<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/NCT03768128</url>
  </required_header>
  <id_info>
    <org_study_id>16-4049-12</org_study_id>
    <nct_id>NCT03768128</nct_id>
  </id_info>
  <brief_title>Safety and Performance of the Journey™ II UNI Unicompartmental Knee System</brief_title>
  <acronym>JII-Uni</acronym>
  <official_title>A Prospective, Multicenter Post-Market Clinical Follow-up Study to Evaluate the Safety and Performance of the Journey™ II UNI Unicompartmental Knee System</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>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This clinical study will evaluate the early to midterm safety and performance of the JOURNEY™&#xD;
      II UNI UKS in patients with non-inflammatory degenerative joint disease of the knee requiring&#xD;
      lateral or medial knee compartment replacement. Clinical, radiographic, health economic and&#xD;
      safety outcomes will be evaluated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To assess the safety and performance of the JOURNEY™ II UNI UKS in patients with&#xD;
      unicompartmental degeneration of the knee by demonstrating non-inferiority of the cumulative&#xD;
      percent implant survival in subjects with the JOURNEY™ II UNI UKS implanted, compared to a&#xD;
      literature reference rate of 91.7% (AOA annual report 2015)12 at 5 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 10, 2018</start_date>
  <completion_date type="Anticipated">June 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2025</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Implant survival 5 years postoperatively</measure>
    <time_frame>5 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Device-related adverse events</measure>
    <time_frame>5 year</time_frame>
    <description>All AEs will be collected and reported</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiographic assessments</measure>
    <time_frame>5 year</time_frame>
    <description>To assess changes in implant fixation and bone integrity, an evaluation will be performed based upon comparison of Antero posterior and Lateral radiographs over multiple time-points. Radiographs will be also evaluated for radiolucencies, osteolysis, implant positioning, implant migration, implant loosening, periprosthetic fracture, wear of the articulating surfaces of replacement components</description>
  </secondary_outcome>
  <enrollment type="Actual">154</enrollment>
  <condition>Non-inflammatory Degenerative Joint Disease (NIDJD) of the Knee</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Journey™ II UNI Unicompartmental Knee System</intervention_name>
    <description>Journey™ II UNI UKS is a CE Marked medical device. The device has been designed to treat both medial and lateral unicompartmental disease.&#xD;
It is a comprehensive system designed to allow surgeons to perform UKA. It is comprised of the following anatomic components: Oxidized zirconium femoral components Titanium tibial components with a grit-blasted surface Polyethylene tibial insert components The device is asymmetric and is available in oxidized zirconium to reduce wear and increase implant longevity.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        JOURNEY™ II UNI Unicompartmental Knee System (UKS) in patients with non-inflammatory&#xD;
        degenerative joint disease (NIDJD) of the knee requiring either medial or lateral&#xD;
        compartment knee replacement.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects must meet all of the following criteria for inclusion in the study.&#xD;
&#xD;
               1. Unicompartmental, NIDJD, including OA, traumatic arthritis, or avascular&#xD;
                  necrosis.&#xD;
&#xD;
               2. Eighteen (18) years of age or older at the time of surgery.&#xD;
&#xD;
               3. Skeletally mature in the judgement of the PI.&#xD;
&#xD;
               4. Has met an acceptable preoperative medical clearance and is free of (or&#xD;
                  acceptably managed) cardiac, pulmonary, hematological, infection, or other&#xD;
                  conditions that would pose an excessive operative risk.&#xD;
&#xD;
               5. Willing and able to participate in required follow-up visits at the&#xD;
                  investigational site and to complete study procedures and questionnaires.&#xD;
&#xD;
               6. Consented to participate in the study by signing the EC-approved ICF.&#xD;
&#xD;
                  Exclusion Criteria:&#xD;
&#xD;
          -  Subjects meeting any of the following criteria must be excluded from participation in&#xD;
             the study.&#xD;
&#xD;
               1. Correction of functional deformity.&#xD;
&#xD;
               2. Revision procedures where other treatments or devices have failed.&#xD;
&#xD;
               3. Treatment of fractures that are unmanageable using other techniques.&#xD;
&#xD;
               4. Inadequate bone stock to support the device which would make the procedure&#xD;
                  unjustifiable, including but not limited to severe osteopenia/osteoporosis or&#xD;
                  family history of severe osteoporosis/osteopenia.&#xD;
&#xD;
               5. Body Mass Index (BMI) &gt; 40.&#xD;
&#xD;
               6. Collateral ligament insufficiency.&#xD;
&#xD;
               7. Active infection, treated or untreated, systemic or at the site of the planned&#xD;
                  surgery or previous intra-articular infections.&#xD;
&#xD;
               8. Incomplete or deficient soft tissue surrounding the knee.&#xD;
&#xD;
               9. Conditions that may interfere with the UKA survival or outcome, including but not&#xD;
                  limited to Paget's disease, Charcot disease, vascular insufficiency, muscular&#xD;
                  atrophy, uncontrolled diabetes, renal insufficiency or neuromuscular disease.&#xD;
&#xD;
              10. Diagnosis of an immunosuppressive disorder.&#xD;
&#xD;
              11. Known allergy to study device or one or more of its components.&#xD;
&#xD;
              12. Pregnant or planning to become pregnant during the course of the study.&#xD;
&#xD;
              13. Subject, in the opinion of the PI, has an emotional or neurological condition&#xD;
                  that would pre-empt their ability or willingness to participate in the study&#xD;
                  including mental illness, mental retardation&#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>Rush University Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OrthoIllinois, LTD</name>
      <address>
        <city>Rockford</city>
        <state>Illinois</state>
        <zip>61114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Poliambulanza Institute Hospital Foundation</name>
      <address>
        <city>Brescia</city>
        <zip>25124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Clinico Villa Aprica</name>
      <address>
        <city>Como</city>
        <zip>22100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zeromski Hospital</name>
      <address>
        <city>Kraków</city>
        <zip>31-913</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Miejski Zabrze</name>
      <address>
        <city>Zabrze</city>
        <zip>41-803</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
    <country>Poland</country>
    <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>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>July 25, 2023</last_update_submitted>
  <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>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/NCT03768128
org study id: 16-4049-12
nct id: NCT03768128
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This clinical study will evaluate the early to midterm safety and performance of the JOURNEY™
      II UNI UKS in patients with non-inflammatory degenerative joint disease of the knee requiring
      lateral or medial knee compartment replacement. Clinical, radiographic, health economic and
      safety outcomes will be evaluated.
To assess the safety and performance of the JOURNEY™ II UNI UKS in patients with
      unicompartmental degeneration of the knee by demonstrating non-inferiority of the cumulative
      percent implant survival in subjects with the JOURNEY™ II UNI UKS implanted, compared to a
      literature reference rate of 91.7% (AOA annual report 2015)12 at 5 years.
observational model: Other
time perspective: Prospective
measure: Implant survival 5 years postoperatively
time frame: 5 years
measure: Device-related adverse events
time frame: 5 year
description: All AEs will be collected and reported
measure: Radiographic assessments
time frame: 5 year
description: To assess changes in implant fixation and bone integrity, an evaluation will be performed based upon comparison of Antero posterior and Lateral radiographs over multiple time-points. Radiographs will be also evaluated for radiolucencies, osteolysis, implant positioning, implant migration, implant loosening, periprosthetic fracture, wear of the articulating surfaces of replacement components
intervention type: Device
intervention name: Journey™ II UNI Unicompartmental Knee System
description: Journey™ II UNI UKS is a CE Marked medical device. The device has been designed to treat both medial and lateral unicompartmental disease.
It is a comprehensive system designed to allow surgeons to perform UKA. It is comprised of the following anatomic components: Oxidized zirconium femoral components Titanium tibial components with a grit-blasted surface Polyethylene tibial insert components The device is asymmetric and is available in oxidized zirconium to reduce wear and increase implant longevity.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Italy
country: Poland
country: United States
responsible party type: Sponsor
mesh term: Joint Diseases
mesh term: Osteoarthritis
sharing ipd: No