Dislocated Stable Distal Both-Bone Forearm Fractures in Children

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2006 by Colaris, Joost, M.D.
Sponsor:
Information provided by:
Colaris, Joost, M.D.
ClinicalTrials.gov Identifier:
NCT00397852
First received: November 8, 2006
Last updated: NA
Last verified: November 2006
History: No changes posted

November 8, 2006
November 8, 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: 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.
 
Recruiting
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: joost w colaris, drs 0031642220265 joostcolaris@hotmail.com
Netherlands
 
 
NCT00397852
colaris05
Not Provided
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