Wrist Injuries, Wrist Fractures, Distal Radius Fractures, Closed Reduction of Fracture and Application of Plaster Cast, Radius Fracture Distal
Conditions
Brief summary
The investigators test the efficacy of closed reduction in displaced distal radial fractures in the emergency department.
Detailed description
in a multicenter cluster randomized trial the investigators aim to include 134 patients with displaced distal radial fractures awaiting surgery and randomize between closed reduction followed by plaster casting and plaster casting alone. Primairy outcomes are pain in the days leading up to surgery and postoperative hand- and wrist function. Secondary outcomes are length of stay in the emergency department, length of surgey, return to work and complications.
Interventions
PROCEDUREclosed reduction
the intervention of closed fracture reduction widely known and part of daily practice. we test the eficacy of this intervention by not performing it in our test group.
PROCEDUREno closed reduction
no reduction will be performed
Sponsors
Maasstad Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
cluster randomization
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* displaced distal radial fracture eligible for surgery
Exclusion criteria
* ISS traumascore \>16 * open fracture * multiple fractures in ipsilateral extremety * neurovascular damage * previous injury in the same wrist * inability to complete questionnaires
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| daily pain scores | usually 2-10 days | pain reported in the days awaiting surgery on the visual analog scale (VAS) scoring from 0 to 10 where 0 equals no pain and 10 the worst pain imaginable. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| function | 6 weeks, 3, 6 and 12 months | hand function as reported by the patient reported hand and wrist evaluation (PRHWE) questionnaire. scoring from 0 to 100 with 0 meaning perfect function with no impairment or pain and 100 meaning no function at all with maximum pain. |
| Number of complications | 1 year | The investigators will report all complications including, but not limited to: nerve damage, CRPS, infection, bleeding, malunion and need for revision surgery will be tracked. |
| Wrist mobility | 6 weeks and 3 months | Range of motion will be reported in form of wrist flexion and extension and pro- and supination, in degrees. |
| length of stay in emergency department | baseline | length of stay in emergency department |
| quality of life in EQ5D5L | 1 year | reported by the EQ5D5L questionnaire. EQ-5D-5L health states can be summarised using a 5-digit code or represented by a single summary number (index value), which reflects how good or bad a health state is according to the preferences of the general population of a country/region. |
Countries
Netherlands
Contacts
Primary ContactBas M Derksen, MsC
Outcome results
None listed