Bicepspees tenodese of tenotomie bij arthroscopische rotator cuff repair: Een internationaal multicenter prospectief gerandomiseerde klinische trial.
- Conditions
- Rotator cuff, Arthroscopic treatment, Bicepstendon, Popeye, Cosmesis
- Registration Number
- NL-OMON20398
- Lead Sponsor
- OLVG Amsterdam
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 98
Patients older than 50 years who are indicated to undergo repair of a moderately sized rotator cuff (infraspinatus and/or supraspinatus) tendon rupture (sized smaller than 3cm measured using an arthroscopic ruler), who are encountered with an inflamed, unstable or partially torn LHB tendon.
Patients need to be able to read and write in Dutch or English language in order to complete the questionnaires, and sign informed consent.
Patients are excluded form this study in case of an acute, traumatic or partial thickness rotator cuff rupture, or in case a full thickness tear is larger than 3 cm measured using an arthroscopic ruler. (This excludes patients who have a massive rotator cuff rupture, since these patients are more likely to have a re-rupture within one year).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Functional outcome measured using the Constant score.
- Secondary Outcome Measures
Name Time Method In addition, the Dutch Oxford Shoulder Test (DOST) and the Disabilities of the Arm Shoulder and Hand (DASH) questionnaire will be assessed. Other evaluations concern: cosmetic appearance evaluated by the ‘‘Popeye’’ deformity, arm cramping pain, elbow flexion strength (measured with a hand dynamometer), cost-effectiveness (evaluated with the EQ-5D), and an MRI evaluation.