<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/NCT03227692</url>
  </required_header>
  <id_info>
    <org_study_id>K.CR.I.AP.16.39</org_study_id>
    <nct_id>NCT03227692</nct_id>
  </id_info>
  <brief_title>Persona TKA With iASSIST Knee System and iASSIST Knee System</brief_title>
  <official_title>Randomized Controlled Study Comparing iASSIST Knee System Versus Conventional Instrumentation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zimmer Biomet</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zimmer Biomet</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the accuracy of knee component alignment between&#xD;
      patients operated with iASSIST Knee (Investigational group) versus patients operated without&#xD;
      iASSIST Knee (Control group) using the same implant system.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective： To compare the accuracy of knee component alignment between patients operated with&#xD;
      iASSIST Knee (Investigational group) versus patients operated without iASSIST Knee (Control&#xD;
      group) using the same implant system.&#xD;
&#xD;
      Endpoint： Primary： The alignment accuracy of the knee femoral and tibial components at 6&#xD;
      months for the investigational group compared to the control group.&#xD;
&#xD;
      Secondary：Health Status after TKA, Operating Room efficiency and Complication rate after TKA&#xD;
      for the investigational group compared to the control group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 18, 2017</start_date>
  <completion_date type="Actual">December 2, 2019</completion_date>
  <primary_completion_date type="Actual">November 14, 2019</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>
    <intervention_model_description>At surgery, intervention group using iASSIST Knee system. At surgery, conventional group not using iASSIST Knee system.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Persona TKA with iASSIST Knee system (Investigational group) or Persona TKA with conventional instrumentation (Control group). The randomization scheme is based on equal numbers per group. The randomization will occur via a random number generator (computer) using blocked randomization procedure. The PI or his/her team does not have influence on the randomization scheme. Sealed opaque envelopes, which will be prepared based on predetermined randomization assignment, will be provided to each study site before study initiation.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Alignment Accuracy of the Knee Femoral Components in Coronal Plain</measure>
    <time_frame>Postoperative 6 months</time_frame>
    <description>Ratio of subject, whose knee implant is positioned within 3 degrees from perpendicular to mechanical axis of lower extremity, is compared between groups by CT data taken at 6 month after surgery.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Alignment Accuracy of the Knee Femoral Components in Sagittal Plain</measure>
    <time_frame>Postoperative 6 months</time_frame>
    <description>Ratio of subject, whose knee implant is positioned within 3 degrees from perpendicular to mechanical axis of lower extremity, is compared between groups by CT data taken at 6 month after surgery.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Alignment Accuracy of the Knee Tibial Components in Coronal Plain</measure>
    <time_frame>Postoperative 6 months</time_frame>
    <description>Ratio of subject, whose knee implant is positioned within 3 degrees from perpendicular to mechanical axis of lower extremity, is compared between groups by CT data taken at 6 month after surgery.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Alignment Accuracy of the Knee Tibial Components in Sagittal Plain</measure>
    <time_frame>Postoperative 6 months</time_frame>
    <description>Ratio of subject, whose knee implant is positioned within 3 degrees from preoperatively determined target angle, is compared between groups by CT data taken at 6 month after surgery.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Surgery Time</measure>
    <time_frame>Intraoperative, an average of 2 hours</time_frame>
    <description>Surgery time from skin incision to closure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Instrument Trays Used</measure>
    <time_frame>Intraoperative</time_frame>
    <description>Number of instrument trays used instraoperatively. This number includes number of Total Knee Arthroplasty specific instrument tray, does not include other general surgical instruments/kits.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>KSS - Objective Score at 6 Month Postoperatively</measure>
    <time_frame>6 month postoperative</time_frame>
    <description>KSS-Objective score is physician-derived component and allows for more than 100 points in patients with greater than 125° of flexion and a stable painless knee as outlined below. Lowest possible score is 0.&#xD;
Higher score means better outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>KSS-Patient Satisfaction at 6 Month Postoperatively</measure>
    <time_frame>6 month postoperative</time_frame>
    <description>KSS-Patient Satisfaction is patient-derived score and is a five-question 40-point scale that is collected preoperatively and at each follow-up visit. Lowest possible score is 0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>KSS-function Score at 6 Month Postoperatively</measure>
    <time_frame>6 month postoperative</time_frame>
    <description>KSS-function score is patient-derived score and composed of four subgroups and has a maximum score of 100.&#xD;
&quot;Walking and Standing&quot; has a maximum value of 30 points, &quot;Standard Activities&quot; has a maximum of 30 points, &quot;Advanced Activities&quot; has a maximum of 25 points and &quot;Discretionary Activities&quot; has a maximum of 15 points.&#xD;
Lowest possible score is 0. Higher score means better outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>KSS-Patient Expectations at 6 Month Postoperatively</measure>
    <time_frame>6 month postoperative</time_frame>
