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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-02

Study Completion Date

2019-08-29

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.

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

one Group with upper arm cast one Group with forearm cast

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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upper arm combi cast

standardized treatment

Group Type ACTIVE_COMPARATOR

combi cast

Intervention Type DEVICE

upper arm or forearm combi cast

forearm combi cast

Treatment with a forearm combi cast should be a sufficient immobilization

Group Type EXPERIMENTAL

combi cast

Intervention Type DEVICE

upper arm or forearm combi cast

Interventions

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combi cast

upper arm or forearm combi cast

Intervention Type DEVICE

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