Study Stopped
IRB terminated study due to non compliance with continuing review date.
Diagnosing Extremity Fractures and/or Dislocations Using Ultrasound Presenting to the Emergency Department
1 other identifier
interventional
323
1 country
1
Brief 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?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2006
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 24, 2006
CompletedFirst Posted
Study publicly available on registry
July 26, 2006
CompletedStudy Start
First participant enrolled
August 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedDecember 13, 2010
December 1, 2010
4.3 years
July 24, 2006
December 10, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Faster diagnosis and sooner definitive treatment for extremity fractures or dislocations.
1 hour
Secondary Outcomes (1)
Unnecessary evacuation in the pre hospital combat setting.
2 hours
Study Arms (1)
A
EXPERIMENTALThose with extremity fractures.
Interventions
Eligibility Criteria
You may qualify if:
- clinical suspicion of a fracture and/or dislocation of an extremity
- Age Greater than 18 years
- English speaking
- able to give consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234, United States
Related 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.
PMID: 12733676BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John G. McManus, MD
US Army Institute of Surgical Research
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- FED
Study Record Dates
First Submitted
July 24, 2006
First Posted
July 26, 2006
Study Start
August 1, 2006
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
December 13, 2010
Record last verified: 2010-12