Treatment of Unstable Both-Bone Midshaft Forearm Fractures in Children

This study is currently recruiting participants.

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

First Received: April 12, 2006 Last Updated: February 23, 2007 History of Changes

Sponsored by:	Colaris, Joost, M.D.
Information provided by:	Colaris, Joost, M.D.
ClinicalTrials.gov Identifier:	NCT00314587

Purpose

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.

Condition	Intervention
Fracture	Procedure: 1 or 2 elastic stable intramedullary nails

MedlinePlus related topics: Fractures

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Crossover Assignment
Official Title:	Treatment of Unstable Both-Bone Midshaft Forearm Fractures in Children: A Randomized Trial Between 1 and 2 Elastic Stable Intramedullary Nails

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

Primary Outcome Measures:

pronation and supination

Secondary Outcome Measures:

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

Estimated Enrollment:	60
Study Start Date:	January 2006

Detailed 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.

Eligibility

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

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00314587

Contacts

Contact: Joost W Colaris, M.D.

0031-642220265

joostcolaris@hotmail.com

Locations

Netherlands, Zuid Holland
HAGA, Juliana Children's Hospital	Recruiting
Den Haag, Zuid Holland, Netherlands, 2566ER
Contact: Joost W Colaris, M.D. 0031-642220265 joostcolaris@hotmail.com
Principal Investigator: Joost W Colaris, M.D.
Erasmus Medical Centre, Sophia Children's Hospital	Recruiting
Rotterdam, Zuid Holland, Netherlands, 3015GJ
Contact: Joost W Colaris, M.D. 0031-642220265 joostcolaris@hotmail.com
Principal Investigator: Joost W Colaris, M.D.

Sponsors and Collaborators

Colaris, Joost, M.D.

Investigators

Principal Investigator:

Joost W Colaris, M.D.

HAGA/Erasmus Medical Centre

More Information

No publications provided

Study ID Numbers:	colaris01
Study First Received:	April 12, 2006
Last Updated:	February 23, 2007
ClinicalTrials.gov Identifier:	NCT00314587 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
midshaft
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 May 07, 2009