<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/NCT02240186</url>
  </required_header>
  <id_info>
    <org_study_id>14-002930</org_study_id>
    <secondary_id>Foundation</secondary_id>
    <nct_id>NCT02240186</nct_id>
  </id_info>
  <brief_title>Comparative Effectiveness Between Microprocessor Knees and Non-Microprocessor Knees</brief_title>
  <acronym>MPK-AOPA</acronym>
  <official_title>Comparative Effectiveness Between Microprocessor Knees and Non-Microprocessor Knees</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American Orthotic and Prosthetic Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will assess if the functional performance and musculoskeletal outcome of&#xD;
      transfemoral amputees are improved after receiving a Microprocessor Knee (MPK) compared to a&#xD;
      Non-Microprocessor Knees (NMPK).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study design is a reversal design whereby only the prosthetic knee joint will be changed.&#xD;
      Each subject will be tested using their current NMPK, fit and tested with a MPK, and then&#xD;
      tested again with their NMPK. MPK prostheses from all manufacturers will be considered&#xD;
      appropriate for testing. Each MPK to be used in this study is FDA approved. The foot will be&#xD;
      in the L5981 class, e.g. flex foot or equivalent. The same socket, suspension, and foot will&#xD;
      be used throughout the study in order to eliminate these confounding variables. All&#xD;
      prosthesis fittings will be performed by the subject's own certified prosthetist according to&#xD;
      manufacturers' fitting guidelines.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2014</start_date>
  <completion_date type="Actual">December 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>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>Daily Activity Measured With Triaxial Accelerometers</measure>
    <time_frame>Baseline (tested on subjects' current NMPK), 10 weeks (after 10 weeks acclimation time to the study MPK) , 4 weeks (subjects placed back on NMPK and tested after 4 weeks re-acclimation time)</time_frame>
    <description>Measurements will be obtained three times using activity monitors attached to waist, and bilaterally to the ankle and thigh for a period of 4 consecutive days, including 2 weekdays and 2 weekend days. Primary outcome will be the difference in activity level between the NMPK and MPK measurements.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Falls as Assessed by the Prosthesis Evaluation Questionnaire Addendum (PEQ-A)</measure>
    <time_frame>Baseline (tested on subjects' current NMPK), 10 weeks (after 10 weeks acclimation time to the study MPK) , 4 weeks (subjects placed back on NMPK and tested after 4 weeks re-acclimation time)</time_frame>
    <description>The Prosthesis Evaluation Questionnaire (PEQ) addendum (PEQ-A) is a self-administered questionnaire to quantify balance confidence, concentration, stumbles, and falls. The outcome will be difference in falls per month between the Non-Microprocessor Knee (NPMK) and MPK measurements. The number of falls was recorded as the sum of items #5 and #7 in the PEQ-A.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction as Assessed by the Prosthesis Evaluation Questionnaire (PEQ)</measure>
    <time_frame>Baseline (tested on subjects' current NMPK), 10 weeks (after 10 weeks acclimation time to the study MPK) , 4 weeks (subjects placed back on NMPK and tested after 4 weeks re-acclimation time)</time_frame>
    <description>The condition-specific Prosthesis Evaluation Questionnaire (PEQ) was used to quantify patient satisfaction with each prosthesis. The outcome was a difference in PEQ scores between the NPMK and MPK measurements.&#xD;
The PEQ is a self-administered questionnaire composed of nine validated scales (ambulation, appearance, frustration, perceived response, residual limb health, social burden, sounds, utility, well being). Scores range from 0 to 100 for each sub-scale. Higher scores indicated a higher functioning prosthesis/quality of life.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Lower Limb Amputation Above Knee (Injury)</condition>
  <arm_group>
    <arm_group_label>Prosthetic knee joints</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each subject will be tested using their current Non-Microprocessor Knee (NMPK) , fit and tested with a Microprocessor Knee (MPK), and then tested again with their NMPK, e.g. A-B-A design.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Microprocessor Knee (MPK)</intervention_name>
    <description>MPKs are prosthetic knees that use a microprocessor to control the prosthetic knee mechanism and adjust knee stiffness.</description>
    <arm_group_label>Prosthetic knee joints</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Non-Microprocessor Knee (NMPK)</intervention_name>
    <description>A NMPK is a mechanical knee with either hydraulic or pneumatic controls.</description>
    <arm_group_label>Prosthetic knee joints</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Unilateral transfemoral amputee&#xD;
&#xD;
          -  Medicare Functional Classification Level K2 or K3&#xD;
&#xD;
          -  Currently using NMPK prosthesis&#xD;
&#xD;
          -  No current residual limb problems, such as skin breakdown&#xD;
&#xD;
          -  Able to ambulate without a gait aid&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous stroke or other neuromuscular complications currently affecting gait&#xD;
