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FAST: Clinical Feasibility

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03775408
Recruitment Status : Recruiting
First Posted : December 13, 2018
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre

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

Condition or disease Intervention/treatment
Femur Fracture Device: 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.

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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Femoral Antegrade Starting Tool (FAST): Clinical Feasibility Pilot Study
Actual Study Start Date : May 21, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
FAST Patients
Patients at Sunnybrook Health Sciences Centre with femur fractures that will undergo a femoral antegrade intramedullary nailing procedure.
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.




Primary Outcome Measures :
  1. Procedure Time [ Time Frame: 1 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 :
  1. Fluoroscopic Images [ Time Frame: 1 day ]
    Number of fluoroscopic images used to obtain start point

  2. Number of guidewire drilling attempts [ Time Frame: 1 day ]
    Number of times the guidewire has been drilled into the bone to test the alignment.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients hospitalized at Sunnybrook Health Sciences Centre
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Femoral head or neck fractures

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03775408


Contacts
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Contact: Sebastian Tomescu, MD MSc FRCS 416-928-3279 sebastian.tomescu@sunnybrook.ca
Contact: Richard Jenkinson, MD MSc FRCS 416-480-6160 richard.jenkinson@sunnybrook.ca

Locations
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Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Sebastian Tomescu, MD MSc FRCS    416-928-3279    sebastian.tomescu@sunnybrook.ca   
Contact: Richard Jenkinson, MD MSc FRCS    416-480-6160    richard.jenkinson@sunnybrook.ca   
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
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Principal Investigator: Sebastian Tomescu, MD MSc FRCS Sunnybrook Health Sciences Centre
Publications:
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Responsible Party: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT03775408    
Other Study ID Numbers: FAST2019
First Posted: December 13, 2018    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Femoral Fractures
Fractures, Bone
Wounds and Injuries
Leg Injuries