Treatment of Unstable Both-Bone Midshaft Forearm Fractures in Children

NCT ID: NCT00314587

Last Updated: 2007-02-26

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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The investigators created a randomized clinical trial between 1 or 2 elastic stable intramedullary nails to find out what kind of treatment is optimal for unstable both-bone midshaft forearm fractures.

Detailed Description

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Children who arrive at the emergency unit with an unstable both-bone midshaft forearm fracture will be asked to join the trial.

If the fracture will be unstable during reposition in the operating room, a randomization between 1 or 2 ESIN will be done.

The aftertreatment will be the same for both groups: above elbow plaster for 3 weeks. Outpatient clinic visits till a follow-up of 9 months. During these visits we will investigate: consolidation and dislocation on X-ray, function of both arms, complaints in daily living and complications.

Conditions

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Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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1 or 2 elastic stable intramedullary nails

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Stable both-bone forearm fracture
* Age \< 16 years old
* Dislocation
* Unstable

Exclusion Criteria

* Fracture older than 1 week
* No informed consent
* Refracture
* Open fracture (Gustillo 2 and 3)
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, M.D.

Role: PRINCIPAL_INVESTIGATOR

HAGA/Erasmus Medical Centre

Locations

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Erasmus Medical Centre, Sophia Children's Hospital

Rotterdam, South Holland, Netherlands

Site Status RECRUITING

HAGA, 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, M.D.

Role: CONTACT

0031-642220265

Facility Contacts

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Joost W Colaris, M.D.

Role: primary

0031-642220265

Joost W Colaris, M.D.

Role: primary

0031-642220265

Other Identifiers

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colaris01

Identifier Type: -

Identifier Source: org_study_id

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