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Treatment of Unstable Both-Bone Midshaft Forearm Fractures in Children

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2006 by Colaris, Joost, M.D..
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00314587
First Posted: April 14, 2006
Last Update Posted: February 26, 2007
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.
Information provided by:
Colaris, Joost, M.D.
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Unstable Both-Bone Midshaft Forearm Fractures in Children: A Randomized Trial Between 1 and 2 Elastic Stable Intramedullary Nails

Resource links provided by NLM:


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

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:

  • 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
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): NCT00314587


Contacts
Contact: Joost W Colaris, M.D. 0031-642220265 joostcolaris@hotmail.com

Locations
Netherlands
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

ClinicalTrials.gov Identifier: NCT00314587     History of Changes
Other Study ID Numbers: colaris01
First Submitted: April 12, 2006
First Posted: April 14, 2006
Last Update Posted: February 26, 2007
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