Actively Recruiting
Exploring the Feasibility of Silk Fibroin Surgical Mesh in Rotator Cuff Tears Repair Enhancement
Led by Weiliang Shen, Ph.D., M.D. · Updated on 2025-01-09
20
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Exploring the Feasibility of Silk Fibroin Surgical Mesh in Rotator Cuff Tears Repair Enhancement
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 50 and 75 years old
- Rotator cuff tear confirmed by clinical and MRI examination requiring surgery
- Tear classified as type IV or higher by Sugaya criteria
- Persistent or recurrent shoulder pain for over 3 months
- Full-thickness tendon tear 1-5 cm involving supraspinatus and/or infraspinatus
- History of failed non-surgical treatment
- Willingness to participate and cooperate with surgery and follow-up
- Intraoperative confirmation of full-thickness tear 1-5 cm
- Tendons can cover more than 50% of the humeral greater tuberosity
You will not qualify if you...
- Pregnant or breastfeeding women
- Contraindications for surgery or anesthesia or allergies to implant components
- Unable to undergo MRI due to claustrophobia or other reasons
- Previous rotator cuff repair on the affected side or other injuries in the same limb
- Injury to the subscapular muscle
- Other diseases affecting treatment evaluation, such as grade 3 shoulder joint disease by Hamada classification
- Fatty infiltration of rotator cuff tendon grade 3 or higher by Goutallier classification
- Use of oral steroids or steroid injections within 6 weeks before surgery
- Participation in other interventional clinical trials within 3 months prior
- Conditions affecting healing such as uncontrolled blood sugar, heavy drinking, or smoking
AI-Screening
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Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
J
Jinchun Ye
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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