Exploring the Feasibility of Silk Fibroin Surgical Mesh in Rotator Cuff Tears Repair Enhancement

Launched by WEILIANG SHEN, PH.D., M.D. · Jan 8, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new approach to help repair rotator cuff tears in the shoulder using a special material called silk fibroin surgical mesh. Rotator cuff tears can cause significant pain and limit movement, especially in people aged 50 to 75, which is why they often require surgery. The trial aims to see if this silk mesh can provide better support during the healing process, potentially leading to improved recovery and fewer re-injuries.

To be eligible for the trial, participants should be between 50 and 75 years old and have a confirmed full-thickness rotator cuff tear that has not improved with non-surgical treatments. They should also have experienced shoulder pain for at least three months. Participants will undergo surgery where the silk mesh will be used to reinforce the repair of their torn rotator cuff. Throughout the trial, patients will receive thorough care and follow-up to monitor their healing. This trial is an exciting opportunity for those who have struggled with rotator cuff issues and are looking for new solutions to enhance their recovery.

Gender

ALL

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. 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.