<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/NCT02976428</url>
  </required_header>
  <id_info>
    <org_study_id>HAGRP01</org_study_id>
    <nct_id>NCT02976428</nct_id>
  </id_info>
  <brief_title>Conventional vs. Sensor Guided Soft Tissue Balancing in TKA RCT</brief_title>
  <official_title>Randomized Controlled Trial of Sensor Guided Knee Balancing Compared to Standard Balancing Technique in Total Knee Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hamilton Health Sciences Corporation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hamilton Health Sciences Corporation</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>
      To ensure a successful outcome after total knee replacement (TKR) soft tissue balance and&#xD;
      proper implant position are very important during the surgical procedure. Soft tissues are&#xD;
      structures in the knee including ligaments, muscles, tendons, and menisci that stabilize and&#xD;
      cushion the knee joint. Lack of proper soft tissue balance or imprecise implant positioning&#xD;
      may result in knee stiffness, pain, instability and limited range of motion (ROM). This may&#xD;
      result in implant failure and the need for revision surgery. As part of standard practice&#xD;
      orthopedic surgeons use a manual knee balancer device to help guide soft tissue balancing to&#xD;
      achieve optimal knee balance. New sensor-assisted technology can provide surgeons with&#xD;
      measurable information to help achieve soft tissue balancing, providing surgeons with&#xD;
      immediate visual feedback during the surgery. This feedback, transmitted wirelessly by the&#xD;
      sensor, gives surgeons electronic information on soft tissue balance and implant position.The&#xD;
      purpose of this study is to determine if a sensor guided soft tissue balancing device&#xD;
      (Verasense) is more effective at balancing the knee during surgery as compared to standard&#xD;
      soft tissue balancing performed with a manual balancer device.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is that of a prospective double-blind randomized controlled trial of patients&#xD;
      presenting for elective primary TKR to compare the outcomes of TKR using conventional soft&#xD;
      tissue balancing with a tensiometer device versus augmenting the soft tissue balancing with&#xD;
      the OrthoSensor VerasenseTM sensor device. The primary outcome will be rate of unbalanced&#xD;
      TKRs based on the quantitative Verasense definition of a well balanced knee defined as a&#xD;
      mediolateral intercompartmental loading difference of ≤15 pounds through ROM. Secondary&#xD;
      outcomes include differences in clinical outcome scores and patient satisfaction among sensor&#xD;
      guided cases and controls.&#xD;
&#xD;
      Patients will be randomized to receive TKR with the Triathlon total knee system (Stryker) in&#xD;
      the case and control group according to: (1) control group with standard balancing techniques&#xD;
      used and sensor data obtained in blinded fashion and not used to balance the TKR implant, (2)&#xD;
      experimental case group with sensor guided balancing where sensor data is used to balance the&#xD;
      TKR within defined parameters.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Actual">September 3, 2020</completion_date>
  <primary_completion_date type="Actual">May 15, 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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of Unbalanced TKRs</measure>
    <time_frame>Intraoperative at end of procedure prior to wound closure</time_frame>
    <description>The rate of unbalanced TKRs will be assessed based on the Verasense sensor device quantitative definition of a well balanced knee. A well balanced knee is defined as having a mediolateral intercompartmental loading difference of ≤15 pounds through ROM [Gustke et al., Walker et al].</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Knee Society Score</measure>
    <time_frame>Preoperative, 6 weeks, 6 months and 1 year postoperative</time_frame>
    <description>Overall clinical function as measured by Knee Society Score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxford Knee Score</measure>
    <time_frame>Preoperative, 6 weeks, 6 months and 1 year postoperative</time_frame>
    <description>Subjective function as measured by Oxford Knee Score patient report outcome measure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction</measure>
    <time_frame>1 year postoperative</time_frame>
    <description>Patient satisfaction with total knee replacement; likert scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical knee function: varus/valgus alignment</measure>
    <time_frame>Preoperative, intraoperative, 6 weeks, 6 months and 1 year postoperative</time_frame>
    <description>Assessment of clinical knee function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical knee function: anteroposterior stability</measure>
    <time_frame>Preoperative, intraoperative, 6 weeks, 6 months and 1 year postoperative</time_frame>
    <description>Assessment of clinical knee function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical knee function: extension lag</measure>
    <time_frame>Preoperative, intraoperative, 6 weeks, 6 months and 1 year postoperative</time_frame>
    <description>Assessment of clinical knee function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical knee function: anatomic alignment</measure>
    <time_frame>Preoperative, intraoperative, 6 weeks, 6 months and 1 year postoperative</time_frame>
    <description>Assessment of clinical knee function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical knee function: knee ROM</measure>
    <time_frame>Preoperative, intraoperative, 6 weeks, 6 months and 1 year postoperative</time_frame>
    <description>Assessment of clinical knee function</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">184</enrollment>
  <condition>Total Knee Arthroplasty</condition>
  <arm_group>
    <arm_group_label>Standard Soft Tissue Balancing</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In the control group where the sensor device is not used in optimization of knee balance and alignment, definitive implants will be cemented in place and the sensor trial inserted using a thickness based on prior standard bearing insert trialing. Peak load data will be captured intraoperatively through full ROM. Custom shims will be affixed to the sensor to replicate thickness of the standard trial. The knee will then be cycled and loads recorded in the medial and lateral compartments at 10, 45 and 90 degrees of flexion. The surgeon will be blinded to the sensor output and the system will be located outside of their visual field.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sensor Guided Soft Tissue Balancing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In the experimental group where the sensor device is used to optimize balance and alignment, the sensor trial will be inserted and tibial baseplate rotated until medial and lateral femoral contact points are parallel on the sensor output. Quantitative balance is defined as a mediolateral intercompartmental loading difference of ≤15 pounds. Flexion balance is achieved when femoral contact point position is within the midposterior third of the tibial insert and intercompartmental loads are balanced. Loads in the medial and lateral compartments are recorded at 10, 45 and 90 degrees. If compartment loads differ by &gt;15 lbs between compartments, unbalanced, further soft tissue release/bone resection will be done to achieve a side to side compartment pressure difference of &lt;15 lbs through ROM.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Sensor Guided Soft Tissue Balancing</intervention_name>
    <description>Primary TKR with soft tissue balancing with a sensor guided device.</description>
    <arm_group_label>Sensor Guided Soft Tissue Balancing</arm_group_label>
    <other_name>Triathlon (Stryker, Mahwah, NJ)</other_name>
    <other_name>Verasense (OrthoSensor Inc., Dania Beach, FL)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Standard Soft Tissue Balancing</intervention_name>
    <description>Primary TKR with soft tissue balancing with a standard of care manual tensiometer device.</description>
    <arm_group_label>Standard Soft Tissue Balancing</arm_group_label>
    <other_name>Triathlon (Stryker, Mahwah, NJ)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients scheduled to undergo elective primary unilateral TKR for a diagnosis of&#xD;
             osteoarthritis to be performed at the study site by the primary investigators&#xD;
&#xD;
          -  Willingness and ability to give informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inflammatory arthropathy&#xD;
&#xD;
          -  Ligament insufficiencies&#xD;
&#xD;
          -  Contraindications to posterior cruciate retaining TKR including: deformity &gt;15 degrees&#xD;
             or fixed-flexion contracture &gt;15 degrees&#xD;
&#xD;
          -  Previous high tibial osteotomy&#xD;
&#xD;
          -  Scheduled to undergo sequential bilateral TKR under one anesthetic&#xD;
&#xD;
          -  Scheduled to undergo revision TKR surgery&#xD;
&#xD;
          -  Neuromuscular disorder limiting mobility or ability to comply with physiotherapy&#xD;
&#xD;
          -  Previous recurrent deep knee infection&#xD;
&#xD;
          -  Major bone loss requiring structural bone graft or augmented components&#xD;
&#xD;
          -  Functionally limiting peripheral vascular disease&#xD;
&#xD;
          -  Patients receiving associated worker's compensation benefits (WSIB)&#xD;
&#xD;
          -  Ethanol/drug abuse/psychiatric disorder&#xD;
&#xD;
          -  Inability or unwillingness to give written informed consent to participate&#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>Mitch Winemaker, MD, FRCSC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hamilton Health Sciences Corporation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hamilton Health Sciences Juravinski Hospital</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8V 1C3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Gustke KA, Golladay GJ, Roche MW, Elson LC, Anderson CR. A new method for defining balance: promising short-term clinical outcomes of sensor-guided TKA. J Arthroplasty. 2014 May;29(5):955-60. doi: 10.1016/j.arth.2013.10.020. Epub 2013 Oct 24.</citation>
    <PMID>24269069</PMID>
  </reference>
  <reference>
    <citation>Walker PS, Meere PA, Bell CP. Effects of surgical variables in balancing of total knee replacements using an instrumented tibial trial. Knee. 2014 Jan;21(1):156-61. doi: 10.1016/j.knee.2013.09.002. Epub 2013 Sep 19.</citation>
    <PMID>24103411</PMID>
  </reference>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>August 31, 2022</last_update_submitted>
  <last_update_submitted_qc>August 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hamilton Health Sciences Corporation</investigator_affiliation>
    <investigator_full_name>Mitch Winemaker</investigator_full_name>
    <investigator_title>Chief Orthopedic Surgery, Hamilton Health Sciences Juravinski Hospital</investigator_title>
  </responsible_party>
  <keyword>knee soft tissue balancing</keyword>
  <keyword>sensor-guided</keyword>
  <keyword>range of motion</keyword>
  <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/NCT02976428
org study id: HAGRP01
nct id: NCT02976428
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To ensure a successful outcome after total knee replacement (TKR) soft tissue balance and
      proper implant position are very important during the surgical procedure. Soft tissues are
      structures in the knee including ligaments, muscles, tendons, and menisci that stabilize and
      cushion the knee joint. Lack of proper soft tissue balance or imprecise implant positioning
      may result in knee stiffness, pain, instability and limited range of motion (ROM). This may
      result in implant failure and the need for revision surgery. As part of standard practice
      orthopedic surgeons use a manual knee balancer device to help guide soft tissue balancing to
      achieve optimal knee balance. New sensor-assisted technology can provide surgeons with
      measurable information to help achieve soft tissue balancing, providing surgeons with
      immediate visual feedback during the surgery. This feedback, transmitted wirelessly by the
      sensor, gives surgeons electronic information on soft tissue balance and implant position.The
      purpose of this study is to determine if a sensor guided soft tissue balancing device
      (Verasense) is more effective at balancing the knee during surgery as compared to standard
      soft tissue balancing performed with a manual balancer device.
The study is that of a prospective double-blind randomized controlled trial of patients
      presenting for elective primary TKR to compare the outcomes of TKR using conventional soft
      tissue balancing with a tensiometer device versus augmenting the soft tissue balancing with
      the OrthoSensor VerasenseTM sensor device. The primary outcome will be rate of unbalanced
      TKRs based on the quantitative Verasense definition of a well balanced knee defined as a
      mediolateral intercompartmental loading difference of ≤15 pounds through ROM. Secondary
      outcomes include differences in clinical outcome scores and patient satisfaction among sensor
      guided cases and controls.

      Patients will be randomized to receive TKR with the Triathlon total knee system (Stryker) in
      the case and control group according to: (1) control group with standard balancing techniques
      used and sensor data obtained in blinded fashion and not used to balance the TKR implant, (2)
      experimental case group with sensor guided balancing where sensor data is used to balance the
      TKR within defined parameters.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Rate of Unbalanced TKRs
time frame: Intraoperative at end of procedure prior to wound closure
description: The rate of unbalanced TKRs will be assessed based on the Verasense sensor device quantitative definition of a well balanced knee. A well balanced knee is defined as having a mediolateral intercompartmental loading difference of ≤15 pounds through ROM [Gustke et al., Walker et al].
measure: Knee Society Score
time frame: Preoperative, 6 weeks, 6 months and 1 year postoperative
description: Overall clinical function as measured by Knee Society Score
measure: Oxford Knee Score
time frame: Preoperative, 6 weeks, 6 months and 1 year postoperative
description: Subjective function as measured by Oxford Knee Score patient report outcome measure
measure: Patient satisfaction
time frame: 1 year postoperative
description: Patient satisfaction with total knee replacement; likert scale
measure: Clinical knee function: varus/valgus alignment
time frame: Preoperative, intraoperative, 6 weeks, 6 months and 1 year postoperative
description: Assessment of clinical knee function
measure: Clinical knee function: anteroposterior stability
time frame: Preoperative, intraoperative, 6 weeks, 6 months and 1 year postoperative
description: Assessment of clinical knee function
measure: Clinical knee function: extension lag
time frame: Preoperative, intraoperative, 6 weeks, 6 months and 1 year postoperative
description: Assessment of clinical knee function
measure: Clinical knee function: anatomic alignment
time frame: Preoperative, intraoperative, 6 weeks, 6 months and 1 year postoperative
description: Assessment of clinical knee function
measure: Clinical knee function: knee ROM
time frame: Preoperative, intraoperative, 6 weeks, 6 months and 1 year postoperative
description: Assessment of clinical knee function
arm group label: Standard Soft Tissue Balancing
arm group type: Active Comparator
description: In the control group where the sensor device is not used in optimization of knee balance and alignment, definitive implants will be cemented in place and the sensor trial inserted using a thickness based on prior standard bearing insert trialing. Peak load data will be captured intraoperatively through full ROM. Custom shims will be affixed to the sensor to replicate thickness of the standard trial. The knee will then be cycled and loads recorded in the medial and lateral compartments at 10, 45 and 90 degrees of flexion. The surgeon will be blinded to the sensor output and the system will be located outside of their visual field.
arm group label: Sensor Guided Soft Tissue Balancing
arm group type: Experimental
description: In the experimental group where the sensor device is used to optimize balance and alignment, the sensor trial will be inserted and tibial baseplate rotated until medial and lateral femoral contact points are parallel on the sensor output. Quantitative balance is defined as a mediolateral intercompartmental loading difference of ≤15 pounds. Flexion balance is achieved when femoral contact point position is within the midposterior third of the tibial insert and intercompartmental loads are balanced. Loads in the medial and lateral compartments are recorded at 10, 45 and 90 degrees. If compartment loads differ by >15 lbs between compartments, unbalanced, further soft tissue release/bone resection will be done to achieve a side to side compartment pressure difference of <15 lbs through ROM.
intervention type: Procedure
intervention name: Sensor Guided Soft Tissue Balancing
description: Primary TKR with soft tissue balancing with a sensor guided device.
arm group label: Sensor Guided Soft Tissue Balancing
other name: Triathlon (Stryker, Mahwah, NJ)
other name: Verasense (OrthoSensor Inc., Dania Beach, FL)
intervention type: Procedure
intervention name: Standard Soft Tissue Balancing
description: Primary TKR with soft tissue balancing with a standard of care manual tensiometer device.
arm group label: Standard Soft Tissue Balancing
other name: Triathlon (Stryker, Mahwah, NJ)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mitch Winemaker, MD, FRCSC
role: Principal Investigator
affiliation: Hamilton Health Sciences Corporation
facility: 
country: Canada
citation: Gustke KA, Golladay GJ, Roche MW, Elson LC, Anderson CR. A new method for defining balance: promising short-term clinical outcomes of sensor-guided TKA. J Arthroplasty. 2014 May;29(5):955-60. doi: 10.1016/j.arth.2013.10.020. Epub 2013 Oct 24.
PMID: 24269069
citation: Walker PS, Meere PA, Bell CP. Effects of surgical variables in balancing of total knee replacements using an instrumented tibial trial. Knee. 2014 Jan;21(1):156-61. doi: 10.1016/j.knee.2013.09.002. Epub 2013 Sep 19.
PMID: 24103411
responsible party type: Principal Investigator
investigator affiliation: Hamilton Health Sciences Corporation
investigator full name: Mitch Winemaker
investigator title: Chief Orthopedic Surgery, Hamilton Health Sciences Juravinski Hospital
sharing ipd: No