<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/NCT01726972</url>
  </required_header>
  <id_info>
    <org_study_id>369439-1</org_study_id>
    <nct_id>NCT01726972</nct_id>
  </id_info>
  <brief_title>A Retrospective Review of FloSeal Use in Total Shoulder Arthroplasty</brief_title>
  <official_title>A Retrospective Review of FloSeal Use in Total Shoulder Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Western Orthopaedics Research and Education Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Western Orthopaedics Research and Education Foundation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The proposed study aims to objectively assess 2-year clinical and radiographic results for&#xD;
      the rate of glenoid component loosening in total shoulder arthroplasty (TSA). This&#xD;
      retrospective radiographic review will provide evidence for equivalence or superiority in&#xD;
      curtailing loosening, a known complication in arthroplasty, when a hemostatic agent is&#xD;
      utilized in conjunction with cement at the glenoid.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</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>Radiographic Loosening</measure>
    <time_frame>2 years</time_frame>
    <description>Radiographic loosening is defined by the presence of radiolucent lines at the bone-cement interface at 2 years. Lines are measured as being either not-present, less than 2mm or greater than/equal to 2mm, in addition to implant seating and the radiodensity between the flanges of the central peg.</description>
  </primary_outcome>
  <enrollment type="Actual">41</enrollment>
  <condition>Total Shoulder Arthroplasty</condition>
  <condition>Glenohumeral Osteoarthritis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who have previously undergone anatomic total shoulder arthroplasty for the&#xD;
        treatment of glenohumeral osteoarthritis.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must have completed at least 2 years follow-up following their total shoulder&#xD;
             replacement&#xD;
&#xD;
          -  Patients must have had radiographic imaging obtained at that 2 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients less than 21 years of age&#xD;
&#xD;
          -  Patients who have been imprisoned since the time of surgery&#xD;
&#xD;
          -  Patients who are mentally impaired&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80218</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 8, 2012</study_first_submitted>
  <study_first_submitted_qc>November 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 15, 2012</study_first_posted>
  <last_update_submitted>October 22, 2020</last_update_submitted>
  <last_update_submitted_qc>October 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 23, 2020</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>Osteoarthritis</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/NCT01726972
org study id: 369439-1
nct id: NCT01726972
lead sponsor: 
has dmc: No
The proposed study aims to objectively assess 2-year clinical and radiographic results for
      the rate of glenoid component loosening in total shoulder arthroplasty (TSA). This
      retrospective radiographic review will provide evidence for equivalence or superiority in
      curtailing loosening, a known complication in arthroplasty, when a hemostatic agent is
      utilized in conjunction with cement at the glenoid.
observational model: Cohort
time perspective: Retrospective
measure: Radiographic Loosening
time frame: 2 years
description: Radiographic loosening is defined by the presence of radiolucent lines at the bone-cement interface at 2 years. Lines are measured as being either not-present, less than 2mm or greater than/equal to 2mm, in addition to implant seating and the radiodensity between the flanges of the central peg.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: 90 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Osteoarthritis