xml: <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/NCT06040827</url>
    </required_header>
    <id_info>
      <org_study_id>PS220001</org_study_id>
      <nct_id>NCT06040827</nct_id>
    </id_info>
    <brief_title>A Multicenter, Postmarket Surveillance Study of Subjects With the Canary canturioTM te Tibial Extension</brief_title>
    <official_title>A Multicenter, Postmarket Surveillance Study of Subjects With the Canary canturioTM te Tibial Extension</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Canary Medical</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Canary Medical</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>
    </oversight_info>
    <brief_summary>
      <textblock>
        The objectives of this prospective observational cohort study are to evaluate the safety,&#xD;
        reliability, reproducibility, and accuracy of the Canary canturioTM te post-TKA.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Group 1 (Test): Zimmer Persona® Personalized Knee System with Canary canturioTM (CTE) tibial&#xD;
        extension Group 2 (Control): Zimmer Persona® Personalized Knee System with 14 mm +30 mm stem&#xD;
        extension Safety Endpoint The nature, severity, and frequency of safety risks in subjects&#xD;
        with the Canary canturioTM te will be compared to those subjects with the legally marketed&#xD;
        Zimmer Persona® Personalized Knee System with 14 mm x +30 mm stem extension within 5 years&#xD;
        post-TKA.&#xD;
  &#xD;
        The safety endpoint is the percentage of patients that meet any of the following criteria&#xD;
        within 5 years post-TKA:&#xD;
  &#xD;
          -  Revision (tibia only)&#xD;
  &#xD;
          -  Aseptic loosening&#xD;
  &#xD;
          -  Instability (or unrecognized septic loosening)&#xD;
  &#xD;
          -  Intra-operative fracture of bone or device&#xD;
  &#xD;
          -  Post-operative fracture of bone or device&#xD;
  &#xD;
          -  Radiologic changes including:&#xD;
  &#xD;
          -  Lytic lines (radiolucency greater than 2 mm in 2 or more zones)&#xD;
  &#xD;
          -  Focal lysis(progressive osteolytic lesion)&#xD;
  &#xD;
          -  Osteolysis (3mm in more than 1 zone)&#xD;
  &#xD;
          -  Device fracture or failure (tibia only)&#xD;
  &#xD;
          -  Cortical thickening or periosteal reactions&#xD;
  &#xD;
        Secondary Endpoints&#xD;
  &#xD;
        The secondary endpoints (for 5 years post-TKA) are:&#xD;
  &#xD;
        Successful Data Collection&#xD;
  &#xD;
          -  Percent of days with step-count data transmitted&#xD;
  &#xD;
          -  Percent of days with one or more gait bouts triggered and transmitted&#xD;
  &#xD;
          -  Percent of days with qualified gait cycles &gt;0 (applicable for walking speed, stride&#xD;
             length, tibia ROM, functional knee ROM and cadence)&#xD;
  &#xD;
          -  Percent of days with step-count data transmitted and qualified gait cycles &gt;0&#xD;
             (applicable for distance) Pain and Functional Performance&#xD;
  &#xD;
          -  Knee Injury and Osteoarthritis Outcome Score (KOOS - JR)&#xD;
  &#xD;
          -  Numeric Pain Rating Scale (NPRS)&#xD;
  &#xD;
          -  Quality-of-life- EQ-5D-5L&#xD;
  &#xD;
        Effectiveness Endpoints (Reliability, Reproducibility, and Accuracy) The reliability,&#xD;
        precision and accuracy of walking speed using measurements at 1 year and 2 years post TKA&#xD;
        will be assessed with a cohort of 75 patients from Group 1 (with the CTE). Additionally, the&#xD;
        reliability, precision and accuracy of all 7 gait parameters (walking speed, cadence, stride&#xD;
        length, functional knee ROM, tibia ROM, step count and distance) using measurements at 1 year&#xD;
        with 3 different walking speeds, will be assessed with a consecutive cohort of 25 patients&#xD;
        from Group 1 in a gait lab.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Anticipated">September 12, 2023</start_date>
    <completion_date type="Anticipated">December 2028</completion_date>
    <primary_completion_date type="Anticipated">June 2028</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>Safety - Adverse Events</measure>
      <time_frame>5 years post TKA</time_frame>
      <description>The nature, severity, and frequency of safety risks (Adverse Events) in subjects with the Canary canturioTM te will be compared to those subjects with the legally marketed Zimmer Persona® Personalized Knee System with 14 mm x +30 mm stem extension within 5 years post-TKA.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Percent of days with step-count data transmitted</measure>
      <time_frame>5 years post TKA</time_frame>
      <description>Successful Data Collection</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percent of days with one or more gait bouts triggered and transmitted</measure>
      <time_frame>5 years post TKA</time_frame>
      <description>Successful Data Collection</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percent of days with qualified gait cycles &gt;0 (applicable for walking speed meter/second, stride length meter, tibia ROM, functional knee ROM and cadence)</measure>
      <time_frame>5 years post TKA</time_frame>
      <description>Successful Data Collection</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percent of days with step-count data transmitted and qualified gait cycles &gt;0 (applicable for distance in meters)</measure>
      <time_frame>5 years post TKA</time_frame>
