<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/NCT04425603</url>
  </required_header>
  <id_info>
    <org_study_id>R11006-1</org_study_id>
    <nct_id>NCT04425603</nct_id>
  </id_info>
  <brief_title>Anthology Hip Replacement System - Orthopaedic Data Evolution Panel (ODEP) Surveillance Study</brief_title>
  <official_title>Anthology Hip Replacement System - Orthopaedic Data Evolution Panel (ODEP) Surveillance Study</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>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This clinical study will verify the clinical and radiographic performance of the prosthesis&#xD;
      when used in human subjects over a period of 10 years. All complications will be documented.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The clinical evaluations will be based on standard, functional and pain parameters Harris Hip&#xD;
      Score pre-operatively, and at 6 months, 3, 5, 7.5 and 10 years post-operatively. Postal&#xD;
      Oxford questionnaire preoperatively, and yearly thereafter. The objective of this study is to&#xD;
      analyse the clinical and radiographic responses and the complication rates for patients&#xD;
      undergoing primary total hip arthroplasty using the Anthology Hip Replacement System&#xD;
      (Anthology Hip System).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 30, 2007</start_date>
  <completion_date type="Actual">November 8, 2021</completion_date>
  <primary_completion_date type="Actual">November 8, 2021</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>Harris Hip Score - 10 years</measure>
    <time_frame>10 years post operative</time_frame>
    <description>The Harris Hip Score is a joint specific score that consists of 10 items covering domains of pain (1 item, 0-44 points), function (7 items, 0-47 points), functional activities, absence of deformity (1 item, 0 or 4 points), and hip range of motion (2 items, 0-5 points). Scores range from 0 (worst) to 100 (best).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of life with Oxford Hip Score (postal) - 10 years</measure>
    <time_frame>10 years post operative</time_frame>
    <description>Patients are asked to reflect on their pain and functional ability over the previous four weeks. There are two domains (pain and function) with six items or questions in each. Each item has five possible responses. In the original scoring responses were from 1 = least difficult to 5= most difficult. Item scores are summed to give a total score from anywhere between 12 and 60. The lower the score, the better the outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of life with EuroQol Questionnaire (EQ-5D) -10 years</measure>
    <time_frame>10 years post operative</time_frame>
    <description>The descriptive system consists of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which takes one of three responses. The responses record three levels of severity (no problems/some or moderate problems/extreme problems) within a particular dimension. The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. This information can be used as a quantitative measure of health outcome as judged by the individual respondents.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Harris Hip Score</measure>
    <time_frame>Pre-operative and 6 months, 3 years, 5 years, and 7.5 years post operative</time_frame>
    <description>The Harris Hip Score is a joint specific score that consists of 10 items covering domains of pain (1 item, 0-44 points), function (7 items, 0-47 points), functional activities, absence of deformity (1 item, 0 or 4 points), and hip range of motion (2 items, 0-5 points). Scores range from 0 (worst) to 100 (best).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life with Oxford Hip Score (postal)</measure>
    <time_frame>Pre-operative and 6 months, 3 years, 5 years, and 7.5 years post operative</time_frame>
    <description>Patients are asked to reflect on their pain and functional ability over the previous four weeks. There are two domains (pain and function) with six items or questions in each. Each item has five possible responses. In the original scoring responses were from 1 = least difficult to 5= most difficult. Item scores are summed to give a total score from anywhere between 12 and 60. The lower the score, the better the outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life with EuroQol Questionnaire (EQ-5D)</measure>
    <time_frame>Pre-operative and 6 months, 3 years, 5 years, and 7.5 years post operative</time_frame>
    <description>The descriptive system consists of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which takes one of three responses. The responses record three levels of severity (no problems/some or moderate problems/extreme problems) within a particular dimension. The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. This information can be used as a quantitative measure of health outcome as judged by the individual respondents.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Device-related complications</measure>
