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Undislocated Distal Both-Bone Forearm Fractures in Children

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2006 by Colaris, Joost, M.D..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Colaris, Joost, M.D.
ClinicalTrials.gov Identifier:
NCT00397995
First received: November 8, 2006
Last updated: NA
Last verified: November 2006
History: No changes posted
  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: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00397995     History of Changes
Other Study ID Numbers: Colaris04
Study First Received: November 8, 2006
Last Updated: November 8, 2006
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

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on May 21, 2013