for patients treated for fracture (21.8% [95% CI, 17.9% to 26.3%]) or infection (12.5% [95% CI, 11.2% to 13.9%]) and was lowest for those treated for progressive arthritis (4.3% [95% CI, 3.3% to 5.5%]). Patients who underwent rTKA for stiffness or unexplained pain had some of the poorest postoperative joint function (mean Oxford Knee Score, 24 and 25 points, respectively) and had the lowest proportion of responders (48% and 55%, respectively). This study found large differences in patient-relevant outcomes among different indications for first rTKA. The rate of complications was highest following rTKA for fracture or infection. Although rTKA resulted in large improvements in joint function for most patients, those who underwent surgery for stiffness and unexplained pain had worse outcomes. Therapeutic Level III . See Instructions for Authors for a complete description of levels of evidence.
Publisher: British Editorial Society of Bone & Joint Surgery
Date: 2019
DOI: 10.1302/0301-620X.101B1.BJJ-2018-0555.R1
Abstract: The aims of this study were to compare the use of resources, costs, and quality of life outcomes associated with subacromial decompression, arthroscopy only (placebo surgery), and no treatment for subacromial pain in the United Kingdom National Health Service (NHS), and to estimate their cost-effectiveness. The use of resources, costs, and quality-adjusted life-years (QALYs) were assessed in the trial at six months and one year. Results were extrapolated to two years after randomization. Differences between treatment arms, based on the intention-to-treat principle, were adjusted for covariates and missing data were handled using multiple imputation. Incremental cost-effectiveness ratios were calculated, with uncertainty around the values estimated using bootstrapping. Cumulative mean QALYs/mean costs of health care service use and surgery per patient from baseline to 12 months were estimated as 0.640 (standard error (se) 0.024)/£3147 (se 166) in the decompression arm, 0.656 (se 0.020)/£2830 (se 183) in the arthroscopy only arm and 0.522 (se 0.029)/£1451 (se 151) in the no treatment arm. Statistically significant differences in cumulative QALYs and costs were found at six and 12 months for the decompression versus no treatment comparison only. The probabilities of decompression being cost-effective compared with no treatment at a willingness-to-pay threshold of £20 000 per QALY were close to 0% at six months and approximately 50% at one year, with this probability potentially increasing for the extrapolation to two years. The evidence for cost-effectiveness at 12 months was inconclusive. Decompression could be cost-effective in the longer-term, but results of this analysis are sensitive to the assumptions made about how costs and QALYs are extrapolated beyond the follow-up of the trial.
Publisher: British Editorial Society of Bone & Joint Surgery
Date: 10-2011
DOI: 10.1302/0301-620X.93B10.27205
Abstract: Patella subluxation assessed on dynamic MRI has previously been shown to be associated with anterior knee pain. In this MRI study of 60 patients we investigated the relationship between subluxation and multiple bony, cartilaginous and soft-tissue factors that might predispose to subluxation using discriminant function analysis. Patella engagement (% of patella cartilage overlapping with trochlea cartilage) had the strongest relationship with subluxation. Patellae with 30% engagement tended not to sublux those with 30% tended to sublux. Other factors that were associated with subluxation included the tibial tubercle-trochlea notch distance, vastus medialis obliquus distance from patella, patella alta, and the bony and cartilaginous sulcus angles in the superior part of the trochlea. No relationship was found between subluxation and sulcus angles for cartilage and bone in the middle and lower part of the trochlea, cartilage thicknesses and Wiberg classification of the patella. This study indicates that patella engagement is a key factor associated with patellar subluxation. This suggests that in patients with anterior knee pain with subluxation, resistant to conservative management, surgery directed towards improving patella engagement should be considered. A clinical trial is necessary to test this hypothesis.
Publisher: Springer Science and Business Media LLC
Date: 21-04-2017
Publisher: Elsevier BV
Date: 03-2022
DOI: 10.1016/J.JCLINEPI.2021.12.016
Abstract: To create estimates for clinically meaningful changes and differences in pain and joint function for the Oxford Hip and Knee Scores (OHS/OKS) in primary and revision joint replacement. 694,487 primary and revision joint replacement procedures were analyzed from the NHS PROMs dataset between 2012-2020. Minimal important changes (MIC) and differences (MID) were calculated using distribution and anchor-based methods (including receiver-operating characteristic (ROC) curve and predictive-modelling techniques). For comparison of two or more groups (such as in a clinic trial), MID estimates were ∼5 points. For cohort studies investigating changes over time in a single group of patients, MIC This study has calculated contemporary estimates of clinically important changes and differences for the OHS/OKS for primary and revision hip and knee replacement. These estimates can be used to inform s le size calculations and to interpret changes in joint function over time and differences between groups.
Publisher: British Editorial Society of Bone & Joint Surgery
Date: 11-2005
DOI: 10.1302/0301-620X.87B11.16780
Abstract: We inserted an electrode up the femoral neck into the femoral head of ten patients undergoing a metal-on-metal hip resurfacing arthroplasty through a posterior surgical approach and measured the oxygen concentration during the operation. In every patient the blood flow was compromised during surgery, but the extent varied. In three patients, the oxygen concentration was zero at the end of the procedure. The surgical approach caused a mean 60% drop (p 0.005) in oxygen concentration while component insertion led to a further 20% drop (p 0.04). The oxygen concentration did not improve significantly on wound closure. This study demonstrates that during hip resurfacing arthroplasty, patients experience some compromise to their femoral head blood supply and some have complete disruption.
Publisher: Springer Science and Business Media LLC
Date: 06-07-2020
DOI: 10.1186/S40814-020-00635-9
Abstract: Patellar instability is a relatively common condition that leads to disability and restriction of activities. People with recurrent instability may be given the option of physiotherapy or surgery though this is largely driven by clinician preference rather than by a strong evidence base. We sought to determine the feasibility of conducting a definitive trial comparing physiotherapy with surgical treatment for people with recurrent patellar instability. This was a pragmatic, open-label, two-arm feasibility randomised control trial (RCT) with an embedded interview component recruiting across three NHS sites comparing surgical treatment to a package of best conservative care ‘Personalised Knee Therapy’ (PKT). The primary feasibility outcome was the recruitment rate per centre (expected rate 1 to 1.5 participants recruited each month). Secondary outcomes included the rate of follow-up (over 80% expected at 12 months) and a series of participant-reported outcomes taken at 3, 6 and 12 months following randomisation, including the Norwich Patellar Instability Score (NPIS), the Kujala Patellofemoral Disorder Score (KPDS), EuroQol-5D-5L, self-reported global assessment of change, satisfaction at each time point and resources use. We recruited 19 participants. Of these, 18 participants (95%) were followed-up at 12 months and 1 (5%) withdrew. One centre recruited at just over one case per month, one centre was unable to recruit, and one centre recruited at over one case per month after a change in participant screening approach. Ten participants were allocated into the PKT arm, with nine to the surgical arm. Mean Norwich Patellar Instability Score improved from 40.6 (standard deviation 22.1) to 28.2 (SD 25.4) from baseline to 12 months. This feasibility trial identified a number of challenges and required a series of changes to ensure adequate recruitment and follow-up. These changes helped achieve a sufficient recruitment and follow-up rate. The revised trial design is feasible to be conducted as a definitive trial to answer this important clinical question for people with chronic patellar instability. The trial was prospectively registered on the International Standard Randomised Controlled Trial Number registry on the 22/12/2016 (reference number: ISRCTN14950321). www.isrctn.com/ISRCTN14950321
Publisher: Elsevier BV
Date: 08-2015
DOI: 10.1016/J.ARTH.2015.02.039
Abstract: This study identifies optimal OKS values that discriminate post-operative (TKA) patient satisfaction and determines the variation in threshold values by patient characteristics and expectations. It is the first to identify patient improvement using measures (PoPC) that account for patient's pre-operative symptom severity. Of 365 primary TKA patients from a London district general hospital 84% were satisfied at 12 and 24 months. Whilst the overall OKS thresholds (follow-up, change, PoPC) were stable at 12 months (31, 11, 39.7%) and 24 months (35, 12, 38.9%), patients who were older (≥75years), were underweight/normal (BMI<25), had pre-operative symptom severity (OKS≤15) and expected no pain post-surgery, required a greater (potential) improvement to be classed as satisfied. When reporting good patient outcomes, cohorts should be stratified accordingly.
Publisher: Elsevier BV
Date: 06-2013
DOI: 10.1016/J.FAS.2012.12.006
Abstract: Differential diagnosis of Achilles pathology is demanding. This study evaluates the diagnostic accuracy of clinical tests identified for a chronic mid body Achilles tendinopathy. Ultrasound scanning provides the reference standard. Twenty-one participants with, and without, an Achilles tendinopathy, had an ultrasound scan followed immediately by the application of ten clinical tests. The accuracy and reproducibility of each test was determined. The most valid tests are pain on palpation of the tendon (sensitivity 84%, specificity 73%, kappa 0.74-0.96) and the subjective reporting of pain 2-6 cm above the insertion into the calcaneum (sensitivity 78%, specificity 77%, kappa 0.75-0.81). Only location of pain and pain on palpation were found to be sufficiently reliable and accurate, to be recommended for use.
Publisher: Elsevier BV
Date: 04-2008
DOI: 10.1016/J.ARTH.2007.02.015
Abstract: Hybrid hip resurfacing arthroplasty with uncemented acetabular and cemented femoral fixation is increasingly becoming popular as an alternative to total hip arthroplasty. There is concern about femoral neck fractures, and long-term survival has not yet been demonstrated. Thermal necrosis may be an important factor for neck fracture and will affect the viability of the femoral bone. This cadaveric study investigated the thermal effect of thick (1.5 mm, n = 3) and thin (0.5 mm, n = 3) cement mantles 5 thermocouples were used to record temperature at the femoral bone/cement interface during hip resurfacing arthroplasty. The highest recorded temperatures were significantly higher when a thick cement mantle is used (45.4 degrees C), compared to a thin cement mantle (32.7 degrees C). To reduce the potential for thermal necrosis, the thin cement mantle technique is recommended.
Publisher: BMJ
Date: 19-12-2013
DOI: 10.1136/BMJ.F6956
Publisher: Elsevier BV
Date: 11-2016
Publisher: SAGE Publications
Date: 2004
Publisher: Mark Allen Group
Date: 06-2006
DOI: 10.12968/IJTR.2006.13.6.21383
Abstract: The aim of this study was to identify and describe patients' satisfaction after accelerated and usual discharge from hospital following elective orthopaedic surgery. It identified patients' perceived discharge preferences and describes factors that they believed to be important. The research was conducted with 41 patients who had participated in a randomized controlled trial comparing accelerated discharge after Oxford unicompartmental knee replacement with standard care. A qualitative study design using a combination of a validated questionnaire and supplementary open questions was used. The data from this open question underwent content analysis. Both accelerated and usual care patients appeared to be highly satisfied following their knee replacement. This study indicates that patients seem satisfied with early discharge and that the majority who had experienced accelerated discharge would prefer accelerated discharge again in the future, if they required similar surgery. The benefits of being at home, altruism, experience and knowledge were reasons provided for this view.
Publisher: BMJ
Date: 22-02-2019
DOI: 10.1136/BJSPORTS-2018-100223
Abstract: To assess the benefit of arthroscopic partial meniscectomy (APM) in adults with a meniscal tear and knee pain in three defined populations (taking account of the comparison intervention): (A) all patients (any type of meniscal tear with or without radiographic osteoarthritis) (B) patients with any type of meniscal tear in a non-osteoarthritic knee and (C) patients with an unstable meniscal tear in a non-osteoarthritic knee. Systematic review and meta-analysis. A search of MEDLINE, Embase, CENTRAL, Scopus, Web of Science, Clinicaltrials.gov and ISRCTN was performed, unlimited by language or publication date (inception to 18 October 2018). Randomised controlled trials performed in adults with meniscal tears, comparing APM versus (1) non-surgical intervention (2) pharmacological intervention (3) surgical intervention and (4) no intervention. Ten trials were identified: seven compared with non-surgery, one pharmacological and two surgical. Findings were limited by small s le size, small number of trials and cross-over of participants to APM from comparator interventions. In group A (all patients) receiving APM versus non-surgical intervention (physiotherapy), at 6–12 months, there was a small mean improvement in knee pain (standardised mean difference [SMD] 0.22 [95% CI 0.03 to 0.40] five trials, 943 patients I 2 48% Grading of Recommendations Assessment, Development and Evaluation [GRADE]: low), knee-specific quality of life (SMD 0.43 [95% CI 0.10 to 0.75] three trials, 350 patients I 2 56% GRADE: low) and knee function (SMD 0.18 [95% CI 0.04 to 0.33] six trials, 1050 patients I 2 27% GRADE: low). When the analysis was restricted to people without osteoarthritis (group B), there was a small to moderate improvement in knee pain (SMD 0.35 [95% CI 0.04 to 0.66] three trials, 402 patients I 2 58% GRADE: very low), knee-specific quality of life (SMD 0.59 [95% CI 0.11 to 1.07] two trials, 244 patients I 2 71% GRADE: low) and knee function (SMD 0.30 [95% CI 0.06 to 0.53] four trials, 507 patients I 2 44% GRADE: very low). There was no improvement in knee pain, function or quality of life in patients receiving APM compared with placebo surgery at 6–12 months in group A or B (pain: SMD 0.08 [95% CI −0.24 to 0.41] one trial, 146 patients GRADE: low function: SMD −0.08 [95% CI −0.41 to 0.24] one trial, 146 patients GRADE: high quality of life: SMD 0.05 [95% CI −0.27 to 0.38] one trial 146 patients GRADE: high). No trials were identified for people in group C. Performing APM in all patients with knee pain and a meniscal tear is not appropriate, and surgical treatment should not be considered the first-line intervention. There may, however, be a small-to-moderate benefit from APM compared with physiotherapy for patients without osteoarthritis. No trial has been limited to patients failing non-operative treatment or patients with an unstable meniscal tear in a non-arthritic joint research is needed to establish the value of APM in this population. PROSPERO CRD42017056844.
Publisher: SAGE Publications
Date: 26-07-2019
Abstract: After an anterior cruciate ligament (ACL) injury, ACL reconstruction is an elective procedure, and therefore, an understanding of the attributable risk from undergoing ACL reconstruction is necessary for patients to make a fully informed treatment decision. To determine the absolute risk of adverse outcomes including reoperation after ACL reconstruction with comparison, where possible, to the rate of adverse events reported in the general population. Descriptive epidemiology study. National hospital data on all ACL reconstructions performed in England between April 1, 1997, and March 31, 2017, were analyzed. Revision cases, bilateral procedures within 6 months, and cases with concurrent cartilage or multiple ligament surgery were excluded. The primary outcome was the occurrence of at least 1 serious complication (myocardial infarction, stroke, pulmonary embolism, infection requiring surgery, fasciotomy, neurovascular injury, or death) within 90 days. Additionally, 5-year rates of revision ACL reconstruction, contralateral ACL reconstruction, and meniscal surgery were investigated. There were 133,270 ACL reconstructions performed, of which 104,255 were eligible for analysis. Within 90 days, serious complications occurred in 675 (0.65% [95% CI, 0.60-0.70]), including 494 reoperations for infections (0.47% [95% CI, 0.43-0.52]) and 129 for pulmonary embolism (0.12% [95% CI, 0.10-0.15]). Of 54,275 procedures with at least 5 years’ follow-up, 1746 (3.22% [95% CI, 3.07-3.37]) underwent revision ACL reconstruction in the same knee, 1553 underwent contralateral ACL reconstruction (2.86% [95% CI, 2.72-3.01]), and 340 underwent meniscal surgery (0.63% [95% CI, 0.56-0.70]). The overall risk of serious complications fell over time (adjusted odds ratio [OR], 0.96 per year [95% CI, 0.95-0.98]) however, older patients (adjusted OR, 1.11 per 5 years [95% CI, 1.07-1.16]) and patients with a greater modified Charlson Comorbidity Index (adjusted OR, 2.41 per 10 units [95% CI, 1.65-3.51]) were at a higher risk. For every 850 (95% CI, 720-1039) ACL reconstructions, 1 pulmonary embolism could be provoked. For every 213 (95% CI, 195-233), 1 native knee joint infection could be provoked. The overall risk of adverse events after ACL reconstruction is low however, some rare but serious complications, including infections or pulmonary embolism, may occur. Around 3% of patients undergo further ipsilateral or contralateral ACL reconstruction within 5 years. These data will inform shared decision making between clinicians and patients considering their treatment options.
Publisher: BMJ
Date: 12-04-2018
Publisher: Research Square Platform LLC
Date: 25-02-2019
DOI: 10.21203/RS.2.65/V2
Abstract: Background MACRO (Defining best Management for Adults with Chronic RhinOsinusitis) is an NIHR-funded programme of work designed to establish best practice for adults with chronic rhinosinusitis (CRS). The 7-year programme comprises three consecutive workstreams, designed to explore NHS care pathways through analysis of primary and secondary data sources, and to undertake a randomised controlled trial to evaluate a longer-term course of macrolide antibiotics and endoscopic sinus surgery for patients with CRS. A number of outstanding elements still required clarification at the funding stage. This paper reports an expert panel review process designed to agree and finalise the MACRO trial design, ensuring relevance to patients and clinicians whilst maximising trial recruitment and retention. Methods An expert panel consisting of the MACRO programme management group, independent advisors, and patient contributors, was convened to review current evidence and the mixed method data collected as part of the programme, and reach agreement on MACRO trial design. Specifically, agreement was sought for selection of macrolide antibiotic, use of oral steroids, inclusion of CRS phenotypes (with/without nasal polyps), and overall trial design. Results A 12-week course of clarithromycin was agreed as the main trial comparator, due to its increasing use as a first and second line treatment for patients with CRS, and the perceived need to establish its role in CRS management. Oral steroids will be used as a rescue medication during the trial, rather than routinely either pre or post trial randomisation, to limit any potential effects on surgical outcomes and better reflect current UK prescribing habits. Both CRS phenotypes will be included in a single trial to ensure the MACRO trial is both pragmatic and generalisable to primary care. A modified 3-arm trial design was agreed after intense discussions and further exploratory work. Inclusion criteria were amended to ensure that patients recruited would be considered eligible for the treatment offered in the trial, due to having already received appropriate medical therapy as deemed suitable by their ENT surgeon. A proposed 6-week run-in period prior to randomisation was removed due to the new criteria prior to randomisation. Conclusion The expert panel review process resulted in agreement on key elements and an optimal design for the MACRO trial, considered most likely to be successful in terms of both recruitment potential and ability to establish best management of patients with CRS.
Publisher: BMJ
Date: 29-11-2011
DOI: 10.1136/BMJ.D7441
Publisher: Elsevier BV
Date: 2021
Publisher: Elsevier BV
Date: 09-2002
DOI: 10.1016/S0968-0160(02)00016-9
Abstract: A pilot study assessed the feasibility of discharging NHS patients undergoing knee replacement within a day of surgery. Seven patients with medial compartment osteoarthritis were recruited after fulfilling strict exclusion criteria. Pre-operative assessment revealed that all patients had significant dysfunction and pain before operation. They had medial unicompartmental replacement through a short incision without dislocation of the patella. Each patient underwent an accelerated recovery program that included pain control, physiotherapy and self-assessment. Patients were mobilised immediately after operation. Follow-up assessment was performed at 1, 2 and 6 weeks after surgery. All patients, except one (who failed to go home because of an administrative error), returned home the day after surgery. The average pain score for the first 2 weeks after surgery was 2/10. At 6 weeks, knee flexion averaged 125 degrees and all patients were walking independently and painfree. The new protocol allows for early, safe discharge of patients undergoing unicompartmental knee replacement.
Publisher: British Editorial Society of Bone & Joint Surgery
Date: 2004
DOI: 10.1302/0301-620X.86B1.13502
Abstract: Injury to the dorsomedial cutaneous nerve in the foot may occur after operations for hallux valgus. Pressure neuropathy before operation is also described but remains largely unexplored. We have investigated the incidence of sensory deficit in the great toe before operating for hallux valgus and examined to what extent any deficit was related to the degree of angulation of the joint. Forty-three patients with a total of 61 great toes with hallux valgus presenting for consideration of surgical correction had their sensation tested in pre-designated zones using a five-filament set of Semmes-Weinstein monofilaments. These allowed good inter-observer reliability with an intra-class correlation coefficient of 0.84. Sensory symptoms were noted by only 21% of the patients, a measurable reduction in sensation by one monofilament grade or more was found in an additional 44%. No relationship was found between the degree of sensory loss and the degree of angulation. Patients with symptomatic hallux valgus may have sensory loss in the toe without being aware of it. Normal subjective sensation does not reliably predict normal sensory function. Given the potentially high rates of nerve damage following operations for hallux valgus, we recommend objective sensory testing as part of routine assessment before surgery.
Publisher: Elsevier BV
Date: 04-1996
Publisher: Springer Science and Business Media LLC
Date: 23-04-2019
Publisher: Elsevier BV
Date: 06-2010
DOI: 10.1016/J.KNEE.2009.09.003
Abstract: Revision is the gold standard outcome measurement for survival analyses of orthopaedic implants but reliance on revision as an endpoint has been recently questioned. This study, that assesses long-term outcome in a specific group of patients who had undergone total knee replacement (TKR) for osteoarthritis, highlights the main problems facing modern survival analyses. Minimum 12-year survival and outcome data were reviewed for a series of sixty patients under the age of 60 years (mean age 55.4 years) who underwent total knee replacement (TKR) for osteoarthritis. The patients are a subgroup from a larger consecutive series of 1429 patients who underwent TKR between 1987 and 1993 at a single institution. Whilst the main study aim was to compare outcome of TKR using different endpoints, the outcome of TKR in this younger subpopulation could also be investigated. With revision as the primary endpoint the survival for TKR was 82.2% (95% CI 17.3). The mean OKS at follow-up (mean 15.7 years) was 30.9. However, many of the 82% of patients who did not undergo revision had a less than satisfactory outcome. 41% of these patients reported modest or severe pain (using the OKS) at final follow-up. A combined endpoint including revision, poor function and significant pain drastically reduced the survival rate for the operation. Survival based on revision alone provides an acceptable but inaccurate impression of outcome in younger TKR patients (under 60 years). A true representation of the success of TKR should include pain and function as endpoints.
Publisher: Elsevier BV
Date: 03-2006
DOI: 10.1016/J.KNEE.2005.09.001
Abstract: Unicompartmental knee replacements have not performed as well in the lateral compartment as in the medial. This may be because the tibial components have flat or slightly concave surfaces which match the medial plateau but not the convex lateral plateau. The aim of this study was to find the optimal radius for a convex lateral tibial component. Twelve normal lateral tibial plateau were retrieved at knee replacement, and their surface contour in their mid sagittal plane was determined. The optimal circle was fitted and its radius measured. A series of different shaped tibial components were superimposed. From published information about the position of the femoral condyle relative to the tibia in different degrees of flexion, the flexion gap at these angles was determined. The average radius of the lateral tibial plateau was 40 mm. However, as the surface was polyradial it was not clear if this average radius would be optimal. In full flexion, a flat tibial plateau distracted the knee by 8 mm (p<0.001). A 75 mm radius spherical tibial plateau did not alter the knee kinematics significantly and gave rise to a change in joint distraction of 1.5 mm. Spherical tibial plateau of 50 mm and 25 mm radii significantly altered knee kinematics (p<0.001) and resulted in changes in distraction of 3 mm and 4 mm respectively. The optimal shape for a unicompartmental lateral tibial plateau is likely to be a spherical dome with radius of about 75 mm. The incorporation of this shape in the lateral side of a total knee replacement might improve its flexion.
Publisher: Elsevier BV
Date: 04-2012
Publisher: Springer Science and Business Media LLC
Date: 12-2019
DOI: 10.1186/S13063-019-3826-1
Abstract: Optimising the management of peri-operative pain and recovery following knee replacement has been identified as a patient priority. Current pain relief strategies use opiate-based analgesia however, up to 50% of patients experience significant side effects. Local anaesthetic incisional infiltration is one alternative. The length of the duration of action is a major limiting factor of current local anaesthetic techniques. Liposomal bupivacaine has been reported to be effective for up to 72 h. This randomised controlled trial will evaluate the clinical and cost effectiveness of liposomal bupivacaine. SPAARK is a patient-blinded, multi-centre, active comparator, superiority, two-arm, parallel-group randomised controlled trial. Five hundred patients undergoing knee replacement will be recruited and randomised to liposomal bupivacaine plus bupivacaine hydrochloride or bupivacaine hydrochloride alone. The co-primary outcomes are the Quality of Recovery 40 measured at 72 h post-surgery and also cumulative pain measured daily using a 0–10 visual analogue scale for the first 3 days following surgery. Secondary outcomes include cumulative opioid consumption, fitness for discharge, functional outcomes assessed using the Oxford Knee Score and American Knee Society Score, the EuroQol five dimensions instrument and complications. A cost utility analysis is also planned. The clinical effectiveness and cost effectiveness of liposomal bupivacaine have yet to be evaluated in the National Health Service, making this trial appropriate and timely. ISRCTN registry, ISRCTN54191675 . Registered on 14 November 2017.
Publisher: British Editorial Society of Bone & Joint Surgery
Date: 10-2016
DOI: 10.1302/0301-620X.98B10.BJJ-2016-0483.R1
Abstract: The aim of this to study was to compare the previously unreported long-term survival outcome of the Oxford medial unicompartmental knee arthroplasty (UKA) performed by trainee surgeons and consultants. We therefore identified a previously unreported cohort of 1084 knees in 947 patients who had a UKA inserted for anteromedial knee arthritis by consultants and surgeons in training, at a tertiary arthroplasty centre and performed survival analysis on the group with revision as the endpoint. The ten-year cumulative survival rate for revision or exchange of any part of the prosthetic components was 93.2% (95% confidence interval (CI) 86.1 to 100, number at risk 45). Consultant surgeons had a nine-year cumulative survival rate of 93.9% (95% CI 90.2 to 97.6, number at risk 16). Trainee surgeons had a cumulative nine-year survival rate of 93.0% (95% CI 90.3 to 95.7, number at risk 35). Although there was no differences in implant survival between consultants and trainees (p = 0.30), there was a difference in failure pattern whereby all re-operations performed for bearing dislocation (n = 7), occurred in the trainee group. This accounted for 0.6% of the entire cohort and 15% of the re-operations. This is the largest single series of the Oxford UKA ever reported and demonstrates that good results can be achieved by a heterogeneous group of surgeons, including trainees, if performed within a high-volume centre with considerable experience with the procedure. Cite this article: Bone Joint J 2016 (10 Suppl B):22–7.
Publisher: Elsevier BV
Date: 10-2009
DOI: 10.1016/J.KNEE.2008.12.017
Abstract: As implants are made in incremental sizes and usually do not fit perfectly, surgeons have to decide if it is preferable to over or undersize the components. This is particularly important for unicompartmental knee replacement (UKR) tibial components, as overhang may cause irritation of soft tissues and pain, whereas underhang may cause loosening. One hundred and sixty Oxford UKRs were categorised according to whether they had minor ( or=3 mm, 9%) tibial overhang, or tibial underhang (21%). One year post surgery, there was no significant difference in outcome between the groups. Five years after surgery, those with major overhang had significantly worse Oxford Knee Scores (OKS) (p=0.001) and pain scores (p=0.001) than the others. The difference in scores was substantial (OKS=10 points). There was no difference between the 'minor overhang' and the 'underhang' group. We conclude that surgeons must avoid tibial component overhang of 3 mm or more, as this severely compromises the outcome. Although this study showed no difference between minor overhang or underhang, we would advise against significant underhang because of the theoretical risk of component subsidence and loosening.
Publisher: SAGE Publications
Date: 10-06-2022
DOI: 10.1177/26320843221089632
Abstract: The PROMETHEUS programme (PROMoting THE USE of SWATs) was funded by the UK Medical Research Council (MRC) and Clinical Trials Unit (CTU) infrastructure funding from the National Institute for Health Research (NIHR). The purpose was to develop strategies to increase the recruitment and retention evidence base. This paper aims to present observations from this work. The PROMETHUS programme funded 42 SWATs, the average cost of each SWAT was £4007. A central coordination point enabled a concentrated effort in SWAT research activity leading to a rapid increase in the evidence base. The methodological feasibility of undertaking a coordinated SWAT design was established. The international Trial Forge SWAT Network was developed in 2021 to connect research groups in response for the need to connect teams undertaking methodological research. A SWAT reporting template and a database of researchers willing to peer review SWATs are also needed to improve the reporting of SWATs. There is a need to develop a strategy to aid teams to identify a suitable SWAT for their host trial populations and a mechanism to communicate SWAT research priorities. Work is needed to increase the awareness of the methodological importance of SWAT research with research teams and develop engagement strategies to increase SWAT activity. Continued collaboration with the HRA is necessary to refine the SWAT approvals process. The coordination PROMETHEUS provided is crucial to increasing the recruitment retention evidence base. The Trial Forge Network will be key to provide ongoing networking and dissemination opportunities.
Publisher: Springer Science and Business Media LLC
Date: 11-2013
Publisher: British Editorial Society of Bone & Joint Surgery
Date: 07-2020
DOI: 10.1302/0301-620X.102B7.BJJ-2019-0102.R2
Abstract: To calculate how the likelihood of obtaining measurable benefit from hip or knee arthroplasty varies with preoperative patient-reported scores. Existing UK data from 222,933 knee and 209,760 hip arthroplasty patients were used to model an in idual’s probability of gaining meaningful improvement after surgery based on their preoperative Oxford Knee or Hip Score (OKS/OHS). A clinically meaningful improvement after arthroplasty was defined as ≥ 8 point improvement in OHS, and ≥ 7 in OKS. The upper preoperative score threshold, above which patients are unlikely to achieve any meaningful improvement from surgery, is 41 for knees and 40 for hips. At lower scores, the probability of improvement increased towards a maximum of 88% (knee) and 95% for (hips). By our definition of meaningful improvement, patients with preoperative scores above 41 (OKS) and 40 (OHS) should not be routinely referred to secondary care for possible arthroplasty. Using lower thresholds would incrementally increase the probability of meaningful benefit for those referred but will exclude some patients with potential to benefit. The findings are useful to support the complex shared decision-making process in primary care for referral to secondary care and in secondary care for experienced clinicians counselling patients considering knee or hip arthroplasty, but should not be used in isolation. Cite this article: Bone Joint J 2020 -B(7):941–949.
Publisher: Springer Science and Business Media LLC
Date: 04-09-2015
Publisher: Springer Science and Business Media LLC
Date: 07-10-2021
DOI: 10.1186/S13063-021-05403-5
Abstract: Randomised controlled trials in surgery can be a challenge to design and conduct, especially when including a non-surgical comparison. As few as half of initiated surgical trials reach their recruitment target, and failure to recruit is cited as the most frequent reason for premature closure of surgical RCTs. The aim of this qualitative evidence synthesis was to identify and synthesise findings from qualitative studies exploring the challenges in the design and conduct of trials directly comparing surgical and non-surgical interventions. A qualitative evidence synthesis using meta-ethnography was conducted. Six electronic bibliographic databases (Medline, Central, Cinahl, Embase and PsycInfo) were searched up to the end of February 2018. Studies that explored patients’ and health care professionals’ experiences regarding participating in RCTs with a surgical and non-surgical comparison were included. The GRADE-CERQual framework was used to assess confidence in review findings. In total, 3697 abstracts and 49 full texts were screened and 26 published studies reporting experiences of patients and healthcare professionals were included. The focus of the studies (24/26) was primarily related to the challenge of recruitment. Two studies explored reasons for non-compliance to treatment allocation following randomisation. Five themes related to the challenges to these types of trials were identified: (1) radical choice between treatments (2) patients’ discomfort with randomisation: I want the best treatment for me as an in idual (3) challenge of equipoise: patients’ a priori preferences for treatment (4) challenge of equipoise: clinicians’ a priori preferences for treatment and (5) imbalanced presentation of interventions. The marked dichotomy between the surgical and non-surgical interventions was highlighted in this review as making recruitment to these types of trials particularly challenging. This review identified factors that increase our understanding of why patients and clinicians may find equipoise more challenging in these types of trials compared to other trial comparisons. Trialists may wish to consider exploring the balance of potential factors influencing patient and clinician preferences towards treatments before they start recruitment, to enable issues specific to a particular trial to be identified and addressed. This may enable trial teams to make more efficient considered design choices and benefit the delivery of such trials.
Publisher: British Editorial Society of Bone & Joint Surgery
Date: 07-2005
DOI: 10.1302/0301-620X.87B7.16079
Abstract: Polished, tapered stems are now widely used for cemented total hip replacement and many such designs have been introduced. However, a change in stem geometry may have a profound influence on stability. Stems with a wide, rectangular proximal section may be more stable than those which are narrower proximally. We examined the influence of proximal geometry on stability by comparing the two-year migration of the Exeter stem with a more recent design, the CPS-Plus, which has a wider shoulder and a more rectangular cross-section. The hypothesis was that these design features would increase rotational stability. Both stems subsided approximately 1 mm relative to the femur during the first two years after implantation. The Exeter stem was found to rotate into valgus (mean 0.2°, sd 0.42°) and internally rotate (mean 1.28°, sd 0.99°). The CPS-Plus showed no significant valgus rotation (mean 0.2°, sd 0.42°) or internal rotation (mean −0.03°, sd 0.75°). A wider, more rectangular cross-section improves rotational stability and may have a better long-term outcome.
Publisher: Oxford University Press (OUP)
Date: 23-10-2017
DOI: 10.1093/PTJ/PZX103
Abstract: The IDEAL framework is an established method for initial and ongoing evaluations of innovation and practice for complex health care interventions. First derived for surgical sciences and embedded at a global level for evaluating surgery/surgical devices, the IDEAL framework is based on the principle that innovation and evaluation in clinical practice can, and should, evolve together in an ordered manner: from conception to development and then to validation by appropriate clinical studies and, finally, longer-term follow-up. This framework is highly suited to other complex, nonpharmacological interventions, such as physical therapist interventions. This perspective outlines the application of IDEAL to physical therapy in the new IDEAL-Physio framework. The IDEAL-Physio framework comprises 5 stages. In stage 1, the idea phase, formal data collection should begin. Stage 2a is the phase for iterative improvement and adjustment with thorough data recording. Stage 2b involves the onset of formal evaluation using systematically collected group or cohort data. Stage 3 is the phase for formal comparative assessment of treatment, usually involving randomized studies. Stage 4 involves long-term follow-up. The IDEAL-Physio framework is recommended as a method for guiding and evaluating both innovation and practice in physical therapy, with the overall goal of providing better evidence-based care.
Publisher: Elsevier BV
Date: 2021
Publisher: BMJ
Date: 07-02-2019
DOI: 10.1136/BMJ.L185
Abstract: To compare arthroscopic hip surgery with physiotherapy and activity modification for improving patient reported outcome measures in patients with symptomatic femoroacetabular impingement (FAI). Two group parallel, assessor blinded, pragmatic randomised controlled trial. Secondary and tertiary care centres across seven NHS England sites. 222 participants aged 18 to 60 years with symptomatic FAI confirmed clinically and with imaging (radiography or magnetic resonance imaging) were randomised (1:1) to receive arthroscopic hip surgery (n=112) or a programme of physiotherapy and activity modification (n=110). Exclusion criteria included previous surgery, completion of a physiotherapy programme targeting FAI within the preceding 12 months, established osteoarthritis (Kellgren-Lawrence grade ≥2), and hip dysplasia (centre-edge angle degrees). Participants in the physiotherapy group received a goal based programme tailored to in idual patient needs, with emphasis on improving core stability and movement control. A maximum of eight physiotherapy sessions were delivered over five months. Participants in the arthroscopic surgery group received surgery to excise the bone that impinged during hip movements, followed by routine postoperative care. The primary outcome measure was the hip outcome score activities of daily living subscale (HOS ADL) at eight months post-randomisation, with a minimum clinically important difference between groups of 9 points. Secondary outcome measures included additional patient reported outcome measures and clinical assessment. At eight months post-randomisation, data were available for 100 patients in the arthroscopic hip surgery group (89%) and 88 patients in the physiotherapy programme group (80%). Mean HOS ADL was 78.4 (95% confidence interval 74.4 to 82.3) for patients randomised to arthroscopic hip surgery and 69.2 (65.2 to 73.3) for patients randomised to the physiotherapy programme. After adjusting for baseline HOS ADL, age, sex, and study site, the mean HOS ADL was 10.0 points higher (6.4 to 13.6) in the arthroscopic hip surgery group compared with the physiotherapy programme group (P .001)). No serious adverse events were reported in either group. Patients with symptomatic FAI referred to secondary or tertiary care achieve superior outcomes with arthroscopic hip surgery than with physiotherapy and activity modification. ClinicalTrials.gov NCT01893034 .
Publisher: British Editorial Society of Bone & Joint Surgery
Date: 04-2008
DOI: 10.1302/0301-620X.90B4.19648
Abstract: Few independent studies have reported the outcome of resurfacing arthroplasty of the hip. The aim of this study was to report the five-year clinical outcome and seven-year survival of an independent series. A total of 610 Birmingham Hip Resurfacing arthroplasties were performed in 532 patients with a mean age of 51.8 years (16.5 to 81.6). They were followed for between two and eight years 107 patients (120 hips) had been followed up for more than five years. Two patients were lost to follow-up. At a minimum of five years’ follow-up, 79 of 85 hips (93%) had an excellent or good outcome according to the Harris hip score. The mean Oxford hip score was 16.1 points (sd 7.7) and the mean University of California Los Angeles activity score was 6.6 points (sd 1.9). There were no patients with definite radiological evidence of loosening or of narrowing of the femoral neck exceeding 10% of its width. There were 23 revisions (3.8%), giving an overall survival of 95% (95% confidence interval 85.3 to 99.2) at seven years. Fractured neck of femur in 12 hips was the most common indication for revision, followed by aseptic loosening in four. In three hips (three patients) (0.5%), failure was possibly related to metal debris. Considering that these patients are young and active these results are good, and support the use of resurfacing. Further study is needed to address the early failures, particularly those related to fracture and metal debris.
Publisher: Medical Journals Sweden AB
Date: 2009
Publisher: Elsevier BV
Date: 12-2010
DOI: 10.1016/J.KNEE.2009.10.007
Abstract: Despite the theoretical advantages of mobile bearings for lateral unicompartmental replacement (UKR), the failure rate in the initial published series of lateral Oxford UKR's was unacceptably high. The main cause of failure was bearing dislocation. To address this problem we first modified the surgical technique and then introduced a new design with a convex domed tibial plateau. This paper presents the results of these changes. In the original series (n=53), implanted using a standard open approach, there were six dislocations, all of which occurred in the first year. Five of the dislocations were primary and one was secondary to trauma. In the second series (n=65), with the modified technique, there were three dislocations, all of which were primary and occurred in the second and third year. In the third series (n=101, 69 with a minimum 1-year follow-up), with the modified technique and the domed tibial plateau, there was one dislocation which was secondary to trauma and occurred in the second year. At 4 years the dislocation rates in the three series were 11%, 5% and 1.7% and the primary dislocation rates were 10%, 5% and 0%. Both the overall and the primary dislocation rates were significantly different (p=0.04 and p=0.03) in the different series. The combination of the modified surgical technique and new design with a domed tibial component appears to have reduced the early dislocation rate to an acceptable level.
Publisher: Cold Spring Harbor Laboratory
Date: 12-11-2021
DOI: 10.1101/2021.11.10.21266128
Abstract: To examine temporal trends in incidence of arthroscopic subacromial decompression (ASAD) surgery internationally during conduct and after publication of placebo controlled trials finding no evidence of meaningful benefit of ASAD for shoulder impingement. Observational study of incidence rates. Large routinely collected datasets were used: outpatient data from Belgium and UK, and insurance claims and outpatient data from US. UK data were from Clinical Practice Research Datalink and Belgium and US data were from IQVIA. US and UK data spanned 2005 – 2019 and Belgium data 2011 – 2019. Patients were eligible for inclusion in the study if they had at least one visit recorded in the database in a given year and cases were defined as patients undergoing ASAD for the first time in their records in a given year. We calculated incidence of ASAD over time, overall and stratified by age and sex. Characteristics of patients undergoing ASAD were also assessed over time. UK incidence has fallen since a peak of 4.7 per 10,000 person years in 2011 (when the CSAW trial began) to 1.8 in 2019. US incidence shows no clear pattern and remains consistently higher than the UK, at 11.5 per 100,000 person years in 2019. Changes in incidence patterns were similar across different age groups and sexes. The number of cases in Belgium was too small for meaningful conclusions. We found ASAD rates have fallen in the UK during conduct and after publication of two large surgical RCTs from the UK and Finland that questioned the effectiveness of ASAD for shoulder impingement. A similar impact on clinical practice has not been seen in US. Further work to understand the barriers or concerns preventing international uptake of high quality evidence into clinical practice is needed. This is the most comprehensive study of ASAD incidence we are aware of. Routinely collected datasets were used to assess proportions of the patients undergoing this procedure in several countries Standardised case definitions were used across databases to increase comparability of findings Temporal changes in database coverage and quality of reporting can influence findings. The observed variation in ASAD incidence may not be entirely attributable to changes in ASAD surgery rates.
Publisher: Elsevier BV
Date: 2011
DOI: 10.1016/J.KNEE.2009.10.008
Abstract: Accurate preoperative assessment of the patellofemoral joint is especially important in compartment specific knee arthritis. This study aims to show the actual intraoperative grade of patellofemoral cartilage damage that may be reliably detected or excluded by preoperative standard radiographic views. 100 consecutive knees awaiting arthroplasty underwent preoperative lateral and skyline radiographs and were scored using the Ahlback score. Intraoperative cartilage damage was assessed using the Collins score. The sensitivity and specificity were calculated for each grade of cartilage damage. Preoperative anterior knee pain and function were assessed and correlated to the degree of cartilage damage. The lateral radiograph shows poor sensitivity for all grades of disease (0.05-0.23). The skyline shows good sensitivity for grade 4 (large full thickness) damage (0.90) but decreases substantially for grades 1-3 (0.19-0.46). Significantly more people with skyline radiograph joint space narrowing complained of anterior knee pain than those with a normal radiograph (p<0.001). There was only a poor correlation between preoperative anterior pain and intraoperative patellofemoral cartilage damage (r=0.24). The lateral radiograph cannot exclude even large areas of full thickness cartilage damage whereas a normal skyline radiograph can reliably exclude significant (grade 4) patellofemoral disease and should be used in addition to the lateral view.
Publisher: Elsevier BV
Date: 12-2012
DOI: 10.1016/J.KNEE.2012.05.005
Abstract: Patients with medial unicompartmental osteoarthritic disease of the knee requiring arthroplasty can be treated with either Total or Unicompartmental Knee Replacement (TKR or UKR). Currently, the decision to choose one operation over another is not well defined and may depend on the profile of the surgeon consulted. We tested the hypothesis that different surgeons will select different treatment for identical patients requiring knee replacement. Four different surgeons, representing four different levels of expertise, made a forced choice decision of whether they would perform TKR or UKR based on radiographs alone and subsequent additional clinical information including gender and age, in 140 patients. In idual surgeon repeatability was tested by repeat assessment 3 months later. The knee surgeon from the UKR design centre would have performed a UKR in up to 88% of the patients. The remaining surgeons would have performed UKR in 29-48% of patients a variation in decision making of up to 59%. Additional clinical information had little effect on decision making with surgeons maintaining their radiographic based choice in 80 to 87% of cases. The repeatability study showed high within surgeon consistency for treatment choice. Surgeons, given identical information, do not concur on treatment for patients with the same pathology. The decision making process appears heavily influenced by radiographic findings but in idual surgeons are consistent with their own treatment choice. The study shows that consensus treatment for medial osteoarthritis of the knee remains in question.
Publisher: Journal of Orthopaedic & Sports Physical Therapy (JOSPT)
Date: 02-1998
DOI: 10.2519/JOSPT.1998.27.2.134
Abstract: Rehabilitation following anterior cruciate ligament (ACL) reconstruction is varied. Patients are usually prescribed an independent home exercise program, although some patients may attend physical therapy for additional supervised exercise. It is not known whether additional supervised exercise provides any further benefit. The purpose of this study was to compare efficacy for two types of rehabilitation following ACL reconstruction. A randomized controlled trial of 31 ACL-reconstructed patients was used to test the hypothesis that a home program plus supervised rehabilitation (Group S) is more effective than a home program (Group H) alone. Function, activity level, anterior tibial translation, and muscle strength were measured preoperatively and at 3 and 6 months postoperatively. Improvement of function, activity level, muscle strength, and anterior tibial translation was evident in both groups, but no significant differences were found between groups even though the s le size was sufficient to detect small treatment effects. It was concluded that supervised exercise, in addition to a home program, has minimal extra benefit for patients who have undergone ACL reconstruction.
Publisher: National Institute for Health and Care Research
Date: 06-2019
DOI: 10.3310/HTA23320
Abstract: There is no good evidence to support the use of patient-reported outcome measures (PROMs) in setting preoperative thresholds for referral for hip and knee replacement surgery. Despite this, the practice is widespread in the NHS. Can clinical outcome tools be used to set thresholds for hip or knee replacement? What is the relationship between the choice of threshold and the cost-effectiveness of surgery? A systematic review identified PROMs used to assess patients undergoing hip/knee replacement. Their measurement properties were compared and supplemented by analysis of existing data sets. For each candidate score, we calculated the absolute threshold (a preoperative level above which there is no potential for improvement) and relative thresholds (preoperative levels above which in iduals are less likely to improve than others). Owing to their measurement properties and the availability of data from their current widespread use in the NHS, the Oxford Knee Score (OKS) and Oxford Hip Score (OHS) were selected as the most appropriate scores to use in developing the Arthroplasty Candidacy Help Engine (ACHE) tool. The change in score and the probability of an improvement were then calculated and modelled using preoperative and postoperative OKS/OHSs and PROM scores, thereby creating the ACHE tool. Markov models were used to assess the cost-effectiveness of total hip/knee arthroplasty in the NHS for different preoperative values of OKS/OHSs over a 10-year period. The threshold values were used to model how the ACHE tool may change the number of referrals in a single UK musculoskeletal hub. A user group was established that included patients, members of the public and health-care representatives, to provide stakeholder feedback throughout the research process. From a shortlist of four scores, the OHS and OKS were selected for the ACHE tool based on their measurement properties, calculated preoperative thresholds and cost-effectiveness data. The absolute threshold was 40 for the OHS and 41 for the OKS using the preferred improvement criterion. A range of relative thresholds were calculated based on the relationship between a patient’s preoperative score and their probability of improving after surgery. For ex le, a preoperative OHS of 35 or an OKS of 30 translates to a 75% probability of achieving a good outcome from surgical intervention. The economic evaluation demonstrated that hip and knee arthroplasty cost of £20,000 per quality-adjusted life-year for patients with any preoperative score below the absolute thresholds (40 for the OHS and 41 for the OKS). Arthroplasty was most cost-effective for patients with lower preoperative scores. The ACHE tool supports but does not replace the shared decision-making process required before an in idual decides whether or not to undergo surgery. The OHS and OKS can be used in the ACHE tool to assess an in idual patient’s suitability for hip/knee replacement surgery. The system enables evidence-based and informed threshold setting in accordance with local resources and policies. At a population level, both hip and knee arthroplasty are highly cost-effective right up to the absolute threshold for intervention. Our stakeholder user group felt that the ACHE tool was a useful evidence-based clinical tool to aid referrals and that it should be trialled in NHS clinical practice to establish its feasibility. Future work could include (1) a real-world study of the ACHE tool to determine its acceptability to patients and general practitioners and (2) a study of the role of the ACHE tool in supporting referral decisions. The National Institute for Health Research Health Technology Assessment programme.
Publisher: Springer Science and Business Media LLC
Date: 02-2014
Publisher: National Institute for Health and Care Research
Date: 11-2020
DOI: 10.3310/HTA24650
Abstract: Over 100,000 primary knee arthroplasty operations are undertaken annually in the UK. Around 15–30% of patients do not report a good outcome. Better rehabilitation strategies may improve patient-reported outcomes. To compare the outcomes from a traditional outpatient physiotherapy model with those from a home-based rehabilitation programme for people assessed as being at risk of a poor outcome after knee arthroplasty. An in idually randomised, two-arm controlled trial with a blinded outcome assessment, a parallel health economic evaluation and a nested qualitative study. The trial took place in 14 NHS physiotherapy departments. People identified as being at high risk of a poor outcome after knee arthroplasty. A multicomponent home-based rehabilitation package delivered by rehabilitation assistants with supervision from qualified therapists compared with usual-care outpatient physiotherapy. The primary outcome was the Late Life Function and Disability Instrument at 12 months. Secondary outcomes were the Oxford Knee Score (a disease-specific measure of function) Knee injury and Osteoarthritis Outcome Score Quality of Life subscale Physical Activity Scale for the Elderly EuroQol-5 Dimensions, five-level version and physical function assessed using the Figure-of-8 Walk Test, 30-Second Chair Stand Test and Single Leg Stance. Data on the use of health-care services, time off work and informal care were collected using participant diaries. In total, 621 participants were randomised. A total of 309 participants were assigned to the COmmunity based Rehabilitation after Knee Arthroplasty (CORKA) home-based rehabilitation programme, receiving a median of five treatment sessions (interquartile range 4–7 sessions). A total of 312 participants were assigned to usual care, receiving a median of four sessions (interquartile range 2–6 sessions). The primary outcome, Late Life Function and Disability Instrument function total score at 12 months, was collected for 279 participants (89%) in the home-based CORKA group and 287 participants (92%) in the usual-care group. No clinically or statistically significant difference was found between the groups (intention-to-treat adjusted difference 0.49 points, 95% confidence interval –0.89 to 1.88 points p = 0.48). There were no statistically significant differences between the groups in any of the patient-reported or physical secondary outcome measures at 6 or 12 months post randomisation. The health economic analysis found that the CORKA intervention was cheaper to provide than usual care (£66 less per participant). Total societal costs (combining health-care costs and other costs) were lower for the CORKA intervention than usual care (£316 less per participant). Adopting a societal perspective, CORKA had a 75% probability of being cost-effective at a threshold of £30,000 per quality-adjusted life-year. Adopting the narrower health and social care perspective, CORKA had a 43% probability of being cost-effective at the same threshold. The interventions were of short duration and were set within current commissioning guidance for UK physiotherapy. Participants and treating therapists could not be blinded. This randomised controlled trial found no important differences in outcomes when post-arthroplasty rehabilitation was delivered using a home-based, rehabilitation assistant-delivered rehabilitation package or a traditional outpatient model. However, the health economic evaluation found that when adopting a societal perspective, the CORKA home-based intervention was cost-saving and more effective than, and thus dominant over, usual care, owing to reduced time away from paid employment for this group. Further research could look at identifying the risk of poor outcome and further evaluation of a cost-effective treatment, including the workforce model to deliver it. Current Controlled Trials ISRCTN13517704. This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment Vol. 24, No. 65. See the NIHR Journals Library website for further project information.
Publisher: SAGE Publications
Date: 22-12-2022
DOI: 10.1177/26320843221147841
Abstract: PROMoting THE USE of Studies Within A Trial (PROMETHEUS) aimed to improve the evidence base for recruiting and retaining participants in Randomised Controlled Trials (RCTs) by pump-priming and facilitating the start of at least 25 Studies Within A Trial (SWATs) testing recruitment or retention interventions. Ten Clinical Trials Units (CTUs) and one Primary Care Research Centre formed a network to conduct randomised SWATs of recruitment and/or retention strategies. We identified promising recruitment and retention interventions from various sources, which were reviewed by patient and public (PPI) partners to generate an initial priority list of seven recruitment and eight retention interventions. Host trial teams could apply for funding of up to £5000 and receive support from the PROMETHEUS team to design, implement, and report SWATs. We additionally tested the feasibility of undertaking coordinated SWATs across multiple host trials simultaneously. PROMETHEUS funded 42 SWATs, embedded within 31 host trials, across 12 CTUs. The SWAT cost per SWAT was £3535. Of the 42 SWATs, 12 tested the same SWAT in multiple trials ( simultaneous SWAT design) and eight tested a factorial SWAT design. PROMETHEUS will add 18% and 79% more SWATs to the Cochrane systematic review of recruitment strategies and the Cochrane review of retention strategies respectively. The PROMETHEUS programme substantially increased the evidence base for both recruitment and retention strategies within RCTs. Future research should adopt a systematic approach to identifying and targeting gaps in the evidence base and focus on translating SWAT evidence into recruitment and retention practice.
Publisher: British Editorial Society of Bone & Joint Surgery
Date: 2017
DOI: 10.1302/0301-620X.99B1.BJJ-2016-0424.R1
Abstract: The appropriate management for patients with a degenerative tear of the rotator cuff remains controversial, but operative treatment, particularly arthroscopic surgery, is increasingly being used. Our aim in this paper was to compare the effectiveness of arthroscopic with open repair of the rotator cuff. A total of 273 patients were recruited to a randomised comparison trial (136 to arthroscopic surgery and 137 to open surgery) from 19 teaching and general hospitals in the United Kingdom. The surgeons used their usual preferred method of repair. The Oxford Shoulder Score (OSS), two years post-operatively, was the primary outcome measure. Imaging of the shoulder was performed at one year after surgery. The trial is registered with Current Controlled Trials, ISRCTN97804283. The mean OSS improved from 26.3 (standard deviation (sd) 8.2) at baseline, to 41.7 (sd 7.9) two years post-operatively for arthroscopic surgery and from 25.0 (sd 8.0) to 41.5 (sd 7.9) for open surgery. Intention-to-treat (ITT) analysis showed no statistical difference between the groups at two years (difference in OSS score -0.76 95% confidence interval (CI) -2.75 to 1.22 p = 0.452). The confidence interval excluded the pre-determined clinically important difference in the OSS of three points. The rate of re-tear was not significantly different between the two groups (46.4% for arthroscopic and 38.6% for open surgery 95% CI -6.9 to 25.8 p = 0.256). Healed repairs had the most improved OSS. These findings were the same when analysed per-protocol. There is no evidence of difference in effectiveness between open and arthroscopic repair of rotator cuff tears. The rate of re-tear is high in both groups, for all sizes of tear and ages and this adversely affects the outcome. Cite this article: Bone Joint J 2017 -B:107–15.
Publisher: Elsevier BV
Date: 08-2021
Publisher: Elsevier BV
Date: 07-2018
Publisher: Springer Science and Business Media LLC
Date: 17-07-2017
Publisher: Springer Science and Business Media LLC
Date: 08-08-2019
Publisher: Elsevier BV
Date: 07-2018
Publisher: British Editorial Society of Bone & Joint Surgery
Date: 04-10-2023
Publisher: Elsevier BV
Date: 12-2022
DOI: 10.1016/J.JOCA.2022.08.016
Abstract: To investigate trends in the incidence rate and the main indication for revision knee replacement (rKR) over the past 15 years in the UK. Repeated national cross-sectional study from 2006 to 2020 using data from the National Joint Registry (NJR). Crude incidence rates were calculated using population statistics from the Office for National Statistics. Annual total counts of rKR increased from 2,743 procedures in 2006 to 6,819 procedures in 2019 (149% increase). The incidence rate of rKR increased from 6.3 per 100,000 adults in 2006 (95% CI 6.1 to 6.5) to 14 per 100,000 adults in 2019 (95% CI 14 to 14) (122% increase). Annual increases in the incidence rate of rKR became smaller over the study period. There was a 43.6% reduction in total rKR procedures in 2020 (during the Covid-19 pandemic) compared to 2019. Aseptic loosening was the most frequent indication for rKR overall (20.7% procedures). rKR for aseptic loosening peaked in 2012 and subsequently decreased. rKR for infection increased incrementally over the study period to become the most frequent indication in 2019 (2.7 per 100,000 adults [95% CI 2.6 to 2.9]). Infection accounted for 17.1% first linked rKR, 36.5% second linked rKR and 49.4% third or more linked rKR from 2014 to 2019. Recent trends suggest slowing of the rate of increase in the incidence of rKR. Infection is now the most common indication for rKR, following recent decreases in rKR for aseptic loosening. Infection was prevalent in re-revision KR procedures.
Publisher: Research Square Platform LLC
Date: 22-03-2021
DOI: 10.21203/RS.3.RS-321502/V1
Abstract: BackgroundA rotator cuff tear is a common disabling shoulder problem. Symptoms include pain, weakness, lack of mobility and sleep disturbance. Many patients require surgery to repair the tear however, there is a high failure rate. There is a pressing need to improve the outcome of rotator cuff surgery. The use of patch augmentation to provide support to the healing process and improve patient outcomes holds new promise. Different materials (e.g. human/animal skin or intestine tissue, and completely synthetic materials) and processes (e.g. woven or a mesh) have been used to produce patches. However, clinical evidence on their use is limited. The Patch Augmented Rotator Cuff Surgery (PARCS) feasibility study aimed to determine the design of a definitive randomised controlled trial (RCT) assessing the effectiveness and cost-effectiveness of a patch to augment surgical repair of the rotator cuff that is both acceptable to stakeholders and feasible.MethodsA mixed methods feasibility study of a RCT. The project involved six stages: a systematic review of clinical evidence a survey of the British Elbow and Shoulder (BESS) society’s surgical membership a survey of surgeon trialists focus groups and interviews with stakeholders a two-round Delphi study administered via online questionnaires and a two-day Consensus Meeting. ResultsThe BESS surgeons’ survey identified a variety of patches in use (105 (21%) responses received). Twenty-four surgeons (77%) completed the trialist survey relating to trial design. Four focus groups were conducted involving 24 stakeholders. Twenty-nine (67% of invited) in iduals took part in the Delphi. Differing views were held on a number of aspects including the appropriate patient population for trial participation. Agreement on the key research questions and the outline of two potential RCTs were achieved through the Delphi study and the consensus meeting). ConclusionsRandomised comparisons of on-lay patch use for completed rotator cuff repairs, and bridging patch use for partial rotator cuff repairs were identified as areas for further research. The value of an observational study to assess safety concerns of patch use was also highlighted. The main limitation was that the findings were influenced by the participants, who might not necessarily reflect all stakeholders.
Publisher: Elsevier BV
Date: 02-2016
Publisher: British Editorial Society of Bone & Joint Surgery
Date: 07-2009
DOI: 10.1302/0301-620X.91B7.22021
Abstract: Balancing service provision and surgical training is a challenging issue that affects all healthcare systems. A multicentre prospective study of 1501 total hip replacements was undertaken to investigate whether there is an association between surgical outcome and the grade of the operating surgeon, and whether there is any difference in outcome if surgeons’ assistants assist with the operation, rather than orthopaedic trainees. The primary outcome measure was the change in the Oxford hip score (OHS) at five years. Secondary outcomes included the rate of revision and dislocation, operating time, and length of hospital stay. There was no significant difference in ΔOHS or complication rates between operations undertaken by trainers and trainees, or those at which surgeons’ assistants and trainees were the assistant. However, there was a significant difference in the duration of surgery, with a mean reduction of 28 minutes in those in which a surgeons’ assistant was the assistant. This study provides evidence that total hip replacements can be performed safely and effectively by appropriately trained surgeons in training, and that there are potential benefits of using surgeons’ assistants in orthopaedic surgery.
Publisher: SAGE Publications
Date: 21-07-2016
Abstract: Arthroscopic surgery of the knee is one of the most frequently performed orthopaedic procedures. One-third of these procedures are performed for meniscal injuries. It is essential that this commonly performed surgery be supported by robust evidence. To compare the effectiveness of arthroscopic surgery for meniscal injuries in all populations. Systematic review. An online search was conducted for randomized controlled trials (RCTs) and systematic reviews (SRs) that compared treatment options for meniscal injury. The following databases (inception to April 2015) were included in the search: CENTRAL MEDLINE EMBASE NHS Evidence National Guideline Clearing House, Database of Abstracts of Reviews of Effects, Health Technology Assessment ISRCTN Clinicaltrials.gov WHO trials platform. Only studies whose participants were selected on the basis of meniscal injury were included no restrictions were placed on patient demographics. Two independent reviewers applied AMSTAR (A Measurement Tool to Assess Systematic Reviews) criteria for SRs and the Cochrane Collaboration risk-of-bias tool for RCTs. Nine RCTs and 8 SRs were included in the review. No difference was found between arthroscopic meniscal debridement compared with nonoperative management as a first-line treatment strategy for patients with knee pain and a degenerative meniscal tear (mean difference: Knee injury and Osteoarthritis Outcome Score, 1.6 [95% CI, −2.2 to 5.2], pain visual analog scale, −0.06 [95% CI, −0.28 to 0.15]). Some evidence was found to indicate that patients with resistant mechanical symptoms who initially fail nonoperative management may benefit from meniscal debridement No studies compared meniscal repair with meniscectomy or nonoperative management. Initial evidence suggested that meniscal transplant might be favorable in certain patient groups. Further evidence is required to determine which patient groups have good outcomes from each intervention. Given the current widespread use of arthroscopic meniscal surgeries, more research is urgently needed to support evidence-based practice in meniscal surgery in order to reduce the numbers of ineffective interventions and support potentially beneficial surgery.
Publisher: British Editorial Society of Bone & Joint Surgery
Date: 11-2014
DOI: 10.1302/2046-3758.311.2000336
Abstract: Femoroacetabular Junction Impingement (FAI) describes abnormalities in the shape of the femoral head–neck junction, or abnormalities in the orientation of the acetabulum. In the short term, FAI can give rise to pain and disability, and in the long-term it significantly increases the risk of developing osteoarthritis. The Femoroacetabular Impingement Trial (FAIT) aims to determine whether operative or non-operative intervention is more effective at improving symptoms and preventing the development and progression of osteoarthritis. FAIT is a multicentre superiority parallel two-arm randomised controlled trial comparing physiotherapy and activity modification with arthroscopic surgery for the treatment of symptomatic FAI. Patients aged 18 to 60 with clinical and radiological evidence of FAI are eligible. Principal exclusion criteria include previous surgery to the index hip, established osteoarthritis (Kellgren–Lawrence ≥ 2), hip dysplasia (centre-edge angle 20°), and completion of a physiotherapy programme targeting FAI within the previous 12 months. Recruitment will take place over 24 months and 120 patients will be randomised in a 1:1 ratio and followed up for three years. The two primary outcome measures are change in hip outcome score eight months post-randomisation (approximately six-months post-intervention initiation) and change in radiographic minimum joint space width 38 months post-randomisation. ClinicalTrials.gov: NCT01893034. Cite this article: Bone Joint Res 2014 :321–7.
Publisher: British Editorial Society of Bone & Joint Surgery
Date: 06-2019
DOI: 10.1302/0301-620X.101B6.BJJ-2019-0126.R1
Abstract: The aim of the British Association for Surgery of the Knee (BASK) Meniscal Consensus Project was to develop an evidence-based treatment guideline for patients with meniscal lesions of the knee. A formal consensus process was undertaken applying nominal group, Delphi, and appropriateness methods. Consensus was first reached on the terminology relating to the definition, investigation, and classification of meniscal lesions. A series of simulated clinical scenarios was then created and the appropriateness of arthroscopic meniscal surgery or nonoperative treatment in each scenario was rated by the group. The process was informed throughout by the latest published, and previously unpublished, clinical and epidemiological evidence. Scenarios were then grouped together based upon the similarity of clinical features and ratings to form the guideline for treatment. Feedback on the draft guideline was sought from the entire membership of BASK before final revisions and approval by the consensus group. A total of 45 simulated clinical scenarios were refined to five common clinical presentations and six corresponding treatment recommendations. The final guideline stratifies patients based upon a new, standardized classification of symptoms, signs, radiological findings, duration of symptoms, and previous treatment. The 2018 BASK Arthroscopic Meniscal Surgery Treatment Guidance will facilitate the consistent identification and treatment of patients with meniscal lesions. It is hoped that this guidance will be adopted nationally by surgeons and help inform healthcare commissioning guidance. Validation in clinical practice is now required and several areas of uncertainty in relation to treatment should be a priority for future high-quality prospective studies. Cite this article: Bone Joint J 2019 -B:652–659.
Publisher: BMJ
Date: 10-2017
DOI: 10.1136/BMJOPEN-2017-017247
Abstract: Meniscal tears occur frequently in the population and the most common surgical treatment, arthroscopic partial meniscectomy, is performed in approximately two million cases worldwide each year. The purpose of this systematic review is to summarise and critically appraise the evidence for the use of patient-reported outcome measures (PROMs) in patients with meniscal tears. A systematic review was undertaken. Data on reported measurement properties were extracted and the quality of the studies appraised according to Consensus-based Standards for the Selection of Health Measurement Instruments. A search of MEDLINE, Embase, AMED and PsycINFO, unlimited by language or publication date (last search 20 February 2017). Development and validation studies reporting the measurement properties of PROMs in patients with meniscal tears were included. 11 studies and 10 PROMs were included. The overall quality of studies was poor. For measurement of symptoms and functional status, there is only very limited evidence supporting the selection of either the Lysholm Knee Scale, International Knee Documentation Committee Subjective Knee Form or the Dutch version of the Knee injury and Osteoarthritis Outcome Score. For measuring health-related quality of life, only limited evidence supports the selection of the Western Ontario Meniscal Evaluation Tool (WOMET). Of all the PROMs evaluated, WOMET has the strongest evidence for content validity. For patients with meniscal tears, there is poor quality and incomplete evidence regarding the validity of the currently available PROMs. Further research is required to ensure these PROMs truly reflect the symptoms, function and quality of life of patients with meniscal tears. CRD42017056847.
Publisher: Elsevier BV
Date: 02-2019
Publisher: Wiley
Date: 26-11-2012
DOI: 10.1002/LSM.22103
Publisher: British Editorial Society of Bone & Joint Surgery
Date: 06-2019
Publisher: Springer Science and Business Media LLC
Date: 19-01-2018
Publisher: Elsevier BV
Date: 2007
DOI: 10.1016/J.ARTH.2006.02.160
Abstract: Isolated patellofemoral osteoarthritis can be treated with patellofemoral arthroplasty (PFA). In contrast to total knee arthroplasty, the effect of PFA on knee joint kinematics is not known. A study was performed to identify the kinematic changes after PFA. The sagittal plane kinematics was examined in 12 patients who had undergone Avon PFA. An established fluoroscopic method was used to examine the patellar tendon angle (PTA)/knee flexion relationship during functional activities. No significant difference existed between the kinematics of PFA knees compared with normal, except for a uniform elevation in PTA throughout the range. This increase in PTA in the PFA joint represents a 1.6-mm anterior displacement of the patella. The kinematic profile after PFA is close to normal and suggests that the knee is exhibiting more normal loading characteristics than those of the total knee arthroplasty joint.
Publisher: Medical Journals Sweden AB
Date: 2009
Publisher: Elsevier BV
Date: 05-2022
Publisher: Springer Science and Business Media LLC
Date: 13-04-2005
DOI: 10.1007/S00167-004-0569-6
Abstract: Anterior cruciate ligament-deficient (ACLD) knee kinematics during high-demand activities are poorly understood. We have devised a new method, using gait analysis, to more accurately assess 3-D in vivo kinematics of the knee. This has enabled us to report on how knee kinematics are altered after ACL rupture, during running and cutting. Fifteen unilaterally ACLD subjects were assessed using a 12-camera 100 Hz VICON motion analysis system. Simultaneous electromyographical (EMG) recordings were used to assess the role of the sensorimotor system in knee joint stability. All subjects were able to perform demanding cutting activities without experiencing symptoms of instability. We found that running produces fundamentally different kinematic patterns to those seen during walking. Tibiofemoral translation in the anteroposterior plane is controlled to within normal limits. Conversely, coronal translation and rotation are poorly controlled. We found that the injured leg was maintained in greater extension during the stance phase of all running activities studied and that the quadriceps muscle was active for longer during this period. We believe that low-demand activities, such as walking, do not reproduce kinematics relevant to ACLD instability and that future investigations into functional instability in the ACLD knee should focus on coronal and rotational displacements.
Publisher: Elsevier BV
Date: 03-2020
Publisher: Springer Science and Business Media LLC
Date: 12-2018
Publisher: Frontiers Media SA
Date: 14-06-2022
DOI: 10.3389/FPHYS.2022.862793
Abstract: Reduced muscle size and accumulation of paraspinal muscle fat content (PFC) have been reported in lumbopelvic muscles after spaceflights and head-down tilt (HDT) bed rest. While some information is available regarding reconditioning programs on muscle atrophy recovery, the effects on the accumulation of PFC are unknown. Recently, a device (the Functional Re-adaptive Exercise Device—FRED) has been developed which aims to specifically recruit lumbopelvic muscles. This study aimed to investigate the effects of a standard reconditioning (SR) program and SR program supplemented by FRED (SR + FRED) on the recovery of the lumbopelvic muscles following 60-day HDT bed rest. Twenty-four healthy participants arrived at the facility for baseline data collection (BDC) before the bed rest period. They remained in the facility for 13-day post-HDT bed rest and were randomly allocated to one of two reconditioning programs: SR or SR + FRED. Muscle volumes of the lumbar multifidus (LM), lumbar erector spinae (LES), quadratus lumborum (QL), and psoas major (PM) muscles were measured from axial T1-weighted magnetic resonance imaging (MRI) at all lumbar intervertebral disc levels. PFC was determined using a chemical shift-based lipid/water Dixon sequence. Each lumbopelvic muscle was segmented into four equal quartiles (from medial to lateral). MRI of the lumbopelvic region was conducted at BDC, Day-59 of bed rest (HDT59), and Day-13 after reconditioning (R13). Comparing R13 with BDC, the volumes of the LM muscle at L4/L5 and L5/S1, LES at L1/L2, and QL at L3/L4 had not recovered (all— p & 0.05), and the PM muscle remained larger at L1/L2 ( p = 0.001). Accumulation of PFC in the LM muscle at the L4/L5 and L5/S1 levels remained higher in the centro-medial regions at R13 than BDC (all— p & 0.05). There was no difference between the two reconditioning programs. A 2-week reconditioning program was insufficient to fully restore all volumes of lumbopelvic muscles and reverse the accumulation of PFC in the muscles measured to BDC values, particularly in the LM muscle at the lower lumbar levels. These findings suggest that more extended reconditioning programs or alternative exercises may be necessary to fully restore the size and properties of the lumbopelvic muscles after prolonged bed rest.
Publisher: Public Library of Science (PLoS)
Date: 02-04-2020
Publisher: Elsevier BV
Date: 08-2022
Publisher: Elsevier BV
Date: 09-2020
Publisher: Elsevier BV
Date: 09-2013
Publisher: Elsevier BV
Date: 11-2012
DOI: 10.1016/J.JBIOMECH.2012.09.001
Abstract: Interest in soft tissue RadioStereometric Analysis (RSA) is rising. Previous studies have attempted to use this technique to analyse anterior cruciate ligament (ACL) graft constructs, and more recently, the movement of soft tissue as a precursor to RSA follow up of rotator cuff repairs. These methods were either prone to large amounts of marker migration, deemed unsuitable for in vivo use or, where alternative markers such as stainless steel sutures were used, lost the inherent accuracy that makes RSA an attractive tool in the first place. We describe a modification of tantalum marker balls that allows for immediate secure fixation to soft tissue in order to accurately analyse stretch and displacement of soft tissues using RSA. 1.5mm tantalum marker balls were converted to marker beads by pre-drilling with 0.3mm holes, allowing them to be sutured directly to soft tissue. Using an established ACL graft model, the amount of marker micro-motion was then analysed by RSA after cyclical loading between 20 N and 170 N at 25 Hz for 225,000 cycles. None of 40 marker beads loosened or became detached after 225,000 cycles. Mean micro-motion of the markers was <0.1mm. Analysis of elastic stretch, plastic stretch and stiffness of the graft model was possible. This method of attachment of tantalum markers to soft tissue is simple, reliable and provides immediate stability. Although further work is required to establish its suitability for in vivo use, this technique could potentially be used in all areas where soft tissue RSA is of interest.
Publisher: Medical Journals Sweden AB
Date: 10-07-2019
Publisher: BMJ
Date: 11-2022
DOI: 10.1136/BMJOPEN-2022-067427
Abstract: The effective implementation of a fast-changing healthcare delivery innovation, such as robotic-assisted surgery (RAS), into a healthcare system, can be affected (both positively and negatively) by external contextual factors. As part of a wider project investigating ways to optimise the implementation of RAS, this qualitative study aimed to uncover current issues of RAS and predictions about the future of robotic surgery. We refer to ‘current issues’ as the topical and salient challenges and opportunities related to the introduction of RAS in the UK healthcare system, from the perspectives of key stakeholders involved in the delivery and implementation of RAS. Semi-structured interviews and focus groups were conducted. A thematic analysis was conducted to summarise salient issues that were articulated by the participants. The interview s le (n=35) comprised surgeons, wider theatre staff and other relevant personnel involved in the introduction and delivery of RAS services across the UK, including service managers and policymakers/commissioners. Two focus groups were also conducted with surgical trainees (n=7) and members of the public (n=8), respectively. The results revealed a largely positive attitude towards the introduction of RAS technology and an expectation of continued rapid expansion. Areas perceived to be particularly pertinent and requiring ongoing attention were also highlighted, including the need to achieve improved quality control, expertise quantification and training issues and the need to educate the public. Issues of centralisation, service organisation and equity of access were also emphasised. Our study has highlighted a range of issues perceived to be particularly pertinent to the current and future provision of RAS which should be addressed. The areas outlined can enable healthcare managers and surgeons to plan for the adoption and/or expansion of RAS services.
Publisher: Elsevier BV
Date: 07-1994
Publisher: British Editorial Society of Bone & Joint Surgery
Date: 11-1994
Publisher: British Editorial Society of Bone & Joint Surgery
Date: 07-2002
DOI: 10.1302/0301-620X.84B5.0840653
Abstract: When the Oxford unicompartmental meniscal bearing arthroplasty is used in the lateral compartment of the knee, 10% of the bearings dislocate. A radiological review was carried out to establish if dislocation was related to surgical technique. The postoperative radiographs of 46 lateral unicompartmental arthroplasties were analysed. Five variables which related to the position and alignment of the components were measured. Dislocations occurred in six knees. Only one of the five variables, the proximal tibial varus angle, had a statistically significant relationship to dislocation. This variable quantifies the height of the lateral joint line. The mean proximal tibial varus angle for knees the bearings of which had dislocated was 9° and for those which had not it was 5°. In both groups it was greater than would be expected in the normal knee (3°). Our study suggests that a high proximal tibial varus angle is associated with dislocation. The surgical technique should be modified to account for this, with care being taken to avoid damage to or over-distraction of the lateral soft tissues.
Publisher: Elsevier BV
Date: 03-2022
Publisher: Elsevier BV
Date: 09-2002
DOI: 10.1016/S0968-0160(02)00039-X
Abstract: When the Oxford unicompartmental meniscal bearing arthroplasty (UCA) is used in the lateral compartment 10% of the bearings dislocate. A fluoroscopic study was performed to investigate if abnormal mid-sagittal plane kinematics was related to bearing dislocation. Video fluoroscopy is an accepted means of determining in-vivo knee kinematics in the sagittal plane. Video fluoroscopy was obtained of 5 Oxford lateral UCAs 10 years post-operatively and of five normal knees. Patellar tendon angle (PTA), derived from dynamic fluoroscopic images, was used to describe the joint kinematics. This in-vivo experiment demonstrated that the PTA/knee relationship for the Oxford lateral UCA is similar to the normal knee. Both the normal knee (r(2)=0.99) and the Oxford lateral UCA (r(2)=0.98) demonstrated a linear relationship between flexion angle and PTA. No significant difference in PTA was found between the normal knee and the Oxford lateral UCA. This study demonstrated normal kinematics, as indicated by PTA, ten years after implantation of the Oxford lateral UCA. It is therefore reasonable to suggest that abnormal kinematics is not a significant factor relating to meniscal bearing dislocation in the lateral compartment.
Publisher: BMJ
Date: 08-2019
DOI: 10.1136/BMJOPEN-2019-030229
Abstract: To illustrate the need for better evaluation of surgical procedures, we investigated the use and cost of subacromial decompression in England over the last decade compared with other countries and explored how this related to the conduct and outcomes of randomised, placebo-controlled clinical trials. Longitudinal observational study using Hospital Episode Statistics linked to Payment by Results tariffs in England, 2007/2008 to 2016/2017. Hospital care in England Finland New York State, USA Florida State, USA and Western Australia. Patients with subacromial shoulder pain. Subacromial decompression. National procedure rates, costs and variation between clinical commissioning groups in England. Without robust clinical evidence, the use of subacromial decompression in England increased by 91% from 15 112 procedures (30 per 100 000 population) in 2007/2008, to 28 802 procedures (52 per 100 000 population) in 2016/2017, costing over £125 million per year. Rates of use of subacromial decompression are even higher internationally: Finland (131 per 100 000 in 2011), Florida State (130 per 100 000 in 2007), Western Australia (115 per 100 000 in 2013) and New York State (102 per 100 000 in 2006). Two randomised placebo-controlled trials have recently (2018) shown the procedure to be no more effective than placebo or conservative approaches. Health systems appear unable to avoid the rapid widespread use of procedures of unknown effectiveness, and methods for ceasing ineffective treatments are under-developed. Without good evidence, nearly 30 000 subacromial decompression procedures have been commissioned each year in England, costing over £1 billion since 2007/2008. Even higher rates of procedures are carried out in countries with less regulated health systems. High quality randomised trials need to be initiated before widespread adoption of promising operative procedures to avoid overtreatment and wasted resources, and methods to prevent or desist the use of ineffective procedures need to be expedited.
Publisher: Springer Science and Business Media LLC
Date: 13-10-2016
Publisher: Elsevier BV
Date: 06-2019
Publisher: Springer Science and Business Media LLC
Date: 14-05-2020
DOI: 10.1186/S13063-020-04298-Y
Abstract: Anterior cruciate ligament (ACL) rupture is a common knee injury that can lead to poor quality of life, decreased activity and increased risk of secondary osteoarthritis of the knee. Management of patients with a non-acute ACL injury can include a non-surgical (rehabilitation) or surgical (reconstruction) approach. However, insufficient evidence to guide treatment selection has led to high variation in treatment choice for patients with non-acute presentation of ACL injury. The objective of the ACL SNNAP trial is to determine in patients with non-acute anterior cruciate ligament deficiency (ACLD) whether a strategy of non-surgical management (rehabilitation) (with option for later ACL reconstruction only if required) is more clinically effective and cost effective than a strategy of surgical management (reconstruction) without prior rehabilitation with all patients followed up at 18 months. The study is a pragmatic, multi-centre, superiority, randomised controlled trial with two-arm parallel groups and 1:1 allocation. Patients with a symptomatic non-acute ACL deficient knee will be randomised to either non-surgical management (rehabilitation) or surgical management (reconstruction). We aim to recruit 320 patients from approximately 30 secondary care orthopaedic units from across the United Kingdom. Randomisation will occur using a web-based randomisation system. Blinding of patients and clinicians to treatment allocation will not be possible because of the nature of the interventions. Participants will be followed up via self-reported questionnaires at 6, 12 and 18 months. The primary outcome is the Knee injury and Osteoarthritis Outcome Score (KOOS) at 18 months post randomisation. Secondary outcomes will include a return to sport/activity, intervention-related complications, patient satisfaction, expectations of activity, generic health quality of life, knee specific quality of life and resource usage. At present, no evidence-based treatment of non-acute ACL deficiency exists, particularly in the NHS. Moreover, little consensus exists on the management approach for these patients. The proposed trial will address this gap in knowledge regarding the clinical and cost effectiveness of ACL treatment and inform future standards of care for this condition. ISRCTN: 10110685 . Registered on 16 November 2016. ClinicalTrials.gov: NCT02980367 . Registered in December 2016.
Publisher: Informa UK Limited
Date: 07-2016
DOI: 10.2147/PROM.S97774
Publisher: Elsevier BV
Date: 09-2011
Publisher: Elsevier BV
Date: 12-2006
DOI: 10.1016/J.KNEE.2006.07.001
Abstract: The mechanisms of failure for unicompartmental arthroplasty are poorly understood. There is some suggestion that long term ligament degeneration, particularly of the anterior cruciate ligament (ACL), may affect long term survivorship. This study evaluated whether the cruciate mechanism remained functional in the long term (10 years) following UKA. Two separate cohorts of patients who had undergone St Georg Sled medial compartmental arthroplasty had knee kinematics assessed using an established fluoroscopic technique. One group (early) was assessed at a mean of 46 months (3.8 years) since surgery, whilst the other (late) was assessed at a mean of 125 months (10.4) following surgery. No significant difference was found in the sagittal plane kinematics between the two groups or in comparison to the control normal knee. The results suggest that after fixed bearing UKA the cruciate mechanism remains intact over time and the ligaments continue to function similarly to those of the normal knee.
Publisher: Springer Science and Business Media LLC
Date: 12-2016
Publisher: BMJ
Date: 03-2016
Publisher: BMJ
Date: 12-2019
DOI: 10.1136/BMJOPEN-2019-031552
Abstract: Trauma to the nail bed is the most common surgically treated paediatric hand injury. The majority of surgeons replace the nail plate after repairing the nail bed despite a lack of evidence to do so. Replacing the nail plate may be associated with increased postoperative infection. We will investigate the impact of replacing or discarding the nail plate on infection, cosmetic appearance, pain and subsequent healthcare use. The Nail bed INJury Analysis trial (NINJA) aims to answer the question of whether the nail plate should be replaced or discarded after surgical nail bed repair in children. A two-arm parallel group open multicentre randomised control trial of replacing the nail plate or not, as part of a nail bed repair, will be undertaken in children presenting within 48 hours of a nail bed injury requiring surgical repair. The coprimary outcomes are: cosmetic appearance summary score at a minimum of 4 months and surgical site infection at around 7 days following surgery. Secondary outcomes are EuroQol EQ-5D-(Y) the pain intensity experienced at first dressing change child arent satisfaction with nail healing and healthcare resource use. We will recruit a minimum of 416 patients (208 in each group) over 3 years. Children and their parents/carers will be reviewed in clinic around 7 days after their operation and will be assessed for surgical site infection or other problems. The children, or depending on age, their parents/carers, will also be asked to complete a questionnaire and send in photos of their fingernail at a minimum of 4 months postsurgery to assess cosmetic appearance. The South Central Research Ethics Committee approved this study on 4 June 2019 (18/SC/0024). A manuscript to a peer-reviewed journal will be submitted on completion of the trial as per National Institute for Health Research publication policy. The results of this trial will substantially inform clinical practice and provide evidence on whether the practice of replacing the nail plate should continue at the time of nail bed repair. ISRCTN44551796 .
Publisher: National Institute for Health and Care Research
Date: 10-2022
DOI: 10.3310/AVZV0799
Abstract: People with avascular necrosis of the hip have very limited treatment options currently available to stop the progression of this disease this often results in the need for a hip replacement. There is some weak evidence that a class of drugs called bisphosphonates may delay the course of the disease, and this trial was commissioned and set up to provide robust evidence regarding the use of bisphosphonates in adults aged ≥ 18 years with this condition. The aim of the Managing Avascular Necrosis Treatments: an Interventional Study (MANTIS) trial was to evaluate the clinical effectiveness and cost-effectiveness of a 12-month course of alendronate in the treatment of avascular necrosis. This was a 66-month, definitive, multisite, two-arm, parallel-group, placebo-controlled, double-blind, randomised controlled trial, with an internal pilot phase. Eight secondary care NHS hospitals across the UK. Planned trial size – 280 adult patients with avascular necrosis. Participants in the intervention group received 70 mg of alendronate (an oral bisphosphonate) weekly for 12 months. The main outcomes were Oxford Hip Score at 12 months (short-term outcome) and the time to decision that a hip replacement is required at 36 months (long-term outcome). Twenty-one patients were recruited and randomised to receive either the intervention drug, alendronate, or a placebo-matched tablet. This trial was principally limited by low disease prevalence. Other limitations included the late disease stage at which participants were identified and the rapid progression of the disease. This trial was limited by a low recruitment rate. Avascular necrosis of the hip should be treated as a rare disease. Future trials would need to recruit many more sites and recruit over a longer time period, and, for this reason, a registry may provide a more effective means of collecting data pertaining to this disease. The MANTIS trial was terminated at the end of the pilot phase, because it did not meet its go/no-go criteria. The main issue was a poor recruitment rate, owing to a lower than expected disease prevalence and difficulties in identifying the condition at a sufficiently early stage. Those patients who were identified and screened either were too advanced in their disease progression or were already taking medication. We would not recommend that a short-term interventional study is conducted on this condition until its prevalence, geographic foci and natural history and better understood. The difficulty of acquiring this understanding is likely to be a barrier in most health-care markets. One means of developing this understanding would be the introduction of a database/registry for patients suffering from avascular necrosis of the hip. The trial is registered as ISRCTN14015902. This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment Vol. 26, No. 43. See the NIHR Journals Library website for further project information.
Publisher: Elsevier BV
Date: 02-2002
DOI: 10.1016/S0968-0160(01)00132-6
Abstract: The methodological detail about determining the femoral axis on lateral fluoroscopic images of the knee is lacking. This paper reports on the use of the posterior border of the lower femoral diaphysis to represent the axis. This method is accurate, simple, reliable and can be used by researchers studying knee joint kinematics using dynamic video fluoroscopy. It is also useful in the outpatient clinic to assess the flexion/extension position of femoral components after knee arthroplasty.
Publisher: British Editorial Society of Bone & Joint Surgery
Date: 2003
DOI: 10.1302/0301-620X.85B1.13233
Abstract: Before proceeding to longer-term studies, we have studied the early clinical results of a new mobile-bearing total knee prosthesis in comparison with an established fixed-bearing device. Patients requiring bilateral knee replacement consented to have their operations under one anaesthetic using one of each prosthesis. They also agreed to accept the random choice of knee (right or left) and to remain ignorant as to which side had which implant. Outcomes were measured using the American Knee Society Score (AKSS), the Oxford Knee Score (OKS), and determination of the range of movement and pain scores before and at one year after operation. Preoperatively, there was no systematic difference between the right and left knees. One patient died in the perioperative period and one mobile-bearing prosthesis required early revision for dislocation of the meniscal component. At one year the mean AKSS, OKS and pain scores for the new device were slightly better (p 0.025) than those for the fixed-bearing device. There was no difference in the range of movement. We believe that this is the first controlled, blinded trial to compare early function of a new knee prosthesis with that of a standard implant. It demonstrates a small but significant clinical advantage for the mobile-bearing design.
Publisher: Springer Science and Business Media LLC
Date: 21-01-2020
DOI: 10.1007/S00167-019-05840-5
Abstract: Lower limb malalignment is a strong predictor of progression in knee osteoarthritis. The purpose of this study is to identify the in idual alignment variables that predict progression in early to moderate osteoarthritis of the knee. A longitudinal cohort study using data from the Osteoarthritis Initiative. In total, 955 in iduals (1329 knees) with early to moderate osteoarthritis (Kellgren-Lawrence grade 1, 2 or 3) were identified. All subjects had full-limb radiographs analysed using the Osteotomy module within Medicad ® Classic (Hectec GMBH) to give a series of in idual alignment variables relevant to the coronal alignment of the lower limb. Logistic regression models, with generalised estimating equations were used to identify which of these in idual alignment variables predict symptom worsening (WOMAC score 9 points) and or structural progression (joint space narrowing progression in the medial compartment 0.7mm) over 24 months. In idual alignment variable were associated with both valgus and varus alignment (mechanical Lateral Distal Femoral Angle, Medial Proximal Tibial Angle and mechanical Lateral Distal Tibial Angle). Only the Medial Proximal Tibial Angle was significantly associated with structural progression and none of the variables was associated with symptom progression. The odds of joint space narrowing progression in the medial compartment occurring at 24 months increased by 21% for every one degree decrease (more varus) in Medial Proximal Tibial Angle ( p 0.001) Our results suggest that the risk of structural progression in the medial compartment is associated with greater varus alignment of the proximal tibia. Level III, retrospective cohort study.
Publisher: Elsevier BV
Date: 04-2021
Publisher: Elsevier BV
Date: 2005
DOI: 10.1016/J.KNEE.2004.01.002
Abstract: Sagittal plane video fluoroscopy was used to analyse the bilateral knee kinematics of patients with unilateral ACL deficiency (ACLD) before, and 4 months after, hamstrings graft ACL reconstruction. Kinematics were studied during weight resisted knee extension, passive knee extension, and a step up. Thigh EMG records were also obtained from five subjects. In addition, six uninjured control subjects were analysed to establish normal kinematics. Kinematics were analysed by calculating the angle between the long axis of the tibia and the patella tendon through the range of knee flexion. Shear forces were calculated using a model of knee extension and force plate data. A maximum anterior TT of 7.3 (S.D. 2.1) mm was recorded in ACL intact (ACLI) knees during the weightbearing activity. Hamstrings activity was able to control ATT in the ACLD tibia to within the normal range of translation of the ACLI knee. Despite clinical improvements, ATT increased postoperatively in the reconstructed knees to 11.6 (S.D. 3.8) mm (P<0.048). The findings suggest that the ACL has only a minor role in the control of ATT during activity, and that the extent of ATT is more closely related to the level of quadriceps-generated shear force. A reduction in hamstrings force is proposed as the most likely cause for increased ATT post reconstruction. These findings have implications for the development of ACL rehabilitation regimes, and also may modify graft choice and the surgical aims of the procedure.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 02-2009
Publisher: Wiley
Date: 31-10-2013
DOI: 10.1111/ANS.12328
Publisher: American Medical Association (AMA)
Date: 06-2022
Publisher: Elsevier BV
Date: 06-2007
DOI: 10.1016/J.KNEE.2007.01.001
Abstract: Proprioception was assessed after knee replacement to compare total (TKA) to unicompartmental (UKA) knee arthroplasty. Thirty-four patients were recruited seventeen patients underwent TKA and seventeen patients underwent UKA. The patient's age was similar in both groups. Two measures of proprioception, joint position sense (JPS) and postural sway (PS) were measured. Function was assessed using the Oxford Knee Score (OKS). Measurements were taken pre-operatively and 6 months post-operatively on both the operated and contralateral leg. Pre-operatively, no differences in JPS or PS were found between groups or between limbs in either group. Post-operatively, both groups had significant improvement of JPS in the operated limb only (20% increase). The improvement in JPS was similar in both groups. PS also improved significantly in both groups although the improvement of PS in the UKA group was twice that for the TKA group. The OKS improved by a similar amount in both groups. Both UKA and TKA result in a significant improvement in proprioception. Dynamic aspects of proprioception improve more after UKA than TKA, which may explain, in part, why UKA patients have superior functional outcome to that of TKA patients.
Publisher: National Institute for Health and Care Research
Date: 11-2021
DOI: 10.3310/HTA25660
Abstract: Although routine NHS data potentially include all patients, confounding limits their use for causal inference. Methods to minimise confounding in observational studies of implantable devices are required to enable the evaluation of patients with severe systemic morbidity who are excluded from many randomised controlled trials. Stage 1 – replicate the Total or Partial Knee Arthroplasty Trial (TOPKAT), a surgical randomised controlled trial comparing unicompartmental knee replacement with total knee replacement using propensity score and instrumental variable methods. Stage 2 – compare the risk benefits and cost-effectiveness of unicompartmental knee replacement with total knee replacement surgery in patients with severe systemic morbidity who would have been ineligible for TOPKAT using the validated methods from stage 1. This was a cohort study. Data were obtained from the National Joint Registry database and linked to hospital inpatient (Hospital Episode Statistics) and patient-reported outcome data. Stage 1 – people undergoing unicompartmental knee replacement surgery or total knee replacement surgery who met the TOPKAT eligibility criteria. Stage 2 – participants with an American Society of Anesthesiologists grade of ≥ 3. The patients were exposed to either unicompartmental knee replacement surgery or total knee replacement surgery. The primary outcome measure was the postoperative Oxford Knee Score. The secondary outcome measures were 90-day postoperative complications (venous thromboembolism, myocardial infarction and prosthetic joint infection) and 5-year revision risk and mortality. The main outcome measures for the health economic analysis were health-related quality of life (EuroQol-5 Dimensions) and NHS hospital costs. In stage 1, propensity score stratification and inverse probability weighting replicated the results of TOPKAT. Propensity score adjustment, propensity score matching and instrumental variables did not. Stage 2 included 2256 unicompartmental knee replacement patients and 57,682 total knee replacement patients who had severe comorbidities, of whom 145 and 23,344 had linked Oxford Knee Scores, respectively. A statistically significant but clinically irrelevant difference favouring unicompartmental knee replacement was observed, with a mean postoperative Oxford Knee Score difference of 2 points using propensity score stratification no significant difference was observed using inverse probability weighting. Unicompartmental knee replacement more than halved the risk of venous thromboembolism [relative risk 0.33 (95% confidence interval 0.15 to 0.74) using propensity score stratification relative risk 0.39 (95% confidence interval 0.16 to 0.96) using inverse probability weighting]. Unicompartmental knee replacement was not associated with myocardial infarction or prosthetic joint infection using either method. In the long term, unicompartmental knee replacement had double the revision risk of total knee replacement [hazard ratio 2.70 (95% confidence interval 2.15 to 3.38) using propensity score stratification hazard ratio 2.60 (95% confidence interval 1.94 to 3.47) using inverse probability weighting], but half of the mortality [hazard ratio 0.52 (95% confidence interval 0.36 to 0.74) using propensity score stratification insignificant effect using inverse probability weighting]. Unicompartmental knee replacement had lower costs and higher quality-adjusted life-year gains than total knee replacement for stage 2 participants. Although some propensity score methods successfully replicated TOPKAT, unresolved confounding may have affected stage 2. Missing Oxford Knee Scores may have led to information bias. Propensity score stratification and inverse probability weighting successfully replicated TOPKAT, implying that some (but not all) propensity score methods can be used to evaluate surgical innovations and implantable medical devices using routine NHS data. Unicompartmental knee replacement was safer and more cost-effective than total knee replacement for patients with severe comorbidity and should be considered the first option for suitable patients. Further research is required to understand the performance of propensity score methods for evaluating surgical innovations and implantable devices. This trial is registered as EUPAS17435. This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment Vol. 25, No. 66. See the NIHR Journals Library website for further project information.
Publisher: Elsevier BV
Date: 10-2005
DOI: 10.1016/J.KNEE.2005.01.002
Abstract: Unicompartmental knee arthroplasty (UKA) is appropriate for one in four patients with osteoarthritic knees. This study was performed to compare the safety, effectiveness and economic viability of a new accelerated protocol with current standard care in a state healthcare system. A single blind RCT design was used. Eligible patients were screened for NSAID tolerance, social circumstances and geographical location before allocation to an accelerated recovery group (A) or standard care group (S). Primary outcome was the Oxford Knee Assessment at 6 months post operation, compared using independent Mann-Whitney U-tests. A simple difference in costs incurred was calculated. The study power was sufficient to avoid type 2 errors. Forty-one patients were included. The average stay for Group A was 1.5 days. Group S averaged 4.3 days. No significant difference in outcomes was found between groups. The new protocol achieved cost savings of 27% and significantly reduced hospital bed occupancy. In addition, patient satisfaction was assessed as greater with the accelerated discharge than with the routine discharge time. The strict inclusion criteria meant that 75% of eligible patients were excluded. However, a large percentage of these were due to the distances patients lived from the hospital.
Publisher: British Editorial Society of Bone & Joint Surgery
Date: 03-2012
DOI: 10.1302/0301-620X.94B3.27425
Abstract: We obtained information from the Elective Orthopaedic Centre on 1523 patients with baseline and six-month Oxford hip scores (OHS) after undergoing primary hip replacement (THR) and 1784 patients with Oxford knee scores (OKS) for primary knee replacement (TKR) who completed a six-month satisfaction questionnaire. Receiver operating characteristic curves identified an absolute change in OHS of 14 points or more as the point that discriminates best between patients’ satisfaction levels and an 11-point change for the OKS. Satisfaction is highest (97.6%) in patients with an absolute change in OHS of 14 points or more, compared with lower levels of satisfaction (81.8%) below this threshold. Similarly, an 11-point absolute change in OKS was associated with 95.4% satisfaction compared with 76.5% below this threshold. For the six-month OHS a score of 35 points or more distinguished patients with the highest satisfaction level, and for the six-month OKS 30 points or more identified the highest level of satisfaction. The thresholds varied according to patients’ pre-operative score, where those with severe pre-operative pain/function required a lower six-month score to achieve the highest levels of satisfaction. Our data suggest that the choice of a six-month follow-up to assess patient-reported outcomes of THR/TKR is acceptable. The thresholds help to differentiate between patients with different levels of satisfaction, but external validation will be required prior to general implementation in clinical practice.
Publisher: Elsevier BV
Date: 10-2018
DOI: 10.1016/J.KNEE.2018.06.001
Abstract: The aim of this study was to deliver standardised terminology for the identification and stratification of patients with meniscal lesions of the knee. A national group of expert surgeons was convened by the British Association for Surgery of the Knee (BASK) and a formal consensus process was undertaken following a validated methodology. A combination of nominal group techniques and an iterative Delphi process was used to develop and refine relevant definitions. Where appropriate, definitions were placed into categories to facilitate use in clinical practice and guideline development. A degenerative meniscus develops progressively with degradation of meniscal tissue and this may be revealed by intra-meniscal high signal on magnetic resonance imaging (MRI). A meniscal tear was defined as a defect or split in the meniscocapsular complex, which can occur in a degenerative or non-degenerative meniscus. Degenerative meniscal lesions (high signal or tear) are frequent in the general population and are often incidental findings on knee MRI. Symptoms were defined and classified into three groups: (1) strongly suggestive of a treatable meniscal lesion, (2) potentially suggestive of a treatable meniscal lesion, (3) osteoarthritic. A strategy for radiological imaging (radiograph ± MRI) was agreed for the investigation of the patients with a possible meniscal tear. Meniscal lesions and tear patterns on MRI imaging were defined and classified with reference to potential treatability: (1) target, (2) possible target, (3) no target. The agreed terminology will enable patients with meniscal lesions to be identified and stratified consistently in clinical practice, research and guideline development.
Publisher: Springer Berlin Heidelberg
Date: 2013
Publisher: Elsevier BV
Date: 09-1996
Publisher: BMJ
Date: 10-2019
DOI: 10.1136/BMJOPEN-2018-025357
Abstract: We have previously developed and validated the Arthritis Research UK Musculoskeletal Health Questionnaire (MSK-HQ) for use across musculoskeletal care pathways, showing encouraging psychometric test results. The objective of this study was to determine the responsiveness of MSK-HQ following MSK treatments and to determine the minimally important change (MIC). We collected data in four cohorts from community physiotherapy and secondary-care orthopaedic hip, knee and shoulder clinics. 592 in iduals were recruited 210 patients treated with physiotherapy for a range of MSK conditions in primary care 150 patients undergoing hip replacement, 150 patients undergoing knee replacement and 82 undergoing shoulder surgery in secondary care. Preoperative data were collected including the MSK-HQ, European Quality of Life-5D (EQ-5D) and the OHS, OKS or OSS in each joint-specific group. The same scores, together with anchor questions, were collected postintervention at 3 months for the physiotherapy group and 6 months for all others. Following COnsensus-based Standards for the selection of health status Measurement INstruments (COSMIN) guidelines, responsiveness was assessed using correlation between scores and the MIC was calculated for the entire cohort using receiver operating characteristic curve analysis. The MSK-HQ demonstrated strong correlation (R=0.73) with EQ-5D across the entire cohort and with each of the joint-specific Oxford scores (hip R=0.87, knee R=0.92 and shoulder R=0.77). Moderate correlation was seen between MSK-HQ and EQ-5D across each in idual group (R value range 0.60–0.68), apart from the hip group where correlation was strong (R=0.77). The effect size with MSK-HQ was 0.93, in the entire cohort, double that measured with EQ-5D (0.43). In all subgroups, MSK-HQ measured a greater treatment effect compared with EQ-5D. The MIC is 5.5 (95% CI 2.7 to 8.3). Our study demonstrates that the MSK-HQ questionnaire is responsive to change across a range of musculoskeletal conditions, supporting its use as a generic MSK measurement instrument.
Publisher: BMJ
Date: 02-2019
DOI: 10.1136/BMJOPEN-2018-024944
Abstract: Central lumbar spinal stenosis (LSS) is a common cause of pain, reduced function and quality of life in older adults. Current management of LSS includes surgery to decompress the spinal canal and alleviate symptoms. However, evidence supporting surgical decompression derives from unblinded randomised trials with high cross-over rates or cohort studies showing modest benefits. This protocol describes the design of the SUrgery for Spinal Stenosis (SUcceSS) trial —the first randomised placebo-controlled trial of decompressive surgery for symptomatic LSS. SUcceSS will be a prospectively registered, randomised placebo-controlled trial of decompressive spinal surgery. 160 eligible participants (80 participants/group) with symptomatic LSS will be randomised to either surgical spinal decompression or placebo surgical intervention. The placebo surgical intervention is identical to surgical decompression in all other ways with the exception of the removal of any bone or ligament. All participants and assessors will be blinded to treatment allocation. Outcomes will be assessed at baseline and at 3, 6, 12 and 24 months. The coprimary outcomes will be function measured with the Oswestry Disability Index and the proportion of participants who have meaningfully improved their walking capacity at 3 months postrandomisation. Secondary outcomes include back pain intensity, lower limb pain intensity, disability, quality of life, anxiety and depression, neurogenic claudication score, perceived recovery, treatment satisfaction, adverse events, reoperation rate and rehospitalisation rate. Those who decline to be randomised will be invited to participate in a parallel observational cohort. Data analysis will be blinded and by intention to treat. A trial-based cost-effectiveness analysis will determine the potential incremental cost per quality-adjusted life year gained. Ethics approval has been granted by the NSW Health (reference:17/247/POWH/601) and the Monash University (reference: 12371) Human Research Ethics Committees. Dissemination of results will be via journal articles and presentations at national and international conferences. ACTRN12617000884303 Pre-results.
Publisher: JMIR Publications Inc.
Date: 14-09-2023
DOI: 10.2196/47179
Publisher: Wiley
Date: 15-10-2009
DOI: 10.1002/JOR.21015
Abstract: Locally destructive soft tissue pseudotumor has been reported in patients following metal-on-metal hip resurfacing arthroplasty (MoMHRA). A delayed hypersensitivity reaction type IV to nickel (Ni), chromium (Cr), or cobalt (Co) has been suggested to play a role in its aetiology. The aim of this study was to investigate the incidence and level of metal-induced systemic hypersensitivity in patients with MoMHRA, both with and without pseudotumor by measuring lymphocyte proliferation responses to metals. A total of 92 patients were investigated: (1) MoMHRA patients with pseudotumors (nine female, one male) (2) MoMHRA patients without pseudotumors (30 female, 30 male) and (3) age-matched control subjects without metal implants (9 female, 13 male). The venous blood s les were collected for serum Ni, Co, and Cr ion level measurements and lymphocyte transformation tests (LTT). A higher incidence and level of enhanced lymphocyte reactivity only to Ni was found in patients with MoMHRA compared to the patients without MoM implants, reflecting exposure and immune reactivity. However, lymphocyte reactivity to Co, Cr, and Ni did not significantly differ in patients with pseudotumors compared to those patients without pseudotumors. This suggests that systemic hypersensitivity type IV reactions, as measured by lymphocyte proliferation response to these metals, may not be the dominant biological reaction involved in the occurrence of the soft tissue pseudotumors.
Publisher: SAGE Publications
Date: 03-2013
Abstract: The relationship between contralateral hip arthritis and co-morbid medical conditions that affect a patient's ability to walk, and outcome following total hip arthroplasty (THA) is not fully understood. We investigated this relationship in a prospective, multi-centre study. 1497 hips (1428 patients) were recruited. At five years follow-up there was complete data for 1053 hips. We recorded Oxford Hip Score (OHS) and Charnley Class (CC) both pre-operatively and at one and five years after surgery. Pre-Operatively there was a significant difference in OHS between CC categories and OHS deteriorated from CC-A to CC-C (p .001). The absolute OHS was significantly worse in CC-C compared to CC-A. Patients who remained in CC-A at five year follow-up had a larger change in OHS (mean 24) compared to those who had changed from CC-A to CC-C at five years (mean 21) p .001. The OHS an outcome measure frequently used for THA is influenced by several extraneous factors which may be present pre-operatively but also change over time. These factors include the condition of the opposite hip as well as other disease processes that affect a patient's locomotion and therefore interpretation of OHS in isolation without additional information may not be appropriate.
Publisher: Wiley
Date: 08-02-2021
DOI: 10.1111/ANS.16546
Abstract: Impact factor (IF) is widely accepted as a measure of a journal's quality but it can be influenced by self‐citation. However, the SCImago Journal Rank (SJR) is based on journal prestige, excludes self‐citation and considers quality of citations of a journal. This study aimed to investigate journal editors' use of self‐citation and whether this correlated with IFs or SJR in trauma and orthopaedic (T& O) journals. T& O journals on the SJR database were identified. From each journal, data including country of publication, number of annual issues, IF, SJR indicator and citable articles were extracted. The editorial(s) of each issue in 2018 were reviewed. The total number of times the editors cited their own previous work or their journal (in the preceding 2 years, 2016–2017) were identified. Regression analyses were performed to investigate the association of editorial self‐citation with journal IF or SJR indicator. Of the 270 journals identified, 43 T& O journals with 151 editorials were included in the final analysis. A positive correlation between journal self‐citation in the editorial and IF ( P = 0.02) and SJR indicator ( P = 0.02) was found. Citation by editors of their own publications within editorials also positively correlated with IF ( P = 0.04) but not for SJR indicator ( P = 0.19). There was a positive linear relationship between journal IF and SJR indicators ( P 0.01). Editor self‐citation influences the IF and SJR indicators in T& O journals. Therefore, these metrics should be considered in conjunction with other factors such as audience, topics included and international presence when evaluating journals.
Publisher: British Editorial Society of Bone & Joint Surgery
Date: 08-2009
DOI: 10.1302/0301-620X.91B8.22562
Abstract: Inflammatory pseudotumours occasionally occur after metal-on-metal hip resurfacing and often lead to revision. Our aim was to determine the severity of this complication by assessing the outcome of revision in these circumstances and by comparing this with the outcome of other metal-on-metal hip resurfacing revisions as well as that of matched primary total hip replacements. We identified 53 hips which had undergone metal-on-metal hip resurfacing and required revision at a mean of 1.59 years (0.01 to 6.69) after operation. Of these, 16 were revised for pseudotumours, 21 for fracture and 16 for other reasons. These were matched by age, gender and diagnosis with 103 patients undergoing primary total hip replacement with the Exeter implant. At a mean follow-up of three years (0.8 to 7.2) the outcome of metal-on-metal hip resurfacing revision for pseudotumour was poor with a mean Oxford hip score of 20.9 (sd 9.3) and was significantly worse (p 0.001) than the outcome for fracture with a mean Oxford hip score of 40.2 (sd 9.2) or that for other causes with a mean Oxford hip score of 37.8 (sd 9.4). The clinical outcome of revision for pseudotumour was also significantly worse (p 0.001) than the outcome of matched primary total hip replacements. By contrast, the outcome for fracture and other causes was not significantly different from that of matched primary total hip replacements (p = 0.065). After revision for pseudotumour there were three cases of recurrent dislocation, three of palsy of the femoral nerve, one of stenosis of the femoral artery and two of loosening of the component. Five hips required further revision. In three of these there was evidence of recurrent pseudotumour, and one is currently awaiting further revision. The incidence of major complications after revision for pseudotumour (50%) was significantly higher (p = 0.018) than that after revision for other causes (14%). The outcome of revision for pseudotumour is poor and consideration should be given to early revision to limit the extent of the soft-tissue destruction. The outcome of resurfacing revision for other causes is good.
Publisher: British Editorial Society of Bone & Joint Surgery
Date: 03-1993
DOI: 10.1302/0301-620X.75B2.8444956
Abstract: Failure of conservative treatment is the usual indication for the reconstruction of a knee with deficiency of the anterior cruciate ligament (ACL) and this depends on subjective judgement. The ability of muscles to protect the subluxing joint by reflex contraction could provide an objective measurement. We have studied 30 patients with unilateral ACL deficiency by measuring the latency of reflex hamstring contraction. We found that the mean latency in the injured leg was nearly twice that in the unaffected limb (99 ms and 53 ms respectively). There was a significant correlation between the differential latency and the frequency of 'giving way' indicating that functional instability may be due, in part, to loss of proprioception. Measures of proprioception, including reflex hamstring latency, may be useful in providing an objective assessment of the efficacy of conservative treatment and the need for surgery.
Publisher: Springer Science and Business Media LLC
Date: 19-08-2015
Publisher: Elsevier BV
Date: 03-2020
Publisher: Elsevier BV
Date: 03-2008
DOI: 10.1016/J.KNEE.2007.11.008
Abstract: The in vivo kinematics of 10 patients after combined anterior cruciate ligament reconstruction (ACLR group) and Oxford unicompartmental knee arthroplasty (UKA) was compared to those of 10 Oxford UKA patients with an intact ACL (ACLI group) and a group of 22 normal knees. The kinematics during a step-up exercise and a deep knee bend exercise was measured using a fluoroscopic technique. The patellar tendon angle (PTA) to knee flexion angle relationship during both exercises was similar for all three groups of subjects. For the UKA groups the pattern of mobile bearing movement during both exercises was similar. This study demonstrates that normal knee kinematics is achieved in the ACL deficient arthritic knee following ACLR and UKA. As a result these patients, who tend to be young and high demand, have excellent outcome and achieve high levels of function. As the relative position of the components and thus component loading are similar to the ACLI UKA, we would expect similar long term survival.
Publisher: Springer Science and Business Media LLC
Date: 11-2013
Publisher: British Editorial Society of Bone & Joint Surgery
Date: 04-2021
DOI: 10.1302/0301-620X.103B4.BJJ-2020-1560.R1
Abstract: To estimate the measurement properties for the Oxford Knee Score (OKS) in patients undergoing revision knee arthroplasty (responsiveness, minimal detectable change (MDC-90), minimal important change (MIC), minimal important difference (MID), internal consistency, construct validity, and interpretability). Secondary data analysis was performed for 10,727 patients undergoing revision knee arthroplasty between 2013 to 2019 using a UK national patient-reported outcome measure (PROM) dataset. Outcome data were collected before revision and at six months postoperatively, using the OKS and EuroQol five-dimension score (EQ-5D). Measurement properties were assessed according to COnsensus-based Standards for the selection of health status Measurement Instruments (COSMIN) guidelines. A total of 9,219 patients had complete outcome data. Mean preoperative OKS was 16.7 points (SD 8.1), mean postoperative OKS 29.1 (SD 11.4), and mean change in OKS + 12.5 (SD 10.7). Median preoperative EQ-5D index was 0.260 (interquartile range (IQR) 0.055 to 0.691), median postoperative EQ-5D index 0.691 (IQR 0.516 to 0.796), and median change in EQ-5D index + 0.240 (IQR 0.000 to 0.567). Internal consistency was good with Cronbach’s α 0.88 (baseline) and 0.94 (post-revision). Construct validity found a high correlation of OKS total score with EQ-5D index ( r = 0.76 (baseline), r = 0.83 (post-revision), p 0.001). The OKS was responsive with standardized effect size (SES) 1.54 (95% confidence interval (CI) 1.51 to 1.57), compared to SES 0.83 (0.81 to 0.86) for the EQ-5D index. The MIC for the OKS was 7.5 points (95% CI 5.5 to 8.5) based on the optimal cut-off with specificity 0.72, sensitivity 0.60, and area under the curve 0.66. The MID for the OKS was 5.2 points. The MDC-90 was 3.9 points. The OKS did not demonstrate significant floor or ceiling effects. This study found that the OKS was a useful and valid instrument for assessment of outcome following revision knee arthroplasty. The OKS was responsive to change and demonstrated good measurement properties. Cite this article: Bone Joint J 2021 -B(4):627–634.
Publisher: Springer Science and Business Media LLC
Date: 11-2013
Publisher: National Institute for Health and Care Research
Date: 09-2021
DOI: 10.3310/HTA25530
Abstract: The use of placebo comparisons for randomised trials assessing the efficacy of surgical interventions is increasingly being considered. However, a placebo control is a complex type of comparison group in the surgical setting and, although powerful, presents many challenges. To provide a summary of knowledge on placebo controls in surgical trials and to summarise any recommendations for designers, evaluators and funders of placebo-controlled surgical trials. To carry out a state-of-the-art workshop and produce a corresponding report involving key stakeholders throughout. A workshop to discuss and summarise the existing knowledge and to develop the new guidelines. To assess what a placebo control entails and to assess the understanding of this tool in the context of surgery is considered, along with when placebo controls in surgery are acceptable (and when they are desirable). We have considered ethics arguments and regulatory requirements, how a placebo control should be designed, how to identify and mitigate risk for participants in these trials, and how such trials should be carried out and interpreted. The use of placebo controls is justified in randomised controlled trials of surgical interventions provided that there is a strong scientific and ethics rationale. Surgical placebos might be most appropriate when there is poor evidence for the efficacy of the procedure and a justified concern that results of a trial would be associated with a high risk of bias, particularly because of the placebo effect. The use of placebo controls is justified in randomised controlled trials of surgical interventions provided that there is a strong scientific and ethics rationale. Feasibility work is recommended to optimise the design and implementation of randomised controlled trials. An outline for best practice was produced in the form of the Applying Surgical Placebo in Randomised Evaluations (ASPIRE) guidelines for those considering the use of a placebo control in a surgical randomised controlled trial. Although the workshop participants involved international members, the majority of participants were from the UK. Therefore, although every attempt was made to make the recommendations applicable to all health systems, the guidelines may, unconsciously, be particularly applicable to clinical practice in the UK NHS. Future work should evaluate the use of the ASPIRE guidelines in making decisions about the use of a placebo-controlled surgical trial. In addition, further work is required on the appropriate nomenclature to adopt in this space. Funded by the Medical Research Council UK and the National Institute for Health Research as part of the Medical Research Council–National Institute for Health Research Methodology Research programme.
Publisher: Elsevier BV
Date: 11-2018
Publisher: British Editorial Society of Bone & Joint Surgery
Date: 08-2010
DOI: 10.1302/0301-620X.92B8.22860
Abstract: We have compared the outcome of hemiarthroplasty of the shoulder in three distinct diagnostic groups, using survival analysis as used by the United Kingdom national joint registers, patient-reported outcome measures (PROMs) as recommended by Darzi in the 2008 NHS review, and transition and satisfaction questions. A total of 72 hemiarthroplasties, 19 for primary osteoarthritis (OA) with an intact rotator cuff, 22 for OA with a torn rotator cuff, and 31 for rheumatoid arthritis (RA), were followed up for between three and eight years. All the patients survived, with no revisions or dislocations and no significant radiological evidence of loosening. The mean new Oxford shoulder score (minimum/worst 0, maximum/best 48) improved significantly for all groups (p 0.001), in the OA group with an intact rotator cuff from 21.4 to 38.8 (effect size 2.9), in the OA group with a torn rotator cuff from 13.3 to 27.2 (effect size 2.1) and in the RA group from 13.7 to 28.0 (effect size 3.1). By this assessment, and for the survival analysis, there was no significant difference between the groups. However, when ratings using the patient satisfaction questions were analysed, eight (29.6%) of the RA group were ‘disappointed’, compared with one (9.1%) of the OA group with cuff intact and one (7.7%) of the OA group with cuff torn. All patients in the OA group with cuff torn indicated that they would undergo the operation again, compared to ten (90.9%) in the OA group with cuff intact and 20 (76.9%) in the RA group. The use of revision rates alone does not fully represent outcome after hemiarthroplasty of the shoulder. Data from PROMs provides more information about change in pain and the ability to undertake activities and perform tasks. The additional use of satisfaction ratings shows that both the rates of revision surgery and PROMs need careful interpretation in the context of patient expectations.
Publisher: Elsevier BV
Date: 10-2017
DOI: 10.1016/J.INJURY.2017.08.014
Abstract: Segmental tibial fractures are complex injuries with a prolonged recovery time. Current definitive treatment options include intramedullary fixation or a circular external fixator. However, there is uncertainty as to which surgical option is preferable and there are no sufficiently rigorous multi-centre trials that have answered this question. The objective of this study was to determine whether patient and surgeon opinion was permissive for a randomised controlled trial (RCT) comparing intramedullary nailing to the application of a circular external fixator. A convenience questionnaire survey of attending surgeons was conducted during the United Kingdom's Orthopaedic Trauma Society annual meeting 2017 to determine the treatment modalities used for a segmental tibial fracture (n=63). Patient opinion was obtained from clinical patients who had been treated for a segmental tibial fracture as part of a patient and public involvement focus group with questions covering the domains of surgical preference, treatment expectations, outcome, the consent process and follow-up regime (n=5). Based on the surgeon survey, 39% routinely use circular frame fixation following segmental tibial fracture compared to 61% who use nail fixation. Nail fixation was reported as the treatment of choice for a closed injury in a healthy patient in 81% of surgeons, and by 86% for a patient with a closed fracture who was obese. Twenty-one percent reported that they would use a nail for an open segmental tibia fracture in diabetics who smoked, whilst 57% would opt for a nail for a closed injury with compartment syndrome, and only 27% would use a nail for an open segmental injury in a young fit sports person. The patient and public preference exercise identified that sleep, early functional outcomes and psychosocial measures of outcomes are important. We concluded that a RCT comparing definitive fixation with an intramedullary nail and a circular external fixator is justified as there remains uncertainty on the optimal surgical management for segmental tibial fractures. Furthermore, psychosocial factors and early post-operative outcomes should be reported as core outcome measures as part of such a trial.
Publisher: Springer Science and Business Media LLC
Date: 28-09-2022
DOI: 10.1007/S11136-022-03262-4
Abstract: In order to enable cost-utility analysis of shoulder pain conditions and treatments, this study aimed to develop and evaluate mapping algorithms to estimate the EQ-5D health index from the Oxford Shoulder Score (OSS) when health outcomes are only assessed with the OSS. 5437 paired OSS and EQ-5D questionnaire responses from four national multicentre randomised controlled trials investigating different shoulder pathologies and treatments were split into training and testing s les. Separate EQ-5D-3L and EQ-5D-5L analyses were undertaken. Transfer to utility (TTU) regression (univariate linear, polynomial, spline, multivariable linear, two-part logistic-linear, tobit and adjusted limited dependent variable mixture models) and response mapping (ordered logistic regression and seemingly unrelated regression (SUR)) models were developed on the training s le. These were internally validated, and their performance evaluated on the testing s le. Model performance was evaluated over 100-fold repeated training–testing s le splits. For the EQ-5D-3L analysis, the multivariable linear and splines models had the lowest mean square error (MSE) of 0.0415. The SUR model had the lowest mean absolute error (MAE) of 0.136. Model performance was greatest in the mid-range and best health states, and lowest in poor health states. For the EQ-5D-5L analyses, the multivariable linear and splines models had the lowest MSE (0.0241–0.0278) while the SUR models had the lowest MAE (0.105–0.113). The developed models now allow accurate estimation of the EQ-5D health index when only the OSS responses are available as a measure of patient-reported health outcome.
Publisher: BMJ
Date: 08-2021
DOI: 10.1136/BMJOPEN-2021-052598
Abstract: To evaluate whether a home-based rehabilitation programme for people assessed as being at risk of a poor outcome after knee arthroplasty offers superior outcomes to traditional outpatient physiotherapy. A prospective, single-blind, two-arm randomised controlled superiority trial. 14 National Health Service physiotherapy departments in the UK. 621 participants identified at high risk of a poor outcome after knee arthroplasty using a bespoke screening tool. A multicomponent home-based rehabilitation programme delivered by rehabilitation assistants with supervision from qualified therapists versus usual care outpatient physiotherapy. The primary outcome was the Late-Life Function and Disability Instrument (LLFDI) at 12 months. Secondary outcomes were the Oxford Knee Score (a disease-specific measure of function), Knee injury and Osteoarthritis Outcome Score Quality of Life subscale, Physical Activity Scale for the Elderly, 5 dimension, 5 level version of Euroqol (EQ-5D-5L) and physical function assessed using the Figure of 8 Walk test, 30 s Chair Stand Test and Single Leg Stance. 621 participants were randomised between March 2015 and January 2018. 309 were assigned to CORKA (Community Rehabilitation after Knee Arthroplasty) home-based rehabilitation, receiving a median five treatment sessions (IQR 4–7). 312 were assigned to usual care, receiving a median 4 sessions (IQR 2–6). The primary outcome, LLFDI function total score at 12 months, was collected for 279 participants (89%) in the home-based CORKA group and 287 participants (92%) in the usual care group. No clinically or statistically significant difference was found between the groups (intention-to-treat adjusted difference=0.49 points 95% CI −0.89 to 1.88 p=0.48). There were no statistically significant differences between the groups on any of the patient-reported or physical secondary outcome measures at 6 or 12 months. There were 18 participants in the intervention group reporting a serious adverse event (5.8%), only one directly related to the intervention, all other adverse events recorded throughout the trial related to underlying chronic medical conditions. The CORKA intervention was not superior to usual care. The trial detected no significant differences, clinical or statistical, between the two groups on either primary or secondary outcomes. CORKA offers an evaluation of an intervention utilising a different service delivery model for this patient group. ISRCTN13517704 .
Publisher: Elsevier BV
Date: 03-2014
Publisher: Elsevier BV
Date: 04-2012
Publisher: National Institute for Health and Care Research
Date: 04-2020
DOI: 10.3310/HTA24200
Abstract: Late-stage medial compartment knee osteoarthritis can be treated using total knee replacement or partial (unicompartmental) knee replacement. There is high variation in treatment choice and insufficient evidence to guide selection. To assess the clinical effectiveness and cost-effectiveness of partial knee replacement compared with total knee replacement in patients with medial compartment knee osteoarthritis. The findings are intended to guide surgical decision-making for patients, surgeons and health-care providers. This was a randomised, multicentre, pragmatic comparative effectiveness trial that included an expertise component. The target s le size was 500 patients. A web-based randomisation system was used to allocate treatments. Twenty-seven NHS hospitals (68 surgeons). Patients with medial compartment knee osteoarthritis. The trial compared the overall management strategy of partial knee replacement treatment with total knee replacement treatment. No specified brand or subtype of implant was investigated. The Oxford Knee Score at 5 years was the primary end point. Secondary outcomes included activity scores, global health measures, transition items, patient satisfaction (Lund Score) and complications (including reoperation, revision and composite ‘failure’ – defined by minimal Oxford Knee Score improvement and/or reoperation). Cost-effectiveness was also assessed. A total of 528 patients were randomised (partial knee replacement, n = 264 total knee replacement, n = 264). The follow-up primary outcome response rate at 5 years was 88% and both operations had good outcomes. There was no significant difference between groups in mean Oxford Knee Score at 5 years (difference 1.04, 95% confidence interval –0.42 to 2.50). An area under the curve analysis of the Oxford Knee Score at 5 years showed benefit in favour of partial knee replacement over total knee replacement, but the difference was within the minimal clinically important difference [mean 36.6 (standard deviation 8.3) ( n = 233), mean 35.1 (standard deviation 9.1) ( n = 231), respectively]. Secondary outcome measures showed consistent patterns of benefit in the direction of partial knee replacement compared with total knee replacement although most differences were small and non-significant. Patient-reported improvement (transition) and reflection (would you have the operation again?) showed statistically significant superiority for partial knee replacement only, but both of these variables could be influenced by the lack of blinding. The frequency of reoperation (including revision) by treatment received was similar for both groups: 22 out of 245 for partial knee replacement and 28 out of 269 for total knee replacement patients. Revision rates at 5 years were 10 out of 245 for partial knee replacement and 8 out of 269 for total knee replacement. There were 28 ‘failures’ of partial knee replacement and 38 ‘failures’ of total knee replacement (as defined by composite outcome). Beyond 1 year, partial knee replacement was cost-effective compared with total knee replacement, being associated with greater health benefits (measured using quality-adjusted life-years) and lower health-care costs, reflecting lower costs of the index surgery and subsequent health-care use. It was not possible to blind patients in this study and there was some non-compliance with the allocated treatment interventions. Surgeons providing partial knee replacement were relatively experienced with the procedure. Both total knee replacement and partial knee replacement are effective, offer similar clinical outcomes and have similar reoperation and complication rates. Some patient-reported measures of treatment approval were significantly higher for partial knee replacement than for total knee replacement. Partial knee replacement was more cost-effective (more effective and cost saving) than total knee replacement at 5 years. Further (10-year) follow-up is in progress to assess the longer-term stability of these findings. Current Controlled Trials ISRCTN03013488 and ClinicalTrials.gov NCT01352247. This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment Vol. 24, No. 20. See the NIHR Journals Library website for further project information.
Publisher: BMJ
Date: 10-2023
Publisher: BMJ
Date: 07-2020
DOI: 10.1136/BMJOPEN-2019-028915
Abstract: To estimate the relationship between patient characteristics and referral decisions made by musculoskeletal hubs, and to assess the possible impact of an evidence-based referral tool. Retrospective analysis of medical records and decision tree model evaluating policy changes using local and national data. One musculoskeletal interface clinic (hub) in England. 922 adults aged ≥50 years referred by general practitioners with symptoms of knee or hip osteoarthritis. We assessed the current frequency and determinants of referrals from one hub and the change in referrals that would occur at this centre and nationally if evidence-based thresholds for referral (Oxford Knee and Hip Scores, OKS/OHS) were introduced. OKS/OHS, referrals for surgical assessment, referrals for arthroplasty, costs and quality-adjusted life years. Of 110 patients with knee symptoms attending face-to-face hub consultations, 49 (45%) were referred for surgical assessment the mean OKS for these 49 patients was 18 (range: 1–41). Of 101 hip patients, 36 (36%) were referred for surgical assessment (mean OHS: 21, range: 5–44). No patients referred for surgical assessment were above previously reported economic thresholds for OKS (43) or OHS (45). Setting thresholds of OKS ≤31 and OHS ≤35 might have resulted in an additional 22 knee referrals and 26 hip referrals in our cohort. Extrapolating hub results across England suggests a possible increase in referrals nationally, of around 13 000 additional knee replacements and 4500 additional hip replacements each year. Musculoskeletal hubs currently consider OKS/OHS and other factors when making decisions about referral to secondary care for joint replacement. Those referred typically have low OHS/OKS, and introducing evidence-based OKS/OHS thresholds would prevent few inappropriate (high-functioning, low-pain) referrals. However, our findings suggest that some patients not currently referred could benefit from arthroplasty based on OKS/OHS. More research is required to explore other important patient characteristics currently influencing hub decisions.
Publisher: Elsevier BV
Date: 09-2008
Publisher: Scientific Archives LLC
Date: 31-12-2021
Publisher: Elsevier BV
Date: 04-2009
DOI: 10.1016/J.MEDENGPHY.2008.05.007
Abstract: The recent development in Oxford lateral unicompartmental knee arthroplasty (UKA) design requires a valid method of assessing its kinematics. In particular, the use of single plane fluoroscopy to reconstruct the 3D kinematics of the implanted knee. The method has been used previously to investigate the kinematics of UKA, but mostly it has been used in conjunction with total knee arthroplasty (TKA). However, no accuracy assessment of the method when used for UKA has previously been reported. In this study we performed computer simulation tests to investigate the effect of the different geometry of the unicompartmental implant has on the accuracy of the method in comparison to the total knee implants. A phantom was built to perform in vitro tests to determine the accuracy of the method for UKA. The computer simulations suggested that the use of the method for UKA would prove less accurate than for TKA's. The rotational degrees of freedom for the femur showed greatest disparity between the UKA and TKA. The phantom tests showed that the in-plane translations were accurate to <0.5mm RMS and the out-of-plane translations were less accurate with 4.1mm RMS. The rotational accuracies were between 0.6 degrees and 2.3 degrees which are less accurate than those reported in the literature for TKA, however, the method is sufficient for studying overall knee kinematics.
Publisher: Elsevier BV
Date: 03-1996
Publisher: Elsevier BV
Date: 2017
DOI: 10.1016/J.MSKSP.2016.12.007
Abstract: Space medicine offers some unique challenges, especially in terms of research methodology. A specific challenge for astronaut reconditioning involves identification of what aspects of terrestrial research methodology hold and which require modification. This paper reviews this area and presents appropriate solutions where possible. It is concluded that spaceflight rehabilitation research should remain question roblem driven and is broadly similar to the terrestrial equivalent on small populations, such as rare diseases and various sports. Astronauts and Medical Operations personnel should be involved at all levels to ensure feasibility of research protocols. There is room for creative and hybrid methodology but careful systematic observation is likely to be more achievable and fruitful than complex trial based comparisons. Multi-space agency collaboration will be critical to pool data from small groups of astronauts with the accepted use of standardised outcome measures across all agencies. Systematic reviews will be an essential component. Most limitations relate to the inherent small s le size available for human spaceflight research. Early adoption of a co-operative model for spaceflight rehabilitation research is therefore advised.
Publisher: Springer Science and Business Media LLC
Date: 07-01-2021
DOI: 10.1186/S40814-020-00714-X
Abstract: Clinically, a distinction is made between types of rotator cuff tear, traumatic and non-traumatic, and this sub-classification currently informs the treatment pathway. It is currently recommended that patients with traumatic rotator cuff tears are fast tracked for surgical opinion. However, there is uncertainty about the most clinically and cost-effective intervention for patients with traumatic rotator cuff tears and further research is required. SPeEDy will assess the feasibility of a fully powered, multi-centre randomised controlled trial (RCT) to test the hypothesis that, compared to surgical repair (and usual post-operative rehabilitation), a programme of physiotherapist-led exercise is not clinically inferior, but is more cost-effective for patients with traumatic rotator cuff tears. SPeEDy is a two-arm, multi-centre pilot and feasibility RCT with integrated Quintet Recruitment Intervention (QRI) and further qualitative investigation of patient experience. A total of 76 patients with traumatic rotator cuff tears will be recruited from approximately eight UK NHS hospitals and randomly allocated to either surgical repair and usual post-operative rehabilitation or a programme of physiotherapist-led exercise. The QRI is a mixed-methods approach that includes data collection and analysis of screening logs, audio recordings of recruitment consultations, interviews with patients and clinicians involved in recruitment, and review of study documentation as a basis for developing action plans to address identified difficulties whilst recruitment to the RCT is underway. A further s le of patient participants will be purposively s led from both intervention groups and interviewed to explore reasons for initial participation, treatment acceptability, reasons for non-completion of treatment, where relevant, and any reasons for treatment crossover. Research to date suggests that there is uncertainty regarding the most clinically and cost-effective interventions for patients with traumatic rotator cuff tears. There is a clear need for a high-quality, fully powered, RCT to better inform clinical practice. Prior to this, we first need to undertake a pilot and feasibility RCT to address current uncertainties about recruitment, retention and number of and reasons for treatment crossover. ClinicalTrials.gov ( NCT04027205 ) – Registered on 19 July 2019. Available via
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 03-2005
DOI: 10.1097/01.BLO.0000150372.92398.BA
Abstract: We did an in vivo fluoroscopic study comparing the sagittal plane kinematics of mobile-bearing and fixed-bearing total knee arthroplasties in a unique group of patients. These patients were part of a larger bilateral randomized controlled outcome trial with each patient having received both types of total knee arthroplasties. Invited patients did three exercises with each of their different knee replacements extension against gravity, flexion against gravity, and a step-up. These exercises were recorded using video fluoroscopy, and a series of still digital images over the flexion range were retrieved. The relationship of patella tendon angle to knee flexion angle for each patient was derived. The patella tendon angle to knee flexion angle of the mobile-bearing knee behaved in a linear manner more closely replicating the normal knee, whereas the fixed-bearing knee behaved in a nonlinear, more variable manner. This pattern of results was similar for all three exercises with each patient having one knee replacement that behaved differently in the sagittal plane when compared with their other knee replacement. These kinematic differences may explain the clinical differences observed in the randomized controlled trials that compared these two total knee arthroplasties.
Publisher: Elsevier BV
Date: 03-2001
DOI: 10.1016/S0968-0160(01)00062-X
Abstract: A randomised controlled trial was performed to evaluate early outcome for two types of anterior cruciate ligament reconstruction. Sixty patients undergoing cruciate reconstruction were randomized into two groups. Group PT underwent reconstruction using a patella tendon autograft, whereas Group (SG) had a semitendinosus/gracilis autograft (SG). IKDC, Lysholm, and Tegner scores, KT1000 values and muscle strength were recorded pre-operatively, at 6 months and 1 year follow up. The functional scores, activity level, muscle strength and anterior tibial translation improved in both groups. No significant difference between groups was found for any measurement at 6 months and 1 year despite adequate study power. The study indicates that the 1 year results for either technique are equally favourable.
Publisher: BMJ
Date: 13-10-2020
DOI: 10.1136/BMJ.M3576
Abstract: To evaluate whether a progressive course of outpatient physiotherapy offers superior outcomes to a single physiotherapy review and home exercise based intervention when targeted at patients with a predicted poor outcome after total knee arthroplasty. Parallel group randomised controlled trial. 13 secondary and tertiary care centres in the UK providing postoperative physiotherapy. 334 participants with knee osteoarthritis who were defined as at risk of a poor outcome after total knee arthroplasty, based on the Oxford knee score, at six weeks postoperatively. 163 were allocated to therapist led outpatient rehabilitation and 171 to a home exercise based protocol. All participants were reviewed by a physiotherapist and commenced 18 sessions of rehabilitation over six weeks, either as therapist led outpatient rehabilitation (progressive goal oriented functional rehabilitation protocol, modified weekly in one-one contact sessions) or as physiotherapy review followed by a home exercise based regimen (without progressive input from a physiotherapist). Primary outcome was Oxford knee score at 52 weeks, with a 4 point difference between groups considered to be clinically meaningful. Secondary outcomes included additional patient reported outcome measures of pain and function at 14, 26, and 52 weeks post-surgery. 334 patients were randomised. Eight were lost to follow-up. Intervention compliance was more than 85%. The between group difference in Oxford knee score at 52 weeks was 1.91 (95% confidence interval −0.18 to 3.99) points, favouring the outpatient rehabilitation arm (P=0.07). When all time point data were analysed, the between group difference in Oxford knee score was a non-clinically meaningful 2.25 points (0.61 to 3.90, P=0.01). No between group differences were found for secondary outcomes of average pain (0.25 points, −0.78 to 0.28, P=0.36) or worst pain (0.22 points, −0.71 to 0.41, P=0.50) at 52 weeks or earlier time points, or of satisfaction with outcome (odds ratio 1.07, 95% confidence interval 0.71 to 1.62, P=0.75) or post-intervention function (4.64 seconds, 95% confidence interval −14.25 to 4.96, P=0.34). Outpatient therapist led rehabilitation was not superior to a single physiotherapist review and home exercise based regimen in patients at risk of poor outcomes after total knee arthroplasty. No clinically relevant differences were observed across primary or secondary outcome measures. Current Controlled Trials ISRCTN23357609 and ClinicalTrials.gov NCT01849445 .
Publisher: Elsevier BV
Date: 04-2022
DOI: 10.1016/J.SPINEE.2021.11.007
Abstract: Prolonged bedrest induces accumulation of intramuscular lipid concentration (ILC) in the lumbar musculature however, spatial distribution of ILC has not been determined. Artificial gravity (AG) mitigates some adaptations induced by 60 day bedrest by creating a head-to-feet force while participants are in a supine position. To quantify the spatial distribution of accumulation of ILC in the lumbar musculature after 60 day bedrest, and whether this can be mitigated by AG exposure. Prospective longitudinal study. Twenty-four healthy in iduals (8 females) participated in the study: Eight received 30 min continuous AG (cAG) Eight received 6 × 5 min AG (iAG), interspersed with rests Eight were not exposed to AG (CRTL). From 3T magnetic resonance imaging (MRI), axial images were selected to assess lumbar multifidus (LM), lumbar erector spinae (LES), quadratus lumborum (QL), and psoas major (PM) muscles from L1/L2 to L5/S1 intervertebral disc levels. Chemical shift-based 2-echo lipid and/or water Dixon sequence was used to measure tissue composition. Each lumbar muscle was segmented into four equal quartiles (from medial to lateral). Participants arrived at the facility for the baseline data collection before undergoing a 60 day strict 6° head-down tilt (HDT) bedrest period. MRI of the lumbopelvic region was conducted at baseline and Day-59 of bedrest. Participants performed all activities, including hygiene, in 6° HDT and were discouraged from moving excessively or unnecessarily. At the L4/L5 and L5/S1 intervertebral disc levels, 60-day bedrest induced a greater increase in ILC in medial and lateral regions (∼+4%) of the LM than central regions (∼+2% p<.05). A smaller increase in ILC was induced in the lateral region of LES (∼+1%) at L1/L2 and L2/L3 than at the centro-medial region (∼+2% p<.05). There was no difference between CRTL and intervention groups. Inhomogeneous spatial distribution of accumulation of ILC was found in the lumbar musculature after 60 day bedrest. These findings might reflect pathophysiological mechanisms related to muscle disuse and contribute to localized lumbar spine dysfunction. Altered spatial distribution of ILC may impair lumbar spine function after prolonged body unloading, which could increase injury risk to vulnerable soft tissues, such as the lumbar intervertebral discs. These novel results may represent a new biomarker of lumbar deconditioning for astronauts, bedridden, sedentary in iduals, or those with chronic back pain. Changes are potentially modifiable but not by the AG protocols tested here.
Publisher: Springer Science and Business Media LLC
Date: 08-2023
DOI: 10.1186/S13643-023-02290-6
Abstract: The aim of this systematic review was to summarise the evidence for the clinical effectiveness of revision knee arthroplasty (rKA) compared to non-operative treatment for the management of patients with elective, aseptic causes for a failed knee arthroplasty. MEDLINE, Embase, AMED and PsychINFO were searched from inception to 1st December 2020 for studies on patients considering elective, aseptic rKA. Patient-relevant outcomes (PROs) were defined as implant survivorship, joint function, quality of life (QoL), complications and hospital admission impact. No studies compared elective, aseptic rKA to non-operative management. Forty uncontrolled studies reported on PROs following elective, aseptic rKA (434434 rKA). Pooled estimates for implant survivorship were: 95.5% (95% CI 93.2–97.7%) at 1 year [seven studies (5524 rKA)], 90.8% (95% CI 87.6–94.0%) at 5 years [13 studies (5754 rKA)], 87.4% (95% CI 81.7–93.1%) at 10 years [nine studies (2188 rKA)], and 83.2% (95% CI 76.7–89.7%) at 15 years [two studies (452 rKA)]. Twelve studies (2382 rKA) reported joint function and/or QoL: all found large improvements from baseline to follow-up. Mortality rates were low (0.16% to 2% within 1 year) [four studies (353064 rKA)]. Post-operative complications were common (9.1 to 37.2% at 90 days). Higher-quality evidence is needed to support patients with decision-making in elective, aseptic rKA. This should include studies comparing operative and non-operative management. Implant survivorship following elective, aseptic rKA was ~ 96% at 1 year, ~ 91% at 5 years and ~ 87% at 10 years. Early complications were common after elective, aseptic rKA and the rates summarised here can be shared with patients during informed consent. PROSPERO CRD42020196922
Publisher: British Editorial Society of Bone & Joint Surgery
Date: 09-2019
DOI: 10.1302/0301-620X.101B9.BJJ-2019-0335.R1
Abstract: The aim of this study was to determine the long-term risk of undergoing knee arthroplasty in a cohort of patients with meniscal tears who had undergone arthroscopic partial meniscectomy (APM). A retrospective national cohort of patients with a history of isolated APM was identified over a 20-year period. Patients with prior surgery to the same knee were excluded. The primary outcome was knee arthroplasty. Hazard ratios (HRs) were adjusted by patient age, sex, year of APM, Charlson comorbidity index, regional deprivation, rurality, and ethnicity. Risk of arthroplasty in the index knee was compared with the patient’s contralateral knee (with vs without a history of APM). A total of 834 393 patients were included (mean age 50 years 37% female). Of those with at least 15 years of follow-up, 13.49% (16 256/120 493 95% confidence interval (CI) 13.30 to 13.69) underwent subsequent arthroplasty within this time. In women, 22.07% (95% CI 21.64 to 22.51) underwent arthroplasty within 15 years compared with 9.91% of men (95% CI 9.71 to 10.12), corresponding to a risk ratio (RR) of 2.23 (95% CI 2.16 to 2.29). Relative to the general population, patients with a history of APM were over ten times more likely (RR 10.27 95% CI 10.07 to 10.47) to undergo arthroplasty rising to almost 40 times more likely (RR 39.62 95% CI 27.68 to 56.70) at a younger age (30 to 39 years). In patients with a history of APM in only one knee, the risk of arthroplasty in that knee was greatly elevated in comparison with the contralateral knee (no APM HR 2.99 95% CI 2.95 to 3.02). Patients developing a meniscal tear undergoing APM are at greater risk of knee arthroplasty than the general population. This risk is three-times greater in the patient’s affected knee than in the contralateral knee. Women in the cohort were at double the risk of progressing to knee arthroplasty compared with men. These important new reference data will inform shared decision making and enhance approaches to treatment, prevention, and clinical surveillance. Cite this article: Bone Joint J 2019 -B:1071–1080.
