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ID
Source
Brief title
Health condition
Displaced distal radius fractures, suitable for conservative treatment after reduction.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Fracture re-displacement
Secondary outcome
Surgical intervention rate, functional outcome, complication rate, analgesics use, pain severity, cost-effectiveness
Background summary
Rationale:
Distal radius fractures (DRF) are the most common fractures in the adult population. There is no consensus on conservative treatment of a displaced DRF.
Objective:
To evaluate the cost-effectiveness of treatment with a circumferential cast compared to treatment with a splint, in patients with a reduced distal radius fracture. The hypothesis is that reduced distal radius fractures treated with a circumferential cast instead of a splint, results in less fracture re-displacement, fewer surgical interventions, less complications and lower costs.
Study design: Cluster randomized design, randomization will take place on hospital level. All patients will be followed for 1 year.
Study population: Adult patients with a primary displaced fracture of the radius which is treated conservatively after closed reduction.
Intervention:
In one group the fracture will be initially immobilized with a circumferential below-elbow cast. In the other group the fracture will be initially immobilized with a below-elbow splint.
Study objective
Reduced distal radius fractures, primarily treated with a circumferential cast instead of a dorsal splint, results in less fracture re-displacement, fewer surgical interventions, less complications and lower costs.
Study design
Baseline, 1 week, 2 weeks, 6 weeks, 3 months, 6 months, 12 months
Intervention
Below-elbow circumferential casting or below-elbow splinting
Inclusion criteria
Primary displaced distal radius fracture, treated with closed reduction. Age above 18 years
Exclusion criteria
Failure to reach proper fracture alignment after reduction(s), insufficient command of the Dutch language, both-bone fracture (styloid fracture excluded), concomitant injuries to ipsilateral extremity, multiple trauma patient
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8311 |
| CCMO | NL71020.078.19 |
| OMON | NL-OMON48181 |