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
Recruitment status was Recruiting
Sponsor:
Colaris, Joost, M.D.
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
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | April 12, 2006 | ||||
| Last Updated Date | February 23, 2007 | ||||
| Start Date ICMJE | January 2006 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
pronation and supination | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00314600 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
complications, function, esthetics, complaints in daily living, X-rays | ||||
| Original Secondary Outcome Measures ICMJE |
complications, function, esthetics, complains in daily living, X-rays | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Treatment of Non-Dislocated Midshaft Both-Bone Fractures | ||||
| Official Title ICMJE | Above Elbow Cast in Non-Dislocated Both-Bone Midshaft Forearm Fractures in Children: Necessity or Needless Cruelty? A Randomized Trial | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Fracture | ||||
| Intervention ICMJE | Device: above and below elbow cast | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Enrollment ICMJE | 60 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | up to 15 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Netherlands | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00314600 | ||||
| Other Study ID Numbers ICMJE | Colaris02 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Colaris, Joost, M.D. | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Colaris, Joost, M.D. | ||||
| Verification Date | November 2006 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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