<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/NCT03033940</url>
  </required_header>
  <id_info>
    <org_study_id>ATTUNE-SIGMA-2016</org_study_id>
    <nct_id>NCT03033940</nct_id>
  </id_info>
  <brief_title>Total Knee Arthroplasty Videofluoroscopy</brief_title>
  <official_title>Kinematics Analysis: Comparison Between the Cruciate Retaining, Fixed Bearing Primary Total Knee Arthroplasty ATTUNE TM Knee System and the Fixed Bearing PFC Sigma Curved Total Knee Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dr. Renate List</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institute for Biomechanics, ETH Zürich</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective is to quantify and compare the three-dimensional kinematics of the&#xD;
      cruciate retaining (CR), fixed bearing ATTUNETM TKA to the kinematics of the PFC Sigma Curved&#xD;
      CR Fixed Bearing TKA (both DePuy Synthes, Johnson and Johnson) during daily activities.&#xD;
&#xD;
      The secondary objective is to describe the kinematics in terms of range of motion, patterns&#xD;
      of anterior-posterior motion of the nearest medial and lateral points (&quot;posterior femoral&#xD;
      rollback&quot;) and tibio-femoral internal/external rotation as well as the kinetics during daily&#xD;
      activities, such as level gait, a deep knee bend (only ATTUNETM subjects), sitting down onto&#xD;
      a chair, standing up from a chair and stair descent by means of video-fluoroscopy.&#xD;
&#xD;
      Furthermore, the encoded data will be handed over to DePuy Synthes (Johnson and Johnson) and&#xD;
      to the Center for Orthopaedic Engineering of the University of Denver, where it will be used&#xD;
      within a musculoskeletal model with the aim of simulating tibiofemoral contact mechanics and&#xD;
      changes in the musculoskeletal system due to the TKA.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2016</start_date>
  <completion_date type="Actual">December 2018</completion_date>
  <primary_completion_date type="Actual">December 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of the three-dimensional kinematics of the cruciate retaining (CR), fixed bearing ATTUNETM TKA to the kinematics of the PFC Sigma Curved CR Fixed Bearing TKA</measure>
    <time_frame>3 hours</time_frame>
    <description>With video-fluoroscopic assessment it is possible to directly measure the kinematics of the tibial and the femoral components in vivo during daily activities, such as level walking, a deep knee bend (only ATTUNETM subjects), sitting down onto a chair, standing up from a chair and stair descent. Thus, for the first time the present study provides in vivo assessed data of the 3D motion of the ATTUNETM System during daily activities and allows a comparison to a conventional TKA based on the same methodology. The knowledge of the in vivo kinematic behaviour of the ATTUNETM System in comparison to the conventional TKA leads to an improved understanding of the design principle.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">19</enrollment>
  <condition>Total Knee Anthroplasty</condition>
  <arm_group>
    <arm_group_label>ATTUNE TM subjects</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>PFC Sigma subjects</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Observational use of fluoroscopy</intervention_name>
    <arm_group_label>ATTUNE TM subjects</arm_group_label>
    <arm_group_label>PFC Sigma subjects</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        This is a prospective, observational study on 15 subjects with the ATTUNE TM CR Fixed&#xD;
        Bearing TKA and 15 subjects with PFC Sigma Curved CR Fixed Bearing TKA during level&#xD;
        walking, deep knee bend (only ATTUNE TM subjects), sitting down onto a chair, standing up&#xD;
        from a chair and stair descent. The present study extends the subject groups of a previous&#xD;
        feasibility study (KEK-ZH-Nr. 2014-0468) from 5 to 15 ATTUNE TM and from 6 to 15 PFC Sigma&#xD;
        Curved CR Fixed Bearing TKA subjects. Based on a power analysis of the existing data of 5&#xD;
        ATTUNE TM subjects and 6 subjects with a PFC Sigma Curved CR Fixed Bearing TKA in the&#xD;
        previous feasibility study (KEK-ZH-Nr. 2014-0468) the minimal sample size for the&#xD;
        comparative evaluation of 15 subjects within each group was estimated. The participants&#xD;