Publisher: Springer Science and Business Media LLC
Date: 11-2013
Publisher: SAGE Publications
Date: 15-06-2022
DOI: 10.1177/26320843221106950
Abstract: To test the feasibility of undertaking a simultaneous Study Within A Trial (SWAT) to train staff who recruit participants into surgical randomised controlled trials (RCTs), by assessing key uncertainties around recruitment, randomisation, intervention delivery and data collection. Twelve surgical RCTs were eligible. Interested sites (clusters) were randomised 1:1, with recruiting staff (surgeons and nurses) offered training or no training. The primary outcome was the feasibility of recruiting sites across multiple surgical trials simultaneously. Secondary outcomes included numbers/types of staff enrolled, attendance at training, training acceptability, confidence in recruiting and participant recruitment rates six months later. Four RCTs (33%) comprising 91 sites participated. Of these, 29 sites agreed to participate (32%) and were randomised to intervention (15 sites, 29 staff) or control (14 sites, 29 staff). Research nurses attended and found the training to be acceptable no surgeons attended. In the intervention group, there was evidence of increased confidence when pre- and post- training scores were compared (mean difference in change 1.42 95% CI 0.56, 2.27 p = 0.002). There was no effect on recruitment rate. It was feasible to randomise sites across four surgical RCTs in a simultaneous SWAT design. However, as small numbers of trials and sites participated, and no surgeons attended training, strategies to improve these aspects are needed for future evaluations.
Publisher: Springer Science and Business Media LLC
Date: 13-11-2018
Publisher: British Editorial Society of Bone & Joint Surgery
Date: 03-2014
DOI: 10.1302/0301-620X.96B3.32845
Abstract: The primary aim of this study was to develop a patient-reported Activity & Participation Questionnaire (the OKS-APQ) to supplement the Oxford knee score, in order to assess higher levels of activity and participation. The generation of items for the questionnaire involved interviews with 26 patients. Psychometric analysis (exploratory and confirmatory factor analysis and Rasch analysis) guided the reduction of items and the generation of a scale within a prospective study of 122 relatively young patients (mean age 61.5 years (42 to 71)) prior to knee replacement. A total of 99, completed pre-operative and six month post-operative assessments (new items, OKS, Short-Form 36 and American Knee Society Score). The eight-item OKS-APQ scale is unidimensional, reliable (Cronbach’s alpha 0.85 intraclass correlation coefficient (ICC) 0.79 or 0.92 when one outlier was excluded), valid (r 0.5 with related scales) and responsive (effect size 4.16). We recommend that it is used with the OKS with adults of all ages when further detail regarding the levels of activity and participation of a patient is required. Cite this article: Bone Joint J 2014 -B:332–8.
Publisher: British Editorial Society of Bone & Joint Surgery
Date: 12-2007
DOI: 10.1302/0301-620X.89B12.19259
Abstract: Patellofemoral joint degeneration is often considered a contraindication to medial unicompartmental knee replacement. We examined the validity of this preconception using information gathered prospectively on the intra-operative status of the patellofemoral joint in 824 knees in 793 consecutive patients who underwent Oxford unicondylar knee replacement for anteromedial osteoarthritis. All operations were performed between January 1998 and September 2005. A five-point grading system classified degeneration of the patellofemoral joint from none to full-thickness cartilage loss. A subclassification of the presence or absence of any full-thickness cartilage loss was subsequently performed to test selected hypotheses. Outcome was evaluated independently by physiotherapists using the Oxford and the American Knee Society Scores with a minimum follow-up of one year. Full-thickness cartilage loss on the trochlear surface was observed in 100 of 785 knees (13%), on the medial facet of the patella in 69 of 782 knees (9%) and on the lateral facet in 29 of 784 knees (4%). Full-thickness cartilage loss at any location was seen in 128 knees (16%) and did not produce a significantly worse outcome than those with a normal or near-normal joint surface. The severity of the degeneration at any of the intra-articular locations also had no influence on outcome. We concluded that, provided there is not bone loss and grooving of the lateral facet, damage to the articular cartilage of the patellofemoral joint to the extent of full-thickness cartilage loss is not a contraindication to the Oxford mobile-bearing unicompartmental knee replacement.
Publisher: Wiley
Date: 19-07-2019
Publisher: Elsevier BV
Date: 02-2020
DOI: 10.1016/J.CLINBIOMECH.2019.12.010
Abstract: Inertial sensors have the potential to provide objective and practical methods to assess joint and limb function in the clinical setting. The aim of this study is to evaluate the psychometric properties of inertial sensor metrics in the assessment of patients with subacromial shoulder pain. 25 patients with unilateral subacromial shoulder pain and 50 control subjects were recruited. Assessments were carried out on both shoulders for all participants during a short movement procedure. Patients had assessments repeated after receiving three months of physiotherapy. Inertial metrics evaluated included a smoothness measure and speed and power scores derived from the range of angular velocity and acceleration profiles. In idual shoulder scores and asymmetry scores were both evaluated in terms of reliability, known-group validity, convergent validity and responsiveness. Regression analysis identified age to be a significant predictor for all scores, therefore an age matched sub-cohort of control subjects was used for comparative analyses. All scores demonstrated inter-rater reliability (ICC = 0.48-0.82), were able to differentiate pathological from healthy shoulders (AUC = 0.62-0.91) and displayed significant changes following treatment. Scores derived from the range of acceleration and velocity profiles demonstrated the largest effect sizes (Cohens d = 0.8-1.35), and displayed the highest correlation with the Oxford Shoulder Score (r = -0.40 - -0.58). The scores investigated demonstrate good psychometric properties and have potential to complement existing methods of assessment in the clinical or research setting. Further work is required to fully understand their clinical relevance and optimise assessment methods and interpretation.
Publisher: Human Kinetics
Date: 02-2002
DOI: 10.1123/JSR.11.1.40
Abstract: To determine whether the triple-crossover hop and timed shuttle run are able to discriminate between injured and uninjured limbs in subjects with functional ankle instability. A comparative study involving the assessment of functional performance, conducted in a university gymnasium. A volunteer s le of 16 university-age subjects with unilateral functional ankle instability. The triple-crossover hop for distance and timed shuttle run measured functional performance, with the uninjured limb acting as a control. Subjects also rated their ankle symptoms using a self-report questionnaire. The triple-crossover hop and shuttle run did not detect functional deficit despite subjects’ self-report scores indicating functional impairment. Results of the triple-crossover hop and shuttle run used in the clinic should be interpreted with caution, because they will not necessarily identify functional impairment.
Publisher: BMJ
Date: 19-01-2019
DOI: 10.1136/BJSPORTS-2018-100195
Abstract: We investigated the temporal trend and the geographical variation in the rate of an anterior cruciate ligament (ACL) reconstruction and meniscal repair (MR) performed in England during a 20-year window. All hospital episodes for patients undergoing ACL reconstruction or MR between 1 April 1997 and 31 March 2017 were extracted by procedure code from the national hospital episode statistics. Age-standardised and sex-standardised rates of surgery were calculated using Office for National Statistics population data as the denominator and analysed over time both nationally and regionally by National Health Service clinical commissioning group (CCG). Between 1997–1998 and 2016–2017, there were 133 270 cases of ACL reconstruction (124 489 patients) and 42 651 cases of MR (41 120 patients) (isolated or simultaneous). Nationally, the rate of ACL reconstruction increased 12-fold from 2.0/100K population (95% CI 1.9 to 2.1) in 1997–1998 to 24.2/100K (95% CI 23.8 to 24.6) in 2016–2017. The rate of MR increased more than twofold from 3.0/100K (95% CI 2.8 to 3.1) in 1997–1998 to 7.3/100K (95% CI 7.1 to 7.5) in 2016–2017. Of these cases, the rate of simultaneous ACL reconstruction and MR was 2.6/100K (95% CI 2.5 to 2.8) in 2016/2017. In 2016–2017, for patients aged 20–29, the sex-standardised rate of ACL reconstruction was 76.9/100K (95% CI 74.9 to 78.9) and for MR was 19.8/100K (95% CI 18.8 to 20.9). Practice varied by region—in 2016–2017, 14.5% (30/207) of the CCGs performed more than twice the national average rate of ACL reconstruction and 15.0% (31/207) performed more than twice the national average rate of MR. The rate of ACL reconstruction (12-fold) and MR (2.4-fold) has increased in England over the last two decades. There is variation in these rates across geographical regions and further work is required to deliver standardised treatment guidance for appropriate use.
Publisher: John Wiley & Sons, Ltd
Date: 23-06-2014
Publisher: Elsevier BV
Date: 04-2012
Publisher: British Editorial Society of Bone & Joint Surgery
Date: 02-2009
DOI: 10.1302/0301-620X.91B2.21413
Abstract: We randomised 62 knees to receive either cemented or cementless versions of the Oxford unicompartmental knee replacement. The implants used in both arms of the study were similar, except that the cementless components were coated with porous titanium and hydroxyapatite. The tibial interfaces were studied with fluoroscopically-aligned radiographs. At one year there was no difference in clinical outcome between the two groups. Narrow radiolucent lines were seen at the bone-implant interfaces in 75% of cemented tibial components. These were partial in 43%, and complete in 32%. In the cementless implants, partial radiolucencies were seen in 7% and complete radiolucencies in none. These differences are statistically significant (p 0.0001) and imply satisfactory bone ingrowth into the cementless implants.
Publisher: Elsevier BV
Date: 12-2017
DOI: 10.1016/J.KNEE.2017.08.003
Abstract: Since 2011, the knee service at the Nuffield Orthopaedic Centre has been offering a neutralising medial opening wedge high tibial osteotomy (HTO) to a specific group of patients with genu varum and early knee osteoarthritis. An observation was made concerning this group of patients and the presence of CAM deformity at the hip. The aim of this study is to establish whether or not any association exists between the OA phenotype shared by our HTO group and the incidence of CAM deformity at the hip. A cross-sectional study was designed to estimate the prevalence of CAM-type lesions across different groups of in iduals. Our HTO group (n=30) was compared to a pre-arthroplasty group (n=20) and control group (n=20). A total of 70 subjects were identified across the different groups all of whom had long-leg radiographs (LLRs) available for analysis. LLRs were analysed using an in house developed Matlab®-based (Matlab R2009b MathWorks) software package for hip measurements and MediCAD® (Hectec GmbH, Germany) for lower limb alignment measurements. The HTO group had a significantly higher prevalence of CAM lesions (57%) than both the pre-arthroplasty (40%) and control (30%) groups. This difference was maintained when results were adjusted for potential confounding factors (age, gender and laterality). Across the groups, in iduals with tibia vara were more likely to have CAM-deformity of the hip (p=0.021). Patients with symptomatic early knee OA and varus deformity of the knee have a high prevalence of CAM deformity in the hip.
Publisher: IEEE
Date: 2014
Publisher: British Editorial Society of Bone & Joint Surgery
Date: 11-2014
DOI: 10.1302/2046-3758.311.2000313
Abstract: The objective of this study was to explore dimensionality of the Oxford Hip Score (OHS) and examine whether self-reported pain and functioning can be distinguished in the form of subscales. This was a secondary data analysis of the UK NHS hospital episode statistics atient-reported outcome measures dataset containing pre-operative OHS scores on 97 487 patients who were undergoing hip replacement surgery. The proposed number of factors to extract depended on the method of extraction employed. Velicer’s Minimum Average Partial test and the Parallel Analysis suggested one factor, the Cattell’s scree test and Kaiser-over-1 rule suggested two factors. Exploratory factor analysis demonstrated that the two-factor OHS had most of the items saliently loading either of the two factors. These factors were named ‘Pain’ and ‘Function’ and their respective subscales were created. There was some cross-loading of items: 8 (pain on standing up from a chair) and 11 (pain during work). These items were assigned to the ‘Pain’ subscale. The final ‘Pain’ subscale consisted of items 1, 8, 9, 10, 11 and 12. The ‘Function’ subscale consisted of items 2, 3, 4, 5, 6 and 7, with the recommended scoring of the subscales being from 0 (worst) to 100 (best). Cronbach’s alpha was 0.855 for the ‘Pain’ subscale and 0.861 for the ‘Function’ subscale. A confirmatory factor analysis demonstrated that the two-factor model of the OHS had a better fit. However, none of the one-factor or two-factor models was rejected. Factor analyses demonstrated that, in addition to current usage as a single summary scale, separate information on pain and self-reported function can be extracted from the OHS in a meaningful way in the form of subscales. Cite this article: Bone Joint Res 2014 :305–9.
Publisher: British Editorial Society of Bone & Joint Surgery
Date: 12-2007
DOI: 10.1302/0301-620X.89B12.19260
Abstract: Anterior knee pain and/or radiological evidence of degeneration of the patellofemoral joint are considered to be contraindications to unicompartmental knee replacement. The aim of this study was to determine whether this is the case. Between January 2000 and September 2003, in 100 knees (91 patients) in which Oxford unicompartmental knee replacements were undertaken for anteromedial osteoarthritis, pre-operative anterior knee pain and the radiological status of the patellofemoral joint were defined using the Altman and Ahlback systems. Outcome was evaluated at two years with the Oxford knee score and the American Knee Society score. Pre-operatively 54 knees (54%) had anterior knee pain. The clinical outcome was independent of the presence or absence of pre-operative anterior knee pain. Degenerative changes of the patellofemoral joint were seen in 54 patients (54%) on the skyline radiographs, including ten knees (10%) with joint space obliteration. Patients with medial patellofemoral degeneration had a similar outcome to those without. For some outcome measures patients with lateral patellofemoral degeneration had a worse score than those without, but these patients still had a good outcome, with a mean Oxford knee score of 37.6 (SD 9.5). These results show that neither anterior knee pain nor radiologically-demonstrated medial patellofemoral joint degeneration should be considered a contraindication to Oxford unicompartmental knee replacement. With lateral patellofemoral degeneration the situation is less well defined and caution should be observed.
Publisher: BMJ
Date: 12-2020
DOI: 10.1136/BMJOPEN-2020-039552
Abstract: To appraise studies reporting on clinical effectiveness and safety of surgical meshes used to augment rotator cuff repairs (RCRs). Systematic review and meta-analysis. MEDLINE, Embase and Cochrane databases were searched between April 2006 and April 2020. All studies evaluating adults (≥18 years) undergoing RCR were considered. There were no language restrictions. Screening, data extraction and quality appraisal were conducted by two independent reviewers. Meta-analysis was conducted using a random-effects models if ≥2 comparative studies reported the same outcome measure. Risk of bias assessment was undertaken for randomised (RoB2, Cochrane) and comparative studies (ROBINS-I, Cochrane). We included 60 studies, consisting of 7 randomised controlled trials, 13 observational comparative studies and 40 observational case series. All comparative studies reported on shoulder-specific functional outcome scores, 18 on the radiographic occurrence of re-tear and 14 on pain score metrics. All studies contained some risk of bias. Compared with non-augmented repair, a small improvement in shoulder-specific function or pain scores was observed for synthetic patches with a mean improvement of 6.7 points on the University of California Los Angles (UCLA) shoulder score (95% CI 0.1 to 13.4) and 0.46 point reduction on the Visual Analogue Scale (95% CI −0.74 to −0.17), respectively. A reduced likelihood of radiologically observed re-tear was observed for synthetic (risk ratio (RR) 0.41, 95% CI 0.27 to 0.61) and allograft (RR 0.34, 95% CI 0.18 to 0.65) patches. A total of 49 studies reported on the occurrence of complications. Slightly higher crude complication rates were observed following patch-augmented repair (2.1%) than standard repair (1.6%). While several studies suggest a decreased failure rate and small improvements in shoulder function and pain following augmented RCR, a paucity of rigorous clinical evaluation, for both effectiveness and safety, prevents firm recommendations. CRD42017057908.
Publisher: Oxford University Press (OUP)
Date: 30-07-2021
DOI: 10.1093/PTJ/PZAB186
Abstract: Physical therapy is routinely delivered to patients after discharge from the hospital following knee arthroplasty. Posthospitalization physical therapy is thought to be beneficial, particularly for those patients most at risk of poor outcome, the subgroup with persistent function-limiting pain, despite an apparently successful surgery. Research teams have undertaken 3 large-scale multicenter Phase 3 randomized clinical trials designed specifically for patients at risk of poor outcome following knee arthroplasty. All 3 trials screened for poor outcome risk using different methods and investigated different physical therapist interventions delivered in different ways. Despite the variety of types of physical therapy and mode of delivery, all trials found no effects of the enhanced treatment compared with usual care. In all cases, usual care required a lower dosage of physical therapy compared with the enhanced interventions. This Perspective compares and contrasts the 3 trials, speculates on factors that could explain the no-effect findings, and proposes areas for future study designed to benefit the poor outcome phenotype.
Publisher: British Editorial Society of Bone & Joint Surgery
Date: 05-2014
DOI: 10.1302/2046-3758.35.2000270
Abstract: This protocol describes a pragmatic multicentre randomised controlled trial (RCT) to assess the clinical and cost effectiveness of arthroscopic and open surgery in the management of rotator cuff tears. This trial began in 2007 and was modified in 2010, with the removal of a non-operative arm due to high rates of early crossover to surgery. Cite this article: Bone Joint Res 2014 :155–60.
Location: United Kingdom of Great Britain and Northern Ireland
Location: United Kingdom of Great Britain and Northern Ireland
Location: United Kingdom of Great Britain and Northern Ireland
Location: United Kingdom of Great Britain and Northern Ireland
Start Date: 2016
End Date: 2020
Funder: Zimmer Biomet
View Funded ActivityStart Date: 2012
End Date: 2016
Funder: Versus Arthritis
View Funded ActivityStart Date: 2021
End Date: 2023
Funder: NIHR Evaluation Trials and Studies Coordinating Centre
View Funded ActivityStart Date: 2012
End Date: 2013
Funder: Versus Arthritis
View Funded ActivityStart Date: 2016
End Date: 2023
Funder: National Institute for Health Research
View Funded ActivityStart Date: 2018
End Date: 2024
Funder: National Institute for Health Research
View Funded ActivityStart Date: 2020
End Date: 2023
Funder: Versus Arthritis
View Funded ActivityStart Date: 2018
End Date: 2021
Funder: Medical Research Council
View Funded ActivityStart Date: 2016
End Date: 2021
Funder: Wellcome Trust
View Funded ActivityStart Date: 2017
End Date: 2021
Funder: National Health and Medical Research Council
View Funded ActivityStart Date: 2018
End Date: 2020
Funder: Medical Research Council
View Funded ActivityStart Date: 2021
End Date: 2024
Funder: Versus Arthritis
View Funded ActivityStart Date: 2019
End Date: 2022
Funder: Action Medical Research
View Funded ActivityStart Date: 2020
End Date: 2029
Funder: National Institute for Health Research
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