<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/NCT02978573</url>
  </required_header>
  <id_info>
    <org_study_id>PTC-0031 (PAS)</org_study_id>
    <nct_id>NCT02978573</nct_id>
  </id_info>
  <brief_title>Post Approval Study to Evaluate the Effectiveness and Safety of Cartiva Implant in the Treatment of OA of the Great Toe</brief_title>
  <acronym>MOTION</acronym>
  <official_title>A Post Approval Study to Evaluate the Safety and Effectiveness of Cartiva Implant in the Treatment of First Metatarsophalangeal Joint Osteoarthritis as Compared to a Control</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cartiva, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cartiva, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluate and confirm the long-term safety and effectiveness of the Cartiva SCI implant&#xD;
      established by the pivotal trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      As part of the Conditions of Approval of Cartiva SCI for the treatment of first MTP&#xD;
      osteoarthritis, the Food and Drug Administration (FDA) requires additional long term data to&#xD;
      evaluate the long term safety and effectiveness of Cartiva including the durability and&#xD;
      survivorship of the implant. This Post-Approval Study (PAS) addendum is intended to&#xD;
      supplement the initial 24 months follow up period and provide additional long term safety and&#xD;
      effectiveness data on Cartiva&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2016</start_date>
  <completion_date type="Actual">April 27, 2018</completion_date>
  <primary_completion_date type="Actual">April 27, 2018</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Long Term Safety of the Cartiva Implant by demonstrating durability over the long term and no unanticipated safety concerns that arise</measure>
    <time_frame>5 year</time_frame>
    <description>Durability of the implant over the longer term. This will be addressed using survival analysis starting at Month 24 to determine the rate of implant removals among devices that survived to Month 24. A complementary survival analysis starting at index surgery to end of study will also be performed.&#xD;
There are no unanticipated safety concerns that arise after Month 24 up to 5 years. This will be addressed by a) determining the incidence of serious device-related adverse events per year and overall from Month 24 to Year 5; and b) summarizing device-related radiographic complications1 over time from Month 24 to Year 5. Note that this analysis will address both device and procedure related complications and serious device-related adverse events whether observed previously in the 24 month follow up portion of the study or encountered for this first time during the extended follow-up period.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain Scale (VAS)</measure>
    <time_frame>5 year</time_frame>
    <description>Visual Analog Scale (VAS) Pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL)</measure>
    <time_frame>5 year</time_frame>
    <description>Foot and Ankle Ability Measure (FAAM) Activities of Daily Living scores</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Foot and Ankle Ability Measure (FAAM) Sports</measure>
    <time_frame>5 year</time_frame>
    <description>Foot and Ankle Ability Measure (FAAM) Sports scores</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">135</enrollment>
  <condition>Osteoarthritis of First Metatarsalphalangeal Joint</condition>
  <arm_group>
    <arm_group_label>Cartiva</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cartiva Synthetic Cartilage Implant</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cartiva</intervention_name>
    <description>Cartiva Synthetic Cartilage Implant</description>
    <arm_group_label>Cartiva</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject must have been treated with Cartiva under MOTION study protocol PTC-0031; and,&#xD;
&#xD;
          -  Have been informed of the nature of the study, agreeing to its requirements, and have&#xD;
             signed the informed consent approved by the IRB/Ethics Committee for long-term&#xD;
             follow-up.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who underwent a secondary surgical intervention to have the Cartiva implant&#xD;
             removed during the 24-month time period of participation in the MOTION study.&#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>Judith Baumhauer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Rochester</affiliation>
  </overall_official>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>November 11, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 1, 2016</study_first_posted>
  <last_update_submitted>March 20, 2019</last_update_submitted>
  <last_update_submitted_qc>March 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>First MTP Joint</keyword>
  <keyword>Hallux Rigidus</keyword>
  <keyword>Hallux Limitus</keyword>
  <keyword>Cartilage Replacement</keyword>
  <keyword>Osteoarthritis</keyword>
  <keyword>First MTP Joint Osteoarthritis</keyword>
  <keyword>Big Toe Pain</keyword>
  <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/NCT02978573
org study id: PTC-0031 (PAS)
nct id: NCT02978573
lead sponsor: 
has dmc: No
Evaluate and confirm the long-term safety and effectiveness of the Cartiva SCI implant
      established by the pivotal trial.
As part of the Conditions of Approval of Cartiva SCI for the treatment of first MTP
      osteoarthritis, the Food and Drug Administration (FDA) requires additional long term data to
      evaluate the long term safety and effectiveness of Cartiva including the durability and
      survivorship of the implant. This Post-Approval Study (PAS) addendum is intended to
      supplement the initial 24 months follow up period and provide additional long term safety and
      effectiveness data on Cartiva
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Long Term Safety of the Cartiva Implant by demonstrating durability over the long term and no unanticipated safety concerns that arise
time frame: 5 year
description: Durability of the implant over the longer term. This will be addressed using survival analysis starting at Month 24 to determine the rate of implant removals among devices that survived to Month 24. A complementary survival analysis starting at index surgery to end of study will also be performed.
There are no unanticipated safety concerns that arise after Month 24 up to 5 years. This will be addressed by a) determining the incidence of serious device-related adverse events per year and overall from Month 24 to Year 5; and b) summarizing device-related radiographic complications1 over time from Month 24 to Year 5. Note that this analysis will address both device and procedure related complications and serious device-related adverse events whether observed previously in the 24 month follow up portion of the study or encountered for this first time during the extended follow-up period.
measure: Pain Scale (VAS)
time frame: 5 year
description: Visual Analog Scale (VAS) Pain
measure: Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL)
time frame: 5 year
description: Foot and Ankle Ability Measure (FAAM) Activities of Daily Living scores
measure: Foot and Ankle Ability Measure (FAAM) Sports
time frame: 5 year
description: Foot and Ankle Ability Measure (FAAM) Sports scores
arm group label: Cartiva
arm group type: Experimental
description: Cartiva Synthetic Cartilage Implant
intervention type: Device
intervention name: Cartiva
description: Cartiva Synthetic Cartilage Implant
arm group label: Cartiva
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Judith Baumhauer, MD
role: Principal Investigator
affiliation: University of Rochester
responsible party type: Sponsor
mesh term: Osteoarthritis
sharing ipd: No