Department of Operating Rooms, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands
Department of Operating Rooms, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands.
BMJ Open. 2020 Mar 8;10(3):e031864. doi: 10.1136/bmjopen-2019-031864.
Arthroscopic partial meniscectomy (APM) after degenerative meniscus tears is one of the most frequently performed surgeries in orthopaedics. Although several randomised controlled trials (RCTs) have been published that showed no clear benefit compared with sham treatment or non-surgical treatment, the incidence of APM remains high. The common perception by most orthopaedic surgeons is that there are subgroups of patients that need APM to improve, and they argue that each study sample of the existing trials is not representative for the day-to-day patients in the clinic. Therefore, the objective of this individual participant data meta-analysis (IPDMA) is to assess whether there are subgroups of patients with degenerative meniscus lesions who benefit from APM in comparison with non-surgical or sham treatment.
An existing systematic review will be updated to identify all RCTs worldwide that evaluated APM compared with sham treatment or non-surgical treatment in patients with knee symptoms and degenerative meniscus tears. Time and effort will be spent in contacting principal investigators of the original trials and encourage them to collaborate in this project by sharing their trial data. All individual participant data will be validated for missing data, internal data consistency, randomisation integrity and censoring patterns. After validation, all datasets will be combined and analysed using a one-staged and two-staged approach. The RCTs' characteristics will be used for the assessment of clinical homogeneity and generalisability of the findings. The most important outcome will be the difference between APM and control groups in knee pain, function and quality of life 2 years after the intervention. Other outcomes of interest will include the difference in adverse events and mental health.
All trial data will be anonymised before it is shared with the authors. The data will be encrypted and stored on a secure server located in the Netherlands. No major ethical concerns remain. This IPDMA will provide the evidence base to update and tailor diagnostic and treatment protocols as well as (international) guidelines for patients for whom orthopaedic surgeons consider APM. The results will be submitted for publication in a peer-reviewed journal.
CRD42017067240.
关节镜下半月板部分切除术（APM）治疗退行性半月板撕裂是矫形外科最常进行的手术之一。尽管已经发表了几项随机对照试验（RCT），但与假手术或非手术治疗相比，并没有明显的获益，APM 的发生率仍然很高。大多数矫形外科医生的普遍看法是，有一些亚组患者需要进行 APM 以改善病情，他们认为现有试验的研究样本并不能代表诊所中的日常患者。因此，这项个体参与者数据荟萃分析（IPDMA）的目的是评估是否存在退行性半月板病变患者亚组，与非手术或假手术相比，他们从 APM 中获益。
将更新现有的系统评价，以确定全球范围内所有评估 APM 与假手术或非手术治疗膝关节症状和退行性半月板撕裂患者的 RCT。将花费时间和精力联系原始试验的主要研究者，并鼓励他们通过分享试验数据来参与本项目。所有个体参与者数据将验证缺失数据、内部数据一致性、随机化完整性和删失模式。验证后，将所有数据集合并并使用一阶段和两阶段方法进行分析。RCT 的特征将用于评估研究结果的临床同质性和普遍性。最重要的结果将是干预后 2 年时 APM 组和对照组在膝关节疼痛、功能和生活质量方面的差异。其他感兴趣的结果包括不良事件和心理健康方面的差异。
在与作者共享之前，所有试验数据将进行匿名处理。数据将被加密并存储在位于荷兰的安全服务器上。没有重大伦理问题。这项 IPDMA 将为更新和定制诊断和治疗方案以及（国际）患者指南提供证据基础，对于这些患者，矫形外科医生认为需要进行 APM。研究结果将提交给同行评议的期刊发表。
PROSPERO 注册号：CRD42017067240。
