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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00397995 |
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Date of registration:
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08/11/2006 |
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Primary sponsor: |
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Public title:
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Undislocated Distal Both-Bone Forearm Fractures in Children
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Scientific title:
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Treatment of Undislocated Both-Bone Distal Forearm Fractures in Children: A Randomized Trial Between Treatment With Above- and Under Elbow Cast. |
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Date of first enrolment:
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January 2006 |
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Target sample size:
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60 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00397995 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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joost w Colaris, drs |
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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joost w colaris, drs |
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Address:
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Telephone:
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0031642220265 |
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Email:
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joostcolaris@hotmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- both-bone forearm fracture
- distal
- undislocated
- age < 16 years
Exclusion Criteria:
- fracture older than 1 week
- no informed consent
- refracture
- open fracture (Gustillo 2 and 3)
- both fractures type torus
Age minimum:
N/A
Age maximum:
15 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Child
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Distal
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Forearm
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Fracture
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Treatment
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Intervention(s)
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Procedure: above- or under elbow cast
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Primary Outcome(s)
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pronation and supination
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Secondary Outcome(s)
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complications, function, esthetics, complains in daily living, X-rays
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Secondary ID(s)
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Colaris04
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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