<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/NCT02255383</url>
  </required_header>
  <id_info>
    <org_study_id>CSU2014-02K</org_study_id>
    <nct_id>NCT02255383</nct_id>
  </id_info>
  <brief_title>Persona Total Knee Arthroplasty Outcomes Study</brief_title>
  <official_title>Persona The Personalized Knee System TKA Outcomes Study: Prospective Multicenter Study of the Persona Knee System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zimmer Biomet</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zimmer Biomet</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to obtain implant survivorship and clinical outcomes&#xD;
      data for commercially available Persona fixed bearing knee implants used in total knee&#xD;
      arthroplasty. The assessment will include implant survivorship and clinical performance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study design is a prospective, multicenter, study of the commercially available Persona&#xD;
      fixed bearing knee implants. The study will require each site to obtain IRB approval prior to&#xD;
      study enrollment. All potential study subjects will be required to participate in the&#xD;
      Informed Consent Process.&#xD;
&#xD;
      All study subjects will undergo preoperative clinical evaluations prior to their total knee&#xD;
      arthroplasty. The post-operative clinical and radiographic evaluations will be conducted at 6&#xD;
      weeks, 6 months, 1 year, 2, 3, 5, 7, and 10 years.&#xD;
&#xD;
      The primary objective of this study is to obtain implant survivorship and clinical outcomes&#xD;
      data for the commercially available Persona fixed bearing implants used in primary total knee&#xD;
      arthroplasty. The assessments will include: implant survivorship based on removal of a study&#xD;
      device; safety based on incidence and frequency of adverse events; and clinical performance&#xD;
      measured by overall pain and function, quality of life data, radiographic parameters and&#xD;
      survivorship.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">December 2027</completion_date>
  <primary_completion_date type="Anticipated">December 2025</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>Knee Society Score</measure>
    <time_frame>10 years</time_frame>
    <description>Knee Society Score</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>EQ-5D</measure>
    <time_frame>10 years</time_frame>
    <description>EQ-5D</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">737</enrollment>
  <condition>Knee Pain Chronic</condition>
  <condition>Osteoarthritis</condition>
  <condition>Rheumatoid Arthritis</condition>
  <condition>Traumatic Arthritis</condition>
  <condition>Polyarthritis</condition>
  <condition>Moderate Varus, Valgus or Flexion Deformities</condition>
  <condition>Avascular Necrosis of the Femoral Condyle</condition>
  <arm_group>
    <arm_group_label>PERSONA TKA</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Primary total knee arthroplasty subjects that receive the Zimmer Persona Total Knee System</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Zimmer Persona Total Knee System</intervention_name>
    <description>Primary Total Knee Arthroplasty</description>
    <arm_group_label>PERSONA TKA</arm_group_label>
    <other_name>Total Knee Arthroplasty</other_name>
    <other_name>Total Knee Replacement</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient 18-75 years of age, inclusive&#xD;
&#xD;
          -  Patient qualifies for primary total knee arthroplasty based on physical exam and&#xD;
             medical history, including diagnosis of severe knee pain and disability due to at&#xD;
             least one of the following: a) rheumatoid arthritis, osteoarthritis, traumatic&#xD;
             arthritis, polyarthritis; b) collagen disorders and/or avascular necrosis of the&#xD;
             femoral condyle; c) post-traumatic loss of joint configuration, particularly when&#xD;
             there is patellofemoral erosion, dysfunction or prior patellectomy; d) moderate&#xD;
             valgus, varus, or flexion deformities; or e) the salvage of previously failed surgical&#xD;
             attempts that did not include partial or total knee arthroplasty of the ipsilateral&#xD;
             knee&#xD;
&#xD;
          -  Patient has participated in a study-related Informed Consent process&#xD;
&#xD;
          -  Patient is willing and able to provide written Informed Consent by signing and dating&#xD;
             the IRB or EC approved Informed Consent Form&#xD;
&#xD;
          -  Patient is willing and able to complete scheduled study procedures and follow-up&#xD;
             evaluations&#xD;
&#xD;
          -  Independent of study participation, patient is a candidate for commercially available&#xD;
             Persona fixed bearing knee components implanted in accordance with product labeling&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient is currently participating in any other surgical intervention studies or pain&#xD;
             management studies&#xD;
&#xD;
          -  Previous history of infection in the affected joint and/or other local/systemic&#xD;
             infection that may affect the prosthetic joint&#xD;
&#xD;
          -  Insufficient bone stock on femoral or tibial surfaces&#xD;
&#xD;
          -  Skeletal immaturity&#xD;
&#xD;
          -  Neuropathic arthropathy&#xD;
&#xD;
          -  Osteoporosis or any loss of musculature or neuromuscular disease that compromises the&#xD;
             affected limb&#xD;
&#xD;
          -  Stable, painless arthrodesis in a satisfactory functional position&#xD;
&#xD;
          -  Severe instability secondary to the absence of collateral ligament integrity&#xD;
&#xD;
          -  Rheumatoid arthritis accompanied by an ulcer of the skin or a history of recurrent&#xD;
             breakdown of the skin&#xD;
&#xD;
          -  Patient has a known or suspected sensitivity or allergy to one or more of the implant&#xD;
             materials&#xD;
&#xD;
          -  Patient is pregnant or considered a member of a protected population (e.g., prisoner,&#xD;
             mentally incompetent, etc.)&#xD;
&#xD;
          -  Patient has previously received partial or total knee arthroplasty for the ipsilateral&#xD;
             knee&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kacy Arnold, RN, MBA</last_name>
    <role>Study Director</role>
    <affiliation>Zimmer Biomet</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Colorado Joint Replacement</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orthopaedic &amp; Spine Center of the Rockies</name>
      <address>
        <city>Fort Collins</city>
        <state>Colorado</state>
        <zip>80525</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Denver-Vail Orthopedics</name>
      <address>
        <city>Parker</city>
        <state>Colorado</state>
        <zip>80134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rockford Orthopedic Associates</name>
      <address>
        <city>Rockford</city>
        <state>Illinois</state>
        <zip>61114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry County Orthopedics and Sports Medicine</name>
      <address>
        <city>New Castle</city>
        <state>Indiana</state>
        <zip>47362</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UNC Department of Orthopaedics</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599-7055</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OrthoCarolina</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Raleigh Orthopaedic Clinic</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lindner Research Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SportsMedicine Grant &amp; Orthopaedic Associates</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tennessee Orthopaedic Foundation for Education and Research</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37930</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Tech University Health Sciences Center</name>
      <address>
        <city>Lubbock</city>
        <state>Texas</state>
        <zip>79430</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jordan Young Institute</name>
      <address>
        <city>Virginia Beach</city>
        <state>Virginia</state>
        <zip>23462-1784</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>September 29, 2014</study_first_submitted>
  <study_first_submitted_qc>October 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2014</study_first_posted>
  <last_update_submitted>August 27, 2023</last_update_submitted>
  <last_update_submitted_qc>August 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Osteoarthritis</keyword>
  <keyword>Rheumatoid Arthritis</keyword>
  <keyword>Traumatic Arthritis</keyword>
  <keyword>Polyarthritis</keyword>
  <keyword>Total Knee Arthroplasty</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</mesh_term>
    <mesh_term>Necrosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02255383
org study id: CSU2014-02K
nct id: NCT02255383
lead sponsor: 
has dmc: No
The primary objective of this study is to obtain implant survivorship and clinical outcomes
      data for commercially available Persona fixed bearing knee implants used in total knee
      arthroplasty. The assessment will include implant survivorship and clinical performance.
The study design is a prospective, multicenter, study of the commercially available Persona
      fixed bearing knee implants. The study will require each site to obtain IRB approval prior to
      study enrollment. All potential study subjects will be required to participate in the
      Informed Consent Process.

      All study subjects will undergo preoperative clinical evaluations prior to their total knee
      arthroplasty. The post-operative clinical and radiographic evaluations will be conducted at 6
      weeks, 6 months, 1 year, 2, 3, 5, 7, and 10 years.

      The primary objective of this study is to obtain implant survivorship and clinical outcomes
      data for the commercially available Persona fixed bearing implants used in primary total knee
      arthroplasty. The assessments will include: implant survivorship based on removal of a study
      device; safety based on incidence and frequency of adverse events; and clinical performance
      measured by overall pain and function, quality of life data, radiographic parameters and
      survivorship.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Knee Society Score
time frame: 10 years
description: Knee Society Score
measure: EQ-5D
time frame: 10 years
description: EQ-5D
arm group label: PERSONA TKA
arm group type: Other
description: Primary total knee arthroplasty subjects that receive the Zimmer Persona Total Knee System
intervention type: Device
intervention name: Zimmer Persona Total Knee System
description: Primary Total Knee Arthroplasty
arm group label: PERSONA TKA
other name: Total Knee Arthroplasty
other name: Total Knee Replacement
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Kacy Arnold, RN, MBA
role: Study Director
affiliation: Zimmer Biomet
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
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country: United States
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Osteoarthritis
mesh term: Arthritis, Rheumatoid
mesh term: Necrosis
sharing ipd: No