Treatment of Unstable Both-Bone Midshaft Forearm Fractures in Children

Not Applicable

• Conditions: Fracture

• Registration Number: NCT00314587
• Lead Sponsor: Colaris, Joost, M.D.

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.

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-04-12
• Study First Submitted QC: 2006-04-12
• Study First Posted: 2006-04-14
• Status Verified: 2006-11
• Last Update Submitted: 2007-02-23
• Last Update Posted: 2007-02-26

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
pronation and supination

Secondary Outcome Measures

Name	Time	Method
complications, function, esthetics, complaints in daily living, X-rays

Trial Locations

Locations (2)

Erasmus Medical Centre, Sophia Children's Hospital; 🇳🇱 Rotterdam, Zuid Holland, Netherlands

HAGA, Juliana Children's Hospital; 🇳🇱 Den Haag, Zuid Holland, Netherlands