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FAST: Clinical Feasibility

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03775408
Enrollment
10
Registered
2018-12-13
Start date
2019-05-21
Completion date
2021-12-31
Last updated
2021-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Femur Fracture

Brief summary

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

Detailed 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.

Interventions

DEVICEFAST

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

Sponsors

Sunnybrook Health Sciences Centre
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Patients with a femoral shaft fracture * Undergoing anterograde intramedullary nailing procedure

Exclusion criteria

* Femoral head or neck fractures

Design outcomes

Primary

MeasureTime frameDescription
Procedure Time1 dayTime 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

Secondary

MeasureTime frameDescription
Fluoroscopic Images1 dayNumber of fluoroscopic images used to obtain start point
Number of guidewire drilling attempts1 dayNumber of times the guidewire has been drilled into the bone to test the alignment.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026