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Dislocated Stable Distal Both-Bone 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:
NCT00397852
First Posted: November 10, 2006
Last Update Posted: November 10, 2006
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
We create a randomized clinical trial between treatment with and without Kirschner wire fixation of a stable dislocated distal both-bone forearm fracture.

Condition Intervention
Fracture Forearm Distal Child Treatment Procedure: Kirschner-wires or not

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Stable Dislocated Both-Bone Distal Forearm Fractures in Children: A Randomized Trial Between Treatment With en Without Kirschner-Wires

Resource links provided by NLM:


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

Primary Outcome Measures:
  • re-operations/ re-dislocations

Secondary Outcome Measures:
  • pronation and supination
  • complications, function, esthetics, complains in daily living, X-rays

Estimated Enrollment: 110
Study Start Date: January 2006
Detailed Description:

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

After informed consent, a randomization between 2 kinds of treatment will be done: K-wire fixation or no K-wire fixation of the fracture after a stable reposition.

Outpatient clinic visits till a follow-up of 6 months. During these visits we will investigate: the number of re-dislocations, re-operations, consolidation and dislocation on X-ray, function of both arms, complains in daily living and complications.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  • distal
  • dislocated
  • stable after reposition
  • age < 16 years

Exclusion Criteria:

  • fracture older than 1 week
  • no informed consent
  • refracture
  • open fracture (Gustillo 2 and 3)
  • both fractures of type torus
  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): NCT00397852


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, drs    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

ClinicalTrials.gov Identifier: NCT00397852     History of Changes
Other Study ID Numbers: colaris05
First Submitted: November 8, 2006
First Posted: November 10, 2006
Last Update Posted: November 10, 2006
Last Verified: November 2006

Keywords provided by Colaris, Joost, M.D.:
Fracture
Forearm
Distal
Child
Treatment

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries