<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/NCT03286868</url>
  </required_header>
  <id_info>
    <org_study_id>TKA VERA</org_study_id>
    <nct_id>NCT03286868</nct_id>
  </id_info>
  <brief_title>Balancing Kinematically Aligned Total Knee Replacements During Total Primary Knee Arthroplasty Using Verasense</brief_title>
  <official_title>Balancing Kinematically Aligned Total Knee Replacements During Total Primary Knee Arthroplasty Using Verasense</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nova Scotia Health Authority</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nova Scotia Health Authority</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Total Knee Replacement (TKR) is an operation to help with the pain and decreased function&#xD;
      that happens with end stage arthritis of the knee. This operation has been shown to be very&#xD;
      successful at relieving pain and improving patient mobility; however, some studies have shown&#xD;
      that up to 20% of TKR recipients are not happy with their knee replacement.&#xD;
&#xD;
      All of the reasons why some patients are not pleased with the outcome of surgery are not&#xD;
      known, but one of the possible causes is the way the implants are placed, or aligned, during&#xD;
      surgery. Most TKRs are aligned in a fashion that the bones in the leg are completely straight&#xD;
      after surgery. This is known as mechanically aligning a TKR. A different alignment method&#xD;
      known as kinematic alignment respects the natural bow legged or knock kneed alignment of the&#xD;
      patient. It is hoped that kinematically aligning a knee replacement will improve how the knee&#xD;
      feels to the patient and therefore improve their satisfaction.&#xD;
&#xD;
      Another potential factor affecting the outcomes of TKR is obtaining optimal soft tissue&#xD;
      balance. The challenge with balancing a TKR is that traditional operative techniques rely on&#xD;
      subjective feel of the knee stability during surgery. The balance or tension in the knee can&#xD;
      however be objectively measured using specialized intraoperative pressure sensing devices.&#xD;
&#xD;
      The purpose of this study is to assess the impact of kinematically aligned TKR on the&#xD;
      pressures measured by Verasense during total knee replacements. The study will also determine&#xD;
      if differences in the pressure measured during TKR surgery impact patient outcomes after&#xD;
      surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of this research study is to evaluate the use of the Verasense pressure&#xD;
      sensor to optimize intraoperative implant pressures/balance during computer assisted TKR&#xD;
      utilizing pre- and postoperative kinematic alignment techniques.&#xD;
&#xD;
      This is a randomized controlled trial where 60 patients will undergo a kinematically aligned&#xD;
      TKR using VERASENSE pressure sensors. Patients will be randomly assigned to either TKR&#xD;
      balancing using VERASENSE data (TKR-V), or TKR using standard surgeon decision making in&#xD;
      balancing (TKR only). In the TKR only group, the surgeon will perform the surgery while&#xD;
      blinded to the data output of the VERASENSE sensor and will use standard surgeon decision&#xD;
      making to balance the TKR. In the second group, TKR-V, the surgeon will not be blinded to the&#xD;
      data output of the VERASENSE sensor and will use the data to influence how they balance the&#xD;
      TKR.&#xD;
&#xD;
      The primary outcome measure will be postoperative kinematic gait assessment to evaluate the&#xD;
      effect of optimizing patient soft tissue balance using Verasense pressure sensor. Secondary&#xD;
      outcomes will include the number of intraoperative soft tissue releases, and results of&#xD;
      health outcome questionnaires.&#xD;
&#xD;
      Research Questions:&#xD;
&#xD;
        1. What are the differences and similarities between the subjective surgeon-balanced group&#xD;
           (standard of care) compared to the objective Verasense-balanced group?&#xD;
&#xD;
        2. Is there a difference in the number of &quot;poorly balanced&quot; knees between the&#xD;
           surgeon-balanced kinematically aligned groups compared to the Verasense-balanced&#xD;
           kinematically aligned group?&#xD;
&#xD;
        3. Is there an effect of preoperative alignment on ligament balancing using Verasense&#xD;
           pressure sensor?&#xD;
&#xD;
        4. Is there a difference in the number of ligament releases required to optimize soft&#xD;
           tissue balance between the Verasense pressure sensor aided total knee replacements and&#xD;
           those balanced by the surgeon alone?&#xD;
&#xD;
        5. What is the effect of optimizing patient soft tissue balance with Verasenes pressure&#xD;
           sensor on gait parameters measured with Knee KG?&#xD;
&#xD;
      ANOVA will be used to examine pre and post-operative differences in specific features of knee&#xD;
      kinematics between groups. Primary and secondary outcomes will be evaluated using listings&#xD;
      and summary statistics. Improvement in pain and function will be analyzed using t-test or&#xD;
      Wilcoxon Rank tests.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">March 2018</start_date>
  <completion_date type="Anticipated">January 2020</completion_date>
  <primary_completion_date type="Anticipated">January 2020</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>
    <intervention_model_description>Randomized controlled trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>gait assessment</measure>
    <time_frame>2 years</time_frame>
    <description>kinematic gait assessment using KneeKG</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>EQ-5D patient reported outcome measure</measure>
    <time_frame>2 years</time_frame>
    <description>Health status measure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ligament releases</measure>
    <time_frame>Intra-operative</time_frame>
    <description>Number of ligament releases required during knee replacement</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Osteo Arthritis Knee</condition>
  <arm_group>
    <arm_group_label>Standard of Care TKA</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Standard of Care Total Knee Arthroplasty (TKA): No data from the Verasense sensor will be used to influence the surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TKA with Verasense sensor</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Total Knee Arthroplasty (TKA) with Verasense sensor for Intraoperative Balancing: Surgeon will attempt to optimize the intraoperative pressures using the data from the Verasense sensor</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Total Knee Arthroplasty</intervention_name>
    <description>Total Knee Arthroplasty</description>
    <arm_group_label>Standard of Care TKA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Total Knee Arthroplasty with Verasense sensor</intervention_name>
    <description>Total Knee Arthroplasty with Verasense sensor</description>
    <arm_group_label>TKA with Verasense sensor</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Symptomatic arthritis of the knee indicating primary total knee arthroplasty&#xD;
&#xD;
          -  Between the ages of 21 and 80 inclusive&#xD;
&#xD;
          -  Patients willing and able to comply with follow-up requirements and self-evaluations&#xD;
&#xD;
          -  Ability to give informed consent&#xD;
&#xD;
          -  Varus alignment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients less than 21 years of age, or 81 years of age and older&#xD;
&#xD;
          -  Unable to provide consent&#xD;
&#xD;
          -  BMI &gt;45&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Patients with inflammatory arthritis, posttraumatic osteoarthritis, post high tibial&#xD;
             osteotomy, or arthritis due to sepsis will be excluded.&#xD;
&#xD;
          -  Active or prior infection&#xD;
&#xD;
          -  Medical condition precluding major surgery&#xD;
&#xD;
          -  Severe osteoporosis or osteopenia&#xD;
&#xD;
          -  Neuromuscular impairment&#xD;
&#xD;
          -  Significant co-morbidity affecting ability to ambulate&#xD;
&#xD;
          -  Valgus alignment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>August 30, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <last_update_submitted>February 5, 2018</last_update_submitted>
  <last_update_submitted_qc>February 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nova Scotia Health Authority</investigator_affiliation>
    <investigator_full_name>Glen Richardson</investigator_full_name>
    <investigator_title>Principal Investigator</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/NCT03286868
org study id: TKA VERA
nct id: NCT03286868
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
Total Knee Replacement (TKR) is an operation to help with the pain and decreased function
      that happens with end stage arthritis of the knee. This operation has been shown to be very
      successful at relieving pain and improving patient mobility; however, some studies have shown
      that up to 20% of TKR recipients are not happy with their knee replacement.

      All of the reasons why some patients are not pleased with the outcome of surgery are not
      known, but one of the possible causes is the way the implants are placed, or aligned, during
      surgery. Most TKRs are aligned in a fashion that the bones in the leg are completely straight
      after surgery. This is known as mechanically aligning a TKR. A different alignment method
      known as kinematic alignment respects the natural bow legged or knock kneed alignment of the
      patient. It is hoped that kinematically aligning a knee replacement will improve how the knee
      feels to the patient and therefore improve their satisfaction.

      Another potential factor affecting the outcomes of TKR is obtaining optimal soft tissue
      balance. The challenge with balancing a TKR is that traditional operative techniques rely on
      subjective feel of the knee stability during surgery. The balance or tension in the knee can
      however be objectively measured using specialized intraoperative pressure sensing devices.

      The purpose of this study is to assess the impact of kinematically aligned TKR on the
      pressures measured by Verasense during total knee replacements. The study will also determine
      if differences in the pressure measured during TKR surgery impact patient outcomes after
      surgery.
The primary objective of this research study is to evaluate the use of the Verasense pressure
      sensor to optimize intraoperative implant pressures/balance during computer assisted TKR
      utilizing pre- and postoperative kinematic alignment techniques.

      This is a randomized controlled trial where 60 patients will undergo a kinematically aligned
      TKR using VERASENSE pressure sensors. Patients will be randomly assigned to either TKR
      balancing using VERASENSE data (TKR-V), or TKR using standard surgeon decision making in
      balancing (TKR only). In the TKR only group, the surgeon will perform the surgery while
      blinded to the data output of the VERASENSE sensor and will use standard surgeon decision
      making to balance the TKR. In the second group, TKR-V, the surgeon will not be blinded to the
      data output of the VERASENSE sensor and will use the data to influence how they balance the
      TKR.

      The primary outcome measure will be postoperative kinematic gait assessment to evaluate the
      effect of optimizing patient soft tissue balance using Verasense pressure sensor. Secondary
      outcomes will include the number of intraoperative soft tissue releases, and results of
      health outcome questionnaires.

      Research Questions:

        1. What are the differences and similarities between the subjective surgeon-balanced group
           (standard of care) compared to the objective Verasense-balanced group?

        2. Is there a difference in the number of "poorly balanced" knees between the
           surgeon-balanced kinematically aligned groups compared to the Verasense-balanced
           kinematically aligned group?

        3. Is there an effect of preoperative alignment on ligament balancing using Verasense
           pressure sensor?

        4. Is there a difference in the number of ligament releases required to optimize soft
           tissue balance between the Verasense pressure sensor aided total knee replacements and
           those balanced by the surgeon alone?

        5. What is the effect of optimizing patient soft tissue balance with Verasenes pressure
           sensor on gait parameters measured with Knee KG?

      ANOVA will be used to examine pre and post-operative differences in specific features of knee
      kinematics between groups. Primary and secondary outcomes will be evaluated using listings
      and summary statistics. Improvement in pain and function will be analyzed using t-test or
      Wilcoxon Rank tests.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized controlled trial
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: gait assessment
time frame: 2 years
description: kinematic gait assessment using KneeKG
measure: EQ-5D patient reported outcome measure
time frame: 2 years
description: Health status measure
measure: Ligament releases
time frame: Intra-operative
description: Number of ligament releases required during knee replacement
arm group label: Standard of Care TKA
arm group type: Placebo Comparator
description: Standard of Care Total Knee Arthroplasty (TKA): No data from the Verasense sensor will be used to influence the surgery
arm group label: TKA with Verasense sensor
arm group type: Experimental
description: Total Knee Arthroplasty (TKA) with Verasense sensor for Intraoperative Balancing: Surgeon will attempt to optimize the intraoperative pressures using the data from the Verasense sensor
intervention type: Procedure
intervention name: Total Knee Arthroplasty
description: Total Knee Arthroplasty
arm group label: Standard of Care TKA
intervention type: Device
intervention name: Total Knee Arthroplasty with Verasense sensor
description: Total Knee Arthroplasty with Verasense sensor
arm group label: TKA with Verasense sensor
criteria: 
gender: All
minimum age: 21 Years
maximum age: 80 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Nova Scotia Health Authority
investigator full name: Glen Richardson
investigator title: Principal Investigator
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee