ORCID Profile
0000-0003-1818-5800
Current Organisation
University of Oxford
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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: 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: Wiley
Date: 30-09-2019
DOI: 10.1111/ECI.13169
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: Springer Science and Business Media LLC
Date: 12-2018
Publisher: Springer Science and Business Media LLC
Date: 11-2013
Publisher: Springer Science and Business Media LLC
Date: 11-2013
Publisher: Public Library of Science (PLoS)
Date: 02-04-2020
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: 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: 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: Springer Science and Business Media LLC
Date: 13-11-2018
Publisher: Springer Science and Business Media LLC
Date: 2013
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: 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: 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: 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: 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: Elsevier BV
Date: 2018
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: 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: Springer Science and Business Media LLC
Date: 08-08-2019
Publisher: Public Library of Science (PLoS)
Date: 21-09-2020
Publisher: BMJ
Date: 08-2016
Publisher: Springer Science and Business Media LLC
Date: 09-05-2015
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: 10-2004
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: 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: 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: 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
No related grants have been discovered for Jonathan Rees.