Fracture Evaluated in Emergency Room by Ultra Sound | NCT01071733

Studies
Fracture Evaluated in Emergency Room by Ultra Sound

NCT01071733

Sponsor

University of Aarhus

Status

Withdrawn

Last Update Posted

Nov 20, 2017Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Fracture
Ultrasonography

Interventions

Not provided

Countries

Denmark

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

Sep 2012

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

study was never initiated due to logistic causes

Expanded Access Info

Start Date

Dec 2009

Primary Completion Date

Sep 2013Estimated

Completion Date

Dec 2013Estimated

First Submitted Date

Feb 18, 2010

First Submission Date that Met QC Criteria

Feb 18, 2010

First Posted Date

Feb 19, 2010Estimated

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

Nov 17, 2017

Last Update Posted Date

Nov 20, 2017Actual

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 compare fracture diagnostic, conventional x-ray versus ultrasound.

Detailed Description

to compare fracture diagnostic, conventional x-ray versus ultrasound in an emergency room department.

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Recent trauma to the wrist, ankle or fingers
clinical exam by ER staff and x-ray indication.
informed concent

Exclusion Criteria:

open fracture
wounds
unstable fractures requiring cast immobilisation before x-ray
multi traumatised patients

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

patients in emergency room

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mogens P Jensen, phd, md	Dep. of Reumatology, Aarhus University Hospital, Denmark	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aarhus University Hospital Emergency Dep.		Aarhus		8000	Denmark

Label	Type	Description	Intervention Names
ultrasound wrist
ultrasound finger
ultrasound ankle