<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/NCT04399928</url>
  </required_header>
  <id_info>
    <org_study_id>SR 16-4845-15 (R11019)</org_study_id>
    <nct_id>NCT04399928</nct_id>
  </id_info>
  <brief_title>EU Safety and Efficacy Study Regarding the R3 Acetabular Hip System</brief_title>
  <official_title>A Prospective, Multicenter, Non-randomized, Clinical Outcomes Study of the R3◊ Acetabular System in Patients With Degenerative Hip Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Smith &amp; Nephew Orthopaedics AG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Smith &amp; Nephew, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to determine the long-term safety and effectiveness from the&#xD;
      R3 Acetabular Hip System. The study hypothesis is that implant survivorship of the R3 cup is&#xD;
      at least 97% at 3 years, 95% at 5 years, 93% at 7 years, and 90% at 10 years follow-up.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multicenter prospective observational post-market clinical follow-up study that&#xD;
      will include 500 patients who will have total hip replacement with the R3 Acetabular System&#xD;
      and either cemented or cementless hip stem.&#xD;
&#xD;
      Effectiveness will be assessed by comparison of changes in parameters contained in the HOOS&#xD;
      questionnaire and based upon incidence of revision and change in Harris Hip Score and UCLA&#xD;
      Rating. Safety will be measured by assessing all adverse events experienced by patients from&#xD;
      study enrolment through to study completion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 18, 2009</start_date>
  <completion_date type="Actual">April 1, 2022</completion_date>
  <primary_completion_date type="Actual">February 1, 2022</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>Revision for any reason</measure>
    <time_frame>10 years post-op</time_frame>
    <description>Implant survivorship at 10 years post study procedure. A revision is a surgical procedure of the study hip where one or more of the study components are removed and replaced with new implants.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Reported Outcome (PRO): Hip Disability and Osteoarthritis Outcome Score (HOOS)</measure>
    <time_frame>10 years post-op</time_frame>
    <description>The HOOS is developed as an instrument to assess the subject's opinion about their hip and associated problems. HOOS consists of 5 subscales: Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec), and hip related Quality of Life (QOL).&#xD;
Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Reported Outcome (PRO): modified Harris Hip Score (HHS)</measure>
    <time_frame>10 years post-op</time_frame>
    <description>Effectiveness assessed by comparison of changes in parameters from baseline through 10 year post. 2 subscales (8 items), Scores summed and normalized to 100, Excellent: 90 - 100 points Good: 80 - 89 points Fair: 70 - 79 points Poor: &lt; 70 points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Reported Outcome (PRO): University of California, Los Angeles (UCLA) rating</measure>
    <time_frame>10 years post-op</time_frame>
    <description>UCLA Activity Score is a measure of physical activity levels in subjects undergoing total joint arthroplasty. The scale is from 1 - 10 with higher values indicating greater physical function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety Assessment</measure>
    <time_frame>10 years post-op</time_frame>
    <description>Safety will be measured by assessing all adverse events experienced by patients up to study completion or termination.</description>
  </secondary_outcome>
  <enrollment type="Actual">512</enrollment>
  <condition>Degenerative Joint Disease</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Total Hip Arthroplasty</intervention_name>
    <description>Total hip arthroplasty with the R3 Acetabular Hip system.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        This clinical study can fulfill its objectives only if appropriate subjects are enrolled.&#xD;
        All relevant medical and non-medical conditions should be taken into consideration when&#xD;
        deciding whether a particular patient is suitable. Subjects will be enrolled consecutively.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Subjects must meet all of the following characteristics for inclusion in the study.&#xD;
&#xD;
          -  Patient is 18-75 years old and he/she is skeletally mature&#xD;
&#xD;
          -  Patient requires primary total hip arthroplasty due to non-inflammatory degenerative&#xD;
             joint disease (e.g. osteoarthritis, post-traumatic arthritis, avascular necrosis,&#xD;
             dysplasia/DDH or inflammatory joint disease (e.g., rheumatoid arthritis)&#xD;
&#xD;
          -  Patient has met an acceptable preoperative medical clearance and is free from or&#xD;
             treated for cardiac, pulmonary, hematological, etc., conditions that would pose&#xD;
             excessive operative risk&#xD;
&#xD;
          -  The patient is willing to comply the follow-up schedule&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Subjects with any of the following characteristics must be excluded from the participation&#xD;
        in the study.&#xD;
&#xD;
          -  Patient has active infection or sepsis (treated or untreated)&#xD;
&#xD;
          -  Patient is a prisoner or has an emotional or neurological condition that would&#xD;
