<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/NCT03034811</url>
  </required_header>
  <id_info>
    <org_study_id>K.CR.I.G.16.16</org_study_id>
    <nct_id>NCT03034811</nct_id>
  </id_info>
  <brief_title>Persona Partial Knee Clinical Outcomes Study</brief_title>
  <official_title>Persona Partial Knee Clinical Outcomes Study</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>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to obtain implant survivorship and clinical outcomes&#xD;
      data for the commercially available Persona Partial Knee System.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study design is a prospective, multicenter, noncontrolled study of the commercially&#xD;
      available Persona Partial Knee. The study will require each site to obtain IRB approval prior&#xD;
      to 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 partial knee&#xD;
      arthroplasty. Investigators will collect clinical data for a required 2 years with the option&#xD;
      to continue follow-up assessment up to 10 years. Follow-up clinical visits include 3 months,&#xD;
      1 year, 2, 5, and 10 years post-operatively.&#xD;
&#xD;
      The primary objective of this study is to obtain implant survivorship and clinical outcomes&#xD;
      data for the commercially available Persona Partial Knee System. The assessments will&#xD;
      include: implant survivorship based on revision with removal of the study device; safety&#xD;
      based on incidence and frequency of adverse events; and clinical performance measured by&#xD;
      overall pain and function, quality of life data, radiographic parameters, and survivorship.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 8, 2017</start_date>
  <completion_date type="Anticipated">July 2029</completion_date>
  <primary_completion_date type="Anticipated">September 2027</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>Oxford Knee Score</measure>
    <time_frame>10 years</time_frame>
    <description>A Patient reported functional outcome score for knee arthroplasty</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>EQ-5D</measure>
    <time_frame>10 years</time_frame>
    <description>a questionnaire completed by the Patient and assesses his/her General health Status. The EQ5D is used to derive a Quality of life index used for health economics considerations.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">643</enrollment>
  <condition>Osteoarthritis</condition>
  <condition>Avascular Necrosis</condition>
  <condition>Traumatic Arthritis</condition>
  <condition>Conditional Tibial Condyle or Plateau Fractures</condition>
  <condition>Conditional Revision of the Articular Surface</condition>
  <arm_group>
    <arm_group_label>PPK subjects</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Subjects that receive the Persona Partial Knee system</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Persona Partial Knee system</intervention_name>
    <description>Fixed bearing partial knee</description>
    <arm_group_label>PPK subjects</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient is at least 18 years of age&#xD;
&#xD;
          -  Patient qualifies for knee arthroplasty based upon physical exam and medical history,&#xD;
             and meets the approved indications for use of the Persona Partial Knee system.&#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/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 the commercially&#xD;
             available Persona Partial Knee, 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;
          -  Infection, sepsis, and osteomyelitis&#xD;
&#xD;
          -  Rheumatoid arthritis or other forms of inflammatory joint disease&#xD;
&#xD;
          -  Insufficiency of the collateral, anterior or posterior cruciate ligaments which would&#xD;
             preclude stability of the device&#xD;
&#xD;
          -  Full thickness damage to the weight bearing area of the contralateral compartment&#xD;
&#xD;
          -  Uncooperative patient or patient with neurologic disorders who is incapable of&#xD;
             following directions&#xD;
&#xD;
          -  Insufficient bone stock to provide adequate support and/or fixation to the prosthesis&#xD;
&#xD;
          -  Metabolic disorders which may impair bone formation&#xD;
&#xD;
          -  Osteomalacia&#xD;
&#xD;
          -  Distant foci of infections which may spread to the implant site&#xD;
&#xD;
          -  Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram&#xD;
&#xD;
          -  Vascular insufficiency, muscular atrophy, neuromuscular disease&#xD;
&#xD;
          -  Incomplete or deficient soft tissue surrounding the knee&#xD;
&#xD;
          -  Charcot's disease&#xD;
&#xD;
          -  Fixed varus deformity (not passively correctable) of greater than 15 degrees&#xD;
&#xD;
          -  Fixed flexion deformity (not passively correctable) of greater than 15 degrees&#xD;
&#xD;
          -  Patient is pregnant or considered a member of a protected population (e.g., prisoner,&#xD;
             mentally incompetent, etc.)&#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>Hillary Overholser</last_name>
    <role>Study Director</role>
    <affiliation>Zimmer Biomet</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sah Orthopaedic Associates</name>
      <address>
        <city>Fremont</city>
        <state>California</state>
        <zip>94538</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Panorama Orthopedics &amp; Spine Center</name>
      <address>
        <city>Golden</city>
