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Undislocated Distal Both-Bone Forearm Fractures in Children

NCT ID: NCT00397995

Last Updated: 2006-11-10

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Brief Summary

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We create a randomized clinical trial between above- and below elbow cast to find out what kind of treatment is optimal for undislocated both-bone distal forearm fractures.

Detailed Description

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children who arrive at the emergency unit with a undislocated both-bone distal forearm fracture will be asked to join the trial.

After informed consent, a randomization between 2 kinds of cast will be done.

Outpatient clinic visits till a follow-up of 6 months. During these visits we will investigate: consolidation and dislocation on X-ray, function of both arms, complains in daily living and complications.

Conditions

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Fracture Forearm Distal Child Treatment

Keywords

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Fracture Forearm Distal Child Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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above- or under elbow cast

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* both-bone forearm fracture
* distal
* undislocated
* age \< 16 years

Exclusion Criteria

* fracture older than 1 week
* no informed consent
* refracture
* open fracture (Gustillo 2 and 3)
* both fractures type torus
Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Colaris, Joost, M.D.

INDIV

Sponsor Role lead

Principal Investigators

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joost w Colaris, drs

Role: PRINCIPAL_INVESTIGATOR

Locations

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Erasmus Medical Centre location Sophia Children's hospital

Rotterdam, South Holland, Netherlands

Site Status RECRUITING

HAGA, location Juliana Children's Hospital

The Hague, South Holland, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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joost w colaris, drs

Role: CONTACT

Phone: 0031642220265

Email: [email protected]

Facility Contacts

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joost w colaris, drs

Role: primary

joost w colaris

Role: primary

Other Identifiers

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Colaris04

Identifier Type: -

Identifier Source: org_study_id