xml: <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/NCT06033651</url>
    </required_header>
    <id_info>
      <org_study_id>version 1 27/6/2023</org_study_id>
      <nct_id>NCT06033651</nct_id>
    </id_info>
    <brief_title>Long Term Follow up of the Titanium Modular Revision Hip System, With Review of Metal Ion Levels</brief_title>
    <acronym>TinT10</acronym>
    <official_title>Long Term Follow up of the Titanium Modular Revision Hip System, With Review of Metal Ion Levels</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust</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>
        Patients are to be approached to attend clinic who have been identified as being implanted&#xD;
        with either a Lima Corporate Delta Revision TT, Delta One TT or the Delta Multihole Systems&#xD;
        hip systems between 2011 and 2013, a minimum of 10 years since hip surgery. They will be&#xD;
        x-rayed (AP pelvis and a lateral view) and a blood test will be taken and sent to a lab in&#xD;
        Surrey to check titanium levels.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Since its popularisation in the 1960's, Hip replacements have become one of the NHS's highest&#xD;
        volume procedures. Unfortunately, hip replacements can fail with on average 8,500 revision&#xD;
        hip replacements being performed each year pre-covid. Often this is very complex with&#xD;
        destruction of the normal anatomy leaving surgeons with a significant challenge in ensuring&#xD;
        appropriate positioning of the socket within the confines of the patient's anatomy.&#xD;
  &#xD;
        The Lima Corporate Delta Revision TT, Delta One TT and Delta Multihole Systems are designed&#xD;
        to help surgeons with this very problem by providing the option of a 'face changer' allowing&#xD;
        surgeons to place a socket within a socket.&#xD;
  &#xD;
        To allow for this function, the 'face changer' must connect with the acetabular cup (socket).&#xD;
        Through research, it is widely known that when metals interact within the body, they can&#xD;
        cause wear and shedding of metal debris. This process is known as metallosis and can result&#xD;
        in metal ions being released into the surrounding bone and tissues as well as being absorbed&#xD;
        into the blood stream.&#xD;
  &#xD;
        The risk of this is highest when there is significant movement between the components (such&#xD;
        as in metal-on-metal hip replacements). It is less of an issue at other interfaces which are&#xD;
        not intended to allow movement between them. That said, our hypothesis is that the increase&#xD;
        in the number of interfaces which gives us the flexibility we need, may increase the release&#xD;
        of free metal ions in the blood stream. The aim of this study is to therefore identify if&#xD;
        this is in fact the case and if so, whether the increase in ions is sufficient for surgeons&#xD;
        to bear in mind.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 30, 2023</start_date>
    <completion_date type="Anticipated">November 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2024</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 survivourship of the modular acetabular hip system at 10 years post-op</measure>
      <time_frame>Once blood results are back from the specialist assessment laboratory (approximately 3 weeks post clinic visit).</time_frame>
      <description>By looking at titanium ion blood levels and pelvis x-rays, this gives an indication of whether the device is loosening and failing in this particular hip system.</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Hip Surgery</condition>
    <arm_group>
      <arm_group_label>Only 1 arm for the study</arm_group_label>
      <description>All participants shall receive the same treatment.</description>
    </arm_group>
    <intervention>
      <intervention_type>Radiation</intervention_type>
      <intervention_name>x-ray</intervention_name>
      <description>A sample of blood will be taken and sent to a lab in Surrey to check for metal ions.</description>
      <arm_group_label>Only 1 arm for the study</arm_group_label>
      <other_name>blood sample</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          All adult patients who had Lima Corporate modular titanium acetabular component implants&#xD;
          implanted between 2012 and 2013.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          All adult patients who had Lima Corporate modular titanium acetabular component implants&#xD;
          implanted between 2012 and 2013.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Deceased patients Patients who have undergone a subsequent acetabular revision Patients&#xD;
          that lack capacity Prisoners in the custody of HM Prison service or who are offenders&#xD;
          supervised by the probation service in England or Wales.&#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>Robin Banerjee</last_name>
      <role>Principal Investigator</role>
      <affiliation>The Robert Jones and Agnes Hunt Orthopaedic Hospital Foundation Trust</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Julie Steen</last_name>
      <phone>+441691404418</phone>
      <phone_ext>4418</phone_ext>
      <email>julie.steen@nhs.net</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Thomas Banks</last_name>
      <phone>+441691404418</phone>
      <email>thomas.banks3@nhs.net</email>
    </overall_contact_backup>
    <reference>
      <citation>Ben-Shlomo Y, Blom A, Boulton C, Brittain R, Clark E, Dawson-Bowling S, Deere K, Esler C, Espinoza O, Evans J, Goldberg A, Gregson C, Howard P, Jameson S, Jennison T, Judge A, Lawrence S, Lenguerrand E, Marques E, McCormack V, Newell C, Pegg D, Penfold C, Porter M, Price A, Reed M, Rees J, Royall M, Sayers A, Stonadge J, Swanson M, Taylor D, Toms A, Watts A, Whitehouse M, Wilkinson M, Wilton T, Young E. The National Joint Registry 19th Annual Report 2022 [Internet]. London: National Joint Registry; 2022 Oct. Available from http://www.ncbi.nlm.nih.gov/books/NBK587525/</citation>
      <PMID>36516281</PMID>
    </reference>
    <reference>
      <citation>Liu TK, Liu SH, Chang CH, Yang RS. Concentration of metal elements in the blood and urine in the patients with cementless total knee arthroplasty. Tohoku J Exp Med. 1998 Aug;185(4):253-62. doi: 10.1620/tjem.185.253.</citation>
      <PMID>9865472</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06033651
  org study id: version 1 27/6/2023
  nct id: NCT06033651
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Patients are to be approached to attend clinic who have been identified as being implanted
        with either a Lima Corporate Delta Revision TT, Delta One TT or the Delta Multihole Systems
        hip systems between 2011 and 2013, a minimum of 10 years since hip surgery. They will be
        x-rayed (AP pelvis and a lateral view) and a blood test will be taken and sent to a lab in
        Surrey to check titanium levels.
  Since its popularisation in the 1960's, Hip replacements have become one of the NHS's highest
        volume procedures. Unfortunately, hip replacements can fail with on average 8,500 revision
        hip replacements being performed each year pre-covid. Often this is very complex with
        destruction of the normal anatomy leaving surgeons with a significant challenge in ensuring
        appropriate positioning of the socket within the confines of the patient's anatomy.
  
        The Lima Corporate Delta Revision TT, Delta One TT and Delta Multihole Systems are designed
        to help surgeons with this very problem by providing the option of a 'face changer' allowing
        surgeons to place a socket within a socket.
  
        To allow for this function, the 'face changer' must connect with the acetabular cup (socket).
        Through research, it is widely known that when metals interact within the body, they can
        cause wear and shedding of metal debris. This process is known as metallosis and can result
        in metal ions being released into the surrounding bone and tissues as well as being absorbed
        into the blood stream.
  
        The risk of this is highest when there is significant movement between the components (such
        as in metal-on-metal hip replacements). It is less of an issue at other interfaces which are
        not intended to allow movement between them. That said, our hypothesis is that the increase
        in the number of interfaces which gives us the flexibility we need, may increase the release
        of free metal ions in the blood stream. The aim of this study is to therefore identify if
        this is in fact the case and if so, whether the increase in ions is sufficient for surgeons
        to bear in mind.
  observational model: Cohort
  time perspective: Prospective
  measure: The survivourship of the modular acetabular hip system at 10 years post-op
  time frame: Once blood results are back from the specialist assessment laboratory (approximately 3 weeks post clinic visit).
  description: By looking at titanium ion blood levels and pelvis x-rays, this gives an indication of whether the device is loosening and failing in this particular hip system.
  arm group label: Only 1 arm for the study
  description: All participants shall receive the same treatment.
  intervention type: Radiation
  intervention name: x-ray
  description: A sample of blood will be taken and sent to a lab in Surrey to check for metal ions.
  arm group label: Only 1 arm for the study
  other name: blood sample
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Robin Banerjee
  role: Principal Investigator
  affiliation: The Robert Jones and Agnes Hunt Orthopaedic Hospital Foundation Trust
  last name: Julie Steen
  phone: +441691404418
  phone ext: 4418
  email: julie.steen@nhs.net
  last name: Thomas Banks
  phone: +441691404418
  email: thomas.banks3@nhs.net
  citation: Ben-Shlomo Y, Blom A, Boulton C, Brittain R, Clark E, Dawson-Bowling S, Deere K, Esler C, Espinoza O, Evans J, Goldberg A, Gregson C, Howard P, Jameson S, Jennison T, Judge A, Lawrence S, Lenguerrand E, Marques E, McCormack V, Newell C, Pegg D, Penfold C, Porter M, Price A, Reed M, Rees J, Royall M, Sayers A, Stonadge J, Swanson M, Taylor D, Toms A, Watts A, Whitehouse M, Wilkinson M, Wilton T, Young E. The National Joint Registry 19th Annual Report 2022 [Internet]. London: National Joint Registry; 2022 Oct. Available from http://www.ncbi.nlm.nih.gov/books/NBK587525/
  PMID: 36516281
  citation: Liu TK, Liu SH, Chang CH, Yang RS. Concentration of metal elements in the blood and urine in the patients with cementless total knee arthroplasty. Tohoku J Exp Med. 1998 Aug;185(4):253-62. doi: 10.1620/tjem.185.253.
  PMID: 9865472
  responsible party type: Sponsor
  sharing ipd: No