<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/NCT04496102</url>
  </required_header>
  <id_info>
    <org_study_id>OrthoTU12</org_study_id>
    <nct_id>NCT04496102</nct_id>
  </id_info>
  <brief_title>Cemented vs Cementless in Bilateral TKA</brief_title>
  <official_title>Comparison of Efficacy Between Cemented and Cementless Total Knee Arthroplasty in Bilateral Total Knee Arthroplasty. A Prospective Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Thammasat University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Thammasat University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      To compare the functional outcomes between cemented and cementless TKA in bilateral knee&#xD;
      replacement patient.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To compare early functional outcomes, radiographic finding and operative time between&#xD;
      cemented and cementless modern implant in sequential bilateral total kee arthroplasty.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 1, 2020</start_date>
  <completion_date type="Anticipated">March 2021</completion_date>
  <primary_completion_date type="Anticipated">December 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Compare mean Forgotten joint score between 2 groups</measure>
    <time_frame>at 1 year</time_frame>
    <description>The total score ranges from 0-100, where a high score is the best outcome</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Operative time</measure>
    <time_frame>intra-operative assessment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>modified the Western Ontario and McMaster Universities Osteoarthritis Index score</measure>
    <time_frame>post-op 2, 6 week, 3, 6, 12 month</time_frame>
    <description>The total score ranges from 0-96, where a high score is the worse outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain level</measure>
    <time_frame>Once daily 1-14 days after surgery then once a week until 3 months</time_frame>
    <description>VAS for pain (0-100)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Range of knee motion</measure>
    <time_frame>post-op 2, 6 week, 3, 6, 12 month</time_frame>
    <description>flexion and extension (degrees) which measured by long goniometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>complication</measure>
    <time_frame>until 1 year after surgery</time_frame>
    <description>such as fracture, infection, stiffness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiological finding</measure>
    <time_frame>post-op 2, 6 week, 3, 6, 12 month</time_frame>
    <description>Radiolucent line at femoral, tibial and patellar components which measured from radiolucent intervals (measured in millimetres) between the cement or prostheses and the bone according to the knee society total knee arthroplasty roentgenographic evaluation and scoring system</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Osteoarthritis</condition>
  <condition>Total Knee Arthroplasty</condition>
  <arm_group>
    <arm_group_label>Cemented TKA</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Cemented TKA (Triathlon, Stryker) include patellar resurfacing</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cementless TKA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cementless TKA (Triathlon Tritanium, Stryker) include patellar resurfacing</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Triathlon</intervention_name>
    <description>Modern TKA design (Triathlon) with patellar resurfacing</description>
    <arm_group_label>Cemented TKA</arm_group_label>
    <arm_group_label>Cementless TKA</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA status 1 or 2&#xD;
&#xD;
          -  Diagnosed with bilateral osteoarthritis of the knees&#xD;
&#xD;
          -  Participant understand and consent to the protocol of the trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Morbid obesity (BMI &gt;40)&#xD;
&#xD;
          -  Inflammatory arthritis&#xD;
&#xD;
          -  Osteoporosis&#xD;
&#xD;
          -  Metabolic bone disease&#xD;
&#xD;
          -  Bone defect that seen from radiographs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Supakit Kanitnate, M.D.</last_name>
    <phone>+66899853635</phone>
    <email>naypeng@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Thammasat University</name>
      <address>
        <city>Khlong Luang</city>
        <state>Pathum Thani</state>
        <zip>12120</zip>
        <country>Thailand</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>supakit kanitnate, M.D.</last_name>
      <phone>+66899853635</phone>
      <email>naypeng@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>Nattapol Tammachote, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <last_update_submitted>July 30, 2020</last_update_submitted>
  <last_update_submitted_qc>July 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Thammasat University</investigator_affiliation>
    <investigator_full_name>Supakit Kanitnate</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>cemented</keyword>
  <keyword>cementless</keyword>
  <keyword>total knee arthroplasty</keyword>
  <keyword>short term outcome</keyword>
  <keyword>functional outcome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
  </condition_browse>
  <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/NCT04496102
org study id: OrthoTU12
nct id: NCT04496102
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
To compare the functional outcomes between cemented and cementless TKA in bilateral knee
      replacement patient.
To compare early functional outcomes, radiographic finding and operative time between
      cemented and cementless modern implant in sequential bilateral total kee arthroplasty.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Compare mean Forgotten joint score between 2 groups
time frame: at 1 year
description: The total score ranges from 0-100, where a high score is the best outcome
measure: Operative time
time frame: intra-operative assessment
measure: modified the Western Ontario and McMaster Universities Osteoarthritis Index score
time frame: post-op 2, 6 week, 3, 6, 12 month
description: The total score ranges from 0-96, where a high score is the worse outcome
measure: Pain level
time frame: Once daily 1-14 days after surgery then once a week until 3 months
description: VAS for pain (0-100)
measure: Range of knee motion
time frame: post-op 2, 6 week, 3, 6, 12 month
description: flexion and extension (degrees) which measured by long goniometer
measure: complication
time frame: until 1 year after surgery
description: such as fracture, infection, stiffness
measure: Radiological finding
time frame: post-op 2, 6 week, 3, 6, 12 month
description: Radiolucent line at femoral, tibial and patellar components which measured from radiolucent intervals (measured in millimetres) between the cement or prostheses and the bone according to the knee society total knee arthroplasty roentgenographic evaluation and scoring system
arm group label: Cemented TKA
arm group type: Active Comparator
description: Cemented TKA (Triathlon, Stryker) include patellar resurfacing
arm group label: Cementless TKA
arm group type: Experimental
description: Cementless TKA (Triathlon Tritanium, Stryker) include patellar resurfacing
intervention type: Device
intervention name: Triathlon
description: Modern TKA design (Triathlon) with patellar resurfacing
arm group label: Cemented TKA
arm group label: Cementless TKA
criteria: 
gender: All
minimum age: 50 Years
maximum age: 80 Years
healthy volunteers: No
last name: Supakit Kanitnate, M.D.
phone: +66899853635
email: naypeng@hotmail.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Thailand
responsible party type: Principal Investigator
investigator affiliation: Thammasat University
investigator full name: Supakit Kanitnate
investigator title: Principal Investigator
mesh term: Osteoarthritis
sharing ipd: No