Comparing Forearm and Upper Arm Combi Cast for Distal Forearm Fractures in Children

Study Overview
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Brief Summary
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The standard treatment for children with closed reduction of displaced distal forearm fractures is an immobilization with an upper arm combicast. The hypothesis is that an forearm immobilization with combicast in children 4-16 years might be sufficient.

Detailed Description
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Children with distal radial or forearm fractures needing closed reduction are eligible for this study. By drawing lots either an immobilization with an upper arm or forearm combicast will be performed. Regular controls after 5, 10, 28 days, 4 weeks and 7 weeks will be performed to check the rate of displacement, consolidation time, wearing comfort and movement of the elbow joint after taking off the cast.

Official Title
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Randomized Controlled Trial Comparing Forearm and Upper Arm Combi Cast for Immobilization After Closed Reduced Distal Forearm Fractures in Children

Conditions
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Salter-Harris Type I, Salter-Harris Type 2, Radius Fractures, Forearm Fracture

Intervention / Treatment
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* Device: combi cast


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: open growth Zone displaced metaphyseal radial or forearm fractures including Salter harris fracture 1 and 2 which require closed reduction written informed consent Exclusion Criteria: intraarticular fractures open fractures unstable fractures

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 16 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
Interventional Model Description: one Group with upper arm cast one Group with forearm cast
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: upper arm combi cast<br>standardized treatment | Device: combi cast<br>* upper arm or forearm combi cast<br>|
| Experimental: forearm combi cast<br>Treatment with a forearm combi cast should be a sufficient immobilization | Device: combi cast<br>* upper arm or forearm combi cast<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| secondary displacement of the fracture | radiological evaluation | Significant difference of secondary displaced fractures 28 days after closed reduction of fracture | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wearing comfort of the two different casts | help in daily life in hours | 5, 10, 28 days, 4 weeks, 7 weeks after closed reduction of fracture | 
| Mobilisation of elbow joint after cast removal | Mobility of the elbow joint in degrees (flection and extension measurement) | 4 weeks and 7 weeks after closed reduction of fracture | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cast, fracture, immobilization, displacement, child