None listed
Conditions
Interventions
Procedure/Surgery : This study is designed as an interventional study comparing the test and control groups. The intervention is applied to the test group, where acellular dermal matrix(SC Derm) is in
Sponsors
Samsung Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Men and women aged 40 years or older 2) Full-thickness tears of the supraspinatus and infraspinatus on MRI 3) Completion of repair classified as Type I after arthroscopic rotator cuff repair 4) Patients in whom the surgeon determines that insertion of ADM is necessary to prevent subacromial impingement (based on age, tear size, degree of retraction, extent of fatty degeneration, level of activity, etc.)
Exclusion criteria
Exclusion criteria: 1) Patients who have previously undergone surgery on the same shoulder 2) Patients with a history of arthritis or previous treatment for infection in the same shoulder 3) Patients with cartilage damage on MRI or during arthroscopy 4) Full-thickness tears of the subscapularis (Yoo and Rhee Classification III or higher) 5) Patients who have not had follow-up in the outpatient clinic for more than one year 6) Patients with acute rotator cuff tears due to an accident 7) Patients with allergies to acellular dermal allograft tissue 8) Individuals who do not consent to participate in the study 9) Individuals currently participating in other clinical studies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain Visual Analogue Scale at 6 months ± 1 month after complete sealing of subarticular rotator cuff | — |
Secondary
| Measure | Time frame |
|---|---|
| Range of motion (forward elevation, external rotation, internal rotation) after complete sealing of subarticular rotator cuff;Pain Visual Analogue Scale at 2 days (every 8 hours) after complete sealing of the subarticular rotator cuff, 2 months ± 1 month, 12 months ± 1 month;Fuction Visual Analogue Scale after complete sealing of subarticular rotator cuff;American Shoulder and Elbow Surgeons Standard Evalution score after complete sealing of subarticular rotator cuff;The Constant score after complete sealing of subarticular rotator cuff;Simple shoulder test after complete sealing of subarticular rotator cuff;Checking Re-Rupture or re-tear case on MRI after complete sealing of subarticular rotator cuff | — |
Countries
Korea, Republic of
Contacts
Public Contactjaechul Yoo
Samsung Medical Center
Outcome results
None listed