<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/NCT02230215</url>
  </required_header>
  <id_info>
    <org_study_id>105453</org_study_id>
    <nct_id>NCT02230215</nct_id>
  </id_info>
  <brief_title>Assessment of Conventional and Patient-specific Instrumentation in Total Knee Arthroplasty</brief_title>
  <official_title>Assessment of Conventional and Patient-specific Instrumentation in Total Knee Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lawson Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Canadian Orthopaedic Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Smith &amp; Nephew, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Lawson Health Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will use a special type of x-ray called radiostereometric analysis (RSA) imaging&#xD;
      to determine whether patient-specific instrumentation for total knee arthroplasty&#xD;
      (replacement) has an effect on implant loosening compared to conventional instrumentation.&#xD;
      Secondary objectives will include assessment of post-operative implant alignment, patient&#xD;
      satisfaction, operative time and surgical instrument use, cost, and environmental impact.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective randomized controlled trial which will enroll 50 patients undergoing&#xD;
      total knee replacement surgery. All study patients will undergo an MRI prior to surgery. Half&#xD;
      (25)of these patients will be randomized to have their MRI used to develop a patient-specific&#xD;
      instrument to be used during their surgery. The other half (25) will have conventional&#xD;
      instrumentation (CI) used for their knee replacement surgery.&#xD;
&#xD;
      All patients will have the same type of knee implant used for their total knee replacement&#xD;
      (Genesis II posterior stabilized (Smith &amp; Nephew).&#xD;
&#xD;
      Patients will not know which group they have been randomized to. For patients randomized into&#xD;
      the patient-specific randomization group, If the surgeon is not happy with the&#xD;
      patient-specific instrumentation, they have the option to switch to conventional&#xD;
      instrumentation at any time during the surgery.&#xD;
&#xD;
      • Length of operation, number of instruments used, amount of OR room waste and number and&#xD;
      type of adjustments to the patient specific instrumentation will be tracked.&#xD;
&#xD;
      During the surgery, all patients in the study will have tantalum marker beads placed in the&#xD;
      bone surrounding their knee replacement. These beads will be used as markers to measure&#xD;
      implant fixation over the next two years. All patients will undergo a special type of x-ray&#xD;
      imaging called RSA imaging to quantify implant fixation over time.&#xD;
&#xD;
      RSA examinations will occur at 6 weeks, 3 months, 6 months, 1 year, and 2 years at the&#xD;
      Robart's Research Institute after their standard of care visit with orthopaedic surgeon.&#xD;
&#xD;
      Model based RSA software used to measure motion of implant components relative to bone&#xD;
      markers.&#xD;
&#xD;
      All patients will complete our standard outcome measures in the form of surveys completed at&#xD;
      their follow-up visits after surgery. •&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2015</start_date>
  <completion_date type="Actual">August 2018</completion_date>
  <primary_completion_date type="Actual">August 2018</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluating the Change in Implant Fixation assessed using RSA imaging</measure>
    <time_frame>2 weeks, 6 weeks, 3 months 6 months, 1 year, 2 years</time_frame>
    <description>Model based RSA will be used to measure the migration of the implant components relative to the bone between all time points.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Outcomes including Satisfaction</measure>
    <time_frame>Preoperatively, 1 year, 2 year</time_frame>
    <description>Patient reported outcome measures provide important insight into how well total knee replacement performs from the patient's perspective. We will obtain patient surveys using four common, validated outcome measures: Knee Society Score, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Short Form 12 Health Survey (SF-12), and University of California, Los Angeles (UCLA) Activity Score</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Component Alignment</measure>
    <time_frame>1 year, 2 year</time_frame>
    <description>Using standard 3 foot hip-to-ankle radiographs to determine radiographic alignment of the implant components and mechanical axis of the limb.</description>
  </other_outcome>
  <other_outcome>
    <measure>Cost</measure>
    <time_frame>Intraoperatively</time_frame>
    <description>Tracking time and instruments used per procedure and waste collected.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Patient-Specific Instrumentation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients to have a total knee replacement surgery completed using Patient-Specific Instrumentation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Traditional Instrumentation</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients to have a total knee replacement surgery done using traditional instrumentation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Total Knee Arthroplasty with use of Visionaire Patient-Specific Instrumentation</intervention_name>
    <description>The manufacturing of a patient-specific instrument to be used by the orthopaedic surgeon during the knee replacement surgery.</description>
    <arm_group_label>Patient-Specific Instrumentation</arm_group_label>
    <other_name>Visionaire Patient Specific Instrumentation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Undergoing primary total knee replacement surgery&#xD;
&#xD;
          -  No previous knee hardware (ie.Uni-Knees, or high tibial osteotomy)&#xD;
&#xD;
          -  BMI &lt; 40&#xD;
&#xD;
          -  Study patients should live within 100 km of our facility to ensure availability for&#xD;
             follow-up&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy or considering pregnancy&#xD;
&#xD;
          -  BMI &gt; 40&#xD;
&#xD;
          -  Unable to undergo MRI screening&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Douglas Naudie, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>London Health Sciences Centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A5A5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>August 19, 2014</study_first_submitted>
  <study_first_submitted_qc>September 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2014</study_first_posted>
  <last_update_submitted>November 7, 2018</last_update_submitted>
  <last_update_submitted_qc>November 7, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 8, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Lawson Health Research Institute</investigator_affiliation>
    <investigator_full_name>Douglas Naudie</investigator_full_name>
    <investigator_title>Orthopaedic Surgeon</investigator_title>
  </responsible_party>
  <keyword>Total Knee Replacement</keyword>
  <keyword>Visionaire</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</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/NCT02230215
org study id: 105453
nct id: NCT02230215
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
This study will use a special type of x-ray called radiostereometric analysis (RSA) imaging
      to determine whether patient-specific instrumentation for total knee arthroplasty
      (replacement) has an effect on implant loosening compared to conventional instrumentation.
      Secondary objectives will include assessment of post-operative implant alignment, patient
      satisfaction, operative time and surgical instrument use, cost, and environmental impact.
This is a prospective randomized controlled trial which will enroll 50 patients undergoing
      total knee replacement surgery. All study patients will undergo an MRI prior to surgery. Half
      (25)of these patients will be randomized to have their MRI used to develop a patient-specific
      instrument to be used during their surgery. The other half (25) will have conventional
      instrumentation (CI) used for their knee replacement surgery.

