<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/NCT02253680</url>
  </required_header>
  <id_info>
    <org_study_id>RCTTKR-01</org_study_id>
    <nct_id>NCT02253680</nct_id>
  </id_info>
  <brief_title>The Use of Compression Bandages in Total Knee Replacement Surgery</brief_title>
  <official_title>A Prospective, Randomised Control Trial Investigating the Use of a Two-layer, Short-stretch Compression Bandage in Elective Total Knee Replacement - Feasibility</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northumbria Healthcare NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Northumbria Healthcare NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The use of compression bandages in elective orthopaedic knee surgery is well regarded,&#xD;
      however, there is a lack of robust, well-designed evidence to support this.&#xD;
&#xD;
      The aim is to determine the feasibility of conducting a randomised control trial comparing&#xD;
      the use of a compression bandage worn post-operatively for 24 hours after elective total knee&#xD;
      replacement, compared to standard practice (wool and crepe, non-compressive dressing).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>November 2013</start_date>
  <completion_date type="Anticipated">August 2015</completion_date>
  <primary_completion_date type="Anticipated">November 2014</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility</measure>
    <time_frame>6 months</time_frame>
    <description>Additionally, the study is a feasibility study to estimate (via the pilot trial) rates of patient recruitment, randomisation, retention and response, logistics of trial methodology, and resource utilisation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Knee range of motion</measure>
    <time_frame>6 months</time_frame>
    <description>Range of motion of the knee compared to the pre-operative knee.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain</measure>
    <time_frame>6 months</time_frame>
    <description>Post-operative pain scores measured by visual analogue scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction</measure>
    <time_frame>6 months</time_frame>
    <description>Oxford knee score and EQ-5D scores pre-operatively and at six months</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Knee ROM</measure>
    <time_frame>6 months</time_frame>
    <description>Circumference of knee 10cm above, at and below patella</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Routine care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Wool and crepe bandage for 24 hours post-operatively</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Compression bandage</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Actico, inelastic, short-stretch compression bandage worn 24 hours post-operatively</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Actico, short-stretch, inelastic dressing</intervention_name>
    <description>Worn 24hr post-operatively</description>
    <arm_group_label>Compression bandage</arm_group_label>
    <other_name>Compression bandage</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 18&#xD;
&#xD;
          -  Able to give written, informed consent&#xD;
&#xD;
          -  Primary total knee replacement&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Extensive peripheral vascular disease&#xD;
&#xD;
          -  Lower limb neurological disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mike Reed, MD FRCS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northumbria NHS Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Wansbeck District General Hospital</name>
      <address>
        <city>Ashington</city>
        <state>Northumberland</state>
        <zip>NE639JJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northumbria Healthcare NHS Foundation Trust</name>
      <address>
        <city>Ashington</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 1, 2013</study_first_submitted>
  <study_first_submitted_qc>September 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <last_update_submitted>September 30, 2014</last_update_submitted>
  <last_update_submitted_qc>September 30, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 1, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northumbria Healthcare NHS Foundation Trust</investigator_affiliation>
    <investigator_full_name>Mike Reed</investigator_full_name>
    <investigator_title>Consultant Trauma and Orthopaedic Surgeon</investigator_title>
  </responsible_party>
  <keyword>Osteoarthritis</keyword>
  <keyword>Total knee replacement</keyword>
  <keyword>Enhanced recovery</keyword>
  <keyword>Compression bandages</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</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/NCT02253680
org study id: RCTTKR-01
nct id: NCT02253680
lead sponsor: 
has dmc: Yes
The use of compression bandages in elective orthopaedic knee surgery is well regarded,
      however, there is a lack of robust, well-designed evidence to support this.

      The aim is to determine the feasibility of conducting a randomised control trial comparing
      the use of a compression bandage worn post-operatively for 24 hours after elective total knee
      replacement, compared to standard practice (wool and crepe, non-compressive dressing).
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Feasibility
time frame: 6 months
description: Additionally, the study is a feasibility study to estimate (via the pilot trial) rates of patient recruitment, randomisation, retention and response, logistics of trial methodology, and resource utilisation.
measure: Knee range of motion
time frame: 6 months
description: Range of motion of the knee compared to the pre-operative knee.
measure: Pain
time frame: 6 months
description: Post-operative pain scores measured by visual analogue scale
measure: Patient satisfaction
time frame: 6 months
description: Oxford knee score and EQ-5D scores pre-operatively and at six months
measure: Knee ROM
time frame: 6 months
description: Circumference of knee 10cm above, at and below patella
arm group label: Routine care
arm group type: No Intervention
description: Wool and crepe bandage for 24 hours post-operatively
arm group label: Compression bandage
arm group type: Experimental
description: Actico, inelastic, short-stretch compression bandage worn 24 hours post-operatively
intervention type: Procedure
intervention name: Actico, short-stretch, inelastic dressing
description: Worn 24hr post-operatively
arm group label: Compression bandage
other name: Compression bandage
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Mike Reed, MD FRCS
role: Principal Investigator
affiliation: Northumbria NHS Trust
facility: 
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Northumbria Healthcare NHS Foundation Trust
investigator full name: Mike Reed
investigator title: Consultant Trauma and Orthopaedic Surgeon
mesh term: Osteoarthritis