Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.
Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
BMJ Open. 2024 Aug 21;14(8):e090233. doi: 10.1136/bmjopen-2024-090233.
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.
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.
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.
ISRCTN17972668.
复发性髌骨脱位是一种使人虚弱的肌肉骨骼疾病，主要影响青少年和 30 岁以下的成年人。它可能持续数十年，导致疼痛和软骨及软组织损伤，潜在地导致骨关节炎。复发性髌骨脱位可以通过物理治疗或手术治疗。然而，尚不清楚哪种治疗方法最有效。
复发性髌骨脱位：个性化治疗或手术治疗（REPPORT）是一项实用的、多中心、双臂、优效性、随机对照试验。它将比较个性化、分阶段和渐进性康复的初始管理策略（称为个性化膝关节治疗）与复发性髌骨脱位的手术治疗的临床和成本效益。该试验的目标样本量为 276 名参与者，将从英国各地约 20 个地点招募。参与者将通过中央基于计算机的最小化系统随机分配到两个治疗组。治疗分配将按照 1:1 的比例进行，按年龄、髌骨高位和招募地点分层。主要结局是 18 个月随机分组后参与者报告的膝关节损伤和骨关节炎结局 4 域评分的功能。将从医疗保健系统和个人社会服务的角度进行健康经济学评价。次要结局数据包括髌骨不稳定、健康效用、工作/教育状况、对社会角色和治疗的满意度、卫生资源利用和不良事件，将在 6、12、18 和 24 个月收集。分析将基于意向治疗，并按照 CONSORT 声明报告。
该试验于 2023 年 3 月 30 日获得东米德兰兹-诺丁汉 2 研究伦理委员会的批准。结果将通过同行评议的出版物、在国家和国际会议上的演讲、在通俗易懂的摘要中、以及通过 REPPORT 网站和社交媒体渠道传播。
ISRCTN82435254。
