NCT02133794

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2014

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 8, 2014

Completed
24 days until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

May 8, 2014

Status Verified

April 1, 2014

Enrollment Period

6 months

First QC Date

April 23, 2014

Last Update Submit

May 6, 2014

Conditions

Hip Fracture

Keywords

Hip fractureTomosynthesisX-rayEmergency room

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • ER wait time

    End of study

Study Arms (1)

Tomosynthesis

EXPERIMENTAL
Device: Tomosynthesis

Interventions

TomosynthesisDEVICE
Also known as: GE Discovery 650
Tomosynthesis

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Juravinski Hospital

Hamilton, Ontario, Canada

Location

MeSH Terms

Conditions

Hip FracturesEmergencies

Interventions

Mammography

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Naveen Parasu

Study Record Dates

First Submitted

April 23, 2014

First Posted

May 8, 2014

Study Start

June 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

May 8, 2014

Record last verified: 2014-04

Locations

CA(1)