Fracture
Conditions
Keywords
fracture, forearm, midshaft, child, treatment
Brief summary
The investigators created a randomized clinical trial between 1 or 2 elastic stable intramedullary nails to find out what kind of treatment is optimal for unstable both-bone midshaft forearm fractures.
Detailed description
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.
Interventions
PROCEDURE1 or 2 elastic stable intramedullary nails
Sponsors
Colaris, Joost, M.D.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 15 Years
Healthy volunteers
Yes
Inclusion criteria
* Stable both-bone forearm fracture * Age \< 16 years old * Dislocation * Unstable
Exclusion criteria
* Fracture older than 1 week * No informed consent * Refracture * Open fracture (Gustillo 2 and 3)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pronation and supination | — |
Secondary
| Measure | Time frame |
|---|---|
| complications, function, esthetics, complaints in daily living, X-rays | — |
Countries
Netherlands
Contacts
Primary ContactJoost W Colaris, M.D.
Outcome results
None listed