Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

April 12, 2006
February 23, 2007
January 2006
Not Provided
pronation and supination
Same as current
Complete list of historical versions of study NCT00314600 on ClinicalTrials.gov Archive Site
complications, function, esthetics, complaints in daily living, X-rays
complications, function, esthetics, complains in daily living, X-rays
Not Provided
Not Provided
 
Treatment of Non-Dislocated Midshaft Both-Bone Fractures
Above Elbow Cast in Non-Dislocated Both-Bone Midshaft Forearm Fractures in Children: Necessity or Needless Cruelty? A Randomized Trial

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

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Fracture
Device: above and below elbow cast
Not Provided
Colaris JW, Reijman M, Allema JH, Biter LU, Bloem RM, van de Ven CP, de Vries MR, Kerver AJ, Verhaar JA. Early conversion to below-elbow cast for non-reduced diaphyseal both-bone forearm fractures in children is safe: preliminary results of a multicentre randomised controlled trial. Arch Orthop Trauma Surg. 2013 Oct;133(10):1407-14. doi: 10.1007/s00402-013-1812-8. Epub 2013 Jul 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
Not Provided
Not Provided

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
Both
up to 15 Years
Yes
Contact: Joost W Colaris, M.D. 0031-642220265 joostcolaris@hotmail.com
Netherlands
 
NCT00314600
Colaris02
Not Provided
Not Provided
Colaris, Joost, M.D.
Not Provided
Principal Investigator: Joost W Colaris, M.D. HAGA/Erasmus Medical Centre
Colaris, Joost, M.D.
November 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP