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Tomosynthesis Use in Detecting Subtle Occult Hip Fractures

Primary Purpose

Hip Fracture

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Tomosynthesis
Sponsored by
Medical Imaging Informatics Research Centre at McMaster
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hip Fracture focused on measuring Hip fracture, Tomosynthesis, X-ray, Emergency room

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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

Sites / Locations

  • Juravinski Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tomosynthesis

Arm Description

Outcomes

Primary Outcome Measures

Number of patients with hip fracture detected with tomosynthesis versus x-ray alone.

Secondary Outcome Measures

ER wait time

Full Information

First Posted
April 23, 2014
Last Updated
May 6, 2014
Sponsor
Medical Imaging Informatics Research Centre at McMaster
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1. Study Identification

Unique Protocol Identification Number
NCT02133794
Brief Title
Tomosynthesis Use in Detecting Subtle Occult Hip Fractures
Official Title
Tomosynthesis Use in Detecting Subtle Occult Hip Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical Imaging Informatics Research Centre at McMaster

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fracture
Keywords
Hip fracture, Tomosynthesis, X-ray, Emergency room

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tomosynthesis
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Tomosynthesis
Other Intervention Name(s)
GE Discovery 650
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
ER wait time
Time Frame
End of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
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
Facility Information:
Facility Name
Juravinski Hospital
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naveen Parasu

12. IPD Sharing Statement

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Tomosynthesis Use in Detecting Subtle Occult Hip Fractures

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