<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/NCT03756714</url>
  </required_header>
  <id_info>
    <org_study_id>TFCCFF.PMCF.2017.12</org_study_id>
    <nct_id>NCT03756714</nct_id>
  </id_info>
  <brief_title>Safety and Performance of the TFCC FastFix in the Wrist</brief_title>
  <official_title>Safety and Performance of the TFCC FastFix in the Wrist</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Smith &amp; Nephew, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </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>
      Assess safety and performance post-market of the TFCC FastFix in the wrist.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 28, 2018</start_date>
  <completion_date type="Actual">September 29, 2021</completion_date>
  <primary_completion_date type="Actual">September 29, 2021</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>Rate (%) of clinical success of six months post-operative. Clinical success is defined as wrists without signs of device failure and/or re-intervention after assessment by surgeon</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <enrollment type="Actual">88</enrollment>
  <condition>Suture Retention Device to Facilitate Triangular Fibrocartilage Complex (TFCC) Repair</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who had TFCC repair using TFCC FastFix device&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who have undergone TFCC repair using the TFCC FastFix Device&#xD;
&#xD;
          -  Patients aged 18 years and older&#xD;
&#xD;
          -  Patients that are &gt; 12 months post-operative.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who are &lt; 12 months post-operative&#xD;
&#xD;
          -  Subject is entered in another investigational drug, biologic, or device study or has&#xD;
             been treated with an investigational product within 12 months post-operative.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Stephan Mangin</last_name>
    <role>Study Chair</role>
    <affiliation>Smith &amp; Nephew, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Miami Orthopedics &amp; Sport Medicine Institute</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33146</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>October 1, 2021</last_update_submitted>
  <last_update_submitted_qc>October 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03756714
org study id: TFCCFF.PMCF.2017.12
nct id: NCT03756714
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Assess safety and performance post-market of the TFCC FastFix in the wrist.
observational model: Cohort
time perspective: Retrospective
measure: Rate (%) of clinical success of six months post-operative. Clinical success is defined as wrists without signs of device failure and/or re-intervention after assessment by surgeon
time frame: 6 months
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Stephan Mangin
role: Study Chair
affiliation: Smith & Nephew, Inc.
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No