Rotator cuff tear
Conditions
Interventions
Experimental group:Use of silk fibroin hernia repair mesh as rotator cuff repair mesh with suture or/and anchor fixation for rotator cuff tear repair.
Sponsors
The First Affiliated Hospital of Medical School of Zhejiang University
Eligibility
Sex/Gender
All
Age
45 Years to 70 Years
Inclusion criteria
Inclusion criteria: Preoperative: 1. Age range of 45 to 70 years old (inclusive), gender not limited; 2. Clinical and MRI examinations show full-thickness rotator cuff tear, requiring surgery; 3. Those with persistent or recurrent shoulder pain for more than 3 months; 4. Full-thickness tear of the supraspinatus tendon and/or infraspinatus tendon; 5. History of non-surgical treatment failure; 6. Understand the purpose of the experiment, cooperate with surgical treatment and follow-up, voluntarily participate in the experiment and sign an informed consent form; During the operation: 7. Confirmed that both the supraspinatus and infraspinatus tendons of the rotator cuff are full-thickness tears; 8. Or a full-thickness tear of a single tendon exceeding 3cm.
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. Combining any disease or symptom that may affect the efficacy evaluator, such as Hamada classification of grade 3 shoulder joint disease; 7. Residual rotator cuff tendon fat infiltration classified by Goutallier as>=grade 3; 8. Individuals who have taken oral steroids or received steroid injections within 6 weeks prior to surgery; 9. Participants who have participated in other interventional clinical trials within the past 3 months prior to the start 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; | — |
Countries
China
Contacts
Public ContactYouzhi Cai
The First Affiliated Hospital of Medical School of Zhejiang University
Outcome results
None listed