<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/NCT03272178</url>
  </required_header>
  <id_info>
    <org_study_id>201708094</org_study_id>
    <nct_id>NCT03272178</nct_id>
  </id_info>
  <brief_title>Impact of Component Design and Fixation in Total Knee Arthroplasty</brief_title>
  <official_title>Impact of Component Design and Fixation in Bone Remodeling After Total Knee Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Stryker Nordic</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Washington University School of Medicine</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>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine implant design and determine if method of fixation&#xD;
      cemented versus cementless results in different bone loss patterns. The investigators also&#xD;
      want to determine if clinical outcomes correlate with bone density changes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients who present to the clinical practices of Dr. Ryan Nunley and Dr. Robert Barrack and&#xD;
      are suitable candidates for primary total knee arthroplasty(TKA) type assigned either&#xD;
      cemented or cementless and Triathlon knee or Depuy by surgeon will be screened for&#xD;
      eligibility and invited to participate. Data collected for the study will include standard of&#xD;
      care clinical and radiographic evaluations collected during office visits and surgery, Dual&#xD;
      Energy X-Ray Absorptiometry(DEXA) Bone density monitoring, as well as study-specific patient&#xD;
      questionnaires. Clinical, radiographic and questionnaire data will be collected&#xD;
      pre-operatively, at the time of surgery, and at 6 weeks, 1 year and beyond, and 2 years and&#xD;
      beyond post-operatively. Patients will complete the following outcomes questionnaires&#xD;
      preoperatively: New Knee Society Score, Oxford Knee Score, UCLA Activity Score, SF-12, and&#xD;
      EQ-5D. The following questionnaires will be collected at four to six weeks, six months, one&#xD;
      year and beyond, and two years and beyond postoperatively: New Knee Society Score, Forgotten&#xD;
      Joint Score, Washington University Knee Satisfaction and Function Questionnaire, Oxford Knee&#xD;
      Score, UCLA Activity Score, SF-12, and EQ-5D, and a Pain Drawing.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 20, 2017</start_date>
  <completion_date type="Actual">November 15, 2021</completion_date>
  <primary_completion_date type="Actual">November 15, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in bone density</measure>
    <time_frame>2 years</time_frame>
    <description>Patients will have a DEXA scan to look for change in bone loss at 6 weeks, 1 year, and 2 year to determine bone loss patterns and geometry</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>knee society score</measure>
    <time_frame>2 years</time_frame>
    <description>Knee society score questionnaire will be completed preoperatively, 6 weeks, 1 year, and 2 year.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Forgotten joint score</measure>
    <time_frame>2 years</time_frame>
    <description>Forgotten join score questionnaire will be completed preoperatively, 6 weeks, 1 year, and 2 year.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxford knee score</measure>
    <time_frame>2 years</time_frame>
    <description>Oxford knee score questionnaire will be completed preoperatively, 6 weeks, 1 year, and 2 year.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>UCLA Activity score</measure>
    <time_frame>2 years</time_frame>
    <description>UCLA questionnaire will be completed preoperatively, 6 weeks, 1 year, and 2 year.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SF-12</measure>
    <time_frame>2 years</time_frame>
    <description>SF-12 questionnaire will be completed preoperatively, 6 weeks, 1 year, and 2 year.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ-5D</measure>
    <time_frame>2 years</time_frame>
    <description>EQ-5D questionnaire will be completed preoperatively, 6 weeks, 1 year, and 2 year.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Arthroplasties, Knee Replacement</condition>
  <arm_group>
    <arm_group_label>Triathlon knee total knee arthroplasty</arm_group_label>
    <description>50 Patients who are assigned to Triathlon knee, half cemented/half cementless</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Depuy knee total knee arthroplasty</arm_group_label>
    <description>50 Patients who are assigned to Depuy knee, half cemented/half cementless</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Depuy total knee implant</intervention_name>
    <description>patients from Dr Nunley's clinic will get a Depuy implant</description>
    <arm_group_label>Depuy knee total knee arthroplasty</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Triathlon total knee implant</intervention_name>
    <description>patients from Dr Barrack's clinic will get a Triathlon implant</description>
    <arm_group_label>Triathlon knee total knee arthroplasty</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        A. Patients who qualify for a Primary Total Knee Arthroplasty using Stryker Triathlon&#xD;
        Implant(thin tray) or Depuy Attune(thick tray) Implant&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who qualify for a Primary Total knee using Triathlon Implant(thin tray) or&#xD;
             Depuy Attune(thick tray) Implant&#xD;
&#xD;
          -  18-75 years of age&#xD;
&#xD;
          -  Willing to sign informed consent&#xD;
&#xD;
          -  Willing to return for all follow-up visits&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with inflammatory arthritis&#xD;
&#xD;
          -  BMI &gt; 40&#xD;
&#xD;
          -  Patient with an active infection or suspected infection in the joint&#xD;
&#xD;
          -  Patient who have undergone osteotomy&#xD;
&#xD;
          -  Patients who have a previous diagnosis of osteopenia/osteoporosis or patients with&#xD;
             weak bones and/or currently on medications to increase bone density/who have poor bone&#xD;
             quality&#xD;
&#xD;
          -  Patients who have had previous patella fracture or surgery&#xD;
&#xD;
          -  Patients who have had previous knee or hip replacement surgery on the ipsilateral side&#xD;
&#xD;
          -  Patients who require patellar resurfacing&#xD;
&#xD;
          -  Patient with major medical/muscular/orthopedic deformities&#xD;
&#xD;
          -  Unable to undergo DEXA scanning.&#xD;
&#xD;
          -  Female patients of childbearing potential and an interest in getting pregnant in the&#xD;
             future *NOTE: Patients receiving simultaneous bilateral total knee arthroplasties are&#xD;
             eligible. Both knees are eligible for enrollment as long as all other&#xD;
             inclusion/exclusion criteria are met for each knee. If only one knee is eligible it&#xD;
             will be included. Patients receiving staged bilaterals are also eligible, provided&#xD;
             that each knee meets the inclusion exclusion criteria.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>August 22, 2017</study_first_submitted>
  <study_first_submitted_qc>September 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>November 29, 2021</last_update_submitted>
  <last_update_submitted_qc>November 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03272178
org study id: 201708094
nct id: NCT03272178
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The purpose of this study is to determine implant design and determine if method of fixation
      cemented versus cementless results in different bone loss patterns. The investigators also
      want to determine if clinical outcomes correlate with bone density changes.
Patients who present to the clinical practices of Dr. Ryan Nunley and Dr. Robert Barrack and
      are suitable candidates for primary total knee arthroplasty(TKA) type assigned either
      cemented or cementless and Triathlon knee or Depuy by surgeon will be screened for
      eligibility and invited to participate. Data collected for the study will include standard of
      care clinical and radiographic evaluations collected during office visits and surgery, Dual
      Energy X-Ray Absorptiometry(DEXA) Bone density monitoring, as well as study-specific patient
      questionnaires. Clinical, radiographic and questionnaire data will be collected
      pre-operatively, at the time of surgery, and at 6 weeks, 1 year and beyond, and 2 years and
      beyond post-operatively. Patients will complete the following outcomes questionnaires
      preoperatively: New Knee Society Score, Oxford Knee Score, UCLA Activity Score, SF-12, and
      EQ-5D. The following questionnaires will be collected at four to six weeks, six months, one
      year and beyond, and two years and beyond postoperatively: New Knee Society Score, Forgotten
      Joint Score, Washington University Knee Satisfaction and Function Questionnaire, Oxford Knee
      Score, UCLA Activity Score, SF-12, and EQ-5D, and a Pain Drawing.
observational model: Cohort
time perspective: Prospective
measure: Change in bone density
time frame: 2 years
description: Patients will have a DEXA scan to look for change in bone loss at 6 weeks, 1 year, and 2 year to determine bone loss patterns and geometry
measure: knee society score
time frame: 2 years
description: Knee society score questionnaire will be completed preoperatively, 6 weeks, 1 year, and 2 year.
measure: Forgotten joint score
time frame: 2 years
description: Forgotten join score questionnaire will be completed preoperatively, 6 weeks, 1 year, and 2 year.
measure: Oxford knee score
time frame: 2 years
description: Oxford knee score questionnaire will be completed preoperatively, 6 weeks, 1 year, and 2 year.
measure: UCLA Activity score
time frame: 2 years
description: UCLA questionnaire will be completed preoperatively, 6 weeks, 1 year, and 2 year.
measure: SF-12
time frame: 2 years
description: SF-12 questionnaire will be completed preoperatively, 6 weeks, 1 year, and 2 year.
measure: EQ-5D
time frame: 2 years
description: EQ-5D questionnaire will be completed preoperatively, 6 weeks, 1 year, and 2 year.
arm group label: Triathlon knee total knee arthroplasty
description: 50 Patients who are assigned to Triathlon knee, half cemented/half cementless
arm group label: Depuy knee total knee arthroplasty
description: 50 Patients who are assigned to Depuy knee, half cemented/half cementless
intervention type: Device
intervention name: Depuy total knee implant
description: patients from Dr Nunley's clinic will get a Depuy implant
arm group label: Depuy knee total knee arthroplasty
intervention type: Device
intervention name: Triathlon total knee implant
description: patients from Dr Barrack's clinic will get a Triathlon implant
arm group label: Triathlon knee total knee arthroplasty
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor