<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/NCT03782298</url>
  </required_header>
  <id_info>
    <org_study_id>SMD.PEEK.RET.EXT</org_study_id>
    <nct_id>NCT03782298</nct_id>
  </id_info>
  <brief_title>Safety and Performance of PEEK Anchors (Dynomite, Spyromite, Raptomite) in Extremities</brief_title>
  <official_title>Safety and Performance of PEEK Anchors (Dynomite, Spyromite, Raptormite, Footprint Ultra PK SL) in Extremities</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>
      Safety and performance of the study devices in extremities over a time period of 6 months&#xD;
      after intervention.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 12, 2019</start_date>
  <completion_date type="Actual">August 15, 2019</completion_date>
  <primary_completion_date type="Actual">August 15, 2019</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Safety and performance of the study devices in extremities over a time period of 6 months after intervention.</measure>
    <time_frame>6 months</time_frame>
    <description>Clinical success is defined as extremity repairs without signs of device failure and/or re-intervention as assessed by the surgeon.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety and performance of the study devices in extremities over a time period of 12 months after intervention</measure>
    <time_frame>12 months</time_frame>
    <description>Clinical success is defined as extremity repairs without signs of device failure and/or re-intervention as assessed by the surgeon</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Visual Analog Scale (VAS) - pain</measure>
    <time_frame>12 months</time_frame>
    <description>0 to 10 is the scoring range of pain for the joint that received treatment with the anchor</description>
  </other_outcome>
  <other_outcome>
    <measure>Range of Motion (ROM)</measure>
    <time_frame>12 months</time_frame>
    <description>Shoulder-full functional arc, forward flexion angle, internal, external rotation will be captured in degrees.</description>
  </other_outcome>
  <enrollment type="Actual">122</enrollment>
  <condition>Medial or Lateral Instability Repairs/Reconstructions</condition>
  <condition>Hallux Valgus Repairs</condition>
  <condition>Achilles Tendon Repairs/Reconstructions</condition>
  <condition>Midfoot Reconstructions</condition>
  <condition>Metatarsal Ligament/Tendon Repairs/Reconstructions</condition>
  <condition>Bunionectomy</condition>
  <condition>Scapholunate Ligament Reconstructions</condition>
  <condition>Ulnar</condition>
  <condition>Lateral Epicondylitis Repair</condition>
  <condition>Bicep Tendon Reattachments</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Spyromite, Dynomite, Raptomite, Footprint Ultra PK SL</intervention_name>
    <description>Observational, post-market, clinical follow-up study</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects who have undergone extremity joint repair using the study devices, PEEK Anchors&#xD;
        (Dynomite, Spyromite, Raptomite, Footprint Ultra PK SL)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects who have undergone extremity joint repair using the study devices.&#xD;
&#xD;
          -  Subjects aged 18 years and older at the time of surgery.&#xD;
&#xD;
        Exclusion Criteria:&#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;
&#xD;
          -  Subjects who are &lt; 3 months post-operative&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Judth Horner</last_name>
    <role>Study Chair</role>
    <affiliation>Smith &amp; Nephew, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>OrthoCarolina</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Precision Orthopaedic Specialties, Inc.</name>
      <address>
        <city>Chardon</city>
        <state>Ohio</state>
        <zip>44024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foot and Ankle Associates of North Texas-Grapevine</name>
      <address>
        <city>Grapevine</city>
        <state>Texas</state>
        <zip>76051</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bear Creek Surgery Center</name>
      <address>
        <city>Keller</city>
        <state>Texas</state>
        <zip>76248</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fowler Kennedy Sport Medicine Clinic</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 3K7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>November 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>June 16, 2020</last_update_submitted>
  <last_update_submitted_qc>June 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Dynomite</keyword>
  <keyword>Spyromite</keyword>
  <keyword>Raptormite</keyword>
  <keyword>Foot</keyword>
  <keyword>Ankle</keyword>
  <keyword>Wrist</keyword>
  <keyword>Hand</keyword>
  <keyword>Elbow</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tennis Elbow</mesh_term>
    <mesh_term>Hallux Valgus</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/NCT03782298
org study id: SMD.PEEK.RET.EXT
nct id: NCT03782298
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Safety and performance of the study devices in extremities over a time period of 6 months
      after intervention.
observational model: Case-Only
time perspective: Retrospective
measure: Safety and performance of the study devices in extremities over a time period of 6 months after intervention.
time frame: 6 months
description: Clinical success is defined as extremity repairs without signs of device failure and/or re-intervention as assessed by the surgeon.
measure: Safety and performance of the study devices in extremities over a time period of 12 months after intervention
time frame: 12 months
description: Clinical success is defined as extremity repairs without signs of device failure and/or re-intervention as assessed by the surgeon
measure: Visual Analog Scale (VAS) - pain
time frame: 12 months
description: 0 to 10 is the scoring range of pain for the joint that received treatment with the anchor
measure: Range of Motion (ROM)
time frame: 12 months
description: Shoulder-full functional arc, forward flexion angle, internal, external rotation will be captured in degrees.
intervention type: Device
intervention name: Spyromite, Dynomite, Raptomite, Footprint Ultra PK SL
description: Observational, post-market, clinical follow-up study
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Judth Horner
role: Study Chair
affiliation: Smith & Nephew, Inc.
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
country: United States
responsible party type: Sponsor
mesh term: Tennis Elbow
mesh term: Hallux Valgus
sharing ipd: No