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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
Information provided by:
Colaris, Joost, M.D. Identifier:
First received: April 12, 2006
Last updated: February 23, 2007
Last verified: November 2006
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
Procedure: 1 or 2 elastic stable intramedullary nails

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


Ages Eligible for Study:   up to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT00314587

Contact: Joost W Colaris, M.D. 0031-642220265

HAGA, Juliana Children's Hospital Recruiting
Den Haag, Zuid Holland, Netherlands, 2566ER
Contact: Joost W Colaris, M.D.    0031-642220265   
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   
Principal Investigator: Joost W Colaris, M.D.         
Sponsors and Collaborators
Colaris, Joost, M.D.
Principal Investigator: Joost W Colaris, M.D. HAGA/Erasmus Medical Centre
  More Information Identifier: NCT00314587     History of Changes
Other Study ID Numbers: colaris01
Study First Received: April 12, 2006
Last Updated: February 23, 2007

Keywords provided by Colaris, Joost, M.D.:

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries processed this record on April 28, 2017