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Diagnosing Extremity Fractures and/or Dislocations Using Ultrasound Presenting to the Emergency Department

NCT ID: NCT00356837

Last Updated: 2010-12-13

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

TERMINATED

Clinical Phase

NA

Total Enrollment

323 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2010-11-30

Brief Summary

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The purpose of this study is to determine the efficacy of ultrasound in diagnosing the presence or absence of extremity fractures or dislocations.

Hypothesis: Can ultrasound be used as an accurate and effective method for determining the presence or absence of extremity fractures or dislocations? Is there a difference in amount of pain experienced prior to and after the ultrasound?

Detailed Description

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This prospective, multicenter cohort study. The sampling method will be a convenience sample of all adult patients presenting to the ED with symptoms concerning a fracture and/or dislocation of an extremity. Once a patient has been deemed an appropriate candidate for the study, written consent will be obtained from one of the Associate Investigators. Once consent has been obtained, a resident physician will perform the ultrasound examination on the affected extremity(s) and note their findings.

Conditions

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Fractures Dislocations

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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A

Those with extremity fractures.

Group Type EXPERIMENTAL

Ultrasound

Intervention Type PROCEDURE

use ultrasound to confirm diagnosis of extremity fractures

Interventions

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Ultrasound

use ultrasound to confirm diagnosis of extremity fractures

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* clinical suspicion of a fracture and/or dislocation of an extremity
* Age Greater than 18 years
* English speaking
* able to give consent

Exclusion Criteria

* Age less than 18 years, including emancipated minors
* Unstable patients with B/P below 90mmHg systolic
* Open, unstable, or suspected compound fracture
* Physician has reviewed X-Rays and made diagnosis before ultrasound could be done
* X-Rays will not be ordered
* Patient is pregnant
* Patient cannot give own consent
* English is not the patient's primary language
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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United States Army Institute of Surgical Research

FED

Sponsor Role lead

Responsible Party

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USAISR

Principal Investigators

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John G. McManus, MD

Role: PRINCIPAL_INVESTIGATOR

US Army Institute of Surgical Research

Locations

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Brooke Army Medical Center

Fort Sam Houston, Texas, United States

Site Status

Countries

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United States

References

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Kirkpatrick AW, Brown R, Diebel LN, Nicolaou S, Marshburn T, Dulchavsky SA. Rapid diagnosis of an ulnar fracture with portable hand-held ultrasound. Mil Med. 2003 Apr;168(4):312-3.

Reference Type BACKGROUND
PMID: 12733676 (View on PubMed)

Other Identifiers

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H-06-004

Identifier Type: -

Identifier Source: org_study_id