      <description>Successful Data Collection</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Knee Injury and Osteoarthritis Outcome Score (KOOS - JR)</measure>
      <time_frame>5 years post TKA</time_frame>
      <description>Pain and Functional Performance</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Numeric Pain Rating Scale (NPRS)</measure>
      <time_frame>5 years post TKA</time_frame>
      <description>Pain and Functional Performance</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality-of-life- EQ-5D-5L</measure>
      <time_frame>5 years post TKA</time_frame>
      <description>Pain and Functional Performance</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">600</enrollment>
    <condition>Knee Osteoarthritis</condition>
    <arm_group>
      <arm_group_label>Group 1 (Test)</arm_group_label>
      <description>Zimmer Persona® Personalized Knee System with Canary canturioTM (CTE) tibial extension</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 2 ( Control)</arm_group_label>
      <description>Group 2 (Control): Zimmer Persona® Personalized Knee System with 14 mm +30 mm stem extension</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Total Knee Arthroplasty</intervention_name>
      <description>The nature, severity, and frequency of safety risks (Adverse Events) in subjects with the Canary canturioTM te will be compared to those subjects with the legally marketed Zimmer Persona® Personalized Knee System with 14 mm x +30 mm stem extension within 5 years post-TKA.</description>
      <arm_group_label>Group 1 (Test)</arm_group_label>
      <arm_group_label>Group 2 ( Control)</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients indicated for a total knee arthroplasty&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patient must be 18 years of age or older&#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&#xD;
               osteoarthritis, limited to:&#xD;
  &#xD;
               o Mild or Moderate valgus, varus, or flexion deformities&#xD;
  &#xD;
            -  Patient must be willing and able to complete the protocol required follow-up&#xD;
  &#xD;
            -  Patient is indicated for a 58mm tibial stem extension&#xD;
  &#xD;
            -  Patient has participated in the study-related informed consent process&#xD;
  &#xD;
            -  Patient is willing and able to provide written Informed Consent by signing and dating&#xD;
               the IRB approved informed consent&#xD;
  &#xD;
            -  Patient has a platform-compatible personal computer located in their dwelling with&#xD;
               appropriate wireless internet access and a USB port&#xD;
  &#xD;
            -  Independent of study participation, patient is a candidate for commercially available&#xD;
               Persona Personalized Knee System implanted in accordance with product labeling&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Simultaneous bilateral TKA&#xD;
  &#xD;
            -  Staged bilateral TKA less than 6 months from indexed procedure&#xD;
  &#xD;
            -  Patient is a current alcohol or drug abuser&#xD;
  &#xD;
            -  Patient is known to be pregnant, breastfeeding, or considered a member of a protected&#xD;
               class (e.g., prisoner, mentally incompetent, etc.)&#xD;
  &#xD;
            -  Patient has a psychiatric illness or cognitive deficit that will not allow proper&#xD;
               informed consent and participation in follow-up program&#xD;
  &#xD;
            -  Patient has previous history of infection in the affected joint and/or a local or&#xD;
               systemic infection that may affect the prosthetic joint&#xD;
  &#xD;
            -  Patient with mental or neurologic conditions who are unwilling or incapable of&#xD;
               following postoperative care instructions&#xD;
  &#xD;
            -  Patient with skeletal immaturity&#xD;
  &#xD;
            -  Patient has insufficient bone stock on femoral or tibial surfaces&#xD;
  &#xD;
            -  Patient with Neuropathic Arthropathy&#xD;
  &#xD;
            -  Patient has osteoporosis, or any loss of musculature or neuromuscular disease that&#xD;
               compromises the affected limb&#xD;
  &#xD;
            -  Patient has severe instability secondary to the absence of collateral ligament&#xD;
               integrity.&#xD;
  &#xD;
            -  Patient has a stable, painless arthrodesis in a satisfactory functional position&#xD;
  &#xD;
            -  Patient has rheumatoid arthritis accompanied by an ulcer of the skin or a history of&#xD;
               recurrent breakdown of the skin&#xD;
  &#xD;
            -  Patient has a known or suspected sensitivity to one or more of the implant materials&#xD;
  &#xD;
            -  Patient is undergoing procedures or treatments using ionizing radiation&#xD;
  &#xD;
            -  Patients with known symptomatic foot, hip or spinal injuries and/or conditions that&#xD;
               could affect gait&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <location>
      <facility>
        <name>South Bend Orthopaedics</name>
        <address>
          <city>South Bend</city>
          <state>Indiana</state>
          <zip>46544</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>September 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>total knee arthroplasty</keyword>
    <keyword>Canary canturio™te</keyword>
    <keyword>Zimmer Persona® Personalized Knee System</keyword>
    <keyword>Zimmer Persona® Personalized Knee System with Canary canturioTM (CTE) tibial extension</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>
  
  
text: 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/NCT06040827
  org study id: PS220001
  nct id: NCT06040827
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  The objectives of this prospective observational cohort study are to evaluate the safety,
        reliability, reproducibility, and accuracy of the Canary canturioTM te post-TKA.
  Group 1 (Test): Zimmer Persona® Personalized Knee System with Canary canturioTM (CTE) tibial
        extension Group 2 (Control): Zimmer Persona® Personalized Knee System with 14 mm +30 mm stem
        extension Safety Endpoint The nature, severity, and frequency of safety risks in subjects
        with the Canary canturioTM te will be compared to those subjects with the legally marketed
        Zimmer Persona® Personalized Knee System with 14 mm x +30 mm stem extension within 5 years
        post-TKA.
  
        The safety endpoint is the percentage of patients that meet any of the following criteria
        within 5 years post-TKA:
  
          -  Revision (tibia only)
  
          -  Aseptic loosening
  
          -  Instability (or unrecognized septic loosening)
  
          -  Intra-operative fracture of bone or device
  
          -  Post-operative fracture of bone or device
  
          -  Radiologic changes including:
  
          -  Lytic lines (radiolucency greater than 2 mm in 2 or more zones)
  
          -  Focal lysis(progressive osteolytic lesion)
  
          -  Osteolysis (3mm in more than 1 zone)
  
          -  Device fracture or failure (tibia only)
  
          -  Cortical thickening or periosteal reactions
  
        Secondary Endpoints
  
        The secondary endpoints (for 5 years post-TKA) are:
  
        Successful Data Collection
  
          -  Percent of days with step-count data transmitted
  
          -  Percent of days with one or more gait bouts triggered and transmitted
  
          -  Percent of days with qualified gait cycles >0 (applicable for walking speed, stride
             length, tibia ROM, functional knee ROM and cadence)
  
          -  Percent of days with step-count data transmitted and qualified gait cycles >0
             (applicable for distance) Pain and Functional Performance
  
          -  Knee Injury and Osteoarthritis Outcome Score (KOOS - JR)
  
          -  Numeric Pain Rating Scale (NPRS)
  
          -  Quality-of-life- EQ-5D-5L
  
        Effectiveness Endpoints (Reliability, Reproducibility, and Accuracy) The reliability,
        precision and accuracy of walking speed using measurements at 1 year and 2 years post TKA
        will be assessed with a cohort of 75 patients from Group 1 (with the CTE). Additionally, the
        reliability, precision and accuracy of all 7 gait parameters (walking speed, cadence, stride
        length, functional knee ROM, tibia ROM, step count and distance) using measurements at 1 year
        with 3 different walking speeds, will be assessed with a consecutive cohort of 25 patients
        from Group 1 in a gait lab.
  observational model: Cohort
  time perspective: Prospective
  measure: Safety - Adverse Events
  time frame: 5 years post TKA
  description: The nature, severity, and frequency of safety risks (Adverse Events) in subjects with the Canary canturioTM te will be compared to those subjects with the legally marketed Zimmer Persona® Personalized Knee System with 14 mm x +30 mm stem extension within 5 years post-TKA.
  measure: Percent of days with step-count data transmitted
  time frame: 5 years post TKA
  description: Successful Data Collection
  measure: Percent of days with one or more gait bouts triggered and transmitted
  time frame: 5 years post TKA
  description: Successful Data Collection
  measure: Percent of days with qualified gait cycles >0 (applicable for walking speed meter/second, stride length meter, tibia ROM, functional knee ROM and cadence)
  time frame: 5 years post TKA
  description: Successful Data Collection
  measure: Percent of days with step-count data transmitted and qualified gait cycles >0 (applicable for distance in meters)
  time frame: 5 years post TKA
  description: Successful Data Collection
  measure: Knee Injury and Osteoarthritis Outcome Score (KOOS - JR)
  time frame: 5 years post TKA
  description: Pain and Functional Performance
  measure: Numeric Pain Rating Scale (NPRS)
  time frame: 5 years post TKA
  description: Pain and Functional Performance
  measure: Quality-of-life- EQ-5D-5L
  time frame: 5 years post TKA
  description: Pain and Functional Performance
  arm group label: Group 1 (Test)
  description: Zimmer Persona® Personalized Knee System with Canary canturioTM (CTE) tibial extension
  arm group label: Group 2 ( Control)
  description: Group 2 (Control): Zimmer Persona® Personalized Knee System with 14 mm +30 mm stem extension
  intervention type: Device
  intervention name: Total Knee Arthroplasty
  description: The nature, severity, and frequency of safety risks (Adverse Events) in subjects with the Canary canturioTM te will be compared to those subjects with the legally marketed Zimmer Persona® Personalized Knee System with 14 mm x +30 mm stem extension within 5 years post-TKA.
  arm group label: Group 1 (Test)
  arm group label: Group 2 ( Control)
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Osteoarthritis
  mesh term: Osteoarthritis, Knee