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Dislocated Unstable 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:
NCT00398268
First received: November 8, 2006
Last updated: NA
Last verified: November 2006
History: No changes posted
  Purpose

We create a follow-up study of Kirschner wire fixation of a unstable dislocated distal both-bone forearm fracture.


Condition Intervention
Fracture
Forearm
Distal
Child
Treatment
 Procedure: Kirschner-wire fixation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Unstable Dislocated Both-Bone Distal Forearm Fractures in Children: A Follow-up Study

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 dislocated both-bone distal forearm fracture will be asked to join the trial.

After an unstable reposition, the fracture will be fixated with 2 Kirschner-wires. The arm will be immobilised in above elbow cast during 4 weeks. 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
  • dislocated
  • unstable 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00398268

Locations
Netherlands
HAGA, location Juliana Children's Hospital Recruiting
Den Haag, 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: NCT00398268     History of Changes
Other Study ID Numbers: colaris06
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 16, 2013