<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/NCT02186587</url>
  </required_header>
  <id_info>
    <org_study_id>1206872</org_study_id>
    <nct_id>NCT02186587</nct_id>
  </id_info>
  <brief_title>iTotal Pilot Study of ConforMIS Custom Total Knee Implant</brief_title>
  <official_title>CT-navigated, Patient-specific Custom Total Knee Replacement Versus Standard Total Knee Replacement: Comparison With a Marker-less Gait Analysis System and Validated Outcome Scores</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Missouri-Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Missouri-Columbia</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To compare the outcomes of patients receiving the ConforMIS custom total knee implant to the&#xD;
      outcomes of patients who receiving an off-the-shelf total knee implant.&#xD;
&#xD;
      Hypothesis: Patient-specific, custom total knee implants manufactured from patient CT data,&#xD;
      and implanted with CT-navigated custom instruments will show faster functional recovery,&#xD;
      including gait and patient functional outcome scores, when compared to standard,&#xD;
      off-the-shelf total knee components inserted with non-navigated instruments (the present&#xD;
      standard of care in total knee surgery).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The experimental design was changed based on enrollment hurdles to be a single cohort&#xD;
      observational study where ConforMIS patients were enrolled and followed for 6 months with 6&#xD;
      minute walk used as the primary outcome measure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">April 2016</completion_date>
  <primary_completion_date type="Actual">June 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Distance Measured During 6-minute Walk Test</measure>
    <time_frame>6 months</time_frame>
    <description>Subjects will walk for 6 minutes and the distance covered will be measured in feet.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Knee Arthroplasty, Total</condition>
  <arm_group>
    <arm_group_label>ConforMIS</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Subjects who receive a ConforMIS custom total knee implant.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ConforMIS custom total knee</intervention_name>
    <description>Total knee arthroplasty using ConforMIS custom total knee system with follow-up at 6 months</description>
    <arm_group_label>ConforMIS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - undergoing total knee arthroplasty&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - BMI &gt;40&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sonny Bal, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Professor - PI</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Missouri Orthopaedic Institute</name>
      <address>
        <city>Columbia</city>
        <state>Missouri</state>
        <zip>65212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>July 7, 2014</study_first_submitted>
  <study_first_submitted_qc>July 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <results_first_submitted>April 14, 2016</results_first_submitted>
  <results_first_submitted_qc>November 22, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">January 19, 2017</results_first_posted>
  <last_update_submitted>April 27, 2023</last_update_submitted>
  <last_update_submitted_qc>April 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 23, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>ConforMIS</title>
          <description>Subjects in this arm will receive a ConforMIS custom total knee implant.&#xD;
ConforMIS custom total knee</description>
        </group>
        <group group_id="P2">
          <title>Off-the-shelf</title>
          <description>Subjects in this arm will receive an off-the-shelf total knee implant.&#xD;
Off-the-shelf 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="28"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>ConforMIS</title>
          <description>Subjects in this arm will be having a ConforMIS custom total knee implant as part of standard of care.&#xD;
ConforMIS custom total knee</description>
        </group>
        <group group_id="B2">
          <title>Off-the-shelf</title>
          <description>Subjects in this arm will receive an off-the-shelf total knee implant as part of standard of care.&#xD;
Off-the-shelf 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="28"/>
            <count group_id="B2" value="0"/>
            <count group_id="B3" value="28"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B3" value="9"/>
                  </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="18"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Distance Measured During 6-minute Walk Test</title>
        <description>Subjects will walk for 6 minutes and the distance covered will be measured in feet.</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ConforMIS</title>
            <description>Subjects in this arm will be having a ConforMIS custom total knee implant as part of standard of care.&#xD;
ConforMIS custom total knee</description>
          </group>
        </group_list>
        <measure>
          <title>Distance Measured During 6-minute Walk Test</title>
          <description>Subjects will walk for 6 minutes and the distance covered will be measured in feet.</description>
          <units>feet</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1060" spread="373"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>ConforMIS</title>
          <description>Subjects in this arm will receive a ConforMIS custom total knee implant.&#xD;
ConforMIS custom total knee</description>
        </group>
        <group group_id="E2">
          <title>Off-the-shelf</title>
          <description>Subjects in this arm will receive an off-the-shelf total knee implant.&#xD;
Off-the-shelf 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="28"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>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="1" subjects_at_risk="28"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>knee stiffness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </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>Sonny B. Bal, MD, PI</name_or_title>
      <organization>University of Missouri - Department of Orthopaedic Surgery</organization>
      <phone>573-882-6762</phone>
      <email>BalB@health.missouri.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/NCT02186587
org study id: 1206872
nct id: NCT02186587
lead sponsor: 
has dmc: Yes
To compare the outcomes of patients receiving the ConforMIS custom total knee implant to the
      outcomes of patients who receiving an off-the-shelf total knee implant.

      Hypothesis: Patient-specific, custom total knee implants manufactured from patient CT data,
      and implanted with CT-navigated custom instruments will show faster functional recovery,
      including gait and patient functional outcome scores, when compared to standard,
      off-the-shelf total knee components inserted with non-navigated instruments (the present
      standard of care in total knee surgery).
The experimental design was changed based on enrollment hurdles to be a single cohort
      observational study where ConforMIS patients were enrolled and followed for 6 months with 6
      minute walk used as the primary outcome measure.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Distance Measured During 6-minute Walk Test
time frame: 6 months
description: Subjects will walk for 6 minutes and the distance covered will be measured in feet.
arm group label: ConforMIS
arm group type: Other
description: Subjects who receive a ConforMIS custom total knee implant.
intervention type: Device
intervention name: ConforMIS custom total knee
description: Total knee arthroplasty using ConforMIS custom total knee system with follow-up at 6 months
arm group label: ConforMIS
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sonny Bal, MD
role: Principal Investigator
affiliation: Professor - PI
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 