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Optimal conservative treatment of displaced wrist fractures.


- candidate number5076
- NTR NumberNTR1618
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR7-jan-2009
- Secondary IDs01 
- Public TitleOptimal conservative treatment of displaced wrist fractures.
- Scientific TitleOptimal position of the wrist in plaster cast in the conservative treatment of posterior displaced distal radius fracture.
- ACRONYMN/A
- hypothesisConservative conservative treatment of displaced wrist fractures with a cast in which the wrist is 20 degrees dorsiflexed is better than a neutral position in terms of re-dislocation and functional outcome.
- Healt Condition(s) or Problem(s) studiedPosterior displaced distal radius fracture
- Inclusion criteria1. Ages 18 and over;
2. unilateral distal radius fracture with posterior displacement;
3. Normal wrist function prior to trauma;
4. Presents to ER at Viecuri Venlo.
- Exclusion criteria1. Indication for operative treatment;
2. previous wrist fracture;
3. multitrauma;
4. unable to attend to follow up at the participating hospital;
5. non-dutch speakers or persons with a cognitive deficit.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- control[default]
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 2-feb-2009
- planned closingdate31-dec-2009
- Target number of participants150
- InterventionsConservative treatment with a plaster cast.
- Primary outcome1. Functional outcome measured with the PRWE questionnnaire;
2. objective functional parameters: Grip strength and range of motion;
3. amount of redislocation as measured on control X-rays.
- Secondary outcome1. Occurrence of sudeck's dystrophy;
2. Pain during treatment;
3. occurence of secondary operative treatment.
- Timepoints1 week: radiologic control, VAS-score to evaluate pain;
6 weeks, objective functional parameters: Grip strength and range of motion, VAS score and assess occurence of Dystrophy;
3 months and 6 months: subjective and objective functional outcome.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES D. Rijpsma
- CONTACT for SCIENTIFIC QUERIES D. Rijpsma
- Sponsor/Initiator VieCuri Medisch Centrum voor Noord-Limburg
- Funding
(Source(s) of Monetary or Material Support)
VieCuri Medisch Centrum voor Noord-Limburg
- PublicationsN/A
- Brief summaryThis randomized, controlled, prospective study will compare conservative treatment of displaced distal radius fractures with a plaster cast in a neutral position against a cast with the wrist 20 degrees dorsiflexed. Functional outcome and redislocation are objectively assesed.
- Main changes (audit trail)
- RECORD7-jan-2009 - 8-feb-2009


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