Clinically diagnosed rotator cuff injuries without substantial tissue loss, including repairable partial-thickness tears and small full-thickness tears
Conditions
Interventions
Control Group:Standard surgical treatment for rotator cuff repair.
Treatment Group:Standard surgical treatment combined with acellular matrix patch for rotator cuff repair.
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged >=18 years and <=75 years, regardless of gender. 2. Clinically diagnosed with a rotator cuff injury without substantial tissue loss, including repairable partial-thickness tears and small full-thickness tears. 3. Persistent or recurrent shoulder pain for more than 3 months, with failure of relevant non-surgical treatment. 4. The subject or their legal guardian is able to understand the trial objectives, willing to cooperate with surgical treatment and follow-up, voluntarily participates in the trial, and provides written informed consent.
Exclusion criteria
Exclusion criteria: 1. Rotator cuff tendon tear caused by acute injury. 2. History of previous rotator cuff repair on the affected side, or concurrent injury to other bones, joints, or muscle soft tissues of the ipsilateral limb. 3. Concurrent shoulder arthropathy classified as Hamada type >3; 4. Residual tendon fatty infiltration graded as Goutallier grade >=3; 5. Severe calcification of the rotator cuff tendons. 6. Injury to the subscapularis or teres minor tendon requiring repair. 7. Shoulder joint instability. 8. Concurrent active infection. 9. Hematologic diseases or abnormalities, or coagulation disorders. 10. Concurrent severe hepatic or renal insufficiency (Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) >3 times the upper limit of normal; serum creatinine >3.0 mg/dL (266 µmol/L) or on dialysis) or severe underlying cardiocerebrovascular diseases requiring surgical intervention during the trial period. 11. Poorly controlled diabetes (fasting blood glucose >=10.0 mmol/L). 12. Use of oral steroids or steroid injections within 6 weeks prior to surgery. 13. Contraindications to surgery or anesthesia, or known allergy to any component of the implant product. 14. Pregnancy or planned pregnancy during the trial period. 15. Currently participating in any other drug or medical device clinical trial and has not yet completed the follow-up period. 16. Other conditions considered by the investigator as unsuitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Re-tear at 180 Days Postoperatively; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Device Deficiencies (Evaluated in the Treatment Group Only);CMS Score;Incidence of Shoulder Stiffness;Delivery System Performance Evaluation;Incidence of Infection;VAS Pain Score;Target Tendon Re-intervention Rate;Surgical Success Rate;Incidence of Adverse Events;Tendon Healing Status;ASES Score;Incidence of Serious Adverse Events; | — |
Countries
China
Contacts
Public ContactYinghui Hua
Huashan Hospital, Fudan University
Outcome results
None listed