<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/NCT02211794</url>
  </required_header>
  <id_info>
    <org_study_id>R11009-7</org_study_id>
    <nct_id>NCT02211794</nct_id>
  </id_info>
  <brief_title>Journey II BCS EU Observational Trial</brief_title>
  <official_title>A Prospective, Non-randomized, Consecutive Series, Multicenter, Observational Trial to Evaluate the Clinical Outcome of Total Knee Arthroplasty Using Journey II BCS Total Knee System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Smith &amp; Nephew Orthopaedics AG</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>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Post-market study to confirm the safety and efficacy of the Journey II BCS knee prosthesis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Multicenter, prospective, observational study to collect relevant clinical data from 167&#xD;
      subjects implanted with the Journey II BCS Knee System. Data from eligible subjects, who have&#xD;
      provided written informed consent for the collection of their coded data will be recorded&#xD;
      from the patient's medical file on specially designed case report forms (CRF's).&#xD;
&#xD;
      Total study duration for participants will be 10 years with follow-up visits planned at 3&#xD;
      months, 1 year, 2 years, 5 years and 10 years post-surgery. An interim analysis describing&#xD;
      the clinical outcome is planned after 5 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Anticipated">June 2026</completion_date>
  <primary_completion_date type="Anticipated">June 2026</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>Revision for any reason</measure>
    <time_frame>10Years</time_frame>
    <description>The goal of this study is to confirm the safety and efficacy of the Journey II BCS knee prosthesis by demonstrating non-inferiority of the cumulative percent success in subjects implanted with the JOURNEY II BCS Total Knee System compared to a literature reference rate of 94.3% (AOA annual report 201121) at 10 years. &quot;Success&quot; is defined as 10 year survival of the study device without revision for any reason.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>EQ-5D questionnaire</measure>
    <time_frame>pre-op, 3month, 1yr, 2yr, 5yr, 10yr</time_frame>
    <description>patient's opinion about his state of health, according to a visual analogue scale and 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression, (each dimension having 3 levels: no problems, some problems, extreme problems)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee Pain Evaluation Form questionnaire</measure>
    <time_frame>3month, 1yr, 2yr</time_frame>
    <description>Assessment of post-operative knee pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>2011 Knee Society Score</measure>
    <time_frame>pre-op, 3month, 1yr, 2yr, 5yr, 10yr</time_frame>
    <description>A clinical follow-up and patient satisfaction, patient's expectations and a self-assessment of the physical outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>radiographic evaluation</measure>
    <time_frame>pre-op, discharge, 3month, 1yr, 5yr, 10yr</time_frame>
    <description>The Knee Society Total Knee Arthroplasty Roentographic Evaluation and Scoring System will be used to analyse radiographic findings at each visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>complication rate (adverse events and revisions)</measure>
    <time_frame>discharge, 3month, 1yr, 2yr, 5yr, 10yr</time_frame>
    <description>complications will be assessed at each visit.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">175</enrollment>
  <condition>Degenerative Joint Disease</condition>
  <arm_group>
    <arm_group_label>1 cohort</arm_group_label>
    <description>subject requires primary total knee arthroplasty with the Journey II BCS Total Knee System, including patella resurfacing due to degenerative joint disease (primary osteoarthritis, post-traumatic arthritis, avascular necrosis, rheumatoid arthritis)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>data collection</intervention_name>
    <arm_group_label>1 cohort</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        a patient population consisting of 150 cases and recruited from 4 different countries, will&#xD;
        be followed up when undergoing TKA as part of their standard care&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  subject requires primary total knee arthroplasty with the Journey II BCS Total Knee&#xD;
             System, including patella resurfacing&#xD;
&#xD;
          -  subject requires primary total knee arthroplasty due to degenerative joint disease&#xD;
             (primary osteoarthritis, post-traumatic arthritis, avascular necrosis, rheumatoid&#xD;
             arthritis)&#xD;
&#xD;
          -  subject is of legal age to consent, agrees to consent to and to follow the study visit&#xD;
             schedule, by signing the EC approved informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age &gt; 75 years&#xD;
&#xD;
          -  conditions that may interfere with the TKA survival or outcome (i.e., Paget's or&#xD;
             Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes,&#xD;
             moderate to severe renal insufficiency or neuromuscular disease)&#xD;
&#xD;
          -  subject has inadequate bone stock to support the device&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mike Risebury, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>North Hampshire Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Fabio Catani, Prof</last_name>
    <role>Study Chair</role>
    <affiliation>University of Modena and Reggio Emilia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jan Victor, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>UZ Ghent</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gijs Van Hellemondt</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sint-Maartenskliniek Nijmegen</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Stig Heir</last_name>
    <role>Principal Investigator</role>
    <affiliation>Martina Hansens Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UZ Gent</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Modena and Reggio Emilia</name>
      <address>
        <city>Modena</city>
        <zip>41124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sint Maartenskliniek</name>
      <address>
        <city>Nijmegen</city>
        <zip>9500</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Martina Hansens Hospital</name>
      <address>
        <city>Sandvika</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Hampshire Hospital</name>
      <address>
        <city>Basingstoke</city>
        <zip>RG24 7AL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>Norway</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>July 22, 2014</study_first_submitted>
  <study_first_submitted_qc>August 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 7, 2014</study_first_posted>
  <last_update_submitted>January 18, 2023</last_update_submitted>
  <last_update_submitted_qc>January 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 19, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Total Knee Arthroplasty</keyword>
  <keyword>degenerative joint disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Joint Diseases</mesh_term>
    <mesh_term>Osteoarthritis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>BSI Publication</ipd_description>
  </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/NCT02211794
org study id: R11009-7
nct id: NCT02211794
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Post-market study to confirm the safety and efficacy of the Journey II BCS knee prosthesis.
Multicenter, prospective, observational study to collect relevant clinical data from 167
      subjects implanted with the Journey II BCS Knee System. Data from eligible subjects, who have
      provided written informed consent for the collection of their coded data will be recorded
      from the patient's medical file on specially designed case report forms (CRF's).

      Total study duration for participants will be 10 years with follow-up visits planned at 3
      months, 1 year, 2 years, 5 years and 10 years post-surgery. An interim analysis describing
      the clinical outcome is planned after 5 years.
observational model: Cohort
time perspective: Prospective
measure: Revision for any reason
time frame: 10Years
description: The goal of this study is to confirm the safety and efficacy of the Journey II BCS knee prosthesis by demonstrating non-inferiority of the cumulative percent success in subjects implanted with the JOURNEY II BCS Total Knee System compared to a literature reference rate of 94.3% (AOA annual report 201121) at 10 years. "Success" is defined as 10 year survival of the study device without revision for any reason.
measure: EQ-5D questionnaire
time frame: pre-op, 3month, 1yr, 2yr, 5yr, 10yr
description: patient's opinion about his state of health, according to a visual analogue scale and 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression, (each dimension having 3 levels: no problems, some problems, extreme problems)
measure: Knee Pain Evaluation Form questionnaire
time frame: 3month, 1yr, 2yr
description: Assessment of post-operative knee pain
measure: 2011 Knee Society Score
time frame: pre-op, 3month, 1yr, 2yr, 5yr, 10yr
description: A clinical follow-up and patient satisfaction, patient's expectations and a self-assessment of the physical outcome
measure: radiographic evaluation
time frame: pre-op, discharge, 3month, 1yr, 5yr, 10yr
description: The Knee Society Total Knee Arthroplasty Roentographic Evaluation and Scoring System will be used to analyse radiographic findings at each visit.
measure: complication rate (adverse events and revisions)
time frame: discharge, 3month, 1yr, 2yr, 5yr, 10yr
description: complications will be assessed at each visit.
arm group label: 1 cohort
description: subject requires primary total knee arthroplasty with the Journey II BCS Total Knee System, including patella resurfacing due to degenerative joint disease (primary osteoarthritis, post-traumatic arthritis, avascular necrosis, rheumatoid arthritis)
intervention type: Other
intervention name: data collection
arm group label: 1 cohort
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Mike Risebury, MD
role: Principal Investigator
affiliation: North Hampshire Hospital
last name: Fabio Catani, Prof
role: Study Chair
affiliation: University of Modena and Reggio Emilia
last name: Jan Victor, Prof
role: Principal Investigator
affiliation: UZ Ghent
last name: Gijs Van Hellemondt
role: Principal Investigator
affiliation: Sint-Maartenskliniek Nijmegen
last name: Stig Heir
role: Principal Investigator
affiliation: Martina Hansens Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
country: Belgium
country: Italy
country: Netherlands
country: Norway
country: United Kingdom
responsible party type: Sponsor
mesh term: Joint Diseases
mesh term: Osteoarthritis
sharing ipd: Yes
ipd description: BSI Publication