Academic Journal
Recurrent patellar dislocation: personalised therapy or operative treatment? The REPPORT randomised trial protocol
العنوان: | Recurrent patellar dislocation: personalised therapy or operative treatment? The REPPORT randomised trial protocol |
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المؤلفون: | Arnold, S., Haque, A., Aujla, M., Barrows, R., Beard, D., Chandler, C., Chandler, E., Ellard, D. R., Eldridge, J., Ferreira, M., Foster, N. E., Griffin, J., Mason, J., Mandalia, V., Parsons, H., Ray, G., Stewart, K., Thompson, P., Underwood, M., Whitehouse, M. R., Zanganeh, M., Metcalfe, A., Smith, T. |
المساهمون: | Orthopaedic Department, Mandalia, Vipul |
بيانات النشر: | BMJ |
سنة النشر: | 2024 |
المجموعة: | RD&E Research Repository (Royal Devon and Exeter NHS Foundation Trust) |
مصطلحات موضوعية: | Humans, Patellar Dislocation/surgery/therapy, Recurrence, Cost-Benefit Analysis, Adult, Pragmatic Clinical Trials as Topic, Adolescent, Physical Therapy Modalities, Multicenter Studies as Topic, Young Adult, Orthopaedic & trauma surgery, Randomized Controlled Trial, Surgery, TRAUMA MANAGEMENT, (RACER-Knee and RACER-Hip) and one completed (START:REACTS) NIHR funded studies, (AM chief investigator of two) that have, or have had, additional support from, Stryker Ltd. There is no link to the current trial. AM, MU, HP, NEF and MF are, coinvestigators on grants funded by the Australian NHMRC. MU is chief, investigator or coinvestigator on multiple previous and current research grants, from the UK National Institute for Health Research and is a coinvestigator on, grants funded by the Norwegian MRC. He was an NIHR Senior Investigator until, March 2021. He is a director and shareholder of Clinvivo Ltd that provides, electronic data collection for health services research. He is part of an, academic partnership with Serco Ltd, funded by the European Social Fund |
الوصف: | INTRODUCTION: Recurrent patellar dislocation is a debilitating musculoskeletal condition, affecting mainly adolescents and adults under the age of 30. It can persist for many decades, causing pain and cartilage and soft-tissue damage, potentially leading to osteoarthritis. Recurrent patellar dislocation can be managed with physiotherapy or surgery. However, it is not known which treatment is most effective. METHODS AND ANALYSIS: Recurrent Patellar Dislocation: Personalised Therapy or Operative Treatment (REPPORT) is a pragmatic, multicentre, two-arm, superiority, randomised controlled trial. It will compare the clinical and cost-effectiveness of an initial management strategy of personalised, phased and progressive rehabilitation, termed personalised knee therapy versus surgery for recurrent patellar dislocation.The trial's target sample size is 276 participants who will be recruited from approximately 20 sites across the UK. Participants will be randomly allocated to the two treatment groups via a central computer-based minimisation system. Treatment allocation will be in a 1:1 ratio, stratified by age, presence of patella alta and recruitment site.The primary outcome is participant-reported function using the Knee injury and Osteoarthritis Outcome 4-domain score at 18 months post randomisation. Health economic evaluation will be conducted from a healthcare system and personal social services perspective. Secondary outcome data including patellar instability, health utility, work/education status, satisfaction with social roles and treatment, health resource use and adverse events will be collected at 6, 12, 18 and 24 months. Analysis will be on an intention-to-treat basis and reported in-line with the Consolidated Standards of Reporting Trials statement. ETHICS AND DISSEMINATION: The trial was approved by the East Midlands-Nottingham 2 Research Ethics Committee on 30 March 2023.Results will be disseminated via peer-reviewed publications, presentations at national and international conferences, in lay ... |
نوع الوثيقة: | article in journal/newspaper |
اللغة: | English |
Relation: | https://www.ncbi.nlm.nih.gov/pmc/articles/pmid/39174058/; Arnold S, Haque A, Aujla M, Barrows R, Beard D, Chandler C, et al. Recurrent patellar dislocation: personalised therapy or operative treatment? The REPPORT randomised trial protocol. BMJ open. 2024;14(8):e090233.; BMJ open; PMC11340708; https://hdl.handle.net/11287/623392 |
DOI: | 10.1136/bmjopen-2024-090233 |
الاتاحة: | https://hdl.handle.net/11287/623392 https://doi.org/10.1136/bmjopen-2024-090233 |
Rights: | © Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. |
رقم الانضمام: | edsbas.FE6E2630 |
قاعدة البيانات: | BASE |
DOI: | 10.1136/bmjopen-2024-090233 |
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