What this Trial Is About

Rotator cuff tears cause shoulder pain and limit movement, significantly affecting daily activities. The likelihood of these tears increases with age, reaching up to 54% in people over 60. Most tears do not heal on their own and may worsen over time. Surgical treatment usually involves stitching the tendon back to its original spot using anchors. However, large tears often have fat infiltration and tendon pulling back, making repairs under tension prone to failure and re-tearing. This study explores the use of a silk fibroin surgical mesh, a biocompatible patch, to support large or irreparable tears and potentially improve healing by reducing tension and promoting tissue growth. Participants will undergo surgery for rotator cuff tears, where the silk fibroin mesh patch made from mulberry silk protein may be used to reinforce the repair area. The mesh aims to restore tendon integrity and joint stability. The study focuses on full-thickness tears between 1 and 5 cm, involving the supraspinatus and/or infraspinatus tendons. During surgery, eligibility is confirmed by tear size and tendon coverage of the humeral tuberosity. The study is conducted in phases 2 and 3 to evaluate the mesh's feasibility in enhancing repair outcomes. Participants, aged 50 to 75, will be followed for 12 months after surgery to track healing and repair success. Researchers will assess the rate of re-tearing after one year as the main outcome. Assessments include clinical exams and MRI scans before surgery, along with monitoring pain and shoulder function. Participants must consent to follow-up visits and cooperate with study procedures. Safety and effectiveness of the mesh will be monitored throughout the study period to better understand its potential benefits in rotator cuff tear repair.

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