NCT00356837

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?

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
323

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 26, 2006

Completed
6 days until next milestone

Study Start

First participant enrolled

August 1, 2006

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

December 13, 2010

Status Verified

December 1, 2010

Enrollment Period

4.3 years

First QC Date

July 24, 2006

Last Update Submit

December 10, 2010

Conditions

Outcome Measures

Primary Outcomes (1)

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

    1 hour

Secondary Outcomes (1)

  • Unnecessary evacuation in the pre hospital combat setting.

    2 hours

Study Arms (1)

A

EXPERIMENTAL

Those with extremity fractures.

Procedure: Ultrasound

Interventions

UltrasoundPROCEDURE

use ultrasound to confirm diagnosis of extremity fractures

A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • clinical suspicion of a fracture and/or dislocation of an extremity
  • Age Greater than 18 years
  • English speaking
  • able to give consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

Related 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.

    PMID: 12733676BACKGROUND

MeSH Terms

Conditions

Fractures, BoneJoint Dislocations

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Wounds and InjuriesJoint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • John G. McManus, MD

    US Army Institute of Surgical Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
FED

Study Record Dates

First Submitted

July 24, 2006

First Posted

July 26, 2006

Study Start

August 1, 2006

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

December 13, 2010

Record last verified: 2010-12

Locations