DART II. Post-traumatic osteoarthritis of the wrist in elderly patients with displaced intra-articular distal radius fractures. A follow-up study of the DART trial.
Recruiting
- Conditions
- articular degeneration after traumaposttraumatic osteoarthritis10005944
- Registration Number
- NL-OMON49854
- Lead Sponsor
- Reinier de Graaf Groep
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 154
Inclusion Criteria
Participant of the DART study or NITEP Nordic Radius study (AO type C fracture)
Mentally competent
Dutch fluency and literacy
Informed consent
Exclusion Criteria
Incomplete follow-up period during participation of the DART study
Fracture of the contralateral wrist in the history
Rheumatoid arthritis
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The degree of radio-carpal osteoarthritis on X-ray and and CT scan 2 and 5<br /><br>years after the intra-articular distal radius fracture.</p><br>
- Secondary Outcome Measures
Name Time Method <p>An assessment will be made if there is a correlation between the primary<br /><br>outcome and secondary outcomes, such as patient reported outcome measures<br /><br>(PROMs) including the Patient-Rated Wrist Evaluation score (PRWE), Disability<br /><br>of the Arm, Shoulder and Hand (DASH), Michigan Hand Outcome Questionnaire<br /><br>(MHOQ), Quality of life (EQ-5D-3L and 15D) and Pain Catastrophizing Scale<br /><br>(PCS). Further secondary outcomes are the frailty score, range of motion (ROM),<br /><br>grip strength, complications and additional costs as a result of<br /><br>osteoarthritis.</p><br>