<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/NCT03261986</url>
  </required_header>
  <id_info>
    <org_study_id>17-066</org_study_id>
    <nct_id>NCT03261986</nct_id>
  </id_info>
  <brief_title>A Prospective RSA and Clinical Evaluation of the Trident II Acetabular Cup</brief_title>
  <official_title>A Prospective RSA and Clinical Evaluation of the Trident II Acetabular Cup</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Midwest Orthopaedics at Rush</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Midwest Orthopaedics at Rush</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to use radiostereometric analysis (RSA) and clinical outcome&#xD;
      measures to evaluate early post-operative implant stability and the clinical performance of&#xD;
      Stryker's Trident II Acetabular Cup.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proposed study is a prospective evaluation of data from patients undergoing primary total&#xD;
      hip arthroplasty using the Trident II acetabular cup. Fifty patients will be recruited for&#xD;
      this study. All patients that qualify for the study per the inclusion-exclusion criteria and&#xD;
      provide written informed consent will receive the Trident II acetabular cup and RSA beads.&#xD;
      Implant stability, through RSA, will be measured throughout the first two postoperative&#xD;
      (post-op) years per the following schedule: immediate post-op and 6 weeks, 3 months, 6&#xD;
      months, 1 year, and 2 years following surgery. Patients will be discharged and seen for&#xD;
      follow-up assessments as per standard of care. Adverse events that are related to the index&#xD;
      joint will be collected. Health outcome questionnaires will be collected. The health outcome&#xD;
      questionnaires will include: EQ-5D, HOOS JR and Harris Hip Score. Health outcome&#xD;
      questionnaires will be completed pre-operatively and again at 6 weeks, 3 months, 6 months, 1&#xD;
      year and 2 years following surgery. Conventional x-ray analysis will be performed&#xD;
      pre-operatively and again at 6 weeks, 1 year and 2 years following surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">June 9, 2017</start_date>
  <completion_date type="Anticipated">February 9, 2022</completion_date>
  <primary_completion_date type="Anticipated">October 9, 2020</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Does the Trident II Cup achieve acceptable fixation to the underlying bone?</measure>
    <time_frame>3 years</time_frame>
    <description>The Trident II Cup proximal migration will be assessed. Migration of less than 0.2mm at 2 years and without continuous migration between post-operative year 1 and 2 will indicate acceptable fixation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>What are the migration patterns of the Trident II acetabular cup over the first two post-operative years?</measure>
    <time_frame>3 years</time_frame>
    <description>Migration patterns will be assessed using RSA analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Is there a significant difference in health status and functional outcome before and after hip arthroplasty using Trident II Cup?</measure>
    <time_frame>3 years</time_frame>
    <description>The health status and functional outcome will be assessed via Harris Hip Score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Is there a significant difference in health status and functional outcome before and after hip arthroplasty using Trident II Cup?</measure>
    <time_frame>3 years</time_frame>
    <description>The health status and functional outcome will be assessed via EQ-5D.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Is there a correlation between radiolucent lines measured by Charnley-DeLee zone analysis and migration characteristics using RSA?</measure>
    <time_frame>3 years</time_frame>
    <description>X-ray radiographs will be taken at pre-op, 6 weeks, 1 year and 2 year appointments. It may take up to 3 years after study start for all patients to reach the 2 year visit mark, depending on how long enrollment takes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Can inducible displacements measured at 1 year post-operative distinguish patients identified by RSA measurements as having inadequate fixation?</measure>
    <time_frame>2 years</time_frame>
    <description>Inducible displacements will be measured using RSA exams at the 1 year follow-up. It may take up to 2 years after study start for all patients to reach the 1 year visit mark, depending on how long enrollment takes.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Total Hip Arthroplasty</condition>
  <condition>Acetabular Cup</condition>
  <arm_group>
    <arm_group_label>Trident II acetabular cup</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Subjects receive the Trident II acetabular cup and RSA beads and undergo a series of post-operative RSA exams.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Radiostereometric Analysis</intervention_name>
    <description>RSA exams of the operative hip are received post-op day 1, and at 6 weeks, 3 months, 6 months, 1 year and 2 years following surgery</description>
    <arm_group_label>Trident II acetabular cup</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>total hip arthroplasty with RSA bead implantation</intervention_name>
    <description>Patients receive RSA beads inserted into the bone surrounding the Trident II implant.</description>
    <arm_group_label>Trident II acetabular cup</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Symptomatic arthritis of the hip indicating surgical intervention&#xD;
&#xD;
          2. Scheduled to undergo a primary total hip arthroplasty&#xD;
&#xD;
          3. Patient is a candidate for the Trident II acetabular cup in accordance with product&#xD;
             labeling -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients less than 18 years of age, or older than 85 years of age.&#xD;
&#xD;
          2. Severe hip dysplasia (Crowe Type III or IV) in the affected hip&#xD;
&#xD;
          3. History of congenital dislocation&#xD;
&#xD;
          4. Prior arthroplasty of the affected hip&#xD;
&#xD;
          5. Active or prior infection of the affected hip&#xD;
&#xD;
          6. Morbid obesity (BMI &gt; 40)&#xD;
&#xD;
          7. Medical condition precluding major surgery&#xD;
&#xD;
          8. Severe osteoporosis&#xD;
&#xD;
          9. Neuromuscular impairment&#xD;
&#xD;
         10. Patients with known allergy to metals&#xD;
&#xD;
         11. Pregnancy&#xD;
&#xD;
         12. Patients on dialysis or creatinine &gt; 2.0&#xD;
&#xD;
         13. Patient is immuno-suppressed -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Scott Sporer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Midwest Orthopaedics at Rush</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Midwest Orthopaedics at Rush</name>
      <address>
        <city>Naperville</city>
        <state>Illinois</state>
        <zip>60563</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>March 12, 2020</last_update_submitted>
  <last_update_submitted_qc>March 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Trident</keyword>
  <keyword>RSA</keyword>
  <keyword>THA</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03261986
org study id: 17-066
nct id: NCT03261986
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The objective of this study is to use radiostereometric analysis (RSA) and clinical outcome
      measures to evaluate early post-operative implant stability and the clinical performance of
      Stryker's Trident II Acetabular Cup.
The proposed study is a prospective evaluation of data from patients undergoing primary total
      hip arthroplasty using the Trident II acetabular cup. Fifty patients will be recruited for
      this study. All patients that qualify for the study per the inclusion-exclusion criteria and
      provide written informed consent will receive the Trident II acetabular cup and RSA beads.
      Implant stability, through RSA, will be measured throughout the first two postoperative
      (post-op) years per the following schedule: immediate post-op and 6 weeks, 3 months, 6
      months, 1 year, and 2 years following surgery. Patients will be discharged and seen for
      follow-up assessments as per standard of care. Adverse events that are related to the index
      joint will be collected. Health outcome questionnaires will be collected. The health outcome
      questionnaires will include: EQ-5D, HOOS JR and Harris Hip Score. Health outcome
      questionnaires will be completed pre-operatively and again at 6 weeks, 3 months, 6 months, 1
      year and 2 years following surgery. Conventional x-ray analysis will be performed
      pre-operatively and again at 6 weeks, 1 year and 2 years following surgery.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Does the Trident II Cup achieve acceptable fixation to the underlying bone?
time frame: 3 years
description: The Trident II Cup proximal migration will be assessed. Migration of less than 0.2mm at 2 years and without continuous migration between post-operative year 1 and 2 will indicate acceptable fixation.
measure: What are the migration patterns of the Trident II acetabular cup over the first two post-operative years?
time frame: 3 years
description: Migration patterns will be assessed using RSA analysis.
measure: Is there a significant difference in health status and functional outcome before and after hip arthroplasty using Trident II Cup?
time frame: 3 years
description: The health status and functional outcome will be assessed via Harris Hip Score.
measure: Is there a significant difference in health status and functional outcome before and after hip arthroplasty using Trident II Cup?
time frame: 3 years
description: The health status and functional outcome will be assessed via EQ-5D.
measure: Is there a correlation between radiolucent lines measured by Charnley-DeLee zone analysis and migration characteristics using RSA?
time frame: 3 years
description: X-ray radiographs will be taken at pre-op, 6 weeks, 1 year and 2 year appointments. It may take up to 3 years after study start for all patients to reach the 2 year visit mark, depending on how long enrollment takes.
measure: Can inducible displacements measured at 1 year post-operative distinguish patients identified by RSA measurements as having inadequate fixation?
time frame: 2 years
description: Inducible displacements will be measured using RSA exams at the 1 year follow-up. It may take up to 2 years after study start for all patients to reach the 1 year visit mark, depending on how long enrollment takes.
arm group label: Trident II acetabular cup
arm group type: Other
description: Subjects receive the Trident II acetabular cup and RSA beads and undergo a series of post-operative RSA exams.
intervention type: Radiation
intervention name: Radiostereometric Analysis
description: RSA exams of the operative hip are received post-op day 1, and at 6 weeks, 3 months, 6 months, 1 year and 2 years following surgery
arm group label: Trident II acetabular cup
intervention type: Procedure
intervention name: total hip arthroplasty with RSA bead implantation
description: Patients receive RSA beads inserted into the bone surrounding the Trident II implant.
arm group label: Trident II acetabular cup
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Scott Sporer, MD
role: Principal Investigator
affiliation: Midwest Orthopaedics at Rush
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No