<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/NCT04461626</url>
  </required_header>
  <id_info>
    <org_study_id>CSA2014-02K</org_study_id>
    <nct_id>NCT04461626</nct_id>
  </id_info>
  <brief_title>Prospective Multi-centre Outcomes Study of Persona Knee System in Total Knee Arthroplasty</brief_title>
  <official_title>Prospective Multi-centre Outcomes Study of Persona Knee System in Total Knee Arthroplasty</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, multi-centre, non comparative, post market clinical follow-up study&#xD;
      involving orthopaedic surgeons skilled in TKA and experienced implanting the devices included&#xD;
      in this study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objectives of the study are to document the implant survivorship and clinical outcomes&#xD;
      data for the Persona fixed bearing implants used in primary total knee arthroplasty (TKA).&#xD;
      The study will include a maximum of 20 centres and up to 1000 implanted knees. Each centre&#xD;
      may enrol up to a maximum of 100 implanted knees to permit assessment of the consistency of&#xD;
      outcomes across a variety of investigators and clinical settings.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 19, 2014</start_date>
  <completion_date type="Actual">June 30, 2023</completion_date>
  <primary_completion_date type="Actual">June 30, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Implant Survivorship</measure>
    <time_frame>Up to 5 years post surgery</time_frame>
    <description>Implant survivorship based on removal of the study device and will be summarized using Kaplan-Meier analysis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adverse Events (Safety)</measure>
    <time_frame>Up to 5 years post surgery</time_frame>
    <description>Safety based on incidence and frequency of adverse events</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical Performance</measure>
    <time_frame>Up to 5 years post surgery</time_frame>
    <description>Clinical Performance measured by overall pain and function and qualify of life Measured using EQ5D questionnaire and Knee Society Score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical Performance</measure>
    <time_frame>Up to 5 years post surgery</time_frame>
    <description>Clinical Performance measured by physician assessment of radiographs form. Data collected include the position and assessment of the radiographs of the operated knee</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1017</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Persona fixed bearing knee system</arm_group_label>
    <description>Persona fixed bearing knee system (All patients will received Persona fixed bearing knee system)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Persona fixed bearing knee system (All patients will receive Persona fixed bearing knee system)</intervention_name>
    <arm_group_label>Persona fixed bearing knee system</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study population will consist of patients who require primary TKA and satisfy eligible&#xD;
        criteria outlined in this section. In order to avoid potential selection bias, each&#xD;
        investigator will offer study participation to each consecutive eligible patient presenting&#xD;
        as a candidate for primary TKA using the Persona fixed bearing knee system.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 to 80 years old, inclusive&#xD;
&#xD;
          -  Qualifies for a primary TKA based on physical exam and medical history, including&#xD;
             diagnosis of severe knee pain and disability due to at least one of the following:&#xD;
&#xD;
               1. Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.&#xD;
&#xD;
               2. Collagen disorders and/ or avascular necrosis of femoral condyle.&#xD;
&#xD;
               3. Post-traumatic loss of joint configuration, particularly when there is&#xD;
                  patellofemoral erosion, dysfunction or prior patellectomy.&#xD;
&#xD;
               4. Moderate valgus, varus or flexion deformities.&#xD;
&#xD;
               5. The salvage of previously failed surgical attempts that did not include partial&#xD;
                  or total knee arthroplasty of the ipsilateral knee.&#xD;
&#xD;
          -  Participated in a study-related informed consent process.&#xD;
&#xD;
          -  Willing and able to provide written informed consent by signing and dating the IRB/EC&#xD;
             approved informed consent form.&#xD;
&#xD;
          -  Willing and able to complete scheduled study procedures and follow-up evaluations.&#xD;
&#xD;
          -  Independent of study participation, patient is a candidate for commercially available&#xD;
             Persona fixed bearing knee system implanted in accordance with product labelling.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently participating in any other surgical intervention studies or pain management&#xD;
             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;
          -  Any loss of musculature or neuromuscular disease that compromises the 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;
          -  Known or suspected sensitivity or allergy to one or more of the implant materials.&#xD;
&#xD;
          -  Pregnant or considered a member of a protected population (e.g. prisoner, mentally&#xD;
             incompetent, etc.)&#xD;
&#xD;
