Study of Silk Fibroin Surgical Mesh to Improve Repair of Rotator Cuff Tears in Adults Aged 50 to 75

What this Trial Is About

Rotator cuff tears cause shoulder pain and limit movement, significantly impacting daily life. The chance of these tears increases with age, affecting over half of people older than 60. Most tears do not heal on their own and may worsen over time. Large tears often involve fat buildup and tendon pulling back, making repair challenging and increasing the risk of re-tearing after surgery. This study evaluates the use of a silk fibroin surgical mesh to support and improve healing in large rotator cuff tear repairs that are difficult to fix with standard surgery. The study involves using a silk fibroin surgical mesh, a biocompatible patch made from silk protein, placed over the damaged rotator cuff area during surgery. This mesh aims to reinforce the repair by reducing tension on the tendon and promoting tissue healing and cell growth, potentially lowering the chance of re-tears. The trial focuses on patients aged 50 to 75 who require surgery for large full-thickness rotator cuff tears, with follow-up lasting 12 months after surgery. Participants will be monitored for tendon healing and shoulder function through various assessments, including imaging and clinical scoring systems like the Constant-Murley and Oxford Shoulder Scores. Researchers will track re-tear rates at 6 and 12 months after surgery, muscle condition, fatty tissue infiltration, and tendon thickness. Safety and repair success will be observed throughout the year-long follow-up to understand the meshs potential benefits in rotator cuff repair.

Exploring the Feasibility of Silk Fibroin Surgical Mesh in Rotator Cuff Tears Repair Enhancement