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Wrist fractures treated with plaster cast or operation: what leads to the best outcome in patients older than 50 years?


- candidate number3210
- NTR NumberNTR1280
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-apr-2008
- Secondary IDs08-2-009 MEC azM
- Public TitleWrist fractures treated with plaster cast or operation: what leads to the best outcome in patients older than 50 years?
- Scientific TitleA randomized trial comparing plaster cast immobilization versus operation in elderly patients with distal radius fractures
- ACRONYMRADIUS STUDY: Randomized Assessment of Distal radius fracture Interventions in Unstable Subtypes
- hypothesisOpen reduction and internal fixation (ORIF) using locking-plate distal radius osteosynthesis leads to an improved functional outcome (DASH score) in elderly (>50 years) (independent in activities of daily living) patients with a displaced distal radius fracture (AO type A2, A3, B1, C1, and C2).
- Healt Condition(s) or Problem(s) studiedFracture , Distal radius, Plate fixation, Plaster cast immobilization
- Inclusion criteria1. Age > 50 years
2. Primary displaced unilateral fracture of distal radius (open fractures are included)
a. AO (Arbeitsgemeinschaft fur Osteosynthesefragen) type A2
b. AO type A3
c. AO type B1
d. AO type C1
e. AO type C2
3. Independent for activities of daily living (yes/no question)
4. Inadequate reduction of distal radius fracture at emergency department (For specific criteria see below) and/or
5. Inadequate reduction of distal radius at 1 week follow-up at the outpatient department: Therapeutic failure is defined as fracture displacement when the dorsal or volar angulations are more than 10, intra-articular step-off > 1mm, or the ulnar variance is more than 3mm. This failure accounts for both redisplacement after initial adequate alignment during conservative treatment (including manipulative reduction) on the emergency department) and for secondary failure after surgical reduction.
- Exclusion criteria1. Fracture of contralateral arm
2. Other fractures at the ipsilateral arm (excluded carpal fractures)
3. Pre-existent abnormalities fractured distal radius
4. Primary unilateral fracture distal radius AO type A1, B2, B3 and C3
5. Pathological fractures (due to metastasis, secondary osteoporosis)
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jun-2008
- planned closingdate1-jun-2012
- Target number of participants200
- InterventionsOpen reduction and internal fixation using locking-plate and angular stable screw fixation versus plaster cast immobilization
- Primary outcomeMain study parameter/endpoint
Functional outcome parameters:
Disability of Arm, Shoulder and Hand (DASH) score, Musculoskeletal Function Assessment (MFA)
- Secondary outcomeSecondary study parameters/endpoints
Functional outcome parameters:
Short Form 36 (SF-36) health survey questionnaire, Patient Related Wrist Evaluation (PRWE), Range of motion, Pain level (VAS), Cost-effectiveness analysis Radiographic analysis: Lidstrom score
Complications:
complex regional pain syndrome type-I, infection, re-operation, arthrodesis, general surgical complications (pneumonia, myocardial infarction, etc).
- TimepointsFollow-up 1 month, and 3, 6, 12 and 24 months
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD PhD M. Poeze
- CONTACT for SCIENTIFIC QUERIESMD PhD M. Poeze
- Sponsor/Initiator University Hospital Maastricht (AZM), Department of Surgery
- Funding
(Source(s) of Monetary or Material Support)
University Hospital Maastricht (AZM)
- PublicationsN/A
- Brief summaryComplication rate for treatment of displaced intra-articular distal radius fractures is low, although functional disability remains a significant problem with up to 30% of patients suffering long-term functional restrictions after conservative treatment. Whether operative correction improves this functional outcome compared to conservative treatment remains unclear.
- Main changes (audit trail)
- RECORD17-apr-2008 - 25-apr-2008


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