<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/NCT01674816</url>
  </required_header>
  <id_info>
    <org_study_id>CE12.006</org_study_id>
    <nct_id>NCT01674816</nct_id>
  </id_info>
  <brief_title>Minimally Invasive Three-dimensional Knee Kinematic Assessment and Surgical Guidance Using Ultrasonic Rigid Registration</brief_title>
  <official_title>(Étude de la cinématique Tridimensionnelle du Genou et Guidage Chirurgical Minimalement Effractifs Par Recalage Rigide échographique)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre hospitalier de l'Université de Montréal (CHUM)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eiffel Medtech</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre hospitalier de l'Université de Montréal (CHUM)</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Problem:&#xD;
&#xD;
      Currently, no system allows precise kinematic assessment of the knee and accurate guiding of&#xD;
      orthopedic surgical actions in a minimally invasive fashion. However, such a system would&#xD;
      prove useful in the clinical setting to improve the quality of surgical interventions at the&#xD;
      knee.&#xD;
&#xD;
      Hypothesis:&#xD;
&#xD;
      A novel knee kinematic assessment and surgical guidance tool using 3D personalized imaging&#xD;
      and minimally invasive bony fixation allows precise kinematic assessment and surgical&#xD;
      guidance in the routine clinical setting.&#xD;
&#xD;
      Objectives :&#xD;
&#xD;
        -  Demonstrating the capacity of the system to precisely measure 3D knee kinematics&#xD;
&#xD;
        -  Quantifying the reproducibility of the kinematic measurements&#xD;
&#xD;
        -  Measuring the impact of knee surgical procedures on knee kinematics&#xD;
&#xD;
        -  Assessing the correlations between measured articular kinematics and clinical results&#xD;
           after knee surgery&#xD;
&#xD;
        -  Integrating the novel measuring system to the surgical flow of three knee surgical&#xD;
           procedures&#xD;
&#xD;
        -  Quantifying the precision and reproducibility of the surgical actions guided by the&#xD;
           system&#xD;
&#xD;
        -  Comparing the clinical results of surgeries guided by the system to those performed with&#xD;
           the traditional technique&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A novel knee kinematic assessment and surgical guidance tool using 3D personalized imaging&#xD;
      and minimally invasive bony fixation allows precise kinematic assessment and surgical&#xD;
      guidance in the routine clinical setting.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">December 1, 2023</start_date>
  <completion_date type="Anticipated">December 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>3D knee kinematic assessment</measure>
    <time_frame>1 day</time_frame>
    <description>The system should be able to precisely and reproducibly measure 3D knee kinematics (tibio-femoral flexion, abduction-adduction, transverse rotation, and anterio-posterior and medio-lateral translations)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Precision of guided surgical actions</measure>
    <time_frame>During surgery</time_frame>
    <description>The system should allow the surgeon to realize surgical actions, like bone cuts and guide-wire placement, within one degree and one millimeter of the desired target.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Precision of guided surgical actions</measure>
    <time_frame>On post-operative imaging (six weeks after surgery)</time_frame>
    <description>The system should allow the surgeon to realize surgical actions, like bone cuts and guide-wire placement, within one degree and one millimeter of the desired target.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical results</measure>
    <time_frame>At each post-operative visit (six weeks, six months, one year, and two years after surgery)</time_frame>
    <description>The clinical results after surgery will be assessed using patient questionnaire and clinical examination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical results</measure>
    <time_frame>At each post-operative visit (six weeks, six months, one year, and two years after surgery)</time_frame>
    <description>The clinical results after surgery will be assessed using the International Knee Society score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical results</measure>
    <time_frame>At each post-operative visit (six weeks, six months, one year, and two years after surgery)</time_frame>
    <description>The clinical results after surgery will be assessed using the KOOS score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical results</measure>
    <time_frame>At each post-operative visit (six weeks, six months, one year, and two years after surgery)</time_frame>
    <description>The clinical results after surgery will be assessed using the SF-12 score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical results</measure>
    <time_frame>At each post-operative visit (six weeks, six months, one year, and two years after surgery)</time_frame>
    <description>The clinical results after surgery will be assessed using the Marx activity scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical results</measure>
    <time_frame>At each post-operative visit (six weeks, six months, one year, and two years after surgery)</time_frame>
    <description>The clinical results after surgery will be assessed through angular and linear measurements using 3D imaging.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <condition>Knee Instability</condition>
  <condition>3D Knee Kinematics</condition>
  <condition>Precision of Surgical Actions</condition>
  <condition>Clinical Outcomes</condition>
  <arm_group>
    <arm_group_label>Repeated Measurements of Knee Alignment and Kinematics</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in the Repeated Measurements Arm will have the kinematic measurement protocol repeated twice before and twice after the surgical procedure; the procedure itself will be performed with the traditional technique, i.e without guidance by the system.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Computer Guidance of Surgical Actions</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in the Computer Guidance of Surgical Actions Arm will have the kinematic measurement protocol performed only once before and once after the surgical procedure; the procedure itself will be performed with guidance by the system.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Repeated Measurements of Knee Alignment and Kinematics</intervention_name>
    <description>Repeated Measurements of Knee Alignment and Kinematics using tools developed by Eiffel Medtech Inc.</description>
    <arm_group_label>Repeated Measurements of Knee Alignment and Kinematics</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Computer Guidance of Surgical Actions</intervention_name>
    <description>Computer Guidance of Surgical Actions using tools developed by Eiffel Medtech Inc.</description>
    <arm_group_label>Computer Guidance of Surgical Actions</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients awaiting a knee surgery (total knee arthroplasty (TKA), high tibial osteotomy&#xD;
             (HTO), anterior cruciate ligament reconstruction(ACLR))&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active infection&#xD;
&#xD;
          -  Atypical morphology and/or alignment of the lower limbs&#xD;
&#xD;
          -  Knee instability (other than secondary to ACL deficiency in patients awaiting ACLR)&#xD;
&#xD;
          -  Knee flexion contracture of 10 degrees or more&#xD;
&#xD;
          -  Knee flexion of less than 120 degrees&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Frédéric Lavoie, MD, MSc, FRCSC</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHUM</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Frédéric Lavoie, MD MSc FRCSC</last_name>
    <phone>1-514-890-8000</phone>
    <phone_ext>25900</phone_ext>
    <email>fredericlavoiemd@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Fidaa Al-Shakfa, MSc</last_name>
    <phone>1-514-890-8000</phone>
    <phone_ext>26103</phone_ext>
    <email>f.alshakfa.crchum@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Centre Hospitalier de l'Université de Montréal (CHUM)</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H2L 4M1</zip>
        <country>Canada</country>
      </address>
    </facility>
    <investigator>
      <last_name>Frédéric Lavoie, MD MSc FRCSC</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>August 6, 2012</study_first_submitted>
  <study_first_submitted_qc>August 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2012</study_first_posted>
  <last_update_submitted>November 10, 2022</last_update_submitted>
  <last_update_submitted_qc>November 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 14, 2022</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>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
  </condition_browse>
  <!-- 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/NCT01674816
org study id: CE12.006
nct id: NCT01674816
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Problem:

      Currently, no system allows precise kinematic assessment of the knee and accurate guiding of
      orthopedic surgical actions in a minimally invasive fashion. However, such a system would
      prove useful in the clinical setting to improve the quality of surgical interventions at the
      knee.

      Hypothesis:

      A novel knee kinematic assessment and surgical guidance tool using 3D personalized imaging
      and minimally invasive bony fixation allows precise kinematic assessment and surgical
      guidance in the routine clinical setting.

      Objectives :

        -  Demonstrating the capacity of the system to precisely measure 3D knee kinematics

        -  Quantifying the reproducibility of the kinematic measurements

        -  Measuring the impact of knee surgical procedures on knee kinematics

        -  Assessing the correlations between measured articular kinematics and clinical results
           after knee surgery

        -  Integrating the novel measuring system to the surgical flow of three knee surgical
           procedures

        -  Quantifying the precision and reproducibility of the surgical actions guided by the
           system

        -  Comparing the clinical results of surgeries guided by the system to those performed with
           the traditional technique
A novel knee kinematic assessment and surgical guidance tool using 3D personalized imaging
      and minimally invasive bony fixation allows precise kinematic assessment and surgical
      guidance in the routine clinical setting.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: 3D knee kinematic assessment
time frame: 1 day
description: The system should be able to precisely and reproducibly measure 3D knee kinematics (tibio-femoral flexion, abduction-adduction, transverse rotation, and anterio-posterior and medio-lateral translations)
measure: Precision of guided surgical actions
time frame: During surgery
description: The system should allow the surgeon to realize surgical actions, like bone cuts and guide-wire placement, within one degree and one millimeter of the desired target.
measure: Precision of guided surgical actions
time frame: On post-operative imaging (six weeks after surgery)
description: The system should allow the surgeon to realize surgical actions, like bone cuts and guide-wire placement, within one degree and one millimeter of the desired target.
measure: Clinical results
time frame: At each post-operative visit (six weeks, six months, one year, and two years after surgery)
description: The clinical results after surgery will be assessed using patient questionnaire and clinical examination.
measure: Clinical results
time frame: At each post-operative visit (six weeks, six months, one year, and two years after surgery)
description: The clinical results after surgery will be assessed using the International Knee Society score.
measure: Clinical results
time frame: At each post-operative visit (six weeks, six months, one year, and two years after surgery)
description: The clinical results after surgery will be assessed using the KOOS score.
measure: Clinical results
time frame: At each post-operative visit (six weeks, six months, one year, and two years after surgery)
description: The clinical results after surgery will be assessed using the SF-12 score.
measure: Clinical results
time frame: At each post-operative visit (six weeks, six months, one year, and two years after surgery)
description: The clinical results after surgery will be assessed using the Marx activity scale.
measure: Clinical results
time frame: At each post-operative visit (six weeks, six months, one year, and two years after surgery)
description: The clinical results after surgery will be assessed through angular and linear measurements using 3D imaging.
arm group label: Repeated Measurements of Knee Alignment and Kinematics
arm group type: Active Comparator
description: Patients in the Repeated Measurements Arm will have the kinematic measurement protocol repeated twice before and twice after the surgical procedure; the procedure itself will be performed with the traditional technique, i.e without guidance by the system.
arm group label: Computer Guidance of Surgical Actions
arm group type: Active Comparator
description: Patients in the Computer Guidance of Surgical Actions Arm will have the kinematic measurement protocol performed only once before and once after the surgical procedure; the procedure itself will be performed with guidance by the system.
intervention type: Device
intervention name: Repeated Measurements of Knee Alignment and Kinematics
description: Repeated Measurements of Knee Alignment and Kinematics using tools developed by Eiffel Medtech Inc.
arm group label: Repeated Measurements of Knee Alignment and Kinematics
intervention type: Device
intervention name: Computer Guidance of Surgical Actions
description: Computer Guidance of Surgical Actions using tools developed by Eiffel Medtech Inc.
arm group label: Computer Guidance of Surgical Actions
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Frédéric Lavoie, MD, MSc, FRCSC
role: Principal Investigator
affiliation: CHUM
last name: Frédéric Lavoie, MD MSc FRCSC
phone: 1-514-890-8000
phone ext: 25900
email: fredericlavoiemd@gmail.com
last name: Fidaa Al-Shakfa, MSc
phone: 1-514-890-8000
phone ext: 26103
email: f.alshakfa.crchum@gmail.com
facility: 
investigator: 
country: Canada
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee