Comparing Traditional Maximal Repair and BioBrace Bridging Reconstruction for Large or Massive Rotator Cuff Tears Assessing Patient Outcomes, Shoulder Function, and Healing Over Two Years

What this Trial Is About

Researchers are evaluating if using BioBrace4 to repair large or massive rotator cuff tears leads to better patient outcomes compared to the traditional maximal repair method. The study focuses on patients with MRI-confirmed tears larger than 3 cm involving two tendons supraspinatus and infraspinatus. The purpose is to compare clinical, radiographic, and functional results including re-tear rates, patient-reported outcomes, shoulder strength, range of motion, muscle activation, biomechanics, and imaging findings using x-rays and MRI. Participants will be randomly assigned to one of two groups. One group will receive the standard maximal rotator cuff repair using the SCOI-row technique with suture anchors to recreate the rotator cable. The experimental group will undergo bridging reconstruction with BioBrace, a bioinductive scaffold made of porous collagen and bio-resorbable microfilaments, placed between the torn tendons after bursa debridement and tissue preparation. Both procedures aim to repair the torn rotator cuff but use different surgical techniques and materials. During the study, patients will be followed for two years with assessments at baseline, 6 months, 1 year, and 2 years. Evaluations include radiographic or clinical failure rates, muscle atrophy, fatty infiltration, healing rates, shoulder function surveys WORC, American Shoulder and Elbow Surgeon survey, quality of life EQ-5D-5L, range of motion, shoulder strength, and muscle biomechanics. Imaging with MRI and x-rays will monitor structural outcomes. This thorough follow-up will help researchers assess and compare the long-term results of both repair methods.

Maximal Repair Versus Bridging Reconstruction with BioBrace®