xml: <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/NCT06042426</url>
    </required_header>
    <id_info>
      <org_study_id>2306117408</org_study_id>
      <nct_id>NCT06042426</nct_id>
    </id_info>
    <brief_title>Effects of Perioperative Intravenous Dexamethasone in Clinical Outcomes After Total Knee Arthroplasty in a Hispanic Population</brief_title>
    <official_title>Effects of Perioperative Intravenous Dexamethasone in Clinical Outcomes After Total Knee Arthroplasty in a Hispanic Population: A Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Puerto Rico</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Puerto Rico</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to evaluate the efficacy of an intravenous (IV) perioperative&#xD;
        dexamethasone regime in the clinical outcomes after a robotic-assisted Total Knee&#xD;
        Arthroplasty (TKA) in a Hispanic population. The study aims to propose an alternative to&#xD;
        opioid-based pain treatment following TKA. The study hopefully validates the use of a&#xD;
        two-dose, 8mg intravenous dexamethasone regimen for improving pain and range of motion scores&#xD;
        in patients undergoing primary, unilateral TKA for osteoarthritis. One dose will be applied&#xD;
        prior to incision and the other at post-operative day (POD) 1.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">February 2024</completion_date>
    <primary_completion_date type="Anticipated">February 2024</primary_completion_date>
    <phase>Phase 4</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>POD 1 Visual Analogue Scale Pain Scores</measure>
      <time_frame>Measured at 7:00AM day after surgery</time_frame>
      <description>Range: 0-10 (10 indicates highest degree of pain)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>POD 2 Visual Analogue Scale Pain Scores</measure>
      <time_frame>Measured at 7:00AM two days after surgery</time_frame>
      <description>Range: 0-10 (10 indicates highest degree of pain)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>POD 3 Visual Analogue Scale Pain Scores</measure>
      <time_frame>Measured at 7:00AM three days after surgery</time_frame>
      <description>Range: 0-10 (10 indicates highest degree of pain)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>POD 1 Range of Motion</measure>
      <time_frame>Measured at 7:00AM the day after surgery</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>POD 2 Range of Motion</measure>
      <time_frame>Measured at 7:00AM two days after surgery</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>POD 3 Range of Motion</measure>
      <time_frame>Measured at 7:00AM three days after surgery</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Daily Dextrose Concentration (mg/dL)</measure>
      <time_frame>Measured at 7:00AM for 3 days after surgery</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Length of Stay</measure>
      <time_frame>From hospital admission to the date of discharge (About 3 days)</time_frame>
      <description>Measured in days</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Osteoarthritis, Knee</condition>
    <arm_group>
      <arm_group_label>Patients receiving intravenous dexamethasone</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Patients receiving intravenous morphine and oral oxycodone</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Dexamethasone</intervention_name>
      <description>Two 8 mg doses. One dose applied prior to incision and the other at POD1</description>
      <arm_group_label>Patients receiving intravenous dexamethasone</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Morphine</intervention_name>
      <description>Morphine 0.1 mg per kg intravenous every 6 hours</description>
      <arm_group_label>Patients receiving intravenous morphine and oral oxycodone</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Oxycodone and acetaminophen</intervention_name>
      <description>2 tabs of oral oxycodone combined with acetaminophen every 6 hours (the same pill includes both drugs)</description>
      <arm_group_label>Patients receiving intravenous morphine and oral oxycodone</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patient with Hispanic self-identification&#xD;
  &#xD;
            -  Primary robotic-assisted TKA for treatment of primary osteoarthritis&#xD;
  &#xD;
            -  Age ≥ 21&#xD;
  &#xD;
            -  Receiving seven days of inpatient rehabilitation after medical discharge&#xD;
  &#xD;
            -  Patient with adequate glycemic control (HbA1c&lt;7.5%)&#xD;
  &#xD;
            -  Patients who provide written informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Age ≤ 21&#xD;
  &#xD;
            -  Chronic steroid use prior to surgery&#xD;
  &#xD;
            -  Previous allergies or adverse reactions to steroid drugs&#xD;
  &#xD;
            -  Indications for surgery other than primary osteoarthritis&#xD;
  &#xD;
            -  History of narcotics abuse such as opioids&#xD;
  &#xD;
            -  Surgeries performed without robotic-assistance&#xD;
  &#xD;
            -  Outpatient or Home rehabilitation programs after medical discharge&#xD;
  &#xD;
            -  Requirement of revision surgery orthopaedic implants&#xD;
  &#xD;
            -  Patients with inadequate glycemic control (HbA1c≥7.5%)&#xD;
  &#xD;
            -  Other medical conditions, such as osteoporosis, fungal infections, glaucoma, joint&#xD;
               infections, peptic ulcer disease which could worsen with steroid administration.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>24 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Antonio M López Otero, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Orthopaedic Surgery Section, University of Puerto Rico Medical Sciences Campus San Juan, Puerto Rico</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Alexandra M Claudio Marcano, MD</last_name>
      <phone>787-221-5210</phone>
      <email>alexandra.claudio1@upr.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Norberto J Torres, MD</last_name>
      <phone>787-403-8109</phone>
      <email>norberto.torres1@upr.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of Puerto Ric-Dr. Federico Trilla Hospital</name>
        <address>
          <city>Carolina</city>
          <zip>00984</zip>
          <country>Puerto Rico</country>
        </address>
      </facility>
      <contact>
        <last_name>Antonio M Otero López, MD</last_name>
        <phone>787-758-2525</phone>
        <email>antonio.otero3@upr.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>Puerto Rico</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>September 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>TKA</keyword>
    <keyword>Primary osteoarthritis</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Osteoarthritis</mesh_term>
      <mesh_term>Osteoarthritis, Knee</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Acetaminophen</mesh_term>
      <mesh_term>Dexamethasone</mesh_term>
      <mesh_term>Morphine</mesh_term>
      <mesh_term>Oxycodone</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06042426
  org study id: 2306117408
  nct id: NCT06042426
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  The purpose of this study is to evaluate the efficacy of an intravenous (IV) perioperative
        dexamethasone regime in the clinical outcomes after a robotic-assisted Total Knee
        Arthroplasty (TKA) in a Hispanic population. The study aims to propose an alternative to
        opioid-based pain treatment following TKA. The study hopefully validates the use of a
        two-dose, 8mg intravenous dexamethasone regimen for improving pain and range of motion scores
        in patients undergoing primary, unilateral TKA for osteoarthritis. One dose will be applied
        prior to incision and the other at post-operative day (POD) 1.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Investigator)
  measure: POD 1 Visual Analogue Scale Pain Scores
  time frame: Measured at 7:00AM day after surgery
  description: Range: 0-10 (10 indicates highest degree of pain)
  measure: POD 2 Visual Analogue Scale Pain Scores
  time frame: Measured at 7:00AM two days after surgery
  description: Range: 0-10 (10 indicates highest degree of pain)
  measure: POD 3 Visual Analogue Scale Pain Scores
  time frame: Measured at 7:00AM three days after surgery
  description: Range: 0-10 (10 indicates highest degree of pain)
  measure: POD 1 Range of Motion
  time frame: Measured at 7:00AM the day after surgery
  measure: POD 2 Range of Motion
  time frame: Measured at 7:00AM two days after surgery
  measure: POD 3 Range of Motion
  time frame: Measured at 7:00AM three days after surgery
  measure: Daily Dextrose Concentration (mg/dL)
  time frame: Measured at 7:00AM for 3 days after surgery
  measure: Length of Stay
  time frame: From hospital admission to the date of discharge (About 3 days)
  description: Measured in days
  arm group label: Patients receiving intravenous dexamethasone
  arm group type: Experimental
  arm group label: Patients receiving intravenous morphine and oral oxycodone
  arm group type: Active Comparator
  intervention type: Drug
  intervention name: Dexamethasone
  description: Two 8 mg doses. One dose applied prior to incision and the other at POD1
  arm group label: Patients receiving intravenous dexamethasone
  intervention type: Drug
  intervention name: Morphine
  description: Morphine 0.1 mg per kg intravenous every 6 hours
  arm group label: Patients receiving intravenous morphine and oral oxycodone
  intervention type: Drug
  intervention name: Oxycodone and acetaminophen
  description: 2 tabs of oral oxycodone combined with acetaminophen every 6 hours (the same pill includes both drugs)
  arm group label: Patients receiving intravenous morphine and oral oxycodone
  criteria: 
  gender: All
  minimum age: 24 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Antonio M López Otero, MD
  role: Principal Investigator
  affiliation: Orthopaedic Surgery Section, University of Puerto Rico Medical Sciences Campus San Juan, Puerto Rico
  last name: Alexandra M Claudio Marcano, MD
  phone: 787-221-5210
  email: alexandra.claudio1@upr.edu
  last name: Norberto J Torres, MD
  phone: 787-403-8109
  email: norberto.torres1@upr.edu
  facility: 
  contact: 
  country: Puerto Rico
  responsible party type: Sponsor
  mesh term: Osteoarthritis
  mesh term: Osteoarthritis, Knee
  mesh term: Acetaminophen
  mesh term: Dexamethasone
  mesh term: Morphine
  mesh term: Oxycodone