<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/NCT03277989</url>
  </required_header>
  <id_info>
    <org_study_id>US17-TAR-001</org_study_id>
    <nct_id>NCT03277989</nct_id>
  </id_info>
  <brief_title>INFINITY™Total Ankle Replacement Follow-up</brief_title>
  <acronym>ITAR</acronym>
  <official_title>INFINITY™Total Ankle Replacement Follow-up</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stryker Trauma GmbH</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stryker Trauma GmbH</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study Title INFINITY™Total Ankle Replacement Follow-up (ITAR) Study Design Prospective,&#xD;
      multi-site, multi-year post-market clinical follow-up study Study Group Primary/Unilateral&#xD;
      and/or bilateral Total Ankle Arthroplasty subjects implanted with INFINITY™ Total Ankle&#xD;
      System Number of Subjects 150 with 9 sites&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary outcome measure of this post-market clinical observational study is to collect&#xD;
      data relating to the INFINITY™ Total Ankle System survivorship at 10 years. The secondary&#xD;
      outcome measures are to characterize the improvements after implantation over a 10 year&#xD;
      period using patient reported outcome measures related to quality of life, pain and&#xD;
      functional improvements, safety of the implants, as well as radiographic assessments (X-Rays)&#xD;
&#xD;
      The outcome measures collected in this study will be analyzed and reported as required for&#xD;
      local, regional, and country requirements (i.e., regulatory authorities and notified bodies).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Business Decision&#xD;
  </why_stopped>
  <start_date type="Actual">October 9, 2017</start_date>
  <completion_date type="Actual">March 31, 2023</completion_date>
  <primary_completion_date type="Actual">March 31, 2023</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>Survivorship of the INFINITY™ Total Ankle System at 10 years</measure>
    <time_frame>10 years</time_frame>
    <description>The primary outcome measure of this post-market clinical observational study is to collect data relating to the INFINITY™ Total Ankle System survivorship at 10 years.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Radiographic evaluation-physician reported questionnaire</measure>
    <time_frame>Pre-op through 10 years</time_frame>
    <description>Identify and assess the implant for component loosening and/or subsidence, any osteolysis and/or cyst formation through radiographic evaluation early and throughout the lifetime of the implant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PROMIS® Global Health</measure>
    <time_frame>Pre-op through 10 years</time_frame>
    <description>Compare the improvements in self-reported physical, mental, and social health measures from pre-op through 10 years post operatively; assessed by PROMIS® Global Health.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ankle Osteoarthritis Score (AOS)</measure>
    <time_frame>Pre-op through 10 years</time_frame>
    <description>Compare pain and functional improvement in the Ankle Osteoarthritis Score (AOS), which is a visual analogue scale specifically designed as a modification of the Foot Function Index.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FAOS questionnaire</measure>
    <time_frame>Pre-op through 10 years</time_frame>
    <description>Compare the improvement in patient/physician reported function scores from pre-op through 10 years post-operatively, assessed by the FAOS questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TAR satisfaction questionnaire</measure>
    <time_frame>Pre-op through 10 years</time_frame>
    <description>Compare satisfaction of total ankle replacement post operatively utilizing a four point scale</description>
  </secondary_outcome>
  <enrollment type="Actual">148</enrollment>
  <condition>Arthritis, Rheumatoid</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Primary/Unilateral and/or bilateral Total Ankle Arthroplasty subjects implanted with&#xD;
        INFINITY™ Total Ankle System&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be 21 years of age or older at the time of surgery;&#xD;
&#xD;
          -  Diagnosed with unilateral and/or bilateral ankle joint disease;&#xD;
&#xD;
          -  Diagnosed with ankle joint damage from rheumatoid arthritis, post-traumatic, or&#xD;
             degenerative arthritis;&#xD;
&#xD;
          -  Willing and able to consent to participate (written, informed consent;&#xD;
&#xD;
          -  Willing and able to attend the requested follow-up visits;&#xD;
&#xD;
          -  A clinical decision has been made to use INFINITY™ Total Ankle System replacement&#xD;
             prior to enrollment in the research.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with an ankle condition, as determined by the investigator, to be an&#xD;
             inappropriate candidate for a total ankle replacement;&#xD;
&#xD;
          -  Subjects requiring revision total ankle replacement of the ankle being considered for&#xD;
             study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rebecca Gibson</last_name>
    <role>Study Director</role>
    <affiliation>Stryker Nordic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Eisenhower Medical Center</name>
      <address>
        <city>Rancho Mirage</city>
        <state>California</state>
        <zip>92270</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orthopaedic &amp; Spine Center of the Rockies</name>
      <address>
        <city>Fort Collins</city>
        <state>Colorado</state>
        <zip>80525</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois Bone &amp; Joint Institute</name>
      <address>
        <city>Libertyville</city>
        <state>Illinois</state>
        <zip>60048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orthopaedic Associates of Michigan, PC</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49525</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beaumont Hospital-Royal Oak</name>
      <address>
        <city>Royal Oak</city>
        <state>Michigan</state>
        <zip>48073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Slocum Center for Orthopedics &amp; Sports Medicine</name>
      <address>
        <city>Eugene</city>
        <state>Oregon</state>
        <zip>97401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UT Erlanger</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Campbell Clinic</name>
      <address>
        <city>Germantown</city>
        <state>Tennessee</state>
        <zip>38138</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>September 8, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <last_update_submitted>March 31, 2023</last_update_submitted>
  <last_update_submitted_qc>March 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 4, 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>Arthritis, Rheumatoid</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/NCT03277989
org study id: US17-TAR-001
nct id: NCT03277989
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
Study Title INFINITY™Total Ankle Replacement Follow-up (ITAR) Study Design Prospective,
      multi-site, multi-year post-market clinical follow-up study Study Group Primary/Unilateral
      and/or bilateral Total Ankle Arthroplasty subjects implanted with INFINITY™ Total Ankle
      System Number of Subjects 150 with 9 sites
The primary outcome measure of this post-market clinical observational study is to collect
      data relating to the INFINITY™ Total Ankle System survivorship at 10 years. The secondary
      outcome measures are to characterize the improvements after implantation over a 10 year
      period using patient reported outcome measures related to quality of life, pain and
      functional improvements, safety of the implants, as well as radiographic assessments (X-Rays)

      The outcome measures collected in this study will be analyzed and reported as required for
      local, regional, and country requirements (i.e., regulatory authorities and notified bodies).
observational model: Other
time perspective: Prospective
measure: Survivorship of the INFINITY™ Total Ankle System at 10 years
time frame: 10 years
description: The primary outcome measure of this post-market clinical observational study is to collect data relating to the INFINITY™ Total Ankle System survivorship at 10 years.
measure: Radiographic evaluation-physician reported questionnaire
time frame: Pre-op through 10 years
description: Identify and assess the implant for component loosening and/or subsidence, any osteolysis and/or cyst formation through radiographic evaluation early and throughout the lifetime of the implant.
measure: PROMIS® Global Health
time frame: Pre-op through 10 years
description: Compare the improvements in self-reported physical, mental, and social health measures from pre-op through 10 years post operatively; assessed by PROMIS® Global Health.
measure: Ankle Osteoarthritis Score (AOS)
time frame: Pre-op through 10 years
description: Compare pain and functional improvement in the Ankle Osteoarthritis Score (AOS), which is a visual analogue scale specifically designed as a modification of the Foot Function Index.
measure: FAOS questionnaire
time frame: Pre-op through 10 years
description: Compare the improvement in patient/physician reported function scores from pre-op through 10 years post-operatively, assessed by the FAOS questionnaire.
measure: TAR satisfaction questionnaire
time frame: Pre-op through 10 years
description: Compare satisfaction of total ankle replacement post operatively utilizing a four point scale
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Rebecca Gibson
role: Study Director
affiliation: Stryker Nordic
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Arthritis, Rheumatoid
sharing ipd: No