<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/NCT02204748</url>
  </required_header>
  <id_info>
    <org_study_id>13002</org_study_id>
    <secondary_id>R011373503</secondary_id>
    <nct_id>NCT02204748</nct_id>
  </id_info>
  <brief_title>Kinematic Analysis: Posterior Stabilized, Fixed Bearing Total Knee Arthroplasty With Attune Knee System</brief_title>
  <official_title>Kinematic Analysis: Posterior Stabilized, Fixed Bearing Total Knee Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Tennessee, Knoxville</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>DePuy Orthopaedics</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>The University of Tennessee, Knoxville</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A better understanding of knee joint kinematics is important to explain the premature&#xD;
      polyethylene wear failures within total knee arthroplasties (TKAs) and to help design a&#xD;
      prosthesis that most closely approximates the normal knee. Specifically, posterior&#xD;
      stabilizing (PS) knees have been found to be associated with lower amounts of posterior&#xD;
      femoral rollback, higher occurrence of reverse axial rotation and increased amount of&#xD;
      condylar lift-off. The DePuy Synthes Joint Reconstruction's Attune PS fixed bearing (FB) knee&#xD;
      system has incorporated subtle changes in its design to address restoration of kinematics&#xD;
      that more closely resemble those of a normal knee. To understand if this design is able to&#xD;
      effectively restore kinematics in the implanted knee, further in vivo analysis is necessary.&#xD;
      This pilot study will analyze 5 subjects with the Attune PS FB 3 months post-operatively&#xD;
      using the University of Tennessee's mobile fluoroscopy unit while performing three daily&#xD;
      activities, level walking, ramp down and deep knee bend. Since this is a pilot study, there&#xD;
      is no hypothesis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">August 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Femoro-tibial Kinematics - Translation and Lift-off for Deep Knee Bend</measure>
    <time_frame>3 months post-operative</time_frame>
    <description>Amount of translation and lift-off for implanted knee in vivo under fluoroscopic surveillance during deep knee bend activity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Femoro-tibial Kinematics: Translation and Lift-off for Gait</measure>
    <time_frame>3 months post-operative</time_frame>
    <description>Amount of translation and lift-off for implanted knee in vivo under fluoroscopic surveillance during gait activity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Femoro-tibial Kinematics: Translation and Lift-off for Ramp Down</measure>
    <time_frame>3 months post-operative</time_frame>
    <description>Amount of translation and lift-off for implanted knee in vivo under fluoroscopic surveillance during ramp down activity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Femoro-tibial Kinematics - Deep Knee Bend</measure>
    <time_frame>3 months post-operative</time_frame>
    <description>Degree of axial rotation and weight-bearing range-of-motion for implanted knee in vivo under fluoroscopic surveillance during deep knee bend activity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Femoro-tibial Kinematics - Gait</measure>
    <time_frame>3 months post-operative</time_frame>
    <description>Degree of axial rotation and weight-bearing range-of-motion for implanted knee in vivo under fluoroscopic surveillance during gait activity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Femoro-tibial Kinematics - Ramp Down</measure>
    <time_frame>3 months post-operative</time_frame>
    <description>Degree of axial rotation and maximum weight-bearing range-of-motion for implanted knee in vivo under fluoroscopic surveillance during ramp down activity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Max Ground Reaction Force - Deep Knee Bend</measure>
    <time_frame>3 months post-operative</time_frame>
    <description>Collected simultaneously with fluoroscopy data, ground reaction forces were obtained using a force plate (fixed to the ground) while subject performed activity. Maximum force measured in the vertical direction measured during the described activity, then normalized with respect to participant's body weight. As such, the data are presented as the percentage of the individuals' body weight that was supported on the implanted knee using a force plate (fixed to the ground) and has been termed &quot;maximum reaction force.&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Max Ground Reaction Force - Gait</measure>
    <time_frame>3 months post-operative</time_frame>
    <description>Collected simultaneously with fluoroscopy data, ground reaction forces were obtained using a force plate (fixed to the ground) while subject performed activity. Maximum force measured in the vertical direction measured during the described activity, then normalized with respect to participant's body weight. As such, the data are presented as the percentage of the individuals' body weight that was supported on the implanted knee using a force plate (fixed to the ground) and has been termed &quot;maximum reaction force.&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Max Ground Reaction Force - Ramp Down</measure>
    <time_frame>3 months post-operative</time_frame>
    <description>Collected simultaneously with fluoroscopy data, ground reaction forces were obtained using a force plate (fixed to the ground) while subject performed activity. Maximum force measured in the vertical direction measured during the described activity was normalized with respect to participant's body weight. As such, the data are presented as the percentage of the individuals' body weight that was supported on the implanted knee using a force plate (fixed to the ground) and has been termed &quot;maximum reaction force.&quot;</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">5</enrollment>
  <condition>Total Knee Arthroplasty</condition>
  <condition>Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>DePuy Attune PS FB TKA</arm_group_label>
    <description>Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>DePuy Attune posterior stabilizing fixed bearing knee system</intervention_name>
    <arm_group_label>DePuy Attune PS FB TKA</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients will have been implanted with the DePuy Attune PS FB knee system by Dr. Thomas&#xD;
        Fehring of OrthoCarolina, PA in Charlotte, NC.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least three (3) months post-operative with no other surgical procedures conducted&#xD;
             within the past six months&#xD;
&#xD;
          -  Between 30-80 years of age&#xD;
&#xD;
          -  Body weight of less than 280 lbs&#xD;
&#xD;
          -  Must be between 160cm (5'3) and 193cm (6'4) tall&#xD;
&#xD;
          -  Body Mass Index (BMI) &gt;18.5 and &lt;35&#xD;
&#xD;
          -  Judged clinically successful with a Knee Society score (KSS) of greater than 80&#xD;
&#xD;
          -  Have good-to-excellent post-operative passive flexion with no ligamentous laxity or&#xD;
             pain&#xD;
&#xD;
          -  Must be able to walk on level ground without aid of any kind, perform a ramp descent,&#xD;
             and a deep knee bend (DKB), all without assistance&#xD;
&#xD;
          -  Will have a DePuy Attune PS TKA&#xD;
&#xD;
          -  Must be willing to sign the Informed Consent (IC) and HIPAA forms to participate in&#xD;
             the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Pregnant or potentially pregnant females will be excluded from the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Adrija Sharma, Ph. D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Tennessee</affiliation>
  </overall_official>
  <overall_official>
    <last_name>William R Hamel, Ph. D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Tennessee</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>OrthoCarolina Research Institute</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Tennessee</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37996</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>July 28, 2014</study_first_submitted>
  <study_first_submitted_qc>July 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <results_first_submitted>August 13, 2015</results_first_submitted>
  <results_first_submitted_qc>January 5, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">February 4, 2016</results_first_posted>
  <last_update_submitted>October 8, 2019</last_update_submitted>
  <last_update_submitted_qc>October 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Tennessee, Knoxville</investigator_affiliation>
    <investigator_full_name>Richard Komistek</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>DePuy Attune PS FB TKA</title>
          <description>Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative.&#xD;
DePuy Attune posterior stabilizing fixed bearing knee system</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>DePuy Attune PS FB TKA</title>
          <description>Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative.&#xD;
DePuy Attune posterior stabilizing fixed bearing knee system</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="5"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="66.2" spread="8.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Femoro-tibial Kinematics - Translation and Lift-off for Deep Knee Bend</title>
        <description>Amount of translation and lift-off for implanted knee in vivo under fluoroscopic surveillance during deep knee bend activity.</description>
        <time_frame>3 months post-operative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>DePuy Attune PS FB TKA</title>
            <description>Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative.&#xD;
DePuy Attune posterior stabilizing fixed bearing knee system</description>
          </group>
        </group_list>
        <measure>
          <title>Femoro-tibial Kinematics - Translation and Lift-off for Deep Knee Bend</title>
          <description>Amount of translation and lift-off for implanted knee in vivo under fluoroscopic surveillance during deep knee bend activity.</description>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Lateral Anterior Posterior Deep Knee Bend</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.89" spread="3.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Medial Anterior Posterior Deep Knee Bend</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.58" spread="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Femoro-tibial Kinematics: Translation and Lift-off for Gait</title>
        <description>Amount of translation and lift-off for implanted knee in vivo under fluoroscopic surveillance during gait activity.</description>
        <time_frame>3 months post-operative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>DePuy Attune PS FB TKA</title>
            <description>Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative.&#xD;
DePuy Attune posterior stabilizing fixed bearing knee system</description>
          </group>
        </group_list>
        <measure>
          <title>Femoro-tibial Kinematics: Translation and Lift-off for Gait</title>
