A Randomized Clinical Trial Comparing Arthroscopic Double- Versus Single-layer Reconstruction of the Rotator Cuff: Clinical and Radiological Outcome
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Rotator Cuff Tear
- Sponsor
- Austrian Research Group for Regenerative and Orthopedic Medicine
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Retear rate
- Last Updated
- 5 years ago
Overview
Brief Summary
Retear rates after arthroscopic rotator cuff repairs remain unsatisfactorily high. Recently, attention has been paid to restore the rotator cuff's native anatomy by reconstructing the superior joint capsule. However, the debate whether to reconstruct only the superficial tendinous part or also the deeper capsulo-ligamentous part of the rotator cuff is ongoing. Thus, the intention of the present study is to compare double-layer versus single-layer arthroscopic rotator cuff repair regarding retear rate and clinical outcome.
Investigators
Philipp Heuberer
Principal Investigator
Austrian Research Group for Regenerative and Orthopedic Medicine
Eligibility Criteria
Inclusion Criteria
- •patients with repairable supra- and infraspinatus tears scheduled for arthroscopic rotator cuff fixation
- •tear size of at least 2.5 cm and up to 4.0 cm
- •signed informed consent
Exclusion Criteria
- •axillary nerve palsy
Outcomes
Primary Outcomes
Retear rate
Time Frame: 12 months postoperatively
Comparison of re-ruptures rate evaluated with magnetic resonance imaging between groups
Secondary Outcomes
- qDASH(baseline, 24 and 60 months postoperatively)
- ASES(baseline, 24 and 60 months postoperatively)
- SST(baseline and 24 months postoperatively)
- Constant-Murley score(baseline, 24 and 60 months postoperatively)
- Satisfaction with the procedure(24 and 60 months postoperatively)
- SSV(baseline, 24 and 60 months postoperatively)
- Tendon integrity(baseline and 60 months postoperatively)
- VAS(baseline, 24 and 60 months postoperatively)
- WORC(baseline and 24 months postoperatively)
- Range of motion (ROM)(baseline, 24 and 60 months postoperatively)
- SF-36(baseline, 24 and 60 months postoperatively)