<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/NCT02986061</url>
  </required_header>
  <id_info>
    <org_study_id>Knee-UC</org_study_id>
    <nct_id>NCT02986061</nct_id>
  </id_info>
  <brief_title>To Catheterize or Not? in Total Knee Arthroplasty With Combined Spinal-epidural Analgesia</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Southwest Hospital, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Southwest Hospital, China</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study was to investigate whether urinary catheterization could be avoided for&#xD;
      all patients undergoing total knee arthroplasty under combined spinal-epidural analgesia plus&#xD;
      multi-site infiltration analgesia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <primary_completion_date type="Anticipated">January 2017</primary_completion_date>
  <phase>N/A</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative urinary retention</measure>
    <time_frame>7 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Postoperative urinary tract infection</measure>
    <time_frame>7 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Urine volume</measure>
    <time_frame>3 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Length of stay</measure>
    <time_frame>14 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraoperative intravenous fluid</measure>
    <time_frame>1 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of the surgery</measure>
    <time_frame>1 day</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Urinary Catheter</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with indwelling urinary catheter</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Study Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients without indwelling urinary catheter</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Urinary catheter</intervention_name>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 40 years and older, who were scheduled for a primary TKA for end-stage&#xD;
             osteoarthritis and those who were willing and able to return for follow-up over at&#xD;
             least a 1-month postoperative period.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Revisions, bilateral procedures, surgical history of urinary system, urinary tract&#xD;
             infection and systematical conditions (renal disease, renal failure, chronic renal&#xD;
             insufficiency, or an indwelling catheter at the time of surgery) needing&#xD;
             intraoperative monitoring urine output.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Wei-Nan Zeng, MD</last_name>
    <email>weinanzeng@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Center for Joint Surgery, Southwest Hospital, Third Military Medical University</name>
      <address>
        <city>Chongqing</city>
        <state>Chongqing</state>
        <zip>400038</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wei-Nan Zeng, MD</last_name>
      <email>weinanzeng@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <last_update_submitted>December 7, 2016</last_update_submitted>
  <last_update_submitted_qc>December 7, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 8, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Southwest Hospital, China</investigator_affiliation>
    <investigator_full_name>Liu Yang</investigator_full_name>
    <investigator_title>Director</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02986061
org study id: Knee-UC
nct id: NCT02986061
lead sponsor: 
has dmc: Yes
The aim of this study was to investigate whether urinary catheterization could be avoided for
      all patients undergoing total knee arthroplasty under combined spinal-epidural analgesia plus
      multi-site infiltration analgesia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Postoperative urinary retention
time frame: 7 days
measure: Postoperative urinary tract infection
time frame: 7 days
measure: Urine volume
time frame: 3 days
measure: Length of stay
time frame: 14 days
measure: Intraoperative intravenous fluid
time frame: 1 day
measure: Duration of the surgery
time frame: 1 day
arm group label: Control Group
arm group type: Active Comparator
description: Patients with indwelling urinary catheter
arm group label: Study Group
arm group type: No Intervention
description: Patients without indwelling urinary catheter
intervention type: Device
intervention name: Urinary catheter
arm group label: Control Group
criteria: 
gender: Male
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: No
last name: Wei-Nan Zeng, MD
email: weinanzeng@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Southwest Hospital, China
investigator full name: Liu Yang
investigator title: Director
sharing ipd: No