<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/NCT02230657</url>
  </required_header>
  <id_info>
    <org_study_id>WHOZ01</org_study_id>
    <nct_id>NCT02230657</nct_id>
  </id_info>
  <brief_title>A Prospective, Randomized Trial Comparing Same Day Discharge and Overnight Hospital Stay Among Total Hip Arthroplasties Done by the Direct Anterior Approach</brief_title>
  <official_title>A Prospective, Randomized Trial Comparing Same Day Discharge and Overnight Hospital Stay Among Total Hip Arthroplasties Done by the Direct Anterior Approach</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rothman Institute Orthopaedics</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Anderson Orthopaedic Clinic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Rothman Institute Orthopaedics</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to identify differences in satisfaction, pain and length of stay&#xD;
      between patients undergoing hip replacement who are discharged from the hospital on the day&#xD;
      of surgery compared to patients who stay one night in the hospital.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <primary_completion_date type="Actual">August 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <primary_outcome>
    <measure>Patient Satisfaction</measure>
    <time_frame>Discharge through 30 days post-op</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <condition>Osteoarthritis of the Hip</condition>
  <arm_group>
    <arm_group_label>Same day Discharge</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Next day discharge</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Same day discharge</intervention_name>
    <arm_group_label>Same day Discharge</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Next day discharge</intervention_name>
    <arm_group_label>Next day discharge</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Primary THA without acute hip fracture or prior hardware that would need to be removed&#xD;
             at the time of surgery&#xD;
&#xD;
          -  Unilateral THA&#xD;
&#xD;
          -  Pre-operative Body Mass Index (BMI) &lt; 40 kg/m2&#xD;
&#xD;
          -  Age &lt; 75 years at time of surgery&#xD;
&#xD;
          -  Pre-operative hemoglobin &gt; 10 g/dL if pre-operative hemoglobin data is available&#xD;
&#xD;
          -  No history of cardiopulmonary disease that would necessitate inpatient monitoring&#xD;
             after surgery&#xD;
&#xD;
          -  Pre-operative ambulatory status does not require the use of a walker or wheelchair&#xD;
&#xD;
          -  No chronic pre-operative opioid medication use or opioid addiction&#xD;
&#xD;
          -  Assistance available at home after discharge from hospital&#xD;
&#xD;
          -  No other condition or circumstance that would preclude rapid discharge from the&#xD;
             hospital after surgery&#xD;
&#xD;
          -  Subject's English proficiency allows understanding of study and Informed Consent&#xD;
&#xD;
          -  Subject consented to participate in this study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Revision THA&#xD;
&#xD;
          -  Bilateral THA&#xD;
&#xD;
          -  Pre-operative BMI ≥ 40 kg/m2&#xD;
&#xD;
          -  Age ≥ 75 at time of surgery&#xD;
&#xD;
          -  Pre-operative hemoglobin ≤ 10 g/dL if pre-operative hemoglobin data is available&#xD;
&#xD;
          -  History of cardiopulmonary disease requiring acute inpatient monitoring&#xD;
&#xD;
          -  Pre-operative ambulatory status requiring the use of a walker or wheelchair&#xD;
&#xD;
          -  Chronic pre-operative opioid medication use or opioid addiction&#xD;
&#xD;
          -  Limited or no assistance available at home after discharge from hospital&#xD;
&#xD;
          -  Any other condition or circumstance that would preclude rapid discharge from the&#xD;
             hospital&#xD;
&#xD;
          -  Subject not proficient in English&#xD;
&#xD;
          -  Subject did not consent to participate in this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Rothman Institute</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Anderson Orthopaedic Clinic</name>
      <address>
        <city>Alexandria</city>
        <state>Virginia</state>
        <zip>22306</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>August 29, 2014</study_first_submitted>
  <study_first_submitted_qc>August 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2014</study_first_posted>
  <last_update_submitted>October 20, 2015</last_update_submitted>
  <last_update_submitted_qc>October 20, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 21, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis, Hip</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02230657
org study id: WHOZ01
nct id: NCT02230657
lead sponsor: 
collaborator: 
The purpose of this study is to identify differences in satisfaction, pain and length of stay
      between patients undergoing hip replacement who are discharged from the hospital on the day
      of surgery compared to patients who stay one night in the hospital.
measure: Patient Satisfaction
time frame: Discharge through 30 days post-op
arm group label: Same day Discharge
arm group type: Active Comparator
arm group label: Next day discharge
arm group type: Active Comparator
intervention type: Procedure
intervention name: Same day discharge
arm group label: Same day Discharge
intervention type: Procedure
intervention name: Next day discharge
arm group label: Next day discharge
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Osteoarthritis, Hip