Treatment of Unstable Both-Bone Midshaft Forearm Fractures in Children

February 23, 2007 updated by: Colaris, Joost, M.D.

Treatment of Unstable Both-Bone Midshaft Forearm Fractures in Children: A Randomized Trial Between 1 and 2 Elastic Stable Intramedullary Nails

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment

60

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, 2566ER
        • Recruiting
        • HAGA, Juliana Children's Hospital
        • Contact:
        • Principal Investigator:
          • Joost W Colaris, M.D.
      • Rotterdam, Zuid Holland, Netherlands, 3015GJ
        • Recruiting
        • Erasmus Medical Centre, Sophia Children's Hospital
        • Contact:
        • Principal Investigator:
          • Joost W Colaris, M.D.

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

Yes

Genders Eligible for Study

All

Description

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)

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
pronation and supination

Secondary Outcome Measures

Outcome Measure
complications, function, esthetics, complaints 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, M.D., HAGA/Erasmus Medical Centre

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

April 12, 2006

First Submitted That Met QC Criteria

April 12, 2006

First Posted (Estimate)

April 14, 2006

Study Record Updates

Last Update Posted (Estimate)

February 26, 2007

Last Update Submitted That Met QC Criteria

February 23, 2007

Last Verified

November 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • colaris01

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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