<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/NCT01717001</url>
  </required_header>
  <id_info>
    <org_study_id>Komistek 1</org_study_id>
    <nct_id>NCT01717001</nct_id>
  </id_info>
  <brief_title>Comparison of Knee Kinematics for Subjects Implanted With Either a ConforMIS or Traditional Knee Implant</brief_title>
  <official_title>In Vivo Determination &amp; Comparison of Knee Kinematics for Subjects Implanted With Either a Personalized ConforMIS or Traditional Knee Implant</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ConforMIS, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ConforMIS, Inc.</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. Previously, most experimental&#xD;
      studies of knee kinematics have involved cadaveric, in vitro analyses, or have not tested the&#xD;
      knee in a weight-bearing mode. Others have used exoskeletal linkages and skin markers that&#xD;
      permit error due to undesired motions between markers and the underlying bone. More recently,&#xD;
      fluoroscopy has been used to assess in vivo kinematics for subjects having a TKA.&#xD;
&#xD;
      ConforMIS has attempted to follow a clearly different path than the major orthopaedic&#xD;
      companies. They have chosen to offer patients a personalized knee implant based off of each&#xD;
      patient's femoral and tibial bone geometry. The hypothesis is that these subjects will&#xD;
      experience a more normal-like kinematic pattern, eliminating paradoxical anterior sliding&#xD;
      during weight-bearing knee flexion. Therefore, the objective for this study is to analyze the&#xD;
      in vivo kinematics for 25 patients implanted with a personalized ConforMIS TKA and 25&#xD;
      patients implanted with a traditional TKA design to determine if there are any kinematic&#xD;
      differences between these TKA designs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Each subject will be asked to perform five activities in one continuous sequence: (1) stand&#xD;
      up from a chair, (2) walk up stairs, (3) walk down stairs, (4) level walking, and (5) a deep&#xD;
      knee bend. Subjects will be video recorded from the waist down while performing the&#xD;
      activities. The speed level of each trial will be based on the comfort level of the patient.&#xD;
      The fluoroscopic images will be stored digitally for subsequent analysis on secure servers&#xD;
      and workstations at the University of Tennessee.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2012</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">August 2014</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Post-operative Range of Motion</measure>
    <time_frame>at least 6 months post-surgery</time_frame>
    <description>Comparison of amount of flexion achieved by the knee between the two arms</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">66</enrollment>
  <condition>Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>ConforMIS</arm_group_label>
    <description>Patients with ConforMIS implants</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Total Knee Implant</arm_group_label>
    <description>Patients implanted with standard total knee implant</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who are at least 6 month post-op with a ConforMIS knee replacement or a standard&#xD;
        total knee replacement who meets the inclusion/exclusion criteria&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least 6 months post-op with no other surgical procedures conducted within the past&#xD;
             6 months&#xD;
&#xD;
          -  Between 40-70 years of age&#xD;
&#xD;
          -  Body weight of less than 250lbs&#xD;
&#xD;
          -  BMI of less than 38&#xD;
&#xD;
          -  Pregnant females will be excluded&#xD;
&#xD;
          -  TKA patients will be judged Clinically successful with an American Knee Society score&#xD;
             of greater than 90&#xD;
&#xD;
          -  Must have 100 degrees post-op passive flexion with no ligamentous laxity or pain&#xD;
&#xD;
          -  Participants must be able to walk on level ground without aid of any kind and&#xD;
             ascend/descend stairs without assistance.&#xD;
&#xD;
          -  All potential subjects will have either a personalized ConforMIS™ TKA or a traditional&#xD;
             TKA manufactured by an orthopaedic company other than ConforMIS.&#xD;
&#xD;
          -  Patients from the physician's list who do not meet the study requirements will not be&#xD;
             considered.&#xD;
&#xD;
          -  Patients must be willing to sign the Informed Consent and HIPAA forms to participate&#xD;
             in the study.&#xD;
&#xD;
          -  Patients must be between 160cm (5'3) and 193cm (6'4) tall.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard D Komistek, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Univeristy of Tennessee</affiliation>
  </overall_official>
  <overall_official>
    <last_name>William Kurtz, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tennessee Orthopedic Alliance</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Tennessee</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37996</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tennessee Orthopedic Alliance</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>October 26, 2012</study_first_submitted>
  <study_first_submitted_qc>October 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <results_first_submitted>December 2, 2020</results_first_submitted>
  <results_first_submitted_qc>December 30, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">December 31, 2020</results_first_posted>
  <last_update_submitted>December 30, 2020</last_update_submitted>
  <last_update_submitted_qc>December 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 31, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>kinematics</keyword>
  <keyword>knee joint</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>ConforMIS</title>
          <description>Patients with ConforMIS implants</description>
        </group>
        <group group_id="P2">
          <title>Standard Total Knee Implant</title>
          <description>Patients implanted with standard total knee implant</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="38"/>
                <participants group_id="P2" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Subjects who were implanted with either a first generation iTotal CR (Conformis arm) or PS (Standard Total Knee Implant arm) were not included in analysis.</population>
      <group_list>
        <group group_id="B1">
          <title>ConforMIS</title>
          <description>Patients with ConforMIS implants</description>
        </group>
        <group group_id="B2">
          <title>Standard Total Knee Implant</title>
          <description>Patients implanted with standard total knee implant</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="24"/>
            <count group_id="B2" value="14"/>
            <count group_id="B3" value="38"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="24"/>
                    <count group_id="B2" value="14"/>
                    <count group_id="B3" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60.2" spread="7.7"/>
                    <measurement group_id="B2" value="66.7" spread="5.7"/>
                    <measurement group_id="B3" value="62.6" spread="7.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <description>Data not accessible and not used for analysis</description>
          <population>Data not accessible and not used for analysis</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Female</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="24"/>
                    <count group_id="B2" value="14"/>
                    <count group_id="B3" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Post-operative Range of Motion</title>
        <description>Comparison of amount of flexion achieved by the knee between the two arms</description>
        <time_frame>at least 6 months post-surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ConforMIS</title>
            <description>Patients with ConforMIS implants</description>
          </group>
          <group group_id="O2">
            <title>Standard Total Knee Implant</title>
            <description>Patients implanted with standard total knee implant</description>
          </group>
        </group_list>
        <measure>
          <title>Post-operative Range of Motion</title>
          <description>Comparison of amount of flexion achieved by the knee between the two arms</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="24"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="103.8" spread="14.7"/>
                    <measurement group_id="O2" value="95.8" spread="21.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>ConforMIS</title>
          <description>Patients with ConforMIS implants</description>
        </group>
        <group group_id="E2">
          <title>Standard Total Knee Implant</title>
          <description>Patients implanted with standard total knee implant</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="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </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="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>Rebecca Robertson</name_or_title>
      <organization>University of Tennessee</organization>
      <phone>865-974-2093</phone>
      <email>rrober28@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/NCT01717001
org study id: Komistek 1
nct id: NCT01717001
lead sponsor: 
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. Previously, most experimental
      studies of knee kinematics have involved cadaveric, in vitro analyses, or have not tested the
      knee in a weight-bearing mode. Others have used exoskeletal linkages and skin markers that
      permit error due to undesired motions between markers and the underlying bone. More recently,
      fluoroscopy has been used to assess in vivo kinematics for subjects having a TKA.

      ConforMIS has attempted to follow a clearly different path than the major orthopaedic
      companies. They have chosen to offer patients a personalized knee implant based off of each
      patient's femoral and tibial bone geometry. The hypothesis is that these subjects will
      experience a more normal-like kinematic pattern, eliminating paradoxical anterior sliding
      during weight-bearing knee flexion. Therefore, the objective for this study is to analyze the
      in vivo kinematics for 25 patients implanted with a personalized ConforMIS TKA and 25
      patients implanted with a traditional TKA design to determine if there are any kinematic
      differences between these TKA designs.
Each subject will be asked to perform five activities in one continuous sequence: (1) stand
      up from a chair, (2) walk up stairs, (3) walk down stairs, (4) level walking, and (5) a deep
      knee bend. Subjects will be video recorded from the waist down while performing the
      activities. The speed level of each trial will be based on the comfort level of the patient.
      The fluoroscopic images will be stored digitally for subsequent analysis on secure servers
      and workstations at the University of Tennessee.
observational model: Case-Control
time perspective: Prospective
measure: Post-operative Range of Motion
time frame: at least 6 months post-surgery
description: Comparison of amount of flexion achieved by the knee between the two arms
arm group label: ConforMIS
description: Patients with ConforMIS implants
arm group label: Standard Total Knee Implant
description: Patients implanted with standard total knee implant
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: No
last name: Richard D Komistek, PhD
role: Principal Investigator
affiliation: Univeristy of Tennessee
last name: William Kurtz, MD
role: Principal Investigator
affiliation: Tennessee Orthopedic Alliance
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Osteoarthritis
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 