<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/NCT01661647</url>
  </required_header>
  <id_info>
    <org_study_id>CE 12.005</org_study_id>
    <nct_id>NCT01661647</nct_id>
  </id_info>
  <brief_title>3D Kinematic Assessment of the Human Knee During Physical and Daily Life Activities</brief_title>
  <official_title>(Étude de la cinématique Tridimensionnelle du Genou Humain Lors de Gestes Sportifs et de la Vie Courante)</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 : Precise and personalized 3D knee kinematic assessment during physical and daily&#xD;
      life activities is a challenge; therefore, it was never performed on an important number of&#xD;
      individuals. However, a better understanding of 3D knee kinematics during such activities&#xD;
      would allow a better understanding of this often injured joint.&#xD;
&#xD;
      Hypothesis: A new system using personalized 3D bone imaging and a percutaneous bone fixation&#xD;
      device that can be used under local anesthesiaallows for precise and reproducible assessment&#xD;
      of 3D knee kinematics during physical and daily life activities.&#xD;
&#xD;
      Objectives :&#xD;
&#xD;
        -  To study human knee 3D kinematics during dynamic activities using a novel minimally&#xD;
           invasive measuring system&#xD;
&#xD;
        -  Investigate the correlations between standard clinical knee laxity tests and measured 3D&#xD;
           knee kinematics during dynamic activities&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">July 2, 2024</start_date>
  <completion_date type="Anticipated">December 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2025</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>3D knee kinematics</measure>
    <time_frame>On the day of the surgery, before knee arthroscopy</time_frame>
    <description>The investigators will investigate if 3D knee kinematics can be precisely and safely measured under local anesthesia during various motor tasks (walking, squatting, pivoting, jumping): kinematic data will be analyzed in search of signs of artefact movement and kinematic aberrations, which would indicate problems with the measurement system.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation of kinematic data with clinical laxity tests</measure>
    <time_frame>On the day of surgery, before knee arthroscopy</time_frame>
    <description>With the kinematic measurement device attached to the bones of the lower limbs, various knee laxity tests will be performed by a physician while the kinematics of the knee are recorded; correlations will be sought between the subjective evaluation of the physician and the kinematic data.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>3D Knee Kinematics</condition>
  <arm_group>
    <arm_group_label>3D knee kinematic assessment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3D knee kinematic assessment under local anesthesia</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>3D knee kinematic assessment under local anesthesia</intervention_name>
    <description>3D knee kinematic assessment under local anesthesia</description>
    <arm_group_label>3D knee kinematic assessment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients awaiting knee arthroscopy under local anesthesia for a medial meniscal tear&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active infection&#xD;
&#xD;
          -  Severe swelling of the knee&#xD;
&#xD;
          -  Knee flexion contracture&#xD;
&#xD;
          -  Knee flexion less than 120 degrees&#xD;
&#xD;
          -  Gross limping&#xD;
&#xD;
          -  Inability to perform the various motor tasks required by the study protocol&#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>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>CHUM</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H2X 3E4</zip>
        <country>Canada</country>
      </address>
    </facility>
    <contact>
      <last_name>Frédéric Lavoie, MD MSc FRCSC</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>July 16, 2012</study_first_submitted>
  <study_first_submitted_qc>August 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 9, 2012</study_first_posted>
  <last_update_submitted>July 31, 2023</last_update_submitted>
  <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
  </intervention_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/NCT01661647
org study id: CE 12.005
nct id: NCT01661647
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Problem : Precise and personalized 3D knee kinematic assessment during physical and daily
      life activities is a challenge; therefore, it was never performed on an important number of
      individuals. However, a better understanding of 3D knee kinematics during such activities
      would allow a better understanding of this often injured joint.

      Hypothesis: A new system using personalized 3D bone imaging and a percutaneous bone fixation
      device that can be used under local anesthesiaallows for precise and reproducible assessment
      of 3D knee kinematics during physical and daily life activities.

      Objectives :

        -  To study human knee 3D kinematics during dynamic activities using a novel minimally
           invasive measuring system

        -  Investigate the correlations between standard clinical knee laxity tests and measured 3D
           knee kinematics during dynamic activities
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: 3D knee kinematics
time frame: On the day of the surgery, before knee arthroscopy
description: The investigators will investigate if 3D knee kinematics can be precisely and safely measured under local anesthesia during various motor tasks (walking, squatting, pivoting, jumping): kinematic data will be analyzed in search of signs of artefact movement and kinematic aberrations, which would indicate problems with the measurement system.
measure: Correlation of kinematic data with clinical laxity tests
time frame: On the day of surgery, before knee arthroscopy
description: With the kinematic measurement device attached to the bones of the lower limbs, various knee laxity tests will be performed by a physician while the kinematics of the knee are recorded; correlations will be sought between the subjective evaluation of the physician and the kinematic data.
arm group label: 3D knee kinematic assessment
arm group type: Experimental
description: 3D knee kinematic assessment under local anesthesia
intervention type: Device
intervention name: 3D knee kinematic assessment under local anesthesia
description: 3D knee kinematic assessment under local anesthesia
arm group label: 3D knee kinematic assessment
criteria: 
gender: All
minimum age: N/A
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: 
contact: 
country: Canada
responsible party type: Sponsor
mesh term: Anesthetics