&#xD;
          -  Currently undergoing dialysis treatments&#xD;
&#xD;
          -  Amputation of the contralateral limb&#xD;
&#xD;
          -  Poor fit of current NMPK prosthesis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kenton R Kaufman, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Kaufman KR, Bernhardt KA, Symms K. Functional assessment and satisfaction of transfemoral amputees with low mobility (FASTK2): A clinical trial of microprocessor-controlled vs. non-microprocessor-controlled knees. Clin Biomech (Bristol, Avon). 2018 Oct;58:116-122. doi: 10.1016/j.clinbiomech.2018.07.012. Epub 2018 Jul 19.</citation>
    <PMID>30077128</PMID>
  </results_reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>September 8, 2014</study_first_submitted>
  <study_first_submitted_qc>September 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 15, 2014</study_first_posted>
  <results_first_submitted>October 3, 2018</results_first_submitted>
  <results_first_submitted_qc>December 11, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">December 12, 2018</results_first_posted>
  <last_update_submitted>December 11, 2018</last_update_submitted>
  <last_update_submitted_qc>December 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 12, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Kenton R. Kaufman, Ph.D.</investigator_full_name>
    <investigator_title>Professor of Biomedical Engineering, College of Medicine</investigator_title>
  </responsible_party>
  <keyword>Microprocessor-controlled knee</keyword>
  <keyword>prosthesis</keyword>
  <keyword>amputation</keyword>
  <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>September 1, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/86/NCT02240186/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Prosthetic Knee Joints</title>
          <description>Each subject will be tested using their current Non-Microprocessor Knee (NMPK) , fit and tested with a Microprocessor Knee (MPK), and then tested again with their NMPK, e.g. A-B-A design.&#xD;
Microprocessor Knee (MPK): MPKs are prosthetic knees that use a microprocessor to control the prosthetic knee mechanism and adjust knee stiffness.&#xD;
Non-Microprocessor Knee (NMPK): A NMPK is a mechanical knee with either hydraulic or pneumatic controls.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Prosthetic Knee Joints</title>
          <description>Each subject will be tested using their current Non-Microprocessor Knee (NMPK) , fit and tested with a Microprocessor Knee (MPK), and then tested again with their NMPK, e.g. A-B-A design.&#xD;
Microprocessor Knee (MPK): MPKs are prosthetic knees that use a microprocessor to control the prosthetic knee mechanism and adjust knee stiffness.&#xD;
Non-Microprocessor Knee (NMPK): A NMPK is a mechanical knee with either hydraulic or pneumatic controls.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="50"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="69" spread="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                  </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="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Daily Activity Measured With Triaxial Accelerometers</title>
        <description>Measurements will be obtained three times using activity monitors attached to waist, and bilaterally to the ankle and thigh for a period of 4 consecutive days, including 2 weekdays and 2 weekend days. Primary outcome will be the difference in activity level between the NMPK and MPK measurements.</description>
        <time_frame>Baseline (tested on subjects' current NMPK), 10 weeks (after 10 weeks acclimation time to the study MPK) , 4 weeks (subjects placed back on NMPK and tested after 4 weeks re-acclimation time)</time_frame>
        <population>Activity measurement data were available for analysis on 46 baseline participants, 31 MPK participants, and 18 NMPK participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Prosthetic Knee Joints</title>
            <description>Each subject will be tested using their current Non-Microprocessor Knee (NMPK) , fit and tested with a Microprocessor Knee (MPK), and then tested again with their NMPK, e.g. A-B-A design.&#xD;
Microprocessor Knee (MPK): MPKs are prosthetic knees that use a microprocessor to control the prosthetic knee mechanism and adjust knee stiffness.&#xD;
Non-Microprocessor Knee (NMPK): A NMPK is a mechanical knee with either hydraulic or pneumatic controls.</description>
          </group>
        </group_list>
        <measure>
          <title>Daily Activity Measured With Triaxial Accelerometers</title>
          <description>Measurements will be obtained three times using activity monitors attached to waist, and bilaterally to the ankle and thigh for a period of 4 consecutive days, including 2 weekdays and 2 weekend days. Primary outcome will be the difference in activity level between the NMPK and MPK measurements.</description>
          <population>Activity measurement data were available for analysis on 46 baseline participants, 31 MPK participants, and 18 NMPK participants.</population>
          <units>% of Day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.64" spread="8362"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MPK</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.68" spread="11.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NMPK</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.23" spread="10.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.01</p_value>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Falls as Assessed by the Prosthesis Evaluation Questionnaire Addendum (PEQ-A)</title>
        <description>The Prosthesis Evaluation Questionnaire (PEQ) addendum (PEQ-A) is a self-administered questionnaire to quantify balance confidence, concentration, stumbles, and falls. The outcome will be difference in falls per month between the Non-Microprocessor Knee (NPMK) and MPK measurements. The number of falls was recorded as the sum of items #5 and #7 in the PEQ-A.</description>
        <time_frame>Baseline (tested on subjects' current NMPK), 10 weeks (after 10 weeks acclimation time to the study MPK) , 4 weeks (subjects placed back on NMPK and tested after 4 weeks re-acclimation time)</time_frame>
        <population>Data for falls were available for analysis on 46 baseline participants, 30 MPK participants, and 17 NMPK participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Prosthetic Knee Joints</title>
            <description>Each subject will be tested using their current Non-Microprocessor Knee (NMPK) , fit and tested with a Microprocessor Knee (MPK), and then tested again with their NMPK, e.g. A-B-A design.&#xD;
Microprocessor Knee (MPK): MPKs are prosthetic knees that use a microprocessor to control the prosthetic knee mechanism and adjust knee stiffness.&#xD;
Non-Microprocessor Knee (NMPK): A NMPK is a mechanical knee with either hydraulic or pneumatic controls.</description>
          </group>
        </group_list>
        <measure>
          <title>Falls as Assessed by the Prosthesis Evaluation Questionnaire Addendum (PEQ-A)</title>
          <description>The Prosthesis Evaluation Questionnaire (PEQ) addendum (PEQ-A) is a self-administered questionnaire to quantify balance confidence, concentration, stumbles, and falls. The outcome will be difference in falls per month between the Non-Microprocessor Knee (NPMK) and MPK measurements. The number of falls was recorded as the sum of items #5 and #7 in the PEQ-A.</description>
          <population>Data for falls were available for analysis on 46 baseline participants, 30 MPK participants, and 17 NMPK participants.</population>
          <units>Falls per month</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="0.0" upper_limit="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MPK</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="3.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NMPK</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" lower_limit="0.0" upper_limit="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.01</p_value>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Satisfaction as Assessed by the Prosthesis Evaluation Questionnaire (PEQ)</title>
        <description>The condition-specific Prosthesis Evaluation Questionnaire (PEQ) was used to quantify patient satisfaction with each prosthesis. The outcome was a difference in PEQ scores between the NPMK and MPK measurements.&#xD;
The PEQ is a self-administered questionnaire composed of nine validated scales (ambulation, appearance, frustration, perceived response, residual limb health, social burden, sounds, utility, well being). Scores range from 0 to 100 for each sub-scale. Higher scores indicated a higher functioning prosthesis/quality of life.</description>
        <time_frame>Baseline (tested on subjects' current NMPK), 10 weeks (after 10 weeks acclimation time to the study MPK) , 4 weeks (subjects placed back on NMPK and tested after 4 weeks re-acclimation time)</time_frame>
        <population>Not all participants completed all the scales in the questionnaire.</population>
        <group_list>
          <group group_id="O1">
            <title>Prosthetic Knee Joints - NMPK Baseline</title>
            <description>Each subject will be tested using their current Non-Microprocessor Knee (NMPK) , fit and tested with a Microprocessor Knee (MPK), and then tested again with their NMPK, e.g. A-B-A design.&#xD;
Microprocessor Knee (MPK): MPKs are prosthetic knees that use a microprocessor to control the prosthetic knee mechanism and adjust knee stiffness.&#xD;
Non-Microprocessor Knee (NMPK): A NMPK is a mechanical knee with either hydraulic or pneumatic controls.</description>
          </group>
          <group group_id="O2">
            <title>Prosthetic Knee Joint - MPK</title>
            <description>Each subject will be tested using their current Non-Microprocessor Knee (NMPK) , fit and tested with a Microprocessor Knee (MPK), and then tested again with their NMPK, e.g. A-B-A design.&#xD;
Microprocessor Knee (MPK): MPKs are prosthetic knees that use a microprocessor to control the prosthetic knee mechanism and adjust knee stiffness.&#xD;
Non-Microprocessor Knee (NMPK): A NMPK is a mechanical knee with either hydraulic or pneumatic controls.</description>
          </group>
          <group group_id="O3">
            <title>Prosthetic Knee Joint - NMPK</title>
            <description>Each subject will be tested using their current Non-Microprocessor Knee (NMPK) , fit and tested with a Microprocessor Knee (MPK), and then tested again with their NMPK, e.g. A-B-A design.&#xD;
Microprocessor Knee (MPK): MPKs are prosthetic knees that use a microprocessor to control the prosthetic knee mechanism and adjust knee stiffness.&#xD;
Non-Microprocessor Knee (NMPK): A NMPK is a mechanical knee with either hydraulic or pneumatic controls.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Satisfaction as Assessed by the Prosthesis Evaluation Questionnaire (PEQ)</title>
          <description>The condition-specific Prosthesis Evaluation Questionnaire (PEQ) was used to quantify patient satisfaction with each prosthesis. The outcome was a difference in PEQ scores between the NPMK and MPK measurements.&#xD;
The PEQ is a self-administered questionnaire composed of nine validated scales (ambulation, appearance, frustration, perceived response, residual limb health, social burden, sounds, utility, well being). Scores range from 0 to 100 for each sub-scale. Higher scores indicated a higher functioning prosthesis/quality of life.</description>
          <population>Not all participants completed all the scales in the questionnaire.</population>
          <units>Score 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="48"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Ambulation</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.07" spread="17.14"/>
                    <measurement group_id="O2" value="49.58" spread="24.61"/>
                    <measurement group_id="O3" value="45.31" spread="20.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Appearance</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64.55" spread="18.81"/>
                    <measurement group_id="O2" value="74.43" spread="20.64"/>
                    <measurement group_id="O3" value="62.80" spread="19.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Frustration</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.48" spread="29.44"/>
                    <measurement group_id="O2" value="66.28" spread="28.67"/>
                    <measurement group_id="O3" value="56.29" spread="28.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Perceived Response</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="40"/>
                    <count group_id="O2" value="28"/>
                    <count group_id="O3" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85.23" spread="12.29"/>
                    <measurement group_id="O2" value="89.28" spread="12.88"/>
                    <measurement group_id="O3" value="90.00" spread="9.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Residual Limb Health</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.46" spread="19.95"/>
                    <measurement group_id="O2" value="77.08" spread="15.58"/>
                    <measurement group_id="O3" value="76.31" spread="18.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Burden</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="29"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.21" spread="22.75"/>
                    <measurement group_id="O2" value="71.71" spread="23.00"/>
                    <measurement group_id="O3" value="66.06" spread="29.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sounds</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.96" spread="25.28"/>
                    <measurement group_id="O2" value="81.70" spread="23.22"/>
                    <measurement group_id="O3" value="85.13" spread="16.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Utility</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.96" spread="16.48"/>
                    <measurement group_id="O2" value="64.09" spread="21.07"/>
                    <measurement group_id="O3" value="52.52" spread="14.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Well Being</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.47" spread="21.81"/>
                    <measurement group_id="O2" value="62.00" spread="22.18"/>
                    <measurement group_id="O3" value="61.10" spread="20.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.01</p_value>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Acclimation period through assessment after reversion to the NMPK, up 6 months.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Prosthetic Knee Joints</title>
          <description>Each subject will be tested using their current Non-Microprocessor Knee (NMPK) , fit and tested with a Microprocessor Knee (MPK), and then tested again with their NMPK, e.g. A-B-A design.&#xD;
Microprocessor Knee (MPK): MPKs are prosthetic knees that use a microprocessor to control the prosthetic knee mechanism and adjust knee stiffness.&#xD;
Non-Microprocessor Knee (NMPK): A NMPK is a mechanical knee with either hydraulic or pneumatic controls.</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="50"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
              </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="0" subjects_at_risk="50"/>
              </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>Dr. Kenton Kaufman, Principal Investigator</name_or_title>
      <organization>Mayo Clinic</organization>
      <phone>507-284-2262</phone>
      <email>kaufman.kenton@mayo.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/NCT02240186
org study id: 14-002930
secondary id: Foundation
nct id: NCT02240186
lead sponsor: 
collaborator: 
has dmc: No
This study will assess if the functional performance and musculoskeletal outcome of
      transfemoral amputees are improved after receiving a Microprocessor Knee (MPK) compared to a
      Non-Microprocessor Knees (NMPK).
The study design is a reversal design whereby only the prosthetic knee joint will be changed.
      Each subject will be tested using their current NMPK, fit and tested with a MPK, and then
      tested again with their NMPK. MPK prostheses from all manufacturers will be considered
      appropriate for testing. Each MPK to be used in this study is FDA approved. The foot will be
      in the L5981 class, e.g. flex foot or equivalent. The same socket, suspension, and foot will
      be used throughout the study in order to eliminate these confounding variables. All
      prosthesis fittings will be performed by the subject's own certified prosthetist according to
      manufacturers' fitting guidelines.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Daily Activity Measured With Triaxial Accelerometers
time frame: Baseline (tested on subjects' current NMPK), 10 weeks (after 10 weeks acclimation time to the study MPK) , 4 weeks (subjects placed back on NMPK and tested after 4 weeks re-acclimation time)
description: Measurements will be obtained three times using activity monitors attached to waist, and bilaterally to the ankle and thigh for a period of 4 consecutive days, including 2 weekdays and 2 weekend days. Primary outcome will be the difference in activity level between the NMPK and MPK measurements.
measure: Falls as Assessed by the Prosthesis Evaluation Questionnaire Addendum (PEQ-A)
time frame: Baseline (tested on subjects' current NMPK), 10 weeks (after 10 weeks acclimation time to the study MPK) , 4 weeks (subjects placed back on NMPK and tested after 4 weeks re-acclimation time)
description: The Prosthesis Evaluation Questionnaire (PEQ) addendum (PEQ-A) is a self-administered questionnaire to quantify balance confidence, concentration, stumbles, and falls. The outcome will be difference in falls per month between the Non-Microprocessor Knee (NPMK) and MPK measurements. The number of falls was recorded as the sum of items #5 and #7 in the PEQ-A.
measure: Patient Satisfaction as Assessed by the Prosthesis Evaluation Questionnaire (PEQ)
time frame: Baseline (tested on subjects' current NMPK), 10 weeks (after 10 weeks acclimation time to the study MPK) , 4 weeks (subjects placed back on NMPK and tested after 4 weeks re-acclimation time)
description: The condition-specific Prosthesis Evaluation Questionnaire (PEQ) was used to quantify patient satisfaction with each prosthesis. The outcome was a difference in PEQ scores between the NPMK and MPK measurements.
The PEQ is a self-administered questionnaire composed of nine validated scales (ambulation, appearance, frustration, perceived response, residual limb health, social burden, sounds, utility, well being). Scores range from 0 to 100 for each sub-scale. Higher scores indicated a higher functioning prosthesis/quality of life.
arm group label: Prosthetic knee joints
arm group type: Experimental
description: Each subject will be tested using their current Non-Microprocessor Knee (NMPK) , fit and tested with a Microprocessor Knee (MPK), and then tested again with their NMPK, e.g. A-B-A design.
intervention type: Device
intervention name: Microprocessor Knee (MPK)
description: MPKs are prosthetic knees that use a microprocessor to control the prosthetic knee mechanism and adjust knee stiffness.
arm group label: Prosthetic knee joints
intervention type: Device
intervention name: Non-Microprocessor Knee (NMPK)
description: A NMPK is a mechanical knee with either hydraulic or pneumatic controls.
arm group label: Prosthetic knee joints
criteria: 
gender: All
minimum age: 55 Years
maximum age: N/A
healthy volunteers: No
last name: Kenton R Kaufman, PhD
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
citation: Kaufman KR, Bernhardt KA, Symms K. Functional assessment and satisfaction of transfemoral amputees with low mobility (FASTK2): A clinical trial of microprocessor-controlled vs. non-microprocessor-controlled knees. Clin Biomech (Bristol, Avon). 2018 Oct;58:116-122. doi: 10.1016/j.clinbiomech.2018.07.012. Epub 2018 Jul 19.
PMID: 30077128
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Kenton R. Kaufman, Ph.D.
investigator title: Professor of Biomedical Engineering, College of Medicine
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 