<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/NCT03798847</url>
  </required_header>
  <id_info>
    <org_study_id>JIIXR.PMCF.2018.13</org_study_id>
    <nct_id>NCT03798847</nct_id>
  </id_info>
  <brief_title>Safety and Performance of Journey II XR Total Knee System</brief_title>
  <acronym>JIIXR</acronym>
  <official_title>Safety and Performance of Journey II XR Total Knee System. A Retrospective, Multicenter Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Smith &amp; Nephew, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Smith &amp; Nephew, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</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 objective of this study is to estimate the safety and performance of Journey II XR TKS&#xD;
      based on retrospective data.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2018</start_date>
  <completion_date type="Actual">September 10, 2020</completion_date>
  <primary_completion_date type="Actual">September 10, 2020</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Revision of one or more study device components</measure>
    <time_frame>12 weeks follow up</time_frame>
    <description>Measure of the number of revision cases</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>12 weeks follow up</time_frame>
    <description>All collected and reported AEs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health care utilization: Hospitalization</measure>
    <time_frame>implantation through study completion, approximately 3 years</time_frame>
    <description>Length of hospital stay for primary (index) surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health care utilization: Hospitalization</measure>
    <time_frame>Implantation through study completion, approximately 3 years</time_frame>
    <description>Hospitalizations (admission for inpatient care) occurring after the hospitalization for the index surgery (number and length of stay)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health care utilization: Rehabilitation</measure>
    <time_frame>Implantation through study completion, approximately 3 years</time_frame>
    <description>number of sessions and duration of rehabilitation in weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health care utilization: Outpatient visits</measure>
    <time_frame>Implantation through study completion, approximately 3 years</time_frame>
    <description>Number and type of outpatient visits</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Care Utilization: Re-operations</measure>
    <time_frame>Implantation through study completion, approximately 3 years</time_frame>
    <description>Number of re-operations and revisions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life: EQ-5D-3L</measure>
    <time_frame>Implantation through study completion, approximately 3 years</time_frame>
    <description>EuroQol Five Dimensions Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life: KSS</measure>
    <time_frame>Implantation through study completion, approximately 3 years</time_frame>
    <description>2011 Knee Society Score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Return to Work</measure>
    <time_frame>Implantation through study completion, approximately 3 years</time_frame>
    <description>Changes in employment status will be recorded with the date on which the change occurred and the change status.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Technical Difficulties Encountered During Device Implantation</measure>
    <time_frame>Implantation through study completion, approximately 3 years</time_frame>
    <description>Number of technical difficulties encountered with the device</description>
  </secondary_outcome>
  <enrollment type="Actual">683</enrollment>
  <condition>Journey II XR Total Knee System</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Journey II XR TKA</intervention_name>
    <description>Journey II XR Total Knee System</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subject received primary uni- or bi-lateral total knee arthroplasty with the Journey II XR&#xD;
        TKS for approved indication&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject received primary uni- or bi-lateral total knee arthroplasty with the Journey&#xD;
             II XR TKS for approved indication;&#xD;
&#xD;
          -  The TKA occurred at least 12 weeks prior to enrollment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Orthopedic Institute of the West</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rush Copley Orthopaedics</name>
      <address>
        <city>Aurora</city>
        <state>Illinois</state>
        <zip>60504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jerry Orthopaedic Institute</name>
      <address>
        <city>Port Huron</city>
        <state>Michigan</state>
        <zip>48060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Reno Orthopedic Clinic</name>
      <address>
        <city>Reno</city>
        <state>Nevada</state>
        <zip>89503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orthopaedic Center of New Jersey</name>
      <address>
        <city>Somerset</city>
        <state>New Jersey</state>
        <zip>08873</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital for Joint Diseases Orthopaedics Institute</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regenerative Orthopedic Center (ROC)</name>
      <address>
        <city>Oregon City</city>
        <state>Oregon</state>
        <zip>97045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Health &amp; Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>San Antonio Orthopaedic Specialists</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78258</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Anderson Orthopaedic Clinic</name>
      <address>
        <city>Alexandria</city>
        <state>Virginia</state>
        <zip>22306</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Scott Orthopedic Center</name>
      <address>
        <city>Huntington</city>
        <state>West Virginia</state>
        <zip>25702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aurora Medical Center</name>
      <address>
        <city>Kenosha</city>
        <state>Wisconsin</state>
        <zip>53142</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>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>July 12, 2023</last_update_submitted>
  <last_update_submitted_qc>July 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Journey II XR Total Knee System</keyword>
  <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/NCT03798847
org study id: JIIXR.PMCF.2018.13
nct id: NCT03798847
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The objective of this study is to estimate the safety and performance of Journey II XR TKS
      based on retrospective data.
observational model: Other
time perspective: Retrospective
measure: Revision of one or more study device components
time frame: 12 weeks follow up
description: Measure of the number of revision cases
measure: Adverse Events
time frame: 12 weeks follow up
description: All collected and reported AEs
measure: Health care utilization: Hospitalization
time frame: implantation through study completion, approximately 3 years
description: Length of hospital stay for primary (index) surgery
measure: Health care utilization: Hospitalization
time frame: Implantation through study completion, approximately 3 years
description: Hospitalizations (admission for inpatient care) occurring after the hospitalization for the index surgery (number and length of stay)
measure: Health care utilization: Rehabilitation
time frame: Implantation through study completion, approximately 3 years
description: number of sessions and duration of rehabilitation in weeks
measure: Health care utilization: Outpatient visits
time frame: Implantation through study completion, approximately 3 years
description: Number and type of outpatient visits
measure: Health Care Utilization: Re-operations
time frame: Implantation through study completion, approximately 3 years
description: Number of re-operations and revisions
measure: Quality of Life: EQ-5D-3L
time frame: Implantation through study completion, approximately 3 years
description: EuroQol Five Dimensions Questionnaire
measure: Quality of Life: KSS
time frame: Implantation through study completion, approximately 3 years
description: 2011 Knee Society Score
measure: Return to Work
time frame: Implantation through study completion, approximately 3 years
description: Changes in employment status will be recorded with the date on which the change occurred and the change status.
measure: Technical Difficulties Encountered During Device Implantation
time frame: Implantation through study completion, approximately 3 years
description: Number of technical difficulties encountered with the device
intervention type: Device
intervention name: Journey II XR TKA
description: Journey II XR Total Knee System
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
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country: United States
responsible party type: Sponsor
sharing ipd: No