Polyester Patch in Massive Rotator Cuff Repair Improves Healing
Completed
- Conditions
- Rotator Cuff Tear
- Registration Number
- NCT02976285
- Lead Sponsor
- Etzel Clinic
- Brief Summary
The purpose of this study was to assess the impact and potential advantage of a novel synthetic patch augmentation in repair of massive rotator cuff (RC) tears, using clinical and radiological approaches. The investigators hypothesized that implanting this patch will improve individual shoulder function, while reducing re-tear rates compared to the current literature.
- Detailed Description
To evaluate this, patches were implanted into 54 shoulders and prospectively followed up clinically and radiologically.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
Inclusion Criteria
- Inclusion criteria were age greater 18 years and a RC tear involving at least two tendons, presenting a massive RC-tear as described by Gerber et al.
Exclusion Criteria
- We excluded patients older than 75, fatty infiltration grade 4 according to Goutallier, re-ruptures of former repairs and cases with severe osteoarthritis.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Function assessed with the Subjective Shoulder Value 25 months Function assessed with the Constant-Murley-Score 25 months
- Secondary Outcome Measures
Name Time Method Tendon integrity evaluated radiologically 1-35 months