<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/NCT01721278</url>
  </required_header>
  <id_info>
    <org_study_id>12/LO/0768</org_study_id>
    <nct_id>NCT01721278</nct_id>
  </id_info>
  <brief_title>Furlong Evolution® Hip Trial</brief_title>
  <official_title>A Prospective Multicentre Clinical Surveillance Study To Evaluate The Stability, Efficacy And Safety Of The Furlong Evolution® Hip Stem In Primary Total Hip Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Imperial College London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Joint Replacement Instrumented Orthopaedics Ltd</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Imperial College London</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Total hip replacement (THR) is a highly effective procedure in relieving pain and restoring&#xD;
      function. Many different implants can be used in artificial hip joints. Hydroxyapatiteceramic&#xD;
      (HAC) coating has become a well established The JRI Furlong® HAC femoral stem is one such&#xD;
      implant with good long term survivorship. The femoral implant has been used since 1985 and&#xD;
      published findings have shown a 97.4% survivorship at a mean of 17 years follow up in&#xD;
      patients. The Furlong Evolution® design is based on the tried and tested Furlong HAC but with&#xD;
      some modifications.&#xD;
&#xD;
      This is a 10 year multicentre clinical surveillance study, which aims to assess the clinical,&#xD;
      functional and radiological performance of the Furlong Evolution® Hip stem in human patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Purpose and Design:&#xD;
&#xD;
      The Furlong Evolution® design is based on the tried and tested Furlong H.A.C implant but with&#xD;
      some modifications. It still retains its full H.A.C coating and is much shorter in length.&#xD;
      This potentially makes it easier to introduce into the femoral canal, which may result in&#xD;
      less soft tissue damage and lower rate of femoral fracture. This would be very beneficial,&#xD;
      should revision (implant replacement) be required at a later date. This potential&#xD;
      characteristic has been highlighted as an important component of determining the clinical&#xD;
      effectiveness of a total hip replacement.&#xD;
&#xD;
      As per the National Institute of Clinical Excellence (NICE) guidelines the best prostheses&#xD;
      demonstrates a revision rate (the rate at which they need to be replaced) of 10% or less at&#xD;
      10 years. This should be regarded as the current benchmark in the selection of prostheses for&#xD;
      primary Total Hip Replacement (THR). It is also considered reasonable to recommend a&#xD;
      prostheses with a maximum of 3% revision rate at 3 years which would indicate performance&#xD;
      would then be subjected to annual review (up to 10 years) to ensure that the revision rate&#xD;
      remains consistent with the 10year benchmark. The Orthopaedic Data Evaluation Panel (ODEP)&#xD;
      was established to evaluate data on the outcomes of prostheses provided by manufactures and&#xD;
      to inform the NHS which products are compliant with the benchmarks set by NICE. Therefore&#xD;
      this study will be a ODEP compliant multicentre prospective surveillance study of the Furlong&#xD;
      Evolution® Hip Stem that will assess the clinical, functional and radiographical performance&#xD;
      over a 10 year period in compliance with the NICE guidelines.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Anticipated">October 2022</completion_date>
  <primary_completion_date type="Anticipated">October 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>The performance of the Furlong Evolution Hip Stem will be assessed clinically and radiographically of all participants. Number of participants who have reported complications, adverse events &amp; serious adverse events will act as a measure of safety.</measure>
    <time_frame>10 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Questionnaires (Oxford Hip,EQ5D &amp; Harris Hip Score) will be obtained from participating subjects to evaluate patient function &amp; satisfaction &amp; quality of life at each follow up visit.</measure>
    <time_frame>10 years</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">700</enrollment>
  <condition>Focus: A Multicentre Prospective Clinical Surveillance Study Aims to Assess the Clinical, Functional and Radiological Outcome of the Furlong Evolution® Hip Stem</condition>
  <eligibility>
    <study_pop>
      <textblock>
        As per ODEP guidelines, a minimum of 500 cohort size is required for benchmark validation&#xD;
        of the clinical performance of a new orthopaedic implant. We will be using a total sample&#xD;
        size of 700 patients over 10 centres to ensure we meet the benchmark validation criteria.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. All patients consenting to total hip replacement&#xD;
&#xD;
          2. All patients deemed suitable for total hip replacement&#xD;
&#xD;
          3. All patients passing pre-assessment deeming them medically fit enough for total hip&#xD;
             replacement.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients deemed unsuitable for Total Hip Replacement&#xD;
&#xD;
          2. Patients who refuse to have surgery opting for other modes of treatment&#xD;
&#xD;
          3. Patients who are unable to consent due to a lack of capacity&#xD;
&#xD;
          4. Patients unable to understand English&#xD;
&#xD;
          5. Any patient under the age of 18 years.&#xD;
&#xD;
          6. Patients who are pregnant or breast feeding&#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>Professor Justin Cobb, MCh FRCS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Imperial College London</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Justin Cobb, MCh FRCS</last_name>
    <phone>02033117687</phone>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hardeep Johal, BSc (Hons)</last_name>
    <phone>020 33115216</phone>
    <email>h.johal@imperial.ac.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Charing Cross hospital</name>
      <address>
        <city>London</city>
        <zip>w6 8rf</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hardeep Johal, BSc (Hons)</last_name>
      <phone>020 33115216</phone>
      <email>h.johal@imperial.ac.uk</email>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>October 16, 2012</study_first_submitted>
  <study_first_submitted_qc>November 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 4, 2012</study_first_posted>
  <last_update_submitted>March 9, 2022</last_update_submitted>
  <last_update_submitted_qc>March 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT01721278
org study id: 12/LO/0768
nct id: NCT01721278
lead sponsor: 
collaborator: 
has dmc: No
Total hip replacement (THR) is a highly effective procedure in relieving pain and restoring
      function. Many different implants can be used in artificial hip joints. Hydroxyapatiteceramic
      (HAC) coating has become a well established The JRI Furlong® HAC femoral stem is one such
      implant with good long term survivorship. The femoral implant has been used since 1985 and
      published findings have shown a 97.4% survivorship at a mean of 17 years follow up in
      patients. The Furlong Evolution® design is based on the tried and tested Furlong HAC but with
      some modifications.

      This is a 10 year multicentre clinical surveillance study, which aims to assess the clinical,
      functional and radiological performance of the Furlong Evolution® Hip stem in human patients.
Purpose and Design:

      The Furlong Evolution® design is based on the tried and tested Furlong H.A.C implant but with
      some modifications. It still retains its full H.A.C coating and is much shorter in length.
      This potentially makes it easier to introduce into the femoral canal, which may result in
      less soft tissue damage and lower rate of femoral fracture. This would be very beneficial,
      should revision (implant replacement) be required at a later date. This potential
      characteristic has been highlighted as an important component of determining the clinical
      effectiveness of a total hip replacement.

      As per the National Institute of Clinical Excellence (NICE) guidelines the best prostheses
      demonstrates a revision rate (the rate at which they need to be replaced) of 10% or less at
      10 years. This should be regarded as the current benchmark in the selection of prostheses for
      primary Total Hip Replacement (THR). It is also considered reasonable to recommend a
      prostheses with a maximum of 3% revision rate at 3 years which would indicate performance
      would then be subjected to annual review (up to 10 years) to ensure that the revision rate
      remains consistent with the 10year benchmark. The Orthopaedic Data Evaluation Panel (ODEP)
      was established to evaluate data on the outcomes of prostheses provided by manufactures and
      to inform the NHS which products are compliant with the benchmarks set by NICE. Therefore
      this study will be a ODEP compliant multicentre prospective surveillance study of the Furlong
      Evolution® Hip Stem that will assess the clinical, functional and radiographical performance
      over a 10 year period in compliance with the NICE guidelines.
observational model: Cohort
time perspective: Prospective
measure: The performance of the Furlong Evolution Hip Stem will be assessed clinically and radiographically of all participants. Number of participants who have reported complications, adverse events & serious adverse events will act as a measure of safety.
time frame: 10 years
measure: Questionnaires (Oxford Hip,EQ5D & Harris Hip Score) will be obtained from participating subjects to evaluate patient function & satisfaction & quality of life at each follow up visit.
time frame: 10 years
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Professor Justin Cobb, MCh FRCS
role: Principal Investigator
affiliation: Imperial College London
last name: Justin Cobb, MCh FRCS
phone: 02033117687
last name: Hardeep Johal, BSc (Hons)
phone: 020 33115216
email: h.johal@imperial.ac.uk
facility: 
status: Recruiting
contact: 
country: United Kingdom
responsible party type: Sponsor