    <description>KSS-Patient Expectations is patient-derived score and is a three-question fifteen-point scale that is collected pre-operatively and post-operatively. The pre-operative questions reflect the patient's opinion on the extent to which the patient expects that operation will improve knee pain, and ability to perform activities of daily living and recreational activities. The post-operative questions reflect the extent to which postoperative outcome has met the patient's pre-operative expectations with respect to pain and function.&#xD;
The score ranges from 3 to 15. Higher score means better outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxford Knee Score at 6 Month Postoperatively</measure>
    <time_frame>6 month postoperative</time_frame>
    <description>Patient Reported Outcome specific for knee disease. Score range from 0 to 48. Higher score means better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ-5D-3L at 6 Month Postoperatively</measure>
    <time_frame>6 month postoperative</time_frame>
    <description>EQ-5D is patient reported outcome measure to score patient's health related quality of life with minimum score of -0.111 and maximum score of 1.000.&#xD;
Higher score means better outcomes.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">93</enrollment>
  <condition>Osteoarthritis, Knee</condition>
  <arm_group>
    <arm_group_label>Persona with iASSIST Knee</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Having total knee arthroplasty (Persona Knee System) surgery with the use of a navigation system iASSIST Knee.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Persona without iASSIST Knee</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Having total knee arthroplasty surgery (Persona Knee System) with the use of conventional surgical instruments, and without a navigation system iASSIST Knee.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Persona Knee System</intervention_name>
    <description>Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.</description>
    <arm_group_label>Persona with iASSIST Knee</arm_group_label>
    <arm_group_label>Persona without iASSIST Knee</arm_group_label>
    <other_name>Persona Knee</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Total Knee Arthroplasty</intervention_name>
    <description>Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.</description>
    <arm_group_label>Persona with iASSIST Knee</arm_group_label>
    <arm_group_label>Persona without iASSIST Knee</arm_group_label>
    <other_name>TKA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>iAssist Knee</intervention_name>
    <description>Osteotomy of TKA is navigated by iAssist system, iAssist requires pin inserted in bone.</description>
    <arm_group_label>Persona with iASSIST Knee</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        In order to be eligible to participate in this study, a patient must meet all of the&#xD;
        following criteria.&#xD;
&#xD;
          -  Knee (either unilateral or bilateral) osteoarthritis (varus deformity only)&#xD;
&#xD;
          -  Male or female&#xD;
&#xD;
          -  At least 20 years of age&#xD;
&#xD;
          -  Patients willing to return for follow-up evaluations.&#xD;
&#xD;
        Study Specific Requirements for Principal Investigator/Site&#xD;
&#xD;
          -  Principal Investigator (PI) must have experience of at least 5 TKAs of iASSIST Knee&#xD;
             with Persona and Persona conventional instrument system before any study specific&#xD;
             activities.&#xD;
&#xD;
          -  Site has sufficient resources to take limb CT scanning at 6 months follow-up visit.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Absolute contraindications include:&#xD;
&#xD;
          -  Knee degenerative diseases other than knee osteoarthritis (such as necrosis/rheumatoid&#xD;
             arthritis)&#xD;
&#xD;
          -  Too severe OA deformation (FTA: &gt; 190 degrees/&lt; 175 degrees)&#xD;
&#xD;
          -  Active infection (or within 6 weeks after infection)&#xD;
&#xD;
          -  Sepsis&#xD;
&#xD;
          -  Osteomyelitis&#xD;
&#xD;
          -  Any type of implant is inserted in the affected side of lower extremity&#xD;
&#xD;
          -  Hip and/or foot disease on the affected side&#xD;
&#xD;
        Additional contraindications include:&#xD;
&#xD;
          -  Uncooperative patient or patient with neurologic disorders who are incapable of&#xD;
             following directions&#xD;
&#xD;
          -  Diagnosed osteoporosis or osteomalacia&#xD;
&#xD;
          -  Metabolic disorders which may impair bone formation&#xD;
&#xD;
          -  Distant foci of infections which may spread to the implant site&#xD;
&#xD;
          -  Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram&#xD;
&#xD;
          -  Vascular insufficiency, muscular atrophy or neuromuscular disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Toshihiro Ohdera, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fukuoka Orthopaedic Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sumitomo Hopital</name>
      <address>
        <city>Ōsaka</city>
        <state>Osaka</state>
        <zip>530-0005</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Japanese Red Cross Medical Center</name>
      <address>
        <city>Shibuya</city>
        <state>Tokyo</state>
        <zip>150-8935</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yamaguchi Prefectural Grand Medical Center</name>
      <address>
        <city>Hōfu</city>
        <state>Yamaguchi</state>
        <zip>747-8511</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>July 20, 2017</study_first_submitted>
  <study_first_submitted_qc>July 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <results_first_submitted>March 5, 2020</results_first_submitted>
  <results_first_submitted_qc>March 5, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">March 19, 2020</results_first_posted>
  <last_update_submitted>June 16, 2020</last_update_submitted>
  <last_update_submitted_qc>June 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2020</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, Knee</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 27, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/92/NCT03227692/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Persona With iASSIST Knee</title>
          <description>Having total knee arthroplasty (Persona Knee System) surgery with the use of a navigation system iASSIST Knee.&#xD;
Persona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.&#xD;
Total Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.&#xD;
iAssist Knee: Osteotomy of TKA is navigated by iAssist system, iAssist requires pin inserted in bone.</description>
        </group>
        <group group_id="P2">
          <title>Persona Without iASSIST Knee</title>
          <description>Having total knee arthroplasty surgery (Persona Knee System) with the use of conventional surgical instruments, and without a navigation system iASSIST Knee.&#xD;
Persona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.&#xD;
Total Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="47"/>
                <participants group_id="P2" count="46"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
                <participants group_id="P2" count="41"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Persona With iASSIST Knee</title>
          <description>Having total knee arthroplasty (Persona Knee System) surgery with the use of a navigation system iASSIST Knee.&#xD;
Persona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.&#xD;
Total Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.&#xD;
iAssist Knee: Osteotomy of TKA is navigated by iAssist system, iAssist requires pin inserted in bone.</description>
        </group>
        <group group_id="B2">
          <title>Persona Without iASSIST Knee</title>
          <description>Having total knee arthroplasty surgery (Persona Knee System) with the use of conventional surgical instruments, and without a navigation system iASSIST Knee.&#xD;
Persona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.&#xD;
Total Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.</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="42"/>
            <count group_id="B2" value="41"/>
            <count group_id="B3" value="83"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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="73.3" spread="9.0"/>
                    <measurement group_id="B2" value="76.1" spread="9.0"/>
                    <measurement group_id="B3" value="74.8" spread="9.0"/>
                  </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="35"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="66"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="83"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <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>Japan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>KSS - Objective Score</title>
          <description>KSS-Objective score is physician-derived component and allows for more than 100 points in patients with greater than 125° of flexion and a stable painless knee as outlined below. Lowest possible score is 0.&#xD;
Higher score means better outcomes.</description>
          <units>score on scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34.8" spread="20.2"/>
                    <measurement group_id="B2" value="36.1" spread="19.8"/>
                    <measurement group_id="B3" value="35.4" spread="19.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>KSS-Patient Satisfaction</title>
          <description>KSS-Patient Satisfaction is patient-derived score and is a five-question 40-point scale that is collected preoperatively and at each follow-up visit. Lowest possible score is 0.&#xD;
Higher score means better outcomes.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12.7" spread="6.3"/>
                    <measurement group_id="B2" value="15.1" spread="6.1"/>
                    <measurement group_id="B3" value="13.9" spread="6.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>KSS-Function Score</title>
          <description>KSS-function score is patient-derived score and composed of four subgroups and has a maximum score of 100.&#xD;
&quot;Walking and Standing&quot; has a maximum value of 30 points, &quot;Standard Activities&quot; has a maximum of 30 points, &quot;Advanced Activities&quot; has a maximum of 25 points and &quot;Discretionary Activities&quot; has a maximum of 15 points.&#xD;
Lowest possible score is 0. Higher score means better outcomes.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38.5" spread="0.2"/>
                    <measurement group_id="B2" value="39.1" spread="17.6"/>
                    <measurement group_id="B3" value="38.8" spread="18.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>KSS-Patient Expectation</title>
          <description>KSS-Patient Expectations is patient-derived score and is a three-question fifteen-point scale that is collected pre-operatively and post-operatively. The pre-operative questions reflect the patient's opinion on the extent to which the patient expects that operation will improve knee pain, and ability to perform activities of daily living and recreational activities. The post-operative questions reflect the extent to which postoperative outcome has met the patient's pre-operative expectations with respect to pain and function.&#xD;
The score ranges from 3 to 15. Higher score means better outcomes.</description>
          <units>score on scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13.1" spread="2.0"/>
                    <measurement group_id="B2" value="12.9" spread="1.7"/>
                    <measurement group_id="B3" value="13.0" spread="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Oxford Knee Score</title>
          <description>Patient Reported Outcome specific for knee disease. Score range from 0 to 48. Higher score means better outcome.</description>
          <units>score on scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22.0" spread="9.1"/>
                    <measurement group_id="B2" value="25.0" spread="8.4"/>
                    <measurement group_id="B3" value="23.5" spread="8.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>EQ-5D-3L</title>
          <description>EQ-5D is patient reported outcome measure to score patient's health related quality of life with minimum score of -0.111 and maximum score of 1.000.&#xD;
Higher score means better outcomes.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.6" spread="0.2"/>
                    <measurement group_id="B2" value="0.6" spread="0.1"/>
                    <measurement group_id="B3" value="0.6" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Alignment Accuracy of the Knee Femoral Components in Coronal Plain</title>
        <description>Ratio of subject, whose knee implant is positioned within 3 degrees from perpendicular to mechanical axis of lower extremity, is compared between groups by CT data taken at 6 month after surgery.</description>
        <time_frame>Postoperative 6 months</time_frame>
        <population>Patients who have CT data at 6 month after surgery were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Persona With iASSIST Knee</title>
            <description>Having total knee arthroplasty (Persona Knee System) surgery with the use of a navigation system iASSIST Knee.&#xD;
Persona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.&#xD;
Total Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.&#xD;
iAssist Knee: Osteotomy of TKA is navigated by iAssist system, iAssist requires pin inserted in bone.</description>
          </group>
          <group group_id="O2">
            <title>Persona Without iASSIST Knee</title>
            <description>Having total knee arthroplasty surgery (Persona Knee System) with the use of conventional surgical instruments, and without a navigation system iASSIST Knee.&#xD;
Persona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.&#xD;
Total Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Alignment Accuracy of the Knee Femoral Components in Coronal Plain</title>
          <description>Ratio of subject, whose knee implant is positioned within 3 degrees from perpendicular to mechanical axis of lower extremity, is compared between groups by CT data taken at 6 month after surgery.</description>
          <population>Patients who have CT data at 6 month after surgery were included in the analysis.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>within 3 degrees</title>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                    <measurement group_id="O2" value="36"/>
                  </measurement_list>
                </category>
                <category>
                  <title>outlier</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Alignment Accuracy of the Knee Femoral Components in Sagittal Plain</title>
        <description>Ratio of subject, whose knee implant is positioned within 3 degrees from perpendicular to mechanical axis of lower extremity, is compared between groups by CT data taken at 6 month after surgery.</description>
        <time_frame>Postoperative 6 months</time_frame>
        <population>Patients who have CT data at 6 month after surgery were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Persona With iASSIST Knee</title>
            <description>Having total knee arthroplasty (Persona Knee System) surgery with the use of a navigation system iASSIST Knee.&#xD;
Persona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.&#xD;
Total Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.&#xD;
iAssist Knee: Osteotomy of TKA is navigated by iAssist system, iAssist requires pin inserted in bone.</description>
          </group>
          <group group_id="O2">
            <title>Persona Without iASSIST Knee</title>
            <description>Having total knee arthroplasty surgery (Persona Knee System) with the use of conventional surgical instruments, and without a navigation system iASSIST Knee.&#xD;
Persona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.&#xD;
Total Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Alignment Accuracy of the Knee Femoral Components in Sagittal Plain</title>
          <description>Ratio of subject, whose knee implant is positioned within 3 degrees from perpendicular to mechanical axis of lower extremity, is compared between groups by CT data taken at 6 month after surgery.</description>
          <population>Patients who have CT data at 6 month after surgery were included in the analysis.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>within 3 degrees</title>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                    <measurement group_id="O2" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>outlier</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Alignment Accuracy of the Knee Tibial Components in Coronal Plain</title>
        <description>Ratio of subject, whose knee implant is positioned within 3 degrees from perpendicular to mechanical axis of lower extremity, is compared between groups by CT data taken at 6 month after surgery.</description>
        <time_frame>Postoperative 6 months</time_frame>
        <population>Patients who have CT data at 6 month after surgery were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Persona With iASSIST Knee</title>
            <description>Having total knee arthroplasty (Persona Knee System) surgery with the use of a navigation system iASSIST Knee.&#xD;
Persona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.&#xD;
Total Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.&#xD;
iAssist Knee: Osteotomy of TKA is navigated by iAssist system, iAssist requires pin inserted in bone.</description>
          </group>
          <group group_id="O2">
            <title>Persona Without iASSIST Knee</title>
            <description>Having total knee arthroplasty surgery (Persona Knee System) with the use of conventional surgical instruments, and without a navigation system iASSIST Knee.&#xD;
Persona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.&#xD;
Total Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Alignment Accuracy of the Knee Tibial Components in Coronal Plain</title>
          <description>Ratio of subject, whose knee implant is positioned within 3 degrees from perpendicular to mechanical axis of lower extremity, is compared between groups by CT data taken at 6 month after surgery.</description>
          <population>Patients who have CT data at 6 month after surgery were included in the analysis.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>within 3 degrees</title>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>outlier</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Alignment Accuracy of the Knee Tibial Components in Sagittal Plain</title>
        <description>Ratio of subject, whose knee implant is positioned within 3 degrees from preoperatively determined target angle, is compared between groups by CT data taken at 6 month after surgery.</description>
        <time_frame>Postoperative 6 months</time_frame>
        <population>Patients who have CT data at 6 month after surgery were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Persona With iASSIST Knee</title>
            <description>Having total knee arthroplasty (Persona Knee System) surgery with the use of a navigation system iASSIST Knee.&#xD;
Persona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.&#xD;
Total Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.&#xD;
iAssist Knee: Osteotomy of TKA is navigated by iAssist system, iAssist requires pin inserted in bone.</description>
          </group>
          <group group_id="O2">
            <title>Persona Without iASSIST Knee</title>
            <description>Having total knee arthroplasty surgery (Persona Knee System) with the use of conventional surgical instruments, and without a navigation system iASSIST Knee.&#xD;
Persona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.&#xD;
Total Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Alignment Accuracy of the Knee Tibial Components in Sagittal Plain</title>
          <description>Ratio of subject, whose knee implant is positioned within 3 degrees from preoperatively determined target angle, is compared between groups by CT data taken at 6 month after surgery.</description>
          <population>Patients who have CT data at 6 month after surgery were included in the analysis.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>within 3 degrees</title>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                    <measurement group_id="O2" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>outlier</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Surgery Time</title>
        <description>Surgery time from skin incision to closure</description>
        <time_frame>Intraoperative, an average of 2 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Persona With iASSIST Knee</title>
            <description>Having total knee arthroplasty (Persona Knee System) surgery with the use of a navigation system iASSIST Knee.&#xD;
Persona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.&#xD;
Total Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.&#xD;
iAssist Knee: Osteotomy of TKA is navigated by iAssist system, iAssist requires pin inserted in bone.</description>
          </group>
          <group group_id="O2">
            <title>Persona Without iASSIST Knee</title>
            <description>Having total knee arthroplasty surgery (Persona Knee System) with the use of conventional surgical instruments, and without a navigation system iASSIST Knee.&#xD;
Persona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.&#xD;
Total Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.</description>
          </group>
        </group_list>
        <measure>
          <title>Surgery Time</title>
          <description>Surgery time from skin incision to closure</description>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="125.1" spread="34.6"/>
                    <measurement group_id="O2" value="114.2" spread="32.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Instrument Trays Used</title>
        <description>Number of instrument trays used instraoperatively. This number includes number of Total Knee Arthroplasty specific instrument tray, does not include other general surgical instruments/kits.</description>
        <time_frame>Intraoperative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Persona With iASSIST Knee</title>
            <description>Having total knee arthroplasty (Persona Knee System) surgery with the use of a navigation system iASSIST Knee.&#xD;
Persona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.&#xD;
Total Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.&#xD;
iAssist Knee: Osteotomy of TKA is navigated by iAssist system, iAssist requires pin inserted in bone.</description>
          </group>
          <group group_id="O2">
            <title>Persona Without iASSIST Knee</title>
            <description>Having total knee arthroplasty surgery (Persona Knee System) with the use of conventional surgical instruments, and without a navigation system iASSIST Knee.&#xD;
Persona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.&#xD;
Total Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Instrument Trays Used</title>
          <description>Number of instrument trays used instraoperatively. This number includes number of Total Knee Arthroplasty specific instrument tray, does not include other general surgical instruments/kits.</description>
          <units>trays</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.2" spread="2.2"/>
                    <measurement group_id="O2" value="4.9" spread="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>KSS - Objective Score at 6 Month Postoperatively</title>
        <description>KSS-Objective score is physician-derived component and allows for more than 100 points in patients with greater than 125° of flexion and a stable painless knee as outlined below. Lowest possible score is 0.&#xD;
Higher score means better outcomes.</description>
        <time_frame>6 month postoperative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Persona With iASSIST Knee</title>
            <description>Having total knee arthroplasty (Persona Knee System) surgery with the use of a navigation system iASSIST Knee.&#xD;
Persona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.&#xD;
Total Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.&#xD;
iAssist Knee: Osteotomy of TKA is navigated by iAssist system, iAssist requires pin inserted in bone.</description>
          </group>
          <group group_id="O2">
            <title>Persona Without iASSIST Knee</title>
            <description>Having total knee arthroplasty surgery (Persona Knee System) with the use of conventional surgical instruments, and without a navigation system iASSIST Knee.&#xD;
Persona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.&#xD;
Total Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.</description>
          </group>
        </group_list>
        <measure>
          <title>KSS - Objective Score at 6 Month Postoperatively</title>
          <description>KSS-Objective score is physician-derived component and allows for more than 100 points in patients with greater than 125° of flexion and a stable painless knee as outlined below. Lowest possible score is 0.&#xD;
Higher score means better outcomes.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80.8" spread="13.9"/>
                    <measurement group_id="O2" value="77.2" spread="17.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>KSS-Patient Satisfaction at 6 Month Postoperatively</title>
        <description>KSS-Patient Satisfaction is patient-derived score and is a five-question 40-point scale that is collected preoperatively and at each follow-up visit. Lowest possible score is 0.</description>
        <time_frame>6 month postoperative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Persona With iASSIST Knee</title>
            <description>Having total knee arthroplasty (Persona Knee System) surgery with the use of a navigation system iASSIST Knee.&#xD;
Persona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.&#xD;
Total Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.&#xD;
iAssist Knee: Osteotomy of TKA is navigated by iAssist system, iAssist requires pin inserted in bone.</description>
          </group>
          <group group_id="O2">
            <title>Persona Without iASSIST Knee</title>
            <description>Having total knee arthroplasty surgery (Persona Knee System) with the use of conventional surgical instruments, and without a navigation system iASSIST Knee.&#xD;
Persona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.&#xD;
Total Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.</description>
          </group>
        </group_list>
        <measure>
          <title>KSS-Patient Satisfaction at 6 Month Postoperatively</title>
          <description>KSS-Patient Satisfaction is patient-derived score and is a five-question 40-point scale that is collected preoperatively and at each follow-up visit. Lowest possible score is 0.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.6" spread="8.2"/>
                    <measurement group_id="O2" value="25.0" spread="8.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>KSS-function Score at 6 Month Postoperatively</title>
        <description>KSS-function score is patient-derived score and composed of four subgroups and has a maximum score of 100.&#xD;
&quot;Walking and Standing&quot; has a maximum value of 30 points, &quot;Standard Activities&quot; has a maximum of 30 points, &quot;Advanced Activities&quot; has a maximum of 25 points and &quot;Discretionary Activities&quot; has a maximum of 15 points.&#xD;
Lowest possible score is 0. Higher score means better outcomes.</description>
        <time_frame>6 month postoperative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Persona With iASSIST Knee</title>
            <description>Having total knee arthroplasty (Persona Knee System) surgery with the use of a navigation system iASSIST Knee.&#xD;
Persona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.&#xD;
Total Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.&#xD;
iAssist Knee: Osteotomy of TKA is navigated by iAssist system, iAssist requires pin inserted in bone.</description>
          </group>
          <group group_id="O2">
            <title>Persona Without iASSIST Knee</title>
            <description>Having total knee arthroplasty surgery (Persona Knee System) with the use of conventional surgical instruments, and without a navigation system iASSIST Knee.&#xD;
Persona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.&#xD;
Total Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.</description>
          </group>
        </group_list>
        <measure>
          <title>KSS-function Score at 6 Month Postoperatively</title>
          <description>KSS-function score is patient-derived score and composed of four subgroups and has a maximum score of 100.&#xD;
&quot;Walking and Standing&quot; has a maximum value of 30 points, &quot;Standard Activities&quot; has a maximum of 30 points, &quot;Advanced Activities&quot; has a maximum of 25 points and &quot;Discretionary Activities&quot; has a maximum of 15 points.&#xD;
Lowest possible score is 0. Higher score means better outcomes.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.6" spread="23.7"/>
                    <measurement group_id="O2" value="61.5" spread="18.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>KSS-Patient Expectations at 6 Month Postoperatively</title>
        <description>KSS-Patient Expectations is patient-derived score and is a three-question fifteen-point scale that is collected pre-operatively and post-operatively. The pre-operative questions reflect the patient's opinion on the extent to which the patient expects that operation will improve knee pain, and ability to perform activities of daily living and recreational activities. The post-operative questions reflect the extent to which postoperative outcome has met the patient's pre-operative expectations with respect to pain and function.&#xD;
The score ranges from 3 to 15. Higher score means better outcomes.</description>
        <time_frame>6 month postoperative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Persona With iASSIST Knee</title>
            <description>Having total knee arthroplasty (Persona Knee System) surgery with the use of a navigation system iASSIST Knee.&#xD;
Persona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.&#xD;
Total Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.&#xD;
iAssist Knee: Osteotomy of TKA is navigated by iAssist system, iAssist requires pin inserted in bone.</description>
          </group>
          <group group_id="O2">
            <title>Persona Without iASSIST Knee</title>
            <description>Having total knee arthroplasty surgery (Persona Knee System) with the use of conventional surgical instruments, and without a navigation system iASSIST Knee.&#xD;
Persona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.&#xD;
Total Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.</description>
          </group>
        </group_list>
        <measure>
          <title>KSS-Patient Expectations at 6 Month Postoperatively</title>
          <description>KSS-Patient Expectations is patient-derived score and is a three-question fifteen-point scale that is collected pre-operatively and post-operatively. The pre-operative questions reflect the patient's opinion on the extent to which the patient expects that operation will improve knee pain, and ability to perform activities of daily living and recreational activities. The post-operative questions reflect the extent to which postoperative outcome has met the patient's pre-operative expectations with respect to pain and function.&#xD;
The score ranges from 3 to 15. Higher score means better outcomes.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.5" spread="3.1"/>
                    <measurement group_id="O2" value="10.1" spread="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Oxford Knee Score at 6 Month Postoperatively</title>
        <description>Patient Reported Outcome specific for knee disease. Score range from 0 to 48. Higher score means better outcome.</description>
        <time_frame>6 month postoperative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Persona With iASSIST Knee</title>
            <description>Having total knee arthroplasty (Persona Knee System) surgery with the use of a navigation system iASSIST Knee.&#xD;
Persona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.&#xD;
Total Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.&#xD;
iAssist Knee: Osteotomy of TKA is navigated by iAssist system, iAssist requires pin inserted in bone.</description>
          </group>
          <group group_id="O2">
            <title>Persona Without iASSIST Knee</title>
            <description>Having total knee arthroplasty surgery (Persona Knee System) with the use of conventional surgical instruments, and without a navigation system iASSIST Knee.&#xD;
Persona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.&#xD;
Total Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.</description>
          </group>
        </group_list>
        <measure>
          <title>Oxford Knee Score at 6 Month Postoperatively</title>
          <description>Patient Reported Outcome specific for knee disease. Score range from 0 to 48. Higher score means better outcome.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.2" spread="9.2"/>
                    <measurement group_id="O2" value="37.7" spread="6.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>EQ-5D-3L at 6 Month Postoperatively</title>
        <description>EQ-5D is patient reported outcome measure to score patient's health related quality of life with minimum score of -0.111 and maximum score of 1.000.&#xD;
Higher score means better outcomes.</description>
        <time_frame>6 month postoperative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Persona With iASSIST Knee</title>
            <description>Having total knee arthroplasty (Persona Knee System) surgery with the use of a navigation system iASSIST Knee.&#xD;
Persona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.&#xD;
Total Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.&#xD;
iAssist Knee: Osteotomy of TKA is navigated by iAssist system, iAssist requires pin inserted in bone.</description>
          </group>
          <group group_id="O2">
            <title>Persona Without iASSIST Knee</title>
            <description>Having total knee arthroplasty surgery (Persona Knee System) with the use of conventional surgical instruments, and without a navigation system iASSIST Knee.&#xD;
Persona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.&#xD;
Total Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.</description>
          </group>
        </group_list>
        <measure>
          <title>EQ-5D-3L at 6 Month Postoperatively</title>
          <description>EQ-5D is patient reported outcome measure to score patient's health related quality of life with minimum score of -0.111 and maximum score of 1.000.&#xD;
Higher score means better outcomes.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="0.2"/>
                    <measurement group_id="O2" value="0.8" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Surgery to 6 month postoperative visit</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Persona With iASSIST Knee</title>
          <description>Having total knee arthroplasty (Persona Knee System) surgery with the use of a navigation system iASSIST Knee.&#xD;
Persona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.&#xD;
Total Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.&#xD;
iAssist Knee: Osteotomy of TKA is navigated by iAssist system, iAssist requires pin inserted in bone.</description>
        </group>
        <group group_id="E2">
          <title>Persona Without iASSIST Knee</title>
          <description>Having total knee arthroplasty surgery (Persona Knee System) with the use of conventional surgical instruments, and without a navigation system iASSIST Knee.&#xD;
Persona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.&#xD;
Total Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Malignant Lymphoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <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="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Postoperative Supracondylar Fracture of femur</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
              </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>Senior Manager of Clinical Affairs</name_or_title>
      <organization>Zimmer Biomet G.K.</organization>
      <phone>+81-3-6402-6610</phone>
      <email>takahito.nakai@zimmerbiomet.com</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/NCT03227692
org study id: K.CR.I.AP.16.39
nct id: NCT03227692
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The purpose of this study is to compare the accuracy of knee component alignment between
      patients operated with iASSIST Knee (Investigational group) versus patients operated without
      iASSIST Knee (Control group) using the same implant system.
Objective： To compare the accuracy of knee component alignment between patients operated with
      iASSIST Knee (Investigational group) versus patients operated without iASSIST Knee (Control
      group) using the same implant system.

      Endpoint： Primary： The alignment accuracy of the knee femoral and tibial components at 6
      months for the investigational group compared to the control group.

      Secondary：Health Status after TKA, Operating Room efficiency and Complication rate after TKA
      for the investigational group compared to the control group.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: At surgery, intervention group using iASSIST Knee system. At surgery, conventional group not using iASSIST Knee system.
primary purpose: Supportive Care
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Persona TKA with iASSIST Knee system (Investigational group) or Persona TKA with conventional instrumentation (Control group). The randomization scheme is based on equal numbers per group. The randomization will occur via a random number generator (computer) using blocked randomization procedure. The PI or his/her team does not have influence on the randomization scheme. Sealed opaque envelopes, which will be prepared based on predetermined randomization assignment, will be provided to each study site before study initiation.
measure: Number of Participants With Alignment Accuracy of the Knee Femoral Components in Coronal Plain
time frame: Postoperative 6 months
description: Ratio of subject, whose knee implant is positioned within 3 degrees from perpendicular to mechanical axis of lower extremity, is compared between groups by CT data taken at 6 month after surgery.
measure: Number of Participants With Alignment Accuracy of the Knee Femoral Components in Sagittal Plain
time frame: Postoperative 6 months
description: Ratio of subject, whose knee implant is positioned within 3 degrees from perpendicular to mechanical axis of lower extremity, is compared between groups by CT data taken at 6 month after surgery.
measure: Number of Participants With Alignment Accuracy of the Knee Tibial Components in Coronal Plain
time frame: Postoperative 6 months
description: Ratio of subject, whose knee implant is positioned within 3 degrees from perpendicular to mechanical axis of lower extremity, is compared between groups by CT data taken at 6 month after surgery.
measure: Number of Participants With Alignment Accuracy of the Knee Tibial Components in Sagittal Plain
time frame: Postoperative 6 months
description: Ratio of subject, whose knee implant is positioned within 3 degrees from preoperatively determined target angle, is compared between groups by CT data taken at 6 month after surgery.
measure: Surgery Time
time frame: Intraoperative, an average of 2 hours
description: Surgery time from skin incision to closure
measure: Number of Instrument Trays Used
time frame: Intraoperative
description: Number of instrument trays used instraoperatively. This number includes number of Total Knee Arthroplasty specific instrument tray, does not include other general surgical instruments/kits.
measure: KSS - Objective Score at 6 Month Postoperatively
time frame: 6 month postoperative
description: KSS-Objective score is physician-derived component and allows for more than 100 points in patients with greater than 125° of flexion and a stable painless knee as outlined below. Lowest possible score is 0.
Higher score means better outcomes.
measure: KSS-Patient Satisfaction at 6 Month Postoperatively
time frame: 6 month postoperative
description: KSS-Patient Satisfaction is patient-derived score and is a five-question 40-point scale that is collected preoperatively and at each follow-up visit. Lowest possible score is 0.
measure: KSS-function Score at 6 Month Postoperatively
time frame: 6 month postoperative
description: KSS-function score is patient-derived score and composed of four subgroups and has a maximum score of 100.
"Walking and Standing" has a maximum value of 30 points, "Standard Activities" has a maximum of 30 points, "Advanced Activities" has a maximum of 25 points and "Discretionary Activities" has a maximum of 15 points.
Lowest possible score is 0. Higher score means better outcomes.
measure: KSS-Patient Expectations at 6 Month Postoperatively
time frame: 6 month postoperative
description: KSS-Patient Expectations is patient-derived score and is a three-question fifteen-point scale that is collected pre-operatively and post-operatively. The pre-operative questions reflect the patient's opinion on the extent to which the patient expects that operation will improve knee pain, and ability to perform activities of daily living and recreational activities. The post-operative questions reflect the extent to which postoperative outcome has met the patient's pre-operative expectations with respect to pain and function.
The score ranges from 3 to 15. Higher score means better outcomes.
measure: Oxford Knee Score at 6 Month Postoperatively
time frame: 6 month postoperative
description: Patient Reported Outcome specific for knee disease. Score range from 0 to 48. Higher score means better outcome.
measure: EQ-5D-3L at 6 Month Postoperatively
time frame: 6 month postoperative
description: EQ-5D is patient reported outcome measure to score patient's health related quality of life with minimum score of -0.111 and maximum score of 1.000.
Higher score means better outcomes.
arm group label: Persona with iASSIST Knee
arm group type: Experimental
description: Having total knee arthroplasty (Persona Knee System) surgery with the use of a navigation system iASSIST Knee.
arm group label: Persona without iASSIST Knee
arm group type: Active Comparator
description: Having total knee arthroplasty surgery (Persona Knee System) with the use of conventional surgical instruments, and without a navigation system iASSIST Knee.
intervention type: Device
intervention name: Persona Knee System
description: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.
arm group label: Persona with iASSIST Knee
arm group label: Persona without iASSIST Knee
other name: Persona Knee
intervention type: Procedure
intervention name: Total Knee Arthroplasty
description: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.
arm group label: Persona with iASSIST Knee
arm group label: Persona without iASSIST Knee
other name: TKA
intervention type: Device
intervention name: iAssist Knee
description: Osteotomy of TKA is navigated by iAssist system, iAssist requires pin inserted in bone.
arm group label: Persona with iASSIST Knee
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Toshihiro Ohdera, M.D.
role: Principal Investigator
affiliation: Fukuoka Orthopaedic Hospital
facility: 
facility: 
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Osteoarthritis, Knee
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 