Tomosynthesis Use in Detecting Subtle Occult Hip Fractures

May 6, 2014 updated by: Naveen Parasu, Medical Imaging Informatics Research Centre at McMaster
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada
        • Juravinski Hospital
        • Principal Investigator:
          • Naveen Parasu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Tomosynthesis
Device: Tomosynthesis
Other Names:
  • GE Discovery 650

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
ER wait time
Time Frame: End of study
End of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical Imaging Informatics Research Centre at McMaster

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (ANTICIPATED)

December 1, 2014

Study Completion (ANTICIPATED)

December 1, 2014

Study Registration Dates

First Submitted

April 23, 2014

First Submitted That Met QC Criteria

May 6, 2014

First Posted (ESTIMATE)

May 8, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

May 8, 2014

Last Update Submitted That Met QC Criteria

May 6, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Parasu-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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