Bioinductive patch as an augmentation for rotator cuff repair, a systematic review and meta-analysis

Warren et al., 2024 | J Shoulder Elbow Surg | Meta Analysis

Citation

Warren Jonathan R, Domingo-Johnson El R, ... Cil Akin. Bioinductive patch as an augmentation for rotator cuff repair, a systematic review and meta-analysis. J Shoulder Elbow Surg. 2024-Nov;33(11):2515-2529. doi:10.1016/j.jse.2024.05.002

Abstract

BACKGROUND: Rotator cuff tears are a prevalent cause of shoulder pain and dysfunction. For those who fail initial conservative treatment, operative intervention can be pursued. A significant and common complication after rotator cuff repair (RCR) is retearing or nonhealing. Numerous augmentations to traditional suture RCR have been studied. Of these, the Smith + Nephew Regeneten bioinductive collagen patch has had promising initial results; however, analytic data for its use are lacking, and there is no meta-analysis comparing the available data to historical RCR outcomes. METHODS: A PRISMA-guided literature search was conducted using Ovid MEDLINE, PubMED, Cochrane, and ClinicalTrials.gov. Thirteen studies met inclusion and exclusion criteria. Only clinical trials on full and partial-thickness tears were included. American Shoulder and Elbow Surgeon score, Constant-Murley Score, the visual analog scale for pain, the minimal clinically important difference (MCID), tendon thickness, and complication rates were primary outcomes of interest. A meta-analysis was performed to determine the overall complication and retear rate from the included studies. RESULTS: American Shoulder and Elbow Surgeon score, Constant-Murley Score, and visual analog scale for pain improved significantly in all studies that reported them, and most patients achieved MCID. Patient-reported outcome measure improvements were similar to historical improvements in standard RCR, and a similar proportion of patients achieved MCID after standard repair. Tendon thickness improved significantly and to a similar degree as standard RCR. Overall retear rate after full thickness RCR augmented with the bioinductive patch was 8.3%. For partial thickness RCR, total retear rate was of 1.1% across all patients. The overall complication rate with the bioinductive patch was 15.5% across all full-thickness RCR studies and 16.2% in partial thickness RCR. We found overall retear rate to be lower after augmentation with the bioinductive patch compared to traditional repair; however, the overall complication rate was similar for full-thickness tears and higher for partial-thickness tears. Lastly, adverse reactions to the bioinductive patch were noted at 0.2%. CONCLUSIONS: The bioinductive collagen patch appears to be a safe augmentation for rotator cuff repair. Patients are likely to experience significant subjective improvement in patient-reported outcome measures and significant increases in tendon thickness. Retear rate has been a concern after RCR for decades, and the bioinductive patch may help mitigate this risk. There is lack of case-control studies comparing the bioinductive patch to traditional suture RCR. Such data are needed to better determine the role of the bioinductive patch in the treatment of full and partial-thickness rotator cuff repairs.

Key Findings

American Shoulder and Elbow Surgeon score, Constant-Murley Score, and visual analog scale for pain improved significantly in all studies that reported them, and most patients achieved MCID. Patient-reported outcome measure improvements were similar to historical improvements in standard RCR, and a similar proportion of patients achieved MCID after standard repair. Tendon thickness improved significantly and to a similar degree as standard RCR. Overall retear rate after full thickness RCR augment

Outcomes Measured

• Requires manual extraction

Population

MeSH Terms

• Humans
• Collagen
• Rotator Cuff
• Rotator Cuff Injuries

Evidence Classification

• Level: Meta Analysis
• Publication Types: Journal Article, Meta-Analysis, Systematic Review
• Vertical: collagen

Provenance

• PMID: 38942225
• DOI: 10.1016/j.jse.2024.05.002
• PMCID: Not in PMC
• Verified: 2026-04-09 via PubMed E-utilities API

Source extracted via PubMed E-utilities API on 2026-04-09