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Treatment of Non-Dislocated Midshaft Both-Bone Fractures

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:
NCT00314600
First received: April 12, 2006
Last updated: February 23, 2007
Last verified: November 2006
History of Changes
  Purpose

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 Intervention
Fracture
 Device: above and below elbow cast

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

Resource links provided by NLM:

MedlinePlus related topics: Fractures
U.S. FDA Resources

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 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.

  Eligibility

Ages Eligible for Study:   up to 15 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00314600     History of Changes
Other Study ID Numbers: Colaris02
Study First Received: April 12, 2006
Last Updated: February 23, 2007
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
Cast

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on June 18, 2013