Use of Patch Augmentation in Rotator Cuff Repair: A Systematic Review Protocol.

Objective: To evaluate the effectiveness of using a graft for reinforcement in rotator cuff repair compared to no use, as well as the effectiveness of different types of grafts, considering healing and shoulder function as primary outcomes, through a systematic review and meta-analysis of randomized controlled trials (RCTs). Methods: We will conduct a systematic review of RCTs following the guidelines of the Cochrane Handbook for Systematic Reviews of Interventions and of the Preferred Reporting Items for Systematic reviews and Meta-Analyses for Protocols (PRISMA-P) statement. Only RCTs with adult participants comparing repair with a reinforcing graft versus the standard repair, or comparing different types of grafts, will be included. An electronic search will be conducted in the MEDLINE (PubMed), Cochrane Central Register of Controlled Trials (CENTRAL), Embase, and SciELO databases, as well as gray literature. Data management and extraction will be performed using a standardized form that will assess the characteristics of the studies, participants, and intervention, as well as the outcomes and methodological domains. The primary outcomes will be healing and shoulder functional assessment, and the secondary outcomes, pain, range of motion, adverse events, complications, quality of life, and cost-effectiveness. Risk of bias will be assessed with the Risk of Bias, version 2.0 (RoB 2.0), and the certainty of evidence, through the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. Descriptive, subgroup, and sensitivity analyses will be performed when applicable. Conclusion: The review is expected to consolidate evidence on the effectiveness of using a graft for reinforcement in rotator cuff repair. It has been registered in the International Prospective Register of Systematic Reviews (PROSPERO) under number 1106892.