Treatment of Stable Both-Bone Midshaft Forearm Fractures in Children

Not Applicable

• Conditions: Fracture; Forearm; Midshaft; Child; Treatment

• Registration Number: NCT00398242
• Lead Sponsor: Colaris, Joost, M.D.

Brief Summary

We create a randomized clinical trial between the treatment with above elbow armcast alone and the treatment of above elbow in combination with a short arm cast for stable midshaft both-bone forearm fractures.

Detailed Description

children who arrive at the emergency unit with a stable both-bone midshaft forearm fracture will be asked to join the trial.

If the fracture will be stable during reposition in the operating room, a randomization between 2 kinds of plaster treatment will be done.

Outpatient clinic visits till a follow-up of 6 months. During these visits we will investigate: consolidation and dislocation on X-ray, function of both arms, complains in daily living and complications.

Study Timeline

• Study Start: 2006-01
• Status Verified: 2006-11
• Study First Submitted: 2006-11-08
• Study First Submitted QC: 2006-11-08
• Last Update Submitted: 2006-11-08
• Study First Posted: 2006-11-10
• Last Update Posted: 2006-11-10

Recruitment & Eligibility

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

Inclusion Criteria

• both-bone forearm fracture
• age < 16 years
• dislocation
• stable

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, 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