Back to resultsDiagnosing Extremity Fractures and/or Dislocations Using Ultrasound Presenting to the Emergency Department
Primary Purpose
Fractures, Dislocations
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Fractures
Eligibility Criteria
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
Sites / Locations
- Brooke Army Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
Those with extremity fractures.
Outcomes
Primary Outcome Measures
Faster diagnosis and sooner definitive treatment for extremity fractures or dislocations.
Secondary Outcome Measures
Unnecessary evacuation in the pre hospital combat setting.
Full Information
NCT ID
NCT00356837
First Posted
July 24, 2006
Last Updated
December 10, 2010
Sponsor
United States Army Institute of Surgical Research
1. Study Identification
Unique Protocol Identification Number
NCT00356837
Brief Title
Diagnosing Extremity Fractures and/or Dislocations Using Ultrasound Presenting to the Emergency Department
Official Title
Diagnosing Extremity Fractures and/or Dislocations Using Ultrasound in Adult Patients Presenting to the Emergency Department
Study Type
Interventional
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Terminated
Why Stopped
IRB terminated study due to non compliance with continuing review date.
Study Start Date
August 2006 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
United States Army Institute of Surgical Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
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?
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fractures, Dislocations
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
323 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Those with extremity fractures.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound
Intervention Description
use ultrasound to confirm diagnosis of extremity fractures
Primary Outcome Measure Information:
Title
Faster diagnosis and sooner definitive treatment for extremity fractures or dislocations.
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Unnecessary evacuation in the pre hospital combat setting.
Time Frame
2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John G. McManus, MD
Organizational Affiliation
US Army Institute of Surgical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brooke Army Medical Center
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
12733676
Citation
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.
Results Reference
background
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Diagnosing Extremity Fractures and/or Dislocations Using Ultrasound Presenting to the Emergency Department
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