<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/NCT03790306</url>
  </required_header>
  <id_info>
    <org_study_id>QIIIS</org_study_id>
    <nct_id>NCT03790306</nct_id>
  </id_info>
  <brief_title>Opioid Free and Therapy Minimized Advantages Using HANA Table for Total Hip Arthroplasty</brief_title>
  <official_title>Opioid Free and Therapy Minimized Advantages Using HANA Table for Total Hip Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Elizabeth Medical Center, Utica, NY</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>St. Elizabeth Medical Center, Utica, NY</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To prove that anterior approach total hip arthroplasty using the HANA table can be performed&#xD;
      with little, if any, need for opioids using a combination of education, optimized pre op and&#xD;
      post op pain protocols and optimized recovery tools.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Methods:&#xD;
&#xD;
      Data Collection:&#xD;
&#xD;
        -  pre-op assessment/physical therapy evaluation&#xD;
&#xD;
        -  post op assessment - PACU, phase II (Prior to discharge)&#xD;
&#xD;
        -  phone calls after discharge (post op day 1, 2, 3)&#xD;
&#xD;
        -  follow up assessment in surgeon's office (3 and 6 weeks post op)&#xD;
&#xD;
        -  Ortech&#xD;
&#xD;
        -  Swiftpath&#xD;
&#xD;
        -  HOOS jr&#xD;
&#xD;
      Pre-optimization:&#xD;
&#xD;
        -  All patients enroll in SwiftPath education program&#xD;
&#xD;
        -  Optimized BMI, hemoglobin, albumin, glucose control, A1C and blood pressure control&#xD;
&#xD;
      Total Joint procedure:&#xD;
&#xD;
      -anterior approach using the HANA table THA preformed with intra-articular block&#xD;
&#xD;
      Pain Management regimen:&#xD;
&#xD;
        -  Pre op PT teaching&#xD;
&#xD;
        -  post op multimodal pain regimen&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 15, 2019</start_date>
  <completion_date type="Actual">March 30, 2020</completion_date>
  <primary_completion_date type="Actual">January 24, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Pre-operative Narcotic Use</measure>
    <time_frame>Pre-operatively</time_frame>
    <description>Percentage of patients that used used opioids pre-operatively</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Patients That Took Any Opioids Throughout 6-week Follow-up Period</measure>
    <time_frame>6 weeks</time_frame>
    <description>Number of patients that took any opioids throughout 6-week follow-up period</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Short Physical Performance Battery</measure>
    <time_frame>6 Weeks</time_frame>
    <description>Assessment tool measuring gait speed, balance and chair stand test. Scores range from 0 to 4 with higher scores indicating a better outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Numeric Pain Scores</measure>
    <time_frame>6 Weeks</time_frame>
    <description>A numeric pain score (0-10, 0 is no pain and 10 is worst imaginable pain). This will be used to assess patients level of pain relating to opioid use and recovery. Both 'best' pain level and 'worst' pain level as reported by the patient will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep Quality</measure>
    <time_frame>6 Weeks</time_frame>
    <description>The percentage of patients where pain interrupts sleep 'never' or 'rarely' will be combined together and reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Adhere to Prescribed Post op Recovery Protocol</measure>
    <time_frame>2 weeks</time_frame>
    <description>Number of Participants Who Adhere to Prescribed Post op Recovery Protocol collected via a questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of Stay in Hospital</measure>
    <time_frame>1 week</time_frame>
    <description>Average number of days in hospital after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients That Return to Work 6 Weeks After Surgery</measure>
    <time_frame>6 weeks</time_frame>
    <description>questionnaire asking the patient to report whether or not they have returned to employment and at what capacity (using Department of Labor physical employment scale). Patients will answer &quot;yes&quot; or &quot;no&quot; when asked if they have returned to work.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients Who Return to Driving 6 Weeks After Surgery</measure>
    <time_frame>6 Weeks</time_frame>
    <description>Patients will respond yes or no when asked if they have resumed driving.</description>
  </secondary_outcome>
  <enrollment type="Actual">207</enrollment>
  <condition>Arthropathy of Hip Joint</condition>
  <condition>Osteoarthritis, Hip</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Males and females presenting seeking elective unilateral total hip arthoplasty that fall&#xD;
        within inclusion criteria listed above&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Elective total hip arthroplasty&#xD;
&#xD;
          -  unilateral&#xD;
&#xD;
          -  patient surgeries scheduled to be performed at the hospital and surgery center&#xD;
&#xD;
          -  patients must enroll in SwiftPath&#xD;
&#xD;
          -  Ability to read and understand English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient diagnosis of schizophrenia, bipolar disease, dementia&#xD;
&#xD;
          -  previous burn to affected extremity&#xD;
&#xD;
          -  BMI &gt; 40&#xD;
&#xD;
          -  Hemoglobin &lt;12 female, &lt;13 male&#xD;
&#xD;
          -  Albumin less than 3.5&#xD;
&#xD;
          -  A1C &gt;8.0&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrew Wickline, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Elizabeth's Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St. Elizabeth's Medical Center</name>
      <address>
        <city>Utica</city>
        <state>New York</state>
        <zip>13501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 31, 2018</study_first_posted>
  <results_first_submitted>February 5, 2020</results_first_submitted>
  <results_first_submitted_qc>March 13, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">March 17, 2020</results_first_posted>
  <last_update_submitted>October 21, 2020</last_update_submitted>
  <last_update_submitted_qc>October 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St. Elizabeth Medical Center, Utica, NY</investigator_affiliation>
    <investigator_full_name>Dr Andrew B. Wickline</investigator_full_name>
    <investigator_title>Orthopedic Surgeon</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis, Hip</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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>March 13, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/06/NCT03790306/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>THR With HANA Table</title>
          <description>Patients undergoing Total Hip Replacement (THR) with use of the Hip And kNee Arthroplasty (HANA) table.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="207"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="207"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>THR With HANA Table</title>
          <description>Patients undergoing Total Hip Replacement (THR) with use of the Hip And kNee Arthroplasty (HANA) table.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="207"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="68.7" spread="9.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="116"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="202"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="207"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Pre-operative Narcotic Use</title>
        <description>Percentage of patients that used used opioids pre-operatively</description>
        <time_frame>Pre-operatively</time_frame>
        <group_list>
          <group group_id="O1">
            <title>THR With HANA Table</title>
            <description>Patients undergoing Total Hip Replacement (THR) with use of the Hip And kNee Arthroplasty (HANA) table.</description>
          </group>
        </group_list>
        <measure>
          <title>Pre-operative Narcotic Use</title>
          <description>Percentage of patients that used used opioids pre-operatively</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="207"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Patients That Took Any Opioids Throughout 6-week Follow-up Period</title>
        <description>Number of patients that took any opioids throughout 6-week follow-up period</description>
        <time_frame>6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>THR With HANA Table</title>
            <description>Patients undergoing Total Hip Replacement (THR) with use of the Hip And kNee Arthroplasty (HANA) table.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients That Took Any Opioids Throughout 6-week Follow-up Period</title>
          <description>Number of patients that took any opioids throughout 6-week follow-up period</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="207"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="128"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Short Physical Performance Battery</title>
        <description>Assessment tool measuring gait speed, balance and chair stand test. Scores range from 0 to 4 with higher scores indicating a better outcome.</description>
        <time_frame>6 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>THR With HANA Table</title>
            <description>Patients undergoing Total Hip Replacement (THR) with use of the Hip And kNee Arthroplasty (HANA) table.</description>
          </group>
        </group_list>
        <measure>
          <title>Short Physical Performance Battery</title>
          <description>Assessment tool measuring gait speed, balance and chair stand test. Scores range from 0 to 4 with higher scores indicating a better outcome.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="207"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Balance</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.95" spread="0.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Gait</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.89" spread="0.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chair</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.17" spread="1.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Numeric Pain Scores</title>
        <description>A numeric pain score (0-10, 0 is no pain and 10 is worst imaginable pain). This will be used to assess patients level of pain relating to opioid use and recovery. Both 'best' pain level and 'worst' pain level as reported by the patient will be reported.</description>
        <time_frame>6 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>THR With HANA Table</title>
            <description>Patients undergoing Total Hip Replacement (THR) with use of the Hip And kNee Arthroplasty (HANA) table.</description>
          </group>
        </group_list>
        <measure>
          <title>Numeric Pain Scores</title>
          <description>A numeric pain score (0-10, 0 is no pain and 10 is worst imaginable pain). This will be used to assess patients level of pain relating to opioid use and recovery. Both 'best' pain level and 'worst' pain level as reported by the patient will be reported.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="207"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Best pain level</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00966" spread="0.139"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Worst pain level</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.14" spread="1.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sleep Quality</title>
        <description>The percentage of patients where pain interrupts sleep 'never' or 'rarely' will be combined together and reported.</description>
        <time_frame>6 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>THR With HANA Table</title>
            <description>Patients undergoing Total Hip Replacement (THR) with use of the Hip And kNee Arthroplasty (HANA) table.</description>
          </group>
        </group_list>
        <measure>
          <title>Sleep Quality</title>
          <description>The percentage of patients where pain interrupts sleep 'never' or 'rarely' will be combined together and reported.</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="207"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="184"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Adhere to Prescribed Post op Recovery Protocol</title>
        <description>Number of Participants Who Adhere to Prescribed Post op Recovery Protocol collected via a questionnaire</description>
        <time_frame>2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>THR With HANA Table</title>
            <description>Patients undergoing Total Hip Replacement (THR) with use of the Hip And kNee Arthroplasty (HANA) table.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Adhere to Prescribed Post op Recovery Protocol</title>
          <description>Number of Participants Who Adhere to Prescribed Post op Recovery Protocol collected via a questionnaire</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="207"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="206"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Length of Stay in Hospital</title>
        <description>Average number of days in hospital after surgery</description>
        <time_frame>1 week</time_frame>
        <group_list>
          <group group_id="O1">
            <title>THR With HANA Table</title>
            <description>Patients undergoing Total Hip Replacement (THR) with use of the Hip And kNee Arthroplasty (HANA) table.</description>
          </group>
        </group_list>
        <measure>
          <title>Length of Stay in Hospital</title>
          <description>Average number of days in hospital after surgery</description>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="207"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4175" lower_limit="0" upper_limit="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients That Return to Work 6 Weeks After Surgery</title>
        <description>questionnaire asking the patient to report whether or not they have returned to employment and at what capacity (using Department of Labor physical employment scale). Patients will answer &quot;yes&quot; or &quot;no&quot; when asked if they have returned to work.</description>
        <time_frame>6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>THR With HANA Table</title>
            <description>Patients undergoing Total Hip Replacement (THR) using the Hip And kNee Arthroplasty (HANA) table</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients That Return to Work 6 Weeks After Surgery</title>
          <description>questionnaire asking the patient to report whether or not they have returned to employment and at what capacity (using Department of Labor physical employment scale). Patients will answer &quot;yes&quot; or &quot;no&quot; when asked if they have returned to work.</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="207"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients Who Return to Driving 6 Weeks After Surgery</title>
        <description>Patients will respond yes or no when asked if they have resumed driving.</description>
        <time_frame>6 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>THR With HANA Table</title>
            <description>Patients undergoing Total Hip Replacement (THR) with use of the Hip And kNee Arthroplasty (HANA) table.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients Who Return to Driving 6 Weeks After Surgery</title>
          <description>Patients will respond yes or no when asked if they have resumed driving.</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="207"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="182"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 year</time_frame>
      <group_list>
        <group group_id="E1">
          <title>THR With HANA Table</title>
          <description>Patients undergoing Total Hip Replacement (THR) with use of the Hip And kNee Arthroplasty (HANA) table.</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="207"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="207"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</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="207"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>
    <point_of_contact>
      <name_or_title>Andrew Wickline, MD</name_or_title>
      <organization>Genesee Orthopedic &amp; Hand Surgery Associates, P.C.</organization>
      <phone>315-735-4496</phone>
      <email>awickline23@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/NCT03790306
org study id: QIIIS
nct id: NCT03790306
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To prove that anterior approach total hip arthroplasty using the HANA table can be performed
      with little, if any, need for opioids using a combination of education, optimized pre op and
      post op pain protocols and optimized recovery tools.
Methods:

      Data Collection:

        -  pre-op assessment/physical therapy evaluation

        -  post op assessment - PACU, phase II (Prior to discharge)

        -  phone calls after discharge (post op day 1, 2, 3)

        -  follow up assessment in surgeon's office (3 and 6 weeks post op)

        -  Ortech

        -  Swiftpath

        -  HOOS jr

      Pre-optimization:

        -  All patients enroll in SwiftPath education program

        -  Optimized BMI, hemoglobin, albumin, glucose control, A1C and blood pressure control

      Total Joint procedure:

      -anterior approach using the HANA table THA preformed with intra-articular block

      Pain Management regimen:

        -  Pre op PT teaching

        -  post op multimodal pain regimen
observational model: Cohort
time perspective: Prospective
measure: Pre-operative Narcotic Use
time frame: Pre-operatively
description: Percentage of patients that used used opioids pre-operatively
measure: Number of Patients That Took Any Opioids Throughout 6-week Follow-up Period
time frame: 6 weeks
description: Number of patients that took any opioids throughout 6-week follow-up period
measure: Short Physical Performance Battery
time frame: 6 Weeks
description: Assessment tool measuring gait speed, balance and chair stand test. Scores range from 0 to 4 with higher scores indicating a better outcome.
measure: Numeric Pain Scores
time frame: 6 Weeks
description: A numeric pain score (0-10, 0 is no pain and 10 is worst imaginable pain). This will be used to assess patients level of pain relating to opioid use and recovery. Both 'best' pain level and 'worst' pain level as reported by the patient will be reported.
measure: Sleep Quality
time frame: 6 Weeks
description: The percentage of patients where pain interrupts sleep 'never' or 'rarely' will be combined together and reported.
measure: Number of Participants Who Adhere to Prescribed Post op Recovery Protocol
time frame: 2 weeks
description: Number of Participants Who Adhere to Prescribed Post op Recovery Protocol collected via a questionnaire
measure: Length of Stay in Hospital
time frame: 1 week
description: Average number of days in hospital after surgery
measure: Number of Patients That Return to Work 6 Weeks After Surgery
time frame: 6 weeks
description: questionnaire asking the patient to report whether or not they have returned to employment and at what capacity (using Department of Labor physical employment scale). Patients will answer "yes" or "no" when asked if they have returned to work.
measure: Number of Patients Who Return to Driving 6 Weeks After Surgery
time frame: 6 Weeks
description: Patients will respond yes or no when asked if they have resumed driving.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 30 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Andrew Wickline, MD
role: Principal Investigator
affiliation: St. Elizabeth's Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: St. Elizabeth Medical Center, Utica, NY
investigator full name: Dr Andrew B. Wickline
investigator title: Orthopedic Surgeon
mesh term: Osteoarthritis, Hip
sharing ipd: Undecided
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 