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…
ID
Source
Brief title
Condition
- Fractures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Difference between groups in proportion of fracture re-displacement of the
initial reduced distal radius fracture. Besides, differences in medical
consumption, absence from work or decreased productivity, and patient costs,
will be assessed.
Secondary outcome
- pain medication use
- surgical interventions
- physical examination of range of motion of the arm and grip strength
- recovery of functioning: QUICK-DASH and PRWE questionnaires
- change in pain severity: number rating scale (NRS) for pain
- general quality of life: EQ-5D-5L
- total costs: intramural and extramural medical costs (iMCQ) and productivity
loss (iPCQ)
- adverse events.
Background summary
Distal radius fractures (DRF) are the most common fractures in the adult
population. There is no consensus on conservative treatment of a displaced DRF.
Study 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.
Intervention
In one group the fracture will be initially immobilized with circumferential
below-elbow cast, and in the other group the fracture will be initially
immobilized with below-elbow splint.
Study burden and risks
The burden is primarily time (visit of outpatient clinic, and to fill in
questionnaires). There is no direct benefit from participation or group
relatedness.
's Gravendijksewal 230
Rotterdam 3015 CE
NL
's Gravendijksewal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria: 18 year or older, with a primary displaced fracture
of the distal radius which is treated conservatively after closed reduction,
and who are willing to comply with the study protocol.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study: failure to reach proper fracture alignment
(5) after reduction(s) in the emergency room, inability to complete study forms
due to any mental status or insufficient command of the Dutch language,
both-bone forearm fracture (styloid ulnae fracture excluded), concomitant
injuries to ipsilateral extremity or multi-traumata.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL71020.078.19 |