Tomosynthesis Use in Detecting Subtle Occult Hip Fractures

NCT ID: NCT02133794

Last Updated: 2014-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2014-12-31

Brief Summary

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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

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Conditions

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Hip Fracture

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Tomosynthesis

Group Type EXPERIMENTAL

Tomosynthesis

Intervention Type DEVICE

Interventions

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Tomosynthesis

Intervention Type DEVICE

Other Intervention Names

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GE Discovery 650

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical Imaging Informatics Research Centre at McMaster

OTHER

Sponsor Role lead

Responsible Party

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Naveen Parasu

Dr. Naveen Parasu

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Juravinski Hospital

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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Parasu-001

Identifier Type: -

Identifier Source: org_study_id

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