<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/NCT03257371</url>
  </required_header>
  <id_info>
    <org_study_id>2002751</org_study_id>
    <nct_id>NCT03257371</nct_id>
  </id_info>
  <brief_title>A Biologic Joint Replacement Strategy to Treat Patients With Severe Knee Trauma and Post-Traumatic Knee Osteoarthritis</brief_title>
  <official_title>A Biologic Joint Replacement Strategy to Treat Patients With Severe Knee Trauma and Post-Traumatic Knee Osteoarthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>James Stannard</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Missouri-Columbia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      With IRB approval and informed consent, patients (n=10) (18-50 years old) with post-traumatic&#xD;
      knee OA and requiring a tibial plateau and meniscus arthroplasty plus a femoral condyle&#xD;
      arthroplasty will be enrolled in the study. Primary criteria for inclusion will be Grade IV&#xD;
      changes in the articular cartilage of the femoral condyle and tibial plateau and meniscal&#xD;
      pathology in the medial or lateral femorotibial joint as determined by physical examination,&#xD;
      diagnostic imaging and knee arthroscopy by the PI. Exclusion criteria include Grade III or IV&#xD;
      changes in any other compartment of the knee, acute injury to any other part of the affected&#xD;
      lower extremity, or inability to comply with the protocol.&#xD;
&#xD;
      After enrollment, patients will undergo standardized knee radiography, and complete&#xD;
      assessments (described below). Size-matched (standard clinical methodology) proximal tibia&#xD;
      with meniscus and distal femur allografts from the same donor will be obtained from a tissue&#xD;
      bank (Musculoskeletal Transplant Foundation, Edison, NJ) who has licensed the MOPS&#xD;
      technology. The medial or lateral femoral condyle will be replaced using our novel&#xD;
      instrumentation and technique described above. Tibial plateau-meniscus grafts will be trimmed&#xD;
      and used to replace the entire medial or lateral tibial condyle while sparing the attachments&#xD;
      of ACL, PCL and respective collateral ligament. The tibial plateau graft will be fixated&#xD;
      using commercial available implants used for bone fixation. In the event that the meniscus&#xD;
      has been detached from the tibial plateau during graft harvest, the periphery of the meniscus&#xD;
      will be sutured to the capsule following standard meniscus transplant procedure.&#xD;
&#xD;
      Patients will undergo controlled post-operative rehabilitation according to standard&#xD;
      protocols for osteochondral with concurrent meniscus allografts.&#xD;
&#xD;
      Range of motion, VAS pain score, SF-12, Tegner score, International Knee Documentation&#xD;
      Committee (IKDC) subjective and objective scores, PROMIS Bank v1.2 - Physical&#xD;
      Function-Mobility, PROMIS v1.1 - Global Health, PROMIS Bank v1.1- Pain Interference, PROMIS&#xD;
      Bank v1.2 - Physical Function and Marx score as well as complete radiographs of the affected&#xD;
      knee will be obtained prior to surgery and at 6 weeks, 3 months, 6 months, and 12 months&#xD;
      after surgery to evaluate healing, function and evidence for arthrosis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 30, 2016</start_date>
  <completion_date type="Actual">July 2019</completion_date>
  <primary_completion_date type="Actual">July 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Analogue Scale Pain Score</measure>
    <time_frame>12 months</time_frame>
    <description>patient reported Visual Analogue Scale Pain Score, 0 no pain, 10 maximum pain</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tegner Activity Level Scale</measure>
    <time_frame>12 months</time_frame>
    <description>Patient reported outcome scale related to work and sporting activities, The Tegner activity scale is a one-item score that graded activity based on work and sports activities on a scale of 0 to 10. Zero represents disability because of knee problems and 10 represents national or international level soccer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>International Knee Documentation Committee (IKDC) Total Score</measure>
    <time_frame>12 months</time_frame>
    <description>Knee specific patient reported outcome, ranges from 0 to 100. This final number is interpreted as a measure of function with higher scores representing higher levels of function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PROMIS - Physical Function and Mobility</measure>
    <time_frame>12 months</time_frame>
    <description>A survey related to physical function and mobility, T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.&#xD;
On the T-score metric:&#xD;
A score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population. A higher score is better for this outcome measure as it indicates more function/mobility compared to the mean of the reference population.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">10</enrollment>
  <condition>Post-traumatic Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Post-traumatic knee OA</arm_group_label>
    <description>post-traumatic knee OA and requiring a tibial plateau and meniscus arthroplasty plus a femoral condyle arthroplasty</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        patients (n=10) (18-50 years old) with post-traumatic knee OA and requiring a tibial&#xD;
        plateau and meniscus arthroplasty plus a femoral condyle arthroplasty&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient requiring repair via tibial plateau and meniscus arthroplasty plus a femoral&#xD;
             condyle arthroplasty&#xD;
&#xD;
          2. The subject is able and willing to consent to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Acute injury to any other part of the affected lower extremity&#xD;
&#xD;
          2. The subject is unwilling, or unable to consent due to psychiatric condition or legal&#xD;
             incompetence&#xD;
&#xD;
          3. BMI &gt; 40&#xD;
&#xD;
          4. Age &gt; 50 at the time of enrollment&#xD;
&#xD;
          5. The subject is either pregnant, or a prisoner&#xD;
&#xD;
          6. Currently involved in a workers' compensation case at the time of enrollment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>James Stannard, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Missouri, Department of Orthopaedic Surgery</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>January 2021</verification_date>
  <study_first_submitted>August 18, 2017</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <results_first_submitted>November 5, 2020</results_first_submitted>
  <results_first_submitted_qc>January 5, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">January 26, 2021</results_first_posted>
  <last_update_submitted>January 5, 2021</last_update_submitted>
  <last_update_submitted_qc>January 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Missouri-Columbia</investigator_affiliation>
    <investigator_full_name>James Stannard</investigator_full_name>
    <investigator_title>Chairman, Department of Orthopaedic Sugery; Medical Director, Missouri Orthopaedic Surgery</investigator_title>
  </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>
  <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>June 23, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/71/NCT03257371/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Post-traumatic Knee OA</title>
          <description>post-traumatic knee OA and requiring a tibial plateau and meniscus arthroplasty plus a femoral condyle arthroplasty</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>This study was fully enrolled.</population>
      <group_list>
        <group group_id="B1">
          <title>Post-traumatic Knee OA</title>
          <description>post-traumatic knee OA and requiring a tibial plateau and meniscus arthroplasty plus a femoral condyle arthroplasty</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="10"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41.4" lower_limit="34" upper_limit="50"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Visual Analogue Scale Pain Score</title>
        <description>patient reported Visual Analogue Scale Pain Score, 0 no pain, 10 maximum pain</description>
        <time_frame>12 months</time_frame>
        <population>7 patients completed the study without needing revision/TKA surgery or being lost to follow-up</population>
        <group_list>
          <group group_id="O1">
            <title>Post-traumatic Knee OA</title>
            <description>post-traumatic knee OA and requiring a tibial plateau and meniscus arthroplasty plus a femoral condyle arthroplasty</description>
          </group>
        </group_list>
        <measure>
          <title>Visual Analogue Scale Pain Score</title>
          <description>patient reported Visual Analogue Scale Pain Score, 0 no pain, 10 maximum pain</description>
          <population>7 patients completed the study without needing revision/TKA surgery or being lost to follow-up</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3" lower_limit="0" upper_limit="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Tegner Activity Level Scale</title>
        <description>Patient reported outcome scale related to work and sporting activities, The Tegner activity scale is a one-item score that graded activity based on work and sports activities on a scale of 0 to 10. Zero represents disability because of knee problems and 10 represents national or international level soccer.</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Post-traumatic Knee OA</title>
            <description>post-traumatic knee OA and requiring a tibial plateau and meniscus arthroplasty plus a femoral condyle arthroplasty</description>
          </group>
        </group_list>
        <measure>
          <title>Tegner Activity Level Scale</title>
          <description>Patient reported outcome scale related to work and sporting activities, The Tegner activity scale is a one-item score that graded activity based on work and sports activities on a scale of 0 to 10. Zero represents disability because of knee problems and 10 represents national or international level soccer.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3" lower_limit="2" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>International Knee Documentation Committee (IKDC) Total Score</title>
        <description>Knee specific patient reported outcome, ranges from 0 to 100. This final number is interpreted as a measure of function with higher scores representing higher levels of function.</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Post-traumatic Knee OA</title>
            <description>post-traumatic knee OA and requiring a tibial plateau and meniscus arthroplasty plus a femoral condyle arthroplasty</description>
          </group>
        </group_list>
        <measure>
          <title>International Knee Documentation Committee (IKDC) Total Score</title>
          <description>Knee specific patient reported outcome, ranges from 0 to 100. This final number is interpreted as a measure of function with higher scores representing higher levels of function.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.6" lower_limit="39.1" upper_limit="64.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PROMIS - Physical Function and Mobility</title>
        <description>A survey related to physical function and mobility, T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.&#xD;
On the T-score metric:&#xD;
A score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population. A higher score is better for this outcome measure as it indicates more function/mobility compared to the mean of the reference population.</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Post-traumatic Knee OA</title>
            <description>post-traumatic knee OA and requiring a tibial plateau and meniscus arthroplasty plus a femoral condyle arthroplasty</description>
          </group>
        </group_list>
        <measure>
          <title>PROMIS - Physical Function and Mobility</title>
          <description>A survey related to physical function and mobility, T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.&#xD;
On the T-score metric:&#xD;
A score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population. A higher score is better for this outcome measure as it indicates more function/mobility compared to the mean of the reference population.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Physical Function</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.2" lower_limit="27.7" upper_limit="46.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mobility</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.1" lower_limit="37.7" upper_limit="47.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>AE data was followed for one year.</time_frame>
      <desc>AE:&#xD;
I. Bleeding II. Infection III. Pain that is uncontrolled with standard post-operative analgesia protocol&#xD;
SAE:&#xD;
I. Bleeding that is significant enough to require extended hospitalization or unplanned critical care interventions II. Infection that is significant enough to require extended hospitalization or unplanned critical care interventions III. Pain that is significant enough to require extended hospitalization or unplanned critical care interventions</desc>
      <group_list>
        <group group_id="E1">
          <title>Post-traumatic Knee OA</title>
          <description>post-traumatic knee OA and requiring a tibial plateau and meniscus arthroplasty plus a femoral condyle arthroplasty</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="10"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Revision or TKA surgery</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="10"/>
              </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="4" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Bone Grafting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Knee Arthroscopy</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="10"/>
              </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>
    <limitations_and_caveats>1 Patient was lost to follow-up after their 6 week follow-up.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. James Cook</name_or_title>
      <organization>University of Missouri</organization>
      <phone>573-882-7189</phone>
      <email>cookjl@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/NCT03257371
org study id: 2002751
nct id: NCT03257371
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
With IRB approval and informed consent, patients (n=10) (18-50 years old) with post-traumatic
      knee OA and requiring a tibial plateau and meniscus arthroplasty plus a femoral condyle
      arthroplasty will be enrolled in the study. Primary criteria for inclusion will be Grade IV
      changes in the articular cartilage of the femoral condyle and tibial plateau and meniscal
      pathology in the medial or lateral femorotibial joint as determined by physical examination,
      diagnostic imaging and knee arthroscopy by the PI. Exclusion criteria include Grade III or IV
      changes in any other compartment of the knee, acute injury to any other part of the affected
      lower extremity, or inability to comply with the protocol.

      After enrollment, patients will undergo standardized knee radiography, and complete
      assessments (described below). Size-matched (standard clinical methodology) proximal tibia
      with meniscus and distal femur allografts from the same donor will be obtained from a tissue
      bank (Musculoskeletal Transplant Foundation, Edison, NJ) who has licensed the MOPS
      technology. The medial or lateral femoral condyle will be replaced using our novel
      instrumentation and technique described above. Tibial plateau-meniscus grafts will be trimmed
      and used to replace the entire medial or lateral tibial condyle while sparing the attachments
      of ACL, PCL and respective collateral ligament. The tibial plateau graft will be fixated
      using commercial available implants used for bone fixation. In the event that the meniscus
      has been detached from the tibial plateau during graft harvest, the periphery of the meniscus
      will be sutured to the capsule following standard meniscus transplant procedure.

      Patients will undergo controlled post-operative rehabilitation according to standard
      protocols for osteochondral with concurrent meniscus allografts.

      Range of motion, VAS pain score, SF-12, Tegner score, International Knee Documentation
      Committee (IKDC) subjective and objective scores, PROMIS Bank v1.2 - Physical
      Function-Mobility, PROMIS v1.1 - Global Health, PROMIS Bank v1.1- Pain Interference, PROMIS
      Bank v1.2 - Physical Function and Marx score as well as complete radiographs of the affected
      knee will be obtained prior to surgery and at 6 weeks, 3 months, 6 months, and 12 months
      after surgery to evaluate healing, function and evidence for arthrosis.
observational model: Cohort
time perspective: Prospective
measure: Visual Analogue Scale Pain Score
time frame: 12 months
description: patient reported Visual Analogue Scale Pain Score, 0 no pain, 10 maximum pain
measure: Tegner Activity Level Scale
time frame: 12 months
description: Patient reported outcome scale related to work and sporting activities, The Tegner activity scale is a one-item score that graded activity based on work and sports activities on a scale of 0 to 10. Zero represents disability because of knee problems and 10 represents national or international level soccer.
measure: International Knee Documentation Committee (IKDC) Total Score
time frame: 12 months
description: Knee specific patient reported outcome, ranges from 0 to 100. This final number is interpreted as a measure of function with higher scores representing higher levels of function.
measure: PROMIS - Physical Function and Mobility
time frame: 12 months
description: A survey related to physical function and mobility, T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.
On the T-score metric:
A score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population. A higher score is better for this outcome measure as it indicates more function/mobility compared to the mean of the reference population.
arm group label: Post-traumatic knee OA
description: post-traumatic knee OA and requiring a tibial plateau and meniscus arthroplasty plus a femoral condyle arthroplasty
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: James Stannard, MD
role: Principal Investigator
affiliation: University of Missouri, Department of Orthopaedic Surgery
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Missouri-Columbia
investigator full name: James Stannard
investigator title: Chairman, Department of Orthopaedic Sugery; Medical Director, Missouri Orthopaedic Surgery
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: 1 Patient was lost to follow-up after their 6 week follow-up.
point of contact: 