Computerized Tomography to Help Diagnosis Pediatrics Scaphoid Fractures.

NCT ID: NCT00292006

Last Updated: 2017-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Completion Date

2007-06-30

Brief Summary

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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

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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.

Conditions

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Scaphoid Bone Fracture

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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Computerized tomography

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role lead

Principal Investigators

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Tim P Carey, MD, FRCSC

Role: STUDY_CHAIR

Western University, Canada

Locations

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London Health Sciences Center Victoria Hospital

London, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 15925164 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15514541 (View on PubMed)

Other Identifiers

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11955

Identifier Type: -

Identifier Source: org_study_id

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