Treatment of Stable Both-Bone Midshaft 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:
NCT00398242
First received: November 8, 2006
Last updated: NA
Last verified: November 2006
History: No changes posted
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind
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.

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, 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 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.

  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
  • 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
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: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00398242     History of Changes
Other Study ID Numbers: Colaris03
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
midshaft
child
treatment

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on August 19, 2014