<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/NCT02256904</url>
  </required_header>
  <id_info>
    <org_study_id>HMR 01</org_study_id>
    <nct_id>NCT02256904</nct_id>
  </id_info>
  <brief_title>RSA and Clinical Comparison of Anatomical and Mechanical Alignment in Total Knee Replacement</brief_title>
  <official_title>Biomechanical and Radiostereometric Analysis of the GMK Sphere Primary Total Knee Replacement. A Randomized, Double Blind Comparison of Anatomical Versus Mechanical Alignment in Total Knee Replacement.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maisonneuve-Rosemont Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Maisonneuve-Rosemont Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Current practice in orthopedics is to recommend TKA implantation with the femoral and tibial&#xD;
      components perpendicular to their mechanical axis. Therefore, current surgical technique does&#xD;
      not replicate natural knee anatomy and biomechanics. An alternative alignment method that&#xD;
      attempts to replicate the kinematics of the knee is &quot; kinematic alignment &quot;. The principle&#xD;
      behind kinematic alignment is placement of the TKA components so that the orthogonal 3-D&#xD;
      orientation of the 3 axes that describe normal knee kinematics is restored to that of the&#xD;
      prearthritic knee. Theoretical benefits of kinematic alignment include less ligamentous&#xD;
      release to balance the knee intra-operatively, more rapid recovery, better range of motion&#xD;
      (ROM), less post-operative pain, better knee biomechanics, and improved patient satisfaction.&#xD;
      However, a major concern is that there are no mid- or long-term data on implant survivorship&#xD;
      (absence of loosening) in TKA based on &quot;anatomical&quot; implantation. The investigators propose&#xD;
      to compare the clinical results of TKA implanted with mechanical alignment (standard&#xD;
      practice) to kinematic alignment, in a double-blind, randomized trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Problem to be addressed Knee osteoarthritis is a degenerative joint disease that is very&#xD;
      prevalent in the general population and can cause significant functional impairment. Total&#xD;
      knee arthroplasty (TKA) is the definitive treatment of choice, but rarely accomplishes&#xD;
      complete restoration of natural knee biomechanics. Various factors may influence&#xD;
      post-operative function: pre-operative state of the knee, patient age, implant position, and&#xD;
      design. The natural lower limb anatomy presents a femoral joint surface that is slightly&#xD;
      valgus according to its mechanical axis (1-5 degrees) and a tibial joint surface that is&#xD;
      slightly varus (1-4 degrees). This combination results in an oblique joint line orientation&#xD;
      (1-3 degrees) and a mechanical axis passing near the centre of the knee joint (line between&#xD;
      the centre of the femoral head and the centre of the ankle). Natural lower limb alignment&#xD;
      helps balancing load between the internal and external knee compartments at heel strike.&#xD;
      Current practice in orthopedics is to recommend TKA implantation with the femoral and tibial&#xD;
      components perpendicular to their mechanical axis (0 degrees). In addition, in order to&#xD;
      maintain ligament balance (a rectangular space) in flexion, external rotation of the femoral&#xD;
      implant is suggested (2-5 degrees according to posterior femoral condyle surfaces).&#xD;
      Therefore, current surgical technique does not replicate natural knee anatomy and&#xD;
      biomechanics. An alternative alignment method that attempts to replicate the kinematics of&#xD;
      the knee is &quot; kinematic alignment &quot;. The principle behind kinematic alignment is placement of&#xD;
      the TKA components so that the orthogonal 3-D orientation of the 3 axes that describe normal&#xD;
      knee kinematics is restored to that of the prearthritic knee. Theoretical benefits of&#xD;
      kinematic alignment include less ligamentous release to balance the knee intra-operatively,&#xD;
      more rapid recovery, better range of motion (ROM), less post-operative pain, better knee&#xD;
      biomechanics, and improved patient satisfaction. However, a major concern is that there are&#xD;
      no mid- or long-term data on implant survivorship (absence of loosening) in TKA based on&#xD;
      &quot;anatomical&quot; implantation. Because the anatomical alignment differs from the classic&#xD;
      mechanical alignment, some authors raised concerns regarding mid-term implant stability with&#xD;
      the anatomical implantation technique.&#xD;
&#xD;
      We propose to compare the clinical results of TKA implanted with mechanical alignment&#xD;
      (standard practice) to kinematic alignment, in a double-blind, randomized trial. To&#xD;
      standardize surgical technique and minimize potential bias, both procedures will be&#xD;
      undertaken with personalized instruments built by Medacta, based on each patient's CT-scan.&#xD;
&#xD;
      There are 2 primary objectives of this research. First, implant stability with respect to&#xD;
      bone will be measured over time by RSA, and long-term survivorship will be estimated. Second,&#xD;
      we will determine if anatomical implantation provides clinical advantages, with respect to&#xD;
      knee kinematic analysis, functional performance tests and validated self-reported&#xD;
      questionnaires on pain, function and stiffness.&#xD;
&#xD;
      Radiostereometric analysis (RSA) RSA, first developed in Lund, Sweden, is a radiographic&#xD;
      technique for accurately assessing implant position relative to host bone. RSA is the gold&#xD;
      standard for measuring implant stability in the short-term and predicting implant&#xD;
      survivorship in the long-term. It has been implemented for several decades and its safety is&#xD;
      well documented. RSA is 10 times more accurate than conventional radiography in analyzing&#xD;
      implant migration patterns. Patterns of micromigration exhibited by various prostheses and&#xD;
      fixation techniques within the first post-operative year has been shown to predict long-term&#xD;
      component fixation to bone.&#xD;
&#xD;
      Knee biomechanical evaluation Estimating the therapeutic efficacy of knee TKA is subjective&#xD;
      in current clinical practice because methods of functional biomechanics assessment are&#xD;
      complex and difficult to apply. It was suggested that gait measurements should be monitored&#xD;
      after surgery for patients with knee osteoarthritis (OA) to evaluate treatment outcome and&#xD;
      recovery. KneeKGTM (Emovi Inc., Laval, Quebec, Canada), a simple and minimally-invasive&#xD;
      method of measuring 3D knee kinematics, has been developed and is now available commercially.&#xD;
      In this system, motion sensors are quasi-rigidly attached to the leg with a non-invasive&#xD;
      ancillary system, which reduces errors in skin movement in relation to bone. This measurement&#xD;
      tool has been validated by satisfactory assessment of its accuracy and the reproducibility of&#xD;
      femoro-tibial 3D kinematics during gait.&#xD;
&#xD;
      Principal research questions&#xD;
&#xD;
        -  Compare the migration between anatomically- and mechanically-aligned implants at 2 years&#xD;
           and predict the long-term survivorship of total knee prostheses inserted with these two&#xD;
           techniques.&#xD;
&#xD;
        -  Compare the clinical results of anatomical and mechanical total knee alignment with self&#xD;
           reported pain, function and stiffness questionnaire scores.&#xD;
&#xD;
        -  Compare knee kinematics between the 2 groups and identify biomechanical markers that&#xD;
           explain subjective differences (if found with clinical scores).&#xD;
&#xD;
        -  Compare kinematics measured with the 2 techniques to those of asymptomatic knees.&#xD;
&#xD;
        -  Determine if anatomical alignment offers some technical benefits (reduced&#xD;
           intra-operative ligament balance and ligaments releases) compared to a mechanical&#xD;
           alignment technique.&#xD;
&#xD;
        -  Compare post-operative rehabilitation in both groups (flexion, extension, straight leg&#xD;
           raising, walking without assistance, etc.).&#xD;
&#xD;
      Hypothesis TKA implanted with with anatomical alignment will provide better clinical outcomes&#xD;
      and knee kinematics closer to normal than TKA implanted with a mechanical alignment&#xD;
      technique, Implant longevity will show similar micro migration patterns between the two&#xD;
      groups as measured by RSA up to 2 years after implantation thereby predicting that long-term&#xD;
      implant survivorship will be similar in both groups.&#xD;
&#xD;
      Why is this trial needed now? Current technological advances in knee arthroplasty surgery&#xD;
      have allowed surgeons to implant TKA with considerable accuracy. We however are not sure if&#xD;
      the position we are placing the knee in is the &quot;correct&quot; position for most patients. It is&#xD;
      thought that the relatively high percentage of patients that are not completely satisfied&#xD;
      with the outcome of their knee replacement may have the implants in a suboptimal position for&#xD;
      that individual patient. The traditional mechanical alignment may not be the optimal position&#xD;
      for these patients. The anatomical alignment technique may reduce the percentage of&#xD;
      dissatisfied patients. Implant companies with this technology are currently marketing this to&#xD;
      surgeons and patients without clinical data to support this claim. There is also the&#xD;
      possibility that placing an artificial knee joint in an anatomic position may impart a&#xD;
      negative impact on longevity of the implant, thus increasing early revision rates and the&#xD;
      significant health costs associated with this. Thus it becomes mandatory to evaluate this new&#xD;
      technology before its widespread adoption in clinical practice to determine the real benefits&#xD;
      or disadvantages of changing from a successful clinical practice (mechanical alignment) used&#xD;
      over the last 40 years.&#xD;
&#xD;
      Trial results This proposed clinical trial will have a direct impact on patient care if it&#xD;
      demonstrates that anatomical alignment TKA provides better clinical results than mechanical&#xD;
      alignment TKA and similar migration patterns measured by RSA. Then the use of anatomic&#xD;
      alignment may become the gold standard for TKA procedures. Lacking accurate investigation and&#xD;
      surgical tools, anatomical alignment was abandoned in the early TKA era. Mechanical alignment&#xD;
      was selected to minimize errors and secondary failures. With novel technologies (personalized&#xD;
      instruments built on MRI), anatomical alignment might be the best way to replicate knee&#xD;
      biomechanics and improve patient outcomes after TKA. The proposed study will allow us to&#xD;
      establish the real value of anatomical alignment and its safety.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">April 13, 2015</start_date>
  <completion_date type="Anticipated">January 2025</completion_date>
  <primary_completion_date type="Actual">October 15, 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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Component migration measured with Radiostereophotometry</measure>
    <time_frame>2 years</time_frame>
    <description>In the first 40 cases (20 in each group), we will compare the migration with a RSA system between anatomically- and mechanically-aligned implants at 2 years and predict the long-term survivorship of total knee prostheses inserted with these two techniques.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical scores</measure>
    <time_frame>2 years</time_frame>
    <description>In all randomized subject, we will compare the clinical results of anatomical and mechanical total knee alignment with self reported pain, function and stiffness questionnaire scores. Validated clinical scores will be used: WOMAC, KOOS and SF-12</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee kinematics measured with the Knee KG (Emovi inc.)</measure>
    <time_frame>2 years</time_frame>
    <description>In all randomized cases, we will compare post operative knee kinematics with the Knee KG system (Emovi inc) between the 2 groups and identify biomechanical markers that explain subjective differences (if found with clinical scores).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Technical benefits</measure>
    <time_frame>1 month</time_frame>
    <description>In all randomized cases, we will determine if anatomical alignment offers some technical benefits (reduced intra-operative ligament balance and ligaments releases) compared to a mechanical alignment technique.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rehabilitation</measure>
    <time_frame>1 month</time_frame>
    <description>In all cases, we will compare post-operative rehabilitation in both groups (flexion, extension, straight leg raising, walking without assistance, etc.).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">134</enrollment>
  <condition>Personal Satisfaction</condition>
  <condition>Genu Varum</condition>
  <arm_group>
    <arm_group_label>Anatomical</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>67 subjects will be randomized to receive an Anatomical TKA with the My knee instruments and a GMK sphere device.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mechanical</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>67 subjects will be randomized to receive a Mechanical TKA with the My knee instruments and the GMK sphere device.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Anatomical TKA</intervention_name>
    <description>Personalized Medacta plastic cutting blocks will be manufactured according to patient Ct-scan.The anatomical cutting blocks will be design to resurface the femoral and tibial bones to restore each patient's pre-arthritic anatomy within specific margins: maximum of 5 degrees valgus/varus tibial or femoral cut and overall lower limb alignment within +/-3 degrees of varus/valgus). GMK sphere TKA will be implanted using the manufactured cutting blocks.</description>
    <arm_group_label>Anatomical</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Mechanical TKA</intervention_name>
    <description>Personalized Medacta plastic cutting blocks will be manufactured according to patient Ct-scan. In the mechanical group, femoral and tibial cutting blocks will be designed for a 0-degree angle according to the mechanical axis. Femoral rotation will be aligned with the femoral trans-epicondylar axis. Tibial rotation will follow femoral rotation. GMK sphere TKA will be implanted using the manufactured cutting blocks.</description>
    <arm_group_label>Mechanical</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient qualifies for primary TKA&#xD;
&#xD;
          2. Patient understands the study conditions&#xD;
&#xD;
          3. Patient is capable of giving informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Other joint damage of the lower limbs&#xD;
&#xD;
          2. Extra-articular knee deformation of the lower limb&#xD;
&#xD;
          3. Hip arthroplasty on the surgical side&#xD;
&#xD;
          4. Contraindication to CT-scan&#xD;
&#xD;
          5. Acute or chronic infection of the lower limb&#xD;
&#xD;
          6. Progressive local or systemic infection&#xD;
&#xD;
          7. Alcohol or drug abuse&#xD;
&#xD;
          8. Psychiatric illness/mental disorder&#xD;
&#xD;
          9. Pregnancy&#xD;
&#xD;
         10. Less than 18 years of age&#xD;
&#xD;
         11. Known allergy to the implant materials&#xD;
&#xD;
         12. Muscular loss, neuromuscular disease or vascular deficiency of the affected limb&#xD;
             making the operation unjustifiable&#xD;
&#xD;
         13. Any neuromuscular disorder&#xD;
&#xD;
         14. Severe instability secondary to advanced destruction of osteochondral structures or&#xD;
             loss of integrity of the lateral ligament&#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>Pascal Andre Vendittoli, MD, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Research Director and surgeon</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hopital Maisonneuve Rosemont</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H1T 2M4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>September 30, 2014</study_first_submitted>
  <study_first_submitted_qc>October 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 6, 2014</study_first_posted>
  <last_update_submitted>March 16, 2023</last_update_submitted>
  <last_update_submitted_qc>March 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Maisonneuve-Rosemont Hospital</investigator_affiliation>
    <investigator_full_name>Pascal André Vendittoli</investigator_full_name>
    <investigator_title>clinical researcher, MD, MSc, FRCSC</investigator_title>
  </responsible_party>
  <keyword>Alignment</keyword>
  <keyword>Kinematic</keyword>
  <keyword>knee</keyword>
  <keyword>satisfaction</keyword>
  <keyword>function</keyword>
  <keyword>survivorship</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Genu Varum</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/NCT02256904
org study id: HMR 01
nct id: NCT02256904
lead sponsor: 
has dmc: No
Current practice in orthopedics is to recommend TKA implantation with the femoral and tibial
      components perpendicular to their mechanical axis. Therefore, current surgical technique does
      not replicate natural knee anatomy and biomechanics. An alternative alignment method that
      attempts to replicate the kinematics of the knee is " kinematic alignment ". The principle
      behind kinematic alignment is placement of the TKA components so that the orthogonal 3-D
      orientation of the 3 axes that describe normal knee kinematics is restored to that of the
      prearthritic knee. Theoretical benefits of kinematic alignment include less ligamentous
      release to balance the knee intra-operatively, more rapid recovery, better range of motion
      (ROM), less post-operative pain, better knee biomechanics, and improved patient satisfaction.
      However, a major concern is that there are no mid- or long-term data on implant survivorship
      (absence of loosening) in TKA based on "anatomical" implantation. The investigators propose
      to compare the clinical results of TKA implanted with mechanical alignment (standard
      practice) to kinematic alignment, in a double-blind, randomized trial.
Problem to be addressed Knee osteoarthritis is a degenerative joint disease that is very
      prevalent in the general population and can cause significant functional impairment. Total
      knee arthroplasty (TKA) is the definitive treatment of choice, but rarely accomplishes
      complete restoration of natural knee biomechanics. Various factors may influence
      post-operative function: pre-operative state of the knee, patient age, implant position, and
      design. The natural lower limb anatomy presents a femoral joint surface that is slightly
      valgus according to its mechanical axis (1-5 degrees) and a tibial joint surface that is
      slightly varus (1-4 degrees). This combination results in an oblique joint line orientation
      (1-3 degrees) and a mechanical axis passing near the centre of the knee joint (line between
      the centre of the femoral head and the centre of the ankle). Natural lower limb alignment
      helps balancing load between the internal and external knee compartments at heel strike.
      Current practice in orthopedics is to recommend TKA implantation with the femoral and tibial
      components perpendicular to their mechanical axis (0 degrees). In addition, in order to
      maintain ligament balance (a rectangular space) in flexion, external rotation of the femoral
      implant is suggested (2-5 degrees according to posterior femoral condyle surfaces).
      Therefore, current surgical technique does not replicate natural knee anatomy and
      biomechanics. An alternative alignment method that attempts to replicate the kinematics of
      the knee is " kinematic alignment ". The principle behind kinematic alignment is placement of
      the TKA components so that the orthogonal 3-D orientation of the 3 axes that describe normal
      knee kinematics is restored to that of the prearthritic knee. Theoretical benefits of
      kinematic alignment include less ligamentous release to balance the knee intra-operatively,
      more rapid recovery, better range of motion (ROM), less post-operative pain, better knee
      biomechanics, and improved patient satisfaction. However, a major concern is that there are
      no mid- or long-term data on implant survivorship (absence of loosening) in TKA based on
      "anatomical" implantation. Because the anatomical alignment differs from the classic
      mechanical alignment, some authors raised concerns regarding mid-term implant stability with
      the anatomical implantation technique.

