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NCT00397995 Clinical Trial

Undislocated Distal Both-Bone Forearm Fractures in Children

Child Clinical Trial

Official title:
Treatment of Undislocated Both-Bone Distal Forearm Fractures in Children: A Randomized Trial Between Treatment With Above- and Under Elbow Cast.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00397995
Other study ID # Colaris04
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 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 above- and below elbow cast to find out what kind of treatment is optimal for undislocated both-bone distal forearm fractures.

Description:

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

After informed consent, a randomization between 2 kinds of cast 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
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

- undislocated

- age < 16 years

Exclusion Criteria:

- fracture older than 1 week

- no informed consent

- refracture

- open fracture (Gustillo 2 and 3)

- both fractures type torus

Study Design

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

Related Conditions & MeSH terms

Intervention

Procedure:
• above- or under elbow cast

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
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