<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/NCT03245320</url>
  </required_header>
  <id_info>
    <org_study_id>T-TSS-002</org_study_id>
    <nct_id>NCT03245320</nct_id>
  </id_info>
  <brief_title>Clinical Evaluation of the TITAN™ Total Shoulder System</brief_title>
  <official_title>A Post-Market Observational Study to Evaluate Performance and Safety of the TITAN™ Total Shoulder System</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>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A post market, non-randomized, multi-center, open-label,clinical study using survivorship to&#xD;
      study the safety and efficacy of the Integra® TITAN™ Total Shoulder System 1.0 (TAS) when&#xD;
      used for total shoulder arthroplasty.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Observational, multi-center, post-market study to provide data on the performance and safety&#xD;
      of the TITAN™ Total Shoulder System. The study will enroll patients that underwent total&#xD;
      shoulder arthroplasty with the TITAN™ Total Shoulder System per standard of care less than 5&#xD;
      years ago. Available retrospective data up to the 2-year time point will be collected, per&#xD;
      the study protocol, from medical record reviews. Prospective observational data will be&#xD;
      collected from the time of patient enrollment during the following postoperative clinical&#xD;
      visits: 1 year, 2 years, 5 years and 10 years post-surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">March 20, 2017</start_date>
  <completion_date type="Anticipated">June 2028</completion_date>
  <primary_completion_date type="Anticipated">June 2026</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Implant survival at 2 years</measure>
    <time_frame>2 years</time_frame>
    <description>Implant survivorship is defined as absence of device removal or revision of one or more of the implant component(s).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Implant survival .</measure>
    <time_frame>5 and 10 years</time_frame>
    <description>Implant survivorship is defined as absence of device removal or revision of one or more of the implant component(s).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relative change of Range of Motion (ROM) compared to baseline</measure>
    <time_frame>2, 5, and 10 years</time_frame>
    <description>Relative change of Range of Motion (ROM) compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiographic assessment</measure>
    <time_frame>2, 5, and 10 years</time_frame>
    <description>Radiographic assessment for loosening, malpositioned implant, subsidence, subluxation, and radiolucency</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relative change in Quality Of Life (EQ-5D) compared to baseline</measure>
    <time_frame>2, 5, and 10 years</time_frame>
    <description>Relative change in Quality Of Life (EQ-5D) compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relative change of American Shoulder and Elbow Surgeon Score (ASES) compared to baseline</measure>
    <time_frame>2, 5, and 10 years</time_frame>
    <description>Relative change of American Shoulder and Elbow Surgeon Score (ASES) compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relative change of PENN Pain and Function Score (PENN) compared to baseline</measure>
    <time_frame>2, 5, and 10 years</time_frame>
    <description>Relative change of PENN Pain and Function Score (PENN) compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relative change in Quality Of Life (SF-12V1) compared to baseline</measure>
    <time_frame>2, 5, and 10 years</time_frame>
    <description>Relative change in Quality Of Life (SF-12V1) compared to baseline</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">50</enrollment>
  <condition>Arthritis</condition>
  <condition>Arthritis, Degenerative</condition>
  <condition>Rheumatoid Arthritis</condition>
  <condition>Post-traumatic Arthrosis of Other Joints, Shoulder Region</condition>
  <condition>Rotator Cuff Syndrome of Shoulder and Allied Disorders</condition>
  <condition>Fracture</condition>
  <condition>Avascular Necrosis</condition>
  <condition>Joint Instability</condition>
  <condition>Joint Trauma</condition>
  <condition>Dislocation, Shoulder</condition>
  <condition>Pain, Shoulder</condition>
  <arm_group>
    <arm_group_label>TITAN™ Total Shoulder System Generation 1.0</arm_group_label>
    <description>Integra TITAN™ Total Shoulder System Generation 1.0</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Integra TITAN™ Total Shoulder Generation 1.0</intervention_name>
    <description>Total Shoulder Arthroplasty or Hemiarthroplasty</description>
    <arm_group_label>TITAN™ Total Shoulder System Generation 1.0</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subject has undergone shoulder arthroplasty with the first generation TITAN Total Shoulder&#xD;
        System.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject has undergone shoulder arthroplasty with the first generation TITAN Total&#xD;