      All patients will have the same type of knee implant used for their total knee replacement
      (Genesis II posterior stabilized (Smith & Nephew).

      Patients will not know which group they have been randomized to. For patients randomized into
      the patient-specific randomization group, If the surgeon is not happy with the
      patient-specific instrumentation, they have the option to switch to conventional
      instrumentation at any time during the surgery.

      • Length of operation, number of instruments used, amount of OR room waste and number and
      type of adjustments to the patient specific instrumentation will be tracked.

      During the surgery, all patients in the study will have tantalum marker beads placed in the
      bone surrounding their knee replacement. These beads will be used as markers to measure
      implant fixation over the next two years. All patients will undergo a special type of x-ray
      imaging called RSA imaging to quantify implant fixation over time.

      RSA examinations will occur at 6 weeks, 3 months, 6 months, 1 year, and 2 years at the
      Robart's Research Institute after their standard of care visit with orthopaedic surgeon.

      Model based RSA software used to measure motion of implant components relative to bone
      markers.

      All patients will complete our standard outcome measures in the form of surveys completed at
      their follow-up visits after surgery. •
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Evaluating the Change in Implant Fixation assessed using RSA imaging
time frame: 2 weeks, 6 weeks, 3 months 6 months, 1 year, 2 years
description: Model based RSA will be used to measure the migration of the implant components relative to the bone between all time points.
measure: Patient Outcomes including Satisfaction
time frame: Preoperatively, 1 year, 2 year
description: Patient reported outcome measures provide important insight into how well total knee replacement performs from the patient's perspective. We will obtain patient surveys using four common, validated outcome measures: Knee Society Score, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Short Form 12 Health Survey (SF-12), and University of California, Los Angeles (UCLA) Activity Score
measure: Component Alignment
time frame: 1 year, 2 year
description: Using standard 3 foot hip-to-ankle radiographs to determine radiographic alignment of the implant components and mechanical axis of the limb.
measure: Cost
time frame: Intraoperatively
description: Tracking time and instruments used per procedure and waste collected.
arm group label: Patient-Specific Instrumentation
arm group type: Experimental
description: Patients to have a total knee replacement surgery completed using Patient-Specific Instrumentation
arm group label: Traditional Instrumentation
arm group type: No Intervention
description: Patients to have a total knee replacement surgery done using traditional instrumentation.
intervention type: Device
intervention name: Total Knee Arthroplasty with use of Visionaire Patient-Specific Instrumentation
description: The manufacturing of a patient-specific instrument to be used by the orthopaedic surgeon during the knee replacement surgery.
arm group label: Patient-Specific Instrumentation
other name: Visionaire Patient Specific Instrumentation
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Douglas Naudie, MD
role: Principal Investigator
affiliation: London Health Sciences Centre
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Lawson Health Research Institute
investigator full name: Douglas Naudie
investigator title: Orthopaedic Surgeon
mesh term: Osteoarthritis
sharing ipd: No