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NCT06766630
Exploring the Feasibility of Silk Fibroin Surgical Mesh in Rotator Cuff Tears Repair Enhancement
Phase 2, PHASE3 trial testing Silk fibroin surgical mesh in Rotator Cuff Tear in 20 participants. Currently enrolling.
19 December 2025
Quick facts
| Lead sponsor | Weiliang Shen, Ph.D., M.D. |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 19 December 2024 |
| Primary completion | 19 December 2025 |
| Estimated completion | 19 December 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- Silk fibroin surgical mesh
Conditions studied
- Rotator Cuff Tear — all drugs for Rotator Cuff Tear →
Sponsor
Weiliang Shen, Ph.D., M.D.
Who can join
Adults 50 to 75, any sex, with Rotator Cuff Tear. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06766630
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06766630 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Weiliang Shen, Ph.D., M.D.
- Last refreshed: 9 January 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06766630.
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