MedPath

FAST: Clinical Feasibility

Conditions
Femur Fracture
Interventions
Device: FAST
Registration Number
NCT03775408
Lead Sponsor
Sunnybrook Health Sciences Centre
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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
10
Inclusion Criteria
  • Patients with a femoral shaft fracture
  • Undergoing anterograde intramedullary nailing procedure
Exclusion Criteria
  • Femoral head or neck fractures

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
FAST PatientsFASTPatients at Sunnybrook Health Sciences Centre with femur fractures that will undergo a femoral antegrade intramedullary nailing procedure.
Primary Outcome Measures
NameTimeMethod
Procedure Time1 day

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

Secondary Outcome Measures
NameTimeMethod
Fluoroscopic Images1 day

Number of fluoroscopic images used to obtain start point

Number of guidewire drilling attempts1 day

Number of times the guidewire has been drilled into the bone to test the alignment.

Trial Locations

Locations (1)

Sunnybrook Health Sciences Centre

🇨🇦

Toronto, Ontario, Canada

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