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Treatment of Non-Dislocated Midshaft Both-Bone Fractures

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
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
  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: 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

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 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   (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
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: 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
Study First Received: April 12, 2006
Last Updated: February 23, 2007

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 September 21, 2017