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Clinical Trials/NCT00397852
NCT00397852
Unknown
Not Applicable

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

Colaris, Joost, M.D.2 sites in 1 country110 target enrollmentJanuary 2006

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fracture
Sponsor
Colaris, Joost, M.D.
Enrollment
110
Locations
2
Primary Endpoint
re-operations/ re-dislocations
Last Updated
19 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
January 2006
End Date
TBD
Last Updated
19 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Colaris, Joost, M.D.

Eligibility Criteria

Inclusion Criteria

  • both-bone forearm fracture
  • 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

Outcomes

Primary Outcomes

re-operations/ re-dislocations

Secondary Outcomes

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

Study Sites (2)

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