Using silk mesh to improve surgery for rotator cuff tears

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.