xml: <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/NCT06019832</url>
    </required_header>
    <id_info>
      <org_study_id>202303366</org_study_id>
      <nct_id>NCT06019832</nct_id>
    </id_info>
    <brief_title>Analysis of Stem and Non-Stem Tibial Component</brief_title>
    <official_title>Analysis of Varus Collapse in Obese Patients With Stem and Non-Stem Tibial Components Following Primary Total Knee Arthroplasty</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Jacob M. Elkins</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Iowa</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>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to compare rates of varus collapse, aseptic loosening, and&#xD;
        implant failure in female obese patients undergoing total knee arthroplasty (TKA) and will&#xD;
        review the degree of influence of stemmed tibial components versus non-stemmed tibial&#xD;
        components on varus collapse and aseptic loosening, a consequence of implant micromotion.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The purpose of this study is to identify varus collapse, aseptic loosening, and implant&#xD;
        failure in female obese patients undergoing total knee arthroplasty (TKA). In addition, this&#xD;
        study will review the degree of influence of stemmed tibial components versus non-stemmed&#xD;
        tibial components on varus collapse and aseptic loosening, a consequence of implant&#xD;
        micromotion.&#xD;
  &#xD;
        Female patients with BMI of 35 kg/m2 and above will be randomized into two groups: the&#xD;
        non-stem tibial component (control group) and the stem tibial component (treatment group).&#xD;
        Previous studies done in the past in normal weight patients showed that there is little or no&#xD;
        advantage in using the stem tibial implants over the non-stem ones. Theoretically,&#xD;
        biomechanical studies have suggested that there may be improved fixation and load&#xD;
        distribution with the use of stem tibial implants. Thus, it is necessary to see if there is&#xD;
        any difference between both implant options among female patients who have the highest&#xD;
        incidence of varus collapse. In terms of design, the stem tibial implants are slightly longer&#xD;
        than the non-stem ones. They are designed to extends deeper into the tibia to enhance&#xD;
        fixation and improve load distribution. The use of either stem tibial implants is usually&#xD;
        based on patients' characteristics and surgeons' preference.&#xD;
  &#xD;
        Following informed consent, standard perioperative patient-reported metrics will be collected&#xD;
        (Knee Injury and Osteoarthritis Outcome Score for Joint Replacement [KOOS-JR], American Knee&#xD;
        Society score, and Patient-Reported Outcome Measurement Information System 10 [PROMIS-10])&#xD;
        before surgery and after surgery (6 weeks, 12 weeks, 1 year, 2 years, 3 years, and 5 years).&#xD;
        After surgery, study participants will receive routine surgical care which includes two knee&#xD;
        radiographs at 12 weeks and one year. In addition to this, the study participants will be&#xD;
        evaluated at 2 years, 3 years, and 5 years postoperative periods where they will complete&#xD;
        routine PROMs as listed above and have knee radiographs during each visit.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 8, 2023</start_date>
    <completion_date type="Anticipated">July 19, 2025</completion_date>
    <primary_completion_date type="Anticipated">July 19, 2025</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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Varus Collapse</measure>
      <time_frame>up to 5 years post surgery</time_frame>
      <description>The investigators will track rate of varus collapse.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Aseptic loosening</measure>
      <time_frame>up to 5 years post surgery</time_frame>
      <description>The investigators will track rates of aseptic loosening.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">54</enrollment>
    <condition>Obesity</condition>
    <condition>Aseptic Loosening</condition>
    <condition>Varus Collapse</condition>
    <arm_group>
      <arm_group_label>Group A: Stemmed Tibial Implant</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>This study group will receive a stemmed tibial implant as part of their TKA.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group B: Non-Stemmed Tibial implant</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>This study group will receive a non-stemmed tibial implant as part of their TKA.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Total Knee Arthroplasty (TKA)</intervention_name>
      <description>Both study arms will undergo TKA</description>
      <arm_group_label>Group A: Stemmed Tibial Implant</arm_group_label>
      <arm_group_label>Group B: Non-Stemmed Tibial implant</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Stemmed Tibial Implant</intervention_name>
      <description>A stemmed tibial implant</description>
      <arm_group_label>Group A: Stemmed Tibial Implant</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Non-stemmed tibial implant</intervention_name>
      <description>non-stemmed tibial implants</description>
      <arm_group_label>Group B: Non-Stemmed Tibial implant</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion criteria:&#xD;
  &#xD;
            -  Female adult patients with severe osteoarthritis scheduled to have primary total knee&#xD;
               arthroplasty&#xD;
  &#xD;
            -  35 kg/m2 and above&#xD;
  &#xD;
            -  Only patients from the PI's clinic will be included.&#xD;
  &#xD;
            -  Women who are still menstruating and are currently on contraceptives and women who are&#xD;
               in menopause.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who have some active local or widespread infection (including secondary or&#xD;
               inflammatory osteoarthritis)&#xD;
  &#xD;
            -  medical conditions that put them at risk of complications or death during and after&#xD;
               the study would not be eligible for surgery&#xD;
  &#xD;
            -  Patients with previous knee surgery on arthroplasty site will be excluded&#xD;
  &#xD;
            -  Pregnant patients and women who are capable of getting pregnant&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>99 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Jacob Elkins, MD, PHD</last_name>
      <phone>+1 319 335 7529</phone>
      <email>jacob-elkins@uiowa.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Iowa Hospitals and Clinics</name>
        <address>
          <city>Iowa City</city>
          <state>Iowa</state>
          <zip>52242</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jacob M Elkins, MD, PhD</last_name>
        <email>jacob-elkins@uiowa.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>University of Iowa</investigator_affiliation>
      <investigator_full_name>Jacob M. Elkins</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Shock</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06019832
  org study id: 202303366
  nct id: NCT06019832
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  The purpose of this study is to compare rates of varus collapse, aseptic loosening, and
        implant failure in female obese patients undergoing total knee arthroplasty (TKA) and will
        review the degree of influence of stemmed tibial components versus non-stemmed tibial
        components on varus collapse and aseptic loosening, a consequence of implant micromotion.
