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

This study has been terminated.
(IRB terminated study due to non compliance with continuing review date.)
Sponsor:
Information provided by:
United States Army Institute of Surgical Research
ClinicalTrials.gov Identifier:
NCT00356837
First received: July 24, 2006
Last updated: December 10, 2010
Last verified: December 2010
History of Changes
  Purpose

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?


Condition Intervention
Fractures
Dislocations
 Procedure: Ultrasound

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Diagnosing Extremity Fractures and/or Dislocations Using Ultrasound in Adult Patients Presenting to the Emergency Department

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by United States Army Institute of Surgical Research:

Primary Outcome Measures:
  • Faster diagnosis and sooner definitive treatment for extremity fractures or dislocations. [ Time Frame: 1 hour ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Unnecessary evacuation in the pre hospital combat setting. [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 323
Study Start Date: August 2006
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Those with extremity fractures.
 Procedure: Ultrasound
use ultrasound to confirm diagnosis of extremity fractures

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00356837

Locations
United States, Texas
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234
Sponsors and Collaborators
United States Army Institute of Surgical Research
Investigators
Principal Investigator: John G. McManus, MD US Army Institute of Surgical Research
  More Information

Publications:

Responsible Party: John G. McManus, LTC,, USAISR
ClinicalTrials.gov Identifier: NCT00356837     History of Changes
Other Study ID Numbers: H-06-004
Study First Received: July 24, 2006
Last Updated: December 10, 2010
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Dislocations
Emergencies
Fractures, Bone
 Wounds and Injuries
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013