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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.