  The purpose of this study is to identify varus collapse, aseptic loosening, and implant
        failure in female obese patients undergoing total knee arthroplasty (TKA). In addition, this
        study will review the degree of influence of stemmed tibial components versus non-stemmed
        tibial components on varus collapse and aseptic loosening, a consequence of implant
        micromotion.
  
        Female patients with BMI of 35 kg/m2 and above will be randomized into two groups: the
        non-stem tibial component (control group) and the stem tibial component (treatment group).
        Previous studies done in the past in normal weight patients showed that there is little or no
        advantage in using the stem tibial implants over the non-stem ones. Theoretically,
        biomechanical studies have suggested that there may be improved fixation and load
        distribution with the use of stem tibial implants. Thus, it is necessary to see if there is
        any difference between both implant options among female patients who have the highest
        incidence of varus collapse. In terms of design, the stem tibial implants are slightly longer
        than the non-stem ones. They are designed to extends deeper into the tibia to enhance
        fixation and improve load distribution. The use of either stem tibial implants is usually
        based on patients' characteristics and surgeons' preference.
  
        Following informed consent, standard perioperative patient-reported metrics will be collected
        (Knee Injury and Osteoarthritis Outcome Score for Joint Replacement [KOOS-JR], American Knee
        Society score, and Patient-Reported Outcome Measurement Information System 10 [PROMIS-10])
        before surgery and after surgery (6 weeks, 12 weeks, 1 year, 2 years, 3 years, and 5 years).
        After surgery, study participants will receive routine surgical care which includes two knee
        radiographs at 12 weeks and one year. In addition to this, the study participants will be
        evaluated at 2 years, 3 years, and 5 years postoperative periods where they will complete
        routine PROMs as listed above and have knee radiographs during each visit.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Varus Collapse
  time frame: up to 5 years post surgery
  description: The investigators will track rate of varus collapse.
  measure: Aseptic loosening
  time frame: up to 5 years post surgery
  description: The investigators will track rates of aseptic loosening.
  arm group label: Group A: Stemmed Tibial Implant
  arm group type: Active Comparator
  description: This study group will receive a stemmed tibial implant as part of their TKA.
  arm group label: Group B: Non-Stemmed Tibial implant
  arm group type: Active Comparator
  description: This study group will receive a non-stemmed tibial implant as part of their TKA.
  intervention type: Procedure
  intervention name: Total Knee Arthroplasty (TKA)
  description: Both study arms will undergo TKA
  arm group label: Group A: Stemmed Tibial Implant
  arm group label: Group B: Non-Stemmed Tibial implant
  intervention type: Device
  intervention name: Stemmed Tibial Implant
  description: A stemmed tibial implant
  arm group label: Group A: Stemmed Tibial Implant
  intervention type: Device
  intervention name: Non-stemmed tibial implant
  description: non-stemmed tibial implants
  arm group label: Group B: Non-Stemmed Tibial implant
  criteria: 
  gender: Female
  minimum age: 50 Years
  maximum age: 99 Years
  healthy volunteers: No
  last name: Jacob Elkins, MD, PHD
  phone: +1 319 335 7529
  email: jacob-elkins@uiowa.edu
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Sponsor-Investigator
  investigator affiliation: University of Iowa
  investigator full name: Jacob M. Elkins
  investigator title: Assistant Professor
  mesh term: Shock