Massive Rotator Cuff Tears
Conditions
Interventions
Observation group:NA
Sponsors
Shanghai Sixth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1 Age >= 18 years, any gender 2 Imaging criteria: tear size >= 5 cm or accompanied by separation of 2 or more tendons. 3 Persistent shoulder pain and/or limited mobility, not amenable to direct repair, failed conservative treatment (symptoms not relieved after 3 months), and willing to undergo biological induced collagen patch surgery (this treatment is a routine option for massive rotator cuff tears). 4 Assessed by a multidisciplinary team (Orthopedics, Anesthesiology, Geriatrics) as able to tolerate arthroscopic surgery and cooperate with postoperative rehabilitation plan (e.g., wearing a brace as required, attending regular follow-ups). 5 Signed informed consent and completed baseline assessment, voluntarily agreeing to participate in long-term follow-up.
Exclusion criteria
Exclusion criteria: 1 Injury-related contraindications: Traumatic rotator cuff tear (such as a confirmed history of shoulder fracture or dislocation); Presence of other severe shoulder joint lesions (such as labral tears, shoulder arthritis, shoulder instability); Previous history of shoulder surgery (including rotator cuff repair, acromioplasty, etc.). 2 General condition contraindications: Severe cardiovascular or cerebrovascular diseases (such as acute myocardial infarction =180mmHg); History of malignancy (metastatic tumors or active cancer); Severe mental illness (such as dementia, schizophrenia) or inability to comply with follow-up; Active infection (such as shoulder joint infection, systemic sepsis); Severe coagulation disorders (INR >3.0 or platelet count 0.5 or expected survival <1 year. 3 Loss to follow-up or missing data: Missing two consecutive scheduled follow-ups (phone/clinic) and cannot be contacted, or refusal to undergo further evaluation (such as imaging or functional scoring); missing American Shoulder and Elbow Surgeons (ASES) scores and imaging (MRI/ultrasound) within 12 months after treatment and unable to obtain them later. 4 Violation of study protocol: Patients failing to stop medications as required perioperatively (e.g., taking anticoagulants on their own increasing bleeding risk) or refusing postoperative rehabilitation. 5 Conditions that may affect prognosis, including autoimmune diseases, poorly controlled diabetes, pregnancy, etc. 6 Participation in other clinical studies that may affect the results of this study. 7 Patient or family explicitly requests to withdraw from the study, either in writing or orally.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| American Shoulder and Elbow Surgeons (ASES) Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual Analog Scale (VAS) for Pain;Shoulder mobility;Imaging results; | — |
Countries
China
Contacts
Public ContactLiu Xudong
Shanghai Sixth People's Hospital
Outcome results
None listed