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Treatment of Non-Dislocated Midshaft Both-Bone Fractures

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ClinicalTrials.gov 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
Sponsor:
Information provided by:

Study Description
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
Fracture Device: above and below elbow cast

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated 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
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. pronation and supination

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

Eligibility Criteria

Information from the National Library of Medicine

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

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
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00314600


Contacts
Contact: Joost W Colaris, M.D. 0031-642220265 joostcolaris@hotmail.com

Locations
Netherlands
HAGA, Juliana Children's Hospital Recruiting
Den Haag, Zuid Holland, Netherlands, 2566ER
Contact: Joost W Colaris, M.D.    0031-642220265    joostcolaris@hotmail.com   
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    joostcolaris@hotmail.com   
Principal Investigator: Joost W Colaris, M.D.         
Sponsors and Collaborators
Colaris, Joost, M.D.
Investigators
Principal Investigator: Joost W Colaris, M.D. HAGA/Erasmus Medical Centre
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00314600     History of Changes
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.:
Fracture
Forearm
Midshaft
Child
Cast

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries