<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/NCT02219581</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00066081</org_study_id>
    <nct_id>NCT02219581</nct_id>
  </id_info>
  <brief_title>Steroids in Total Knee Arthroplasty</brief_title>
  <official_title>Evaluation of Intravenous Glucocorticoid Therapy in Total Knee Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Thomas L Bradbury</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Emory University</source>
  <oversight_info>
    <has_dmc>Yes</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 if the use of two small doses of intravenous (IV)&#xD;
      steroids around the time of knee replacement surgery decrease a patient's pain or use of pain&#xD;
      medication. The investigators will also determine if the subjects receiving the steroid will&#xD;
      have better pain control and better postoperative outcomes after their surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Adequate pain control after total knee arthroplasty (TKA) is of great importance not only to&#xD;
      maximize patient comfort, but also to ensure optimal outcomes after surgery. This study is&#xD;
      designed to assess whether the use of two small doses of intravenous (IV) steroids around the&#xD;
      time of surgery decrease a patient's pain or use of pain medication. Secondly, the&#xD;
      investigators will also determine if the use of these steroids as part of a multimodal pain&#xD;
      management strategy leads to improved patient outcomes, including pain, nausea and vomiting,&#xD;
      knee function and length of stay in the hospital after surgery. The study will compare the&#xD;
      effect of two different doses of IV dexamethasone given preoperatively before TKA, when&#xD;
      compared to placebo.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Terminated after considerable time in suspended state due to inadequate staffing, the COVID&#xD;
    pandemic, and the Responsible Party leaving Emory in August 2022.&#xD;
  </why_stopped>
  <start_date type="Actual">October 16, 2014</start_date>
  <completion_date type="Actual">December 1, 2015</completion_date>
  <primary_completion_date type="Actual">December 1, 2015</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain Score</measure>
    <time_frame>Baseline, end of hospital stay (up to 3 days), 1, 4, and 12 months post-operatively</time_frame>
    <description>Post-operative pain was assessed using the well-standardized and accepted visual analog pain scale. The scale shows a series of faces ranging from a happy face at 0= &quot;No hurt&quot;, to a crying face at 10= &quot;Hurts worst&quot;. The participant was asked to choose the face that best describes their level of pain. Higher scores indicate higher intensities of pain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Opioid Analgesic Usage</measure>
    <time_frame>1 day post-operatively</time_frame>
    <description>The amount of post-operative opioid analgesic usage is assessed as Oral Morphine Equivalents (OME) which is the amount of an oral morphine drug that would be necessary to equal the pain treatment from opioid morphine.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Soft Tissue Swelling</measure>
    <time_frame>1 day post-operatively</time_frame>
    <description>Evaluation of soft tissue swelling uses a measurement of knee circumference at the midpoint of the patella, with the knee in the maximum amount of extension allowed by the patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Range of Motion (ROM)</measure>
    <time_frame>Baseline, 1 day post-operatively, 1, 4, and 12 months post-operatively</time_frame>
    <description>Maximum passive ROM allowed by the patient will be measured using a goniometer. The ROM measurement is the amount of flexion and extension recorded in degrees. An increased ROM is indicative of better joint mobility.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative Day of Physical Therapy Clearance</measure>
    <time_frame>Up to 3 days post-operatively</time_frame>
    <description>The post-operative day when the participant was cleared by the physical therapy staff to go home was recorded. A shorter clearance time is indicative of better joint function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antiemetic Dose Administered</measure>
    <time_frame>Post-operative Days 1 and 2</time_frame>
    <description>Post-operative nausea and/or vomiting was assessed by the use of the antiemetic Zofran, which was administered as-needed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood Glucose</measure>
    <time_frame>Baseline, Post-operative Day 1</time_frame>
    <description>To assess postoperative glucose levels after steroid administration, blood glucose level will be analyzed using a HemoCue testing system. Diabetes is indicated with a random blood glucose measurement of greater than 200 milligrams per deciliter (mg/dL).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>36-Item Short Form Health Survey (SF-36) Score</measure>
    <time_frame>Baseline, 12 months post-operatively</time_frame>
    <description>The subjects' functional ability will be assessed using the SF-36 questionnaire. The SF-36 Health Survey is a 36-item, self-reported survey of patient health and is a measure of health status. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.) Score</measure>
    <time_frame>Baseline, 1, 4, and 12 months post-operatively</time_frame>
    <description>The KOOS, JR. instrument has 7 items assessing knee stiffness, knee pain, and daily living physical function following knee joint replacement. Responses are given on a 5-point scale where 0 = no pain or disability and 4 = extreme pain or disability. Total raw scores range from 0 to 28, where higher scores indicate increased pain or disability. Total raw scores can be converted to an interval score ranging from 0 to 100 where 0 = total knee disability and 100 = perfect knee health.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of Hospital Stay</measure>
    <time_frame>Up to 3 days post-operatively</time_frame>
    <description>The length of hospital stay in days is reported here. A higher number of days in the hospital indicates slower recovery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Readmitted to the Hospital</measure>
    <time_frame>Up to 12 months post-operatively</time_frame>
    <description>The number of participants with hospital readmissions after being discharged were recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Wound Infections</measure>
    <time_frame>Up to 12 months post-operatively</time_frame>
    <description>The number of participants with the clinical presence of wound drainage and periprosthetic infection were recorded.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Postoperative Pain</condition>
  <condition>Inflammation</condition>
  <condition>Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects undergoing primary total joint arthroplasty of the knee will receive two doses of placebo intravenously in addition to a standard multimodal postoperative pain management regimen typically used for total knee arthroplasty. The first dose of placebo will be given preoperatively within 3 hours of surgery and the second dose will be administered 8 hours after the first dose in the inpatient setting.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dexamethasone 10 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects undergoing primary total joint arthroplasty of the knee will receive two doses of 10 mg dexamethasone. The first dose will be given preoperatively within 3 hours of surgery and the second dose will be administered 8 hours after the first dose in the inpatient setting. Additionally, subjects will also receive a standard multimodal postoperative pain management regimen typically used for total knee arthroplasty.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dexamethasone 20 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects undergoing primary total joint arthroplasty of the knee will receive two doses of 20 mg dexamethasone. The first dose will be given preoperatively within 3 hours of surgery and the second dose will be administered 8 hours after the first dose in the inpatient setting. Additionally, subjects will also receive a standard multimodal postoperative pain management regimen typically used for total knee arthroplasty.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone 10 mg</intervention_name>
    <description>Two doses of dexamethasone 10 mg will be given intravenously. The first dose will be given preoperatively within 3 hours of surgery and the second dose will be administered 8 hours after the first dose in the inpatient setting.</description>
    <arm_group_label>Dexamethasone 10 mg</arm_group_label>
    <other_name>Decadron</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone 20 mg</intervention_name>
    <description>Two doses of dexamethasone 20 mg will be given intravenously. The first dose will be given preoperatively within 3 hours of surgery and the second dose will be administered 8 hours after the first dose in the inpatient setting.</description>
    <arm_group_label>Dexamethasone 20 mg</arm_group_label>
    <other_name>Decadron</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Standard multimodal pain management regimen</intervention_name>
    <description>The standard multimodal postoperative pain management regimen typically used for total knee arthroplasty consists of the following:&#xD;
Preoperative:&#xD;
Decadron: 10 or 20mg IV x 1 2 doses, 8 hours apart (if randomized to study group)&#xD;
Intraoperative:&#xD;
Ropivacaine: Given intraoperatively. Capsule, subcutaneous tissue/skin. Administered in standard fashion. (300mg)&#xD;
Toradol: 30mg q 6hr for 6 total doses. 1st dose given intraoperatively at incision. The dose is 15 mg for older patients or if creatinine clearance (CrCl) is low.&#xD;
Postoperative&#xD;
Tylenol: 1000mg po q 8hr (scheduled)&#xD;
Oxycodone: 5mg or 10mg q 3-4hr prn pain, If intolerant to Oxycodone: second agent line is Hydrocodone or Oral Dilaudid&#xD;
IV Morphine (or Dilaudid): 1 or 2 mg q 2hr prn breakthrough pain&#xD;
Morphine patient-controlled analgesia (PCA): only for failure of the above&#xD;
Morphine Sulfate (MS) Contin: Use as backup prn pain</description>
    <arm_group_label>Dexamethasone 10 mg</arm_group_label>
    <arm_group_label>Dexamethasone 20 mg</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Participants in the placebo arm will receive two doses of saline intravenously. The first dose will be given preoperatively within 3 hours of surgery and the second dose will be administered 8 hours after the first dose in the inpatient setting.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing primary total joint arthroplasty of the knee&#xD;
&#xD;
          -  Adult patients ages 18-100 years&#xD;
&#xD;
          -  Patients must have smart phone and/or device for app usage&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current chronic steroid use&#xD;
&#xD;
          -  Patients undergoing revision knee surgery&#xD;
&#xD;
          -  Patients ambulating preoperatively with assistive devices&#xD;
&#xD;
          -  Patients with avascular necrosis of the operative knee&#xD;
&#xD;
          -  Patients with a history of an adverse reaction to glucocorticoid steroids&#xD;
&#xD;
          -  Patients unable to provide informed consent&#xD;
&#xD;
          -  Patients with inflammatory arthritis&#xD;
&#xD;
          -  Prisoners&#xD;
&#xD;
          -  Current smokers&#xD;
&#xD;
          -  Patients &lt;18 years of age&#xD;
&#xD;
          -  Any patient with a complicated postoperative course that requires transfer to the&#xD;
             Intensive Care Unit (ICU) or to another facility for further management will be&#xD;
             removed from the study.&#xD;
&#xD;
          -  Any contraindication that would prevent the patient from being treated with the&#xD;
             standard multimodal postoperative pain management regimen History of infection of&#xD;
             surgical knee.&#xD;
&#xD;
          -  Patients with diabetes.&#xD;
&#xD;
          -  Patients that have an intolerance to Toradol.&#xD;
&#xD;
          -  Patients that do not have smart phone and/or device for app usage&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas L Bradbury, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emory University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Emory Orthopedic and Spine Hospital</name>
      <address>
        <city>Tucker</city>
        <state>Georgia</state>
        <zip>30084</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>August 13, 2014</study_first_submitted>
  <study_first_submitted_qc>August 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 19, 2014</study_first_posted>
  <results_first_submitted>September 6, 2022</results_first_submitted>
  <results_first_submitted_qc>September 6, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">October 4, 2022</results_first_posted>
  <last_update_submitted>September 6, 2022</last_update_submitted>
  <last_update_submitted_qc>September 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Emory University</investigator_affiliation>
    <investigator_full_name>Thomas L Bradbury</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Osteoarthritis</keyword>
  <keyword>Postoperative pain</keyword>
  <keyword>Total knee arthroplasty</keyword>
  <keyword>Orthopaedics</keyword>
  <keyword>Inflammation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Inflammation</mesh_term>
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Dexamethasone acetate</mesh_term>
    <mesh_term>BB 1101</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 1, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/81/NCT02219581/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Participants undergoing primary total joint arthroplasty of the knee who are randomized to receive two doses of placebo intravenously in addition to a standard multimodal postoperative pain management regimen typically used for total knee arthroplasty. The first dose of placebo will be given preoperatively within 3 hours of surgery and the second dose will be administered 8 hours after the first dose in the inpatient setting.</description>
        </group>
        <group group_id="P2">
          <title>Dexamethasone 10 mg</title>
          <description>Participants undergoing primary total joint arthroplasty of the knee who are randomized to receive two doses of 10 mg dexamethasone. The first dose will be given preoperatively within 3 hours of surgery and the second dose will be administered 8 hours after the first dose in the inpatient setting. Additionally, participants will also receive a standard multimodal postoperative pain management regimen typically used for total knee arthroplasty.</description>
        </group>
        <group group_id="P3">
          <title>Dexamethasone 20 mg</title>
          <description>Participants undergoing primary total joint arthroplasty of the knee who are randomized to receive two doses of 20 mg dexamethasone. The first dose will be given preoperatively within 3 hours of surgery and the second dose will be administered 8 hours after the first dose in the inpatient setting. Additionally, participants will also receive a standard multimodal postoperative pain management regimen typically used for total knee arthroplasty.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Dexamethasone 20 mg</title>
          <description>The participant undergoing primary total joint arthroplasty of the knee was randomized to receive two doses of 20 mg dexamethasone. The first dose was given preoperatively within 3 hours of surgery and the second dose was administered 8 hours after the first dose in the inpatient setting. Additionally, the participant received a standard multimodal postoperative pain management regimen typically used for total knee arthroplasty.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="1"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>To maintain anonymity of the single participant of this study sex is not reported.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                </category>
                <category>
                  <title>Male</title>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Pain Score</title>
        <description>Post-operative pain was assessed using the well-standardized and accepted visual analog pain scale. The scale shows a series of faces ranging from a happy face at 0= &quot;No hurt&quot;, to a crying face at 10= &quot;Hurts worst&quot;. The participant was asked to choose the face that best describes their level of pain. Higher scores indicate higher intensities of pain.</description>
        <time_frame>Baseline, end of hospital stay (up to 3 days), 1, 4, and 12 months post-operatively</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexamethasone 20 mg</title>
            <description>The participant undergoing primary total joint arthroplasty of the knee was randomized to receive two doses of 20 mg dexamethasone. The first dose was given preoperatively within 3 hours of surgery and the second dose was administered 8 hours after the first dose in the inpatient setting. Additionally, the participant received a standard multimodal postoperative pain management regimen typically used for total knee arthroplasty.</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Score</title>
          <description>Post-operative pain was assessed using the well-standardized and accepted visual analog pain scale. The scale shows a series of faces ranging from a happy face at 0= &quot;No hurt&quot;, to a crying face at 10= &quot;Hurts worst&quot;. The participant was asked to choose the face that best describes their level of pain. Higher scores indicate higher intensities of pain.</description>
          <units>units on a scale</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End of hospital stay (up to 3 days post-operative)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 month post-operative</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 months post-operative</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months post-operative</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Opioid Analgesic Usage</title>
        <description>The amount of post-operative opioid analgesic usage is assessed as Oral Morphine Equivalents (OME) which is the amount of an oral morphine drug that would be necessary to equal the pain treatment from opioid morphine.</description>
        <time_frame>1 day post-operatively</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexamethasone 20 mg</title>
            <description>The participant undergoing primary total joint arthroplasty of the knee was randomized to receive two doses of 20 mg dexamethasone. The first dose was given preoperatively within 3 hours of surgery and the second dose was administered 8 hours after the first dose in the inpatient setting. Additionally, the participant received a standard multimodal postoperative pain management regimen typically used for total knee arthroplasty.</description>
          </group>
        </group_list>
        <measure>
          <title>Opioid Analgesic Usage</title>
          <description>The amount of post-operative opioid analgesic usage is assessed as Oral Morphine Equivalents (OME) which is the amount of an oral morphine drug that would be necessary to equal the pain treatment from opioid morphine.</description>
          <units>Oral Morphine Equivalents (OME)</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Soft Tissue Swelling</title>
        <description>Evaluation of soft tissue swelling uses a measurement of knee circumference at the midpoint of the patella, with the knee in the maximum amount of extension allowed by the patient.</description>
        <time_frame>1 day post-operatively</time_frame>
        <population>Measurements of knee circumference were not obtained at any study time point, or measurements have been lost and are no longer available.</population>
        <group_list>
          <group group_id="O1">
            <title>Dexamethasone 20 mg</title>
            <description>The participant undergoing primary total joint arthroplasty of the knee was randomized to receive two doses of 20 mg dexamethasone. The first dose was given preoperatively within 3 hours of surgery and the second dose was administered 8 hours after the first dose in the inpatient setting. Additionally, the participant received a standard multimodal postoperative pain management regimen typically used for total knee arthroplasty.</description>
          </group>
        </group_list>
        <measure>
          <title>Soft Tissue Swelling</title>
          <description>Evaluation of soft tissue swelling uses a measurement of knee circumference at the midpoint of the patella, with the knee in the maximum amount of extension allowed by the patient.</description>
          <population>Measurements of knee circumference were not obtained at any study time point, or measurements have been lost and are no longer available.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Range of Motion (ROM)</title>
        <description>Maximum passive ROM allowed by the patient will be measured using a goniometer. The ROM measurement is the amount of flexion and extension recorded in degrees. An increased ROM is indicative of better joint mobility.</description>
        <time_frame>Baseline, 1 day post-operatively, 1, 4, and 12 months post-operatively</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexamethasone 20 mg</title>
            <description>The participant undergoing primary total joint arthroplasty of the knee was randomized to receive two doses of 20 mg dexamethasone. The first dose was given preoperatively within 3 hours of surgery and the second dose was administered 8 hours after the first dose in the inpatient setting. Additionally, the participant received a standard multimodal postoperative pain management regimen typically used for total knee arthroplasty.</description>
          </group>
        </group_list>
        <measure>
          <title>Range of Motion (ROM)</title>
          <description>Maximum passive ROM allowed by the patient will be measured using a goniometer. The ROM measurement is the amount of flexion and extension recorded in degrees. An increased ROM is indicative of better joint mobility.</description>
          <units>degrees</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="125"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Day Post-Operative</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="105"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Month Post-Operative</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="135"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 Months Post-Operative</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="140"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 Months Post-Operative</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="110"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Post-operative Day of Physical Therapy Clearance</title>
        <description>The post-operative day when the participant was cleared by the physical therapy staff to go home was recorded. A shorter clearance time is indicative of better joint function.</description>
        <time_frame>Up to 3 days post-operatively</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexamethasone 20 mg</title>
            <description>The participant undergoing primary total joint arthroplasty of the knee was randomized to receive two doses of 20 mg dexamethasone. The first dose was given preoperatively within 3 hours of surgery and the second dose was administered 8 hours after the first dose in the inpatient setting. Additionally, the participant received a standard multimodal postoperative pain management regimen typically used for total knee arthroplasty.</description>
          </group>
        </group_list>
        <measure>
          <title>Post-operative Day of Physical Therapy Clearance</title>
          <description>The post-operative day when the participant was cleared by the physical therapy staff to go home was recorded. A shorter clearance time is indicative of better joint function.</description>
          <units>days</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Antiemetic Dose Administered</title>
        <description>Post-operative nausea and/or vomiting was assessed by the use of the antiemetic Zofran, which was administered as-needed.</description>
        <time_frame>Post-operative Days 1 and 2</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexamethasone 20 mg</title>
            <description>The participant undergoing primary total joint arthroplasty of the knee was randomized to receive two doses of 20 mg dexamethasone. The first dose was given preoperatively within 3 hours of surgery and the second dose was administered 8 hours after the first dose in the inpatient setting. Additionally, the participant received a standard multimodal postoperative pain management regimen typically used for total knee arthroplasty.</description>
          </group>
        </group_list>
        <measure>
          <title>Antiemetic Dose Administered</title>
          <description>Post-operative nausea and/or vomiting was assessed by the use of the antiemetic Zofran, which was administered as-needed.</description>
          <units>milligrams (mg)</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Post-operative Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-operative Day 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Blood Glucose</title>
        <description>To assess postoperative glucose levels after steroid administration, blood glucose level will be analyzed using a HemoCue testing system. Diabetes is indicated with a random blood glucose measurement of greater than 200 milligrams per deciliter (mg/dL).</description>
        <time_frame>Baseline, Post-operative Day 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexamethasone 20 mg</title>
            <description>The participant undergoing primary total joint arthroplasty of the knee was randomized to receive two doses of 20 mg dexamethasone. The first dose was given preoperatively within 3 hours of surgery and the second dose was administered 8 hours after the first dose in the inpatient setting. Additionally, the participant received a standard multimodal postoperative pain management regimen typically used for total knee arthroplasty.</description>
          </group>
        </group_list>
        <measure>
          <title>Blood Glucose</title>
          <description>To assess postoperative glucose levels after steroid administration, blood glucose level will be analyzed using a HemoCue testing system. Diabetes is indicated with a random blood glucose measurement of greater than 200 milligrams per deciliter (mg/dL).</description>
          <units>mg/dL</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-operative Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>36-Item Short Form Health Survey (SF-36) Score</title>
        <description>The subjects' functional ability will be assessed using the SF-36 questionnaire. The SF-36 Health Survey is a 36-item, self-reported survey of patient health and is a measure of health status. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability.</description>
        <time_frame>Baseline, 12 months post-operatively</time_frame>
        <population>SF-36 scores are not available. The survey was either not administered or scores have been lost.</population>
        <group_list>
          <group group_id="O1">
            <title>Dexamethasone 20 mg</title>
            <description>The participant undergoing primary total joint arthroplasty of the knee was randomized to receive two doses of 20 mg dexamethasone. The first dose was given preoperatively within 3 hours of surgery and the second dose was administered 8 hours after the first dose in the inpatient setting. Additionally, the participant received a standard multimodal postoperative pain management regimen typically used for total knee arthroplasty.</description>
          </group>
        </group_list>
        <measure>
          <title>36-Item Short Form Health Survey (SF-36) Score</title>
          <description>The subjects' functional ability will be assessed using the SF-36 questionnaire. The SF-36 Health Survey is a 36-item, self-reported survey of patient health and is a measure of health status. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability.</description>
          <population>SF-36 scores are not available. The survey was either not administered or scores have been lost.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.) Score</title>
        <description>The KOOS, JR. instrument has 7 items assessing knee stiffness, knee pain, and daily living physical function following knee joint replacement. Responses are given on a 5-point scale where 0 = no pain or disability and 4 = extreme pain or disability. Total raw scores range from 0 to 28, where higher scores indicate increased pain or disability. Total raw scores can be converted to an interval score ranging from 0 to 100 where 0 = total knee disability and 100 = perfect knee health.</description>
        <time_frame>Baseline, 1, 4, and 12 months post-operatively</time_frame>
        <population>KOOS, JR. scores are not available. The survey was either not administered or scores have been lost.</population>
        <group_list>
          <group group_id="O1">
            <title>Dexamethasone 20 mg</title>
            <description>The participant undergoing primary total joint arthroplasty of the knee was randomized to receive two doses of 20 mg dexamethasone. The first dose was given preoperatively within 3 hours of surgery and the second dose was administered 8 hours after the first dose in the inpatient setting. Additionally, the participant received a standard multimodal postoperative pain management regimen typically used for total knee arthroplasty.</description>
          </group>
        </group_list>
        <measure>
          <title>Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.) Score</title>
          <description>The KOOS, JR. instrument has 7 items assessing knee stiffness, knee pain, and daily living physical function following knee joint replacement. Responses are given on a 5-point scale where 0 = no pain or disability and 4 = extreme pain or disability. Total raw scores range from 0 to 28, where higher scores indicate increased pain or disability. Total raw scores can be converted to an interval score ranging from 0 to 100 where 0 = total knee disability and 100 = perfect knee health.</description>
          <population>KOOS, JR. scores are not available. The survey was either not administered or scores have been lost.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Length of Hospital Stay</title>
        <description>The length of hospital stay in days is reported here. A higher number of days in the hospital indicates slower recovery.</description>
        <time_frame>Up to 3 days post-operatively</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexamethasone 20 mg</title>
            <description>The participant undergoing primary total joint arthroplasty of the knee was randomized to receive two doses of 20 mg dexamethasone. The first dose was given preoperatively within 3 hours of surgery and the second dose was administered 8 hours after the first dose in the inpatient setting. Additionally, the participant received a standard multimodal postoperative pain management regimen typically used for total knee arthroplasty.</description>
          </group>
        </group_list>
        <measure>
          <title>Length of Hospital Stay</title>
          <description>The length of hospital stay in days is reported here. A higher number of days in the hospital indicates slower recovery.</description>
          <units>days</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Readmitted to the Hospital</title>
        <description>The number of participants with hospital readmissions after being discharged were recorded.</description>
        <time_frame>Up to 12 months post-operatively</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexamethasone 20 mg</title>
            <description>The participant undergoing primary total joint arthroplasty of the knee was randomized to receive two doses of 20 mg dexamethasone. The first dose was given preoperatively within 3 hours of surgery and the second dose was administered 8 hours after the first dose in the inpatient setting. Additionally, the participant received a standard multimodal postoperative pain management regimen typically used for total knee arthroplasty.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Readmitted to the Hospital</title>
          <description>The number of participants with hospital readmissions after being discharged were recorded.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Wound Infections</title>
        <description>The number of participants with the clinical presence of wound drainage and periprosthetic infection were recorded.</description>
        <time_frame>Up to 12 months post-operatively</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexamethasone 20 mg</title>
            <description>The participant undergoing primary total joint arthroplasty of the knee was randomized to receive two doses of 20 mg dexamethasone. The first dose was given preoperatively within 3 hours of surgery and the second dose was administered 8 hours after the first dose in the inpatient setting. Additionally, the participant received a standard multimodal postoperative pain management regimen typically used for total knee arthroplasty.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Wound Infections</title>
          <description>The number of participants with the clinical presence of wound drainage and periprosthetic infection were recorded.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Information on adverse events was collected from medical records beginning at the baseline assessment just prior to surgery and continued through the 12 month post-operative assessment (for 12 months total).</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Dexamethasone 20 mg</title>
          <description>The participant undergoing primary total joint arthroplasty of the knee was randomized to receive two doses of 20 mg dexamethasone. The first dose was given preoperatively within 3 hours of surgery and the second dose was administered 8 hours after the first dose in the inpatient setting. Additionally, the participant received a standard multimodal postoperative pain management regimen typically used for total knee arthroplasty.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>There are limitations of the study results due to termination of the study and a small number of study participants.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Thomas L. Bradbury, MD</name_or_title>
      <organization>Emory University</organization>
      <phone>404-759-3912</phone>
      <email>tombradburymd@gmail.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02219581
org study id: IRB00066081
nct id: NCT02219581
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to evaluate if the use of two small doses of intravenous (IV)
      steroids around the time of knee replacement surgery decrease a patient's pain or use of pain
      medication. The investigators will also determine if the subjects receiving the steroid will
      have better pain control and better postoperative outcomes after their surgery.
Adequate pain control after total knee arthroplasty (TKA) is of great importance not only to
      maximize patient comfort, but also to ensure optimal outcomes after surgery. This study is
      designed to assess whether the use of two small doses of intravenous (IV) steroids around the
      time of surgery decrease a patient's pain or use of pain medication. Secondly, the
      investigators will also determine if the use of these steroids as part of a multimodal pain
      management strategy leads to improved patient outcomes, including pain, nausea and vomiting,
      knee function and length of stay in the hospital after surgery. The study will compare the
      effect of two different doses of IV dexamethasone given preoperatively before TKA, when
      compared to placebo.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Pain Score
time frame: Baseline, end of hospital stay (up to 3 days), 1, 4, and 12 months post-operatively
description: Post-operative pain was assessed using the well-standardized and accepted visual analog pain scale. The scale shows a series of faces ranging from a happy face at 0= "No hurt", to a crying face at 10= "Hurts worst". The participant was asked to choose the face that best describes their level of pain. Higher scores indicate higher intensities of pain.
measure: Opioid Analgesic Usage
time frame: 1 day post-operatively
description: The amount of post-operative opioid analgesic usage is assessed as Oral Morphine Equivalents (OME) which is the amount of an oral morphine drug that would be necessary to equal the pain treatment from opioid morphine.
measure: Soft Tissue Swelling
time frame: 1 day post-operatively
description: Evaluation of soft tissue swelling uses a measurement of knee circumference at the midpoint of the patella, with the knee in the maximum amount of extension allowed by the patient.
measure: Range of Motion (ROM)
time frame: Baseline, 1 day post-operatively, 1, 4, and 12 months post-operatively
description: Maximum passive ROM allowed by the patient will be measured using a goniometer. The ROM measurement is the amount of flexion and extension recorded in degrees. An increased ROM is indicative of better joint mobility.
measure: Post-operative Day of Physical Therapy Clearance
time frame: Up to 3 days post-operatively
description: The post-operative day when the participant was cleared by the physical therapy staff to go home was recorded. A shorter clearance time is indicative of better joint function.
measure: Antiemetic Dose Administered
time frame: Post-operative Days 1 and 2
description: Post-operative nausea and/or vomiting was assessed by the use of the antiemetic Zofran, which was administered as-needed.
measure: Blood Glucose
time frame: Baseline, Post-operative Day 1
description: To assess postoperative glucose levels after steroid administration, blood glucose level will be analyzed using a HemoCue testing system. Diabetes is indicated with a random blood glucose measurement of greater than 200 milligrams per deciliter (mg/dL).
measure: 36-Item Short Form Health Survey (SF-36) Score
time frame: Baseline, 12 months post-operatively
description: The subjects' functional ability will be assessed using the SF-36 questionnaire. The SF-36 Health Survey is a 36-item, self-reported survey of patient health and is a measure of health status. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability.
measure: Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.) Score
time frame: Baseline, 1, 4, and 12 months post-operatively
description: The KOOS, JR. instrument has 7 items assessing knee stiffness, knee pain, and daily living physical function following knee joint replacement. Responses are given on a 5-point scale where 0 = no pain or disability and 4 = extreme pain or disability. Total raw scores range from 0 to 28, where higher scores indicate increased pain or disability. Total raw scores can be converted to an interval score ranging from 0 to 100 where 0 = total knee disability and 100 = perfect knee health.
measure: Length of Hospital Stay
time frame: Up to 3 days post-operatively
description: The length of hospital stay in days is reported here. A higher number of days in the hospital indicates slower recovery.
measure: Number of Participants Readmitted to the Hospital
time frame: Up to 12 months post-operatively
description: The number of participants with hospital readmissions after being discharged were recorded.
measure: Number of Participants With Wound Infections
time frame: Up to 12 months post-operatively
description: The number of participants with the clinical presence of wound drainage and periprosthetic infection were recorded.
arm group label: Placebo
arm group type: Placebo Comparator
description: Subjects undergoing primary total joint arthroplasty of the knee will receive two doses of placebo intravenously in addition to a standard multimodal postoperative pain management regimen typically used for total knee arthroplasty. The first dose of placebo will be given preoperatively within 3 hours of surgery and the second dose will be administered 8 hours after the first dose in the inpatient setting.
arm group label: Dexamethasone 10 mg
arm group type: Experimental
description: Subjects undergoing primary total joint arthroplasty of the knee will receive two doses of 10 mg dexamethasone. The first dose will be given preoperatively within 3 hours of surgery and the second dose will be administered 8 hours after the first dose in the inpatient setting. Additionally, subjects will also receive a standard multimodal postoperative pain management regimen typically used for total knee arthroplasty.
arm group label: Dexamethasone 20 mg
arm group type: Experimental
description: Subjects undergoing primary total joint arthroplasty of the knee will receive two doses of 20 mg dexamethasone. The first dose will be given preoperatively within 3 hours of surgery and the second dose will be administered 8 hours after the first dose in the inpatient setting. Additionally, subjects will also receive a standard multimodal postoperative pain management regimen typically used for total knee arthroplasty.
intervention type: Drug
intervention name: Dexamethasone 10 mg
description: Two doses of dexamethasone 10 mg will be given intravenously. The first dose will be given preoperatively within 3 hours of surgery and the second dose will be administered 8 hours after the first dose in the inpatient setting.
arm group label: Dexamethasone 10 mg
other name: Decadron
intervention type: Drug
intervention name: Dexamethasone 20 mg
description: Two doses of dexamethasone 20 mg will be given intravenously. The first dose will be given preoperatively within 3 hours of surgery and the second dose will be administered 8 hours after the first dose in the inpatient setting.
arm group label: Dexamethasone 20 mg
other name: Decadron
intervention type: Drug
intervention name: Standard multimodal pain management regimen
description: The standard multimodal postoperative pain management regimen typically used for total knee arthroplasty consists of the following:
Preoperative:
Decadron: 10 or 20mg IV x 1 2 doses, 8 hours apart (if randomized to study group)
Intraoperative:
Ropivacaine: Given intraoperatively. Capsule, subcutaneous tissue/skin. Administered in standard fashion. (300mg)
Toradol: 30mg q 6hr for 6 total doses. 1st dose given intraoperatively at incision. The dose is 15 mg for older patients or if creatinine clearance (CrCl) is low.
Postoperative
Tylenol: 1000mg po q 8hr (scheduled)
Oxycodone: 5mg or 10mg q 3-4hr prn pain, If intolerant to Oxycodone: second agent line is Hydrocodone or Oral Dilaudid
IV Morphine (or Dilaudid): 1 or 2 mg q 2hr prn breakthrough pain
Morphine patient-controlled analgesia (PCA): only for failure of the above
Morphine Sulfate (MS) Contin: Use as backup prn pain
arm group label: Dexamethasone 10 mg
arm group label: Dexamethasone 20 mg
arm group label: Placebo
intervention type: Drug
intervention name: Placebo
description: Participants in the placebo arm will receive two doses of saline intravenously. The first dose will be given preoperatively within 3 hours of surgery and the second dose will be administered 8 hours after the first dose in the inpatient setting.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Thomas L Bradbury, MD
role: Principal Investigator
affiliation: Emory University
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Emory University
investigator full name: Thomas L Bradbury
investigator title: Associate Professor
mesh term: Osteoarthritis
mesh term: Inflammation
mesh term: Pain, Postoperative
mesh term: Dexamethasone
mesh term: Dexamethasone acetate
mesh term: BB 1101
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: There are limitations of the study results due to termination of the study and a small number of study participants.
point of contact: 