Arthroscopic Rotator Cuff Tear Repair: Single Versus Double Layer Fixation
- Conditions
- Rotator Cuff Tear
- Interventions
- Procedure: single layer fixationProcedure: double layer fixation
- Registration Number
- NCT03362320
- Lead Sponsor
- Austrian Research Group for Regenerative and Orthopedic Medicine
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 70
- 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
- axillary nerve palsy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description single layer fixation single layer fixation Patients with torn infraspinatus and supraspinatus tendon undergoing arthroscopy rotator cuff repair with single layer fixation double layer fixation double layer fixation Patients with torn infraspinatus and supraspinatus tendon undergoing arthroscopy rotator cuff repair with double layer fixation
- Primary Outcome Measures
Name Time Method Retear rate 12 months postoperatively Comparison of re-ruptures rate evaluated with magnetic resonance imaging between groups
- Secondary Outcome Measures
Name Time Method ASES baseline, 24 and 60 months postoperatively Comparison of the American Shoulder and Elbow Surgeons score (ASES) between groups. The ASES is a patient-rated questionnaire with a total between 0 and 100 points with higher scores indicating better outcome.
qDASH baseline, 24 and 60 months postoperatively Comparison of the quick Disability of the Arm, Shoulder and Hand (qDASH) between groups
SST baseline and 24 months postoperatively Comparison of the Simple Shoulder Test (SST) between groups
Constant-Murley score baseline, 24 and 60 months postoperatively Comparison of the total Constant-Murley score (min 0 to max 100; higher values represent a better outcome) between groups
Satisfaction with the procedure 24 and 60 months postoperatively Comparison of satisfaction with the procedure between groups. Satisfaction is evaluated by asking patients one question to rate their satisfaction with the procedure based on a likert scale (4 = 'very satisfied', 3 = 'quite satisfied', 2 = 'moderately satisfied', 1 = 'less satisfied', 0 = 'not at all satisfied').
SSV baseline, 24 and 60 months postoperatively Comparison of the Simple Soulder Value (SSV) between groups
Tendon integrity baseline and 60 months postoperatively Comparison of tendon integrity (re-tear / no re-tear) evaluated with magnetic resonance imaging between groups
VAS baseline, 24 and 60 months postoperatively Comparison of the Visual Analogue Scale (VAS) between groups
WORC baseline and 24 months postoperatively Comparison of the Western Ontario Rotator Cuff Index (WORC) between groups
Range of motion (ROM) baseline, 24 and 60 months postoperatively Comparison of ROMs between groups
SF-36 baseline, 24 and 60 months postoperatively Comparison of the quality-of-life score short form 36 (SF-36) between groups
Trial Locations
- Locations (1)
St. Vincent Shoulder & Sports Clinic
🇦🇹Vienna, Austria