<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/NCT03292003</url>
  </required_header>
  <id_info>
    <org_study_id>16-4049-08</org_study_id>
    <nct_id>NCT03292003</nct_id>
  </id_info>
  <brief_title>Journey II Bi-Cruciate Stabilized (BCS) Total Knee System Retrospective Study</brief_title>
  <official_title>Safety and Performance of Journey II BCS 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>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to estimate the safety and performance of Journey II BCS TKS.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this study is to estimate the safety and performance of Journey II BCS TKS.&#xD;
      Specifically, the study will establish revision rate, treatment- and device-related&#xD;
      complications, and clinical outcomes in a large sample of subjects who received the study&#xD;
      device. Subjects are screened consecutively, beginning at the earliest date of implantation&#xD;
      at each investigative site. Further, reasons for revision will be collected and analyzed. An&#xD;
      analysis will be performed to identify characteristics (patient, surgeon and surgical)&#xD;
      associated with an increased risk for revision. Finally, clinical, functional and quality of&#xD;
      life outcomes will be analyzed to the extent data is available, given the retrospective study&#xD;
      design.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 30, 2016</start_date>
  <completion_date type="Actual">September 24, 2018</completion_date>
  <primary_completion_date type="Actual">January 30, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Revision Rate of Total Knee System</measure>
    <time_frame>implantation through study completion, approximately 3 years</time_frame>
    <description>Number of revisions</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>implantation through study completion, approximately 3 years</time_frame>
    <description>Number of adverse events reported per ISO 14155 guidelines</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>Patient reported outcomes</measure>
    <time_frame>implantation through study completion, approximately 3 years</time_frame>
    <description>EQ-5D-3L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical outcomes</measure>
    <time_frame>implantation through study completion, approximately 3 years</time_frame>
    <description>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>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1694</enrollment>
  <condition>Total Knee Arthroplasty</condition>
  <arm_group>
    <arm_group_label>Journey II BCS Total Knee System</arm_group_label>
    <description>Subjects having TKA with Journey II BCS Total Knee System</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Journey II BCS Total Knee System</intervention_name>
    <arm_group_label>Journey II BCS Total Knee System</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Sites will identify potential subjects by retrospectively reviewing their source documents&#xD;
        in order to identify all patients who received TKA with the Journey II BCS TKS.&#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 BCS Total Knee System for approved indication&#xD;
&#xD;
          -  The TKA occurred at least 12 weeks prior to enrollment&#xD;
&#xD;
          -  Subject records contain Patient Reported Outcome data obtained ≤3 months prior to as&#xD;
             well as ≥6 months post-enrollment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject received the JOURNEY II BCS Total Knee System on the affected knee as a&#xD;
             revision for a previously failed total or unicondylar knee arthroplasty&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Beate Hanson, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Vice President, Global Clinical Strategy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Colorado Orthopaedics</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Andrews Research and Education Foundation</name>
      <address>
        <city>Gulf Breeze</city>
        <state>Florida</state>
        <zip>32571</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Methodist Sports Medicine</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46280</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital for Special Surgery</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Orthopaedics Center</name>
      <address>
        <city>State College</city>
        <state>Pennsylvania</state>
        <zip>16602</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TN Orthopaedic Foundation for Education and Research</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37923</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>Providence Regional Medical Center</name>
      <address>
        <city>Everett</city>
        <state>Washington</state>
        <zip>98021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marra Knee and Shoulder Center</name>
      <address>
        <city>Wheeling</city>
        <state>West Virginia</state>
        <zip>26003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jesse Ziekenhuis</name>
      <address>
        <city>Hasselt</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Leuven Campus</name>
      <address>
        <city>Pellenberg</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Christen Ortho AG</name>
      <address>
        <city>Bern</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Switzerland</country>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>May 20, 2017</study_first_submitted>
  <study_first_submitted_qc>September 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>March 27, 2019</last_update_submitted>
  <last_update_submitted_qc>March 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>rheumatoid arthritis</keyword>
  <keyword>post-traumatic arthritis</keyword>
  <keyword>osteoarthritis</keyword>
  <keyword>degenerative arthritis</keyword>
  <keyword>failed osteotomy</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/NCT03292003
org study id: 16-4049-08
nct id: NCT03292003
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The objective of this study is to estimate the safety and performance of Journey II BCS TKS.
The objective of this study is to estimate the safety and performance of Journey II BCS TKS.
      Specifically, the study will establish revision rate, treatment- and device-related
      complications, and clinical outcomes in a large sample of subjects who received the study
      device. Subjects are screened consecutively, beginning at the earliest date of implantation
      at each investigative site. Further, reasons for revision will be collected and analyzed. An
      analysis will be performed to identify characteristics (patient, surgeon and surgical)
      associated with an increased risk for revision. Finally, clinical, functional and quality of
      life outcomes will be analyzed to the extent data is available, given the retrospective study
      design.
observational model: Case-Only
time perspective: Retrospective
measure: Revision Rate of Total Knee System
time frame: implantation through study completion, approximately 3 years
description: Number of revisions
measure: Adverse Events
time frame: implantation through study completion, approximately 3 years
description: Number of adverse events reported per ISO 14155 guidelines
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: Patient reported outcomes
time frame: implantation through study completion, approximately 3 years
description: EQ-5D-3L
measure: Clinical outcomes
time frame: implantation through study completion, approximately 3 years
description: 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
arm group label: Journey II BCS Total Knee System
description: Subjects having TKA with Journey II BCS Total Knee System
intervention type: Device
intervention name: Journey II BCS Total Knee System
arm group label: Journey II BCS Total Knee System
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Beate Hanson, MD, PhD
role: Study Chair
affiliation: Vice President, Global Clinical Strategy
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Belgium
country: Switzerland
country: United States
responsible party type: Sponsor
sharing ipd: No