- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00292006
Computerized Tomography to Help Diagnosis Pediatrics Scaphoid Fractures.
The Efficiency of Computerized Tomography to Aid in the Diagnosis of Pediatrics Scaphoid Fractures
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Phase
- Phase 1
Contacts and Locations
Study Locations
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Ontario
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London, Ontario, Canada, N6A 5W9
- London Health Sciences Center Victoria Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Pain in anatomical snuffbox, Negative radiographs, less than 18 years old, older than 6 years old, injury less than 1 week old and provision of informed consent
Exclusion Criteria:
- Previous injury to scaphoid bone, other injuries on the same extremity, vascular injury present at the injury site, fracture seen on initial radiographs, injury >1 week old, inability for patient to comply with rehabilitation or form completion, likely problems in maintaining patient follow-up
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Fracture diagnosis
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Tim P Carey, MD, FRCSC, Western University, Canada
Publications and helpful links
General Publications
- Temple CL, Ross DC, Bennett JD, Garvin GJ, King GJ, Faber KJ. Comparison of sagittal computed tomography and plain film radiography in a scaphoid fracture model. J Hand Surg Am. 2005 May;30(3):534-42. doi: 10.1016/j.jhsa.2005.01.001.
- Breederveld RS, Tuinebreijer WE. Investigation of computed tomographic scan concurrent criterion validity in doubtful scaphoid fracture of the wrist. J Trauma. 2004 Oct;57(4):851-4. doi: 10.1097/01.ta.0000124278.29127.42.
Study record dates
Study Major Dates
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11955
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