<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03775408</url>
  </required_header>
  <id_info>
    <org_study_id>FAST2019</org_study_id>
    <nct_id>NCT03775408</nct_id>
  </id_info>
  <brief_title>FAST: Clinical Feasibility</brief_title>
  <official_title>Femoral Antegrade Starting Tool (FAST): Clinical Feasibility Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sunnybrook Health Sciences Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sunnybrook Health Sciences Centre</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the clinical ease of use of the Femoral Antegrade Starting Tool (FAST).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will recruit 10 patients at Sunnybrook Health Sciences Centre that are&#xD;
      scheduled to receive femoral antegrade intramedullary nailing to treat a femur fracture. This&#xD;
      study evaluates the clinical ease of use of the Femoral Antegrade Starting Tool (FAST)&#xD;
      device, and the surgical workflow during entry point selection and guidewire alignment for&#xD;
      intramedullary nailing of femoral fractures. It is hypothesized that the usage of the tool&#xD;
      will reduce surgery time and number of images required.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">May 21, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">December 23, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Procedure Time</measure>
    <time_frame>1 day</time_frame>
    <description>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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fluoroscopic Images</measure>
    <time_frame>1 day</time_frame>
    <description>Number of fluoroscopic images used to obtain start point</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of guidewire drilling attempts</measure>
    <time_frame>1 day</time_frame>
    <description>Number of times the guidewire has been drilled into the bone to test the alignment.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">10</enrollment>
  <condition>Femur Fracture</condition>
  <arm_group>
    <arm_group_label>FAST Patients</arm_group_label>
    <description>Patients at Sunnybrook Health Sciences Centre with femur fractures that will undergo a femoral antegrade intramedullary nailing procedure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>FAST</intervention_name>
    <description>Orthopaedic surgeons will use the FAST device to facilitate entry point selection and alignment of a guidewire for intramedullary nailing of femoral shaft fractures.</description>
    <arm_group_label>FAST Patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients hospitalized at Sunnybrook Health Sciences Centre&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with a femoral shaft fracture&#xD;
&#xD;
          -  Undergoing anterograde intramedullary nailing procedure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Femoral head or neck fractures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sebastian Tomescu, MD MSc FRCS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sunnybrook Health Sciences Centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sunnybrook Health Sciences Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4N 3M5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>26194487</PMID>
  </reference>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>December 12, 2018</study_first_submitted>
  <study_first_submitted_qc>December 12, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 13, 2018</study_first_posted>
  <last_update_submitted>October 20, 2021</last_update_submitted>
  <last_update_submitted_qc>October 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Femoral Fractures</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03775408
org study id: FAST2019
nct id: NCT03775408
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates the clinical ease of use of the Femoral Antegrade Starting Tool (FAST).
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.
observational model: Cohort
time perspective: Prospective
measure: Procedure Time
time frame: 1 day
description: 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
measure: Fluoroscopic Images
time frame: 1 day
description: Number of fluoroscopic images used to obtain start point
measure: Number of guidewire drilling attempts
time frame: 1 day
description: Number of times the guidewire has been drilled into the bone to test the alignment.
arm group label: FAST Patients
description: Patients at Sunnybrook Health Sciences Centre with femur fractures that will undergo a femoral antegrade intramedullary nailing procedure.
intervention type: Device
intervention name: FAST
description: Orthopaedic surgeons will use the FAST device to facilitate entry point selection and alignment of a guidewire for intramedullary nailing of femoral shaft fractures.
arm group label: FAST Patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Sebastian Tomescu, MD MSc FRCS
role: Principal Investigator
affiliation: Sunnybrook Health Sciences Centre
facility: 
country: Canada
citation: 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.
PMID: 26194487
responsible party type: Sponsor
mesh term: Femoral Fractures
sharing ipd: No