Objective To appraise studies reporting on clinical effectiveness and safety of surgical meshes used to augment rotator cuff repairs (RCRs).
Design Systematic review and meta-analysis.
Data sources MEDLINE, Embase and Cochrane databases were searched between April 2006 and April 2020.
Eligibility criteria All studies evaluating adults (≥18 years) undergoing RCR were considered. There were no language restrictions.
Data extraction and synthesis 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).
Results 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%).
Conclusions 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.
Prospero registration number CRD42017057908.
- orthopaedic & trauma surgery
- adverse events
- biotechnology & bioinformatics
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Contributors JAC and AJC conceived the idea, and JAC lead the project. JLR, AR, DB, MD and SH contributed to study design and securing funding. NM contributed to the management of the study. Article screening, data extraction, analysis and interpretation undertaken by MB, NSN and JAC. Literature searches undertaken by GG and updates by GG, MB and NSN. All authors contributed to manuscript writing while MB and JAC undertook reviewer requested revisions.
Funding The study was funded by the National Institute for Health Research (NIHR) Health Technology Assessment Programme (HTA 15/103/03), and it was supported by the NIHR-funded Oxford Biomedical Research Centre (BRC).
Disclaimer The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health.
Competing interests AC has applied for a patent for a device which would be eligible for this type of review if it is approved for clinical use, AR has received educational and research grants from DePuy Ltd.
Patient consent for publication Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available upon reasonable request. All data relevant to the study are included in the article or uploaded as supplementary information. The data set used and analysed for this review will be available from the corresponding author upon a reasonable request.
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