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Treatment of Non-Dislocated Midshaft Both-Bone Fractures

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. Identifier: NCT00314600
Recruitment Status : Unknown
Verified November 2006 by Colaris, Joost, M.D..
Recruitment status was:  Recruiting
First Posted : April 14, 2006
Last Update Posted : February 26, 2007
Information provided by:
Colaris, Joost, M.D.

Brief Summary:
The investigators created a randomized clinical trial to find out what kind of treatment is optimal for non-dislocated both-bone midshaft forearm fractures.

Condition or disease Intervention/treatment Phase
Fracture Device: above and below elbow cast Not Applicable

Detailed Description:

Children who arrive at the emergency unit with a non-dislocated both-bone midshaft forearm fracture will be asked to join the trial. After informed consent we will do a randomization between 6 weeks above elbow cast and 3 weeks above elbow cast in combination with 3 weeks under elbow cast.

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, complaints in daily living and complications.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Above Elbow Cast in Non-Dislocated Both-Bone Midshaft Forearm Fractures in Children: Necessity or Needless Cruelty? A Randomized Trial
Study Start Date : January 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Primary Outcome Measures :
  1. pronation and supination

Secondary Outcome Measures :
  1. complications, function, esthetics, complaints in daily living, X-rays

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.

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

Inclusion Criteria:

  • Both-bone midshaft forearm fracture
  • Age < 16 years old

Exclusion Criteria:

  • Dislocation
  • Fracture older than 1 week
  • No informed consent
  • Refracture
  • Open fracture (Gustillo 2 and 3)
  • Torus fractures of both ulna and radius

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 identifier (NCT number): NCT00314600

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

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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 Not yet 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.
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Principal Investigator: Joost W Colaris, M.D. HAGA/Erasmus Medical Centre

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00314600    
Other Study ID Numbers: Colaris02
First Posted: April 14, 2006    Key Record Dates
Last Update Posted: February 26, 2007
Last Verified: November 2006
Keywords provided by Colaris, Joost, M.D.:
Additional relevant MeSH terms:
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Fractures, Bone
Wounds and Injuries