<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/NCT02244788</url>
  </required_header>
  <id_info>
    <org_study_id>2013-059</org_study_id>
    <nct_id>NCT02244788</nct_id>
  </id_info>
  <brief_title>Humanitarian Use of AVANTA Orthopaedics Proximal Interphalangeal Joint</brief_title>
  <official_title>Humanitarian Use of AVANTA Orthopaedics Proximal Interphalangeal Joint</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital for Special Surgery, New York</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital for Special Surgery, New York</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to allow patients to undergo surgery with the SR™ PIP (Proximal&#xD;
      Interphalangeal) Implants for finger arthritis. This is NOT a research study, but rather, a&#xD;
      requirement by the FDA for humanitarian use of device&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this IRB approved study is to allow patients to undergo surgery with the SR™&#xD;
      PIP (Proximal Interphalangeal) Implants. This is NOT a research study, but rather, a&#xD;
      requirement by the FDA for humanitarian use of device. Use of the SR™ PIP is approved for&#xD;
      humanitarian use by the FDA when either the patient is in need of a revision of failed PIP&#xD;
      prothesis(es) or the patient expects to place his/her hand under loading situation which&#xD;
      preclude the use of an alternative implant in the painful osteo-arthritic and post traumatic&#xD;
      arthritic PIP joint.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Available</overall_status>
  <study_type>Expanded Access</study_type>
  <has_expanded_access>No</has_expanded_access>
  <condition>Arthroplasty of the PIP Joint</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SR™ PIP</intervention_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patient is in need of a revision of failed PIP prosthesis(es)&#xD;
&#xD;
          -  patient expects to place his/her hands under loading situations which preclude the use&#xD;
             of an alternative implant in the painful osteo-arthritic and post traumatic arthritic&#xD;
             PIP joint&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patient is not in need of a revision of a failed PIP prothesis(es)&#xD;
&#xD;
          -  patient is eligible to use an alternative implant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Edward Athanasian, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital for Special Surgery, New York</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Christian Victoria</last_name>
    <phone>646-714-6640</phone>
    <email>victoriac@hss.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Bridget Hayes, MHA, MPH</last_name>
    <phone>212-774-2056</phone>
    <email>hayesb@hss.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hospital for Special Surgery</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Available</status>
    <contact>
      <last_name>Christian Victoria</last_name>
      <phone>646-714-6640</phone>
      <email>victoriac@hss.edu</email>
    </contact>
    <contact_backup>
      <last_name>Bridget Hayes, MHA, MPH</last_name>
      <phone>212-774-2056</phone>
      <email>hayesb@hss.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Edward Athanasian, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Michelle Carlson, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Duretti Fufa, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Robert Hotchkiss, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Lana Kang, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Steve Lee, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Andrew Weiland, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Scott Wolfe, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>September 16, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <last_update_submitted>April 10, 2023</last_update_submitted>
  <last_update_submitted_qc>April 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02244788
org study id: 2013-059
nct id: NCT02244788
lead sponsor: 
The purpose of this study is to allow patients to undergo surgery with the SR™ PIP (Proximal
      Interphalangeal) Implants for finger arthritis. This is NOT a research study, but rather, a
      requirement by the FDA for humanitarian use of device
The purpose of this IRB approved study is to allow patients to undergo surgery with the SR™
      PIP (Proximal Interphalangeal) Implants. This is NOT a research study, but rather, a
      requirement by the FDA for humanitarian use of device. Use of the SR™ PIP is approved for
      humanitarian use by the FDA when either the patient is in need of a revision of failed PIP
      prothesis(es) or the patient expects to place his/her hand under loading situation which
      preclude the use of an alternative implant in the painful osteo-arthritic and post traumatic
      arthritic PIP joint.
intervention type: Device
intervention name: SR™ PIP
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Edward Athanasian, MD
role: Principal Investigator
affiliation: Hospital for Special Surgery, New York
last name: Christian Victoria
phone: 646-714-6640
email: victoriac@hss.edu
last name: Bridget Hayes, MHA, MPH
phone: 212-774-2056
email: hayesb@hss.edu
facility: 
status: Available
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: United States
responsible party type: Sponsor