<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/NCT03032133</url>
  </required_header>
  <id_info>
    <org_study_id>TKA pain</org_study_id>
    <nct_id>NCT03032133</nct_id>
  </id_info>
  <brief_title>Pain Control After Total Knee Arthroplasty</brief_title>
  <official_title>Pain After Total Knee Arthroplasty With Either Regional or Local Pain Katheter</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Technische Universität Dresden</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Mathys Ltd Bettlach</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Technische Universität Dresden</source>
  <oversight_info>
    <has_dmc>No</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>
      Patients are randomized to receive pain control after Total Knee Arthroplasty with either a&#xD;
      regional pain catheter or a local intraarticular pain catheter. Pain, analgetic use and&#xD;
      mobility is asessed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2016</start_date>
  <completion_date type="Actual">December 2018</completion_date>
  <primary_completion_date type="Actual">December 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>pain</measure>
    <time_frame>daily until day 7 after surgery</time_frame>
    <description>Pain on Visual Analog Scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>analgetics</measure>
    <time_frame>daily until day 7 after surgery</time_frame>
    <description>Use of additional analgetics</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mobility</measure>
    <time_frame>daily until day 7 after surgery</time_frame>
    <description>grade of mobility</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Function</measure>
    <time_frame>preoperative, 3 month, 1 year</time_frame>
    <description>Knee Society Score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient reported outcome</measure>
    <time_frame>preoperative, 3 month, 1 year</time_frame>
    <description>Oxford Knee Score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>preoperative, 3 month, 1 year</time_frame>
    <description>EQ 5D</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">140</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Regional pain control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Regional pain catheter</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Local pain control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Local intraarticular pain catheter</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Regional pain control</intervention_name>
    <description>Regional pain catheter</description>
    <arm_group_label>Regional pain control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Local pain control</intervention_name>
    <description>Local intraarticular pain catheter</description>
    <arm_group_label>Local pain control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Indication to Total Knee Arthroplasty&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chronic pain&#xD;
&#xD;
          -  Allergy against local anaesthetics&#xD;
&#xD;
          -  Not understanding study or questionnaires&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jörg Lützner, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>TU Dresden</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universitätsklinikum Carl Gustav Carus</name>
      <address>
        <city>Dresden</city>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 24, 2017</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>February 11, 2019</last_update_submitted>
  <last_update_submitted_qc>February 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Total Knee Arthroplasty</keyword>
  <keyword>Total Knee Replacement</keyword>
  <keyword>Outcome</keyword>
  <keyword>Results</keyword>
  <keyword>Pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
  </condition_browse>
  <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/NCT03032133
org study id: TKA pain
nct id: NCT03032133
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients are randomized to receive pain control after Total Knee Arthroplasty with either a
      regional pain catheter or a local intraarticular pain catheter. Pain, analgetic use and
      mobility is asessed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: pain
time frame: daily until day 7 after surgery
description: Pain on Visual Analog Scale
measure: analgetics
time frame: daily until day 7 after surgery
description: Use of additional analgetics
measure: Mobility
time frame: daily until day 7 after surgery
description: grade of mobility
measure: Function
time frame: preoperative, 3 month, 1 year
description: Knee Society Score
measure: Patient reported outcome
time frame: preoperative, 3 month, 1 year
description: Oxford Knee Score
measure: Quality of Life
time frame: preoperative, 3 month, 1 year
description: EQ 5D
arm group label: Regional pain control
arm group type: Active Comparator
description: Regional pain catheter
arm group label: Local pain control
arm group type: Experimental
description: Local intraarticular pain catheter
intervention type: Procedure
intervention name: Regional pain control
description: Regional pain catheter
arm group label: Regional pain control
intervention type: Procedure
intervention name: Local pain control
description: Local intraarticular pain catheter
arm group label: Local pain control
criteria: 
gender: All
gender based: Yes
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jörg Lützner, MD
role: Principal Investigator
affiliation: TU Dresden
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
sharing ipd: No