<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/NCT02188095</url>
  </required_header>
  <id_info>
    <org_study_id>AAG-O-H-1401</org_study_id>
    <nct_id>NCT02188095</nct_id>
  </id_info>
  <brief_title>Post Market Clinical Follow-Up Study of Excia T® Hip Prosthesis</brief_title>
  <official_title>Post Market Clinical Follow-Up Study of Excia T® Hip Prosthesis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aesculap AG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aesculap AG</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Clinical and radiological 10 year results of Excia T® Hip Stem&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 3, 2014</start_date>
  <completion_date type="Anticipated">July 2025</completion_date>
  <primary_completion_date type="Actual">October 6, 2015</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>Survival Rate of the Implant</measure>
    <time_frame>10 years</time_frame>
    <description>Kaplan-Meier Survival Rate up to 10 years</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hip disability and Osteoarthritis Outcome Score (HOOS)</measure>
    <time_frame>preoperatively, intraoperatively + discharge, after 3 and 12 months 3, 5 and 10 years</time_frame>
    <description>Documentation of clinical outcome with HOOS Score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of functional outcome over follow-up period (Harris Hip Score (HHS))</measure>
    <time_frame>at discharge, after 3 and 12 months 3, 5 and 10 years</time_frame>
    <description>The Harris Hip Score (HHS) is one of the most used scores in total hip arthroplasty, mainly combining range of motion questions with questions regarding daily life activities.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Assessment</measure>
    <time_frame>at 6 examinations during follow-up (discharge, after 3 and 12 months and 3, 5, and 10 years)</time_frame>
    <description>Pain will be measured with a Visual Analogue Scale (VAS), at rest and when walking on flat ground. The Visual Analog Scale (VAS) is a 10 cm line with anchor statements on the left (no pain) and on the right (extreme pain). The patients are asked to mark their current pain level on the line.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Shaftposition ap and lateral</measure>
    <time_frame>10 years</time_frame>
    <description>Radiological documentation of shaftposition in ap and lateral view discharge, after 3 and 12 months and 3, 5, and 10 years</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stress Shielding</measure>
    <time_frame>10 years</time_frame>
    <description>Radiological documentation of stress shielding after 3 and 12 months and 3, 5, and 10 years</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hypertrophies</measure>
    <time_frame>10 years</time_frame>
    <description>Radiological documentation of hypertrophies after 3 and 12 months and 3, 5, and 10 years</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Hip Arthritis</condition>
  <arm_group>
    <arm_group_label>Excia T®</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        primary care clinic&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient gave written informed consent&#xD;
&#xD;
          -  age ≥ 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter Aldinger, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Diakonie-Klinikum Stuttgart</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vulpius Klinik</name>
      <address>
        <city>Bad Rappenau</city>
        <zip>74906</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diakonie Klinikum Stuttgart</name>
      <address>
        <city>Stuttgart</city>
        <zip>70176</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>June 26, 2014</study_first_submitted>
  <study_first_submitted_qc>July 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 11, 2014</study_first_posted>
  <last_update_submitted>August 10, 2023</last_update_submitted>
  <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</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/NCT02188095
org study id: AAG-O-H-1401
nct id: NCT02188095
lead sponsor: 
has dmc: No
Clinical and radiological 10 year results of Excia T® Hip Stem
observational model: Cohort
time perspective: Prospective
measure: Survival Rate of the Implant
time frame: 10 years
description: Kaplan-Meier Survival Rate up to 10 years
measure: Hip disability and Osteoarthritis Outcome Score (HOOS)
time frame: preoperatively, intraoperatively + discharge, after 3 and 12 months 3, 5 and 10 years
description: Documentation of clinical outcome with HOOS Score
measure: Change of functional outcome over follow-up period (Harris Hip Score (HHS))
time frame: at discharge, after 3 and 12 months 3, 5 and 10 years
description: The Harris Hip Score (HHS) is one of the most used scores in total hip arthroplasty, mainly combining range of motion questions with questions regarding daily life activities.
measure: Pain Assessment
time frame: at 6 examinations during follow-up (discharge, after 3 and 12 months and 3, 5, and 10 years)
description: Pain will be measured with a Visual Analogue Scale (VAS), at rest and when walking on flat ground. The Visual Analog Scale (VAS) is a 10 cm line with anchor statements on the left (no pain) and on the right (extreme pain). The patients are asked to mark their current pain level on the line.
measure: Shaftposition ap and lateral
time frame: 10 years
description: Radiological documentation of shaftposition in ap and lateral view discharge, after 3 and 12 months and 3, 5, and 10 years
measure: Stress Shielding
time frame: 10 years
description: Radiological documentation of stress shielding after 3 and 12 months and 3, 5, and 10 years
measure: Hypertrophies
time frame: 10 years
description: Radiological documentation of hypertrophies after 3 and 12 months and 3, 5, and 10 years
arm group label: Excia T®
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Peter Aldinger, Prof. Dr.
role: Principal Investigator
affiliation: Diakonie-Klinikum Stuttgart
facility: 
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Arthritis