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TerminatedNCT00356837Updated Dec 13, 2010

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

An interventional study of Ultrasound in Fractures and Dislocations, sponsored by United States Army Institute of Surgical Research. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-12-13.

Sponsored by United States Army Institute of Surgical Research · Not applicable, Interventional, and Diagnostic

Why this study was terminated
IRB terminated study due to non compliance with continuing review date.
Phase
Not applicable
Study type
Interventional
Enrollment
323
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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?

Read the 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.

02

Conditions studied

  • Fractures
  • Dislocations
03

In context

Joint Dislocations

190 studies on the registry are indexed under Joint Dislocations; 39 are open to participants now.

This study's planned enrollment of 323 is above the median of 53 across 120 interventional studies indexed under Joint Dislocations.

Browse Joint Dislocations studies →

Lead sponsor

United States Army Institute of Surgical Research is the lead sponsor of 24 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
323 participants (estimated)

Study arms

  • Experimental
    A

    Those with extremity fractures.

    Procedure: Ultrasound

Interventions

  • ProcedureUltrasound

    use ultrasound to confirm diagnosis of extremity fractures

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What researchers measure

Primary outcomes

  1. Faster diagnosis and sooner definitive treatment for extremity fractures or dislocations.

    Time frame: 1 hour

Secondary outcomes

  1. Unnecessary evacuation in the pre hospital combat setting.

    Time frame: 2 hours

07

Study locations

1 site
  • Brooke Army Medical Center
    Fort Sam Houston, Texas 78234, United States
08

References and documents

Publications

  • 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. PubMed 12733676 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 13, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00356837
Lead sponsor
United States Army Institute of Surgical Research
First posted
Jul 26, 2006
Start date
Aug 2006
Primary completion
Nov 2010
Completion
Nov 2010
Last update
Dec 13, 2010

Study contacts

John G. McManus, MD
principal investigator · US Army Institute of Surgical Research

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Dec 2010. You cannot join it, but the record below documents what was studied.

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