Refraining From Closed Reduction of Dislocated Distal Radius Fractures in the Emergency Department

Study Overview
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Brief Summary
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The investigators test the efficacy of closed reduction in displaced distal radial fractures in the emergency department.

Detailed Description
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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.

Official Title
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Refraining From Closed Reduction of Dislocated Distal Radius Fractures in the Emergency Department

Conditions
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Wrist Fractures, Distal Radius Fractures, Closed Reduction of Fracture and Application of Plaster Cast, Wrist Injuries, Radius Fracture Distal

Intervention / Treatment
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* Procedure: closed reduction
* Procedure: no closed reduction


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: closed reduction followed by plaster casting<br> | Procedure: closed reduction<br>* 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.<br>|
| Experimental: only plaster casting<br>no closed reduction will be performed | Procedure: no closed reduction<br>* no reduction will be performed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| daily pain scores | 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. | usually 2-10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| function | 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. | 6 weeks, 3, 6 and 12 months | 
| Number of complications | 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. | 1 year | 
| Wrist mobility | Range of motion will be reported in form of wrist flexion and extension and pro- and supination, in degrees. | 6 weeks and 3 months | 
| length of stay in emergency department | length of stay in emergency department | baseline | 
| quality of life in EQ5D5L | 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. | 1 year |