<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/NCT03266874</url>
  </required_header>
  <id_info>
    <org_study_id>H.CR.I.EU.16.26</org_study_id>
    <nct_id>NCT03266874</nct_id>
  </id_info>
  <brief_title>G7 BiSpherical Acetabular Shell PMCF Study</brief_title>
  <official_title>Prospective Multicenter Observational Evaluation of the Use of the G7 BiSpherical Acetabular Shell</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to obtain implant survivorship and clinical outcomes&#xD;
      data for the commercially available G7 BiSpherical Acetabular Shell.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The G7 BiSpherical Acetabular Shell belongs to the G7 multi-bearing platform. It was&#xD;
      developed to provide an additional surgical option for patients in need of a total hip&#xD;
      replacement. The aim of the G7 BiSpherical Acetabular Shell is to increase hip function while&#xD;
      reducing pain.&#xD;
&#xD;
      This study is a multicenter, prospective, non-randomized, non-controlled post market&#xD;
      surveillance study involving orthopedic surgeons skilled in hip arthroplasty procedures. A&#xD;
      minimum of 4 and a maximum of 5 sites will be involved in this study. This number of clinical&#xD;
      centers will permit assessment of consistency among a multitude of investigators. 140-175&#xD;
      implants will be included into the study. Each site will be allowed to enroll 35 patients.&#xD;
      All potential study subjects will be required to participate in the Informed Consent Process.&#xD;
&#xD;
      The safety and performance of the G7 BiSpherical Acetabular Shell will be assessed as&#xD;
      following: implant survivorship based on revision with removal of the study device; safety&#xD;
      based on incidence and frequency of adverse events; and clinical efficacy measured by overall&#xD;
      pain and function, quality of life data and radiographic evaluation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 10, 2017</start_date>
  <completion_date type="Anticipated">December 2031</completion_date>
  <primary_completion_date type="Anticipated">December 2029</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>Implant survivorship is assessed counting the number of implant revisions</measure>
    <time_frame>10 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical efficacy of the device is assessed using the Oxford Hip Score patient questionnaire</measure>
    <time_frame>10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical efficacy of the device is assessed using the Harris Hip Score patient questionnaire</measure>
    <time_frame>10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety is assessed according to the number of complications which are collected via adverse event forms.</measure>
    <time_frame>10 years</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">160</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <condition>Osteoarthritis</condition>
  <condition>Noninflammatory Degenerative Joint Disease</condition>
  <condition>Avascular Necrosis</condition>
  <condition>Correction of Functional Deformity</condition>
  <condition>Non-Union Fracture</condition>
  <condition>Femoral Neck Fractures</condition>
  <condition>Trochanteric Fractures</condition>
  <arm_group>
    <arm_group_label>Patients who received the G7 BiSpherical Cup</arm_group_label>
    <description>Subject in need of a THA who met the inclusion/exclusion criteria and received the G7 BiSpherical cup.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients in need of a Total Hip Arthroplasty (primary or revision) which receive the G7&#xD;
        BiSperical Acetabular Shell and who meet all of the inclusion and none of the exclusion&#xD;
        criteria.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient capable of understanding the surgeon's explanations and following his&#xD;
             instructions, able and willing to participate in the follow-up program and who gave&#xD;
             consent to take part in the study.&#xD;
&#xD;
          -  Patient aged of 18 years or more whose skeleton reached bone maturity.&#xD;
&#xD;
          -  Noninflammatory degenerative joint disease including osteoarthritis and avascular&#xD;
             necrosis.&#xD;
&#xD;
          -  Rheumatoid arthritis.&#xD;
&#xD;
          -  Correction of functional deformity.&#xD;
&#xD;
          -  Treatment of non-union, femoral neck fracture, and trochanteric fractures of the&#xD;
             proximal femur with head involvement, unmanageable by other techniques.&#xD;
&#xD;
          -  Revision procedures where other treatment or devices have failed.&#xD;
&#xD;
        Inclusion criteria specific for patients receiving the G7 BiSpherical Shell with the G7&#xD;
        Freedom Constrained Liner:&#xD;
&#xD;
          -  The Biomet G7 Freedom Constrained Liner is indicated for use as a component of a total&#xD;
             hip prosthesis in primary and revision patients at high risk of dislocation due to a&#xD;
             history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular&#xD;
             disease, or intraoperative instability, and for whom all other options to con-strained&#xD;
             acetabular components have been considered.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Absolute exclusion criteria include:&#xD;
&#xD;
          -  Infection, sepsis, osteomyelitis.&#xD;
&#xD;
        Relative exclusion criteria include:&#xD;
&#xD;
          -  Uncooperative patient or patient with neurologic disorders who is incapable of&#xD;
             following directions.&#xD;
&#xD;
          -  Osteoporosis.&#xD;
&#xD;
