Comparison of clinical outcomes between spacer insertion and rotator cuff repair
- Conditions
- Diseases of the musculoskeletal system and connective tissue
- Registration Number
- KCT0009182
- Lead Sponsor
- Seoul National University Bundang Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 306
1) Men and women older than 40 years of age
2) No symptom relief despite more than 3 months of conservative treatment
3) Greater than 3 centimeters of posterosuperior cuff tear or 2.5 cm of posterosuperior cuff tear with subscapularis tear, and when they require surgical treatment.
4) No known problem with the deltoid muscle
5) Tear associated factors (anteroposterior tear size, retraction size, fatty degeneration of the infraspinatus) in the RoHI classification greater than 6 out of total 9.
1) Previous surgery on the same side shoulder.
2) Concomitant osteoarthritis or history of treatment for infection in the ipsilateral shoulder.
3) Full-thickness injury of the cartilage on MRI.
4) Acute traumatic rotator cuff tear
5) Patients with less than 1 year of outpatient follow-up after surgery
6) Patients with possibility of pregnancy.
7) Pain Visual analogue scale (VAS) score greater than 3 on the contralateral shoulder.
8) Allergic to Copolymer of PLA and -e-caprolactone, ingridients of Inspace?.
9) Autoimmune disease or HIV Ab (+)
10) Those that do not consent to the study
11) Those that are participating in other clinical trials.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method American Shoulder and Elbow Surgeons (ASES) score
- Secondary Outcome Measures
Name Time Method Pain Visual analogue scale;Hospital stay duration;Surgical time;Range of motion;Retear on MRI