<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/NCT02204228</url>
  </required_header>
  <id_info>
    <org_study_id>CP-0960-001</org_study_id>
    <nct_id>NCT02204228</nct_id>
  </id_info>
  <brief_title>TITAN™ Reverse Shoulder System</brief_title>
  <official_title>A Post-market Clinical Follow-up Study of the TITAN™ Reverse Shoulder System Used in Primary or Revision Total Shoulder Arthroplasty</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 Integra® TITAN™ Reverse Shoulder System (TRS) is a semi-constrained total shoulder&#xD;
      construct. When used under the conditions and purposes intended the TRS will relieve pain and&#xD;
      restore some functional joint motion to the affected shoulder. The purpose of this study is&#xD;
      to assess the short, mid and long term outcomes of the TITAN™ Reverse Shoulder System.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Anticipated">September 2033</completion_date>
  <primary_completion_date type="Anticipated">September 2025</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Survival (lack of implant component removal or revision)</measure>
    <time_frame>2 Year</time_frame>
    <description>Any implant revisions or device related adverse events must be reported as soon as the event is discovered. Assessment of adverse events will occur at each clinic visit.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Efficacy assessed by comparing clinical results after surgery as measured with American Shoulder and Elbow Surgeons Score (ASES)</measure>
    <time_frame>2 Year/5 Year/ 7Year/ 10 Year</time_frame>
    <description>Relative change of ASES compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy assessed by comparing clinical results after surgery as measured with EuroQOL-5 Dimension (EQ-5D) score</measure>
    <time_frame>2 Year/5 Year/ 7Year/ 10 Year</time_frame>
    <description>Relative change of EQ-5D score compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy assessed by comparing clinical results after surgery as measured with Range of motion (ROM)</measure>
    <time_frame>2 Year/5 Year/ 7Year/ 10 Year</time_frame>
    <description>Relative change of ROM compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy assessed by comparing clinical results after surgery as measured with Constant score.</measure>
    <time_frame>2 Year/5 Year/ 7Year/ 10 Year</time_frame>
    <description>Relative change of Constant score compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy assessed by comparing clinical results after surgery as measured with Pain Visual Analog Scale (VAS).</measure>
    <time_frame>2 Year/5 Year/ 7Year/ 10 Year</time_frame>
    <description>Relative change of Pain Visual Analog Scale (VAS) compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy assessed by comparing clinical results after surgery as measured with SANE (Single Assessment Numeric Evaluation)</measure>
    <time_frame>2 Year/5 Year/ 7Year/ 10 Year</time_frame>
    <description>Relative change of SANE compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy assessed by comparing clinical results after surgery as measured with Radiographs</measure>
    <time_frame>2 Year/5 Year/ 7Year/ 10 Year</time_frame>
    <description>Outcome after surgery will be evaluated using the Radiographs and comparison with pre-operative data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lack of unanticipated device related serious adverse events.</measure>
    <time_frame>2 Year/5 Year/ 7Year/ 10 Year</time_frame>
    <description>Any device related adverse events must be reported as soon as the event is discovered. Assessment of adverse events will occur at each clinic visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Survival (lack of implant component removal or revision)</measure>
    <time_frame>5 Year/7 Year/10 Year</time_frame>
    <description>Any implant revisions or device related adverse events must be reported as soon as the event is discovered. Assessment of adverse events will occur at each clinic visit.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">151</enrollment>
  <condition>Osteoarthritis of the Shoulder</condition>
  <arm_group>
    <arm_group_label>TITAN™ Reverse Shoulder System (TRS)</arm_group_label>
    <description>TITAN™ Reverse Shoulder System (TRS) is a semi-constrained total shoulder construct.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TITAN™ Reverse Shoulder System (TRS)</intervention_name>
    <description>All patients will be operated on with the TITAN™ Reverse Shoulder System (TRS).</description>
    <arm_group_label>TITAN™ Reverse Shoulder System (TRS)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who require reverse shoulder replacement due to the inclusions below.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects with grossly deficient rotator cuff with severe arthropathy or Subjects with&#xD;
             failed joint replacement with grossly deficient rotator cuff&#xD;
&#xD;
          -  Subjects with a shoulder joint anatomically and structurally suited to receive the&#xD;
             device&#xD;
&#xD;
          -  Subjects at least 21 years of age and skeletally mature at the time of surgery&#xD;
&#xD;
          -  Subject provided consent to participate in the clinical study (having signed the&#xD;
             Informed Consent Form)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects without a functional deltoid muscle&#xD;
&#xD;
          -  Subjects with active local or systemic infection&#xD;
&#xD;
          -  Subjects with inadequate bone stock in the proximal humerus or glenoid fossa for&#xD;
             supporting the components&#xD;
&#xD;
          -  Subjects with poor bone quality such as osteoporosis where there could be considerable&#xD;
             migration of the prosthesis and/or a chance of fracture of the humerus or glenoid&#xD;
&#xD;
          -  Subjects with muscular, neurologic, or vascular deficiencies that compromise the&#xD;
             affected extremity&#xD;
&#xD;
          -  Subjects with known metal allergies&#xD;
&#xD;
          -  Subjects are known to be at risk for lost to follow-up, or failure to return for&#xD;
             scheduled visits&#xD;
&#xD;
          -  Subjects who are prisoners&#xD;
&#xD;
          -  Female subject who are pregnant, nursing, or of childbearing potential while not&#xD;
             practicing effective contraceptive methods&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Derick Bermudez</last_name>
    <role>Study Director</role>
    <affiliation>Smith &amp; Nephew, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Florida</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins University</name>
      <address>
        <city>Columbia</city>
        <state>Maryland</state>
        <zip>21044</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mississipi Bone and Joint Clinic</name>
      <address>
        <city>Starkville</city>
        <state>Mississippi</state>
        <zip>39759</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Active Orthopedics</name>
      <address>
        <city>Glen Ridge</city>
        <state>New Jersey</state>
        <zip>07028</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Westphal Orthopaedics</name>
      <address>
        <city>Lancaster</city>
        <state>Pennsylvania</state>
        <zip>17601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital of the University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</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>
    <facility>
      <name>Clinique Bizet</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Manacor - Llevant</name>
      <address>
        <city>Manacor</city>
        <zip>07500</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barts Health NHS Trust</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
    <country>Spain</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>July 21, 2014</study_first_submitted>
  <study_first_submitted_qc>July 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</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 23, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>osteoarthritis</keyword>
  <keyword>rheumatoid arthritis</keyword>
  <keyword>post traumatic arthritis</keyword>
  <keyword>avascular necrosis</keyword>
  <keyword>severe fractures</keyword>
  <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/NCT02204228
org study id: CP-0960-001
nct id: NCT02204228
lead sponsor: 
has dmc: No
The Integra® TITAN™ Reverse Shoulder System (TRS) is a semi-constrained total shoulder
      construct. When used under the conditions and purposes intended the TRS will relieve pain and
      restore some functional joint motion to the affected shoulder. The purpose of this study is
      to assess the short, mid and long term outcomes of the TITAN™ Reverse Shoulder System.
observational model: Cohort
time perspective: Prospective
measure: Survival (lack of implant component removal or revision)
time frame: 2 Year
description: Any implant revisions or device related adverse events must be reported as soon as the event is discovered. Assessment of adverse events will occur at each clinic visit.
measure: Efficacy assessed by comparing clinical results after surgery as measured with American Shoulder and Elbow Surgeons Score (ASES)
time frame: 2 Year/5 Year/ 7Year/ 10 Year
description: Relative change of ASES compared to baseline
measure: Efficacy assessed by comparing clinical results after surgery as measured with EuroQOL-5 Dimension (EQ-5D) score
time frame: 2 Year/5 Year/ 7Year/ 10 Year
description: Relative change of EQ-5D score compared to baseline
measure: Efficacy assessed by comparing clinical results after surgery as measured with Range of motion (ROM)
time frame: 2 Year/5 Year/ 7Year/ 10 Year
description: Relative change of ROM compared to baseline
measure: Efficacy assessed by comparing clinical results after surgery as measured with Constant score.
time frame: 2 Year/5 Year/ 7Year/ 10 Year
description: Relative change of Constant score compared to baseline
measure: Efficacy assessed by comparing clinical results after surgery as measured with Pain Visual Analog Scale (VAS).
time frame: 2 Year/5 Year/ 7Year/ 10 Year
description: Relative change of Pain Visual Analog Scale (VAS) compared to baseline
measure: Efficacy assessed by comparing clinical results after surgery as measured with SANE (Single Assessment Numeric Evaluation)
time frame: 2 Year/5 Year/ 7Year/ 10 Year
description: Relative change of SANE compared to baseline
measure: Efficacy assessed by comparing clinical results after surgery as measured with Radiographs
time frame: 2 Year/5 Year/ 7Year/ 10 Year
description: Outcome after surgery will be evaluated using the Radiographs and comparison with pre-operative data.
measure: Lack of unanticipated device related serious adverse events.
time frame: 2 Year/5 Year/ 7Year/ 10 Year
description: Any device related adverse events must be reported as soon as the event is discovered. Assessment of adverse events will occur at each clinic visit.
measure: Survival (lack of implant component removal or revision)
time frame: 5 Year/7 Year/10 Year
description: Any implant revisions or device related adverse events must be reported as soon as the event is discovered. Assessment of adverse events will occur at each clinic visit.
arm group label: TITAN™ Reverse Shoulder System (TRS)
description: TITAN™ Reverse Shoulder System (TRS) is a semi-constrained total shoulder construct.
intervention type: Device
intervention name: TITAN™ Reverse Shoulder System (TRS)
description: All patients will be operated on with the TITAN™ Reverse Shoulder System (TRS).
arm group label: TITAN™ Reverse Shoulder System (TRS)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Derick Bermudez
role: Study Director
affiliation: Smith & Nephew, Inc.
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
country: Spain
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Osteoarthritis