<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/NCT03290170</url>
  </required_header>
  <id_info>
    <org_study_id>109512</org_study_id>
    <nct_id>NCT03290170</nct_id>
  </id_info>
  <brief_title>Radiostereometric Analysis of Gap Balancing Versus Measured Resection for the Journey II Total Knee Replacement</brief_title>
  <official_title>Radiostereometric Analysis of Gap Balancing Versus Measured Resection for the Journey II Total Knee Replacement</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lawson Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lawson Health Research Institute</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>
      This is a randomized study comparing the measured resection and gap-balancing surgical&#xD;
      techniques for total knee replacement (TKR) using a cemented Journey II TKR implant system.&#xD;
      We will be comparing the two surgical methods by evaluating implant migration using&#xD;
      radiostereometric analysis (RSA) imaging, evaluating contact kinematics (knee mechanics)&#xD;
      through RSA under dynamic conditions and comparing patient knee outcome scores.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The stability of a total knee replacement (TKR) surgery depends on soft tissue balance (i.e.&#xD;
      balance of supporting ligaments) and bony cuts made during surgery that dictate the rotation&#xD;
      of the femoral (thigh bone) component. Two main techniques predominate for execution of the&#xD;
      bone cuts and soft tissue balance in TKR. In measured resection, pre-determined bony cuts are&#xD;
      made and appropriate balance is obtained by judicious soft tissue releases as required. In&#xD;
      gap balancing, the bony cuts for femoral rotation are driven by the native soft tissues. How&#xD;
      these two surgical approaches affects the biomechanics of the knee invivo is unclear. The&#xD;
      purpose of this study is to examine the patello-femoral articulation as well as coronal&#xD;
      balance of the respective techniques under dynamic conditions. Secondary goals will be to&#xD;
      examine the impact on femoral component position on changes to coronal plane position through&#xD;
      a range of flexion/extension. As patellofemoral symptoms and flexion instability are two of&#xD;
      the most common causes of patient dissatisfaction and revision in the short term, this study&#xD;
      has the potential to have significant patient impact. The study also has the potential to&#xD;
      provide information on long term wear potential if articular incongruity is found. TKA is a&#xD;
      procedure that has good results in most patients, however, up to 20% of patients are not&#xD;
      satisfied with their outcome. (1) Some of these dissatisfied patients require early revision.&#xD;
      Early revisions are often attributed to technical issues, such as revisions required for&#xD;
      instability, patellofemoral symptoms, stiffness or aseptic loosening (2). This highlights the&#xD;
      impact of surgical technique on clinical outcomes. There are two main philosophies on how to&#xD;
      complete bone resections and achieve a balanced TKA. The measured resection technique&#xD;
      utilizes a standard set of bony cuts based on bony landmarks and then balances the knee by&#xD;
      making judicious soft tissue releases. Component position, particularly femoral rotation, is&#xD;
      fairly constant with using this technique. Gap balancing adjusts the bony cuts for femoral&#xD;
      rotation to balance the soft tissues of the knee in flexion, potentially avoiding the&#xD;
      necessity of soft tissue releases. In contrast to the measured resection technique, gap&#xD;
      balancing allows for variable rotation of the femoral component. This variability in femoral&#xD;
      rotation has the potential to impacts the coronal plane motion as well as tracking at the&#xD;
      patellofemoral articulation. Surgeons have strong opinions that both the gap balanced (3) and&#xD;
      measured resection techniques (4) provide superior results. However, in spite of a variety of&#xD;
      literature in support of each technique, little has been done to compare the biomechanics of&#xD;
      each technique. There is a lack of scientifically rigorous assessment of the impact of&#xD;
      surgical technique on femoral rotation, with resultant changes to coronal plane motion. This&#xD;
      prevents the elucidation of potential sources of clinical outcome differences both in the&#xD;
      short term and the long term. The impact of femoral component rotation will be examined by&#xD;
      examining the coronal plane motion. An area impacted by the two TKA techniques is how they&#xD;
      impact coronal plane motion in flexion. There has only been one paper written utilizing&#xD;
      dynamic fluoroscopy to examine the differences in techniques (7). This study examined&#xD;
      lift-off of the lateral component in a comparative study of the two techniques using dynamic&#xD;
      fluoroscopy. This study was limited in nature, with only the ability to quantify the amount&#xD;
      of separation of the femoral component from the tibial component in flexion. It did not&#xD;
      examine the impact of femoral rotation on flexion alignment, or correlate patient&#xD;
      satisfaction scores to the dynamic fluoroscopy findings. With the combination of advanced&#xD;
      imaging to determine component position with respect to bony landmarks (8) as well as dynamic&#xD;
      fluoroscopy, a large area of new information can be gathered. Examination of the impact of&#xD;
      surgical technique with the use of cement to femoral component rotation, and how this impacts&#xD;
      coronal plane motion are achievable goals, with potential for a significant impact on patient&#xD;
      outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">December 20, 2017</start_date>
  <completion_date type="Anticipated">August 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2019</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>Implant migration</measure>
    <time_frame>2 and 6 weeks, 3, 6 and 12 months and 2 years post-operatively</time_frame>
    <description>Comparison of the two surgical techniques using radiostereometric analysis (RSA) imaging</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Contact Kinematics Under Dynamic Conditions</measure>
    <time_frame>3 and 12 months post-operatively</time_frame>
    <description>Comparison of the two surgical techniques using radiostereometric analysis (RSA) imaging</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Patient-reported outcomes (PROs)</measure>
    <time_frame>2 and 6 weeks, 3, 6 and 12 months and 2 years post-operatively</time_frame>
    <description>Comparison of the two surgical techniques using PROs</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <condition>Knee Arthroplasty</condition>
  <arm_group>
    <arm_group_label>Measured resection technique</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Measured resection surgical technique</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gap Balancing Technique</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Gap Balancing surgical technique</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Measured Resection</intervention_name>
    <description>Bony landmarks are used to set femoral component rotation.</description>
    <arm_group_label>Measured resection technique</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Gap Balancing</intervention_name>
    <description>Relies on ligament releases prior to bone cuts.</description>
    <arm_group_label>Gap Balancing Technique</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Over the age of 18 years&#xD;
&#xD;
          -  Primary, unilateral total knee arthroplasty&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of alcoholism&#xD;
&#xD;
          -  Inability to speak or read English (questionnaires are only provided in English)&#xD;
&#xD;
          -  Pregnant women and women with plans to begin a family&#xD;
&#xD;
          -  Inflammatory arthritis -Bilateral total knee arthroplasty&#xD;
&#xD;
          -  Revision total knee arthroplasty&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</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>London Health Sciences Centre - 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>April 2019</verification_date>
  <study_first_submitted>September 19, 2017</study_first_submitted>
  <study_first_submitted_qc>September 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 21, 2017</study_first_posted>
  <last_update_submitted>April 26, 2019</last_update_submitted>
  <last_update_submitted_qc>April 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 29, 2019</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>
  <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>
  <!-- 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/NCT03290170
org study id: 109512
nct id: NCT03290170
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a randomized study comparing the measured resection and gap-balancing surgical
      techniques for total knee replacement (TKR) using a cemented Journey II TKR implant system.
      We will be comparing the two surgical methods by evaluating implant migration using
      radiostereometric analysis (RSA) imaging, evaluating contact kinematics (knee mechanics)
      through RSA under dynamic conditions and comparing patient knee outcome scores.
