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Evaluation of indicators for distal radioulnar joint instability after a distal radius fracture in adults and children.


- candidate number8847
- NTR NumberNTR2672
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-jan-2011
- Secondary IDs 
- Public TitleEvaluation of indicators for distal radioulnar joint instability after a distal radius fracture in adults and children.
- Scientific TitleEvaluation of indicators for distal radioulnar joint instability after a distal radius fracture in adults and children.
- ACRONYM
- hypothesisThe null hypothesis is tested that radiological risk-factors for DRUJ instability may account for clinical DRUJ instability in patients after a consolidated distal radius fracture.
- Healt Condition(s) or Problem(s) studiedDistal radioulnar joint instability, Distal radius fracture
- Inclusion criteria1. Age > 18 years;
2. (Ability to give) informed consent;
3. Between 4 and 24 months after trauma causing distal radius fracture with an associated, non-operatively treated ulnar styloid base fracture;
4. (Near) anatomical consolidated (after plastercast immobilization or operative fixation) distal radius fracture with non-union of the ulnar styloid;
5. Post-traumatic ulnar sided wrist pain;
6. Signed informed consent by the patient or a legal representative.
- Exclusion criteria1. Patient younger than 18 years;
2. Contra-indications for CT-scanning;
3. (Previous) injury to the ipsilateral or contra-lateral wrist;
4. Complex region pain syndrome (Sudecks’ dystrophia).
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jun-2011
- planned closingdate1-jun-2012
- Target number of participants100
- Interventions1. Physical examination;
2. X-rays;
3. CT-scan;
4. MRI-scan;
5. Questionnaires.
- Primary outcome1. Pain;
2. Function;
3. DRUJ instability.
- Secondary outcomeN/A
- TimepointsOne visit 1 to 2 years after distal radius fracture.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES M.M.E. Wijffels
- CONTACT for SCIENTIFIC QUERIES M.M.E. Wijffels
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC)
- PublicationsN/A
- Brief summaryDRUJ instability and ulnar wrist pain is common after distal radius fractures. Radiological riskfactors are identified but influence on outcome is still a matter of debate. Furthermore best modality to evaluate DRUJ instability has to be confirmed. In our study we would like to evaluate radiological riskfactors for DRUJ instabiltiy comparing clinical outcome and evaluate three radiological modalities for predictive value of DRUJ instability.
- Main changes (audit trail)
- RECORD3-jan-2011 - 11-jan-2011


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