        must be able to perform the daily activity tasks mentioned above&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Unilateral TKA (ATTUNETM/Sigma) due to osteoarthritis&#xD;
&#xD;
          -  BMI ≤ 33&#xD;
&#xD;
          -  Good clinical outcome, KOOS &gt; 70&#xD;
&#xD;
          -  No or very low pain VAS &lt; 2&#xD;
&#xD;
          -  At least one year post-op&#xD;
&#xD;
          -  Standardized general health survey score (SF-12) within the normal range for people in&#xD;
             their age group&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Actual significant problem on lower extremities&#xD;
&#xD;
          -  Misaligned TKA&#xD;
&#xD;
          -  Any other arthroplasty at the lower extremities&#xD;
&#xD;
          -  Patient incapable to understand and sign informed consent&#xD;
&#xD;
          -  Incapable of performing the motion tasks&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Institute for Biomechanics, ETH Zurich</name>
      <address>
        <city>Zurich</city>
        <zip>8093</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>January 25, 2017</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>December 19, 2019</last_update_submitted>
  <last_update_submitted_qc>December 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Institute for Biomechanics, ETH Zürich</investigator_affiliation>
    <investigator_full_name>Dr. Renate List</investigator_full_name>
    <investigator_title>Dr. sc. ETH, Group Leader Clinical Movement Biomechanics, Senior Research Associate</investigator_title>
  </responsible_party>
  <!-- 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/NCT03033940
org study id: ATTUNE-SIGMA-2016
nct id: NCT03033940
lead sponsor: 
has dmc: No
The primary objective is to quantify and compare the three-dimensional kinematics of the
      cruciate retaining (CR), fixed bearing ATTUNETM TKA to the kinematics of the PFC Sigma Curved
      CR Fixed Bearing TKA (both DePuy Synthes, Johnson and Johnson) during daily activities.

      The secondary objective is to describe the kinematics in terms of range of motion, patterns
      of anterior-posterior motion of the nearest medial and lateral points ("posterior femoral
      rollback") and tibio-femoral internal/external rotation as well as the kinetics during daily
      activities, such as level gait, a deep knee bend (only ATTUNETM subjects), sitting down onto
      a chair, standing up from a chair and stair descent by means of video-fluoroscopy.

      Furthermore, the encoded data will be handed over to DePuy Synthes (Johnson and Johnson) and
      to the Center for Orthopaedic Engineering of the University of Denver, where it will be used
      within a musculoskeletal model with the aim of simulating tibiofemoral contact mechanics and
      changes in the musculoskeletal system due to the TKA.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Comparison of the three-dimensional kinematics of the cruciate retaining (CR), fixed bearing ATTUNETM TKA to the kinematics of the PFC Sigma Curved CR Fixed Bearing TKA
time frame: 3 hours
description: With video-fluoroscopic assessment it is possible to directly measure the kinematics of the tibial and the femoral components in vivo during daily activities, such as level walking, a deep knee bend (only ATTUNETM subjects), sitting down onto a chair, standing up from a chair and stair descent. Thus, for the first time the present study provides in vivo assessed data of the 3D motion of the ATTUNETM System during daily activities and allows a comparison to a conventional TKA based on the same methodology. The knowledge of the in vivo kinematic behaviour of the ATTUNETM System in comparison to the conventional TKA leads to an improved understanding of the design principle.
arm group label: ATTUNE TM subjects
arm group label: PFC Sigma subjects
intervention type: Radiation
intervention name: Observational use of fluoroscopy
arm group label: ATTUNE TM subjects
arm group label: PFC Sigma subjects
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Switzerland
responsible party type: Sponsor-Investigator
investigator affiliation: Institute for Biomechanics, ETH Zürich
investigator full name: Dr. Renate List
investigator title: Dr. sc. ETH, Group Leader Clinical Movement Biomechanics, Senior Research Associate