<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/NCT03814044</url>
  </required_header>
  <id_info>
    <org_study_id>2018.14.SMD.PEEK.RET.HIP</org_study_id>
    <nct_id>NCT03814044</nct_id>
  </id_info>
  <brief_title>PMCF Study on PEEK Suture Anchors for Hip Indications</brief_title>
  <official_title>PMCF Study on PEEK Suture Anchors for Hip Indications</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>
      Post-market clinical follow-up on the PEEK Suture Anchors in the hip.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 23, 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>Clinical success of the study devices in hip over a time period of 6 months after intervention</measure>
    <time_frame>6 months</time_frame>
    <description>Clinical success is defined as the number of device failures in the hip</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical success of the study devices in hip over a time period of 12 months after intervention</measure>
    <time_frame>12 months</time_frame>
    <description>Clinical success is defined as the number of device failures in the hip</description>
  </secondary_outcome>
  <secondary_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>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Range of Motion (ROM)</measure>
    <time_frame>12 months</time_frame>
    <description>Flexion, extension, abduction, adduction, external/internal rotation will be captured in degrees based on physican's Standard of Care for this retrospective study.</description>
  </secondary_outcome>
  <enrollment type="Actual">162</enrollment>
  <condition>Soft Tissue to Bone Fixation</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PEEK Suture Anchors</intervention_name>
    <description>Subjects who have undergone hip joint repair using PEEK Suture Anchors: Bioraptor Knotless Suture Anchor and SpeedLock Hip</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects who have undergone hip joint repair using PEEK Suture Anchors:&#xD;
&#xD;
          -  Bioraptor Knotless Suture Anchors&#xD;
&#xD;
          -  SpeedLock Hip&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects who have undergone hip joint repair using the study devices.&#xD;
&#xD;
          2. Subjects aged 18 years and older at the time of surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects who are &lt; 12 months post-operative.&#xD;
&#xD;
          2. Subject is entered in another investigational drug, biologic, or device study or has&#xD;
             been treated with an investigational product within 30 days prior to surgery&#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 Horner</last_name>
    <role>Study Chair</role>
    <affiliation>Smith &amp; Nephew, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>DMOS Orthopedic Centers</name>
      <address>
        <city>West Des Moines</city>
        <state>Iowa</state>
        <zip>50266</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Advanced Orthopedic and Sports Medicine</name>
      <address>
        <city>Auburn Hills</city>
        <state>Michigan</state>
        <zip>48326</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Community Hospital - Oklahoma City</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southwest Orthopaedic Reconstructive Specialists</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73139</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>October 24, 2018</study_first_submitted>
  <study_first_submitted_qc>January 21, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>June 17, 2020</last_update_submitted>
  <last_update_submitted_qc>June 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2020</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/NCT03814044
org study id: 2018.14.SMD.PEEK.RET.HIP
nct id: NCT03814044
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Post-market clinical follow-up on the PEEK Suture Anchors in the hip.
observational model: Case-Only
time perspective: Retrospective
measure: Clinical success of the study devices in hip over a time period of 6 months after intervention
time frame: 6 months
description: Clinical success is defined as the number of device failures in the hip
measure: Clinical success of the study devices in hip over a time period of 12 months after intervention
time frame: 12 months
description: Clinical success is defined as the number of device failures in the hip
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: Flexion, extension, abduction, adduction, external/internal rotation will be captured in degrees based on physican's Standard of Care for this retrospective study.
intervention type: Device
intervention name: PEEK Suture Anchors
description: Subjects who have undergone hip joint repair using PEEK Suture Anchors: Bioraptor Knotless Suture Anchor and SpeedLock Hip
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Judith Horner
role: Study Chair
affiliation: Smith & Nephew, Inc.
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No