          -  Metabolic disorders which may impair bone formation.&#xD;
&#xD;
          -  Osteomalacia.&#xD;
&#xD;
          -  Distant foci of infections which may spread to the implant site.&#xD;
&#xD;
          -  Rapid joint destruction, marked bone loss or bone resorption apparent on&#xD;
             roentgenogram.&#xD;
&#xD;
          -  Vascular insufficiency, muscular atrophy or neuromuscular disease.&#xD;
&#xD;
          -  Patient unwilling or unable to give consent, or to comply with the follow-up program.&#xD;
&#xD;
          -  Patient known to be pregnant or breastfeeding.&#xD;
&#xD;
          -  Patient presenting any condition that would, in the judgment of the Investigator,&#xD;
             place the patient at undue risk or interfere with the study.&#xD;
&#xD;
          -  Patient institutionalized or known drug abuser or alcoholic or anyone who cannot&#xD;
             understand what is required of them.&#xD;
&#xD;
          -  Patient belonging to a vulnerable population.&#xD;
&#xD;
        Exclusion criteria specific for patients receiving the G7 BiSpherical Shell with the G7&#xD;
        Freedom Constrained Liner:&#xD;
&#xD;
          -  Bone or musculature compromised by disease, infection, or prior implantation that&#xD;
             cannot provide adequate support or fixation for the prosthesis.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Hassan Achakri</last_name>
    <role>Study Director</role>
    <affiliation>Zimmer Biomet</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cabinet du Dr. Miazzolo</name>
      <address>
        <city>Perpignan</city>
        <zip>66000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orthopädische Chirurgie Müchen OCM</name>
      <address>
        <city>Munich</city>
        <state>Bayern</state>
        <zip>81369</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Herzogin Elisabeth Hospital</name>
      <address>
        <city>Braunschweig</city>
        <state>Niedersachsen</state>
        <zip>38124</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Reinier de Graaf Groep</name>
      <address>
        <city>Delft</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orthoprax AG</name>
      <address>
        <city>Bern</city>
        <zip>3012</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
    <country>Germany</country>
    <country>Netherlands</country>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>August 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>September 7, 2022</last_update_submitted>
  <last_update_submitted_qc>September 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>total hip arthroplasty</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Joint Diseases</mesh_term>
    <mesh_term>Necrosis</mesh_term>
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Femoral Neck Fractures</mesh_term>
    <mesh_term>Hip Fractures</mesh_term>
    <mesh_term>Fractures, Ununited</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/NCT03266874
org study id: H.CR.I.EU.16.26
nct id: NCT03266874
lead sponsor: 
has dmc: No
is fda regulated drug: No
is us export: No
The primary objective of this study is to obtain implant survivorship and clinical outcomes
      data for the commercially available G7 BiSpherical Acetabular Shell.
The G7 BiSpherical Acetabular Shell belongs to the G7 multi-bearing platform. It was
      developed to provide an additional surgical option for patients in need of a total hip
      replacement. The aim of the G7 BiSpherical Acetabular Shell is to increase hip function while
      reducing pain.

      This study is a multicenter, prospective, non-randomized, non-controlled post market
      surveillance study involving orthopedic surgeons skilled in hip arthroplasty procedures. A
      minimum of 4 and a maximum of 5 sites will be involved in this study. This number of clinical
      centers will permit assessment of consistency among a multitude of investigators. 140-175
      implants will be included into the study. Each site will be allowed to enroll 35 patients.
      All potential study subjects will be required to participate in the Informed Consent Process.

      The safety and performance of the G7 BiSpherical Acetabular Shell will be assessed as
      following: implant survivorship based on revision with removal of the study device; safety
      based on incidence and frequency of adverse events; and clinical efficacy measured by overall
      pain and function, quality of life data and radiographic evaluation.
observational model: Cohort
time perspective: Prospective
measure: Implant survivorship is assessed counting the number of implant revisions
time frame: 10 years
measure: Clinical efficacy of the device is assessed using the Oxford Hip Score patient questionnaire
time frame: 10 years
measure: Clinical efficacy of the device is assessed using the Harris Hip Score patient questionnaire
time frame: 10 years
measure: Safety is assessed according to the number of complications which are collected via adverse event forms.
time frame: 10 years
arm group label: Patients who received the G7 BiSpherical Cup
description: Subject in need of a THA who met the inclusion/exclusion criteria and received the G7 BiSpherical cup.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Hassan Achakri
role: Study Director
affiliation: Zimmer Biomet
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
country: Germany
country: Netherlands
country: Switzerland
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Joint Diseases
mesh term: Necrosis
mesh term: Fractures, Bone
mesh term: Femoral Neck Fractures
mesh term: Hip Fractures
mesh term: Fractures, Ununited