Department of Orthopadics, The Second Xiangya Hospital of Central South University, Changsha, Hunan, China.
Central South University, Changsha, Hunan, China.
BMJ Open. 2024 Mar 29;14(3):e077242. doi: 10.1136/bmjopen-2023-077242.
Anterior cruciate ligament (ACL) rupture can be treated surgically or non-surgically, with several surgical interventions available at present. However, the comparatively effective surgical intervention with relatively fewer side effects remains unknown. This study aims to fill in this gap by conducting a Bayesian network meta-analysis (NMA) and provide a theoretical basis for the clinical application.
We will perform a Bayesian NMA and will include randomised controlled trials (RCTs) published in English or Chinese that compare surgical intervention (ie, standard ACL reconstruction, ACL remnant-preserving reconstruction and ACL repair with suture augmentation to conservative therapy or studies that compare one surgical intervention to another for the symptom relief and function recovery of patients with ACL rupture. Primary outcome will be the proportion of patients with symptomatic and functional improvement measured by the Knee Injury and Osteoarthritis Outcome Score before and 6 months after treatment, with scores ranging from 0 (worst) to 100 (best). Secondary outcomes will be knee-specific quality of life (ACL QoL), return to activity and level of sport participation (Tegner or modified Tegner score), health-related QoL (EuroQol Group 5-Dimension 5-Level, EQ-5D-5L), resource use, intervention-related complications and patient satisfaction. We have developed search strategies for PubMed, Embase, the Cochrane Library and Web of Science, retrieving RCTs that meet the inclusion criteria from database inception to 1 December 2023. The methodological quality of the included RCTs will be assessed based on the Cochrane risk of bias table. The relative ranking probability of the best intervention will be estimated using the surface under the cumulative ranking curve. The Bayesian NMA will be conducted by using WinBUGS V.1.4.3. The Grading of Recommendations Assessment, Development and Evaluation approach will be applied to determine our confidence in an overall treatment ranking from the NMA.
Ethical approval for this study is not required because no private or confidential patient data will be used in this study. Findings of this study would be disseminated through the publication in a peer-reviewed medical journal.
CRD42023437115.
前交叉韧带(ACL)断裂可通过手术或非手术治疗,目前有多种手术干预可供选择。然而,哪种手术干预效果更好、副作用更小尚不清楚。本研究旨在通过贝叶斯网状荟萃分析(NMA)填补这一空白,并为临床应用提供理论依据。
我们将进行贝叶斯 NMA,并纳入已发表的英语或中文随机对照试验(RCT),这些 RCT 比较了手术干预(即标准 ACL 重建、ACL 残端保留重建和 ACL 修复联合缝线增强与保守治疗,或比较一种手术干预与另一种手术干预对 ACL 断裂患者症状缓解和功能恢复的影响。主要结局将是治疗前后(6 个月)用膝关节损伤和骨关节炎结果评分(Knee Injury and Osteoarthritis Outcome Score,KOOS)测量的有症状和功能改善的患者比例,评分范围为 0(最差)至 100(最佳)。次要结局将是膝关节特定生活质量(ACL QoL)、活动恢复和运动参与水平(Tegner 或改良 Tegner 评分)、健康相关生活质量(EuroQol Group 5-Dimension 5-Level,EQ-5D-5L)、资源利用、干预相关并发症和患者满意度。我们已经为 PubMed、Embase、Cochrane 图书馆和 Web of Science 制定了检索策略,从数据库建立到 2023 年 12 月 1 日检索符合纳入标准的 RCT。将根据 Cochrane 偏倚风险表评估纳入 RCT 的方法学质量。使用表面累积排序曲线下的概率来估计最佳干预措施的相对排名概率。将使用 WinBUGS V.1.4.3 进行贝叶斯 NMA。将应用推荐评估、制定和评价方法(Grading of Recommendations Assessment, Development and Evaluation approach)来确定我们对 NMA 中整体治疗排名的信心。
本研究不需要伦理批准,因为本研究不会使用患者的任何私人或机密数据。本研究的结果将通过在同行评议的医学期刊上发表来传播。
PROSPERO 注册号:CRD42023437115。