No registrations found.
ID
Source
Brief title
Health condition
distal radius
fracture
plate fixation
plaster cast immobilization
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameter/endpoint
Functional outcome parameters:
Disability of Arm, Shoulder and Hand (DASH) score, Musculoskeletal Function Assessment (MFA)
Secondary outcome
Secondary 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).
Background summary
Complication 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.
Study objective
Open 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).
Study design
Follow-up 1 month, and 3, 6, 12 and 24 months
Intervention
Open reduction and internal fixation using locking-plate and angular stable screw fixation versus plaster cast immobilization
University Medical Center Maastricht
PO Box 5800
M. Poeze
Maastricht 6202 AZ
The Netherlands
+31 (0)43 3876543
m.poeze@surgery.azm.nl
University Medical Center Maastricht
PO Box 5800
M. Poeze
Maastricht 6202 AZ
The Netherlands
+31 (0)43 3876543
m.poeze@surgery.azm.nl
Inclusion criteria
1. 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 10ยบ, 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 criteria
1. 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)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1235 |
| NTR-old | NTR1280 |
| Other | MEC azM : 08-2-009 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |