<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/NCT03772535</url>
  </required_header>
  <id_info>
    <org_study_id>AORI 2018-0100</org_study_id>
    <nct_id>NCT03772535</nct_id>
  </id_info>
  <brief_title>Pharmacogenetics for Pain Management in Joint Replacement Patients</brief_title>
  <acronym>PGx</acronym>
  <official_title>Using Pharmacogenetics to Structure Individual Pain Management Protocols for Joint Replacement Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Anderson Orthopaedic Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Anderson Orthopaedic Research Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the ability to use pharmacogenetic testing in a&#xD;
      joint replacement practice to prescribe the most effective pain medicine for a specific&#xD;
      patient.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">December 3, 2018</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">June 2021</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Genetic variants</measure>
    <time_frame>10 days postoperative</time_frame>
    <description>Percent of subject with genetic variants affecting pain medication</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>pain levels</measure>
    <time_frame>10 days postoperatively</time_frame>
    <description>0-10 subjective pain scale</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Arthroplasty Complications</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Subjects in this arm will receive the standard postoperative pain prescription protocol.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pharmacogenomics Guided Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects in this group will receive postoperative pain prescriptions based on the results of pharmacogenomic testing.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Pharmacogenomics Testing</intervention_name>
    <description>The doctor will use genetic test results to prescribe medications that are a most effective for subject.</description>
    <arm_group_label>Pharmacogenomics Guided Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Primary total hip or total knee arthroplasty cases&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of narcotic dependence&#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>William Hamilton, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Anderson Orthopaedic Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Anderson Orthopaedic Research Institute</name>
      <address>
        <city>Alexandria</city>
        <state>Virginia</state>
        <zip>22307</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>February 10, 2021</last_update_submitted>
  <last_update_submitted_qc>February 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2021</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/NCT03772535
org study id: AORI 2018-0100
nct id: NCT03772535
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The purpose of this study is to determine the ability to use pharmacogenetic testing in a
      joint replacement practice to prescribe the most effective pain medicine for a specific
      patient.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Screening
masking: Single (Participant)
measure: Genetic variants
time frame: 10 days postoperative
description: Percent of subject with genetic variants affecting pain medication
measure: pain levels
time frame: 10 days postoperatively
description: 0-10 subjective pain scale
arm group label: Control Group
arm group type: No Intervention
description: Subjects in this arm will receive the standard postoperative pain prescription protocol.
arm group label: Pharmacogenomics Guided Group
arm group type: Active Comparator
description: Subjects in this group will receive postoperative pain prescriptions based on the results of pharmacogenomic testing.
intervention type: Diagnostic Test
intervention name: Pharmacogenomics Testing
description: The doctor will use genetic test results to prescribe medications that are a most effective for subject.
arm group label: Pharmacogenomics Guided Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: William Hamilton, MD
role: Principal Investigator
affiliation: Anderson Orthopaedic Research Institute
facility: 
country: United States
responsible party type: Sponsor