Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Oxford University, Oxford, Oxfordshire, UK
Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Oxford University, Oxford, Oxfordshire, UK.
BMJ Open. 2020 Dec 7;10(12):e039552. doi: 10.1136/bmjopen-2020-039552.
To appraise studies reporting on clinical effectiveness and safety of surgical meshes used to augment rotator cuff repairs (RCRs).
Systematic review and meta-analysis.
MEDLINE, Embase and Cochrane databases were searched between April 2006 and April 2020.
All studies evaluating adults (≥18 years) undergoing RCR were considered. There were no language restrictions.
Screening, data extraction and quality appraisal were conducted by two independent reviewers. Meta-analysis was conducted using a random-effects models if ≥2 comparative studies reported the same outcome measure. Risk of bias assessment was undertaken for randomised (RoB2, Cochrane) and comparative studies (ROBINS-I, Cochrane).
We included 60 studies, consisting of 7 randomised controlled trials, 13 observational comparative studies and 40 observational case series. All comparative studies reported on shoulder-specific functional outcome scores, 18 on the radiographic occurrence of re-tear and 14 on pain score metrics. All studies contained some risk of bias.Compared with non-augmented repair, a small improvement in shoulder-specific function or pain scores was observed for synthetic patches with a mean improvement of 6.7 points on the University of California Los Angles (UCLA) shoulder score (95% CI 0.1 to 13.4) and 0.46 point reduction on the Visual Analogue Scale (95% CI -0.74 to -0.17), respectively. A reduced likelihood of radiologically observed re-tear was observed for synthetic (risk ratio (RR) 0.41, 95% CI 0.27 to 0.61) and allograft (RR 0.34, 95% CI 0.18 to 0.65) patches. A total of 49 studies reported on the occurrence of complications. Slightly higher crude complication rates were observed following patch-augmented repair (2.1%) than standard repair (1.6%).
While several studies suggest a decreased failure rate and small improvements in shoulder function and pain following augmented RCR, a paucity of rigorous clinical evaluation, for both effectiveness and safety, prevents firm recommendations.
CRD42017057908.
评价报道外科补片增强肩袖修复术(RCR)临床疗效和安全性的研究。
系统评价和荟萃分析。
2006 年 4 月至 2020 年 4 月期间,检索 MEDLINE、Embase 和 Cochrane 数据库。
所有评估接受 RCR 的成年人(≥18 岁)的研究均被纳入。无语言限制。
两名独立审查员进行筛选、资料提取和质量评估。如果≥2 项比较研究报告了相同的结局测量指标,则采用随机效应模型进行荟萃分析。对随机对照试验(RoB2,Cochrane)和比较研究(ROBINS-I,Cochrane)进行偏倚风险评估。
共纳入 60 项研究,包括 7 项随机对照试验、13 项观察性比较研究和 40 项观察性病例系列研究。所有比较研究均报告了与肩部特定功能相关的评分,18 项研究报告了再撕裂的放射学发生率,14 项研究报告了疼痛评分指标。所有研究均存在一定程度的偏倚。与非增强修复相比,合成补片修复后肩部特定功能或疼痛评分略有改善,加州大学洛杉矶分校(UCLA)肩部评分平均提高 6.7 分(95%CI 0.1 至 13.4),视觉模拟评分(VAS)降低 0.46 分(95%CI -0.74 至 -0.17)。合成补片(风险比[RR]0.41,95%CI 0.27 至 0.61)和同种异体移植物(RR 0.34,95%CI 0.18 至 0.65)补片可降低放射学观察到的再撕裂的可能性。共有 49 项研究报告了并发症的发生情况。补片增强修复后的总并发症发生率(2.1%)略高于标准修复(1.6%)。
尽管一些研究表明,增强 RCR 后失败率降低,肩部功能和疼痛略有改善,但由于有效性和安全性的严格临床评估缺乏,无法做出明确的推荐。
PROSPERO 注册号:CRD42017057908。