<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/NCT04436211</url>
  </required_header>
  <id_info>
    <org_study_id>032020</org_study_id>
    <nct_id>NCT04436211</nct_id>
  </id_info>
  <brief_title>Kinematic- Versus Ligament-balanced Mechanical Alignment in TKA</brief_title>
  <official_title>A Prospective Randomized Controlled Trial Evaluating Patient Specific Total Knee Arthroplasty Using Kinematic Alignment Versus Ligament-balanced, Mechanical Alignment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Graz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Graz</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>
      A promising new approach in total knee arthroplasty (TKA) for severe osteoarthritis of the&#xD;
      knee joint is the the kinematic aligned procedure (KA). This technique provides&#xD;
      prosthesis-positioning based on natural and individual axes of movement.&#xD;
&#xD;
      Although first series have shown satisfying results, further verification by prospective&#xD;
      studies and final meta-analyses will be required.&#xD;
&#xD;
      Thus, the kinematic alignment represents one of the few new developments in TKA.&#xD;
&#xD;
      Provided that patients are willing to participate in the study, patients data are collected&#xD;
      preoperatively and during routine follow-up examinations and evaluated prospectively.&#xD;
      Patients will receive either a conventionally mechanical aligned arthroplasty or a&#xD;
      kinematical aligned TKA, according to a randomized procedure.&#xD;
&#xD;
      The kinematic alignment will be achieved by the use of custom-made cutting-blocks. Therefore,&#xD;
      the patients will undergo a computed tomography of the whole leg on the affected side. This&#xD;
      is mandatory in order to provide the individually produced cutting blocks.&#xD;
&#xD;
      In order to ensure comparability, patients are stratified regarding their age and gender&#xD;
      before inclusion.&#xD;
&#xD;
      Outcome will be measured by the use of standard scoring systems regarding function, pain and&#xD;
      ROM (range of motion) three, six and 12 months after surgery.&#xD;
&#xD;
      This study is a monocentric, prospective, randomized and controlled open study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 15, 2020</start_date>
  <completion_date type="Anticipated">March 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">February 15, 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>Change of Range of Motion (ROM) after kinematic vs mechanical aligned TKA</measure>
    <time_frame>3; 6; 12 months</time_frame>
    <description>To assess range of motion a Standard Goniometer will be used. Measurements will be obtained after 3, 6, 12 months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of Pain after kinematic vs mechanical aligned TKA</measure>
    <time_frame>3; 6; 12 months</time_frame>
    <description>The pain will be measured with the Visual Analog Scale (VAS), ranging from 1 to 10. 1 is meaning no pain, 10 is meaning the worst pain imaginable.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of Function after kinematic vs mechanical aligned TKA (OKS)</measure>
    <time_frame>3; 6; 12 months</time_frame>
    <description>Function of the artificial joint will be assessed by the use of the Oxford Knee Score (OKS). The OKS is a patient reported outcome measure that consists of 12 questions about an individual's activities of daily living and how they have been affected by pain after total knee arthroplasty. All questions are scored from 0-4 where four is the best outcome and total scores range from 0 (worst outcome) to 48 (best outcome).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of Function after kinematic vs mechanical aligned TKA (WOMAC)</measure>
    <time_frame>3; 6; 12 months</time_frame>
    <description>Function of the artificial joint will be assessed by the use of the Western Ontario and McMaster Universities Arthritis Index Score (WOMAC). The WOMAC survey is comprised of 24 items divided into three subscales: Pain (5 items), stiffness (2 items), and physical function (17 items). Patients are asked a range of questions about their ability to carry out daily activities such as using the stairs, rising from sitting, lying in bed and conducting light or heavy domestic duties. All the items are scored on a scale of 0-4 (lower scores indicate lower levels of symptoms or physical disability). Values are summed up for a combined WOMAC score.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of Function after kinematic vs mechanical aligned TKA (KSS)</measure>
    <time_frame>3; 6; 12 months</time_frame>
    <description>Function of the artificial joint will be assessed by the use of the Combined Knee Society Score (KSS). The KSS has a &quot;Knee Score&quot; section (7 items) and a &quot;Functional Score&quot; section (3 items). Both sections are scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Osteo Arthritis Knee</condition>
  <arm_group>
    <arm_group_label>TKA (mechanical alignment)</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>TKA (kinematic alignment)</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Total Knee Arthroplasty</intervention_name>
    <description>The common procedure of Total Knee Arthroplasty is investigated in order to compare the techniques of implantation (kinematic vs mechanical alignment)</description>
    <arm_group_label>TKA (kinematic alignment)</arm_group_label>
    <arm_group_label>TKA (mechanical alignment)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Case control study of 50 patients receiving a kinematical aligned TKA and 50 patients&#xD;
        receiving a mechanical aligned TKA.&#xD;
&#xD;
        In order to ensure comparability, patients are stratified regarding their age and gender&#xD;
        before inclusion&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Severe osteoarthritis of the knee joint, intended for total knee arthroplasty&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - malalignment with varus of more than 5° or valgus malpositioning, joint instability&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Patrick Sadoghi</last_name>
    <phone>004331638580971</phone>
    <email>patrick.sadoghi@medunigraz.at</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ines Vielgut</last_name>
    <phone>004331638581946</phone>
    <email>ines.vielgut@medunigraz.at</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Medical University of Graz</name>
      <address>
        <city>Graz</city>
        <zip>8044</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Patrick Sadoghi</last_name>
      <phone>004361538580971</phone>
      <email>patrick.sadoghi@medunigraz.at</email>
    </contact>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>April 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>June 16, 2020</last_update_submitted>
  <last_update_submitted_qc>June 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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/NCT04436211
org study id: 032020
nct id: NCT04436211
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A promising new approach in total knee arthroplasty (TKA) for severe osteoarthritis of the
      knee joint is the the kinematic aligned procedure (KA). This technique provides
      prosthesis-positioning based on natural and individual axes of movement.

      Although first series have shown satisfying results, further verification by prospective
      studies and final meta-analyses will be required.

      Thus, the kinematic alignment represents one of the few new developments in TKA.

      Provided that patients are willing to participate in the study, patients data are collected
      preoperatively and during routine follow-up examinations and evaluated prospectively.
      Patients will receive either a conventionally mechanical aligned arthroplasty or a
      kinematical aligned TKA, according to a randomized procedure.

      The kinematic alignment will be achieved by the use of custom-made cutting-blocks. Therefore,
      the patients will undergo a computed tomography of the whole leg on the affected side. This
      is mandatory in order to provide the individually produced cutting blocks.

      In order to ensure comparability, patients are stratified regarding their age and gender
      before inclusion.

      Outcome will be measured by the use of standard scoring systems regarding function, pain and
      ROM (range of motion) three, six and 12 months after surgery.

      This study is a monocentric, prospective, randomized and controlled open study.
observational model: Case-Control
time perspective: Prospective
measure: Change of Range of Motion (ROM) after kinematic vs mechanical aligned TKA
time frame: 3; 6; 12 months
description: To assess range of motion a Standard Goniometer will be used. Measurements will be obtained after 3, 6, 12 months
measure: Change of Pain after kinematic vs mechanical aligned TKA
time frame: 3; 6; 12 months
description: The pain will be measured with the Visual Analog Scale (VAS), ranging from 1 to 10. 1 is meaning no pain, 10 is meaning the worst pain imaginable.
measure: Change of Function after kinematic vs mechanical aligned TKA (OKS)
time frame: 3; 6; 12 months
description: Function of the artificial joint will be assessed by the use of the Oxford Knee Score (OKS). The OKS is a patient reported outcome measure that consists of 12 questions about an individual's activities of daily living and how they have been affected by pain after total knee arthroplasty. All questions are scored from 0-4 where four is the best outcome and total scores range from 0 (worst outcome) to 48 (best outcome).
measure: Change of Function after kinematic vs mechanical aligned TKA (WOMAC)
time frame: 3; 6; 12 months
description: Function of the artificial joint will be assessed by the use of the Western Ontario and McMaster Universities Arthritis Index Score (WOMAC). The WOMAC survey is comprised of 24 items divided into three subscales: Pain (5 items), stiffness (2 items), and physical function (17 items). Patients are asked a range of questions about their ability to carry out daily activities such as using the stairs, rising from sitting, lying in bed and conducting light or heavy domestic duties. All the items are scored on a scale of 0-4 (lower scores indicate lower levels of symptoms or physical disability). Values are summed up for a combined WOMAC score.
measure: Change of Function after kinematic vs mechanical aligned TKA (KSS)
time frame: 3; 6; 12 months
description: Function of the artificial joint will be assessed by the use of the Combined Knee Society Score (KSS). The KSS has a "Knee Score" section (7 items) and a "Functional Score" section (3 items). Both sections are scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions.
arm group label: TKA (mechanical alignment)
arm group label: TKA (kinematic alignment)
intervention type: Procedure
intervention name: Total Knee Arthroplasty
description: The common procedure of Total Knee Arthroplasty is investigated in order to compare the techniques of implantation (kinematic vs mechanical alignment)
arm group label: TKA (kinematic alignment)
arm group label: TKA (mechanical alignment)
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Patrick Sadoghi
phone: 004331638580971
email: patrick.sadoghi@medunigraz.at
last name: Ines Vielgut
phone: 004331638581946
email: ines.vielgut@medunigraz.at
facility: 
status: Recruiting
contact: 
country: Austria
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee