Treatment of Non-Dislocated Midshaft Both-Bone Fractures

Not Applicable

• Conditions: Fracture

• Registration Number: NCT00314600
• Lead Sponsor: Colaris, Joost, M.D.

Brief Summary

The investigators created a randomized clinical trial to find out what kind of treatment is optimal for non-dislocated both-bone midshaft forearm fractures.

Detailed Description

Children who arrive at the emergency unit with a non-dislocated both-bone midshaft forearm fracture will be asked to join the trial. After informed consent we will do a randomization between 6 weeks above elbow cast and 3 weeks above elbow cast in combination with 3 weeks under elbow cast.

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, 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

• Both-bone midshaft forearm fracture
• Age < 16 years old

Exclusion Criteria

• Dislocation
• Fracture older than 1 week
• No informed consent
• Refracture
• Open fracture (Gustillo 2 and 3)
• Torus fractures of both ulna and radius

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