Comparing Arthroscopic Rotator Cuff Repair With and Without Bioinductive Patch for Full-Thickness Rotator Cuff Tears

What this Trial Is About

Researchers are evaluating the outcomes of arthroscopic rotator cuff repair surgery for patients with full-thickness rotator cuff tears. This study compares the standard surgery to the same surgery augmented with a Bioinductive Implant, which is a patch designed to promote tendon healing. The main focus is to see if the implant improves the repairs integrity one year after surgery, as shown by ultrasound imaging. Participants will be randomly assigned to one of two groups. One group will receive the standard arthroscopic rotator cuff repair surgery alone, while the other group will have the same surgery plus the bioinductive patch implanted during the procedure. Both groups will be followed up with ultrasound imaging one year after surgery to assess the repairs condition. During the study, participants will undergo evaluations including ultrasound imaging one year after surgery to check repair integrity. Additional assessments will track upper extremity function, pain interference, depression, shoulder range of motion, strength, complications, and any need for reoperation for up to two years after surgery. The total participation duration includes preoperative assessments through two years postoperatively to monitor healing and outcomes.

Bioinductive Patch for Full-Thickness Rotator Cuff Tears