Treatment of Unstable Both-Bone Midshaft Forearm Fractures in Children

Fracture Clinical Trial

Official title:

Treatment of Unstable Both-Bone Midshaft Forearm Fractures in Children: A Randomized Trial Between 1 and 2 Elastic Stable Intramedullary Nails

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00314587
• Other study ID #: colaris01
• Status: Recruiting
• Phase: N/A
• First received: April 12, 2006
• Last updated: February 23, 2007
• Start date: January 2006

Study information

• Verified date: November 2006
• Source: Colaris, Joost, M.D.
• Contact: Joost W Colaris, M.D.
• Phone: 0031-642220265
• 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

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.

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.

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:

• 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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fracture
• Fractures, Bone

Intervention

Procedure:
• 1 or 2 elastic stable intramedullary nails

Locations

Country	Name	City	State
Netherlands	HAGA, Juliana Children's Hospital	Den Haag	Zuid Holland
Netherlands	Erasmus Medical Centre, 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, complaints in daily living, X-rays