Computerized Tomography to Help Diagnosis Pediatrics Scaphoid Fractures.
Primary Purpose
Scaphoid Bone, Fracture
Status
Withdrawn
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Computerized tomography
Sponsored by
About this trial
This is an interventional diagnostic trial for Scaphoid Bone focused on measuring clinical scaphoid fracture, pediatric
Eligibility Criteria
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
Sites / Locations
- London Health Sciences Center Victoria Hospital
Outcomes
Primary Outcome Measures
Fracture diagnosis
Secondary Outcome Measures
Full Information
NCT ID
NCT00292006
First Posted
February 14, 2006
Last Updated
August 22, 2017
Sponsor
Lawson Health Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT00292006
Brief Title
Computerized Tomography to Help Diagnosis Pediatrics Scaphoid Fractures.
Official Title
The Efficiency of Computerized Tomography to Aid in the Diagnosis of Pediatrics Scaphoid Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
February 2006
Overall Recruitment Status
Withdrawn
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Lawson Health Research Institute
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scaphoid Bone, Fracture
Keywords
clinical scaphoid fracture, pediatric
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Computerized tomography
Primary Outcome Measure Information:
Title
Fracture diagnosis
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tim P Carey, MD, FRCSC
Organizational Affiliation
Western University, Canada
Official's Role
Study Chair
Facility Information:
Facility Name
London Health Sciences Center Victoria Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
15925164
Citation
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.
Results Reference
background
PubMed Identifier
15514541
Citation
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.
Results Reference
background
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Computerized Tomography to Help Diagnosis Pediatrics Scaphoid Fractures.
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