      We propose to compare the clinical results of TKA implanted with mechanical alignment
      (standard practice) to kinematic alignment, in a double-blind, randomized trial. To
      standardize surgical technique and minimize potential bias, both procedures will be
      undertaken with personalized instruments built by Medacta, based on each patient's CT-scan.

      There are 2 primary objectives of this research. First, implant stability with respect to
      bone will be measured over time by RSA, and long-term survivorship will be estimated. Second,
      we will determine if anatomical implantation provides clinical advantages, with respect to
      knee kinematic analysis, functional performance tests and validated self-reported
      questionnaires on pain, function and stiffness.

      Radiostereometric analysis (RSA) RSA, first developed in Lund, Sweden, is a radiographic
      technique for accurately assessing implant position relative to host bone. RSA is the gold
      standard for measuring implant stability in the short-term and predicting implant
      survivorship in the long-term. It has been implemented for several decades and its safety is
      well documented. RSA is 10 times more accurate than conventional radiography in analyzing
      implant migration patterns. Patterns of micromigration exhibited by various prostheses and
      fixation techniques within the first post-operative year has been shown to predict long-term
      component fixation to bone.

      Knee biomechanical evaluation Estimating the therapeutic efficacy of knee TKA is subjective
      in current clinical practice because methods of functional biomechanics assessment are
      complex and difficult to apply. It was suggested that gait measurements should be monitored
      after surgery for patients with knee osteoarthritis (OA) to evaluate treatment outcome and
      recovery. KneeKGTM (Emovi Inc., Laval, Quebec, Canada), a simple and minimally-invasive
      method of measuring 3D knee kinematics, has been developed and is now available commercially.
      In this system, motion sensors are quasi-rigidly attached to the leg with a non-invasive
      ancillary system, which reduces errors in skin movement in relation to bone. This measurement
      tool has been validated by satisfactory assessment of its accuracy and the reproducibility of
      femoro-tibial 3D kinematics during gait.

      Principal research questions

        -  Compare the migration between anatomically- and mechanically-aligned implants at 2 years
           and predict the long-term survivorship of total knee prostheses inserted with these two
           techniques.

        -  Compare the clinical results of anatomical and mechanical total knee alignment with self
           reported pain, function and stiffness questionnaire scores.

        -  Compare knee kinematics between the 2 groups and identify biomechanical markers that
           explain subjective differences (if found with clinical scores).

        -  Compare kinematics measured with the 2 techniques to those of asymptomatic knees.

        -  Determine if anatomical alignment offers some technical benefits (reduced
           intra-operative ligament balance and ligaments releases) compared to a mechanical
           alignment technique.

        -  Compare post-operative rehabilitation in both groups (flexion, extension, straight leg
           raising, walking without assistance, etc.).

      Hypothesis TKA implanted with with anatomical alignment will provide better clinical outcomes
      and knee kinematics closer to normal than TKA implanted with a mechanical alignment
      technique, Implant longevity will show similar micro migration patterns between the two
      groups as measured by RSA up to 2 years after implantation thereby predicting that long-term
      implant survivorship will be similar in both groups.

