Tomosynthesis Use in Detecting Subtle Occult Hip Fractures | NCT02133794

Studies
Tomosynthesis Use in Detecting Subtle Occult Hip Fractures

NCT02133794

Sponsor

Medical Imaging Informatics Research Centre at McMaster

Status

Unknown status

Last Update Posted

May 8, 2014Estimated

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Hip Fracture

Interventions

Tomosynthesis

Countries

Canada

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

Apr 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2014

Primary Completion Date

Dec 2014Estimated

Completion Date

Dec 2014Estimated

First Submitted Date

Apr 23, 2014

First Submission Date that Met QC Criteria

May 6, 2014

First Posted Date

May 8, 2014Estimated

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

May 6, 2014

Last Update Posted Date

May 8, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Naveen Parasu, Dr. Naveen Parasu, Medical Imaging Informatics Research Centre at McMasterPrincipal Investigator

Lead Sponsor

Medical Imaging Informatics Research Centre at McMasterOTHER

Collaborators

Not provided

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 project is to determine if using tomosynthesis, in conjunction with x-ray, is better at detecting hip fractures than using x-ray alone. The goal of this study will be to include the use of tomosynthesis with x-ray as usual practice when a patient comes to the emergency room with symptoms of a hip fracture.

Detailed Description

Not provided

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

60Estimated

Label	Type	Description	Intervention Names
Tomosynthesis	Experimental		Device: Tomosynthesis

Name	Type	Description	Arm Group Labels	Other Names
Tomosynthesis	Device		Tomosynthesis	GE Discovery 650

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patients with hip fracture detected with tomosynthesis versus x-ray alone.		Participants will be followed up to 3 months post tomosynthesis exam.

Secondary Outcomes

Measure	Description	Time Frame
ER wait time		End of study

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Men and women aged > 18 years who/se:
Present at the ER with a possible hip fracture and
Have a negative x-ray for a hip fracture
Physician has a high clinical suspicion of a hip fracture
Provide provision of informed consent

Exclusion Criteria:

Hip prosthesis on the same side of the suspected hip fracture
Other serious medical illness that is likely to interfere with study participation
Significant psychiatric illness, senility, dementia, alcohol or substance abuse, which could impair the ability to provide informed consent and to adhere to the trial procedures
Pregnant or suspected pregnancy

Accepts Healthy Volunteers

Not provided

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

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Juravinski Hospital		Hamilton	Ontario		Canada

Condition Browse Module

MeSH Terms

ID	Term
D006620	Hip Fractures
D004630	Emergencies

Ancestor Terms

ID	Term
D005264	Femoral Fractures
D050723	Fractures, Bone
D014947	Wounds and Injuries
D025981	Hip Injuries

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008327	Mammography

Ancestor Terms

ID	Term
D011859	Radiography
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided