Treatment of Unstable Both-Bone Midshaft Forearm Fractures in Children

Colaris, Joost, M.D.

Status: Unknown

Conditions: Fracture

Treatments: Procedure: 1 or 2 elastic stable intramedullary nails

Study type: Interventional

Identifiers

NCT00314587

colaris01

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: Under 15 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)