Dislocated Stable 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:
NCT00397852
First received: November 8, 2006
Last updated: NA
Last verified: November 2006
History: No changes posted
  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: 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

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
  • 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00397852     History of Changes
Other Study ID Numbers: colaris05
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 September 30, 2014