Dislocated Stable Distal Both-Bone Forearm Fractures in Children
- Conditions
- FractureForearmDistalChildTreatment
- Registration Number
- NCT00397852
- Lead Sponsor
- Colaris, Joost, M.D.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 110
- both-bone forearm fracture
- distal
- dislocated
- stable after reposition
- age < 16 years
- fracture older than 1 week
- no informed consent
- refracture
- open fracture (Gustillo 2 and 3)
- both fractures of type torus
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method re-operations/ re-dislocations
- Secondary Outcome Measures
Name Time Method pronation and supination complications, function, esthetics, complains in daily living, X-rays
Trial Locations
- Locations (2)
HAGA, location Juliana Children's Hospital
🇳🇱Den Haag, Zuid Holland, Netherlands
Erasmus Medical Centre location Sophia Children's hospital
🇳🇱Rotterdam, Zuid Holland, Netherlands