Multicenter randomized controlled trial on nonoperative versus operative treatment for acute complete tears of the ulnar collateral ligament of the thumb: Cost-effectiveness and functional outcomes (MUSCAT-study)
Recruiting
- Conditions
- Skier's thumb10043237
- Registration Number
- NL-OMON54029
- Lead Sponsor
- Diakonessenhuis Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 126
Inclusion Criteria
Adult patients with an acute complete UCL rupture, including Stener Lesions,
diagnosed using physical examination by the hand surgeon.
Exclusion Criteria
- Patients with a significant (> 1 mm) bone fragment on the radiograph.
- Patients with an additional fracture(s) on the ipsilateral hand.
- Patients with injury older than 13 days.
- Patients with a history of a UCL injury on the ipsilateral hand.
- Patients with impaired hand function prior to injury due to
arthrosis/neurological disorders of the upper limb.
- Polytrauma patients (Injury Severity Score (ISS) = 16 or higher).
- Not able to give informed consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary outcome: hand function expressed as the MHQ at 6 months (from date of<br /><br>injury to 6 months FU).</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary: MHQ measured at 4 weeks after cast immobliization, 3 and 12 months<br /><br>after date of injury, pain, well-being, pain, well-being, understanding medical<br /><br>information, total active motion of the thumb joints, pinch/grip strength,<br /><br>patient satisfaction, patient expectation, quality of life, complications,<br /><br>work-absence, cost-effectiveness measured at 4 weeks after immobilisation<br /><br>(function), 2, 3, 6 and 12 months after date of injury.</p><br>