Dislocated Unstable Distal Both-Bone Forearm Fractures in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00398268
Recruitment Status : Unknown
Verified November 2006 by Colaris, Joost, M.D..
Recruitment status was:  Recruiting
First Posted : November 10, 2006
Last Update Posted : November 10, 2006
Information provided by:
Colaris, Joost, M.D.

Brief Summary:
We create a follow-up study of Kirschner wire fixation of a unstable dislocated distal both-bone forearm fracture.

Condition or disease Intervention/treatment Phase
Fracture Forearm Distal Child Treatment Procedure: Kirschner-wire fixation Not Applicable

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 an unstable reposition, the fracture will be fixated with 2 Kirschner-wires. The arm will be immobilised in above elbow cast during 4 weeks. 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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Unstable Dislocated Both-Bone Distal Forearm Fractures in Children: A Follow-up Study
Study Start Date : January 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. pronation and supination

Secondary Outcome Measures :
  1. complications, function, esthetics, complains in daily living, X-rays

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • both-bone forearm fracture
  • distal
  • dislocated
  • unstable 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00398268

HAGA, location Juliana Children's Hospital Recruiting
Den Haag, Zuid Holland, Netherlands
Contact: joost w colaris, drs    0031642220265   
Sponsors and Collaborators
Colaris, Joost, M.D.
Principal Investigator: joost w colaris, drs Identifier: NCT00398268     History of Changes
Other Study ID Numbers: colaris06
First Posted: November 10, 2006    Key Record Dates
Last Update Posted: November 10, 2006
Last Verified: November 2006

Keywords provided by Colaris, Joost, M.D.:

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries