<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/NCT03250767</url>
  </required_header>
  <id_info>
    <org_study_id>T-TSS-003</org_study_id>
    <nct_id>NCT03250767</nct_id>
  </id_info>
  <brief_title>Clinical Evaluation of the Integra® Titan™ Modular Shoulder System Generation 2.5 for Primary Shoulder Joint Replacement</brief_title>
  <official_title>A Post-Market, Prospective, Multi-Center, Open-Label, Single Arm Clinical Evaluation of the Integra® Titan™ Modular Shoulder System Generation 2.5 for Primary Shoulder Joint Replacement</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, prospective, non-randomized, multi-center, open-label, clinical study using&#xD;
      survivorship as the reference performance goal to study the safety and efficacy of the Titan&#xD;
      Modular Shoulder System 2.5 when used for primary shoulder arthroplasty.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Anticipated">April 1, 2029</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2023</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Implant Survivorship</measure>
    <time_frame>2 years</time_frame>
    <description>Implant survivorship defined as absence of device removal or revision</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Implant Survivorship</measure>
    <time_frame>1,5 and 10 years</time_frame>
    <description>Implant survivorship defined as absence of device removal or revision</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relative change of Range of Motion (ROM) compared to baseline</measure>
    <time_frame>up to 10 years</time_frame>
    <description>Relative change of ROM compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relative change of Constant-Murley Score (CMS) compared to baseline</measure>
    <time_frame>up to 10 years</time_frame>
    <description>Relative change of CMS compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relative change of American Shoulder &amp; Elbow Surgeons Score (ASES) compared to baseline</measure>
    <time_frame>up to 10 years</time_frame>
    <description>Relative change of ASES compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relative change of Single Assessment Numeric Evaluation (SANE) compared to baseline</measure>
    <time_frame>up to 10 years</time_frame>
    <description>Relative change of SANE compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relative change of Simple Shoulder Test (SST) compared to baseline</measure>
    <time_frame>up to 10 years</time_frame>
    <description>Relative change of SST compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relative change of Pain compared to baseline</measure>
    <time_frame>up to 10 years</time_frame>
    <description>Relative change of Visual Analogue Scale (VAS) Pain compared to baseline</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">140</enrollment>
  <condition>Osteo Arthritis Shoulders</condition>
  <condition>Traumatic Arthritis</condition>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>Integra Titan Modular Shoulder System 2.5</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Integra Titan Modular Shoulder System 2.5</intervention_name>
    <description>Primary Shoulder Joint Replacement</description>
    <arm_group_label>Integra Titan Modular Shoulder System 2.5</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with shoulder arthritis requiring primary shoulder joint replacement&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  For total shoulder arthroplasty, subjects must meet a, b, or c below:&#xD;
&#xD;
               1. Severely painful and/or disabled joint resulting from osteoarthritis, traumatic&#xD;
                  arthritis or rheumatoid arthritis&#xD;
&#xD;
               2. Fracture-dislocations of the proximal humerus where the articular surface is&#xD;
                  severely comminuted, separated from its blood supply or where the surgeon's&#xD;
                  experience indicates that alternative methods of treatment are unsatisfactory&#xD;
&#xD;
               3. Other difficult clinical problems where shoulder arthrodesis or resection&#xD;
                  arthroplasty are not acceptable (e.g. -revision of a failed primary component)&#xD;
&#xD;
          -  For shoulder hemiarthroplasty, subjects must meet any of the sub-criteria a - g below:&#xD;
&#xD;
               1. Severely painful and/or disabled joint resulting from osteoarthritis, traumatic&#xD;
                  arthritis or rheumatoid arthritis&#xD;
&#xD;
               2. Fracture-dislocations of the proximal humerus where the articular surface is&#xD;
                  severely comminuted, separated from its blood supply or where the surgeon's&#xD;
                  experience indicates that alternative methods of treatment are unsatisfactory&#xD;
&#xD;
               3. Other difficult clinical problems where shoulder arthrodesis or resection&#xD;
                  arthroplasty are not acceptable (e.g. -revision of a failed primary component)&#xD;
&#xD;
               4. Ununited humeral head fractures&#xD;
&#xD;
               5. Avascular necrosis of the humeral head&#xD;
&#xD;
               6. Rotator cuff arthropathy&#xD;
&#xD;
               7. Deformity and/or limited motion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Absent, irreparable or nonfunctional rotator cuff or other essential muscles.&#xD;
&#xD;
          -  Have an active local or systemic infection.&#xD;
&#xD;
          -  Have inadequate bone stock in the proximal humerus or glenoid fossa for supporting the&#xD;
             components.&#xD;
&#xD;
          -  Have 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;
          -  Have a muscular, neurologic, or vascular deficiencies that compromise the affected&#xD;
             extremity.&#xD;
&#xD;
          -  Have a known sensitivity or allergic reaction to one or more of the implanted&#xD;
             materials.&#xD;
&#xD;
          -  Have a condition that may impair proper wound healing.&#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_contact>
    <last_name>Derick Bermudez</last_name>
    <phone>(+1) 737-932-3602</phone>
    <email>Derick.Bermudez@smith-nephew.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294-0111</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>John Hopkins University</name>
      <address>
        <city>Columbia</city>
        <state>Maryland</state>
        <zip>21044</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jessica Jang</last_name>
    </contact>
  </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>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>The Research Foundation for The State University of New York (SUNY)</name>
      <address>
        <city>Syracuse</city>
        <state>New York</state>
        <zip>13210</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tina Craig</last_name>
      <phone>315-464-8618</phone>
      <email>CraigT@upstate.edu</email>
    </contact>
    <contact_backup>
      <last_name>Carmelita Woods</last_name>
      <email>woodscr@upstate.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Kevin Setter, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Westphal Orthopaedics</name>
      <address>
        <city>Lancaster</city>
        <state>Pennsylvania</state>
        <zip>17601</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Edgar Garcia</last_name>
    </contact>
  </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>
    <status>Recruiting</status>
    <contact>
      <last_name>Evan Bannister</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Rothman Institute</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thema Richardson</last_name>
      <phone>267-339-3615</phone>
      <email>thema.nicholson@rothmaninstitute.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Virginia Health System</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22911</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>August 11, 2017</study_first_submitted>
  <study_first_submitted_qc>August 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 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>
  </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/NCT03250767
org study id: T-TSS-003
nct id: NCT03250767
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
A post market, prospective, non-randomized, multi-center, open-label, clinical study using
      survivorship as the reference performance goal to study the safety and efficacy of the Titan
      Modular Shoulder System 2.5 when used for primary shoulder arthroplasty.
observational model: Case-Only
time perspective: Prospective
measure: Implant Survivorship
time frame: 2 years
description: Implant survivorship defined as absence of device removal or revision
measure: Implant Survivorship
time frame: 1,5 and 10 years
description: Implant survivorship defined as absence of device removal or revision
measure: Relative change of Range of Motion (ROM) compared to baseline
time frame: up to 10 years
description: Relative change of ROM compared to baseline
measure: Relative change of Constant-Murley Score (CMS) compared to baseline
time frame: up to 10 years
description: Relative change of CMS compared to baseline
measure: Relative change of American Shoulder & Elbow Surgeons Score (ASES) compared to baseline
time frame: up to 10 years
description: Relative change of ASES compared to baseline
measure: Relative change of Single Assessment Numeric Evaluation (SANE) compared to baseline
time frame: up to 10 years
description: Relative change of SANE compared to baseline
measure: Relative change of Simple Shoulder Test (SST) compared to baseline
time frame: up to 10 years
description: Relative change of SST compared to baseline
measure: Relative change of Pain compared to baseline
time frame: up to 10 years
description: Relative change of Visual Analogue Scale (VAS) Pain compared to baseline
arm group label: Integra Titan Modular Shoulder System 2.5
intervention type: Device
intervention name: Integra Titan Modular Shoulder System 2.5
description: Primary Shoulder Joint Replacement
arm group label: Integra Titan Modular Shoulder System 2.5
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Derick Bermudez
phone: (+1) 737-932-3602
email: Derick.Bermudez@smith-nephew.com
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Terminated
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Withdrawn
country: United States
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Osteoarthritis