Study of BioBrace Implant to Support Arthroscopic Repair of Large Full-Thickness Rotator Cuff Tears in Adults Aged 40 to 70

What this Trial Is About

This research investigates the treatment of full-thickness rotator cuff tears involving the supraspinatus andor infraspinatus tendons measuring between 2 and 5 cm. It aims to compare the safety and effectiveness of arthroscopic rotator cuff repair augmented with the BioBrace Implant against the standard arthroscopic rotator cuff repair alone. The study is prospective, single-blind, multi-center, randomized, and controlled, focusing on subjects needing surgical repair for these specific tears. Participants will be randomly assigned to one of two groups one undergoing arthroscopic rotator cuff repair with the BioBrace Implant fixed over the repaired tendon using anchors, and the other receiving the standard arthroscopic rotator cuff repair alone. The BioBrace Implant is a bioresorbable, biocomposite scaffold designed to reinforce weakened soft tissue, composed of a collagen sponge and poly-L-lactic-acid PLLA. Treatments follow standard surgical procedures, and the study includes preoperative and postoperative evaluations. Participants will have clinical assessments at baseline before surgery, and then at 6 weeks, 3 months, 6 months, and 12 months after surgery. These evaluations include patient-reported outcome measures and MRI scans to assess the repair integrity and re-tear rates. The primary outcome is the re-tear rate at 6 months post-operation, with secondary outcomes measured at 12 months and patient function and quality of life assessed through standardized questionnaires. Follow-up visits ensure safety monitoring and comprehensive data collection over a year.

BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears