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Recurrent patellar dislocation: personalised therapy or operative treatment? The REPPORT randomised trial protocol

Authors :
Martin Underwood
Helen Parsons
James Mason
David Beard
Manuela Ferreira
Michael R Whitehouse
David R Ellard
Nadine E Foster
Peter Thompson
Kimberley Stewart
Andrew Metcalfe
Aminul Haque
Toby Smith
James Griffin
Mandana Zanganeh
Susanne Arnold
Manjit Aujla
Raegan Barrows
Craig Chandler
Elizabeth Chandler
Jonathan Eldridge
Vipul Mandalia
Georgina Ray
Source :
BMJ Open, Vol 14, Iss 8 (2024)
Publication Year :
2024
Publisher :
BMJ Publishing Group, 2024.

Abstract

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 summaries, and using the REPPORT website and social media channels.Trial registration number ISRCTN17972668.

Subjects

Subjects :
Medicine

Details

Language :
English
ISSN :
20240902 and 20446055
Volume :
14
Issue :
8
Database :
Directory of Open Access Journals
Journal :
BMJ Open
Publication Type :
Academic Journal
Accession number :
edsdoj.be3ce4baa32348c8961b137a8ebe8cc7
Document Type :
article
Full Text :
https://doi.org/10.1136/bmjopen-2024-090233