<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/NCT04501185</url>
  </required_header>
  <id_info>
    <org_study_id>202000226A3</org_study_id>
    <nct_id>NCT04501185</nct_id>
  </id_info>
  <brief_title>Comparison of Clinical Results of Two Cementless Femoral Stem</brief_title>
  <official_title>Comparison of Clinical Results of Two Cementless Femoral Stem</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>United Orthopedic Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Chang Gung Memorial Hospital</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>
      In the present study, two types of cementless femoral stem- UTS Stem and UTF-reduced Stem-&#xD;
      were utilized in total hip arthroplasty. Due to the design for proximal femur fixation, both&#xD;
      femoral stems could prevent stress shielding around the implant, further preventing&#xD;
      osteolysis. The difference between both femoral stems is the length, in which UTS Stem is 20%&#xD;
      shorter than UTF-reduced Stem. The clinical outcomes of both femoral stems will be compared.&#xD;
      Both femoral stems are expected to have equally good radiologic outcome and clinical&#xD;
      performance.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Anticipated">May 2024</completion_date>
  <primary_completion_date type="Anticipated">May 2024</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>Numerical Rating Scale</measure>
    <time_frame>Change from baseline at 1 year</time_frame>
    <description>Numerical Rating Scale is a patient-reported outcome measure. The scale ranges from 0 to 10. A score of 0 represents no pain, while a score of 10 represents extreme pain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Harris Hip Score</measure>
    <time_frame>Change from baseline at 1 year</time_frame>
    <description>Harris Hip Score includes 4 sections that evaluate pain, function, deformity, and range of motion. Total scores is from 0 to 100, higher scores represent a better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Medical Outcome Study Short Form-36</measure>
    <time_frame>Change from baseline at 1 year</time_frame>
    <description>SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and are now widely utilized by managed care organizations and by Medicare for routine monitoring and assessment of care outcomes in adult patients. It consists of two sections, physical component summary and mental component summary, with 36 items in total.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>DEXA scanning</measure>
    <time_frame>Change from baseline at 1 year</time_frame>
    <description>DEXA scanning is used to monitor and quantify bone mineral density, which helps to understand if the implant has an effect on the change of bone mineral density.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Radiolucent line</measure>
    <time_frame>Change from baseline at 1 year</time_frame>
    <description>Radiologic analysis helps observe the existence of radiolucent lines, which can be analyzed to determine if implant loosening occurs.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Morphology of the proximal femur</measure>
    <time_frame>at baseline</time_frame>
    <description>Morphology of the proximal femur was classified using Dorr Type.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Valgus/Varus alignment</measure>
    <time_frame>Change from baseline at 1 year</time_frame>
    <description>Radiologic analysis helps measure the degree of the alignment of the hip.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Osteoarthritis, Hip</condition>
  <arm_group>
    <arm_group_label>UTS Stem</arm_group_label>
    <description>The subjects who received UTS Stem in total hip arthroplasty.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>UTF-reduced Stem</arm_group_label>
    <description>The subjects who received UTF-reduced Stem in total hip arthroplasty.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>total hip arthroplasty</intervention_name>
    <description>The indication for total hip arthroplasty is mainly osteoarthritis.</description>
    <arm_group_label>UTF-reduced Stem</arm_group_label>
    <arm_group_label>UTS Stem</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who receive total hip arthroplasty with either a UTS femoral stem or a UTF-reduced&#xD;
        femoral stem after June, 2020 at Chang Gung Memorial Hospital, Linkou&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients who receive total hip arthroplasty with either a UTS femoral stem or a&#xD;
             UTF-reduced femoral stem after June, 2020&#xD;
&#xD;
          2. Patients who have not received total hip arthroplasty in the past&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who are unable or unwilling to return for follow-up&#xD;
&#xD;
          2. Patients who suffer from mental disorders&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pang-Hsin Hsieh, MD</last_name>
    <role>Study Director</role>
    <affiliation>Chang Gung Memorial Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Pang-Hsin Hsieh, MD</last_name>
    <phone>886-3-3281200</phone>
    <email>hsieh2634@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Joint Reconstruction Division at Chang Gung Memorial Hospital, Linkou</name>
      <address>
        <city>Taoyuan City</city>
        <zip>333</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pang-Hsin Hsieh, MD</last_name>
      <phone>886-3-3281200</phone>
      <email>hsieh2634@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>August 3, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>August 3, 2020</last_update_submitted>
  <last_update_submitted_qc>August 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>total hip arthroplasty</keyword>
  <keyword>total hip replacement</keyword>
  <keyword>femoral stem</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis, Hip</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/NCT04501185
org study id: 202000226A3
nct id: NCT04501185
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
In the present study, two types of cementless femoral stem- UTS Stem and UTF-reduced Stem-
      were utilized in total hip arthroplasty. Due to the design for proximal femur fixation, both
      femoral stems could prevent stress shielding around the implant, further preventing
      osteolysis. The difference between both femoral stems is the length, in which UTS Stem is 20%
      shorter than UTF-reduced Stem. The clinical outcomes of both femoral stems will be compared.
      Both femoral stems are expected to have equally good radiologic outcome and clinical
      performance.
observational model: Cohort
time perspective: Prospective
measure: Numerical Rating Scale
time frame: Change from baseline at 1 year
description: Numerical Rating Scale is a patient-reported outcome measure. The scale ranges from 0 to 10. A score of 0 represents no pain, while a score of 10 represents extreme pain.
measure: Harris Hip Score
time frame: Change from baseline at 1 year
description: Harris Hip Score includes 4 sections that evaluate pain, function, deformity, and range of motion. Total scores is from 0 to 100, higher scores represent a better outcome.
measure: Medical Outcome Study Short Form-36
time frame: Change from baseline at 1 year
description: SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and are now widely utilized by managed care organizations and by Medicare for routine monitoring and assessment of care outcomes in adult patients. It consists of two sections, physical component summary and mental component summary, with 36 items in total.
measure: DEXA scanning
time frame: Change from baseline at 1 year
description: DEXA scanning is used to monitor and quantify bone mineral density, which helps to understand if the implant has an effect on the change of bone mineral density.
measure: Radiolucent line
time frame: Change from baseline at 1 year
description: Radiologic analysis helps observe the existence of radiolucent lines, which can be analyzed to determine if implant loosening occurs.
measure: Morphology of the proximal femur
time frame: at baseline
description: Morphology of the proximal femur was classified using Dorr Type.
measure: Valgus/Varus alignment
time frame: Change from baseline at 1 year
description: Radiologic analysis helps measure the degree of the alignment of the hip.
arm group label: UTS Stem
description: The subjects who received UTS Stem in total hip arthroplasty.
arm group label: UTF-reduced Stem
description: The subjects who received UTF-reduced Stem in total hip arthroplasty.
intervention type: Device
intervention name: total hip arthroplasty
description: The indication for total hip arthroplasty is mainly osteoarthritis.
arm group label: UTF-reduced Stem
arm group label: UTS Stem
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Pang-Hsin Hsieh, MD
role: Study Director
affiliation: Chang Gung Memorial Hospital
last name: Pang-Hsin Hsieh, MD
phone: 886-3-3281200
email: hsieh2634@gmail.com
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Sponsor
mesh term: Osteoarthritis, Hip