          -  Previously received partial or total knee arthroplasty for the ipsilateral knee.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Myung Chul Lee</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fremantle Hospital</name>
      <address>
        <city>West Perth</city>
        <zip>6160</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fortis Health Care, Bangalore</name>
      <address>
        <city>Bangalore</city>
        <zip>560076,</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sant Parmanand Hospital</name>
      <address>
        <city>Delhi</city>
        <zip>110 054</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>All India Institute of Medical Sciences</name>
      <address>
        <city>Delhi</city>
        <zip>110029</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Landmark Hospitals</name>
      <address>
        <city>Hyderabad</city>
        <zip>500085</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Deenanath Mangeshkar Hospital</name>
      <address>
        <city>Pune</city>
        <zip>411004</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kochi University Hospital</name>
      <address>
        <city>Kochi</city>
        <zip>783-8505</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nihon University Hospital</name>
      <address>
        <city>Tokyo</city>
        <zip>101-8309</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GangNeung Asan Hospital</name>
      <address>
        <city>Gangneung</city>
        <zip>25440</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chonnam National University Hwasun Hospital</name>
      <address>
        <city>Hwasun</city>
        <zip>58128</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chungang University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>06973</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>110-460</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul St. Mary's Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>137-701</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>138-736</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>138-736</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pusan National University Yangsan Hospital</name>
      <address>
        <city>Yangsan</city>
        <zip>50612</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Waikato Hospital</name>
      <address>
        <city>Hamilton</city>
        <state>Waikato</state>
        <zip>3204</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Singapore General Hospital</name>
      <address>
        <city>Singapore</city>
        <zip>169608</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>India</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>New Zealand</country>
    <country>Singapore</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>July 9, 2023</last_update_submitted>
  <last_update_submitted_qc>July 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 11, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
  </condition_browse>
  <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/NCT04461626
org study id: CSA2014-02K
nct id: NCT04461626
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a prospective, multi-centre, non comparative, post market clinical follow-up study
      involving orthopaedic surgeons skilled in TKA and experienced implanting the devices included
      in this study.
The objectives of the study are to document the implant survivorship and clinical outcomes
      data for the Persona fixed bearing implants used in primary total knee arthroplasty (TKA).
      The study will include a maximum of 20 centres and up to 1000 implanted knees. Each centre
      may enrol up to a maximum of 100 implanted knees to permit assessment of the consistency of
      outcomes across a variety of investigators and clinical settings.
observational model: Other
time perspective: Prospective
measure: Implant Survivorship
time frame: Up to 5 years post surgery
description: Implant survivorship based on removal of the study device and will be summarized using Kaplan-Meier analysis
measure: Adverse Events (Safety)
time frame: Up to 5 years post surgery
description: Safety based on incidence and frequency of adverse events
measure: Clinical Performance
time frame: Up to 5 years post surgery
description: Clinical Performance measured by overall pain and function and qualify of life Measured using EQ5D questionnaire and Knee Society Score
measure: Clinical Performance
time frame: Up to 5 years post surgery
description: Clinical Performance measured by physician assessment of radiographs form. Data collected include the position and assessment of the radiographs of the operated knee
arm group label: Persona fixed bearing knee system
description: Persona fixed bearing knee system (All patients will received Persona fixed bearing knee system)
intervention type: Device
intervention name: Persona fixed bearing knee system (All patients will receive Persona fixed bearing knee system)
arm group label: Persona fixed bearing knee system
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
last name: Myung Chul Lee
role: Principal Investigator
affiliation: Seoul National University Hospital
facility: 
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country: Australia
country: India
country: Japan
country: Korea, Republic of
country: New Zealand
country: Singapore
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
sharing ipd: No