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Clinical Trials/NCT00398242
NCT00398242
Unknown
Not Applicable

Treatment of Stable Both-Bone Midshaft Forearm Fractures in Children: A Randomized Trial Between Treatment With Above Elbow Cast and a Combination of Above- and Below Elbow Armcast.

Colaris, Joost, M.D.2 sites in 1 country60 target enrollmentJanuary 2006

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fracture
Sponsor
Colaris, Joost, M.D.
Enrollment
60
Locations
2
Primary Endpoint
pronation and supination
Last Updated
19 years ago

Overview

Brief Summary

We create a randomized clinical trial between the treatment with above elbow armcast alone and the treatment of above elbow in combination with a short arm cast for stable midshaft both-bone forearm fractures.

Detailed Description

children who arrive at the emergency unit with a stable both-bone midshaft forearm fracture will be asked to join the trial. If the fracture will be stable during reposition in the operating room, a randomization between 2 kinds of plaster treatment will be done. 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.

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
  • age \< 16 years
  • dislocation

Exclusion Criteria

  • fracture older than 1 week
  • no informed consent
  • refracture
  • open fracture (Gustillo 2 and 3)

Outcomes

Primary Outcomes

pronation and supination

Secondary Outcomes

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

Study Sites (2)

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