    <time_frame>6 months, 3 years, 5 years, 7.5 years, and 10 years post operative</time_frame>
    <description>Complications and adverse events will be noted at each follow-up and using clinical judgement it will be determined whether the event is device related</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of revisions or withdrawals for any reason</measure>
    <time_frame>6 months, 3 years, 5 years, 7.5 years, and 10 years post operative</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiographic evaluations</measure>
    <time_frame>Pre-operative, peri-operative, 6 months, 3 years, 5 years, 7.5 years, and 10 years post operative</time_frame>
    <description>Anterior-posterior, and lateral view x-rays of the femur and pelvis of the affected hip will be evaluated. X-rays will be reviewed and specific information regarding presence/absence/location of radiolucent lines and implant positions and alignment will be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Survival Rate</measure>
    <time_frame>10 years post operative</time_frame>
    <description>The survival rate will be calculated according to the method in accordance with Kaplan-Meier stating the 95% confidence interval.</description>
  </secondary_outcome>
  <enrollment type="Actual">270</enrollment>
  <condition>Primary Osteoarthritis</condition>
  <condition>Secondary Osteoarthritis</condition>
  <condition>Avascular Necrosis</condition>
  <condition>Primary Total Hip Replacement (THR)</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Anthology Hip Replacement System</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Those presenting with primary or secondary osteoarthritis or avascular necrosis of the&#xD;
        femoral head or patients suitable for a primary total hip replacement (THR).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          1. Those presenting with primary or secondary osteoarthritis or avascular necrosis of the&#xD;
             femoral head or patients suitable for a primary total hip replacement. This is the&#xD;
             patient group that will benefit from operative surgery to treat osteoarthritis.&#xD;
&#xD;
          2. Those deemed capable of giving informed consent, understanding the aims of the study&#xD;
             and expressing willingness to comply with the post-operative review programme.&#xD;
             Patients capable of giving informed consent are eligible for inclusion into the study.&#xD;
&#xD;
          3. Participants who signed the Ethics Committee approved specific Informed Consent Form&#xD;
             prior to surgery. Patients who have not given informed consent will not be eligible&#xD;
             for inclusion into the study.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. Patients whose prospects for a recovery to independent mobility would be compromised&#xD;
             by known coexistent, medical problems.&#xD;
&#xD;
          2. Patients not suitable for primary hip replacement.&#xD;
&#xD;
          3. Patients with active or suspected infection.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard Field, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>South West London Elective Orthopaedic Centre (SWLEOC)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Helmut Zahn, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>William Harvey Hospital East Kent NHS Trust</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Pankaj Sharma, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ashford and St. Peter's NHS Trust</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tony Andrade, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Royal Berkshire NHS Foundation Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>William Harvey Hospital East Kent NHS Trust</name>
      <address>
        <city>Ashford</city>
        <zip>TN24 0LZ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ashford and St. Peter's NHS Trust</name>
      <address>
        <city>Chertsey</city>
        <zip>KT16 OPZ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South West London Elective Orthopaedic Centre (SWLEOC)</name>
      <address>
        <city>Epsom</city>
        <zip>KT18 7EG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Berkshire NHS Foundation Trust</name>
      <address>
        <city>Reading</city>
        <zip>RG1 5AN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>January 7, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>September 29, 2022</last_update_submitted>
  <last_update_submitted_qc>September 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 30, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>THR</keyword>
  <keyword>Anthology Hip Replacement</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Necrosis</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/NCT04425603
org study id: R11006-1
nct id: NCT04425603
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
This clinical study will verify the clinical and radiographic performance of the prosthesis
      when used in human subjects over a period of 10 years. All complications will be documented.
