Clinical relevance of Clinician and Patient Reported Outcome Measures in patients with upper extremity injuries by determining Minimal Important Change (COMIC)
Recruiting
- Conditions
- pper extremity injury: clavicle fracture, AC luxation, shoulder dislocation, humerus fracture (proximal, shaft and distal), elbow dislocation, radius fracture (proximal, shaft, distal), ulna fracture (olecranon, shaft, distal), carpal fractures and dislocations, metacarpal fractures and dislocations, finger fractures and dislocations (proximal falanx, midfalanx, distal falanx, PIP, DIP, MCP).
- Registration Number
- NL-OMON22661
- Lead Sponsor
- Amsterdam UMC, location VUmc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 400
Inclusion Criteria
1. Patients with UEI (uni- or bilateral), thus; patients will be included <1 week after injury.
2. Age of 18 years or older.
(3. Extra inclusion criterium for patients suffering hand/wrist injury: unilateral injury)
Exclusion Criteria
1. No sufficient command of the Dutch language.
2. Patients with UE disorders; longer existing complaints (>1 week).
(3. Extra exclusion criterium for patients suffering hand/wrist injury: bilateral injury)
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PROM and CRO scores to estimate MICs for PROMs and CROs.
- Secondary Outcome Measures
Name Time Method - PROM and CRO scores to validate PROMs.<br>- Estimating the MIC for the PROMIS UE v2.0 item bank by using the vignettes method. Development and validation of the required vignettes.