      Why is this trial needed now? Current technological advances in knee arthroplasty surgery
      have allowed surgeons to implant TKA with considerable accuracy. We however are not sure if
      the position we are placing the knee in is the "correct" position for most patients. It is
      thought that the relatively high percentage of patients that are not completely satisfied
      with the outcome of their knee replacement may have the implants in a suboptimal position for
      that individual patient. The traditional mechanical alignment may not be the optimal position
      for these patients. The anatomical alignment technique may reduce the percentage of
      dissatisfied patients. Implant companies with this technology are currently marketing this to
      surgeons and patients without clinical data to support this claim. There is also the
      possibility that placing an artificial knee joint in an anatomic position may impart a
      negative impact on longevity of the implant, thus increasing early revision rates and the
      significant health costs associated with this. Thus it becomes mandatory to evaluate this new
      technology before its widespread adoption in clinical practice to determine the real benefits
      or disadvantages of changing from a successful clinical practice (mechanical alignment) used
      over the last 40 years.

      Trial results This proposed clinical trial will have a direct impact on patient care if it
      demonstrates that anatomical alignment TKA provides better clinical results than mechanical
      alignment TKA and similar migration patterns measured by RSA. Then the use of anatomic
      alignment may become the gold standard for TKA procedures. Lacking accurate investigation and
      surgical tools, anatomical alignment was abandoned in the early TKA era. Mechanical alignment
      was selected to minimize errors and secondary failures. With novel technologies (personalized
      instruments built on MRI), anatomical alignment might be the best way to replicate knee
      biomechanics and improve patient outcomes after TKA. The proposed study will allow us to
      establish the real value of anatomical alignment and its safety.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Component migration measured with Radiostereophotometry
time frame: 2 years
description: In the first 40 cases (20 in each group), we will compare the migration with a RSA system between anatomically- and mechanically-aligned implants at 2 years and predict the long-term survivorship of total knee prostheses inserted with these two techniques.
measure: Clinical scores
time frame: 2 years
description: In all randomized subject, we will compare the clinical results of anatomical and mechanical total knee alignment with self reported pain, function and stiffness questionnaire scores. Validated clinical scores will be used: WOMAC, KOOS and SF-12
measure: Knee kinematics measured with the Knee KG (Emovi inc.)
time frame: 2 years
description: In all randomized cases, we will compare post operative knee kinematics with the Knee KG system (Emovi inc) between the 2 groups and identify biomechanical markers that explain subjective differences (if found with clinical scores).
measure: Technical benefits
time frame: 1 month
description: In all randomized cases, we will determine if anatomical alignment offers some technical benefits (reduced intra-operative ligament balance and ligaments releases) compared to a mechanical alignment technique.
measure: Rehabilitation
time frame: 1 month
description: In all cases, we will compare post-operative rehabilitation in both groups (flexion, extension, straight leg raising, walking without assistance, etc.).
arm group label: Anatomical
arm group type: Experimental
description: 67 subjects will be randomized to receive an Anatomical TKA with the My knee instruments and a GMK sphere device.
arm group label: Mechanical
arm group type: Active Comparator
description: 67 subjects will be randomized to receive a Mechanical TKA with the My knee instruments and the GMK sphere device.
intervention type: Procedure
intervention name: Anatomical TKA
description: Personalized Medacta plastic cutting blocks will be manufactured according to patient Ct-scan.The anatomical cutting blocks will be design to resurface the femoral and tibial bones to restore each patient's pre-arthritic anatomy within specific margins: maximum of 5 degrees valgus/varus tibial or femoral cut and overall lower limb alignment within +/-3 degrees of varus/valgus). GMK sphere TKA will be implanted using the manufactured cutting blocks.
arm group label: Anatomical
intervention type: Procedure
intervention name: Mechanical TKA
description: Personalized Medacta plastic cutting blocks will be manufactured according to patient Ct-scan. In the mechanical group, femoral and tibial cutting blocks will be designed for a 0-degree angle according to the mechanical axis. Femoral rotation will be aligned with the femoral trans-epicondylar axis. Tibial rotation will follow femoral rotation. GMK sphere TKA will be implanted using the manufactured cutting blocks.
arm group label: Mechanical
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pascal Andre Vendittoli, MD, MSc
role: Principal Investigator
affiliation: Research Director and surgeon
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Maisonneuve-Rosemont Hospital
investigator full name: Pascal André Vendittoli
investigator title: clinical researcher, MD, MSc, FRCSC
mesh term: Genu Varum