Exploring the Feasibility of Silk Fibroin Surgical Mesh in Rotator Cuff Tears Repair Enhancement
Recruiting
Phase 2
Phase 3
Interventional Study
Rotator Cuff Tear
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 50 – 75
- Sex
- Any
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 20 (estimated)
- Sponsor
- Weiliang Shen, Ph.D., M.D. · Other
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About This Trial
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 stit…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Preoperative:
1. Age range of 50-75 years old (inclusive), gender not limited;
2. Patients who require surgery due to rotator cuff tears detected by clinical and MRI examination;
3. Evaluated as type IV and above according to Sugaya classification criteria;
4. Patient…
Contacts