Biologic Augmentation Improves Rotator Cuff Integrity But Not Clinically Significant Patient Outcomes: A Meta-Analysis of Randomized Controlled Trials.

Background: Biologic augmentation is increasingly used to enhance tendon healing after rotator cuff repair, with recent American Academy of Orthopaedic Surgeons guideline updates supporting certain implants. However, clinically significant benefits to the patient remain unclear. The primary objectives of this study were (1) to assess whether adding biologic augmentation to rotator cuff repair lowers retear rates and (2) to determine whether biologic augmentation yields superior patient-reported outcomes that exceed the minimal clinically important difference threshold for clinical significance. Methods: Systematic review and meta-analysis were carried out for Level I randomized controlled trials (RCTs) (PubMed, Embase, and CENTRAL) from inception to January 1, 2025, per Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Only RCTs reporting postoperative imaging and patient-reported outcomes of American Shoulder & Elbow Surgeons (ASES), Constant, Simple Shoulder Test (SST), and University of California Los Angeles (UCLA) were included. Random-effects models evaluated retear rates and functional scores; subgroup analyses examined platelet rich plasma (PRP), patch, and other biologics. Mixed-effects models and correlations assessed the relationship between retear and function. Results: Twenty RCTs (1,327 shoulders) were included. Biologic augmentation reduced the retear rate by approximately 12% (14.8% vs. 26.7%; RR 0.62, 95% CI 0.50-0.76, p < 0.0001; I Conclusion: In the included RCTs, biologic augmentation was associated with lower retear rates but not clinically significantly greater patient-reported outcomes after rotator cuff repair. Level of Evidence: Level I, evidence-based systematic review. See Instructions for Authors for a complete description of levels of evidence.