Use of Ultrasound to Evaluate Clavicle Fractures in Pediatric Patients

NCT ID: NCT00652548

Last Updated: 2017-03-31

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

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-03-31

Study Completion Date

2009-09-30

Brief Summary

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This studies investigates the hypothesis that bedside ultrasound is as accurate as plain x-rays for diagnosing clavicle fractures in children in a pediatric emergency department. Children with shoulder injuries are enrolled and receive both an ultrasound imaging (experimental) and x-rays (standard-of-care) to see if ultrasound has the same (or better)accuracy, with less cost, time, and radiation.

Detailed Description

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Conditions

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Fractures

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Age 1-18 years
* Pain from recent shoulder/clavicle injury
* Intact neurovascular exam
* Radiographs performed as part of normal ED evaluation

Exclusion Criteria

* Hemodynamic instability
* Multisystem trauma
* Altered mental status
* Open wounds to injured shoulder
* Developmental delay
* Prior radiographs at another clinic/hospital for this injury
* Previous clavicle fracture on the affected side
* Ultrasound gel allergy
* Non-English-speaking parents/child (unable to give informed consent)
Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Louisville

OTHER

Sponsor Role lead

Responsible Party

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Keith Cross

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Keith P Cross, MD

Role: PRINCIPAL_INVESTIGATOR

University of Louisville

Locations

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Kosair Children's Hospital

Louisville, Kentucky, United States

Site Status

Countries

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United States

Other Identifiers

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IRB #08-0007

Identifier Type: -

Identifier Source: secondary_id

NHRO #1310

Identifier Type: -

Identifier Source: secondary_id

08-0007

Identifier Type: -

Identifier Source: org_study_id

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