<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/NCT03247023</url>
  </required_header>
  <id_info>
    <org_study_id>T-CTAS-002</org_study_id>
    <nct_id>NCT03247023</nct_id>
  </id_info>
  <brief_title>Long Term Follow-up of Integra® Cadence™ Total Ankle System in Primary Ankle Joint Replacement</brief_title>
  <official_title>Long Term Follow-up of Integra® Cadence™ Total Ankle System in Primary Ankle Joint Replacement</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Smith &amp; Nephew, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Smith &amp; Nephew Orthopaedics AG</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </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>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the long term performance and safety data for the Cadence™ Total&#xD;
      Ankle System (CTAS) when used for primary arthroplasty in patients with primary arthritis&#xD;
      (e.g. degenerative disease), secondary arthritis (e.g. post-traumatic, avascular necrosis, if&#xD;
      minimally 2/3 of the talus is preserved), and systemic arthritis of the ankle (e.g.&#xD;
      rheumatoid arthritis, hemochromatosis)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 18, 2017</start_date>
  <completion_date type="Anticipated">September 2029</completion_date>
  <primary_completion_date type="Actual">December 8, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Implant survivorship</measure>
    <time_frame>2 years</time_frame>
    <description>Implant survival defined as absence of device removal or revision</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Relative change of Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) - Mobility compared to baseline</measure>
    <time_frame>up to 10 years</time_frame>
    <description>Relative change of PROMIS PF - Mobility compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relative change of Range of Motion (ROM) compared to baseline</measure>
    <time_frame>up to 10 years</time_frame>
    <description>Relative change of ROM compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relative change of Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL) subscale compared to baseline</measure>
    <time_frame>up to 10 years</time_frame>
    <description>Relative change of FAAM ADL compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relative change of Visual Analogue Scale (VAS) Pain compared to baseline</measure>
    <time_frame>up to 10 years</time_frame>
    <description>Relative change of VAS Pain compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relative change of Quality of Life Measure Short Form - 36v2 (SF-36v2) compared to baseline</measure>
    <time_frame>up to 10 years</time_frame>
    <description>Relative change of SF-36v2 compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Implant survivorship</measure>
    <time_frame>5 and 10 years</time_frame>
    <description>Implant survival defined as absence of device removal or revision</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiographic Success</measure>
    <time_frame>up to 10 years</time_frame>
    <description>Radiographic success as defined as absence of implant radiolucency, subsidence, tilting, migration defined as no evidence of radiolucency &gt;4 mm in more than 3 zones and of subsidence or tilting ˃4 degrees, or migration &gt; 4mm</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">61</enrollment>
  <condition>Degenerative Arthritis</condition>
  <condition>Rheumatoid Arthritis</condition>
  <condition>Traumatic Arthritis</condition>
  <arm_group>
    <arm_group_label>Integra Cadence Total Ankle System</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Implantation of Integra Cadence Total Ankle Sysyem</intervention_name>
    <description>Primary Ankle Arthroplasty</description>
    <arm_group_label>Integra Cadence Total Ankle System</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patient with ankle arthritis requiring total ankle replacement&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Subjects will be included if he/she:&#xD;
&#xD;
          -  Qualifies for primary Total Ankle Replacement (TAR) per the surgeon and has a&#xD;
             diagnosis of one of the following: primary arthritis (e.g. degenerative disease),&#xD;
             secondary arthritis (e.g. post-traumatic, avascular necrosis, if minimally 2/3 of the&#xD;
             talus is preserved), or systemic arthritis of the ankle (e.g. rheumatoid arthritis,&#xD;
             hemochromatosis).&#xD;
&#xD;
          -  Is suitable for TAR with Cadence™ Total Ankle System per the study surgeon based on&#xD;
             the product indication and having considered deformity, stability, bone quality, soft-&#xD;
             tissue envelope, and neurovascular status.&#xD;
&#xD;
          -  Is willing and able to complete scheduled follow-up visits, evaluations and&#xD;
             questionnaires as described in the Informed Consent (or Information Letter and Data&#xD;
             Transfer Authorization Form, as applicable).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Subjects will be excluded from the study if he/she:&#xD;
&#xD;
          -  Is morbidly obese (defined by a Body Mass Index (BMI) &gt; 40 or BMI of 35 - 40 with&#xD;
             significant medical problems caused by or made worse by their weight).&#xD;
&#xD;
          -  Has one of the following conditions, which could compromise the affected limb: ankle&#xD;
             arthrodesis with malleolar exeresis, severe neurological (Charcot's Arthropathy) or&#xD;
             vascular disease, loss of musculature or neuromuscular compromise.&#xD;
&#xD;
          -  Has an active local/systemic infection that may affect the prosthetic joint or has a&#xD;
             recent history of infection.&#xD;
&#xD;
          -  Has a condition that may impair proper wound healing (e.g., poor soft tissue&#xD;
             envelope).&#xD;
&#xD;
          -  Has a metabolic disorder or disease that may compromise bone quality (e.g.&#xD;
             arthrogryposis etc.), physiological or anatomical anomalies, and/or malignancy/local&#xD;
             bone tumors.&#xD;
&#xD;
          -  Has inadequate neuromuscular status (e.g., prior paralysis, severe neuropathy).&#xD;
&#xD;
          -  Has a known sensitivity or allergic reaction to one or more of the implanted&#xD;
             materials.&#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>Universitair Ziekenhuis Gent</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foot and Ankle Institute</name>
      <address>
        <city>Woluwe-St-Lambert</city>
        <zip>B-1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Michael's Hospital</name>
      <address>
        <city>Toronto</city>
        <zip>M5C 1R6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU Tours</name>
      <address>
        <city>Tours</city>
        <zip>37044</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Nostra Senhora del Remei</name>
      <address>
        <city>Barcelona</city>
        <zip>08024</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Cumbria University Hospitals</name>
      <address>
        <city>Carlisle</city>
        <zip>CA2 7HY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Canada</country>
    <country>France</country>
    <country>Spain</country>
    <country>United Kingdom</country>
  </location_countries>
  <removed_countries>
    <country>Luxembourg</country>
  </removed_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>November 30, 2022</last_update_submitted>
  <last_update_submitted_qc>November 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 2, 2022</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</mesh_term>
    <mesh_term>Osteoarthritis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03247023
org study id: T-CTAS-002
nct id: NCT03247023
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will evaluate the long term performance and safety data for the Cadence™ Total
      Ankle System (CTAS) when used for primary arthroplasty in patients with primary arthritis
      (e.g. degenerative disease), secondary arthritis (e.g. post-traumatic, avascular necrosis, if
      minimally 2/3 of the talus is preserved), and systemic arthritis of the ankle (e.g.
      rheumatoid arthritis, hemochromatosis)
observational model: Case-Only
time perspective: Prospective
measure: Implant survivorship
time frame: 2 years
description: Implant survival defined as absence of device removal or revision
measure: Relative change of Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) - Mobility compared to baseline
time frame: up to 10 years
description: Relative change of PROMIS PF - Mobility compared to baseline
measure: Relative change of Range of Motion (ROM) compared to baseline
time frame: up to 10 years
description: Relative change of ROM compared to baseline
measure: Relative change of Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL) subscale compared to baseline
time frame: up to 10 years
description: Relative change of FAAM ADL compared to baseline
measure: Relative change of Visual Analogue Scale (VAS) Pain compared to baseline
time frame: up to 10 years
description: Relative change of VAS Pain compared to baseline
measure: Relative change of Quality of Life Measure Short Form - 36v2 (SF-36v2) compared to baseline
time frame: up to 10 years
description: Relative change of SF-36v2 compared to baseline
measure: Implant survivorship
time frame: 5 and 10 years
description: Implant survival defined as absence of device removal or revision
measure: Radiographic Success
time frame: up to 10 years
description: Radiographic success as defined as absence of implant radiolucency, subsidence, tilting, migration defined as no evidence of radiolucency >4 mm in more than 3 zones and of subsidence or tilting ˃4 degrees, or migration > 4mm
arm group label: Integra Cadence Total Ankle System
intervention type: Device
intervention name: Implantation of Integra Cadence Total Ankle Sysyem
description: Primary Ankle Arthroplasty
arm group label: Integra Cadence Total Ankle System
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Belgium
country: Canada
country: France
country: Spain
country: United Kingdom
country: Luxembourg
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Osteoarthritis
sharing ipd: Undecided