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Treatment of Stable Both-Bone Midshaft Forearm Fractures in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00398242
Recruitment Status : Unknown
Verified November 2006 by Colaris, Joost, M.D..
Recruitment status was:  Recruiting
First Posted : November 10, 2006
Last Update Posted : November 10, 2006
Sponsor:
Information provided by:

Study Description
Brief Summary:
We create a randomized clinical trial between the treatment with above elbow armcast alone and the treatment of above elbow in combination with a short arm cast for stable midshaft both-bone forearm fractures.

Condition or disease Intervention/treatment
Fracture Forearm Midshaft Child Treatment Device: above or below elbow cast for the last 3 weeks of treatment

Detailed Description:

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

If the fracture will be stable during reposition in the operating room, a randomization between 2 kinds of plaster treatment 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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Treatment of Stable Both-Bone Midshaft Forearm Fractures in Children: A Randomized Trial Between Treatment With Above Elbow Cast and a Combination of Above- and Below Elbow Armcast.
Study Start Date : January 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. pronation and supination

Secondary Outcome Measures :
  1. complications, function, esthetics, complains in daily living, X-rays

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • both-bone forearm fracture
  • age < 16 years
  • dislocation
  • stable

Exclusion Criteria:

  • fracture older than 1 week
  • no informed consent
  • refracture
  • open fracture (Gustillo 2 and 3)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00398242


Contacts
Contact: Joost W Colaris 0031642220265 joostcolaris@hotmail.com

Locations
Netherlands
HAGA, location Juliana Children's Hospital Recruiting
Den Haag, Zuid Holland, Netherlands
Contact: Joost W Colaris, Drs    00316-42220265    joostcolaris@hotmail.com   
Erasmus Medical Centre location Sophia Children's hospital Recruiting
Rotterdam, Zuid Holland, Netherlands
Contact: Joost W Colaris         
Sponsors and Collaborators
Colaris, Joost, M.D.
Investigators
Principal Investigator: Joost W Colaris, Drs
More Information

ClinicalTrials.gov Identifier: NCT00398242     History of Changes
Other Study ID Numbers: Colaris03
First Posted: November 10, 2006    Key Record Dates
Last Update Posted: November 10, 2006
Last Verified: November 2006

Keywords provided by Colaris, Joost, M.D.:
fracture
forearm
midshaft
child
treatment

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries