Dislocated Stable Distal Both-Bone Forearm Fractures in Children

Child Clinical Trial

Official title:

Treatment of Stable Dislocated Both-Bone Distal Forearm Fractures in Children: A Randomized Trial Between Treatment With en Without Kirschner-Wires

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00397852
• Other study ID #: colaris05
• 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, drs
• 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 treatment with and without Kirschner wire fixation of a stable dislocated distal both-bone forearm fracture.

Description:

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

After informed consent, a randomization between 2 kinds of treatment will be done: K-wire fixation or no K-wire fixation of the fracture after a stable reposition.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 15 Years

Eligibility

Inclusion Criteria:

• both-bone forearm fracture

• distal

• dislocated

• stable after reposition

• age < 16 years

Exclusion Criteria:

• fracture older than 1 week

• no informed consent

• refracture

• open fracture (Gustillo 2 and 3)

• both fractures of type torus

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Kirschner-wires or not

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	re-operations/ re-dislocations
Secondary	pronation and supination
Secondary	complications, function, esthetics, complains in daily living, X-rays