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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
70
St. Vincent Shoulder & Sports Clinic
Vienna, Austria
Retear rate
Comparison of re-ruptures rate evaluated with magnetic resonance imaging between groups
Time frame: 12 months postoperatively
Constant-Murley score
Comparison of the total Constant-Murley score (min 0 to max 100; higher values represent a better outcome) between groups
Time frame: baseline, 24 and 60 months postoperatively
Range of motion (ROM)
Comparison of ROMs between groups
Time frame: baseline, 24 and 60 months postoperatively
Satisfaction with the procedure
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').
Time frame: 24 and 60 months postoperatively
VAS
Comparison of the Visual Analogue Scale (VAS) between groups
Time frame: baseline, 24 and 60 months postoperatively
SST
Comparison of the Simple Shoulder Test (SST) between groups
Time frame: baseline and 24 months postoperatively
ASES
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.
Time frame: baseline, 24 and 60 months postoperatively
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qDASH
Comparison of the quick Disability of the Arm, Shoulder and Hand (qDASH) between groups
Time frame: baseline, 24 and 60 months postoperatively
WORC
Comparison of the Western Ontario Rotator Cuff Index (WORC) between groups
Time frame: baseline and 24 months postoperatively
SSV
Comparison of the Simple Soulder Value (SSV) between groups
Time frame: baseline, 24 and 60 months postoperatively
SF-36
Comparison of the quality-of-life score short form 36 (SF-36) between groups
Time frame: baseline, 24 and 60 months postoperatively
Tendon integrity
Comparison of tendon integrity (re-tear / no re-tear) evaluated with magnetic resonance imaging between groups
Time frame: baseline and 60 months postoperatively