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
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Rotator cuff tears cause shoulder pain and limit movement, significantly impacting daily life. The chance of these tears increases with age, affecting over half of people older than 60. Most tears do not heal on their own and may worsen over time. Large tears often involve fat buildup and tendon pulling back, making repair challenging and increasing the risk of re-tearing after surgery. This study evaluates the use of a silk fibroin surgical mesh to support and improve healing in large rotator cuff tear repairs that are difficult to fix with standard surgery. The study involves using a silk fibroin surgical mesh, a biocompatible patch made from silk protein, placed over the damaged rotator cuff area during surgery. This mesh aims to reinforce the repair by reducing tension on the tendon and promoting tissue healing and cell growth, potentially lowering the chance of re-tears. The trial focuses on patients aged 50 to 75 who require surgery for large full-thickness rotator cuff tears, with follow-up lasting 12 months after surgery. Participants will be monitored for tendon healing and shoulder function through various assessments, including imaging and clinical scoring systems like the Constant-Murley and Oxford Shoulder Scores. Researchers will track re-tear rates at 6 and 12 months after surgery, muscle condition, fatty tissue infiltration, and tendon thickness. Safety and repair success will be observed throughout the year-long follow-up to understand the mesh's potential benefits in rotator cuff repair.
CONDITIONS
Brief 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, any gender
- Diagnosis of rotator cuff tears requiring surgery confirmed by clinical and MRI exams
- Classified as type IV or higher by Sugaya criteria
- Persistent or recurrent shoulder pain for more than 3 months
- Full-thickness tendon tear of 1 to 5 cm involving supraspinatus and/or infraspinatus tendons
- Failure of prior non-surgical treatments
- Willingness to cooperate with surgery and follow-up and provide informed consent
- Intraoperative confirmation of full-thickness tear between 1 and 5 cm
- Tendons able to cover over 50% of the humeral greater tuberosity
You will not qualify if you...
- Pregnant or breastfeeding women
- Contraindications to surgery or anesthesia, or allergy to implant materials
- Inability to undergo MRI due to claustrophobia or other reasons
- History of rotator cuff repair on the same shoulder or other injuries in the same limb
- Subscapular muscle injury
- Other diseases affecting treatment evaluation, such as grade 3 shoulder joint disease by Hamada classification
- Fatty infiltration grade 3 or higher by Goutallier classification in the rotator cuff tendon
- Use of oral steroids or steroid injections within 6 weeks before surgery
- Participation in other interventional clinical trials within 3 months prior to this trial
- Conditions affecting repair and healing, including uncontrolled blood sugar, heavy drinking, or smoking
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day of surgery
Participants undergo rotator cuff tear repair surgery with the implantation of a silk fibroin surgical mesh and receive immediate post-operative care.
1 surgery visit (in-person)
Duration - Up to 12 months
Participants are monitored after surgery to assess healing, function, and re-tear rates up to 12 months.
Regular follow-up visits over 12 months
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here