<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/NCT01705067</url>
  </required_header>
  <id_info>
    <org_study_id>2011JBCK151</org_study_id>
    <nct_id>NCT01705067</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of the Journey II BCS Total Knee System</brief_title>
  <acronym>NIMBLE</acronym>
  <official_title>A Retro-Prospective, Non-randomized, Consecutive Series, SIngle Cohort, Multicenter Adaptive Design Study to Evaluate the Outcomes of Total Knee Arthroplasty (TKA) Using JOURNEY™ II BCS TotaL Knee SystEm (The NIMBLE 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Assess the safety and efficacy of the JOURNEY II BCS Total Knee System in subjects with&#xD;
      degenerative knee disease requiring primary total knee replacement.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Assess the safety and efficacy of the JOURNEY II BCS Total Knee System in subjects with&#xD;
      degenerative knee disease requiring primary total knee replacement. Pre-operative and&#xD;
      operative assessments collected retrospectively. All postoperative assessments beginning at&#xD;
      the 6 month post-operative time point collected prospectively.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Anticipated">June 2024</completion_date>
  <primary_completion_date type="Anticipated">April 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of ITB Friction Pain</measure>
    <time_frame>6 months post-operatively</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>6 months post-operatively, 1 year post-operatively, 2 years post-operatively, 5 years post-operatively, and 10 years post-operatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiographic Evaluation</measure>
    <time_frame>Baseline and 6 months post-operatively, 1 year post-operatively, 2 years post-operatively, 5 years post-operatively, and 10 years post-operatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee Society Score</measure>
    <time_frame>6 months post-operatively, 1 year post-operatively, 2 years post-operatively, 5 years post-operatively, and 10 years post-operatively</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">209</enrollment>
  <condition>Osteoarthritis, Knee</condition>
  <arm_group>
    <arm_group_label>Journey II BCS TKA</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Subjects having TKA with Journey II BCS Total Knee System</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TKA with Journey II BCS Total Knee System</intervention_name>
    <description>TKA with Journey II BCS Total Knee System</description>
    <arm_group_label>Journey II BCS TKA</arm_group_label>
    <other_name>Journey II BCS</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject received primary total knee arthroplasty with the JOURNEY™ II BCS Total Knee&#xD;
             System due to degenerative joint disease&#xD;
&#xD;
          -  Subject is willing to sign and date an IRB approved consent form&#xD;
&#xD;
          -  Subject is of legal age to consent&#xD;
&#xD;
          -  Subject plans to be available through ten (10) years postoperative follow-up&#xD;
&#xD;
          -  Subject agrees to follow the study protocol&#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;
&#xD;
          -  Subject received TKA on the contralateral knee as a revision for a previously failed&#xD;
             total or unicondylar knee arthroplasty&#xD;
&#xD;
          -  Subject possesses a contralateral or ipsilateral revision hip arthroplasty&#xD;
&#xD;
          -  Subject has ipsilateral hip arthritis resulting in flexion contracture&#xD;
&#xD;
          -  At the time of enrollment, subject has one or more of the following arthroplasties&#xD;
             that are not fully healed and well-functioning, as determined by the investigator:&#xD;
&#xD;
               -  Ipsilateral or contralateral primary total hip arthroplasty or hip resurfacing&#xD;
                  arthroplasty&#xD;
&#xD;
               -  Contralateral primary total knee or unicondylar knee arthroplasty&#xD;
&#xD;
          -  At the time of surgery, subject had an active infection or sepsis (treated or&#xD;
             untreated)&#xD;
&#xD;
          -  At the time of surgery, subject had presence of malignant tumor, metastatic, or&#xD;
             neoplastic disease&#xD;
&#xD;
          -  At the time of surgery, subject had conditions that may interfere with the TKA&#xD;
             survival or outcome (i.e., Paget's or Charcot's disease, vascular insufficiency,&#xD;
             muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or&#xD;
             neuromuscular disease)&#xD;
&#xD;
          -  At the time of surgery, subject had contralateral lower extremity condition causing&#xD;
             abnormal ambulation&#xD;
&#xD;
          -  Subject is pregnant or plans to become pregnant during the study&#xD;
&#xD;
          -  Subject has an emotional or neurological condition that would pre-empt their ability&#xD;
             or willingness to participate in the study&#xD;
&#xD;
          -  At the time of surgery, subject had a BMI&gt;40&#xD;
&#xD;
          -  At the time of enrollment, subject has a BMI&gt;40&#xD;
&#xD;
          -  Subject is enrolled in another investigational drug, biologic, or device study&#xD;
&#xD;
          -  Subject is facing current or impending incarceration&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rachael Winter</last_name>
    <role>Study Director</role>
    <affiliation>rachael.winter@smith-nephew.com</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Joint Replacement Institute at St. Vincent Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fort Wayne Orthopedics</name>
      <address>
        <city>Fort Wayne</city>
        <state>Indiana</state>
        <zip>46804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Methodist Sports Medicine/The Orthopedic Specialist</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>
        <zip>10021-4892</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OrthoCarolina</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Forest University</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157-1070</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wellington Orthopaedics</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45220</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cincinnati Orthopaedic Research Institute</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45249</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minimally Invasive Orthopaedics</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tennessee Orthopaedic Clinics</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>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Evergreen Orthopaedic Clinic</name>
      <address>
        <city>Kirkland</city>
        <state>Washington</state>
        <zip>98034</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>June 21, 2012</study_first_submitted>
  <study_first_submitted_qc>October 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 12, 2012</study_first_posted>
  <last_update_submitted>January 17, 2023</last_update_submitted>
  <last_update_submitted_qc>January 17, 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>Osteoarthritis, Degenerative Knee Disease, TKA</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>


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/NCT01705067
org study id: 2011JBCK151
nct id: NCT01705067
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
Assess the safety and efficacy of the JOURNEY II BCS Total Knee System in subjects with
      degenerative knee disease requiring primary total knee replacement.
Assess the safety and efficacy of the JOURNEY II BCS Total Knee System in subjects with
      degenerative knee disease requiring primary total knee replacement. Pre-operative and
      operative assessments collected retrospectively. All postoperative assessments beginning at
      the 6 month post-operative time point collected prospectively.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Rate of ITB Friction Pain
time frame: 6 months post-operatively
measure: Adverse Events
time frame: 6 months post-operatively, 1 year post-operatively, 2 years post-operatively, 5 years post-operatively, and 10 years post-operatively
measure: Radiographic Evaluation
time frame: Baseline and 6 months post-operatively, 1 year post-operatively, 2 years post-operatively, 5 years post-operatively, and 10 years post-operatively
measure: Knee Society Score
time frame: 6 months post-operatively, 1 year post-operatively, 2 years post-operatively, 5 years post-operatively, and 10 years post-operatively
arm group label: Journey II BCS TKA
arm group type: Other
description: Subjects having TKA with Journey II BCS Total Knee System
intervention type: Device
intervention name: TKA with Journey II BCS Total Knee System
description: TKA with Journey II BCS Total Knee System
arm group label: Journey II BCS TKA
other name: Journey II BCS
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Rachael Winter
role: Study Director
affiliation: rachael.winter@smith-nephew.com
facility: 
facility: 
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country: United States
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee