<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/NCT02999009</url>
  </required_header>
  <id_info>
    <org_study_id>78</org_study_id>
    <nct_id>NCT02999009</nct_id>
  </id_info>
  <brief_title>Trident II Tritanium Acetabular Shell Outcomes Study</brief_title>
  <official_title>A Prospective, Post-market, Multi-center Study of the Trident II Tritanium Acetabular Shell</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stryker Orthopaedics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stryker Orthopaedics</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to review the performance and success rate of an FDA approved&#xD;
      cementless hip replacement part called the Trident II Tritanium Acetabular Shell. The study&#xD;
      will specifically look at the need to revise the hip replacement after 5 years. This will be&#xD;
      compared to how much this happens in patients who have hip replacement with similar&#xD;
      cementless acetabular shells.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 20, 2017</start_date>
  <completion_date type="Anticipated">February 2029</completion_date>
  <primary_completion_date type="Anticipated">February 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Absence of Revision for the Trident II Tritanium Acetabular Shell</measure>
    <time_frame>5 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>All-cause Revision and Removal Rates for the Trident II Tritanium Acetabular Shell</measure>
    <time_frame>10 years</time_frame>
    <description>Survivorship percentage (one reported value) for both all-cause revision + removal will be indicated</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiographic Stability</measure>
    <time_frame>6 weeks, 3-6 months, 1, 2, 5, 7, 10 years</time_frame>
    <description>Numerous parameters will be reviewed by zone, including radiolucency and migration.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">360</enrollment>
  <condition>Arthroplasty, Replacement, Hip</condition>
  <arm_group>
    <arm_group_label>Trident II Tritanium Acetabular Shell</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Trident II Tritanium Acetabular Shell</intervention_name>
    <description>A hemispherical acetabular shell indicated for cementless application.</description>
    <arm_group_label>Trident II Tritanium Acetabular Shell</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        A. Patient has signed an Institutional Review Board (IRB) approved, study specific Informed&#xD;
        Patient Consent Form.&#xD;
&#xD;
        B. Patient is a male or non-pregnant female age 18-80 years of age at the time of study&#xD;
        device implantation.&#xD;
&#xD;
        C. Patient has primary diagnosis of Non-Inflammatory Degenerative Joint Disease.&#xD;
&#xD;
        D. Patient is a candidate for a primary cementless total hip replacement.&#xD;
&#xD;
        E. Patient is willing and able to comply with postoperative scheduled clinical and&#xD;
        radiographic evaluations.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        F. Patient has a Body Mass Index (BMI) ≥ 40.&#xD;
&#xD;
        G. Patient is diagnosed with Inflammatory Arthritis.&#xD;
&#xD;
        H. Patient has an active or suspected latent infection in or about the affected hip joint&#xD;
        at time of study device implantation.&#xD;
&#xD;
        I. Patient has a neuromuscular or neurosensory deficiency, which limits the ability to&#xD;
        evaluate the safety and efficacy of the device.&#xD;
&#xD;
        J. Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic&#xD;
        disorder (e.g. Paget's Disease) leading to progressive bone deterioration.&#xD;
&#xD;
        K. Patient is immunologically suppressed or receiving steroids in excess of normal&#xD;
        physiological requirements (e.g. &gt; 30 days).&#xD;
&#xD;
        L. Patient requires revision surgery of a previously implanted total hip replacement or hip&#xD;
        fusion to the affected joint.&#xD;
&#xD;
        M. Patient has had previous open surgery to the affected joint, not including arthroscopy.&#xD;
&#xD;
        N. Patient requires implantation of a constrained liner.&#xD;
&#xD;
        O. Patient has a known sensitivity to device materials.&#xD;
&#xD;
        P. Patient is a prisoner.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Manoshi Stoker</last_name>
    <role>Study Director</role>
    <affiliation>Sr Director, Clinical Research - Stryker Joint Replacement</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Darshika Mistry</last_name>
    <phone>201-831-5000</phone>
    <email>darshika.mistry@stryker.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hannah Pacheco</last_name>
    <phone>201-831-5000</phone>
    <email>hannah.pacheco@stryker.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Tucson Orthopaedic Institute</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85712</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Southeast Orthopedic Specialists</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32204</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>American Hip Institute</name>
      <address>
        <city>Des Plaines</city>
        <state>Illinois</state>
        <zip>60018</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Center for Orthopaedics and Spine, LLC</name>
      <address>
        <city>Lake Charles</city>
        <state>Louisiana</state>
        <zip>70605</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bobbi Skiles</last_name>
      <phone>337-312-8619</phone>
      <email>bskiles@accurateclinicalresearch.com</email>
    </contact>
    <contact_backup>
      <last_name>Ana Batista</last_name>
      <phone>281-240-1045</phone>
      <email>abatista@accurateclinicalresearch.com</email>
    </contact_backup>
    <investigator>
      <last_name>John Noble, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>St. Joseph Mercy Hospital Health System</name>
      <address>
        <city>Ypsilanti</city>
        <state>Michigan</state>
        <zip>48197</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Rothman Institute</name>
      <address>
        <city>Egg Harbor Township</city>
        <state>New Jersey</state>
        <zip>08234</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital for Special Surgery</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Northwell Health, Lenox Hill Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10075</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bridgette Nixon</last_name>
      <email>bnixon@northwell.edu</email>
    </contact>
    <contact_backup>
      <last_name>Alain Sherman</last_name>
      <email>asherman4@northwell.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Jason Oh, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Michael Mont, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UNC Orthopaedics</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>December 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <last_update_submitted>February 9, 2023</last_update_submitted>
  <last_update_submitted_qc>February 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02999009
org study id: 78
nct id: NCT02999009
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
The purpose of this study is to review the performance and success rate of an FDA approved
      cementless hip replacement part called the Trident II Tritanium Acetabular Shell. The study
      will specifically look at the need to revise the hip replacement after 5 years. This will be
      compared to how much this happens in patients who have hip replacement with similar
      cementless acetabular shells.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Absence of Revision for the Trident II Tritanium Acetabular Shell
time frame: 5 years
measure: All-cause Revision and Removal Rates for the Trident II Tritanium Acetabular Shell
time frame: 10 years
description: Survivorship percentage (one reported value) for both all-cause revision + removal will be indicated
measure: Radiographic Stability
time frame: 6 weeks, 3-6 months, 1, 2, 5, 7, 10 years
description: Numerous parameters will be reviewed by zone, including radiolucency and migration.
arm group label: Trident II Tritanium Acetabular Shell
arm group type: Other
intervention type: Device
intervention name: Trident II Tritanium Acetabular Shell
description: A hemispherical acetabular shell indicated for cementless application.
arm group label: Trident II Tritanium Acetabular Shell
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Manoshi Stoker
role: Study Director
affiliation: Sr Director, Clinical Research - Stryker Joint Replacement
last name: Darshika Mistry
phone: 201-831-5000
email: darshika.mistry@stryker.com
last name: Hannah Pacheco
phone: 201-831-5000
email: hannah.pacheco@stryker.com
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
facility: 
status: Active, not recruiting
country: United States
responsible party type: Sponsor