Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.
Cleveland Clinic London, London, UK.
BMJ Open. 2024 Jun 3;14(6):e085125. doi: 10.1136/bmjopen-2024-085125.
Pain and disability after meniscectomy can be a substantial lifelong problem. There are few treatment options, especially for young people. Non-surgical management (rehabilitation) is an option but increasingly surgeons are performing meniscal allograft transplants (MATs) for these individuals. However, this is still an uncommon procedure, and availability and usage of MAT vary widely both in the UK and internationally. It is not known which treatment option is the most effective and cost-effective.
The Meniscal Transplant surgery or Optimised Rehabilitation trial is an international, multicentre, randomised controlled trial. The aim is to compare the clinical and cost effectiveness of MAT versus an optimised package of individualised, progressive, rehabilitation that we have called personalised knee therapy (PKT).Participants will be recruited from sites across the UK, Australia, Canada and Belgium. The planned 144 participants provide at least 90% power to detect a 10-point difference in the Knee injury and Osteoarthritis Outcome Score (KOOS4) at 24-months post randomisation (primary outcome). A prospectively planned economic evaluation will be conducted from a healthcare system and personal social services perspective. Secondary outcome data including health utility, occupational status, sports participation, mental well-being, further treatment, and adverse events will be collected at 3, 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 London-Bloomsbury Research Ethics Committee on 19 August 2022 (22/LO/0327) and Northern Sydney Local Health District Human Research Ethics Committee, NSW, Australia on the 13 March 2023 (2022/ETH01890).Trial results will be disseminated via peer-reviewed publications, presentations at international conferences, in lay summaries and using social media as appropriate.This protocol adheres to the recommended Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist.
ISRCTN87336549.
半月板切除术后的疼痛和残疾可能是一个长期存在的严重问题。治疗选择很少，尤其是对于年轻人。非手术治疗（康复）是一种选择，但越来越多的外科医生为这些患者进行半月板同种异体移植（MAT）。然而，这仍然是一种不常见的手术，MAT 的可用性和使用在英国和国际上差异很大。目前还不清楚哪种治疗方案最有效和最具成本效益。
半月板移植手术或优化康复试验是一项国际性、多中心、随机对照试验。目的是比较 MAT 与我们称之为个性化、渐进式康复的个体化优化方案（个性化膝关节治疗，PKT）的临床和成本效益。参与者将从英国、澳大利亚、加拿大和比利时的多个站点招募。计划招募的 144 名参与者提供至少 90%的效力，以在随机分组后 24 个月检测膝关节损伤和骨关节炎结果评分（KOOS4）的 10 分差异（主要结局）。将从医疗保健系统和个人社会服务的角度进行前瞻性计划的经济评估。次要结局数据包括健康效用、职业状况、运动参与、心理健康、进一步治疗和不良事件，将在 3、6、12、18 和 24 个月收集。分析将基于意向治疗，并按照临床试验报告的统一标准报告。
该试验于 2022 年 8 月 19 日获得伦敦布卢姆斯伯里研究伦理委员会（22/LO/0327）和澳大利亚新南威尔士州北悉尼地方卫生区人类研究伦理委员会的批准，并于 2023 年 3 月 13 日获得批准（2022/ETH01890）。试验结果将通过同行评审的出版物、国际会议的演讲、通俗易懂的摘要和适当的社交媒体进行传播。本方案符合推荐的干预试验标准协议项目清单（SPIRIT）检查表。
ISRCTN87336549。