          <description>Amount of translation and lift-off for implanted knee in vivo under fluoroscopic surveillance during gait activity.</description>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Lateral Anterior Posterior Gait</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.8" spread="1.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Medial Anterior Posterior Gait</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.24" spread="0.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Femoro-tibial Kinematics: Translation and Lift-off for Ramp Down</title>
        <description>Amount of translation and lift-off for implanted knee in vivo under fluoroscopic surveillance during ramp down activity.</description>
        <time_frame>3 months post-operative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>DePuy Attune PS FB TKA</title>
            <description>Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative.&#xD;
DePuy Attune posterior stabilizing fixed bearing knee system</description>
          </group>
        </group_list>
        <measure>
          <title>Femoro-tibial Kinematics: Translation and Lift-off for Ramp Down</title>
          <description>Amount of translation and lift-off for implanted knee in vivo under fluoroscopic surveillance during ramp down activity.</description>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Lateral Anterior Posterior Ramp Down</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.35" spread="2.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Medial Anterior Posterior Ramp Down</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.58" spread="1.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Max Ground Reaction Force - Deep Knee Bend</title>
        <description>Collected simultaneously with fluoroscopy data, ground reaction forces were obtained using a force plate (fixed to the ground) while subject performed activity. Maximum force measured in the vertical direction measured during the described activity, then normalized with respect to participant's body weight. As such, the data are presented as the percentage of the individuals' body weight that was supported on the implanted knee using a force plate (fixed to the ground) and has been termed &quot;maximum reaction force.&quot;</description>
        <time_frame>3 months post-operative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>DePuy Attune PS FB TKA</title>
            <description>Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative.&#xD;
DePuy Attune posterior stabilizing fixed bearing knee system</description>
          </group>
        </group_list>
        <measure>
          <title>Max Ground Reaction Force - Deep Knee Bend</title>
          <description>Collected simultaneously with fluoroscopy data, ground reaction forces were obtained using a force plate (fixed to the ground) while subject performed activity. Maximum force measured in the vertical direction measured during the described activity, then normalized with respect to participant's body weight. As such, the data are presented as the percentage of the individuals' body weight that was supported on the implanted knee using a force plate (fixed to the ground) and has been termed &quot;maximum reaction force.&quot;</description>
          <units>percentage of body weight</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.3" spread="11.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Max Ground Reaction Force - Gait</title>
        <description>Collected simultaneously with fluoroscopy data, ground reaction forces were obtained using a force plate (fixed to the ground) while subject performed activity. Maximum force measured in the vertical direction measured during the described activity, then normalized with respect to participant's body weight. As such, the data are presented as the percentage of the individuals' body weight that was supported on the implanted knee using a force plate (fixed to the ground) and has been termed &quot;maximum reaction force.&quot;</description>
        <time_frame>3 months post-operative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>DePuy Attune PS FB TKA</title>
            <description>Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative.&#xD;
DePuy Attune posterior stabilizing fixed bearing knee system</description>
          </group>
        </group_list>
        <measure>
          <title>Max Ground Reaction Force - Gait</title>
          <description>Collected simultaneously with fluoroscopy data, ground reaction forces were obtained using a force plate (fixed to the ground) while subject performed activity. Maximum force measured in the vertical direction measured during the described activity, then normalized with respect to participant's body weight. As such, the data are presented as the percentage of the individuals' body weight that was supported on the implanted knee using a force plate (fixed to the ground) and has been termed &quot;maximum reaction force.&quot;</description>
          <units>percentage of body weight</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="106.0" spread="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Max Ground Reaction Force - Ramp Down</title>
        <description>Collected simultaneously with fluoroscopy data, ground reaction forces were obtained using a force plate (fixed to the ground) while subject performed activity. Maximum force measured in the vertical direction measured during the described activity was normalized with respect to participant's body weight. As such, the data are presented as the percentage of the individuals' body weight that was supported on the implanted knee using a force plate (fixed to the ground) and has been termed &quot;maximum reaction force.&quot;</description>
        <time_frame>3 months post-operative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>DePuy Attune PS FB TKA</title>
            <description>Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative.&#xD;
DePuy Attune posterior stabilizing fixed bearing knee system</description>
          </group>
        </group_list>
        <measure>
          <title>Max Ground Reaction Force - Ramp Down</title>
          <description>Collected simultaneously with fluoroscopy data, ground reaction forces were obtained using a force plate (fixed to the ground) while subject performed activity. Maximum force measured in the vertical direction measured during the described activity was normalized with respect to participant's body weight. As such, the data are presented as the percentage of the individuals' body weight that was supported on the implanted knee using a force plate (fixed to the ground) and has been termed &quot;maximum reaction force.&quot;</description>
          <units>percentage of body weight</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.2" spread="15.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Femoro-tibial Kinematics - Deep Knee Bend</title>
        <description>Degree of axial rotation and weight-bearing range-of-motion for implanted knee in vivo under fluoroscopic surveillance during deep knee bend activity.</description>
        <time_frame>3 months post-operative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>DePuy Attune PS FB TKA</title>
            <description>Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative.&#xD;
DePuy Attune posterior stabilizing fixed bearing knee system</description>
          </group>
        </group_list>
        <measure>
          <title>Femoro-tibial Kinematics - Deep Knee Bend</title>
          <description>Degree of axial rotation and weight-bearing range-of-motion for implanted knee in vivo under fluoroscopic surveillance during deep knee bend activity.</description>
          <units>degrees</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Axial Rotation Deep Knee Bend</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.99" spread="5.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Max weight-bearing flexion Deep knee bend</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="118.2" spread="20.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Femoro-tibial Kinematics - Gait</title>
        <description>Degree of axial rotation and weight-bearing range-of-motion for implanted knee in vivo under fluoroscopic surveillance during gait activity.</description>
        <time_frame>3 months post-operative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>DePuy Attune PS FB TKA</title>
            <description>Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative.&#xD;
DePuy Attune posterior stabilizing fixed bearing knee system</description>
          </group>
        </group_list>
        <measure>
          <title>Femoro-tibial Kinematics - Gait</title>
          <description>Degree of axial rotation and weight-bearing range-of-motion for implanted knee in vivo under fluoroscopic surveillance during gait activity.</description>
          <units>degrees</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Axial Rotation Gait</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.28" spread="2.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Max Weight-bearing flexion Gait</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.4" spread="4.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Femoro-tibial Kinematics - Ramp Down</title>
        <description>Degree of axial rotation and maximum weight-bearing range-of-motion for implanted knee in vivo under fluoroscopic surveillance during ramp down activity.</description>
        <time_frame>3 months post-operative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>DePuy Attune PS FB TKA</title>
            <description>Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative.&#xD;
DePuy Attune posterior stabilizing fixed bearing knee system</description>
          </group>
        </group_list>
        <measure>
          <title>Femoro-tibial Kinematics - Ramp Down</title>
          <description>Degree of axial rotation and maximum weight-bearing range-of-motion for implanted knee in vivo under fluoroscopic surveillance during ramp down activity.</description>
          <units>degrees</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Axial Rotation Ramp Down</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.97" spread="4.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Max Weight-bearing flexion Ramp Down</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.6" spread="5.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>DePuy Attune PS FB TKA</title>
          <description>Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative.&#xD;
DePuy Attune posterior stabilizing fixed bearing knee system</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Adrija Sharma, Ph. D.</name_or_title>
      <organization>The University of Tennessee</organization>
      <phone>8659742093</phone>
      <email>asharma1@utk.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02204748
org study id: 13002
secondary id: R011373503
nct id: NCT02204748
lead sponsor: 
collaborator: 
has dmc: No
A better understanding of knee joint kinematics is important to explain the premature
      polyethylene wear failures within total knee arthroplasties (TKAs) and to help design a
      prosthesis that most closely approximates the normal knee. Specifically, posterior
      stabilizing (PS) knees have been found to be associated with lower amounts of posterior
      femoral rollback, higher occurrence of reverse axial rotation and increased amount of
      condylar lift-off. The DePuy Synthes Joint Reconstruction's Attune PS fixed bearing (FB) knee
      system has incorporated subtle changes in its design to address restoration of kinematics
      that more closely resemble those of a normal knee. To understand if this design is able to
      effectively restore kinematics in the implanted knee, further in vivo analysis is necessary.
      This pilot study will analyze 5 subjects with the Attune PS FB 3 months post-operatively
      using the University of Tennessee's mobile fluoroscopy unit while performing three daily
      activities, level walking, ramp down and deep knee bend. Since this is a pilot study, there
      is no hypothesis.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Femoro-tibial Kinematics - Translation and Lift-off for Deep Knee Bend
time frame: 3 months post-operative
description: Amount of translation and lift-off for implanted knee in vivo under fluoroscopic surveillance during deep knee bend activity.
measure: Femoro-tibial Kinematics: Translation and Lift-off for Gait
time frame: 3 months post-operative
description: Amount of translation and lift-off for implanted knee in vivo under fluoroscopic surveillance during gait activity.
measure: Femoro-tibial Kinematics: Translation and Lift-off for Ramp Down
time frame: 3 months post-operative
description: Amount of translation and lift-off for implanted knee in vivo under fluoroscopic surveillance during ramp down activity.
measure: Femoro-tibial Kinematics - Deep Knee Bend
time frame: 3 months post-operative
description: Degree of axial rotation and weight-bearing range-of-motion for implanted knee in vivo under fluoroscopic surveillance during deep knee bend activity.
measure: Femoro-tibial Kinematics - Gait
time frame: 3 months post-operative
description: Degree of axial rotation and weight-bearing range-of-motion for implanted knee in vivo under fluoroscopic surveillance during gait activity.
measure: Femoro-tibial Kinematics - Ramp Down
time frame: 3 months post-operative
description: Degree of axial rotation and maximum weight-bearing range-of-motion for implanted knee in vivo under fluoroscopic surveillance during ramp down activity.
measure: Max Ground Reaction Force - Deep Knee Bend
time frame: 3 months post-operative
description: Collected simultaneously with fluoroscopy data, ground reaction forces were obtained using a force plate (fixed to the ground) while subject performed activity. Maximum force measured in the vertical direction measured during the described activity, then normalized with respect to participant's body weight. As such, the data are presented as the percentage of the individuals' body weight that was supported on the implanted knee using a force plate (fixed to the ground) and has been termed "maximum reaction force."
measure: Max Ground Reaction Force - Gait
time frame: 3 months post-operative
description: Collected simultaneously with fluoroscopy data, ground reaction forces were obtained using a force plate (fixed to the ground) while subject performed activity. Maximum force measured in the vertical direction measured during the described activity, then normalized with respect to participant's body weight. As such, the data are presented as the percentage of the individuals' body weight that was supported on the implanted knee using a force plate (fixed to the ground) and has been termed "maximum reaction force."
measure: Max Ground Reaction Force - Ramp Down
time frame: 3 months post-operative
description: Collected simultaneously with fluoroscopy data, ground reaction forces were obtained using a force plate (fixed to the ground) while subject performed activity. Maximum force measured in the vertical direction measured during the described activity was normalized with respect to participant's body weight. As such, the data are presented as the percentage of the individuals' body weight that was supported on the implanted knee using a force plate (fixed to the ground) and has been termed "maximum reaction force."
arm group label: DePuy Attune PS FB TKA
description: Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative.
intervention type: Device
intervention name: DePuy Attune posterior stabilizing fixed bearing knee system
arm group label: DePuy Attune PS FB TKA
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 30 Years
maximum age: 80 Years
healthy volunteers: No
last name: Adrija Sharma, Ph. D.
role: Principal Investigator
affiliation: University of Tennessee
last name: William R Hamel, Ph. D.
role: Principal Investigator
affiliation: University of Tennessee
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: The University of Tennessee, Knoxville
investigator full name: Richard Komistek
investigator title: Principal Investigator
mesh term: Osteoarthritis
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 