<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/NCT02219230</url>
  </required_header>
  <id_info>
    <org_study_id>40660-A</org_study_id>
    <secondary_id>A62089</secondary_id>
    <nct_id>NCT02219230</nct_id>
  </id_info>
  <brief_title>Use of Passive, Adaptive, and Active Prosthetic Knees in Persons With Unilateral, Transfemoral Amputation</brief_title>
  <acronym>OPK</acronym>
  <official_title>Outcomes Associated With Use of Passive, Adaptive, and Active Prosthetic Knees in Persons With Unilateral, Transfemoral Amputation: a Randomized Crossover Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Össur Ehf</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Washington</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goals of this study are to assess measured, observed, and self-reported outcomes achieved&#xD;
      through the use of passive (mechanical), active(motorized) and adaptive (magnetorheological)&#xD;
      prosthetic knee control systems in individuals with unilateral, transfemoral amputation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      An interrupted time-series trial with pre/post baseline assessments, randomized crossover of&#xD;
      interventions, and within-phase repeated measures is used to evaluate and compare the&#xD;
      effectiveness of the Össur Power Knee II and the Össur Rheo Knee in individuals with&#xD;
      unilateral, transfemoral amputation. A rigorous and clinically-meaningful experimental&#xD;
      protocol is applied to verify study participants receive appropriate training, experience,&#xD;
      and assessment in each knee condition. A suite of standardized and ad-hoc physical&#xD;
      performance tests, patient-reported questionnaires, and monitoring technologies were&#xD;
      carefully selected to assess important, clinically-relevant participant outcomes. Comparative&#xD;
      effectiveness of three prosthetic knee interventions are evaluated using direct measurement&#xD;
      (i.e., timed tests), observed clinical ratings (i.e., subjective assessments of gait quality)&#xD;
      and self-report instruments (i.e., health status surveys). Analyses will focus on identifying&#xD;
      differences between control system technologies inherent to each type of prosthetic knee&#xD;
      (i.e., passive [mechanical], adaptive [magnetorheological], and active [power]). Outcomes&#xD;
      will be used to establish recommendations for which activities and patients knees are most&#xD;
      appropriate or likely to produce a desired effect.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2011</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">September 2013</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>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Timed Up and Go</measure>
    <time_frame>Change from Baseline (mean score at weeks 1, 2, 3, and 4) to Follow-Up (mean score at weeks 8, 12, 16, 20, 24, and 28)</time_frame>
    <description>Timed performance test that measures rising from a chair, walking 3m, and returning to a seated position.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Timed Ramp Test</measure>
    <time_frame>Change from Baseline (mean score at weeks 1, 2, 3, and 4) to Follow-Up (mean score at weeks 8, 12, 16, 20, 24, and 28)</time_frame>
    <description>Timed performance test that involves walking up and down a 14ft ramp.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Timed Stair Test</measure>
    <time_frame>Change from Baseline (mean score at weeks 1, 2, 3, and 4) to Follow-Up (mean score at weeks 8, 12, 16, 20, 24, and 28)</time_frame>
    <description>Timed performance test that involves walking up and down 6 steps.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Step activity</measure>
    <time_frame>Change from Baseline (mean score at weeks 1, 2, 3, and 4) to Follow-Up (mean score at weeks 8, 12, 16, 20, 24, and 28)</time_frame>
    <description>Average daily step counts measured by an accelerometer-based device.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Obstacle course time</measure>
    <time_frame>Change from Baseline (mean score at weeks 1, 2, 3, and 4) to Follow-Up (mean score at weeks 8, 12, 16, 20, 24, and 28)</time_frame>
    <description>Time to walk a 1/2-mile outdoor walking course.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reported Falls</measure>
    <time_frame>Change from Baseline (mean score at weeks 1, 2, 3, and 4) to Follow-Up (mean score at weeks 8, 12, 16, 20, 24, and 28)</time_frame>
    <description>Self-report phone survey.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prosthesis Evaluation Questionnaire (PEQ)</measure>
    <time_frame>Change from Baseline (mean score at weeks 1, 2, 3, and 4) to Follow-Up (mean score at weeks 8, 12, 16, 20, 24, and 28)</time_frame>
    <description>Self-report computerized survey (12 questions)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activities Specific Balance Confidence Scale (ABC)</measure>
    <time_frame>Change from Baseline (mean score at weeks 1, 2, 3, and 4) to Follow-Up (mean score at weeks 8, 12, 16, 20, 24, and 28)</time_frame>
    <description>Self-report computerized survey (18 questions).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Reported Outcomes Measurement Information System (PROMIS)</measure>
    <time_frame>Change from Baseline (mean score at weeks 1, 2, 3, and 4) to Follow-Up (mean score at weeks 8, 12, 16, 20, 24, and 28)</time_frame>
    <description>Self-report computerized questionnaire with 8-14 questions per domain. Includes Physical Function, Fatigue, and General Health subdomains.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Transfemoral Amputation</condition>
  <arm_group>
    <arm_group_label>Prosthetic knee</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects crossed over between interventions (three different prosthetic knees). Knee conditions include 1) Active knee (Ossur Power Knee II); 2) Adaptive knee (Ossur Rheo); and 3) Passive knee (Various manufacturers)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Active knee (Ossur Power Knee II)</intervention_name>
    <description>Prosthetic knee with active control system.</description>
    <arm_group_label>Prosthetic knee</arm_group_label>
    <other_name>Power knee</other_name>
    <other_name>Motorized knee</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Adaptive knee (Ossur Rheo)</intervention_name>
    <description>Prosthetic knee with adaptive control system.</description>
    <arm_group_label>Prosthetic knee</arm_group_label>
    <other_name>Magnetorheological knee</other_name>
    <other_name>Microprocessor knee</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Passive knee (Various manufacturers)</intervention_name>
    <description>Prosthetic knee with mechanical control system.</description>
    <arm_group_label>Prosthetic knee</arm_group_label>
    <other_name>Mechanical knee</other_name>
    <other_name>Hydraulic knee</other_name>
    <other_name>Pneumatic knee</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 45 - 75&#xD;
&#xD;
          -  body weight less than 275lbs&#xD;
&#xD;
          -  unilateral amputation between the hip and knee&#xD;
&#xD;
          -  amputation due to non-vascular causes&#xD;
&#xD;
          -  no other major limb amputations&#xD;
&#xD;
          -  amputation occurred at least 2 years prior&#xD;
&#xD;
          -  stable limb volume (i.e., at least 6 months on an unmodified prosthetic socket)&#xD;
&#xD;
          -  intact skin tissue without open wounds or sores for at least 2 months&#xD;
&#xD;
          -  physiologically stable medical condition (i.e., non-degenerative)&#xD;
&#xD;
          -  possession and regular (i.e., daily) use of a prosthesis with a prosthetic knee with&#xD;
             non-microprocessor (i.e., mechanical or fluid) stance control&#xD;
&#xD;
          -  Medicare functional classification level (MFCL or &quot;K-level&quot;) 3&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  expect to receive or are expected to require a replacement prosthetic socket within 15&#xD;
             months&#xD;
&#xD;
          -  complete reliance on an assistive device (i.e., cane or walker) for ambulation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Brian Hafner, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Washington</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Washington</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Hafner BJ, Askew RL. Physical performance and self-report outcomes associated with use of passive, adaptive, and active prosthetic knees in persons with unilateral, transfemoral amputation: Randomized crossover trial. J Rehabil Res Dev. 2015;52(6):677-700. doi: 10.1682/JRRD.2014.09.0210.</citation>
    <PMID>26560243</PMID>
  </results_reference>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>July 29, 2014</study_first_submitted>
  <study_first_submitted_qc>August 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 18, 2014</study_first_posted>
  <last_update_submitted>December 23, 2015</last_update_submitted>
  <last_update_submitted_qc>December 23, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 28, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Washington</investigator_affiliation>
    <investigator_full_name>Brian Hafner</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <pending_results>
    <submitted>March 26, 2017</submitted>
    <returned>May 5, 2017</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02219230
org study id: 40660-A
secondary id: A62089
nct id: NCT02219230
lead sponsor: 
collaborator: 
has dmc: No
The goals of this study are to assess measured, observed, and self-reported outcomes achieved
      through the use of passive (mechanical), active(motorized) and adaptive (magnetorheological)
      prosthetic knee control systems in individuals with unilateral, transfemoral amputation.
An interrupted time-series trial with pre/post baseline assessments, randomized crossover of
      interventions, and within-phase repeated measures is used to evaluate and compare the
      effectiveness of the Össur Power Knee II and the Össur Rheo Knee in individuals with
      unilateral, transfemoral amputation. A rigorous and clinically-meaningful experimental
      protocol is applied to verify study participants receive appropriate training, experience,
      and assessment in each knee condition. A suite of standardized and ad-hoc physical
      performance tests, patient-reported questionnaires, and monitoring technologies were
      carefully selected to assess important, clinically-relevant participant outcomes. Comparative
      effectiveness of three prosthetic knee interventions are evaluated using direct measurement
      (i.e., timed tests), observed clinical ratings (i.e., subjective assessments of gait quality)
      and self-report instruments (i.e., health status surveys). Analyses will focus on identifying
      differences between control system technologies inherent to each type of prosthetic knee
      (i.e., passive [mechanical], adaptive [magnetorheological], and active [power]). Outcomes
      will be used to establish recommendations for which activities and patients knees are most
      appropriate or likely to produce a desired effect.
allocation: N/A
intervention model: Single Group Assignment
masking: Single (Participant)
measure: Timed Up and Go
time frame: Change from Baseline (mean score at weeks 1, 2, 3, and 4) to Follow-Up (mean score at weeks 8, 12, 16, 20, 24, and 28)
description: Timed performance test that measures rising from a chair, walking 3m, and returning to a seated position.
measure: Timed Ramp Test
time frame: Change from Baseline (mean score at weeks 1, 2, 3, and 4) to Follow-Up (mean score at weeks 8, 12, 16, 20, 24, and 28)
description: Timed performance test that involves walking up and down a 14ft ramp.
measure: Timed Stair Test
time frame: Change from Baseline (mean score at weeks 1, 2, 3, and 4) to Follow-Up (mean score at weeks 8, 12, 16, 20, 24, and 28)
description: Timed performance test that involves walking up and down 6 steps.
measure: Step activity
time frame: Change from Baseline (mean score at weeks 1, 2, 3, and 4) to Follow-Up (mean score at weeks 8, 12, 16, 20, 24, and 28)
description: Average daily step counts measured by an accelerometer-based device.
measure: Obstacle course time
time frame: Change from Baseline (mean score at weeks 1, 2, 3, and 4) to Follow-Up (mean score at weeks 8, 12, 16, 20, 24, and 28)
description: Time to walk a 1/2-mile outdoor walking course.
measure: Reported Falls
time frame: Change from Baseline (mean score at weeks 1, 2, 3, and 4) to Follow-Up (mean score at weeks 8, 12, 16, 20, 24, and 28)
description: Self-report phone survey.
measure: Prosthesis Evaluation Questionnaire (PEQ)
time frame: Change from Baseline (mean score at weeks 1, 2, 3, and 4) to Follow-Up (mean score at weeks 8, 12, 16, 20, 24, and 28)
description: Self-report computerized survey (12 questions)
measure: Activities Specific Balance Confidence Scale (ABC)
time frame: Change from Baseline (mean score at weeks 1, 2, 3, and 4) to Follow-Up (mean score at weeks 8, 12, 16, 20, 24, and 28)
description: Self-report computerized survey (18 questions).
measure: Patient Reported Outcomes Measurement Information System (PROMIS)
time frame: Change from Baseline (mean score at weeks 1, 2, 3, and 4) to Follow-Up (mean score at weeks 8, 12, 16, 20, 24, and 28)
description: Self-report computerized questionnaire with 8-14 questions per domain. Includes Physical Function, Fatigue, and General Health subdomains.
arm group label: Prosthetic knee
arm group type: Experimental
description: Subjects crossed over between interventions (three different prosthetic knees). Knee conditions include 1) Active knee (Ossur Power Knee II); 2) Adaptive knee (Ossur Rheo); and 3) Passive knee (Various manufacturers)
intervention type: Device
intervention name: Active knee (Ossur Power Knee II)
description: Prosthetic knee with active control system.
arm group label: Prosthetic knee
other name: Power knee
other name: Motorized knee
intervention type: Device
intervention name: Adaptive knee (Ossur Rheo)
description: Prosthetic knee with adaptive control system.
arm group label: Prosthetic knee
other name: Magnetorheological knee
other name: Microprocessor knee
intervention type: Device
intervention name: Passive knee (Various manufacturers)
description: Prosthetic knee with mechanical control system.
arm group label: Prosthetic knee
other name: Mechanical knee
other name: Hydraulic knee
other name: Pneumatic knee
criteria: 
gender: All
minimum age: 45 Years
maximum age: 75 Years
healthy volunteers: No
last name: Brian Hafner, PhD
role: Principal Investigator
affiliation: University of Washington
facility: 
country: United States
citation: Hafner BJ, Askew RL. Physical performance and self-report outcomes associated with use of passive, adaptive, and active prosthetic knees in persons with unilateral, transfemoral amputation: Randomized crossover trial. J Rehabil Res Dev. 2015;52(6):677-700. doi: 10.1682/JRRD.2014.09.0210.
PMID: 26560243
responsible party type: Principal Investigator
investigator affiliation: University of Washington
investigator full name: Brian Hafner
investigator title: Associate Professor
submitted: March 26, 2017
returned: May 5, 2017