<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/NCT03274830</url>
  </required_header>
  <id_info>
    <org_study_id>1602_V03_10042019</org_study_id>
    <nct_id>NCT03274830</nct_id>
  </id_info>
  <brief_title>A Post Market Clinical Follow-up Study With the aneXys Cup</brief_title>
  <official_title>A Post Market Clinical Follow-up Study With the aneXys Cup</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mathys Ltd Bettlach</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mathys Ltd Bettlach</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>
      The purpose of the study is the evaluation of the clinical and radiological short- to&#xD;
      long-term safety and performance of the aneXys cup. The data will be used for an ongoing&#xD;
      evaluation of the product safety and performance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective observational multicenter case series providing short-term migration results and&#xD;
      long-term post-market clinical data on the safety and performance of the aneXys cup. The&#xD;
      study includes patients undergoing primary total hip arthroplasty. In total 150 patients in 3&#xD;
      clinics will be included. In each clinic 50 consecutive patients shall be included. In&#xD;
      addition, to meet the regulatory requirements, a total of minimum 20 cases with screw&#xD;
      fixation shall be included in the study.&#xD;
&#xD;
      Clinical and radiological follow-up (FU) is planned after 6-12 weeks, 6 months, 1, 2, 5, 7&#xD;
      and 10 years. An additional FU at 3 years is planned to apply for an ODEP (Orthopaedic Data&#xD;
      Evaluation Panel) rating.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 11, 2020</start_date>
  <completion_date type="Anticipated">February 2032</completion_date>
  <primary_completion_date type="Anticipated">February 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Cup migration after 2 years</measure>
    <time_frame>2 years</time_frame>
    <description>The primary endpoint will be the radiographic evaluation of the acetabular cup migration based on performed EBRA measurements 2 years after surgery.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Harris Hip Score</measure>
    <time_frame>10 years</time_frame>
    <description>The secondary endpoint will be the determination of the clinical outcome using the Harris Hip Score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual analogue scale vor pain</measure>
    <time_frame>10 years</time_frame>
    <description>The secondary endpoint will be the determination of the clinical outcome using the Visual analogue scale for pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual analogue scale for satisfaction</measure>
    <time_frame>10 years</time_frame>
    <description>The secondary endpoint will be the determination of the clinical outcome using the Visual analogue scale for satisfaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Western Ontario and McMaster Universities Osteoarthritis Index</measure>
    <time_frame>10 years</time_frame>
    <description>The secondary endpoint will be the determination of the clinical outcome using the WOMAC.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Osteolysis</measure>
    <time_frame>6-12 weeks - 10 years</time_frame>
    <description>The first endpoint of interest is the occurrence of osteolysis around the cup.</description>
  </other_outcome>
  <other_outcome>
    <measure>Lucent lines</measure>
    <time_frame>6-12 weeks - 10 years</time_frame>
    <description>The second endpoint of interest is the occurrence of lucent lines around the cup.</description>
  </other_outcome>
  <other_outcome>
    <measure>Complications</measure>
    <time_frame>post-op - 10 years</time_frame>
    <description>The first safety endpoint will be the number of complications with respect to the investigational product.</description>
  </other_outcome>
  <other_outcome>
    <measure>Revisions</measure>
    <time_frame>post-op - 10 years</time_frame>
    <description>The second safety endpoint will be the number revisions with respect to the investigational product.</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Arthroplasty, Replacement, Hip</condition>
  <arm_group>
    <arm_group_label>aneXys</arm_group_label>
    <description>cases with aneXys cup and Mathys hip stem</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>aneXys</intervention_name>
    <description>150 patients with the aneXys cup</description>
    <arm_group_label>aneXys</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        see eligibility criteria&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed consent form (signed by participant and investigator)&#xD;
&#xD;
          -  Primary implantation&#xD;
&#xD;
          -  Suffer from primary or secondary osteoarthritis of the hip, femoral head and neck&#xD;
             fractures or necrosis of the femoral head. In all cases a stable anchoring of the&#xD;
             implant has to be possible.&#xD;
&#xD;
          -  Age at inclusion: between 18 and 75 years old&#xD;
&#xD;
          -  Willing to participate in the follow-up examinations&#xD;
&#xD;
          -  Complete recovery is expected&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Missing informed consent form (signed by participant and investigator)&#xD;
&#xD;
          -  Known or suspected non-compliance (e.g. drug or alcohol abuse)&#xD;
&#xD;
