背景:半月板切除术后的疼痛和残疾可能是一个严重的终身问题。治疗方案很少,尤其是年轻人。非手术管理(康复)是一种选择,但越来越多的外科医生正在为这些人进行半月板同种异体移植(MATs)。然而,这仍然是一个不常见的程序,MAT的可用性和使用在英国和国际上差异很大。目前尚不清楚哪种治疗方案是最有效和最具成本效益的。
方法:半月板移植手术或优化康复试验是一项国际性的,多中心,随机对照试验。目的是比较MAT与个性化优化包装的临床和成本效益,进步,我们称之为个性化膝关节治疗(PKT)的康复。参与者将从英国各地的网站招募,澳大利亚,加拿大和比利时。计划的144名参与者在随机化后24个月(主要结果)提供至少90%的功效来检测膝关节损伤和骨关节炎结果评分(KOOS4)的10分差异。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。次要结果数据,包括健康效用,职业状况,体育参与,心理健康,进一步治疗,不良事件将在3,6,12,18和24个月收集。分析将在意向对待的基础上进行,并按照《综合报告标准试验声明》进行报告。
背景: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)和悉尼北部地方卫生区人类研究伦理委员会的批准,新南威尔士州,澳大利亚于2023年3月13日(2022/ETH01890)。试验结果将通过同行评审的出版物传播,在国际会议上的演讲,在摘要中,并酌情使用社交媒体。该方案符合推荐的标准方案项目:干预试验建议(SPIRIT)清单。
背景:ISRCTN87336549。
BACKGROUND: 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.
METHODS: 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.
BACKGROUND: 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.
BACKGROUND: ISRCTN87336549.