Tomosynthesis Use in Detecting Subtle Occult Hip Fractures

Hip Fracture Clinical Trial

Official title:

Tomosynthesis Use in Detecting Subtle Occult Hip Fractures

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02133794
• Other study ID #: Parasu-001
• Status: Not yet recruiting
• Phase: N/A
• First received: April 23, 2014
• Last updated: May 6, 2014
• Start date: June 2014
• Est. completion date: December 2014

Study information

• Verified date: April 2014
• Source: Medical Imaging Informatics Research Centre at McMaster
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fracture
• Hip Fractures

Intervention

Device:
• Tomosynthesis

Locations

Country	Name	City	State
Canada	Juravinski Hospital	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Medical Imaging Informatics Research Centre at McMaster

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	ER wait time		End of study