             pre-empt their ability or unwillingness to participate in the study including mental&#xD;
             illness, mental retardation, linguistic insufficiencies (i.e. immigrants), or&#xD;
             drug/alcohol abuse.&#xD;
&#xD;
          -  Patients with acute hip trauma (femoral neck fracture)&#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>Remes, Associate Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Helsinki</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>AZ Nikolaas</name>
      <address>
        <city>Sint-Niklaas</city>
        <state>Moerlandstraat 1</state>
        <zip>9100</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hvidovre University Hospital</name>
      <address>
        <city>Hvidovre</city>
        <zip>2650</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Helsinki University Hospital</name>
      <address>
        <city>Helsinki</city>
        <zip>FI-00029</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TYKS Turku University Hospital</name>
      <address>
        <city>Turku</city>
        <zip>20880</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Knappschaftskrankenhaus Püttlingen</name>
      <address>
        <city>Püttlingen</city>
        <zip>66346</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medisch Centrum Alkmaar</name>
      <address>
        <city>Alkmaar</city>
        <zip>1815 JD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital La Paz</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Royal Orthopaedic Hospital, NHS Foundation Trust</name>
      <address>
        <city>Birmingham</city>
        <zip>B 31 2AP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Denmark</country>
    <country>Finland</country>
    <country>Germany</country>
    <country>Netherlands</country>
    <country>Spain</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>May 19, 2020</study_first_submitted>
  <study_first_submitted_qc>May 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 22, 2020</study_first_posted>
  <last_update_submitted>May 6, 2022</last_update_submitted>
  <last_update_submitted_qc>May 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Degenerative joint disease</keyword>
  <keyword>Total Hip Arthroplasty</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Joint Diseases</mesh_term>
    <mesh_term>Osteoarthritis</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/NCT04399928
org study id: SR 16-4845-15 (R11019)
nct id: NCT04399928
lead sponsor: 
has dmc: No
is fda regulated drug: No
The objective of this study is to determine the long-term safety and effectiveness from the
      R3 Acetabular Hip System. The study hypothesis is that implant survivorship of the R3 cup is
      at least 97% at 3 years, 95% at 5 years, 93% at 7 years, and 90% at 10 years follow-up.
This is a multicenter prospective observational post-market clinical follow-up study that
      will include 500 patients who will have total hip replacement with the R3 Acetabular System
      and either cemented or cementless hip stem.

      Effectiveness will be assessed by comparison of changes in parameters contained in the HOOS
      questionnaire and based upon incidence of revision and change in Harris Hip Score and UCLA
      Rating. Safety will be measured by assessing all adverse events experienced by patients from
      study enrolment through to study completion.
observational model: Cohort
time perspective: Prospective
measure: Revision for any reason
time frame: 10 years post-op
description: Implant survivorship at 10 years post study procedure. A revision is a surgical procedure of the study hip where one or more of the study components are removed and replaced with new implants.
measure: Patient Reported Outcome (PRO): Hip Disability and Osteoarthritis Outcome Score (HOOS)
time frame: 10 years post-op
description: The HOOS is developed as an instrument to assess the subject's opinion about their hip and associated problems. HOOS consists of 5 subscales: Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec), and hip related Quality of Life (QOL).
Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
measure: Patient Reported Outcome (PRO): modified Harris Hip Score (HHS)
time frame: 10 years post-op
description: Effectiveness assessed by comparison of changes in parameters from baseline through 10 year post. 2 subscales (8 items), Scores summed and normalized to 100, Excellent: 90 - 100 points Good: 80 - 89 points Fair: 70 - 79 points Poor: < 70 points.
measure: Patient Reported Outcome (PRO): University of California, Los Angeles (UCLA) rating
time frame: 10 years post-op
description: UCLA Activity Score is a measure of physical activity levels in subjects undergoing total joint arthroplasty. The scale is from 1 - 10 with higher values indicating greater physical function.
measure: Safety Assessment
time frame: 10 years post-op
description: Safety will be measured by assessing all adverse events experienced by patients up to study completion or termination.
intervention type: Device
intervention name: Total Hip Arthroplasty
description: Total hip arthroplasty with the R3 Acetabular Hip system.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Remes, Associate Professor
role: Principal Investigator
affiliation: University of Helsinki
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Belgium
country: Denmark
country: Finland
country: Germany
country: Netherlands
country: Spain
country: United Kingdom
responsible party type: Sponsor
mesh term: Joint Diseases
mesh term: Osteoarthritis