<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/NCT04434222</url>
  </required_header>
  <id_info>
    <org_study_id>W759</org_study_id>
    <nct_id>NCT04434222</nct_id>
  </id_info>
  <brief_title>Compressive Stockings Therapy After TKA</brief_title>
  <official_title>Effect of Compliance Controlled Postoperative Compressive Stockings Therapy After Total Knee Arthroplasty: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Balgrist University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Balgrist University Hospital</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>
      Due to swelling after total knee arthroplasty, postoperative mobilization and training is&#xD;
      impeded in addition to higher pain level in patients. With postoperative compressive&#xD;
      stockings to prevent oedema, haematoma and postoperative pain we would like to investigate if&#xD;
      compressive stockings reduce postoperative swelling and pain and furthermore improve&#xD;
      mobilization and knee function.&#xD;
&#xD;
      In this randomized controlled trial, 88 patients are randomized in two groups. One group&#xD;
      receives postoperatively compressive stockings for a period of 6 weeks. The control group is&#xD;
      treated without compressive stockings. The patients compressive stockings wearing compliance&#xD;
      is controlled with a temperature sensitive sensor. The patients will be informed about the&#xD;
      implantation of the sensor.&#xD;
&#xD;
      Outcome measures are knee- calf- and ankle swelling in mm, pain, WOMAC and KSS score&#xD;
      preoperatively and at 12 weeks, 12 months and 24 months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    not enough study participants and missing compliance to perform analysis&#xD;
  </why_stopped>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">May 30, 2022</completion_date>
  <primary_completion_date type="Actual">May 30, 2022</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>Single (Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Knee Function KSS 6 weeks postoperative</measure>
    <time_frame>6 weeks postoperative</time_frame>
    <description>Knee Society Score - KSS</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee Function KSS 12 weeks postoperative</measure>
    <time_frame>12 weeks postoperative</time_frame>
    <description>Knee Society Score - KSS</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee Function KSS 1 year postoperative</measure>
    <time_frame>1 year postoperative</time_frame>
    <description>Knee Society Score - KSS</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee Function WOMAC 6 weeks postoperative</measure>
    <time_frame>6 weeks postoperative</time_frame>
    <description>Western Ontario and McMaster Universities Osteoarthritis Index - WOMAC</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee Function WOMAC 12 weeks postoperative</measure>
    <time_frame>12 weeks postoperative</time_frame>
    <description>Western Ontario and McMaster Universities Osteoarthritis Index - WOMAC</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee Function WOMAC 1 year postoperative</measure>
    <time_frame>1 year postoperative</time_frame>
    <description>Western Ontario and McMaster Universities Osteoarthritis Index - WOMAC</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain 6 weeks postoperative</measure>
    <time_frame>6 weeks postoperative</time_frame>
    <description>Visuelle Analogskala - VAS (1-10)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain 12 weeks postoperative</measure>
    <time_frame>12 weeks postoperative</time_frame>
    <description>Visuelle Analogskala - VAS (1-10)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain 1 year postoperative</measure>
    <time_frame>1 year postoperative</time_frame>
    <description>Visuelle Analogskala - VAS (1-10)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Swelling 6 weeks postoperative</measure>
    <time_frame>6 weeks postoperative</time_frame>
    <description>Swelling in mm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Swelling 12 weeks postoperative</measure>
    <time_frame>12 weeks postoperative</time_frame>
    <description>Swelling in mm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Swelling 1 year postoperative</measure>
    <time_frame>1 year postoperative</time_frame>
    <description>Swelling in mm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compliance first 6 weeks postoperativ</measure>
    <time_frame>First 6 weeks postoperativ</time_frame>
    <description>Measured with Orthotimer sensor</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Compliance of Wearing of Compressive Stockings</condition>
  <condition>Total Knee Arthroplasty</condition>
  <arm_group>
    <arm_group_label>Compressive stockings group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group receives postoperatively compressive stockings for a period of 6 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group is treated without compressive stockings.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Compressive stockings</intervention_name>
    <description>Compressive stockings with built in Orthotimer Sensor</description>
    <arm_group_label>Compressive stockings group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients receiving a total knee replacement&#xD;
&#xD;
          -  Written consent of the study participant&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Peripheral arterial disease II, III or IV&#xD;
&#xD;
          -  Diabetes mellitus&#xD;
&#xD;
          -  Systemic inflammatory diseases&#xD;
&#xD;
          -  Benign or malignant neoplasms&#xD;
&#xD;
          -  Revision interventions&#xD;
&#xD;
          -  Right heart failure&#xD;
&#xD;
          -  pulmonary edema&#xD;
&#xD;
          -  Open / chronic skin lesions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Universitätsklinik Balgrist</name>
      <address>
        <city>Zürich</city>
        <zip>8008</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>April 28, 2020</study_first_submitted>
  <study_first_submitted_qc>June 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>June 21, 2022</last_update_submitted>
  <last_update_submitted_qc>June 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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/NCT04434222
org study id: W759
nct id: NCT04434222
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Due to swelling after total knee arthroplasty, postoperative mobilization and training is
      impeded in addition to higher pain level in patients. With postoperative compressive
      stockings to prevent oedema, haematoma and postoperative pain we would like to investigate if
      compressive stockings reduce postoperative swelling and pain and furthermore improve
      mobilization and knee function.

      In this randomized controlled trial, 88 patients are randomized in two groups. One group
      receives postoperatively compressive stockings for a period of 6 weeks. The control group is
      treated without compressive stockings. The patients compressive stockings wearing compliance
      is controlled with a temperature sensitive sensor. The patients will be informed about the
      implantation of the sensor.

      Outcome measures are knee- calf- and ankle swelling in mm, pain, WOMAC and KSS score
      preoperatively and at 12 weeks, 12 months and 24 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Care Provider)
measure: Knee Function KSS 6 weeks postoperative
time frame: 6 weeks postoperative
description: Knee Society Score - KSS
measure: Knee Function KSS 12 weeks postoperative
time frame: 12 weeks postoperative
description: Knee Society Score - KSS
measure: Knee Function KSS 1 year postoperative
time frame: 1 year postoperative
description: Knee Society Score - KSS
measure: Knee Function WOMAC 6 weeks postoperative
time frame: 6 weeks postoperative
description: Western Ontario and McMaster Universities Osteoarthritis Index - WOMAC
measure: Knee Function WOMAC 12 weeks postoperative
time frame: 12 weeks postoperative
description: Western Ontario and McMaster Universities Osteoarthritis Index - WOMAC
measure: Knee Function WOMAC 1 year postoperative
time frame: 1 year postoperative
description: Western Ontario and McMaster Universities Osteoarthritis Index - WOMAC
measure: Pain 6 weeks postoperative
time frame: 6 weeks postoperative
description: Visuelle Analogskala - VAS (1-10)
measure: Pain 12 weeks postoperative
time frame: 12 weeks postoperative
description: Visuelle Analogskala - VAS (1-10)
measure: Pain 1 year postoperative
time frame: 1 year postoperative
description: Visuelle Analogskala - VAS (1-10)
measure: Swelling 6 weeks postoperative
time frame: 6 weeks postoperative
description: Swelling in mm
measure: Swelling 12 weeks postoperative
time frame: 12 weeks postoperative
description: Swelling in mm
measure: Swelling 1 year postoperative
time frame: 1 year postoperative
description: Swelling in mm
measure: Compliance first 6 weeks postoperativ
time frame: First 6 weeks postoperativ
description: Measured with Orthotimer sensor
arm group label: Compressive stockings group
arm group type: Active Comparator
description: Group receives postoperatively compressive stockings for a period of 6 weeks.
arm group label: Control group
arm group type: No Intervention
description: The control group is treated without compressive stockings.
intervention type: Device
intervention name: Compressive stockings
description: Compressive stockings with built in Orthotimer Sensor
arm group label: Compressive stockings group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Switzerland
responsible party type: Sponsor
sharing ipd: No