Computerized Tomography to Help Diagnosis Pediatrics Scaphoid Fractures.

The recruitment status of this study is unknown because the information has not been verified recently.

Verified February 2006 by Lawson Health Research Institute. Recruitment status was Not yet recruiting

First Received on February 14, 2006. No Changes Posted

Sponsor:	Lawson Health Research Institute
Information provided by:	Lawson Health Research Institute
ClinicalTrials.gov Identifier:	NCT00292006

Purpose

The purpose of this study is to find out whether computerized tomography will be better than plain radiographs in determining pediatrics scaphoid fractures.

Condition	Intervention	Phase
Scaphoid Bone Fracture	Device: Computerized tomography	Phase I

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	The Efficiency of Computerized Tomography to Aid in the Diagnosis of Pediatrics Scaphoid Fractures

Resource links provided by NLM:

MedlinePlus related topics: CT Scans Fractures

U.S. FDA Resources

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:

Fracture diagnosis

Estimated Enrollment:	73
Study Start Date:	February 2006
Estimated Study Completion Date:	January 2007

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.

Eligibility

Ages Eligible for Study:	6 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00292006

Contacts

Contact: Tim P Carey	519 685 8021	Timothy.Carey@lhsc.on.ca
Contact: Kellie K Leitch	519 685 8021	Kellie.Leitch@lhsc.on.ca

Locations

Canada, Ontario
London Health Sciences Center Victoria Hospital	Not yet recruiting
London, Ontario, Canada, N6A 5W9
Contact: Timothy P Carey, MD FRCSC 519 685 8021 Timothy.Carey@lhsc.on.ca
Sub-Investigator: Gladys Chan, MD
Sub-Investigator: Kellie K Leitch, MD FRCSC
Sub-Investigator: Gary Joubert, MD FRCSC
Sub-Investigator: Jamie Seabrook, MA

Sponsors and Collaborators

Lawson Health Research Institute

Investigators

Study Chair:

Tim P Carey, MD, FRCSC

University of Western Ontario, Canada

More Information

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.

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.

ClinicalTrials.gov Identifier:	NCT00292006 History of Changes
Other Study ID Numbers:	11955
Study First Received:	February 14, 2006
Last Updated:	February 14, 2006
Health Authority:	Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:

clinical scaphoid fracture
pediatric

Additional relevant MeSH terms:

Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on February 12, 2012