<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/NCT03289000</url>
  </required_header>
  <id_info>
    <org_study_id>16-004</org_study_id>
    <nct_id>NCT03289000</nct_id>
  </id_info>
  <brief_title>A Retrospective Study to Evaluate the ConforMIS iTotal® Posterior Stabilized (PS) Knee Replacement System</brief_title>
  <official_title>A Retrospective Study to Evaluate the ConforMIS iTotal® Posterior Stabilized (PS) Knee Replacement System</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>
      This study is a retrospective, multi-center study, with one single remote follow up contact.&#xD;
      This study will include a minimum of 80 patients and a maximum 100 patients who have been&#xD;
      treated with the ConforMIS iTotal PS knee product.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients will be contacted either by phone or email for a single remote follow-up.&#xD;
      Retrospective data will be collected from medical records including pre-operative, operative&#xD;
      and any follow up visits which have occurred since implantation as available. . All data will&#xD;
      be collected from existing medical records and from single follow up call/email.&#xD;
&#xD;
        -  Demographics and Medical History&#xD;
&#xD;
        -  Pre &amp; Post-Operative Data including Range of Motion&#xD;
&#xD;
        -  Surgical Data&#xD;
&#xD;
        -  Survivorship (phone/email or last known visit)&#xD;
&#xD;
        -  Patient Reported Outcomes (phone/email single time point visit)&#xD;
&#xD;
             -  Patient Satisfaction&#xD;
&#xD;
             -  KOOS Jr.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 24, 2017</start_date>
  <completion_date type="Actual">December 31, 2017</completion_date>
  <primary_completion_date type="Actual">August 4, 2017</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Demographics and Medical History</measure>
    <time_frame>1 year</time_frame>
    <description>Demographics and medical history gathered from medical records</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pre and Post Operative Range of Motion</measure>
    <time_frame>1 year</time_frame>
    <description>Collected retrospectively through medical records, collecting range of motion from pre-operative visits and post-operative visits</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">93</enrollment>
  <condition>Osteo Arthritis Knee</condition>
  <arm_group>
    <arm_group_label>ConforMIS PS Group</arm_group_label>
    <description>Patients who have undergone a total knee replacement with the ConforMIS iTotal PS Knee Replacement System</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>iTotal Posterior Stabilized (PS) Knee Replacement System</intervention_name>
    <description>Patient-specific posterior stabilized total knee replacement and patient specific surgical jigs</description>
    <arm_group_label>ConforMIS PS Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Individuals who are 18 years or older and have received a ConforMIS iTotal PS knee&#xD;
        replacement to treat any condition indicated on the device's instructions for use.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Previously underwent surgical implantation of a ConforMIS iTotal PS knee replacement.&#xD;
&#xD;
          2. Over 18 Years of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. BMI &gt; 40&#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>Tennessee Orthopaedic Alliance</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Scott Orthopedic Center</name>
      <address>
        <city>Huntington</city>
        <state>West Virginia</state>
        <zip>25702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>September 15, 2017</study_first_submitted>
  <study_first_submitted_qc>September 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 20, 2017</study_first_posted>
  <last_update_submitted>November 8, 2018</last_update_submitted>
  <last_update_submitted_qc>November 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>osteoarthritis</keyword>
  <keyword>knee arthroplasty</keyword>
  <keyword>knee replacement</keyword>
  <keyword>patient specific</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/NCT03289000
org study id: 16-004
nct id: NCT03289000
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
This study is a retrospective, multi-center study, with one single remote follow up contact.
      This study will include a minimum of 80 patients and a maximum 100 patients who have been
      treated with the ConforMIS iTotal PS knee product.
Patients will be contacted either by phone or email for a single remote follow-up.
      Retrospective data will be collected from medical records including pre-operative, operative
      and any follow up visits which have occurred since implantation as available. . All data will
      be collected from existing medical records and from single follow up call/email.

        -  Demographics and Medical History

        -  Pre & Post-Operative Data including Range of Motion

        -  Surgical Data

        -  Survivorship (phone/email or last known visit)

        -  Patient Reported Outcomes (phone/email single time point visit)

             -  Patient Satisfaction

             -  KOOS Jr.
observational model: Cohort
time perspective: Retrospective
measure: Demographics and Medical History
time frame: 1 year
description: Demographics and medical history gathered from medical records
measure: Pre and Post Operative Range of Motion
time frame: 1 year
description: Collected retrospectively through medical records, collecting range of motion from pre-operative visits and post-operative visits
arm group label: ConforMIS PS Group
description: Patients who have undergone a total knee replacement with the ConforMIS iTotal PS Knee Replacement System
intervention type: Device
intervention name: iTotal Posterior Stabilized (PS) Knee Replacement System
description: Patient-specific posterior stabilized total knee replacement and patient specific surgical jigs
arm group label: ConforMIS PS Group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee