<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/NCT03023410</url>
  </required_header>
  <id_info>
    <org_study_id>Revision TKA Study</org_study_id>
    <nct_id>NCT03023410</nct_id>
  </id_info>
  <brief_title>Using Intraoperative Sensing Technology to Evaluate Revision Total Knee Arthroplasty</brief_title>
  <official_title>Using Intraoperative Sensing Technology to Evaluate Revision Total Knee Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Orthosensor, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Orthosensor, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will attempt to draw relationships between the soft-tissue related complications&#xD;
      contributing to early TKA revision and the loading and positional patterns from&#xD;
      intraoperative tibial trial sensors. The data from the sensors may enable the surgeon to&#xD;
      address such soft-tissue abnormalities that may otherwise be unknown during traditional total&#xD;
      knee revision procedures. The utilization of sensors should in theory, help diagnose the&#xD;
      potential causes attributing to soft-tissue imbalance and may lead to a decreased need for an&#xD;
      all component revision. Furthermore, the economic implications from converting a total&#xD;
      revision to a partial revision could have a profound effect to the patient and healthcare&#xD;
      provider such as decreased rehabilitation regimes and opportunity for cost savings. Eligible&#xD;
      revision patients who agree to participate will be followed for a period of 12 months&#xD;
      following the revision procedure. Patient reported outcomes measures (PROM) such as the 2011&#xD;
      Knee Society Score (KSS) and the Veterans Rand 12-Item Health Survey (VR-12) will be&#xD;
      collected at baseline (pre-operatively) and at 6 weeks, 6 months and 12 months&#xD;
      post-procedure. All outcomes will be scored to observe changes from baseline at 12-months.&#xD;
      Cost-analyses of sensor-assisted revision TKA will be performed to include OR costs, facility&#xD;
      and physician fees, as well as payments to post-acute collaborators such as SNFs, rehab&#xD;
      hospitals, PT and home care providers. A quantitative analysis of commercial payer claims /&#xD;
      usage data (e.g., CMS Medpar data) will be used to examine costs associated with traditional&#xD;
      revision TKA procedures.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Define Revision Type and Primary Cause</measure>
    <time_frame>Change from Surgical Outcome at 12-months.</time_frame>
    <description>The objective is to evaluate and link the possible causes of early TKA revision procedures using intraoperative sensors in effort to understand why knees fail in addition to examining the economic implications to the patient and hospital.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Knee Society Score</measure>
    <time_frame>Change from Baseline at 12-months</time_frame>
    <description>This survey is subdivided into a knee score that rates only the knee joint itself and a functional score that rates the patient's ability to walk and climb stairs. Patient expectations as well as patient satisfaction are also evaluated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Veterans Rand 12-Item Health Survey</measure>
    <time_frame>Change from Baseline at 12-months</time_frame>
    <description>This survey is primarily used to measure health related quality of life, to estimate disease burden and to evaluate disease-specific impact on general and selected populations. The items on the questionnaire correspond to eight principal health domains including general health perceptions, physical functioning, role limitations due to physical and emotional problems, bodily pain, energy-fatigue , social functioning and mental health</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Partial Revision</arm_group_label>
    <description>A &quot;partial&quot; revision will be indicated when only the tibial liner is changed or only the tibial liner with the tibial tray or only the tibial liner with the femoral component.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Total Revision</arm_group_label>
    <description>A &quot;total&quot; revision will be indicated when all components are completely removed and replaced (tibial tray, femoral component and tibial liner).</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>VERASENSE</intervention_name>
    <description>Sensor-Assisted Revision TKA</description>
    <arm_group_label>Partial Revision</arm_group_label>
    <arm_group_label>Total Revision</arm_group_label>
    <other_name>Sensor-Assisted TKA</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who are candidates for revision TKA and meet all inclusion and no exclusion will&#xD;
        be offered study participation without regard to race, sex, economic status, or religious&#xD;
        belief.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing revision unilateral total knee arthroplasty within the first&#xD;
             5-years of the index procedure&#xD;
&#xD;
          -  Include Male and Female subjects&#xD;
&#xD;
          -  Include subjects 18 years and older&#xD;
&#xD;
          -  Patients should present with idiopathic pain and/or instability/stiffness attributed&#xD;
             to aseptic loosening, polyethylene wear or malrotation&#xD;
&#xD;
          -  Patients able to understand study intent, and agree to study participation&#xD;
&#xD;
          -  Patients must be previously implanted with the following cruciate-retaining (CR) or&#xD;
             posterior-substituting (PS) total knee systems: Stryker TRIATHLON, Zimmer-Biomet&#xD;
             VANGUARD or NEXGEN or Smith and Nephew LEGION or JOURNEY II.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No prior revision surgery on operative side&#xD;
&#xD;
          -  Ligament insufficiencies, prior surgeries such as PCL reconstructions, posterolateral&#xD;
             reconstructions, osteotomies, tibia plateau fractures&#xD;
&#xD;
          -  Culture positive aspiration indicating infection of the joint&#xD;
&#xD;
          -  ASA class &gt; III&#xD;
&#xD;
          -  History of drug or alcohol abuse&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>William Leone, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Holy Cross Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Christopher R Anderson, MS, MBA</last_name>
    <phone>954-577-7770</phone>
    <email>canderson@orthosensor.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Holy Cross Hospital, Orthopedic Institute</name>
      <address>
        <city>Fort Lauderdale</city>
        <state>Florida</state>
        <zip>33334</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>William Leone, MD</last_name>
      <phone>954-489-4575</phone>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>July 14, 2017</last_update_submitted>
  <last_update_submitted_qc>July 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 19, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Revision TKA</keyword>
  <keyword>Instability</keyword>
  <keyword>Stiffness</keyword>
  <keyword>Aseptic Loosening</keyword>
  <keyword>Polyethylene Wear</keyword>
  <keyword>Malrotation</keyword>
  <keyword>Soft Tissue Imbalance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
  </condition_browse>
  <!-- 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/NCT03023410
org study id: Revision TKA Study
nct id: NCT03023410
lead sponsor: 
has dmc: No
This study will attempt to draw relationships between the soft-tissue related complications
      contributing to early TKA revision and the loading and positional patterns from
      intraoperative tibial trial sensors. The data from the sensors may enable the surgeon to
      address such soft-tissue abnormalities that may otherwise be unknown during traditional total
      knee revision procedures. The utilization of sensors should in theory, help diagnose the
      potential causes attributing to soft-tissue imbalance and may lead to a decreased need for an
      all component revision. Furthermore, the economic implications from converting a total
      revision to a partial revision could have a profound effect to the patient and healthcare
      provider such as decreased rehabilitation regimes and opportunity for cost savings. Eligible
      revision patients who agree to participate will be followed for a period of 12 months
      following the revision procedure. Patient reported outcomes measures (PROM) such as the 2011
      Knee Society Score (KSS) and the Veterans Rand 12-Item Health Survey (VR-12) will be
      collected at baseline (pre-operatively) and at 6 weeks, 6 months and 12 months
      post-procedure. All outcomes will be scored to observe changes from baseline at 12-months.
      Cost-analyses of sensor-assisted revision TKA will be performed to include OR costs, facility
      and physician fees, as well as payments to post-acute collaborators such as SNFs, rehab
      hospitals, PT and home care providers. A quantitative analysis of commercial payer claims /
      usage data (e.g., CMS Medpar data) will be used to examine costs associated with traditional
      revision TKA procedures.
observational model: Cohort
time perspective: Prospective
measure: Define Revision Type and Primary Cause
time frame: Change from Surgical Outcome at 12-months.
description: The objective is to evaluate and link the possible causes of early TKA revision procedures using intraoperative sensors in effort to understand why knees fail in addition to examining the economic implications to the patient and hospital.
measure: Knee Society Score
time frame: Change from Baseline at 12-months
description: This survey is subdivided into a knee score that rates only the knee joint itself and a functional score that rates the patient's ability to walk and climb stairs. Patient expectations as well as patient satisfaction are also evaluated.
measure: Veterans Rand 12-Item Health Survey
time frame: Change from Baseline at 12-months
description: This survey is primarily used to measure health related quality of life, to estimate disease burden and to evaluate disease-specific impact on general and selected populations. The items on the questionnaire correspond to eight principal health domains including general health perceptions, physical functioning, role limitations due to physical and emotional problems, bodily pain, energy-fatigue , social functioning and mental health
arm group label: Partial Revision
description: A "partial" revision will be indicated when only the tibial liner is changed or only the tibial liner with the tibial tray or only the tibial liner with the femoral component.
arm group label: Total Revision
description: A "total" revision will be indicated when all components are completely removed and replaced (tibial tray, femoral component and tibial liner).
intervention type: Procedure
intervention name: VERASENSE
description: Sensor-Assisted Revision TKA
arm group label: Partial Revision
arm group label: Total Revision
other name: Sensor-Assisted TKA
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: William Leone, MD
role: Principal Investigator
affiliation: Holy Cross Hospital
last name: Christopher R Anderson, MS, MBA
phone: 954-577-7770
email: canderson@orthosensor.com
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee