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 (KOOS4) 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 six, 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 (CONSORT) statement.
Ethics and dissemination
The trial was approved by the East Midlands - Nottingham 2 Research Ethics Committee on 30th 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
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 (KOOS4) 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 six, 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 (CONSORT) statement.
Ethics and dissemination
The trial was approved by the East Midlands - Nottingham 2 Research Ethics Committee on 30th 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
Original language | English |
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Article number | e090233 |
Number of pages | 10 |
Journal | BMJ Open |
Volume | 14 |
Issue number | 8 |
DOIs | |
Publication status | Published - 21 Aug 2024 |
Bibliographical note
Publisher Copyright:© Author(s) (or their employer(s)) 2024.
Keywords
- recurrent patellar dislocation
- patellar instability
- physiotherapy
- exercise
- surgery
- randomised control trial