<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/NCT02254473</url>
  </required_header>
  <id_info>
    <org_study_id>1405M50501</org_study_id>
    <nct_id>NCT02254473</nct_id>
  </id_info>
  <brief_title>Evaluating the Efficacy of Lateral Heel Wedges of Osteoarthritis of the Knee</brief_title>
  <official_title>Evaluating the Efficacy of Lateral Heel Wedges of Osteoarthritis of the Knee</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>HealthPartners Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Minnesota Medical Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>HealthPartners Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is looking at the efficacy of a sloped insole in patients with knee&#xD;
      osteoarthritis. Regularly wearing a sloped insole over the course of one year will result in&#xD;
      a wider joint space by x-ray in 60% of the subjects, a significant decrease in knee pain,&#xD;
      decreased use of over the counter analgesics, and a clinically important improvement in the&#xD;
      Womac pain and stiffness scale.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Low enrollment.&#xD;
  </why_stopped>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">June 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient Reported Function and Pain</measure>
    <time_frame>Baseline</time_frame>
    <description>Tegner: Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The scale is 0 to 10 where 10 corresponds to normal function and 0 to unable to perform.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient Reported Function and Pain</measure>
    <time_frame>6 weeks</time_frame>
    <description>Tegner: Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The scale is 0 to 10 where 10 corresponds to normal function and 0 to unable to perform.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient Reported Function and Pain</measure>
    <time_frame>3 months</time_frame>
    <description>Tegner: Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The scale is 0 to 10 where 10 corresponds to normal function and 0 to unable to perform.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient Reported Function and Pain</measure>
    <time_frame>6 months</time_frame>
    <description>Tegner: Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The scale is 0 to 10 where 10 corresponds to normal function and 0 to unable to perform.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient Reported Function and Pain</measure>
    <time_frame>9 months</time_frame>
    <description>Tegner: Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The scale is 0 to 10 where 10 corresponds to normal function and 0 to unable to perform.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient Reported Function and Pain</measure>
    <time_frame>12 months</time_frame>
    <description>Tegner: Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The scale is 0 to 10 where 10 corresponds to normal function and 0 to unable to perform.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Kellgren and Lawrence Classification of Osteoarthritis of Knee</measure>
    <time_frame>Baseline</time_frame>
    <description>X-Ray used to measure Kellgren and Lawrence Classification of Osteoarthritis of Knee (joint space in the knee).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Kellgren and Lawrence Classification of Osteoarthritis of Knee</measure>
    <time_frame>6 months</time_frame>
    <description>X-Ray used to measure Kellgren and Lawrence Classification of Osteoarthritis of Knee (joint space in the knee).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Wedge Insert</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive a wedge insert</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Flat insert</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients will receive a flat insert</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Wedge Insert</intervention_name>
    <arm_group_label>Wedge Insert</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Flat Insert</intervention_name>
    <arm_group_label>Flat insert</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients 30 years or older with medial compartment knee Osteoarthritis&#xD;
             (unilateral) and Grade 4 Kellgren-Lawrence39 radiographic changes presenting for&#xD;
             treatment of knee pain.&#xD;
&#xD;
          -  Range of motion knee-flexion beyond 100 degrees and not lacking more than 15 degrees&#xD;
             of extension.&#xD;
&#xD;
          -  Subtalar and forefoot motion permitting foot/ankle eversion with weight bearing.&#xD;
&#xD;
          -  Sufficient shoe toe box height to allow space for the insole and therefore comfort and&#xD;
             compliance.&#xD;
&#xD;
          -  Passive laxity of medial capsule and collateral ligament by knee extension test.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  All other forms of knee arthritis other than OA.&#xD;
&#xD;
          -  Knee Instability- medial pseudo-opening of greater than grade 1 or detectable&#xD;
             Anterior-posterior instability.&#xD;
&#xD;
          -  Less than Grade 4 Kellgren-Lawrence radiographic changes in the medial compartment of&#xD;
             the knee39.&#xD;
&#xD;
          -  Grade 2 or greater Kellgren-Lawrence radiographic39 involvement of the patellofemoral&#xD;
             or lateral compartment.&#xD;
&#xD;
          -  Inadequate knee range of motion&#xD;
&#xD;
          -  Balance problems requiring the use of a walker or wheel chair - ambulation with aid&#xD;
&#xD;
          -  Diabetics with peripheral neuropathy&#xD;
&#xD;
          -  Knee surgery within the past year&#xD;
&#xD;
          -  Intraarticular steroid injection or visco supplementation within 6 months&#xD;
&#xD;
          -  Stiff subtalar or forefoot joints - clinical test&#xD;
&#xD;
          -  Inadequate shoe toe box depth to accommodate the test or control inserts&#xD;
&#xD;
          -  Charcot joint&#xD;
&#xD;
          -  Fixed contracture of the medial capsule and/or collateral ligament- clinical test&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>TRIA Orthopaedic Center</name>
      <address>
        <city>Bloomington</city>
        <state>Minnesota</state>
        <zip>55431</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>September 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <results_first_submitted>January 18, 2019</results_first_submitted>
  <results_first_submitted_qc>August 19, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">September 20, 2019</results_first_posted>
  <last_update_submitted>August 19, 2019</last_update_submitted>
  <last_update_submitted_qc>August 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Knee</keyword>
  <keyword>Osteoarthritis</keyword>
  <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>March 1, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/73/NCT02254473/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Wedge Insert</title>
          <description>Patients will receive a wedge insert&#xD;
Wedge Insert</description>
        </group>
        <group group_id="P2">
          <title>Flat Insert</title>
          <description>Patients will receive a flat insert&#xD;
Flat Insert</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Wedge Insert</title>
          <description>Patients will receive a wedge insert&#xD;
Wedge Insert</description>
        </group>
        <group group_id="B2">
          <title>Flat Insert</title>
          <description>Patients will receive a flat insert&#xD;
Flat Insert</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="9"/>
            <count group_id="B2" value="3"/>
            <count group_id="B3" value="12"/>
          </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="9"/>
                    <count group_id="B2" value="3"/>
                    <count group_id="B3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</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>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                  </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="9"/>
                    <count group_id="B2" value="3"/>
                    <count group_id="B3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </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 group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="9"/>
                    <count group_id="B2" value="3"/>
                    <count group_id="B3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Patient Reported Function and Pain</title>
        <description>Tegner: Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The scale is 0 to 10 where 10 corresponds to normal function and 0 to unable to perform.</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Wedge Insert</title>
            <description>Patients will receive a wedge insert&#xD;
Wedge Insert</description>
          </group>
          <group group_id="O2">
            <title>Flat Insert</title>
            <description>Patients will receive a flat insert&#xD;
Flat Insert</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Reported Function and Pain</title>
          <description>Tegner: Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The scale is 0 to 10 where 10 corresponds to normal function and 0 to unable to perform.</description>
          <units>score on a scale 0-10 (normal)</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.66" lower_limit="1" upper_limit="6"/>
                    <measurement group_id="O2" value="4.66" lower_limit="4" upper_limit="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Patient Reported Function and Pain</title>
        <description>Tegner: Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The scale is 0 to 10 where 10 corresponds to normal function and 0 to unable to perform.</description>
        <time_frame>6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Wedge Insert</title>
            <description>Patients will receive a wedge insert&#xD;
Wedge Insert</description>
          </group>
          <group group_id="O2">
            <title>Flat Insert</title>
            <description>Patients will receive a flat insert&#xD;
Flat Insert</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Reported Function and Pain</title>
          <description>Tegner: Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The scale is 0 to 10 where 10 corresponds to normal function and 0 to unable to perform.</description>
          <units>score on a scale 0-10 (normal)</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.77" lower_limit="1" upper_limit="6"/>
                    <measurement group_id="O2" value="4" lower_limit="2" upper_limit="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Patient Reported Function and Pain</title>
        <description>Tegner: Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The scale is 0 to 10 where 10 corresponds to normal function and 0 to unable to perform.</description>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Wedge Insert</title>
            <description>Patients will receive a wedge insert&#xD;
Wedge Insert</description>
          </group>
          <group group_id="O2">
            <title>Flat Insert</title>
            <description>Patients will receive a flat insert&#xD;
Flat Insert</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Reported Function and Pain</title>
          <description>Tegner: Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The scale is 0 to 10 where 10 corresponds to normal function and 0 to unable to perform.</description>
          <units>score on a scale 0-10 (normal)</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.88" lower_limit="1" upper_limit="7"/>
                    <measurement group_id="O2" value="3.66" lower_limit="2" upper_limit="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Patient Reported Function and Pain</title>
        <description>Tegner: Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The scale is 0 to 10 where 10 corresponds to normal function and 0 to unable to perform.</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Wedge Insert</title>
            <description>Patients will receive a wedge insert&#xD;
Wedge Insert</description>
          </group>
          <group group_id="O2">
            <title>Flat Insert</title>
            <description>Patients will receive a flat insert&#xD;
Flat Insert</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Reported Function and Pain</title>
          <description>Tegner: Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The scale is 0 to 10 where 10 corresponds to normal function and 0 to unable to perform.</description>
          <units>score on a scale 0-10 (normal)</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.66" lower_limit="1" upper_limit="6"/>
                    <measurement group_id="O2" value="3.5" lower_limit="2" upper_limit="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Patient Reported Function and Pain</title>
        <description>Tegner: Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The scale is 0 to 10 where 10 corresponds to normal function and 0 to unable to perform.</description>
        <time_frame>9 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Wedge Insert</title>
            <description>Patients will receive a wedge insert&#xD;
Wedge Insert</description>
          </group>
          <group group_id="O2">
            <title>Flat Insert</title>
            <description>Patients will receive a flat insert&#xD;
Flat Insert</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Reported Function and Pain</title>
          <description>Tegner: Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The scale is 0 to 10 where 10 corresponds to normal function and 0 to unable to perform.</description>
          <units>score on a scale 0-10 (normal)</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.88" lower_limit="1" upper_limit="7"/>
                    <measurement group_id="O2" value="4" lower_limit="3" upper_limit="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Patient Reported Function and Pain</title>
        <description>Tegner: Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The scale is 0 to 10 where 10 corresponds to normal function and 0 to unable to perform.</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Wedge Insert</title>
            <description>Patients will receive a wedge insert&#xD;
Wedge Insert</description>
          </group>
          <group group_id="O2">
            <title>Flat Insert</title>
            <description>Patients will receive a flat insert&#xD;
Flat Insert</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Reported Function and Pain</title>
          <description>Tegner: Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The scale is 0 to 10 where 10 corresponds to normal function and 0 to unable to perform.</description>
          <units>score on a scale 0-10 (normal)</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.17" lower_limit="1" upper_limit="6"/>
                    <measurement group_id="O2" value="4" lower_limit="3" upper_limit="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Kellgren and Lawrence Classification of Osteoarthritis of Knee</title>
        <description>X-Ray used to measure Kellgren and Lawrence Classification of Osteoarthritis of Knee (joint space in the knee).</description>
        <time_frame>Baseline</time_frame>
        <population>Data was not gathered due to pre-mature termination of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Wedge Insert</title>
            <description>Patients will receive a wedge insert&#xD;
Wedge Insert</description>
          </group>
          <group group_id="O2">
            <title>Flat Insert</title>
            <description>Patients will receive a flat insert&#xD;
Flat Insert</description>
          </group>
        </group_list>
        <measure>
          <title>Kellgren and Lawrence Classification of Osteoarthritis of Knee</title>
          <description>X-Ray used to measure Kellgren and Lawrence Classification of Osteoarthritis of Knee (joint space in the knee).</description>
          <population>Data was not gathered due to pre-mature termination of the study.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Kellgren and Lawrence Classification of Osteoarthritis of Knee</title>
        <description>X-Ray used to measure Kellgren and Lawrence Classification of Osteoarthritis of Knee (joint space in the knee).</description>
        <time_frame>6 months</time_frame>
        <population>Data was not gathered due to pre-mature termination of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Wedge Insert</title>
            <description>Patients will receive a wedge insert&#xD;
Wedge Insert</description>
          </group>
          <group group_id="O2">
            <title>Flat Insert</title>
            <description>Patients will receive a flat insert&#xD;
Flat Insert</description>
          </group>
        </group_list>
        <measure>
          <title>Kellgren and Lawrence Classification of Osteoarthritis of Knee</title>
          <description>X-Ray used to measure Kellgren and Lawrence Classification of Osteoarthritis of Knee (joint space in the knee).</description>
          <population>Data was not gathered due to pre-mature termination of the study.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 year</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Wedge Insert</title>
          <description>Patients will receive a wedge insert&#xD;
Wedge Insert</description>
        </group>
        <group group_id="E2">
          <title>Flat Insert</title>
          <description>Patients will receive a flat insert&#xD;
Flat Insert</description>
        </group>
      </group_list>
      <serious_events>
        <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="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>Pain</default_vocab>
        <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="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pain</sub_title>
                <description>Patient experienced increased pain.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Megan Reams</name_or_title>
      <organization>TRIA Orthopaedic Center</organization>
      <phone>952-806-5329</phone>
      <email>megan.reams@tria.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/NCT02254473
org study id: 1405M50501
nct id: NCT02254473
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
This study is looking at the efficacy of a sloped insole in patients with knee
      osteoarthritis. Regularly wearing a sloped insole over the course of one year will result in
      a wider joint space by x-ray in 60% of the subjects, a significant decrease in knee pain,
      decreased use of over the counter analgesics, and a clinically important improvement in the
      Womac pain and stiffness scale.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Patient Reported Function and Pain
time frame: Baseline
description: Tegner: Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The scale is 0 to 10 where 10 corresponds to normal function and 0 to unable to perform.
measure: Patient Reported Function and Pain
time frame: 6 weeks
description: Tegner: Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The scale is 0 to 10 where 10 corresponds to normal function and 0 to unable to perform.
measure: Patient Reported Function and Pain
time frame: 3 months
description: Tegner: Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The scale is 0 to 10 where 10 corresponds to normal function and 0 to unable to perform.
measure: Patient Reported Function and Pain
time frame: 6 months
description: Tegner: Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The scale is 0 to 10 where 10 corresponds to normal function and 0 to unable to perform.
measure: Patient Reported Function and Pain
time frame: 9 months
description: Tegner: Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The scale is 0 to 10 where 10 corresponds to normal function and 0 to unable to perform.
measure: Patient Reported Function and Pain
time frame: 12 months
description: Tegner: Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The scale is 0 to 10 where 10 corresponds to normal function and 0 to unable to perform.
measure: Kellgren and Lawrence Classification of Osteoarthritis of Knee
time frame: Baseline
description: X-Ray used to measure Kellgren and Lawrence Classification of Osteoarthritis of Knee (joint space in the knee).
measure: Kellgren and Lawrence Classification of Osteoarthritis of Knee
time frame: 6 months
description: X-Ray used to measure Kellgren and Lawrence Classification of Osteoarthritis of Knee (joint space in the knee).
arm group label: Wedge Insert
arm group type: Experimental
description: Patients will receive a wedge insert
arm group label: Flat insert
arm group type: Placebo Comparator
description: Patients will receive a flat insert
intervention type: Other
intervention name: Wedge Insert
arm group label: Wedge Insert
intervention type: Other
intervention name: Flat Insert
arm group label: Flat insert
criteria: 
gender: All
minimum age: 30 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 