Bioinductive collagen scaffolds for partial- and full-thickness rotator cuff repair: a systematic review
TL;DR
BCS may improve pain, function, and structural outcomes in selected rotator cuff tears; however, evidence remains limited, heterogeneous, and predominantly non-randomized.
Abstract
Background Partial-thickness rotator cuff tears (PTRCTs) are a common and challenging cause of shoulder pain and dysfunction. Bioinductive collagen scaffolds (BCS) have emerged as a biologic adjunct intended to mimic the extracellular matrix and promote tendon regeneration. The aim of this systematic review was to evaluate the reported clinical outcomes, imaging-based structural findings, safety, and follow-up outcomes of BCS in adults treated for partial-thickness and selected full-thickness rotator cuff tears. Methods A systematic search of Medline, ScienceDirect, and Google Scholar was performed for English-language studies published up to March 2024. The review followed Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 guidelines and was registered in PROSPERO. Eligible studies included adults with PTRCTs or selected full-thickness tears treated with BCS, either as an isolated intervention or as augmentation during repair. Extracted outcomes included patient-reported outcomes, imaging-based tendon healing, adverse events, and follow-up duration. Study quality was assessed using the Critical Appraisal Skills Programme (CASP) checklist. Results Of 161 records identified, four studies involving 315 participants met the inclusion criteria: one retrospective case series, one prospective single-arm study, one prospective follow-up study, and one prospective multicenter registry study. Included studies reported postoperative improvements in functional outcomes, including American Shoulder and Elbow Surgeons, Constant-Murley, and University of California, Los Angeles scores, with pain reduction. Magnetic resonance imaging and ultrasound findings suggested increased tendon thickness and favorable structural healing, with reported healing rates up to 96% within 12–24 months. No major adverse events, foreign-body reactions, or implant-related complications were reported. Heterogeneity precluded meta-analysis. Conclusions BCS may improve pain, function, and structural outcomes in selected rotator cuff tears; however, evidence remains limited, heterogeneous, and predominantly non-randomized.