Using silk mesh to improve surgery for rotator cuff tears
Exploring the Feasibility of Silk Fibroin Surgical Mesh in Rotator Cuff Tears Repair Enhancement
PHASE2; PHASE3 · Second Affiliated Hospital, School of Medicine, Zhejiang University · NCT06766630
This study tests if using silk mesh during surgery can help older patients with rotator cuff tears heal better and prevent re-injury.
Quick facts
| Phase | PHASE2; PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 50 Years to 75 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University (other) |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06766630 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of silk fibroin surgical mesh to enhance the repair of rotator cuff tears. The study focuses on patients aged 50-75 who have significant tears that have not healed with non-surgical treatments. By employing this innovative mesh during surgery, the trial aims to reduce the high rates of re-tearing associated with traditional repair methods. The approach seeks to improve healing outcomes and restore shoulder function in affected individuals.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 50-75 with full-thickness rotator cuff tears who have not responded to previous non-surgical treatments.
Not a fit: Patients with contraindications for surgery or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this could lead to better surgical outcomes and reduced re-tear rates for patients with rotator cuff tears.
How similar studies have performed: While the use of silk fibroin in surgical applications is promising, this specific approach to rotator cuff repair is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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. Patients with persistent or recurrent pain in the shoulder for more than 3 months;
5. Full layer tendon tear of 1-5cm or full layer or complete tear of supraspinatus and/or infraspinatus tendon;
6. History of non-surgical treatment failure;
7. Understand the purpose of the trial, cooperate with surgical treatment and follow-up, voluntarily participate in the trial and sign an informed consent form;
Intraoperative:
8. Confirmed as a full-thickness tear of 1-5cm on the rotator cuff;
9. Tendons can cover more than 50% of the humeral greater tuberosity of the shoulder joint.
Exclusion Criteria:
* 1\. Pregnant and lactating women; 2.Individuals with contraindications for surgery or anesthesia, as well as those who are allergic to known ingredients of implanted products; 3. Unable to undergo MRI examination due to claustrophobia and other reasons; 4. Individuals with a history of rotator cuff repair on the affected side, or combined with other bone, joint, or muscle soft tissue injuries in the same limb; 5.Patients with subscapular muscle injury; 6.Those with any combination of diseases or symptoms that may affect the evaluation of efficacy, such as Hamada classification of grade 3 shoulder joint disease; 7.Those with residual rotator cuff tendon fatty infiltration ≥ grade 3 by Goutallier classification; 8.Individuals who have taken oral steroids or received steroid injections within 6 weeks prior to surgery; 9.Those who have participated in other interventional clinical trials within the past 3 months prior to the conduct of this trial; 10. Researchers believe that clinical trial participants who are not suitable for participation include but are not limited to those with uncontrolled blood sugar levels, heavy drinkers, smokers, and others who affect repair and healing.
Where this trial is running
Hangzhou, Zhejiang
- The Second Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (RECRUITING)
Study contacts
- Study coordinator: Jinchun Ye
- Email: 21918382@zju.edu.cn
- Phone: 86 17857158596
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Rotator Cuff Tear