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

NCT06766630 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-01-09

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Weiliang Shen, Ph.D., M.D.

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-19
Primary Completion
2025-12-19
Completion
2026-12-19

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06766630 on ClinicalTrials.gov