<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/NCT03838978</url>
  </required_header>
  <id_info>
    <org_study_id>CP0002 (formerly CLIN102918)</org_study_id>
    <nct_id>NCT03838978</nct_id>
  </id_info>
  <brief_title>Calypso Knee System Clinical Study, OUS</brief_title>
  <official_title>Evaluation of the Calypso Knee System for Symptom Relief in Subjects With Medial Knee Osteoarthritis, OUS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Moximed</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Moximed</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>
      A study to evaluate the safety and effectiveness of the Calypso Knee System when used in&#xD;
      subjects with symptomatic osteoarthritis of the medial compartment of the knee.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective, multicenter clinical study of the Calypso Knee System. A total of 81 subjects&#xD;
      were enrolled in this study. Male or female subjects age 25 to 65 years, with a diagnosis of&#xD;
      medial knee osteoarthritis and study knee pain with an overall WOMAC pain score ≥ 40 (scale&#xD;
      0-100).&#xD;
&#xD;
      The Calypso group was investigated under two clinical protocols, CP0001 in the USA, and&#xD;
      CP0002 in Europe. Both clinical protocols followed the same supporting protocols and plans,&#xD;
      such as radiographic, statistical, Clinical Events Committee (CEC), etc. The results from the&#xD;
      combined analysis have been reported in both NCT03671213 (CP0001) and NCT03838978 (CP0002).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 8, 2019</start_date>
  <completion_date type="Anticipated">September 2025</completion_date>
  <primary_completion_date type="Actual">January 17, 2022</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>
    <intervention_model_description>Single Arm Study Design</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With Composite Clinical Success (CCS)</measure>
    <time_frame>From baseline to 24 months</time_frame>
    <description>A subject is considered a Composite Clinical Success (CCS), at 24 months, if the subject meets all of the following:&#xD;
Clinically significant improvement of at least 20% from baseline on the WOMAC pain questions in the KOOS Knee questionnaire with a change of ≥10 points&#xD;
Clinically significant improvement of at least 20% from baseline on the WOMAC function questions in the KOOS Knee questionnaire with a change of ≥10 points&#xD;
Freedom from the following device-related serious adverse events:&#xD;
Deep infection requiring surgical intervention (Both arms)&#xD;
Damage to adjacent neurovascular or ligament structures necessitating reconstruction (Both arms)&#xD;
Non-union (HTO only)&#xD;
Maintenance of implant integrity as evaluated by radiographic assessment&#xD;
Endpoint Subsequent Surgical Intervention (SSI)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to Full Weight Bearing (Days)</measure>
    <time_frame>Through study completion (number of days to full weight bearing)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>WOMAC Pain Percent Change to Month 3</measure>
    <time_frame>From baseline to 3 months</time_frame>
    <description>The Knee Injury and Osteoarthritis Outcome Score (KOOS) Knee Survey includes the Western Ontario and McMasters University Osteoarthritis Index (WOMAC) in its complete and original format (with permission), and WOMAC scores can be calculated from the KOOS Knee questionnaire. The response to each question is summed and the resultant scores are transformed to a 0-100 scale. A WOMAC score of zero (0) represents no knee problems and one hundred (100) represents extreme knee problems.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>WOMAC Pain Percent Change to Month 24</measure>
    <time_frame>From baseline to 24 months</time_frame>
    <description>The Knee Injury and Osteoarthritis Outcome Score (KOOS) Knee Survey includes the Western Ontario and McMasters University Osteoarthritis Index (WOMAC) in its complete and original format (with permission), and WOMAC scores can be calculated from the KOOS Knee questionnaire. The response to each question is summed and the resultant scores are transformed to a 0-100 scale. A WOMAC score of zero (0) represents no knee problems and one hundred (100) represents extreme knee problems.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>WOMAC Function Percent Change to Month 3</measure>
    <time_frame>From baseline to 3 months</time_frame>
    <description>The Knee Injury and Osteoarthritis Outcome Score (KOOS) Knee Survey includes the Western Ontario and McMasters University Osteoarthritis Index (WOMAC) in its complete and original format (with permission), and WOMAC scores can be calculated from the KOOS Knee questionnaire. The response to each question is summed and the resultant scores are transformed to a 0-100 scale. A WOMAC score of zero (0) represents no knee problems and one hundred (100) represents extreme knee problems.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>WOMAC Function Percent Change to Month 24</measure>
    <time_frame>From baseline to 24 months</time_frame>