The clinical evaluations will be based on standard, functional and pain parameters Harris Hip
      Score pre-operatively, and at 6 months, 3, 5, 7.5 and 10 years post-operatively. Postal
      Oxford questionnaire preoperatively, and yearly thereafter. The objective of this study is to
      analyse the clinical and radiographic responses and the complication rates for patients
      undergoing primary total hip arthroplasty using the Anthology Hip Replacement System
      (Anthology Hip System).
observational model: Cohort
time perspective: Prospective
measure: Harris Hip Score - 10 years
time frame: 10 years post operative
description: The Harris Hip Score is a joint specific score that consists of 10 items covering domains of pain (1 item, 0-44 points), function (7 items, 0-47 points), functional activities, absence of deformity (1 item, 0 or 4 points), and hip range of motion (2 items, 0-5 points). Scores range from 0 (worst) to 100 (best).
measure: Quality of life with Oxford Hip Score (postal) - 10 years
time frame: 10 years post operative
description: Patients are asked to reflect on their pain and functional ability over the previous four weeks. There are two domains (pain and function) with six items or questions in each. Each item has five possible responses. In the original scoring responses were from 1 = least difficult to 5= most difficult. Item scores are summed to give a total score from anywhere between 12 and 60. The lower the score, the better the outcome.
measure: Quality of life with EuroQol Questionnaire (EQ-5D) -10 years
time frame: 10 years post operative
description: The descriptive system consists of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which takes one of three responses. The responses record three levels of severity (no problems/some or moderate problems/extreme problems) within a particular dimension. The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. This information can be used as a quantitative measure of health outcome as judged by the individual respondents.
measure: Harris Hip Score
time frame: Pre-operative and 6 months, 3 years, 5 years, and 7.5 years post operative
description: The Harris Hip Score is a joint specific score that consists of 10 items covering domains of pain (1 item, 0-44 points), function (7 items, 0-47 points), functional activities, absence of deformity (1 item, 0 or 4 points), and hip range of motion (2 items, 0-5 points). Scores range from 0 (worst) to 100 (best).
measure: Quality of life with Oxford Hip Score (postal)
time frame: Pre-operative and 6 months, 3 years, 5 years, and 7.5 years post operative
description: Patients are asked to reflect on their pain and functional ability over the previous four weeks. There are two domains (pain and function) with six items or questions in each. Each item has five possible responses. In the original scoring responses were from 1 = least difficult to 5= most difficult. Item scores are summed to give a total score from anywhere between 12 and 60. The lower the score, the better the outcome.
measure: Quality of life with EuroQol Questionnaire (EQ-5D)
time frame: Pre-operative and 6 months, 3 years, 5 years, and 7.5 years post operative
description: The descriptive system consists of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which takes one of three responses. The responses record three levels of severity (no problems/some or moderate problems/extreme problems) within a particular dimension. The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. This information can be used as a quantitative measure of health outcome as judged by the individual respondents.
measure: Device-related complications
time frame: 6 months, 3 years, 5 years, 7.5 years, and 10 years post operative
description: Complications and adverse events will be noted at each follow-up and using clinical judgement it will be determined whether the event is device related
measure: Number of revisions or withdrawals for any reason
time frame: 6 months, 3 years, 5 years, 7.5 years, and 10 years post operative
measure: Radiographic evaluations
time frame: Pre-operative, peri-operative, 6 months, 3 years, 5 years, 7.5 years, and 10 years post operative
description: Anterior-posterior, and lateral view x-rays of the femur and pelvis of the affected hip will be evaluated. X-rays will be reviewed and specific information regarding presence/absence/location of radiolucent lines and implant positions and alignment will be recorded.
measure: Survival Rate
time frame: 10 years post operative
description: The survival rate will be calculated according to the method in accordance with Kaplan-Meier stating the 95% confidence interval.
intervention type: Device
intervention name: Anthology Hip Replacement System
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Richard Field, MD
role: Principal Investigator
affiliation: South West London Elective Orthopaedic Centre (SWLEOC)
last name: Helmut Zahn, MD
role: Principal Investigator
affiliation: William Harvey Hospital East Kent NHS Trust
last name: Pankaj Sharma, MD
role: Principal Investigator
affiliation: Ashford and St. Peter's NHS Trust
last name: Tony Andrade, MD
role: Principal Investigator
affiliation: Royal Berkshire NHS Foundation Trust
facility: 
facility: 
facility: 
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Necrosis
sharing ipd: No