<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/NCT02263209</url>
  </required_header>
  <id_info>
    <org_study_id>BMETEU.CR.EU77</org_study_id>
    <nct_id>NCT02263209</nct_id>
  </id_info>
  <brief_title>Investigation to Determine Safety of Taperloc Stems With BioGuard Coating When Used in Cementless Total Hip Arthroplasty</brief_title>
  <official_title>Prospective Clinical Investigation to Determine the Safety of Taperloc Stems With BioGuard Coating and Exceed ABT Taperfit Acetabular Cups With BioGuard Coating When Used in Cementless Total Hip Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zimmer Biomet</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zimmer Biomet</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective clinical investigation to determine the safety of Taperloc stems with BioGuard&#xD;
      coating and Exceed ABT Taperfit acetabular cups with BioGuard coating when used in cementless&#xD;
      total hip arthroplasty&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Bioguard Safety Study: Prospective clinical investigation to determine the safety of Taperloc&#xD;
      stems with BioGuard coating and Exceed ABT Taperfit acetabular cups with BioGuard coating&#xD;
      when used in cementless total hip arthroplasty&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 2013</start_date>
  <completion_date type="Anticipated">May 2025</completion_date>
  <primary_completion_date type="Actual">November 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in normalised peri-implant BMD as measured by DXA</measure>
    <time_frame>6 months post operative</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Osteoarthritis of Hip</condition>
  <arm_group>
    <arm_group_label>Bioguard Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Randomised study to either Bioguard or control stock</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Randomised study to either Bioguard or control stock</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Bioguard Group</intervention_name>
    <description>Patients randomised to receive the study investigative device will receive a Bioguard implant</description>
    <arm_group_label>Bioguard Group</arm_group_label>
    <other_name>Bioguard device</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Control Group</intervention_name>
    <description>Patients randomised to receive the control device will receive a Exceed Taperlock implant</description>
    <arm_group_label>Control Group</arm_group_label>
    <other_name>Exceed Taperlock</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Eligible for cementless primary total hip arthroplasty according to the Surgical&#xD;
             Technique brochure (Appendix 10): &quot;The Taperloc Porous Primary Hip and Exceed ABT&#xD;
             Taperfit Prostheses are marketed for non-cemented use in skeletally mature patients&#xD;
             undergoing primary hip replacement surgery of non inflammatory degenerative joint&#xD;
             disease.&quot;&#xD;
&#xD;
          -  Under 80 and over 40 years of age&#xD;
&#xD;
          -  A pre-operative level of pain and function the same as for conventional joint&#xD;
             replacement.&#xD;
&#xD;
          -  A likelihood of obtaining relief of pain and improved function&#xD;
&#xD;
          -  Full skeletal maturity&#xD;
&#xD;
          -  Ability to follow instructions&#xD;
&#xD;
          -  Good general health for age&#xD;
&#xD;
          -  Willing to return for follow-up evaluations&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients aged over 80 and under 40 years&#xD;
&#xD;
          -  Known allergy to any antibiotics&#xD;
&#xD;
          -  Active infection&#xD;
&#xD;
          -  Revision arthroplasty&#xD;
&#xD;
          -  Marked bone loss which could preclude or compromise adequate fixation of the device&#xD;
&#xD;
          -  Uncooperative subjects&#xD;
&#xD;
          -  Parkinson's Disease&#xD;
&#xD;
          -  Vascular insufficiency of the affected limb, which could compromise bony&#xD;
             ingrowth/implant fixation, i.e., diabetes.&#xD;
&#xD;
          -  Severe instability or deformity of the ligaments and/or surrounding soft tissue which&#xD;
             may preclude stability of the device&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  BMI &gt; 40&#xD;
&#xD;
          -  Use of immunosuppressive drugs&#xD;
&#xD;
          -  Women of child bearing potential&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sudheer Karlakki, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>RJAH, Oswestry</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>RJAH</name>
      <address>
        <city>Oswestry</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>October 8, 2014</study_first_submitted>
  <study_first_submitted_qc>October 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>January 24, 2023</last_update_submitted>
  <last_update_submitted_qc>January 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 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>Osteoarthritis, Hip</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02263209
org study id: BMETEU.CR.EU77
nct id: NCT02263209
lead sponsor: 
has dmc: No
Prospective clinical investigation to determine the safety of Taperloc stems with BioGuard
      coating and Exceed ABT Taperfit acetabular cups with BioGuard coating when used in cementless
      total hip arthroplasty
Bioguard Safety Study: Prospective clinical investigation to determine the safety of Taperloc
      stems with BioGuard coating and Exceed ABT Taperfit acetabular cups with BioGuard coating
      when used in cementless total hip arthroplasty
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change in normalised peri-implant BMD as measured by DXA
time frame: 6 months post operative
arm group label: Bioguard Group
arm group type: Experimental
description: Randomised study to either Bioguard or control stock
arm group label: Control Group
arm group type: Active Comparator
description: Randomised study to either Bioguard or control stock
intervention type: Device
intervention name: Bioguard Group
description: Patients randomised to receive the study investigative device will receive a Bioguard implant
arm group label: Bioguard Group
other name: Bioguard device
intervention type: Device
intervention name: Control Group
description: Patients randomised to receive the control device will receive a Exceed Taperlock implant
arm group label: Control Group
other name: Exceed Taperlock
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: No
last name: Sudheer Karlakki, MD
role: Principal Investigator
affiliation: RJAH, Oswestry
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Osteoarthritis, Hip
sharing ipd: Undecided