Comparing Rotator Cuff Repair Surgery With BioEnthesis Patch Versus Standard Suture Anchor Technique to Improve Healing and Reduce Re-Tears

What this Trial Is About

Researchers are investigating rotator cuff injuries, which are common and challenging to repair due to difficulty in reattaching tendons to bone. The study evaluates a new technology called BioEnthesis, developed to improve tendon-to-bone healing and potentially reduce the high rates of re-tearing seen with standard suture anchor repairs. This Phase 4 trial compares rotator cuff repair surgery using BioEnthesis augmentation against the current standard method to assess improvements in healing outcomes. Participants will undergo rotator cuff repair surgery either with the BioEnthesis allograft patch or with the standard suture and anchor technique. The BioEnthesis patch is designed to enhance structural integrity at the repair site. Patients will be randomly assigned to one of these two groups and will be followed for up to 12 months after surgery to observe differences in healing and re-tear rates. During the study, participants will be assessed before surgery and at 3, 6, and 12 months post-operation. Evaluations include imaging to check for re-tears, pain scales, shoulder strength and range of motion tests, functional assessments of daily living activities, medication usage, and occurrence of any medical or adverse events. The study aims to measure both structural healing and improvements in mobility and pain over the year following surgery.

Rotator Cuff Repairs With or Without BioEnthesis™ Augmentation