<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/NCT02251522</url>
  </required_header>
  <id_info>
    <org_study_id>14-001</org_study_id>
    <nct_id>NCT02251522</nct_id>
  </id_info>
  <brief_title>A Single Time-Point Study to Evaluate the ConforMIS iTotal® (CR) Knee Versus Off-the-Shelf</brief_title>
  <acronym>STEPS</acronym>
  <official_title>A Single Time-Point Study to Evaluate the ConforMIS iTotal® (CR) Knee Replacement System Versus Off-the-Shelf Replacement</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ConforMIS, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ConforMIS, 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>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      It has been noted that patients &quot;dramatically overestimate their functional ability early&#xD;
      after surgery.&quot; Despite use of assistive devices increasing and functional testing scores&#xD;
      decreasing post-surgery, the patient reported outcome scores fail to show worsening. Outcome&#xD;
      questionnaires will be administered and functional testing will be conducted on all patients&#xD;
      to capture these changes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The functional testing used in this study consists of tests that physical therapists use&#xD;
      daily as objective methods to assess patients' functional status. The testing is designed to&#xD;
      closely mimic daily activities that the patients are familiar with.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2014</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">October 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Functional Outcome time differences between the two groups</measure>
    <time_frame>at least 6 months post-op</time_frame>
    <description>The study primary endpoint is to compare functional testing time between patients implanted with the iTotal implant verses the off-the-shelf implants</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Outcomes questionnaire- Knee Society Score</measure>
    <time_frame>At least 6 months post op</time_frame>
    <description>Comparing different patient outcome scores between the two groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Outcomes questionnaire- KOOS</measure>
    <time_frame>At least 6 months post op</time_frame>
    <description>Comparing different patient outcome scores between the two groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Outcomes questionnaire- Forgotten Joint Score</measure>
    <time_frame>At least 6 months post op</time_frame>
    <description>Comparing different patient outcome scores between the two groups</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">873</enrollment>
  <condition>Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>ConforMIS iTotal Knee Replacement System</arm_group_label>
    <description>Patients who have had an iTotal knee replacement at least 6 months prior to testing</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Off-the-Shelf Knee Replacement System</arm_group_label>
    <description>Patients who have had an off-the-shelf knee replacement at least 6 months prior to testing</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ConforMIS Total Knee Replacement System</intervention_name>
    <description>Total knee replacement system using a patient specific implant.</description>
    <arm_group_label>ConforMIS iTotal Knee Replacement System</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Off-the-Shelf Knee Replacement System</intervention_name>
    <description>Total knee replacement system not using a patient specific implant.</description>
    <arm_group_label>Off-the-Shelf Knee Replacement System</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study will include a 1:1 ratio of patients enrolled into both the iTotal arm and the&#xD;
        off-the-shelf total knee arm.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Implant must be at least 6 months post-op and doing well&#xD;
&#xD;
          -  Patient has had a total CR knee implant&#xD;
&#xD;
          -  &gt; 18 years of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Simultaneous bilateral procedure occurred&#xD;
&#xD;
          -  BMI &gt; 40&#xD;
&#xD;
          -  Other physical disability that requires an aid for walking or disability affecting the&#xD;
             hips, spine, contralateral knee or other joint that limits function&#xD;
&#xD;
          -  Participation in another clinical study which would confound results&#xD;
&#xD;
          -  Inability to complete the protocol in the opinion of the clinical staff due to safety&#xD;
             or other reasons&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert Tait, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Orthopaedic Institute of Henderson</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mary O'Connor, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Denver-Vail Orthopedics</name>
      <address>
        <city>Parker</city>
        <state>Colorado</state>
        <zip>80134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute for Orthopaedic Surgery &amp; Sports Medicine</name>
      <address>
        <city>Fort Myers</city>
        <state>Florida</state>
        <zip>33919</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baptist Health South Florida</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33176</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coastal Orthopaedic &amp; Sports Medicine Ctr</name>
      <address>
        <city>Port Saint Lucie</city>
        <state>Florida</state>
        <zip>34996</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bethesda Orthopedic</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Excel Orthopaedic Specialists</name>
      <address>
        <city>Woburn</city>
        <state>Massachusetts</state>
        <zip>01801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Great Lakes Bone &amp; Joint Center</name>
      <address>
        <city>Battle Creek</city>
        <state>Michigan</state>
        <zip>49015</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lederman-Kwartowitz Center for Orthopedics and Sports Medicine</name>
      <address>
        <city>West Bloomfield Township</city>
        <state>Michigan</state>
        <zip>48323</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orthopaedic Institute of Henderson</name>
      <address>
        <city>Henderson</city>
        <state>Nevada</state>
        <zip>89052</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Lawrence Health System</name>
      <address>
        <city>Potsdam</city>
        <state>New York</state>
        <zip>13676</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orthopedic Specialties of Spartanburg</name>
      <address>
        <city>Spartanburg</city>
        <state>South Carolina</state>
        <zip>29303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Orthopedics &amp; Sports Medicine</name>
      <address>
        <city>Cypress</city>
        <state>Texas</state>
        <zip>77429</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vitos Orthopädische Klinik Kassel</name>
      <address>
        <city>Kassel</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MedArtes</name>
      <address>
        <city>Neutraubling</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elblandkliniken Stiftung</name>
      <address>
        <city>Radebeul</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sportklinik Stuttgart</name>
      <address>
        <city>Stuttgart</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>September 22, 2014</study_first_submitted>
  <study_first_submitted_qc>September 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 29, 2014</study_first_posted>
  <last_update_submitted>May 11, 2017</last_update_submitted>
  <last_update_submitted_qc>May 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 15, 2017</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>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/NCT02251522
org study id: 14-001
nct id: NCT02251522
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
It has been noted that patients "dramatically overestimate their functional ability early
      after surgery." Despite use of assistive devices increasing and functional testing scores
      decreasing post-surgery, the patient reported outcome scores fail to show worsening. Outcome
      questionnaires will be administered and functional testing will be conducted on all patients
      to capture these changes.
The functional testing used in this study consists of tests that physical therapists use
      daily as objective methods to assess patients' functional status. The testing is designed to
      closely mimic daily activities that the patients are familiar with.
observational model: Case-Control
time perspective: Other
measure: Functional Outcome time differences between the two groups
time frame: at least 6 months post-op
description: The study primary endpoint is to compare functional testing time between patients implanted with the iTotal implant verses the off-the-shelf implants
measure: Outcomes questionnaire- Knee Society Score
time frame: At least 6 months post op
description: Comparing different patient outcome scores between the two groups
measure: Outcomes questionnaire- KOOS
time frame: At least 6 months post op
description: Comparing different patient outcome scores between the two groups
measure: Outcomes questionnaire- Forgotten Joint Score
time frame: At least 6 months post op
description: Comparing different patient outcome scores between the two groups
arm group label: ConforMIS iTotal Knee Replacement System
description: Patients who have had an iTotal knee replacement at least 6 months prior to testing
arm group label: Off-the-Shelf Knee Replacement System
description: Patients who have had an off-the-shelf knee replacement at least 6 months prior to testing
intervention type: Device
intervention name: ConforMIS Total Knee Replacement System
description: Total knee replacement system using a patient specific implant.
arm group label: ConforMIS iTotal Knee Replacement System
intervention type: Device
intervention name: Off-the-Shelf Knee Replacement System
description: Total knee replacement system not using a patient specific implant.
arm group label: Off-the-Shelf Knee Replacement System
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Robert Tait, MD
role: Principal Investigator
affiliation: Orthopaedic Institute of Henderson
last name: Mary O'Connor, MD
role: Study Chair
affiliation: Yale University
facility: 
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country: Germany
country: United States
responsible party type: Sponsor
mesh term: Osteoarthritis
sharing ipd: No