Diagnosing Extremity Fractures and/or Dislocations Using... | NCT00356837

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

NCT00356837

Sponsor

United States Army Institute of Surgical Research

Status

Terminated

Last Update Posted

Dec 13, 2010Estimated

Enrollment

323Estimated

Phase

Not Applicable

Conditions

Fractures
Dislocations

Interventions

Ultrasound

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2010

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

IRB terminated study due to non compliance with continuing review date.

Expanded Access Info

Start Date

Aug 2006

Primary Completion Date

Nov 2010Actual

Completion Date

Nov 2010Actual

First Submitted Date

Jul 24, 2006

First Submission Date that Met QC Criteria

Jul 24, 2006

First Posted Date

Jul 26, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 10, 2010

Last Update Posted Date

Dec 13, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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?

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

323Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	Those with extremity fractures.	Procedure: Ultrasound

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ultrasound	Procedure	use ultrasound to confirm diagnosis of extremity fractures	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Faster diagnosis and sooner definitive treatment for extremity fractures or dislocations.		1 hour

Secondary Outcomes

Measure	Description	Time Frame
Unnecessary evacuation in the pre hospital combat setting.		2 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John G. McManus, MD	US Army Institute of Surgical Research	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Brooke Army Medical Center		Fort Sam Houston	Texas	78234	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
12733676	Background	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.

ID	Term
D050723	Fractures, Bone
D004204	Joint Dislocations

ID	Term
D014947	Wounds and Injuries
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

ID	Term
D000069453	Ultrasonic Waves
D013016	Sound
D011840	Radiation, Nonionizing
D011827	Radiation