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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00356837
Other study ID # H-06-004
Secondary ID
Status Terminated
Phase N/A
First received July 24, 2006
Last updated December 10, 2010
Start date August 2006
Est. completion date November 2010

Study information

Verified date December 2010
Source United States Army Institute of Surgical Research
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

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?


Description:

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.


Recruitment information / eligibility

Status Terminated
Enrollment 323
Est. completion date November 2010
Est. primary completion date November 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Procedure:
Ultrasound
use ultrasound to confirm diagnosis of extremity fractures

Locations

Country Name City State
United States Brooke Army Medical Center Fort Sam Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
United States Army Institute of Surgical Research

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Erratum in: Mil Med. 2003 Jul;168(7):555. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Faster diagnosis and sooner definitive treatment for extremity fractures or dislocations. 1 hour No
Secondary Unnecessary evacuation in the pre hospital combat setting. 2 hours No
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