NCT06766630

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

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Weiliang Shen, Ph.D., M.D. · Academic / Other
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Rotator cuff tears result in shoulder joint pain and movement disorders, affecting patients' daily lives. The incidence rate rises with age and can be as high as 54% among people over 60 years old. Most rotator cuff tears are unable to heal spontaneously, and the tear area may gradually expand over time. Currently, the main surgical treatment for rotator cuff tears is to use suture anchors to stitch the rotator cuff tendon tissue back to the original anatomical insertion point. Large rotator cuff tears are often accompanied by fat infiltration and tendon retraction. When forcefully sutured, the tension is relatively high, which may lead to non-healing and re-tearing of the rotator cuff. Research indicates that the re-tear rate after rotator cuff tear repair is 20% - 30%, and this probability can reach 40% - 50% for large rotator cuff tears. For these irreparable and large tears, rotator cuff repair typically requires patch augmentation techniques. Surgeries are based on restoring the force couple effect of the rotator cuff as much as possible and covering it with repair materials to achieve reinforcement. Silk fibroin surgical mesh is made of silk fibroin which has good biocompatibility and can be generally placed in the area of rotator cuff tears that cannot be repaired through conventional surgeries. By providing support to the injured rotator cuff tissue, it improves the repair effect. It can reestablish the integrity of the rotator cuff, reducing mechanical tension at the repair site and maintaining the stability of the glenohumeral joint. Besides, it can also promote tissue healing, and cell infiltration and growth, thereby facilitating the biological repair of the injured rotator cuff and reducing the occurrence of postoperative re-tears.

Conditions

• Rotator Cuff Tear

Interventions

Type	Name	Description
DEVICE	Silk fibroin surgical mesh	This product is a mesh patch made of mulberry silk by warp knitting and degumming. The main component is fibroin protein

Timeline

• Start date: 2024-12-19
• Primary completion: 2025-12-19
• Completion: 2026-12-19
• First posted: 2025-01-09
• Last updated: 2025-01-09

Locations

1 site across 1 country: China