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

Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00356837
• Other study ID #: H-06-004
• 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

• Dislocations
• Fractures
• Fractures, Bone

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