Dislocated Stable Distal Both-Bone Forearm Fractures in Children

November 8, 2006 updated by: Colaris, Joost, M.D.

Treatment of Stable Dislocated Both-Bone Distal Forearm Fractures in Children: A Randomized Trial Between Treatment With en Without Kirschner-Wires

We create a randomized clinical trial between treatment with and without Kirschner wire fixation of a stable dislocated distal both-bone forearm fracture.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

After informed consent, a randomization between 2 kinds of treatment will be done: K-wire fixation or no K-wire fixation of the fracture after a stable reposition.

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

Study Type

Interventional

Enrollment

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Zuid Holland
      • Den Haag, Zuid Holland, Netherlands
        • Recruiting
        • HAGA, location Juliana Children's Hospital
        • Contact:
      • Rotterdam, Zuid Holland, Netherlands
        • Recruiting
        • Erasmus Medical Centre location Sophia Children's hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • both-bone forearm fracture
  • distal
  • dislocated
  • stable after reposition
  • age < 16 years

Exclusion Criteria:

  • fracture older than 1 week
  • no informed consent
  • refracture
  • open fracture (Gustillo 2 and 3)
  • both fractures of type torus

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
re-operations/ re-dislocations

Secondary Outcome Measures

Outcome Measure
pronation and supination
complications, function, esthetics, complains in daily living, X-rays

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Colaris, Joost, M.D.

Investigators

  • Principal Investigator: joost w colaris, drs

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Study Registration Dates

First Submitted

November 8, 2006

First Submitted That Met QC Criteria

November 8, 2006

First Posted (Estimate)

November 10, 2006

Study Record Updates

Last Update Posted (Estimate)

November 10, 2006

Last Update Submitted That Met QC Criteria

November 8, 2006

Last Verified

November 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • colaris05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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