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Dislocated Stable Distal Both-Bone Forearm Fractures in Children

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2006 by Colaris, Joost, M.D..
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00397852
First Posted: November 10, 2006
Last Update Posted: November 10, 2006
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.
Information provided by:
Colaris, Joost, M.D.
November 8, 2006
November 10, 2006
November 10, 2006
January 2006
Not Provided
re-operations/ re-dislocations
Same as current
No Changes Posted
  • pronation and supination
  • complications, function, esthetics, complains in daily living, X-rays
Same as current
Not Provided
Not Provided
 
Dislocated Stable Distal Both-Bone Forearm Fractures in Children
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Fracture
  • Forearm
  • Distal
  • Child
  • Treatment
Procedure: Kirschner-wires or not
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
110
Not Provided
Not Provided

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
Sexes Eligible for Study: All
up to 15 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT00397852
colaris05
Not Provided
Not Provided
Not Provided
Not Provided
Colaris, Joost, M.D.
Not Provided
Principal Investigator: joost w colaris, drs
Colaris, Joost, M.D.
November 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP
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