<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/NCT01704326</url>
  </required_header>
  <id_info>
    <org_study_id>DEUK01</org_study_id>
    <nct_id>NCT01704326</nct_id>
  </id_info>
  <brief_title>A Study of Patients Treated With the Journey Deuce Bicompartmental Knee System</brief_title>
  <official_title>A Prospective, Multicenter Consecutive Series Study of Patients Treated With the Journey Deuce Bicompartmental 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, multicenter, consecutive clinical study of the Journey Deuce Knee&#xD;
      System and is intended to evaluate the safety and effectiveness of the new device.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objectives of this study are to assess the safety and effectiveness of the Journey Deuce&#xD;
      Bicompartmental Knee System. Patients will be examined clinically at time intervals&#xD;
      throughout the study duration. Exams will include completion of clinical assessment, x-rays,&#xD;
      and completion of patient questionnaires.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2006</start_date>
  <completion_date type="Actual">May 2012</completion_date>
  <primary_completion_date type="Actual">February 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Knee Society Score</measure>
    <time_frame>Preoperative-2 years</time_frame>
    <description>Assess knee pain, function and range of motion using the Knee Society Clinical Rating System</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Oxford Knee Outcome Questionnaire</measure>
    <time_frame>Preoperative, 6 weeks, 3 months, 6 months, 1 year and 2 years</time_frame>
    <description>Patient evaluation of function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiographic Evaluation</measure>
    <time_frame>6 weeks, 1 year and 2 years</time_frame>
    <description>X-rays will be assessed for evidence of implant loosening, surface wear, migration or any other clinical or radiographic abnormalities.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction</measure>
    <time_frame>6 weeks, 3 months, 6 months, 1 year and 2 years</time_frame>
    <description>Patient satisfaction questionnaire to be completed at each follow-up visit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>When Necessary</time_frame>
    <description>All intra-operative, discharge, and post-operative surgical/hospitalization or study knee-related adverse events will be captured during the study to assess for safety issues.</description>
  </secondary_outcome>
  <enrollment type="Actual">59</enrollment>
  <condition>Osteoarthritis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The patients eligible for this study are non-inflammatory degenerative joint disease&#xD;
        patients requiring a primary unilateral knee surgery. The affected areas must be limited to&#xD;
        the medial and patellofemoral compartments.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient presents with non-inflammatory degenerative joint disease of the medial and&#xD;
             patellofemoral compartments requiring a unilateral knee replacement.&#xD;
&#xD;
          -  Patient is 30 to 75 years of age, inclusive.&#xD;
&#xD;
          -  Patient is willing to consent to participate in the study by signing and dating an&#xD;
             IRB-approved consent form.&#xD;
&#xD;
          -  Patient plans to be available for follow-up through five years postoperative.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient is known to have insufficient femoral or tibial bone stock resulting from&#xD;
             conditions such as cancer, distal femoral/proximal tibial osteotomy, significant&#xD;
             osteoporosis or metabolic bone disorders.&#xD;
&#xD;
          -  Patient is immunosuppressed, has an autoimmune disorder, or an immunosuppressive&#xD;
             disorder (i.e. chronic condition characterized by markedly inhibited ability to&#xD;
             respond to antigenic stimuli.) Examples of such conditions include patients who are on&#xD;
             immunosuppressive therapy (corticosteroid hormones in large amounts, cytotoxic drugs,&#xD;
             antilymphocytic serum or irradiation in large doses) or patients with acquired&#xD;
             immunodeficiency syndrome (AIDS).&#xD;
&#xD;
          -  Patient has inflammatory arthritis (e.g. rheumatoid arthritis)&#xD;
&#xD;
          -  Patient has BMI greater than or equal to 40.&#xD;
&#xD;
          -  Patient has had major knee surgery in the past i.e. HTO, unicondylar knee replacement,&#xD;
             failed fracture fixation.&#xD;
&#xD;
          -  Patient has an active infection, local or systemic.&#xD;
&#xD;
          -  Patient has physical, emotional or neurological conditions that would compromise the&#xD;
             patient's compliance with postoperative rehabilitation and followup (e.g.: drug or&#xD;
             alcohol abuse, serious mental illness, or general neurological conditions such as&#xD;
             Parkinson, Multiple sclerosis, etc.).&#xD;
&#xD;
          -  Patient has ACL deficiency in the study knee.&#xD;
&#xD;
          -  Patient has hip arthritis and/or replacement.&#xD;
&#xD;
          -  Patient has lateral compartment disease.&#xD;
&#xD;
          -  Patient is pregnant or plans to become pregnant during the course of the study.&#xD;
&#xD;
          -  Patient has a known sensitivity to materials in the device.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Orthopaedic Center of Vero Beach</name>
      <address>
        <city>Vero Beach</city>
        <state>Florida</state>
        <zip>32860</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orthopaedic Surgery Specialists, Ltd.</name>
      <address>
        <city>Park Ridge</city>
        <state>Illinois</state>
        <zip>60068</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry County Center for Orthopedic Surgery &amp; Sports Medicine</name>
      <address>
        <city>New Castle</city>
        <state>Indiana</state>
        <zip>47362</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Iowa Orthopaedic Center, PC</name>
      <address>
        <city>Des Moines</city>
        <state>Iowa</state>
        <zip>50314</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>September 24, 2012</study_first_submitted>
  <study_first_submitted_qc>October 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 11, 2012</study_first_posted>
  <last_update_submitted>October 9, 2012</last_update_submitted>
  <last_update_submitted_qc>October 9, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 11, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Deuce</keyword>
  <keyword>Journey Deuce</keyword>
  <keyword>Knee pain</keyword>
  <keyword>Osteoarthritis</keyword>
  <keyword>Bicompartmental</keyword>
  <keyword>Femoral</keyword>
  <keyword>Medial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</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/NCT01704326
org study id: DEUK01
nct id: NCT01704326
lead sponsor: 
has dmc: No
This is a prospective, multicenter, consecutive clinical study of the Journey Deuce Knee
      System and is intended to evaluate the safety and effectiveness of the new device.
The objectives of this study are to assess the safety and effectiveness of the Journey Deuce
      Bicompartmental Knee System. Patients will be examined clinically at time intervals
      throughout the study duration. Exams will include completion of clinical assessment, x-rays,
      and completion of patient questionnaires.
time perspective: Prospective
measure: Change in Knee Society Score
time frame: Preoperative-2 years
description: Assess knee pain, function and range of motion using the Knee Society Clinical Rating System
measure: Oxford Knee Outcome Questionnaire
time frame: Preoperative, 6 weeks, 3 months, 6 months, 1 year and 2 years
description: Patient evaluation of function
measure: Radiographic Evaluation
time frame: 6 weeks, 1 year and 2 years
description: X-rays will be assessed for evidence of implant loosening, surface wear, migration or any other clinical or radiographic abnormalities.
measure: Patient Satisfaction
time frame: 6 weeks, 3 months, 6 months, 1 year and 2 years
description: Patient satisfaction questionnaire to be completed at each follow-up visit
measure: Adverse Events
time frame: When Necessary
description: All intra-operative, discharge, and post-operative surgical/hospitalization or study knee-related adverse events will be captured during the study to assess for safety issues.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 30 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Osteoarthritis