    <description>The Knee Injury and Osteoarthritis Outcome Score (KOOS) Knee Survey includes the Western Ontario and McMasters University Osteoarthritis Index (WOMAC) in its complete and original format (with permission), and WOMAC scores can be calculated from the KOOS Knee questionnaire. The response to each question is summed and the resultant scores are transformed to a 0-100 scale. A WOMAC score of zero (0) represents no knee problems and one hundred (100) represents extreme knee problems.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">81</enrollment>
  <condition>Osteoarthritis, Knee</condition>
  <arm_group>
    <arm_group_label>Calypso Knee System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Calypso Knee System</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Calypso Knee System</intervention_name>
    <description>The Calypso Knee System is an extra-capsular knee implant designed to fill the therapeutic gap between conservative care and more invasive surgical interventions for knee osteoarthritis.</description>
    <arm_group_label>Calypso Knee System</arm_group_label>
    <other_name>MISHA(TM) Knee System</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Participants age - 25 to 65 years&#xD;
&#xD;
          2. Body Mass Index (BMI) of &lt; 35, Weight &lt; 300 lbs (136 kg)&#xD;
&#xD;
          3. Knee osteoarthritis pain on the inner side of knee that has continued after at least 6&#xD;
             months of non-operative treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Symptoms of osteoarthritis in the other knee or in lateral (outer) or patellofemoral&#xD;
             compartments of the target knee&#xD;
&#xD;
          2. Knee ligament or meniscal instability&#xD;
&#xD;
          3. Other bone or joint conditions such as Rheumatoid arthritis, Paget's disease,&#xD;
             Charcot's disease or general conditions such as allergy or hypersensitivity to certain&#xD;
             metals, active infection, certain neurological conditions, use of medication such as&#xD;
             steroids or chemotherapy that could impact study participation or results&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alexandra Kraenzlin</last_name>
    <role>Study Director</role>
    <affiliation>Moximed</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UZ Gent</name>
      <address>
        <city>Gent</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zagiel Med Hospital</name>
      <address>
        <city>Lublin</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolina Medical Center</name>
      <address>
        <city>Warszawa</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mirai Clinic</name>
      <address>
        <city>Warszawa</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SPORTO</name>
      <address>
        <city>Łódź</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Poland</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>February 11, 2019</study_first_submitted>
  <study_first_submitted_qc>February 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <results_first_submitted>May 10, 2023</results_first_submitted>
  <results_first_submitted_qc>June 9, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">June 29, 2023</results_first_posted>
  <disposition_first_submitted>January 10, 2023</disposition_first_submitted>
  <disposition_first_submitted_qc>June 9, 2023</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">June 29, 2023</disposition_first_posted>
  <last_update_submitted>June 9, 2023</last_update_submitted>
  <last_update_submitted_qc>June 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 29, 2023</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</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <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>February 2, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/78/NCT03838978/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>The Calypso Clinical Study enrolled 81 subjects in the investigational (Calypso) arm. The historical control arm (HTO) is from a prior Moximed sponsored clinical trial. The results presented include data from the historical control arm for comparison, per the protocol.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Calypso Knee System</title>
          <description>Calypso Knee System: The Calypso Knee System is an extra-capsular knee implant designed to fill the therapeutic gap between conservative care and more invasive surgical interventions for knee osteoarthritis.</description>
        </group>
        <group group_id="P2">
          <title>High Tibial Osteotomy (HTO)</title>
          <description>Historical Control: HTO is a surgical treatment intended to reduce or eliminate pain and improve the function of a knee affected by medial compartment OA. All subjects underwent an open wedge osteotomy (OWO).&#xD;
The historical control arm (HTO) is from a prior Moximed sponsored clinical trial. The results presented include data from the historical control arm for comparison, per the protocol.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="81"/>
                <participants group_id="P2" count="81"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="73"/>
                <participants group_id="P2" count="65"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="16"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Calypso Knee System</title>
          <description>Calypso Knee System: The Calypso Knee System is an extra-capsular knee implant designed to fill the therapeutic gap between conservative care and more invasive surgical interventions for knee osteoarthritis.</description>
        </group>
        <group group_id="B2">
          <title>High Tibial Osteotomy (HTO)</title>
          <description>Historical Control: HTO is a surgical treatment intended to reduce or eliminate pain and improve the function of a knee affected by medial compartment OA. All subjects underwent an open wedge osteotomy (OWO).</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="81"/>
            <count group_id="B2" value="81"/>
            <count group_id="B3" value="162"/>
          </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="51.2" spread="7.71"/>
                    <measurement group_id="B2" value="52.5" spread="7.58"/>
                    <measurement group_id="B3" value="51.8" spread="7.65"/>
                  </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="32"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="60"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="49"/>
                    <measurement group_id="B2" value="53"/>
                    <measurement group_id="B3" value="102"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="78"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="128"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="30"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="80"/>
                    <measurement group_id="B2" value="80"/>
                    <measurement group_id="B3" value="160"/>
                  </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="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28.4" spread="3.44"/>
                    <measurement group_id="B2" value="29.3" spread="4.36"/>
                    <measurement group_id="B3" value="28.8" spread="3.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Composite Clinical Success (CCS)</title>
        <description>A subject is considered a Composite Clinical Success (CCS), at 24 months, if the subject meets all of the following:&#xD;
Clinically significant improvement of at least 20% from baseline on the WOMAC pain questions in the KOOS Knee questionnaire with a change of ≥10 points&#xD;
Clinically significant improvement of at least 20% from baseline on the WOMAC function questions in the KOOS Knee questionnaire with a change of ≥10 points&#xD;
Freedom from the following device-related serious adverse events:&#xD;
Deep infection requiring surgical intervention (Both arms)&#xD;
Damage to adjacent neurovascular or ligament structures necessitating reconstruction (Both arms)&#xD;
Non-union (HTO only)&#xD;
Maintenance of implant integrity as evaluated by radiographic assessment&#xD;
Endpoint Subsequent Surgical Intervention (SSI)</description>
        <time_frame>From baseline to 24 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Calypso Knee System</title>
            <description>The Calypso Knee System is an extra-capsular knee implant designed to fill the therapeutic gap between conservative care and more invasive surgical interventions for knee osteoarthritis.</description>
          </group>
          <group group_id="O2">
            <title>High Tibial Osteotomy (HTO)</title>
            <description>Historical Control: HTO is a surgical treatment intended to reduce or eliminate pain and improve the function of a knee affected by medial compartment OA. All subjects underwent an open wedge osteotomy (OWO).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Composite Clinical Success (CCS)</title>
          <description>A subject is considered a Composite Clinical Success (CCS), at 24 months, if the subject meets all of the following:&#xD;
Clinically significant improvement of at least 20% from baseline on the WOMAC pain questions in the KOOS Knee questionnaire with a change of ≥10 points&#xD;
Clinically significant improvement of at least 20% from baseline on the WOMAC function questions in the KOOS Knee questionnaire with a change of ≥10 points&#xD;
Freedom from the following device-related serious adverse events:&#xD;
Deep infection requiring surgical intervention (Both arms)&#xD;
Damage to adjacent neurovascular or ligament structures necessitating reconstruction (Both arms)&#xD;
Non-union (HTO only)&#xD;
Maintenance of implant integrity as evaluated by radiographic assessment&#xD;
Endpoint Subsequent Surgical Intervention (SSI)</description>
          <units>percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="81"/>
                <count group_id="O2" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.5"/>
                    <measurement group_id="O2" value="57.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>For missing data in both Arms/Groups, multiple imputation was performed for the primary CCS analysis.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority is demonstrated if the 90% LB &gt; -10.0%. If non-inferiority was met, superiority could be tested. Superiority is demonstrated if 97.5% LB &gt; 0.0%.</non_inferiority_desc>
            <other_analysis_desc>Device group differences and two-sided 90% and 97.5% confidence interval lower bounds (LB) adjusting for propensity score (PS) subclass based on PS subclass weights (ATT). Noninferiority is demonstrated if the 90% LB &gt; -10.0%. Superiority is demonstrated if 97.5% LB &gt;0.0%. Two-sided 97.5% LB is evaluated rather than two-sided 95.0% LB since the superiority type 1 error is split between testing superiority in terms of Month 24 CCS and then separately for a set of superiority secondary endpoints with type 1 error control maintained through the use of Hochberg approach (following demonstration of non-inferiority).</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Full Weight Bearing (Days)</title>
        <time_frame>Through study completion (number of days to full weight bearing)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Calypso Knee System</title>
            <description>The Calypso Knee System is an extra-capsular knee implant designed to fill the therapeutic gap between conservative care and more invasive surgical interventions for knee osteoarthritis.</description>
          </group>
          <group group_id="O2">
            <title>High Tibial Osteotomy (HTO)</title>
            <description>Historical Control: HTO is a surgical treatment intended to reduce or eliminate pain and improve the function of a knee affected by medial compartment OA. All subjects underwent an open wedge osteotomy (OWO).</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Full Weight Bearing (Days)</title>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="81"/>
                <count group_id="O2" value="77"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.4" spread="10.12"/>
                    <measurement group_id="O2" value="58" spread="39.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>WOMAC Pain Percent Change to Month 3</title>
        <description>The Knee Injury and Osteoarthritis Outcome Score (KOOS) Knee Survey includes the Western Ontario and McMasters University Osteoarthritis Index (WOMAC) in its complete and original format (with permission), and WOMAC scores can be calculated from the KOOS Knee questionnaire. The response to each question is summed and the resultant scores are transformed to a 0-100 scale. A WOMAC score of zero (0) represents no knee problems and one hundred (100) represents extreme knee problems.</description>
        <time_frame>From baseline to 3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Calypso Knee System</title>
            <description>The Calypso Knee System is an extra-capsular knee implant designed to fill the therapeutic gap between conservative care and more invasive surgical interventions for knee osteoarthritis.</description>
          </group>
          <group group_id="O2">
            <title>High Tibial Osteotomy (HTO)</title>
            <description>Historical Control: HTO is a surgical treatment intended to reduce or eliminate pain and improve the function of a knee affected by medial compartment OA. All subjects underwent an open wedge osteotomy (OWO).</description>
          </group>
        </group_list>
        <measure>
          <title>WOMAC Pain Percent Change to Month 3</title>
          <description>The Knee Injury and Osteoarthritis Outcome Score (KOOS) Knee Survey includes the Western Ontario and McMasters University Osteoarthritis Index (WOMAC) in its complete and original format (with permission), and WOMAC scores can be calculated from the KOOS Knee questionnaire. The response to each question is summed and the resultant scores are transformed to a 0-100 scale. A WOMAC score of zero (0) represents no knee problems and one hundred (100) represents extreme knee problems.</description>
          <units>percentage of change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="81"/>
                <count group_id="O2" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-55.5" spread="29.3"/>
                    <measurement group_id="O2" value="-33.4" spread="35.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>WOMAC Pain Percent Change to Month 24</title>
        <description>The Knee Injury and Osteoarthritis Outcome Score (KOOS) Knee Survey includes the Western Ontario and McMasters University Osteoarthritis Index (WOMAC) in its complete and original format (with permission), and WOMAC scores can be calculated from the KOOS Knee questionnaire. The response to each question is summed and the resultant scores are transformed to a 0-100 scale. A WOMAC score of zero (0) represents no knee problems and one hundred (100) represents extreme knee problems.</description>
        <time_frame>From baseline to 24 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Calypso Knee System</title>
            <description>The Calypso Knee System is an extra-capsular knee implant designed to fill the therapeutic gap between conservative care and more invasive surgical interventions for knee osteoarthritis.</description>
          </group>
          <group group_id="O2">
            <title>High Tibial Osteotomy (HTO)</title>
            <description>Historical Control: HTO is a surgical treatment intended to reduce or eliminate pain and improve the function of a knee affected by medial compartment OA. All subjects underwent an open wedge osteotomy (OWO).</description>
          </group>
        </group_list>
        <measure>
          <title>WOMAC Pain Percent Change to Month 24</title>
          <description>The Knee Injury and Osteoarthritis Outcome Score (KOOS) Knee Survey includes the Western Ontario and McMasters University Osteoarthritis Index (WOMAC) in its complete and original format (with permission), and WOMAC scores can be calculated from the KOOS Knee questionnaire. The response to each question is summed and the resultant scores are transformed to a 0-100 scale. A WOMAC score of zero (0) represents no knee problems and one hundred (100) represents extreme knee problems.</description>
          <units>percentage of change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="72"/>
                <count group_id="O2" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-76.0" spread="28.2"/>
                    <measurement group_id="O2" value="-64.7" spread="33.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>WOMAC Function Percent Change to Month 3</title>
        <description>The Knee Injury and Osteoarthritis Outcome Score (KOOS) Knee Survey includes the Western Ontario and McMasters University Osteoarthritis Index (WOMAC) in its complete and original format (with permission), and WOMAC scores can be calculated from the KOOS Knee questionnaire. The response to each question is summed and the resultant scores are transformed to a 0-100 scale. A WOMAC score of zero (0) represents no knee problems and one hundred (100) represents extreme knee problems.</description>
        <time_frame>From baseline to 3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Calypso Knee System</title>
            <description>The Calypso Knee System is an extra-capsular knee implant designed to fill the therapeutic gap between conservative care and more invasive surgical interventions for knee osteoarthritis.</description>
          </group>
          <group group_id="O2">
            <title>High Tibial Osteotomy (HTO)</title>
            <description>Historical Control: HTO is a surgical treatment intended to reduce or eliminate pain and improve the function of a knee affected by medial compartment OA. All subjects underwent an open wedge osteotomy (OWO).</description>
          </group>
        </group_list>
        <measure>
          <title>WOMAC Function Percent Change to Month 3</title>
          <description>The Knee Injury and Osteoarthritis Outcome Score (KOOS) Knee Survey includes the Western Ontario and McMasters University Osteoarthritis Index (WOMAC) in its complete and original format (with permission), and WOMAC scores can be calculated from the KOOS Knee questionnaire. The response to each question is summed and the resultant scores are transformed to a 0-100 scale. A WOMAC score of zero (0) represents no knee problems and one hundred (100) represents extreme knee problems.</description>
          <units>percentage of change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="81"/>
                <count group_id="O2" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-52.2" spread="32.0"/>
                    <measurement group_id="O2" value="-25.2" spread="37.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>WOMAC Function Percent Change to Month 24</title>
        <description>The Knee Injury and Osteoarthritis Outcome Score (KOOS) Knee Survey includes the Western Ontario and McMasters University Osteoarthritis Index (WOMAC) in its complete and original format (with permission), and WOMAC scores can be calculated from the KOOS Knee questionnaire. The response to each question is summed and the resultant scores are transformed to a 0-100 scale. A WOMAC score of zero (0) represents no knee problems and one hundred (100) represents extreme knee problems.</description>
        <time_frame>From baseline to 24 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Calypso Knee System</title>
            <description>The Calypso Knee System is an extra-capsular knee implant designed to fill the therapeutic gap between conservative care and more invasive surgical interventions for knee osteoarthritis.</description>
          </group>
          <group group_id="O2">
            <title>High Tibial Osteotomy (HTO)</title>
            <description>Historical Control: HTO is a surgical treatment intended to reduce or eliminate pain and improve the function of a knee affected by medial compartment OA. All subjects underwent an open wedge osteotomy (OWO).</description>
          </group>
        </group_list>
        <measure>
          <title>WOMAC Function Percent Change to Month 24</title>
          <description>The Knee Injury and Osteoarthritis Outcome Score (KOOS) Knee Survey includes the Western Ontario and McMasters University Osteoarthritis Index (WOMAC) in its complete and original format (with permission), and WOMAC scores can be calculated from the KOOS Knee questionnaire. The response to each question is summed and the resultant scores are transformed to a 0-100 scale. A WOMAC score of zero (0) represents no knee problems and one hundred (100) represents extreme knee problems.</description>
          <units>percentage of change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="72"/>
                <count group_id="O2" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-73.9" spread="29.6"/>
                    <measurement group_id="O2" value="-58.8" spread="35.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Index procedure (enrollment) through 24 months (790 days)</time_frame>
      <desc>Serious Adverse Events reported as adjudicated as device and/or procedure related by the Clinical Events Committee (CEC).</desc>
      <group_list>
        <group group_id="E1">
          <title>Calypso Knee System</title>
          <description>The Calypso Knee System is an extra-capsular knee implant designed to fill the therapeutic gap between conservative care and more invasive surgical interventions for knee osteoarthritis.</description>
        </group>
        <group group_id="E2">
          <title>High Tibial Osteotomy (HTO)</title>
          <description>Historical Control: HTO is a surgical treatment intended to reduce or eliminate pain and improve the function of a knee affected by medial compartment OA. All subjects underwent an open wedge osteotomy (OWO).</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>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="81"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="39" subjects_at_risk="81"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infection: Cellulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>Infection: Deep</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="81"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>Infection: Superficial incisional surgical site</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="81"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Anesthesia Complications: Other</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>Discomfort: Catching or pulling sensations</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>Discomfort: Inability to perform certain tasks</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>Hospital readmission: Removal of implant due to dissatisfaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>Nerve injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>Other: Other, bone consolidation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>Pain: Pain</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="81"/>
                <counts group_id="E2" events="30" subjects_affected="29" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>Scar formation: Other</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>Scar formation: Periprosthetic adhesions/fibrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>Swelling: Swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>Wound: Other</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>Wound: Wound dehiscence (post-explant)</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="81"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Psychological event: Other</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Bleeding: Hematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>Thrombophlebitis: Superficial Thrombophlebitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="81"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</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="20" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="81"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Nerve injury</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>Pain: Pain</sub_title>
                <counts group_id="E1" events="18" subjects_affected="16" subjects_at_risk="81"/>
                <counts group_id="E2" events="14" subjects_affected="14" subjects_at_risk="81"/>
              </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>Institution agrees study is multi-center study conducted by Sponsor and agrees not to publish until study completion and not before publication of multicenter results in peer-reviewed journal. Thereafter, Institution may publish its site experience. Sponsor reserves exclusive right to publish results and establish authorship based on compliance, contribution and acceptance of responsibilities. If no publication submitted by Sponsor within 12 months of study closure, Institution may publish.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Alexandra Kraenzlin, Director of Clinical Affairs</name_or_title>
      <organization>Moximed, Inc.</organization>
      <phone>+41 44 515 62 06</phone>
      <email>akraenzlin@moximed.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/NCT03838978
org study id: CP0002 (formerly CLIN102918)
nct id: NCT03838978
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
A study to evaluate the safety and effectiveness of the Calypso Knee System when used in
      subjects with symptomatic osteoarthritis of the medial compartment of the knee.
Prospective, multicenter clinical study of the Calypso Knee System. A total of 81 subjects
      were enrolled in this study. Male or female subjects age 25 to 65 years, with a diagnosis of
      medial knee osteoarthritis and study knee pain with an overall WOMAC pain score ≥ 40 (scale
      0-100).