        <state>Colorado</state>
        <zip>80401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Midwest Orthopaedics at Rush</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</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>Sports Medicine North</name>
      <address>
        <city>Beverly</city>
        <state>Massachusetts</state>
        <zip>01960</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Troy Orthopaedic Associates</name>
      <address>
        <city>Troy</city>
        <state>Michigan</state>
        <zip>48084</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Mexico Orthopaedics</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Midlands Orthopaedics &amp; Neurosurgery</name>
      <address>
        <city>Columbia</city>
        <state>South Carolina</state>
        <zip>29201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Skagit Regional Clinics-Riverbend</name>
      <address>
        <city>Mount Vernon</city>
        <state>Washington</state>
        <zip>98273</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orthopädisches Spital Speising</name>
      <address>
        <city>Vienna</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cliniques Universitaires Saint-Luc</name>
      <address>
        <city>Woluwe-Saint-Lambert</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marseille University-Hospital Centres</name>
      <address>
        <city>Marseille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Public Hospital of Versailles</name>
      <address>
        <city>Versailles</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hessing Stiftung</name>
      <address>
        <city>Augsburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sana Kliniken Sommerfeld</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Waldkrankenhaus Eisenberg</name>
      <address>
        <city>Eisenberg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orthopedic Institute IRCCS</name>
      <address>
        <city>Milan</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione IRCCS Policlinico San Matteo</name>
      <address>
        <city>Pavia</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Alcorcón</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Umea University Hospital</name>
      <address>
        <city>Umea</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital d'Yverdon les Bains</name>
      <address>
        <city>Yverdon les Bains</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Avon Orthopaedic Centre, Southmead Hospital</name>
      <address>
        <city>Bristol</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Derby Hospital</name>
      <address>
        <city>Derby</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harrogate and District NHS Foundation Trust</name>
      <address>
        <city>Harrogate</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Belgium</country>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>Switzerland</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>January 25, 2017</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</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>Noninflammatory degenerative joint disease</keyword>
  <keyword>Osteoarthritis</keyword>
  <keyword>Avascular necrosis</keyword>
  <keyword>Traumatic arthritis</keyword>
  <keyword>Partial knee arthroplasty</keyword>
  <keyword>Unicompartmental 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>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/NCT03034811
org study id: K.CR.I.G.16.16
nct id: NCT03034811
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The primary objective of this study is to obtain implant survivorship and clinical outcomes
      data for the commercially available Persona Partial Knee System.
The study design is a prospective, multicenter, noncontrolled study of the commercially
      available Persona Partial Knee. 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 partial knee
      arthroplasty. Investigators will collect clinical data for a required 2 years with the option
      to continue follow-up assessment up to 10 years. Follow-up clinical visits include 3 months,
      1 year, 2, 5, and 10 years post-operatively.

      The primary objective of this study is to obtain implant survivorship and clinical outcomes
      data for the commercially available Persona Partial Knee System. The assessments will
      include: implant survivorship based on revision with removal of the 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: Oxford Knee Score
time frame: 10 years
description: A Patient reported functional outcome score for knee arthroplasty
measure: EQ-5D
time frame: 10 years
description: a questionnaire completed by the Patient and assesses his/her General health Status. The EQ5D is used to derive a Quality of life index used for health economics considerations.
arm group label: PPK subjects
arm group type: Other
description: Subjects that receive the Persona Partial Knee system
intervention type: Device
intervention name: Persona Partial Knee system
description: Fixed bearing partial knee
arm group label: PPK subjects
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Hillary Overholser
role: Study Director
affiliation: Zimmer Biomet
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Austria
country: Belgium
country: France
country: Germany
country: Italy
country: Spain
country: Sweden
country: Switzerland
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Osteoarthritis
mesh term: Necrosis
sharing ipd: No