The Clinical Efficacy of the Regeneten Bioinductive Implant in Rotator Cuff Repair: A Systematic Review.

Abstract

Despite advancements in surgical techniques for rotator cuff repair, retear rates remain a significant concern. This study systematically reviews the evidence on the effectiveness of the Regeneten Bioinductive Implant in improving healing outcomes. A systematic review of the literature was conducted by searching on PubMed, Embase, Web of Science Core Collection and Cochrane Library. Studies reporting on effectiveness, safety, radiological, clinical outcomes, or patient- reported outcomes after Regeneten use, with at least 12 months of follow-up, were considered. 17 articles were included in this review, encompassing data on 1062 rotator cuff tears, of which 966 were treated with Regeneten. The implant use resulted in retear rates of 0% up to 18% after 5 years in PT tears and 0% up to 35% after 2 years in FT tears. In 1 randomised trial, the retear rate was significantly lower in the implant group compared to the control group. Constant- Murley Score (CMS) and the American Shoulder and Elbow Surgeons (ASES) score showed a sustained improvement compared to pre-operative scores across all studies. MRI showed increased tendon thickness starting from 6 months, with MRI signals suggesting that the implant was integrating with the native tendon and becoming indistinguishable. While using Regeneten for rotator cuff tears of various sizes and chronicity is associated with reduced retear rates in some studies, the clinical outcomes remain within the same range as those seen with traditional rotator cuff repair. Additional randomized controlled trials are required to validate these results and clarify the appropriate indications for using this implant.