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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 18, 2014