Rotator Cuff Tear
Conditions
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.
Interventions
PROCEDUREdouble layer fixation
PROCEDUREsingle layer fixation
Sponsors
Austrian Research Group for Regenerative and Orthopedic Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retear rate | 12 months postoperatively | Comparison of re-ruptures rate evaluated with magnetic resonance imaging between groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Range of motion (ROM) | baseline, 24 and 60 months postoperatively | Comparison of ROMs 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'). |
| VAS | baseline, 24 and 60 months postoperatively | Comparison of the Visual Analogue Scale (VAS) between groups |
| SST | baseline and 24 months postoperatively | Comparison of the Simple Shoulder Test (SST) between groups |
| 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. |
| 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 |
| WORC | baseline and 24 months postoperatively | Comparison of the Western Ontario Rotator Cuff Index (WORC) between groups |
| SSV | baseline, 24 and 60 months postoperatively | Comparison of the Simple Soulder Value (SSV) between groups |
| SF-36 | baseline, 24 and 60 months postoperatively | Comparison of the quality-of-life score short form 36 (SF-36) 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 |
| qDASH | baseline, 24 and 60 months postoperatively | Comparison of the quick Disability of the Arm, Shoulder and Hand (qDASH) between groups |
Countries
Austria
Outcome results
None listed