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NCT00398268 Clinical Trial

Dislocated Unstable Distal Both-Bone Forearm Fractures in Children

Child Clinical Trial

Official title:
Treatment of Unstable Dislocated Both-Bone Distal Forearm Fractures in Children: A Follow-up Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00398268
Other study ID # colaris06
Secondary ID
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 n/a
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 follow-up study of Kirschner wire fixation of a unstable 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 an unstable reposition, the fracture will be fixated with 2 Kirschner-wires. The arm will be immobilised in above elbow cast during 4 weeks. 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
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 15 Years
Eligibility Inclusion Criteria:

- both-bone forearm fracture

- distal

- dislocated

- unstable 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: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Kirschner-wire fixation

Locations
Country Name City State
Netherlands HAGA, location Juliana Children's Hospital Den Haag 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
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