<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/NCT02262364</url>
  </required_header>
  <id_info>
    <org_study_id>APSS-22-01</org_study_id>
    <nct_id>NCT02262364</nct_id>
  </id_info>
  <brief_title>Safety of NStride Autologous Protein Solution in the Treatment of Knee Osteoarthritis (PROGRESS I)</brief_title>
  <official_title>A Pilot Study of a Single Intra-articular Injection of Autologous Protein Solution in Patients With Knee Osteoarthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zimmer Biomet</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Biomet Biologics, LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Zimmer Biomet</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to assess the safety of a single injection of APS.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of this study is to assess the safety of a single injection of APS in&#xD;
      patients with painful unilateral knee osteoarthritis and who have not been able to get&#xD;
      satisfactory pain relief with other treatments through one-month post treatment and monitor&#xD;
      subjects for adverse events through 12 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">October 2016</completion_date>
  <primary_completion_date type="Actual">October 2016</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>1 Year</time_frame>
    <description>Adverse Events and Serious Adverse Events</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to 12 Months in Pain, Stiffness, and Function in Daily Living Measured With WOMAC Questionnaire</measure>
    <time_frame>12 months</time_frame>
    <description>The WOMAC LK 3.1 questionnaire is a validated tool commonly used for assessing knee pain, stiffness, and function. The WOMAC LK 3.1 questionnaire has 24 items that the patient addresses about the knee: 5 items on the pain subscale, 2 on the stiffness subscale, and 17 on the physical function subscale. Each item is answered on a 5-point Likert scale, with grading from 0 (none or never) to 4 (extreme or always). A higher score indicates worse pain, stiffness, or functional limitation.&#xD;
The WOMAC pain subscale consists of five questions scored from 0 to 4. The pain score has a range of 0 (no pain) to 20 (maximal pain).&#xD;
The WOMAC stiffness subscale consists of two questions scored from 0 to 4. The stiffness score has a range of 0 (no stiffness) to 8 (maximal stiffness).&#xD;
The WOMAC physical function subscale consists of seventeen questions scored from 0 to 4. The physical function score has a range of 0 (no functional limitation) to 68 (maximal functional limitation).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to 12 Months in Pain as Measured by the Numeric Rating Scale (NRS)</measure>
    <time_frame>12 months</time_frame>
    <description>The Numeric Rating Scale (NRS) is a validated measure of knee pain. The NRS is an 11 point Likert type scale anchored by 0 &quot;no pain&quot; and 10 &quot;worst possible pain&quot;. Subjects rate their average pain over the last 24 hours.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to 12 Months in Pain as Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS)</measure>
    <time_frame>12 months</time_frame>
    <description>The KOOS questionnaire is a commonly used instrument to assess the patient's opinion about their knee and associated problems. KOOS consists of 5 subscales: Pain (9 questions), Symptoms (7 questions), Function in daily living (ADL) (17 questions), Function in sport and recreation (Sport/Rec) (5 questions) and knee related Quality of Life (QOL) (4 questions). The previous week is used as the time period for answering the questions.&#xD;
A higher score on the KOOS questionnaire indicates fewer problems, and 0 indicates extreme problems. Each subscale score is calculated independently. The mean score of the individual items of each subscale is calculated and divided by 4 (the highest possible score for a single answer option). Traditionally in orthopedics, 100 indicates no problems and 0 indicates extreme problems. The normalized score is transformed to meet this standard.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Osteoarthritis, Knee</condition>
  <arm_group>
    <arm_group_label>NStride APS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive an intra-articular injection of APS.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>APS</intervention_name>
    <description>See above</description>
    <arm_group_label>NStride APS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female ≥40 and ≤75 years old at time of injection..&#xD;
&#xD;
          -  A standing radiograph of the knee showing a Kellgren-Lawrence grade of 2 to 4 (within&#xD;
             6 months of screening).&#xD;
&#xD;
          -  Body mass index ≤40 kg/m2.&#xD;
&#xD;
          -  A Western Ontario and McMaster Universities osteoarthritis index using the Likert&#xD;
             scale, Version 3. (WOMAC LK 3.1) pain subscale total score ≥ 10 and ≤ 19.&#xD;
&#xD;
          -  Has undergone at least two prior conservative OA therapies without satisfactory pain&#xD;
             relief.&#xD;
&#xD;
          -  Patient has failed to get satisfactory pain relief from either HA or steroid&#xD;
             injections or would be considered an appropriate patient to receive either HA or&#xD;
             steroid injections&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of active infection or abnormal effusion in the knee immediately preceding&#xD;
             treatment injection.&#xD;
&#xD;
          -  Presence of symptomatic OA in the non-study knee&#xD;
&#xD;
          -  Diagnosed with rheumatoid arthritis, Reiter's syndrome, psoriatic arthritis, gout,&#xD;
             ankylosing spondylitis, chondromalacia, arthritis secondary to other inflammatory&#xD;
             diseases, or of metabolic origin; HIV, viral hepatitis; chondrocalcinosis, Paget's&#xD;
             disease, villonodular synovitis, and other non-OA joint disease.&#xD;
&#xD;
          -  Disease of spine, hip or other lower extremity joints of sufficient degree to affect&#xD;
             assessment of the index knee&#xD;
&#xD;
          -  Untreated symptomatic injury of index knee (e.g., acute traumatic injury, anterior&#xD;
             cruciate ligament injury, meniscus injury, cartilage lesion).&#xD;
&#xD;
          -  Knee radiographs showing bone-on-bone or other gross cartilage deficits.&#xD;
&#xD;
          -  Presence of surgical hardware or other foreign body in the index knee.&#xD;
&#xD;
          -  Intra-articular steroid injections in the index knee within 3 months of screening.&#xD;
&#xD;
          -  Intra-articular HA in the index knee within 6 months of screening.&#xD;
&#xD;
          -  Other intra-articular therapy in the index knee within 6 months prior to screening.&#xD;
&#xD;
          -  Systemic steroid use within 2 weeks of screening.&#xD;
&#xD;
          -  Planned/anticipated surgery of the index knee during the study period.&#xD;
&#xD;
          -  A history of local anesthetic allergy&#xD;
&#xD;
          -  Use of systemic immunosuppressants within six weeks of treatment.&#xD;
&#xD;
          -  Currently on anticoagulant therapy&#xD;
&#xD;
          -  Any documented clinically significant condition (e.g., diabetes, malignancy), finding,&#xD;
             or psychiatric illness at screening which could compromise patient safety or interfere&#xD;
             with the assessment of the safety and treatment effects of the study injection.&#xD;
&#xD;
          -  Skin breakdown at the index knee where the injection is planned to take place.&#xD;
&#xD;
          -  Pregnant or nursing mothers or women who are planning on getting pregnant during the&#xD;
             time they will be participating in the study.&#xD;
&#xD;
          -  Known drug or alcohol dependence currently or within the last year.&#xD;
&#xD;
          -  Used any investigational drug or device within 30 days prior to screening.&#xD;
&#xD;
          -  Used any investigational biologic within 60 days prior to screening&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mark Klaassen</last_name>
    <role>Principal Investigator</role>
    <affiliation>OSMC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Orthopedic and Sports Medicine Center of Northern Indiana (OSMC)</name>
      <address>
        <city>Elkhart</city>
        <state>Indiana</state>
        <zip>46550</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>September 19, 2014</study_first_submitted>
  <study_first_submitted_qc>October 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <results_first_submitted>February 26, 2018</results_first_submitted>
  <results_first_submitted_qc>October 8, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">February 15, 2019</results_first_posted>
  <last_update_submitted>October 8, 2018</last_update_submitted>
  <last_update_submitted_qc>October 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</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>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>NStride APS</title>
          <description>Subjects will receive an intra-articular injection of APS.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Study Enrollment</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Blood Draw for Device Processing</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </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>Insufficient blood could be drawn</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Injection With APS</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="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Follow-Up Through 12 Months</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="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The included population could generally be characterized as patients with painful unilateral knee OA, who had not been able to get satisfactory pain relief with other treatments.</population>
      <group_list>
        <group group_id="B1">
          <title>NStride APS</title>
          <description>Subjects will receive an intra-articular injection of APS.</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, Customized</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Mean Patient Age</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58.8" spread="9.5"/>
                  </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="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Adverse Events</title>
        <description>Adverse Events and Serious Adverse Events</description>
        <time_frame>1 Year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>NStride APS</title>
            <description>Subjects will receive an intra-articular injection of APS.</description>
          </group>
        </group_list>
        <measure>
          <title>Adverse Events</title>
          <description>Adverse Events and Serious Adverse Events</description>
          <units>events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Adverse Events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serious Adverse Events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to 12 Months in Pain, Stiffness, and Function in Daily Living Measured With WOMAC Questionnaire</title>
        <description>The WOMAC LK 3.1 questionnaire is a validated tool commonly used for assessing knee pain, stiffness, and function. The WOMAC LK 3.1 questionnaire has 24 items that the patient addresses about the knee: 5 items on the pain subscale, 2 on the stiffness subscale, and 17 on the physical function subscale. Each item is answered on a 5-point Likert scale, with grading from 0 (none or never) to 4 (extreme or always). A higher score indicates worse pain, stiffness, or functional limitation.&#xD;
The WOMAC pain subscale consists of five questions scored from 0 to 4. The pain score has a range of 0 (no pain) to 20 (maximal pain).&#xD;
The WOMAC stiffness subscale consists of two questions scored from 0 to 4. The stiffness score has a range of 0 (no stiffness) to 8 (maximal stiffness).&#xD;
The WOMAC physical function subscale consists of seventeen questions scored from 0 to 4. The physical function score has a range of 0 (no functional limitation) to 68 (maximal functional limitation).</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>NStride APS</title>
            <description>Subjects will receive an intra-articular injection of APS.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to 12 Months in Pain, Stiffness, and Function in Daily Living Measured With WOMAC Questionnaire</title>
          <description>The WOMAC LK 3.1 questionnaire is a validated tool commonly used for assessing knee pain, stiffness, and function. The WOMAC LK 3.1 questionnaire has 24 items that the patient addresses about the knee: 5 items on the pain subscale, 2 on the stiffness subscale, and 17 on the physical function subscale. Each item is answered on a 5-point Likert scale, with grading from 0 (none or never) to 4 (extreme or always). A higher score indicates worse pain, stiffness, or functional limitation.&#xD;
The WOMAC pain subscale consists of five questions scored from 0 to 4. The pain score has a range of 0 (no pain) to 20 (maximal pain).&#xD;
The WOMAC stiffness subscale consists of two questions scored from 0 to 4. The stiffness score has a range of 0 (no stiffness) to 8 (maximal stiffness).&#xD;
The WOMAC physical function subscale consists of seventeen questions scored from 0 to 4. The physical function score has a range of 0 (no functional limitation) to 68 (maximal functional limitation).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>WOMAC Pain - Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.2" spread="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>WOMAC Pain - 12 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3" spread="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>WOMAC Stiffness - Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.8" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>WOMAC Stiffness - 12 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6" spread="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>WOMAC Physical Function - Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.6" spread="9.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>WOMAC Physical Function - 12 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.1" spread="9.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to 12 Months in Pain as Measured by the Numeric Rating Scale (NRS)</title>
        <description>The Numeric Rating Scale (NRS) is a validated measure of knee pain. The NRS is an 11 point Likert type scale anchored by 0 &quot;no pain&quot; and 10 &quot;worst possible pain&quot;. Subjects rate their average pain over the last 24 hours.</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>NStride APS</title>
            <description>Subjects will receive an intra-articular injection of APS.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to 12 Months in Pain as Measured by the Numeric Rating Scale (NRS)</title>
          <description>The Numeric Rating Scale (NRS) is a validated measure of knee pain. The NRS is an 11 point Likert type scale anchored by 0 &quot;no pain&quot; and 10 &quot;worst possible pain&quot;. Subjects rate their average pain over the last 24 hours.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>NRS Pain - Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.9" spread="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NRS Pain - 12 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6" spread="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to 12 Months in Pain as Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS)</title>
        <description>The KOOS questionnaire is a commonly used instrument to assess the patient's opinion about their knee and associated problems. KOOS consists of 5 subscales: Pain (9 questions), Symptoms (7 questions), Function in daily living (ADL) (17 questions), Function in sport and recreation (Sport/Rec) (5 questions) and knee related Quality of Life (QOL) (4 questions). The previous week is used as the time period for answering the questions.&#xD;
A higher score on the KOOS questionnaire indicates fewer problems, and 0 indicates extreme problems. Each subscale score is calculated independently. The mean score of the individual items of each subscale is calculated and divided by 4 (the highest possible score for a single answer option). Traditionally in orthopedics, 100 indicates no problems and 0 indicates extreme problems. The normalized score is transformed to meet this standard.</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>NStride APS</title>
            <description>Subjects will receive an intra-articular injection of APS.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to 12 Months in Pain as Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS)</title>
          <description>The KOOS questionnaire is a commonly used instrument to assess the patient's opinion about their knee and associated problems. KOOS consists of 5 subscales: Pain (9 questions), Symptoms (7 questions), Function in daily living (ADL) (17 questions), Function in sport and recreation (Sport/Rec) (5 questions) and knee related Quality of Life (QOL) (4 questions). The previous week is used as the time period for answering the questions.&#xD;
A higher score on the KOOS questionnaire indicates fewer problems, and 0 indicates extreme problems. Each subscale score is calculated independently. The mean score of the individual items of each subscale is calculated and divided by 4 (the highest possible score for a single answer option). Traditionally in orthopedics, 100 indicates no problems and 0 indicates extreme problems. The normalized score is transformed to meet this standard.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>KOOS Pain - Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.9" spread="16.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>KOOS Pain - 1 Week</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.7" spread="16.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>KOOS Pain - 12 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.7" spread="16.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>NStride APS</title>
          <description>Subjects will receive an intra-articular injection of APS.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <description>The event was considered not related to the device and not related to the procedure</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Blood glucose increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Gingival swelling</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Tooth extraction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Joint stiffness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Joint swelling</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Musculoskeletal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Limb discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Foot fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Wheezing</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Respiratory disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" 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>The Investigator must provide the Sponsor at least 90 days to review publications for legal and regulatory compliance and will include in publications a statement that the study was supported by the Sponsor. Sponsor confidential information will not be submitted for publication without Sponsor consent. Sponsor may request delay of publication for 60 days to allow for patent application filing.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Jennifer Woodell-May, PhD</name_or_title>
      <organization>Zimmer Biomet</organization>
      <email>jennifer.woodell-may@zimmerbiomet.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02262364
org study id: APSS-22-01
nct id: NCT02262364
lead sponsor: 
collaborator: 
has dmc: Yes
The primary objective of this study is to assess the safety of a single injection of APS.
The primary objective of this study is to assess the safety of a single injection of APS in
      patients with painful unilateral knee osteoarthritis and who have not been able to get
      satisfactory pain relief with other treatments through one-month post treatment and monitor
      subjects for adverse events through 12 months.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Adverse Events
time frame: 1 Year
description: Adverse Events and Serious Adverse Events
measure: Change From Baseline to 12 Months in Pain, Stiffness, and Function in Daily Living Measured With WOMAC Questionnaire
time frame: 12 months
description: The WOMAC LK 3.1 questionnaire is a validated tool commonly used for assessing knee pain, stiffness, and function. The WOMAC LK 3.1 questionnaire has 24 items that the patient addresses about the knee: 5 items on the pain subscale, 2 on the stiffness subscale, and 17 on the physical function subscale. Each item is answered on a 5-point Likert scale, with grading from 0 (none or never) to 4 (extreme or always). A higher score indicates worse pain, stiffness, or functional limitation.
The WOMAC pain subscale consists of five questions scored from 0 to 4. The pain score has a range of 0 (no pain) to 20 (maximal pain).
The WOMAC stiffness subscale consists of two questions scored from 0 to 4. The stiffness score has a range of 0 (no stiffness) to 8 (maximal stiffness).
The WOMAC physical function subscale consists of seventeen questions scored from 0 to 4. The physical function score has a range of 0 (no functional limitation) to 68 (maximal functional limitation).
measure: Change From Baseline to 12 Months in Pain as Measured by the Numeric Rating Scale (NRS)
time frame: 12 months
description: The Numeric Rating Scale (NRS) is a validated measure of knee pain. The NRS is an 11 point Likert type scale anchored by 0 "no pain" and 10 "worst possible pain". Subjects rate their average pain over the last 24 hours.
measure: Change From Baseline to 12 Months in Pain as Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS)
time frame: 12 months
description: The KOOS questionnaire is a commonly used instrument to assess the patient's opinion about their knee and associated problems. KOOS consists of 5 subscales: Pain (9 questions), Symptoms (7 questions), Function in daily living (ADL) (17 questions), Function in sport and recreation (Sport/Rec) (5 questions) and knee related Quality of Life (QOL) (4 questions). The previous week is used as the time period for answering the questions.
A higher score on the KOOS questionnaire indicates fewer problems, and 0 indicates extreme problems. Each subscale score is calculated independently. The mean score of the individual items of each subscale is calculated and divided by 4 (the highest possible score for a single answer option). Traditionally in orthopedics, 100 indicates no problems and 0 indicates extreme problems. The normalized score is transformed to meet this standard.
arm group label: NStride APS
arm group type: Experimental
description: Subjects will receive an intra-articular injection of APS.
intervention type: Biological
intervention name: APS
description: See above
arm group label: NStride APS
criteria: 
gender: All
minimum age: 40 Years
maximum age: 75 Years
healthy volunteers: No
last name: Mark Klaassen
role: Principal Investigator
affiliation: OSMC
facility: 
country: United States
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 