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NCT03775408 Clinical Trial

FAST: Clinical Feasibility

Femur Fracture Clinical Trial

Official title:
Femoral Antegrade Starting Tool (FAST): Clinical Feasibility Pilot Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03775408
Other study ID # FAST2019
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date May 21, 2019
Est. completion date December 31, 2021

Study information
Verified date October 2021
Source Sunnybrook Health Sciences Centre
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study evaluates the clinical ease of use of the Femoral Antegrade Starting Tool (FAST).

Description:

The investigators will recruit 10 patients at Sunnybrook Health Sciences Centre that are scheduled to receive femoral antegrade intramedullary nailing to treat a femur fracture. This study evaluates the clinical ease of use of the Femoral Antegrade Starting Tool (FAST) device, and the surgical workflow during entry point selection and guidewire alignment for intramedullary nailing of femoral fractures. It is hypothesized that the usage of the tool will reduce surgery time and number of images required.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 10
Est. completion date December 31, 2021
Est. primary completion date December 23, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Patients with a femoral shaft fracture - Undergoing anterograde intramedullary nailing procedure Exclusion Criteria: - Femoral head or neck fractures

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• FAST
Orthopaedic surgeons will use the FAST device to facilitate entry point selection and alignment of a guidewire for intramedullary nailing of femoral shaft fractures.

Locations
Country Name City State
Canada Sunnybrook Health Sciences Centre Toronto Ontario

Sponsors (1)
Lead Sponsor Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Ebrahimi H, Yee A, Whyne C. Surgical process analysis identifies lack of connectivity between sequential fluoroscopic 2D alignment as a critical impediment in femoral intramedullary nailing. Int J Comput Assist Radiol Surg. 2016 Feb;11(2):297-305. doi: 10.1007/s11548-015-1262-6. Epub 2015 Jul 21. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Procedure Time Time of the procedure from the initiation of the guidewire step (surgeon picking up the guidewire) to the removal of the FAST device following acceptable guidewire placement 1 day
Secondary Fluoroscopic Images Number of fluoroscopic images used to obtain start point 1 day
Secondary Number of guidewire drilling attempts Number of times the guidewire has been drilled into the bone to test the alignment. 1 day
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