Undislocated Distal Both-Bone Forearm Fractures in Children

This study is currently recruiting participants.

Verified by Colaris, Joost, M.D., November 2006

First Received: November 8, 2006 No Changes Posted

Sponsored by:	Colaris, Joost, M.D.
Information provided by:	Colaris, Joost, M.D.
ClinicalTrials.gov Identifier:	NCT00397995

Purpose

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.

Condition	Intervention
Fracture Forearm Distal Child Treatment	Procedure: above- or under elbow cast

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Crossover Assignment
Official Title:	Treatment of Undislocated Both-Bone Distal Forearm Fractures in Children: A Randomized Trial Between Treatment With Above- and Under Elbow Cast.

Resource links provided by NLM:

MedlinePlus related topics: Fractures

U.S. FDA Resources

Further study details as provided by Colaris, Joost, M.D.:

Primary Outcome Measures:

pronation and supination

Secondary Outcome Measures:

complications, function, esthetics, complains in daily living, X-rays

Estimated Enrollment:	60
Study Start Date:	January 2006

Detailed 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.

Eligibility

Ages Eligible for Study:	up to 15 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00397995

Contacts

Contact: joost w colaris, drs

0031642220265

joostcolaris@hotmail.com

Locations

Netherlands, Zuid Holland
HAGA, location Juliana Children's Hospital	Recruiting
Den Haag, Zuid Holland, Netherlands
Contact: joost w colaris 0031642220265 joostcolaris@hotmail.com
Erasmus Medical Centre location Sophia Children's hospital	Recruiting
rotterdam, Zuid Holland, Netherlands
Contact: joost w colaris, drs 0031642220265 joostcolaris@hotmail.com

Sponsors and Collaborators

Colaris, Joost, M.D.

Investigators

Principal Investigator:

joost w Colaris, drs

unaffiliated

More Information

No publications provided

Study ID Numbers:	Colaris04
Study First Received:	November 8, 2006
Last Updated:	November 8, 2006
ClinicalTrials.gov Identifier:	NCT00397995 History of Changes
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Colaris, Joost, M.D.:

Fracture
Forearm
Distal
Child
Treatment

Study placed in the following topic categories:

Fractures, Bone
Wounds and Injuries
Disorders of Environmental Origin

Additional relevant MeSH terms:

Fractures, Bone
Wounds and Injuries
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on September 01, 2009