<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/NCT02983292</url>
  </required_header>
  <id_info>
    <org_study_id>T-HRA-003</org_study_id>
    <nct_id>NCT02983292</nct_id>
  </id_info>
  <brief_title>PyroTITAN Humeral Resurfacing Arthroplasty (HRA)</brief_title>
  <acronym>HRA</acronym>
  <official_title>A Clinical and Radiological Study to Evaluate the Safety and Efficacy of the PyroTITAN Humeral Resurfacing Arthroplasty (HRA) Device in a New Cohort of Patients After Product Re-Release</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is designed as a single center, post-market, non-randomized, open-label,&#xD;
      observational clinical study with retrospective and prospective enrollment to evaluate the&#xD;
      2-year post implantation survivorship of the PyroTITAN™ HRA device following the&#xD;
      implementation of a new proof test to identify and eliminate devices with sub-standard&#xD;
      mechanical integrity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is designed as a single center, post-market, non-randomized, open-label,&#xD;
      observational clinical study with retrospective and prospective enrollment to evaluate the&#xD;
      2-year post implantation survivorship of the PyroTITAN™ HRA device following the&#xD;
      implementation of a new proof test to identify and eliminate devices with sub-standard&#xD;
      mechanical integrity. The results will be compared to data collected in a prior study&#xD;
      conducted before implementing the new proof test. The PyroTITAN™ HRA Shoulder prosthesis&#xD;
      device configuration will include humeral resurfacing CAP without cement. Patients will be&#xD;
      selected retrospectively and prospectively for recruitment into the study based upon the&#xD;
      normally accepted criteria for primary shoulder resurfacing arthroplasty.&#xD;
&#xD;
      137 subjects with PyroTITAN™ HRA Shoulder prosthesis arthroplasties will be implanted and&#xD;
      followed for up to 60 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 2016</start_date>
  <completion_date type="Anticipated">November 2023</completion_date>
  <primary_completion_date type="Anticipated">October 2023</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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Device survival</measure>
    <time_frame>October 2020</time_frame>
    <description>Assessment of device survival at the two year time-point</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Device related adverse events</measure>
    <time_frame>October 2020</time_frame>
    <description>Absence of complications (device related Adverse Events), and post-op procedures on the affected joint including additional revision surgeries at 2-year and 5-year time-points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Device functionality</measure>
    <time_frame>October 2020</time_frame>
    <description>Assessment of the functionality of the PyroTITAN™ HRA Shoulder System through clinical assessments at 2-year and 5-year time-points.</description>
  </secondary_outcome>
  <enrollment type="Actual">137</enrollment>
  <condition>Arthritis</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PyroTITAN™ HRA</intervention_name>
    <description>Humeral Resurfacing</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects who require humeral head resurfacing arthroplasty.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients of either sex will be included, if they:&#xD;
&#xD;
          1. Present (prospective cohort) or presented (retrospective cohort) for primary shoulder&#xD;
             surface replacement or arthroplasty with any of the following diagnoses:&#xD;
&#xD;
               1. Osteoarthritis&#xD;
&#xD;
               2. Rheumatoid / Inflammatory Arthritis&#xD;
&#xD;
               3. Post-traumatic arthritis.&#xD;
&#xD;
               4. Focal and large (Hill-Sachs) osteochondral defects.&#xD;
&#xD;
          2. Subject receives (prospective cohort) the PyroTITAN HRA device after the re-release of&#xD;
             the product or received (retrospective cohort) the PyroTITAN HRA device after the re-&#xD;
             release of the product and is enrolled in the study prior to their two-year follow-up&#xD;
             visit.&#xD;
&#xD;
          3. Subject is able to or capable of providing consent to participate in the clinical&#xD;
             investigation.&#xD;
&#xD;
          4. Subject agrees to comply with this protocol, including participating in required&#xD;
             follow-up visits at the investigations site and completing study questionnaires.&#xD;
&#xD;
          5. Subject is at least 18 years of age and skeletally mature at the time of surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients will be excluded from participation if they:&#xD;
&#xD;
          1. Has/had destruction of the proximal humerus to preclude rigid fixation of the humeral&#xD;
             component.&#xD;
&#xD;
          2. Has/had insufficient bone quality as determined by intra- operative evaluation.&#xD;
&#xD;
          3. Has/had arthritis with defective rotator cuff.&#xD;
&#xD;
          4. Has/had had a failed rotator cuff surgery.&#xD;
&#xD;
          5. Has/had loss of musculature, neuromuscular compromise or vascular deficiency in the&#xD;
             affected limb rendering the procedure unjustified.&#xD;
&#xD;
          6. Has/had evidence of active infection.&#xD;
&#xD;
          7. Present/presented with a condition of neuromuscular compromise of the shoulder (e.g.,&#xD;
             neuropathic joints or brachioplexus injury with a flail shoulder joint).&#xD;
&#xD;
          8. Are unwilling or unable to comply with a rehabilitation program or would fail to&#xD;
             return for the postoperative follow- up visits prescribed by the protocol.&#xD;
&#xD;
          9. Are/were skeletally immature.&#xD;
&#xD;
         10. Has/had a known allergic reaction to PyroCarbon.&#xD;
&#xD;
         11. Has/had other conditions such as central nervous system disturbances, alcohol or drug&#xD;
             addiction, etc. that may make effective evaluation of the joint replacement difficult&#xD;
             or impossible.&#xD;
&#xD;
         12. Has/had known, active metastatic or neoplastic disease.&#xD;
&#xD;
         13. Are/were taking &gt; 10mg/day corticosteroids (e.g. prednisone) excluding inhalers,&#xD;
             within 3 months prior to surgery.&#xD;
&#xD;
         14. Are/were under 21 years of age or over 75.&#xD;
&#xD;
         15. Require/required glenoid replacement.&#xD;
&#xD;
         16. Retrospective patients cannot be enrolled if they are two year or greater out from the&#xD;
             index surgery.&#xD;
&#xD;
         17. Women, who are pregnant or are planning to become pregnant.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Belinda Larson</last_name>
    <role>Study Director</role>
    <affiliation>Smith &amp; Nephew, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Brisbane Hand and Upper Limb Research Institute</name>
      <address>
        <city>Brisbane</city>
        <state>Queensland</state>
        <zip>4001</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>December 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>July 7, 2023</last_update_submitted>
  <last_update_submitted_qc>July 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
  </condition_browse>
  <!-- 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/NCT02983292
org study id: T-HRA-003
nct id: NCT02983292
lead sponsor: 
has dmc: No
The study is designed as a single center, post-market, non-randomized, open-label,
      observational clinical study with retrospective and prospective enrollment to evaluate the
      2-year post implantation survivorship of the PyroTITAN™ HRA device following the
      implementation of a new proof test to identify and eliminate devices with sub-standard
      mechanical integrity.
The study is designed as a single center, post-market, non-randomized, open-label,
      observational clinical study with retrospective and prospective enrollment to evaluate the
      2-year post implantation survivorship of the PyroTITAN™ HRA device following the
      implementation of a new proof test to identify and eliminate devices with sub-standard
      mechanical integrity. The results will be compared to data collected in a prior study
      conducted before implementing the new proof test. The PyroTITAN™ HRA Shoulder prosthesis
      device configuration will include humeral resurfacing CAP without cement. Patients will be
      selected retrospectively and prospectively for recruitment into the study based upon the
      normally accepted criteria for primary shoulder resurfacing arthroplasty.

      137 subjects with PyroTITAN™ HRA Shoulder prosthesis arthroplasties will be implanted and
      followed for up to 60 months.
observational model: Cohort
time perspective: Other
measure: Device survival
time frame: October 2020
description: Assessment of device survival at the two year time-point
measure: Device related adverse events
time frame: October 2020
description: Absence of complications (device related Adverse Events), and post-op procedures on the affected joint including additional revision surgeries at 2-year and 5-year time-points.
measure: Device functionality
time frame: October 2020
description: Assessment of the functionality of the PyroTITAN™ HRA Shoulder System through clinical assessments at 2-year and 5-year time-points.
intervention type: Device
intervention name: PyroTITAN™ HRA
description: Humeral Resurfacing
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Belinda Larson
role: Study Director
affiliation: Smith & Nephew, Inc.
facility: 
country: Australia
responsible party type: Sponsor
mesh term: Arthritis