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| Tracking Information | |||||||||
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| First Received Date ICMJE | February 14, 2006 | ||||||||
| Last Updated Date | February 14, 2006 | ||||||||
| Start Date ICMJE | February 2006 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE |
Fracture diagnosis | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Computerized Tomography to Help Diagnosis Pediatrics Scaphoid Fractures. | ||||||||
| Official Title ICMJE | The Efficiency of Computerized Tomography to Aid in the Diagnosis of Pediatrics Scaphoid Fractures | ||||||||
| Brief Summary | The purpose of this study is to find out whether computerized tomography will be better than plain radiographs in determining pediatrics scaphoid fractures. |
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| Detailed Description | Background: The use of plain radiograph in the detection of pediatrics scaphoid fractures has low specificity and sensitivity. Patients with documented anatomical snuffbox tenderness and negative plain radiographs are casted in thumb spica casts and seen by a pediatrics orthopedics surgeon. However few patients with clinical scaphoid fractures have documented scaphoid fractures, with the most common injury of soft tissue injury to the surrounding tissues. The use of CT scan to detect scaphoid fractures is not well documented and may be an appropriate substitute for plain radiographs. Hypothesis: CT scan of the wrist will have higher sensitivity and specificity in detecting pediatrics scaphoid fracture than plain radiographs. |
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| Study Phase | Phase I | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study | ||||||||
| Condition ICMJE |
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| Intervention ICMJE | Device: Computerized tomography | ||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Enrollment ICMJE | 73 | ||||||||
| Completion Date | January 2007 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 6 Years to 18 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Canada | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00292006 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | 11955 | ||||||||
| Study Sponsor ICMJE | Lawson Health Research Institute | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | Lawson Health Research Institute | ||||||||
| Verification Date | February 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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