      The Calypso group was investigated under two clinical protocols, CP0001 in the USA, and
      CP0002 in Europe. Both clinical protocols followed the same supporting protocols and plans,
      such as radiographic, statistical, Clinical Events Committee (CEC), etc. The results from the
      combined analysis have been reported in both NCT03671213 (CP0001) and NCT03838978 (CP0002).
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Single Arm Study Design
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants With Composite Clinical Success (CCS)
time frame: From baseline to 24 months
description: A subject is considered a Composite Clinical Success (CCS), at 24 months, if the subject meets all of the following:
Clinically significant improvement of at least 20% from baseline on the WOMAC pain questions in the KOOS Knee questionnaire with a change of ≥10 points
Clinically significant improvement of at least 20% from baseline on the WOMAC function questions in the KOOS Knee questionnaire with a change of ≥10 points
Freedom from the following device-related serious adverse events:
Deep infection requiring surgical intervention (Both arms)
Damage to adjacent neurovascular or ligament structures necessitating reconstruction (Both arms)
Non-union (HTO only)
Maintenance of implant integrity as evaluated by radiographic assessment
Endpoint Subsequent Surgical Intervention (SSI)
measure: Time to Full Weight Bearing (Days)
time frame: Through study completion (number of days to full weight bearing)
measure: WOMAC Pain Percent Change to Month 3
time frame: From baseline to 3 months
description: The Knee Injury and Osteoarthritis Outcome Score (KOOS) Knee Survey includes the Western Ontario and McMasters University Osteoarthritis Index (WOMAC) in its complete and original format (with permission), and WOMAC scores can be calculated from the KOOS Knee questionnaire. The response to each question is summed and the resultant scores are transformed to a 0-100 scale. A WOMAC score of zero (0) represents no knee problems and one hundred (100) represents extreme knee problems.
measure: WOMAC Pain Percent Change to Month 24
time frame: From baseline to 24 months
description: The Knee Injury and Osteoarthritis Outcome Score (KOOS) Knee Survey includes the Western Ontario and McMasters University Osteoarthritis Index (WOMAC) in its complete and original format (with permission), and WOMAC scores can be calculated from the KOOS Knee questionnaire. The response to each question is summed and the resultant scores are transformed to a 0-100 scale. A WOMAC score of zero (0) represents no knee problems and one hundred (100) represents extreme knee problems.
measure: WOMAC Function Percent Change to Month 3
time frame: From baseline to 3 months
description: The Knee Injury and Osteoarthritis Outcome Score (KOOS) Knee Survey includes the Western Ontario and McMasters University Osteoarthritis Index (WOMAC) in its complete and original format (with permission), and WOMAC scores can be calculated from the KOOS Knee questionnaire. The response to each question is summed and the resultant scores are transformed to a 0-100 scale. A WOMAC score of zero (0) represents no knee problems and one hundred (100) represents extreme knee problems.
measure: WOMAC Function Percent Change to Month 24
time frame: From baseline to 24 months
description: The Knee Injury and Osteoarthritis Outcome Score (KOOS) Knee Survey includes the Western Ontario and McMasters University Osteoarthritis Index (WOMAC) in its complete and original format (with permission), and WOMAC scores can be calculated from the KOOS Knee questionnaire. The response to each question is summed and the resultant scores are transformed to a 0-100 scale. A WOMAC score of zero (0) represents no knee problems and one hundred (100) represents extreme knee problems.
arm group label: Calypso Knee System
arm group type: Experimental
description: Calypso Knee System
intervention type: Device
intervention name: Calypso Knee System
description: The Calypso Knee System is an extra-capsular knee implant designed to fill the therapeutic gap between conservative care and more invasive surgical interventions for knee osteoarthritis.
arm group label: Calypso Knee System
other name: MISHA(TM) Knee System
criteria: 
gender: All
minimum age: 25 Years
maximum age: 65 Years
healthy volunteers: No
last name: Alexandra Kraenzlin
role: Study Director
affiliation: Moximed
facility: 
facility: 
facility: 
facility: 
facility: 
country: Belgium
country: Poland
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 