The stability of a total knee replacement (TKR) surgery depends on soft tissue balance (i.e.
      balance of supporting ligaments) and bony cuts made during surgery that dictate the rotation
      of the femoral (thigh bone) component. Two main techniques predominate for execution of the
      bone cuts and soft tissue balance in TKR. In measured resection, pre-determined bony cuts are
      made and appropriate balance is obtained by judicious soft tissue releases as required. In
      gap balancing, the bony cuts for femoral rotation are driven by the native soft tissues. How
      these two surgical approaches affects the biomechanics of the knee invivo is unclear. The
      purpose of this study is to examine the patello-femoral articulation as well as coronal
      balance of the respective techniques under dynamic conditions. Secondary goals will be to
      examine the impact on femoral component position on changes to coronal plane position through
      a range of flexion/extension. As patellofemoral symptoms and flexion instability are two of
      the most common causes of patient dissatisfaction and revision in the short term, this study
      has the potential to have significant patient impact. The study also has the potential to
      provide information on long term wear potential if articular incongruity is found. TKA is a
      procedure that has good results in most patients, however, up to 20% of patients are not
      satisfied with their outcome. (1) Some of these dissatisfied patients require early revision.
      Early revisions are often attributed to technical issues, such as revisions required for
      instability, patellofemoral symptoms, stiffness or aseptic loosening (2). This highlights the
      impact of surgical technique on clinical outcomes. There are two main philosophies on how to
      complete bone resections and achieve a balanced TKA. The measured resection technique
      utilizes a standard set of bony cuts based on bony landmarks and then balances the knee by
      making judicious soft tissue releases. Component position, particularly femoral rotation, is
      fairly constant with using this technique. Gap balancing adjusts the bony cuts for femoral
      rotation to balance the soft tissues of the knee in flexion, potentially avoiding the
      necessity of soft tissue releases. In contrast to the measured resection technique, gap
      balancing allows for variable rotation of the femoral component. This variability in femoral
      rotation has the potential to impacts the coronal plane motion as well as tracking at the
      patellofemoral articulation. Surgeons have strong opinions that both the gap balanced (3) and
      measured resection techniques (4) provide superior results. However, in spite of a variety of
      literature in support of each technique, little has been done to compare the biomechanics of
      each technique. There is a lack of scientifically rigorous assessment of the impact of
      surgical technique on femoral rotation, with resultant changes to coronal plane motion. This
      prevents the elucidation of potential sources of clinical outcome differences both in the
      short term and the long term. The impact of femoral component rotation will be examined by
      examining the coronal plane motion. An area impacted by the two TKA techniques is how they
      impact coronal plane motion in flexion. There has only been one paper written utilizing
      dynamic fluoroscopy to examine the differences in techniques (7). This study examined
      lift-off of the lateral component in a comparative study of the two techniques using dynamic
      fluoroscopy. This study was limited in nature, with only the ability to quantify the amount
      of separation of the femoral component from the tibial component in flexion. It did not
      examine the impact of femoral rotation on flexion alignment, or correlate patient
      satisfaction scores to the dynamic fluoroscopy findings. With the combination of advanced
      imaging to determine component position with respect to bony landmarks (8) as well as dynamic
      fluoroscopy, a large area of new information can be gathered. Examination of the impact of
      surgical technique with the use of cement to femoral component rotation, and how this impacts
      coronal plane motion are achievable goals, with potential for a significant impact on patient
      outcomes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Implant migration
time frame: 2 and 6 weeks, 3, 6 and 12 months and 2 years post-operatively
description: Comparison of the two surgical techniques using radiostereometric analysis (RSA) imaging
measure: Contact Kinematics Under Dynamic Conditions
time frame: 3 and 12 months post-operatively
description: Comparison of the two surgical techniques using radiostereometric analysis (RSA) imaging
measure: Patient-reported outcomes (PROs)
time frame: 2 and 6 weeks, 3, 6 and 12 months and 2 years post-operatively
description: Comparison of the two surgical techniques using PROs
arm group label: Measured resection technique
arm group type: Experimental
description: Measured resection surgical technique
arm group label: Gap Balancing Technique
arm group type: Experimental
description: Gap Balancing surgical technique
intervention type: Procedure
intervention name: Measured Resection
description: Bony landmarks are used to set femoral component rotation.
arm group label: Measured resection technique
intervention type: Procedure
intervention name: Gap Balancing
description: Relies on ligament releases prior to bone cuts.
arm group label: Gap Balancing Technique
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
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
mesh term: Osteoarthritis, Knee