          -  Enrolment of the investigator, his/her family, employees and other dependent persons&#xD;
&#xD;
          -  Patients younger 18 years old&#xD;
&#xD;
          -  Revision surgery&#xD;
&#xD;
          -  Presence of sepsis or malignant tumours&#xD;
&#xD;
          -  ASA (American Society of Anesthesiologists) Classification &gt;3&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andreas Roth, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitätsklinik Leipzig</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Marion Röthlisberger</last_name>
    <phone>+41 32 644 15 26</phone>
    <email>marion.roethlisberger@mathysmedical.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Monika Lehmann</last_name>
    <email>monika.lehmann1@mathysmedical.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>DRK Kliniken Berlin | Köpernick</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sven Brandstädt, Dr.</last_name>
      <phone>+49 152 01573470</phone>
      <email>-s.brandstaedt@drk-berlin.de</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>DRK Kliniken Berlin | Westend</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thilo John, Dr.</last_name>
      <phone>+49 030 30354255</phone>
      <email>t.john@drk-kliniken-berlin.de</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Leipzig</name>
      <address>
        <city>Leipzig</city>
        <zip>04107</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andreas Roth, Prof.</last_name>
      <phone>+49 (34) 19 723 200</phone>
      <email>Andreas.Roth@medizin.uni-leipzig.de</email>
    </contact>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>August 24, 2017</study_first_submitted>
  <study_first_submitted_qc>September 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 7, 2017</study_first_posted>
  <last_update_submitted>July 9, 2020</last_update_submitted>
  <last_update_submitted_qc>July 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>primary osteoarthritis</keyword>
  <keyword>secondary osteoarthritis</keyword>
  <keyword>femoral head fracture</keyword>
  <keyword>necrosis</keyword>
  <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/NCT03274830
org study id: 1602_V03_10042019
nct id: NCT03274830
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the study is the evaluation of the clinical and radiological short- to
      long-term safety and performance of the aneXys cup. The data will be used for an ongoing
      evaluation of the product safety and performance.
Prospective observational multicenter case series providing short-term migration results and
      long-term post-market clinical data on the safety and performance of the aneXys cup. The
      study includes patients undergoing primary total hip arthroplasty. In total 150 patients in 3
      clinics will be included. In each clinic 50 consecutive patients shall be included. In
      addition, to meet the regulatory requirements, a total of minimum 20 cases with screw
      fixation shall be included in the study.

      Clinical and radiological follow-up (FU) is planned after 6-12 weeks, 6 months, 1, 2, 5, 7
      and 10 years. An additional FU at 3 years is planned to apply for an ODEP (Orthopaedic Data
      Evaluation Panel) rating.
observational model: Case-Only
time perspective: Prospective
measure: Cup migration after 2 years
time frame: 2 years
description: The primary endpoint will be the radiographic evaluation of the acetabular cup migration based on performed EBRA measurements 2 years after surgery.
measure: Harris Hip Score
time frame: 10 years
description: The secondary endpoint will be the determination of the clinical outcome using the Harris Hip Score.
measure: Visual analogue scale vor pain
time frame: 10 years
description: The secondary endpoint will be the determination of the clinical outcome using the Visual analogue scale for pain.
measure: Visual analogue scale for satisfaction
time frame: 10 years
description: The secondary endpoint will be the determination of the clinical outcome using the Visual analogue scale for satisfaction.
measure: The Western Ontario and McMaster Universities Osteoarthritis Index
time frame: 10 years
description: The secondary endpoint will be the determination of the clinical outcome using the WOMAC.
measure: Osteolysis
time frame: 6-12 weeks - 10 years
description: The first endpoint of interest is the occurrence of osteolysis around the cup.
measure: Lucent lines
time frame: 6-12 weeks - 10 years
description: The second endpoint of interest is the occurrence of lucent lines around the cup.
measure: Complications
time frame: post-op - 10 years
description: The first safety endpoint will be the number of complications with respect to the investigational product.
measure: Revisions
time frame: post-op - 10 years
description: The second safety endpoint will be the number revisions with respect to the investigational product.
arm group label: aneXys
description: cases with aneXys cup and Mathys hip stem
intervention type: Device
intervention name: aneXys
description: 150 patients with the aneXys cup
arm group label: aneXys
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Andreas Roth, Prof.
role: Principal Investigator
affiliation: Universitätsklinik Leipzig
last name: Marion Röthlisberger
phone: +41 32 644 15 26
email: marion.roethlisberger@mathysmedical.com
last name: Monika Lehmann
email: monika.lehmann1@mathysmedical.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Germany
responsible party type: Sponsor
sharing ipd: No