Department of Rehabilitation, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Department of Orthopaedic Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Ann Palliat Med. 2021 May;10(5):5908-5918. doi: 10.21037/apm-21-48. Epub 2021 Apr 15.
Recent studies show similar outcomes between lysis of adhesions (LOA) and manipulation under anaesthesia (MUA) in patients with arthrofibrosis within 3 to 6 months after arthroscopic knee procedures. As MUA offers positive efficacy with less expense and more convenience, the first consideration in clinical practice shifting to MUA may save much medical cost when MUA is non-inferior to surgery. There is a lack of evidence comparing the clinical outcomes of these two surgical techniques. The purpose of our study is to determine whether MUA is non-inferior to LOA for improving clinical outcomes in patients with loss of flexion within 3 and 6 months after arthroscopic knee surgery.
This multicentre randomized controlled trial (RCT) will recruit 360 patients within 3 to 6 months after arthroscopic knee surgery with a magnetic resonance imaging (MRI)-confirmed arthrofibrosis to prove non-inferiority of MUA. Patients are randomly assigned to the LOA group (n=180) or the MUA group (n=180) in a 1:1 ratio with random sequences using the SPSS Statistics V.22. The standard surgical procedures will be performed within 2 weeks after randomization, and each patient will receive unified perioperative physical therapy (PT). The primary outcome measure is the range of knee flexion. Secondary outcome measures include physical function, activity level, general health, knee pain, and the occurrence of adverse events. Safety measures include physiological parameters (i.e., blood pressure, pulse, respiratory rate) and complications (i.e., component damage, patellar tendon tear and fracture during surgical procedures, neurological or internal medicine conditions, venous thromboembolism, bleeding and infection postoperatively). The noninferiority margin is defined as a difference of 10 degrees on the range of knee flexion between groups and was assessed with a one-sided α of .025. To investigate relative effectiveness between the groups, linear mixed-effects model will be used for continuous data, and generalised estimating equation for dichotomous data. Analyses will follow the intention-to-treat principle.
Findings of our study will help clinicians determine the risk-benefit balance of MUA and LOA, two frequently used surgical procedures for patients with knee arthrofibrosis.
Chinese Clinical Trial Registry (www.chictr.org.cn); ChiCTR2000033467.
最近的研究表明，在关节镜膝关节手术后 3 至 6 个月内，粘连松解术（LOA）和麻醉下手法松解术（MUA）在关节纤维挛缩患者中的疗效相似。由于 MUA 具有疗效肯定、费用较低和操作方便等优点，当 MUA 不劣于手术时，临床实践可能会首先考虑 MUA，从而节省大量医疗费用。目前还缺乏比较这两种手术技术临床疗效的证据。本研究旨在确定 MUA 是否在改善关节镜膝关节手术后 3 至 6 个月内膝关节屈曲丧失患者的临床疗效方面不劣于 LOA。
这项多中心随机对照试验（RCT）将在关节镜膝关节手术后 3 至 6 个月内招募 360 名经磁共振成像（MRI）证实的关节纤维挛缩患者，以证明 MUA 的非劣效性。将患者按照 1:1 的比例随机分为 LOA 组（n=180）或 MUA 组（n=180），采用 SPSS Statistics V.22 生成随机序列。标准手术程序将在随机分组后 2 周内进行，每位患者将接受统一的围手术期物理治疗（PT）。主要结局指标是膝关节屈曲范围。次要结局指标包括身体功能、活动水平、一般健康状况、膝关节疼痛和不良事件的发生。安全性措施包括生理参数（即血压、脉搏、呼吸频率）和并发症（即手术过程中组件损伤、髌腱撕裂和骨折、神经或内科疾病、静脉血栓栓塞、术后出血和感染）。非劣效性边界定义为两组之间膝关节屈曲范围的差异为 10 度，采用单侧 α 值为 0.025 进行评估。为了研究两组之间的相对疗效，将使用线性混合效应模型分析连续数据，使用广义估计方程分析二分类数据。分析将遵循意向治疗原则。
本研究的结果将帮助临床医生确定 MUA 和 LOA 这两种常用于膝关节纤维挛缩患者的手术方法的风险效益平衡。
中国临床试验注册中心（www.chictr.org.cn）；ChiCTR2000033467。
