Treatment of Unstable Both-Bone Midshaft Forearm Fractures in Children
Recruitment status was: Recruiting
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Treatment of Unstable Both-Bone Midshaft Forearm Fractures in Children: A Randomized Trial Between 1 and 2 Elastic Stable Intramedullary Nails|
- pronation and supination
- complications, function, esthetics, complaints in daily living, X-rays
|Study Start Date:||January 2006|
Children who arrive at the emergency unit with an unstable both-bone midshaft forearm fracture will be asked to join the trial.
If the fracture will be unstable during reposition in the operating room, a randomization between 1 or 2 ESIN will be done.
The aftertreatment will be the same for both groups: above elbow plaster for 3 weeks. Outpatient clinic visits till a follow-up of 9 months. During these visits we will investigate: consolidation and dislocation on X-ray, function of both arms, complaints in daily living and complications.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00314587
|HAGA, Juliana Children's Hospital|
|Den Haag, Zuid Holland, Netherlands, 2566ER|
|Erasmus Medical Centre, Sophia Children's Hospital|
|Rotterdam, Zuid Holland, Netherlands, 3015GJ|
|Principal Investigator:||Joost W Colaris, M.D.||HAGA/Erasmus Medical Centre|