Treatment of Stable Both-Bone Midshaft Forearm Fractures in Children

Child Clinical Trial

Official title:

Treatment of Stable Both-Bone Midshaft Forearm Fractures in Children: A Randomized Trial Between Treatment With Above Elbow Cast and a Combination of Above- and Below Elbow Armcast.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00398242
• Other study ID #: Colaris03
• Status: Recruiting
• Phase: N/A
• First received: November 8, 2006
• Last updated: November 8, 2006
• Start date: January 2006

Study information

• Verified date: November 2006
• Source: Colaris, Joost, M.D.
• Contact: Joost W Colaris
• Phone: 0031642220265
• Email: joostcolaris[@]hotmail.com
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 15 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Child
• Forearm
• Fracture
• Fractures, Bone
• Midshaft
• Treatment

Intervention

Device:
• above or below elbow cast for the last 3 weeks of treatment

Locations

Country	Name	City	State
Netherlands	HAGA, location Juliana Children's Hospital	Den Haag	Zuid Holland
Netherlands	Erasmus Medical Centre location Sophia Children's hospital	Rotterdam	Zuid Holland

Sponsors (1)

Lead Sponsor	Collaborator
Colaris, Joost, M.D.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pronation and supination
Secondary	complications, function, esthetics, complains in daily living, X-rays