The aim of the proposed study is to improve functional outcome using locking angle-stable screw-plate osteosynthesis compared to plaster cast immobilization.
ID
Source
Brief title
Condition
- Fractures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome parameters: Disability of Arm, Shoulder and Hand (DASH) score,
Musculoskeletal Function Assessment (MFA)
Secondary outcome
General and functional outcome parameters: Short Form 12 (SF-12) health survey
questionnaire, and Patient Related Wrist Evaluation (PRWE),
Range of motion,
Pain level (VAS),
Cost-effectiveness analysis,
Radiographic analysis using Lidstrom score
Complication rate.
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
The aim of the proposed study is to improve functional outcome using locking
angle-stable screw-plate osteosynthesis compared to plaster cast
immobilization.
Study design
Prospective randomized controlled clinical trial
Intervention
Plaster cast immobilization is compared to open reduction and internal
fixation.
Study burden and risks
The expectations of this study is that operative treatment is beneficial for
the patient with a distal radius fracture. This risk of specific complications
is low and generally similar in both treatment options. Functional results due
to improved congruency of the radius joint is hypothesized to be higher in the
operative group. Moreover, the burden of the study is not much higher compared
to standard treatment. Follow-up is standardized according to current trauma
guidelines. Literature indicates that both treatment options from the study are
accepted for displaced distal radius fractures. No clear advantage for one
treatment options is found at present in the literature, although there is no
level I evidence present. Both treatment options have their known
complications.
P. Debyelaan 25
6202 AZ
Nederland
P. Debyelaan 25
6202 AZ
Nederland
Listed location countries
Age
Inclusion criteria
1. Age > 55 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 > 2mm, or the ulnar variance is more than 5mm. 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 |
|---|---|
| CCMO | NL20952.068.07 |