Rotator Cuff Tear
Conditions
Interventions
Experimental group:Silk fibroin surgical mesh combined with other sports medicine products to assist in repairing rotator cuff injuries
Sponsors
The Second Affiliated Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
50 Years to 75 Years
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Re-tear rate at 6 months postoperatively; | — |
Secondary
| Measure | Time frame |
|---|---|
| Re-tear rate at 12 months postoperatively;Constant-Murley Score postoperatively;Oxford Shoulder Score postoperatively;Degree of muscle atrophy;Fatty infiltration grading;Tendon healing status;Tendon thickness; | — |
Countries
China
Contacts
Public ContactWeiliang Shen
The Second Affiliated Hospital, Zhejiang University School of Medicine
Outcome results
None listed