NCT00397852UnknownNot 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.3 sites in 1 country110 target enrollmentStarted: January 1, 2006Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 110
- Locations
- 3
- Primary Endpoint
- re-operations/ re-dislocations
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- — to 15 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Investigators
Study Sites (3)
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