ORCID Profile
0000-0003-0055-7637
Current Organisations
Nottingham University Hospitals NHS Trust
,
University of Nottingham
,
Institute of Higher Education Academy
,
Royal College of Physicians
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Publisher: BMJ
Date: 06-2022
DOI: 10.1136/BMJOPEN-2021-059194
Abstract: Vertebral fragility fractures (VFFs) are the most common type of osteoporotic fracture found in older people, resulting in increasing morbidity and excess mortality. These fractures can cause significant pain, requiring admission to hospital. Vertebroplasty (VP) is effective in reducing pain and allowing early mobilisation in hospitalised patients. However, it may be associated with complications such as cement leakage, infection, bleeding at the injection site and fracture of adjacent vertebrae. It is also costly and not readily accessible in many UK hospitals. A recent retrospective study reported that spinal medial branch nerve block (MBNB), typically used to treat facet arthropathy, had similar efficacy in terms of pain relief compared with VP for the treatment of painful VFF. However, to date, no study has prospectively compared MBNB to VP. We therefore propose a prospective feasibility randomised controlled trial (RCT) to compare the role of MBNB to VP, in hospitalised older patients. A parallel, two-arm RCT with participants allocated on a 1:1 ratio to either standard care-VP or MBNB in hospitalised patients aged over 70 with acute osteoporotic vertebral fractures. Follow-up will be at weeks 1, 4 and 8 post intervention. The primary objective is to determine the feasibility and design of a future trial, including specific outcomes of recruitment, adherence to randomisation and safety. Embedded within the trial will be a health economic evaluation to understand resource utilisation and implications of the intervention and a qualitative study of the experiences and insights of trial participants and clinicians. Secondary outcomes will include pain scores, analgesia requirements, resource use and quality of life data. Ethical approval was granted by the Yorkshire & the Humber Research Ethics Committee ( reference 21/YH/0065 ). AVERT (Acute VertEbRal AugmentaTion) has received approval by the Health Research Authority ( reference IRAS 293210 ) and is sponsored by Nottingham University Hospitals NHS Trust ( reference 21HC001 ). Recruitment is ongoing. Results will be presented at relevant conferences and submitted to appropriate journals for publication on completion. NCT18334053 .
Publisher: BMJ
Date: 05-2022
DOI: 10.1136/BMJOPEN-2021-050535
Abstract: To determine the feasibility of designing and conducting a definitive trial to evaluate the effectiveness of sacral fracture fixation compared with non-surgical management among older people admitted with a lateral compression pelvic fragility fracture (PFF). Single-site, parallel, two-arm randomised controlled feasibility trial. A UK tertiary centre hospital. Patients aged ≥70 years who were ambulating pre-injury requiring hospital admission (within 28 days of injury) with a type 1 lateral compression PFF. The intervention group received sacral fracture fixation (cement augmentation±screw fixation) within 7 days of randomisation. Routine preoperative and postoperative care followed each surgical intervention. The control group received usual care consisting of analgesia, and regular input from the medical and therapy team. The feasibility outcomes were the number of eligible patients, willingness to be randomised, adherence to allocated treatment, retention, data on the completeness and variability of the proposed definitive trial outcome measures, and reported adverse events. 241 patients were screened. 13 (5.4%) were deemed eligible to participate. Among the eligible participants, nine (69.2%) were willing to participate. Five participants were randomised to the intervention group and four to the control group. The clinicians involved were willing to allow their patients to be randomised and adhere to the allocated treatment. One participant in the intervention group and two participants in the control group received their allocated treatment. All participants were followed up until 12 weeks post-randomisation, and had an additional safety follow-up assessment at 12 months. Overall, the proportion of completeness of outcome measures was at least 75%. No adverse events were directly related to the trial. There were significant challenges in recruiting sufficient participants which will need to be addressed prior to a definitive trial. ISRCTN16719542 .
Publisher: Massachusetts Medical Society
Date: 05-11-2020
Publisher: Springer Science and Business Media LLC
Date: 10-09-2009
Publisher: American College of Physicians
Date: 21-12-1999
DOI: 10.7326/0003-4819-131-12-199912210-00005
Abstract: Up to 3 years of treatment with alendronate, 5 mg/d, prevents postmenopausal bone loss. To determine whether the effect of alendronate is sustained at 4 years of treatment and persists after treatment is discontinued. Randomized, controlled trial. United States and Europe. 1609 postmenopausal women 45 to 59 years of age. Participants were randomly assigned to receive oral alendronate, 5 mg/d or 2.5 mg/d placebo or open-label estrogen-progestin. Women in the alendronate groups received alendronate for the first 2 years of the study. Treatment was then continued without change or replaced with placebo for the last 2 years of the study. Annual measurement of bone mineral density. By year 4, the bone mineral density of participants in the placebo group had decreased by 1% to 6% (P < 0.001). Four years of treatment with 5 mg of alendronate per day increased bone mineral density at the spine (mean change [+/-SE], 3.8%+/-0.3%), hip (mean, 2.9%+/-0.2%), and total body (mean, 0.9%+/-0.2%) (P < 0.001 overall). By year 4, bone mineral density at most skeletal sites was greater in participants who switched from alendronate to placebo than in those who continuously received placebo. In years 3 and 4, bone loss in participants who switched from alendronate to placebo was similar to that seen during years 1 and 2 in those who continuously received placebo. Compared with 5 mg of alendronate per day, estrogen-medroxyprogesterone acetate produced similar increases in bone mineral density and estradiol-norethisterone acetate produced increases that were substantially greater. Four years of treatment with alendronate or estrogen-progestin prevented postmenopausal bone loss. A residual effect was seen 2 years after alendronate therapy was stopped however, continuous alendronate treatment was more effective in preventing postmenopausal bone loss than 2 years of alendronate followed by 2 years of placebo.
Publisher: Oxford University Press (OUP)
Date: 18-10-2013
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
Location: United Kingdom of Great Britain and Northern Ireland
No related grants have been discovered for Opinder Sahota.