Arthroscopic partial repair with or without biodegradable subacromial spacer (InSpace Balloon): A randomised controlled clinical trial
Phase 3
- Conditions
- Massive Rotator Cuff tearS46.0M75.1Rotator cuff syndromeInjury of muscle(s) and tendon(s) of the rotator cuff of shoulder
- Registration Number
- DRKS00014716
- Lead Sponsor
- Clinical Director (Chairmain) at 3rd Department of Orthopaedics, HYGEIA Private Hospital of Athens, Greece
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
1. Age 55-75
2. Diagnosed symptomatic, a. massive or b. irreparable rotator cuff’s tear (clinically and arthroscopically) {subgroups a. and b.}
3. Arthroscopic Partial Repair as the method of treatment (with or without InSpace Balloon)
4. Sign full written consent
5. Complete their scheduled follow-up
Exclusion Criteria
1. Age<55 or >75
2. Previous operation on the same joint
3. Irreparable subscapularis tear
4. Glenohumeral osteoarthritis
5. AC joint osteoarthritis
6. Ipsilateral shoulder instability
7. significant pathology from the cervical spine (creating symptoms like pain)
8. Rheumatoid arthritis or other systematic diseases
9. Serious psychiatric diseases
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method