             Shoulder System.&#xD;
&#xD;
          2. The first generation TITAN Total Shoulder System is still intact and the subject has&#xD;
             not received any revision surgeries involving the TITAN Total Shoulder System.&#xD;
&#xD;
          3. Subject is willing and able to participate in required follow-up visits at the&#xD;
             investigational site and to complete study procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject, in the opinion of the PI, has an emotional or neurological condition that&#xD;
             would pre-empt their ability or willingness to participate in the study such as mental&#xD;
             illness, or drug or alcohol abuse.&#xD;
&#xD;
          2. Subject is known to be at risk for lost to follow-up, or failure to return for&#xD;
             scheduled visits.&#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>Andrew Tummon</last_name>
    <role>Study Director</role>
    <affiliation>Integra LifeSciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>OrthoIndy</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46278</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Rothman Institute</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>May 3, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <last_update_submitted>March 22, 2023</last_update_submitted>
  <last_update_submitted_qc>March 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 24, 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>
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Joint Instability</mesh_term>
    <mesh_term>Shoulder Pain</mesh_term>
    <mesh_term>Shoulder Dislocation</mesh_term>
    <mesh_term>Necrosis</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/NCT03245320
org study id: T-TSS-002
nct id: NCT03245320
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
A post market, non-randomized, multi-center, open-label,clinical study using survivorship to
      study the safety and efficacy of the Integra® TITAN™ Total Shoulder System 1.0 (TAS) when
      used for total shoulder arthroplasty.
Observational, multi-center, post-market study to provide data on the performance and safety
      of the TITAN™ Total Shoulder System. The study will enroll patients that underwent total
      shoulder arthroplasty with the TITAN™ Total Shoulder System per standard of care less than 5
      years ago. Available retrospective data up to the 2-year time point will be collected, per
      the study protocol, from medical record reviews. Prospective observational data will be
      collected from the time of patient enrollment during the following postoperative clinical
      visits: 1 year, 2 years, 5 years and 10 years post-surgery.
observational model: Case-Control
time perspective: Other
measure: Implant survival at 2 years
time frame: 2 years
description: Implant survivorship is defined as absence of device removal or revision of one or more of the implant component(s).
measure: Implant survival .
time frame: 5 and 10 years
description: Implant survivorship is defined as absence of device removal or revision of one or more of the implant component(s).
measure: Relative change of Range of Motion (ROM) compared to baseline
time frame: 2, 5, and 10 years
description: Relative change of Range of Motion (ROM) compared to baseline
measure: Radiographic assessment
time frame: 2, 5, and 10 years
description: Radiographic assessment for loosening, malpositioned implant, subsidence, subluxation, and radiolucency
measure: Relative change in Quality Of Life (EQ-5D) compared to baseline
time frame: 2, 5, and 10 years
description: Relative change in Quality Of Life (EQ-5D) compared to baseline
measure: Relative change of American Shoulder and Elbow Surgeon Score (ASES) compared to baseline
time frame: 2, 5, and 10 years
description: Relative change of American Shoulder and Elbow Surgeon Score (ASES) compared to baseline
measure: Relative change of PENN Pain and Function Score (PENN) compared to baseline
time frame: 2, 5, and 10 years
description: Relative change of PENN Pain and Function Score (PENN) compared to baseline
measure: Relative change in Quality Of Life (SF-12V1) compared to baseline
time frame: 2, 5, and 10 years
description: Relative change in Quality Of Life (SF-12V1) compared to baseline
arm group label: TITAN™ Total Shoulder System Generation 1.0
description: Integra TITAN™ Total Shoulder System Generation 1.0
intervention type: Device
intervention name: Integra TITAN™ Total Shoulder Generation 1.0
description: Total Shoulder Arthroplasty or Hemiarthroplasty
arm group label: TITAN™ Total Shoulder System Generation 1.0
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Andrew Tummon
role: Study Director
affiliation: Integra LifeSciences
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Osteoarthritis
mesh term: Joint Instability
mesh term: Shoulder Pain
mesh term: Shoulder Dislocation
mesh term: Necrosis