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. 2024 Aug 21;14(8):e090233.
doi: 10.1136/bmjopen-2024-090233.

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

Susanne Arnold  1 , Aminul Haque  1 , Manjit Aujla  1 , Raegan Barrows  1 , David Beard  2 , Craig Chandler  3 , Elizabeth Chandler  3 , David R Ellard  1   4 , Jonathan Eldridge  5 , Manuela Ferreira  6 , Nadine E Foster  7   8 , James Griffin  1 , James Mason  1 , Vipul Mandalia  9 , Helen Parsons  1   4 , Georgina Ray  1 , Kimberley Stewart  1 , Peter Thompson  4 , Martin Underwood  1   4 , Michael R Whitehouse  10   11 , Mandana Zanganeh  1 , Andrew Metcalfe  1   4 , Toby Smith  12
Affiliations

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

Susanne Arnold et al. BMJ Open. .

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.

Keywords: Orthopaedic & trauma surgery; Physical Therapy Modalities; Randomized Controlled Trial; SURGERY; TRAUMA MANAGEMENT.

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Conflict of interest statement

Competing interests: AM, MU, DRE, TS and HP are coinvestigators on two current (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, related to return-to-work initiatives. NEF is chief investigator or coinvestigator on multiple previous and current research grants from the UK NIHR, and Australian NHMRC and MRFF. She was an NIHR Senior Investigator and is currently an Australian National Health and Medical Research Council (NHMRC) Investigator Fellow (ID: 2018182). MRW undertakes teaching on basic sciences for Orthopaedic trainees preparing for the FRCS. His institution receives market rate payment for this teaching from Heraeus. MRW was a coapplicant on a grant funded by Stryker Ltd to investigate the outcomes of the Triathlon total knee replacement which is unrelated to this study. MRW is PI of the National Joint Registry lot 2 contract (statistical analysis) team and PI or coapplicant on multiple previous NIHR funded studies.

Figures

Figure 1
Figure 1. Recurrent Patellar Dislocation: Personalised Therapy or Operative Treatment (REPPORT) participant flow diagram. KOOS4, Knee injury and Osteoarthritis Outcome 4-domain score; PKT, personalised knee therapy.
See this image and copyright information in PMC

References

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