Cost-effectiveness of biceps tenotomy with or without cuff repair in patients with stage 2-3 Goutallier fatty degenerative cuff lesions. A randomized controlled trial
Suspended
- Conditions
- Arthroscopic cuff repairCuff tear / cuff ruptuurBicepstenotomy / BicepstenotomieStage 2-3 Goutallier / stadium 2-3 Goutallier
- Registration Number
- NL-OMON26658
- Lead Sponsor
- Performer: St. Antonius Ziekenhuis, Utrecht/Nieuwegein
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 172
Inclusion Criteria
Competent men and women older than 18 years
- Willing and able to comply with the study protocol
Exclusion Criteria
- Cuff arthropathy according Hamada classification > grade 2
- Full subscapularis tendon tear (delamination or partial avulsion accepted)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome will be quality of life (QOL) measured by the Western Ontario Rotator Cuff (WORC) Index 6 months after surgery. The WORC index is a disease-specific shoulder questionnaire, originally developed at the University of Western Ontario and has been validated in Dutch [24]. It measures quality of life in patients with rotator cuff disease on 5 domains: physical symptoms, sports and recreation, work, lifestyle and emotions. Each item is scored on a non-hatched 100-mm visual analogue scale (VAS). Total score ranges from 0 to 2100, with a higher score indicating a lower quality of life. All items are converted to a score from 0-100%, with a higher score indicating a higher QOL. <br /><br>In addition, an economic analysis will be performed from a societal perspective and a budget impact analysis from societal, government and insurer perspective.
- Secondary Outcome Measures
Name Time Method Secondary outcomes include:<br /><br>• Difference between groups:<br /><br>o General health, measured by RAND-36<br /><br>o Quality of life, measured by EQ-5D-5L<br /><br>o Pain, measured by the VAS score<br /><br>o Function short term (≤ 6 months) and long term (> 6 months – 5 years), measured by the Constant Murley score and glenohumeral range of motion <br /><br>• Re-tear rate at 6 months determined by ultrasound<br /><br>• Productivity losses measured by the Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness (TiC-P).<br /><br>• Relation between participants functional change, their expectation and their satisfaction of treatment.<br /><br>• Complication rate and adverse events.