<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/NCT03260465</url>
  </required_header>
  <id_info>
    <org_study_id>2017-00832; mu21Stoffel</org_study_id>
    <nct_id>NCT03260465</nct_id>
  </id_info>
  <brief_title>Clinical Study With the seleXys PC and the RM Pressfit Vitamys Cup</brief_title>
  <official_title>A Randomized Controlled Trial With the seleXys PC Cup and RM Pressfit Vitamys Cup in Combination With the Optimys Short Stem</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Basel, Switzerland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Basel, Switzerland</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>
      This is a randomized controlled trial with the seleXys PC cup and RM Pressfit vitamys cup in&#xD;
      combination with the optimys short stem. Wear rate and migration is assessed with roentgen&#xD;
      stereophotogrammetric analysis (RSA) measurements.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 30, 2017</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2024</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>
    <intervention_model_description>prospective, randomised single-center study with 2 treatment arms.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Wear Rate</measure>
    <time_frame>3 years</time_frame>
    <description>The principal purpose of this study is to compare the modular seleXys PC Cup with a vitamys inlay to the monoblock RM Pressfit vitamys cup by means of wear rate. In addition, the migration of the two cups and the optimys stem, respectively, will be evaluated.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Hip Joint</condition>
  <condition>Arthritis, Degenerative</condition>
  <arm_group>
    <arm_group_label>seleXys PC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>seleXys PC cup combined with the optimys stem</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RM</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>RM Pressfit vitamys cup combined with the optimys stem</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>seleXys PC</intervention_name>
    <description>Total hip arthroplasty using the seleXys PC cup</description>
    <arm_group_label>seleXys PC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>RM</intervention_name>
    <description>Total hip arthroplasty using the RM cup</description>
    <arm_group_label>RM</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with symptomatic arthritis who are candidates for a primary total hip&#xD;
             arthroplasty with an uncemented femoral stem as determined jointly by the surgeon and&#xD;
             the patient.&#xD;
&#xD;
          -  Patients suitable for an uncemented acetabular component in combination with a 36mm&#xD;
             femoral head (seleXys PC cup: 52mm, 54mm or 56mm; RM Pressfit vitamys: 52mm, 54mm or&#xD;
             56mm)&#xD;
&#xD;
          -  Patients between the ages of 50 and 75 inclusive&#xD;
&#xD;
          -  Patients who understand the conditions of the study and are willing to participate for&#xD;
             the length of the prescribed follow-up&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients that require an acetabular cup size which cannot be used in combination with&#xD;
             a 36mm femoral head&#xD;
&#xD;
          -  Patients that offer no guarantee for regular follow-up controls&#xD;
&#xD;
          -  Patients that have a revision surgery&#xD;
&#xD;
          -  Patients that have a fracture of the femoral neck or a bone tumour in the area of the&#xD;
             femur or pelvis&#xD;
&#xD;
          -  Patients that had a previous osteotomy of the femur or pelvis&#xD;
&#xD;
          -  Pregnant women or those seeking to become pregnant&#xD;
&#xD;
          -  Patients with a history of active infection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Karl Stoffel, Prof. Dr. med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Klinik für Orthopädie und Traumatologie, Universitätsspital Basel</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Karl Stoffel, Prof. Dr. med.</last_name>
    <phone>+41 61 315 27 51</phone>
    <email>Karl.Stoffel@usb.ch</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ilona Ahlborn</last_name>
    <phone>+41 61 328 71 97</phone>
    <email>ilona.ahlborn@usb.ch</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Klinik für Orthopädie und Traumatologie, University Hospital Basel</name>
      <address>
        <city>Basel</city>
        <state>BL</state>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Karl Stoffel, Prof. Dr. med.</last_name>
      <phone>+41 (0) 61 9253841</phone>
      <email>Karl.Stoffel@usb.ch</email>
    </contact>
    <contact_backup>
      <last_name>Ilona Ahlborn</last_name>
      <phone>+41 61 328 71 97</phone>
      <email>ilona.ahlborn@usb.ch</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>August 22, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>April 11, 2022</last_update_submitted>
  <last_update_submitted_qc>April 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>total hip replacement</keyword>
  <keyword>roentgen stereophotogrammetric analysis</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/NCT03260465
org study id: 2017-00832; mu21Stoffel
nct id: NCT03260465
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a randomized controlled trial with the seleXys PC cup and RM Pressfit vitamys cup in
      combination with the optimys short stem. Wear rate and migration is assessed with roentgen
      stereophotogrammetric analysis (RSA) measurements.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: prospective, randomised single-center study with 2 treatment arms.
primary purpose: Treatment
masking: None (Open Label)
measure: Wear Rate
time frame: 3 years
description: The principal purpose of this study is to compare the modular seleXys PC Cup with a vitamys inlay to the monoblock RM Pressfit vitamys cup by means of wear rate. In addition, the migration of the two cups and the optimys stem, respectively, will be evaluated.
arm group label: seleXys PC
arm group type: Experimental
description: seleXys PC cup combined with the optimys stem
arm group label: RM
arm group type: Active Comparator
description: RM Pressfit vitamys cup combined with the optimys stem
intervention type: Device
intervention name: seleXys PC
description: Total hip arthroplasty using the seleXys PC cup
arm group label: seleXys PC
intervention type: Device
intervention name: RM
description: Total hip arthroplasty using the RM cup
arm group label: RM
criteria: 
gender: All
minimum age: 50 Years
maximum age: 75 Years
healthy volunteers: No
last name: Karl Stoffel, Prof. Dr. med.
role: Principal Investigator
affiliation: Klinik für Orthopädie und Traumatologie, Universitätsspital Basel
last name: Karl Stoffel, Prof. Dr. med.
phone: +41 61 315 27 51
email: Karl.Stoffel@usb.ch
last name: Ilona Ahlborn
phone: +41 61 328 71 97
email: ilona.ahlborn@usb.ch
facility: 
status: Recruiting
contact: 
contact backup: 
country: Switzerland
responsible party type: Sponsor
mesh term: Osteoarthritis
sharing ipd: No