FAST: Clinical Feasibility

NCT ID: NCT03775408

Last Updated: 2021-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-21

Study Completion Date

2021-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Femur Fracture

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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FAST Patients

Patients at Sunnybrook Health Sciences Centre with femur fractures that will undergo a femoral antegrade intramedullary nailing procedure.

FAST

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Femoral head or neck fractures
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sunnybrook Health Sciences Centre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sebastian Tomescu, MD MSc FRCS

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Locations

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Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 26194487 (View on PubMed)

Other Identifiers

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FAST2019

Identifier Type: -

Identifier Source: org_study_id