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/NCT05980234</url>
    </required_header>
    <id_info>
      <org_study_id>MDRG2017-89MS-107H</org_study_id>
      <nct_id>NCT05980234</nct_id>
    </id_info>
    <brief_title>MDR - Longevity IT Oblique and Offset Liners</brief_title>
    <official_title>PMCF Study to Provide Safety, Performance, and Clinical Benefits Data of the Longevity IT Oblique and Offset Liners in Primary and Revision Total Hip Arthroplasty - A Retrospective Enrollment/Prospective Follow-up Consecutive Series Study</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_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The objective of this retrospective enrollment/prospective follow-up consecutive series PMCF&#xD;
        study is to collect data confirming safety, performance, and clinical benefits of the&#xD;
        Longevity IT Oblique and Offset liners when used for primary or revision total hip&#xD;
        arthroplasty (implants and instrumentation) at a minimum of 10-year follow-up.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The objective of this retrospective enrollment/prospective follow-up consecutive series PMCF&#xD;
        study is to collect data confirming safety, performance, and clinical benefits of the&#xD;
        Longevity IT Oblique and Offset liners when used for primary and revision total hip&#xD;
        arthroplasty (implants and instrumentation) at 1, 3, 5, 7, and 10 years*. The subject devices&#xD;
        have been on the market since 2010 but have insufficient data to support 10 years of clinical&#xD;
        history. A prospective aspect to the study will be utilized to collect long-term data.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">August 1, 2035</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2035</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>Other</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Incidence of treatment-emergent Adverse Events (safety)</measure>
      <time_frame>10 years</time_frame>
      <description>This will be assessed by recording the incidence and frequency of revisions, complications, and adverse events with particular focus on those that may be related to the study device.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Pain and Functional Performance - Oxford Hip Score</measure>
      <time_frame>10 years</time_frame>
      <description>&quot;The Oxford Hip Score is patient-reported outcome instrument which contains 12 questions on activities of daily living that assess function and residual pain in patients undergoing total hip replacement surgery.&#xD;
  Grading the Oxford Hip Score 0 to 19-May indicate severe hip arthritis... 20 to 29-May indicate moderate to severe hip arthritis... 30 to 39-May indicate mild to moderate hip arthritis... 40 to 48-May indicate satisfactory joint function...&quot; Oxford Hip Score. (n.d.) Segen's Medical Dictionary. (2011). Retrieved August 19 2022 from https://medical-dictionary.thefreedictionary.com/Oxford+Hip+Score</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Performance and Clinical Benefits - Harris Hip Score</measure>
      <time_frame>10 years</time_frame>
      <description>Patient Assessment: reported Harris Hip Score (if available)&#xD;
  Harris Hip Score:&#xD;
  The HHS is divided into three sections. The first section questions is about pain and its impact, which are answered by the patient or client. The second and third sections require the physiotherapist to assess the patient or client's hip joint and function.&#xD;
  The HHS is a measure of dysfunction so the higher the score, the better the outcome for the individual. Results can be recorded and calculated online. The maximum score possible is 100. Results can be interpreted with the following: &lt;70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Performance and Clinical Benefits - Activity Level</measure>
      <time_frame>10 years</time_frame>
      <description>Patient Assessment: activity level&#xD;
  Records patient's activity level on a 10-point scale from 'wholly inactive' to 'regularly particpates in impact sports.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">104</enrollment>
    <condition>Non-inflammatory Degenerative Joint Disease (NIDJD)</condition>
    <condition>Avascular Necrosis</condition>
    <condition>Protrusio Acetabuli</condition>
    <condition>Traumatic Arthritis</condition>
    <condition>Slipped Capital Femoral Epiphyses</condition>
    <condition>Fracture of the Pelvis</condition>
    <condition>Diastrophic Variant</condition>
    <condition>Osteoarthritis</condition>
    <condition>Fused Hip</condition>
    <arm_group>
      <arm_group_label>Longevity IT Oblique Liners</arm_group_label>
      <description>The Longevity IT Oblique liner was designed to provide variable joint anteversion and abduction.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Longevity IT Offset Liners</arm_group_label>
      <description>The Longevity IT Offset liner was designed to lateralize the center of rotation of the cup.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Total Hip Arthroplasty with Longevity IT Oblique Liners</intervention_name>
      <description>Primary or Revision Total Hip Arthroplasty using the Longevity IT Oblique liners according to the approved indications and compatible device.</description>
      <arm_group_label>Longevity IT Oblique Liners</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Total Hip Arthroplasty with Longevity IT Offset Liners</intervention_name>
      <description>Primary or Revision Total Hip Arthroplasty using the Longevity IT Offset liners according to the approved indications and compatible device.</description>
      <arm_group_label>Longevity IT Offset Liners</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The study population should be a consecutive series of subjects implanted with the&#xD;
          Longevity IT Oblique and/or Offset liners in either primary or revision THA. Up to 52&#xD;
          implanted hips with the Oblique liners and up to 52 implanted hips with the Offset liners&#xD;
          will be included in the study.&#xD;
  &#xD;
          The study population for primary statistical analysis will be comprised of males and&#xD;
          females who satisfy the inclusion/exclusion criteria outlined in the protocol. To avoid&#xD;
          potential selection bias, each Investigator will offer study participation to each&#xD;
          consecutive eligible patient presenting as a potential candidate. Eligible candidates who&#xD;
          express interest in study participation will be offered Informed Consent.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Study devices must have been implanted following the appropriate surgical technique&#xD;
               and IFU&#xD;
  &#xD;
            -  Patient must be 18 years of age or older&#xD;
  &#xD;
            -  Patient must be willing and able to sign or verbally consent using the IRB approved&#xD;
               informed consent&#xD;
  &#xD;
            -  Patient must have undergone primary or revision hip arthroplasty with the Longevity IT&#xD;
               Oblique and/or Offset liners according to a cleared indication, which includes the&#xD;
               following:&#xD;
  &#xD;
            -  Noninflammatory degenerative joint disease including osteoarthritis and avascular&#xD;
               necrosis, protrusio acetabuli, traumatic arthritis, slipped capital, epiphysis, fused&#xD;
               hip, fracture of the pelvis, and diastrophic variant&#xD;
  &#xD;
            -  Revision where other devices or treatments have failed&#xD;
  &#xD;
            -  Patient must have reached full skeletal maturity&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Off-label use of study devices&#xD;
  &#xD;
            -  Osteoradionecrosis&#xD;
  &#xD;
            -  Neuromuscular compromise, vascular deficiency or other conditions in the affected limb&#xD;
               that may lead to inadequate skeletal fixation&#xD;
  &#xD;
            -  Systemic or local infection&#xD;
  &#xD;
            -  Uncooperative patient or patient with neurologic disorders who is incapable of&#xD;
               following directions&#xD;
  &#xD;
            -  Patient is known to be pregnant or nursing&#xD;
  &#xD;
            -  Patient is a prisoner&#xD;
  &#xD;
            -  Patient is a known alcohol or drug abuser&#xD;
  &#xD;
            -  Patient has a psychiatric illness or cognitive deficit that will not allow for proper&#xD;
               informed consent&#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>Hillary Overholser</last_name>
      <role>Study Director</role>
      <affiliation>Zimmer Biomet</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Abigail Fishel</last_name>
      <phone>5745261765</phone>
      <email>ABIGAIL.FISHEL@ZIMMERBIOMET.COM</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Lynsey Boyle</last_name>
      <phone>4125527111</phone>
      <email>lynsey.boyle@zimmerbiomet.com</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 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</mesh_term>
      <mesh_term>Joint Diseases</mesh_term>
      <mesh_term>Slipped Capital Femoral Epiphyses</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>
  
  
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/NCT05980234
  org study id: MDRG2017-89MS-107H
  nct id: NCT05980234
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: Yes
  The objective of this retrospective enrollment/prospective follow-up consecutive series PMCF
        study is to collect data confirming safety, performance, and clinical benefits of the
        Longevity IT Oblique and Offset liners when used for primary or revision total hip
        arthroplasty (implants and instrumentation) at a minimum of 10-year follow-up.
  The objective of this retrospective enrollment/prospective follow-up consecutive series PMCF
        study is to collect data confirming safety, performance, and clinical benefits of the
        Longevity IT Oblique and Offset liners when used for primary and revision total hip
        arthroplasty (implants and instrumentation) at 1, 3, 5, 7, and 10 years*. The subject devices
        have been on the market since 2010 but have insufficient data to support 10 years of clinical
        history. A prospective aspect to the study will be utilized to collect long-term data.
  observational model: Cohort
  time perspective: Other
  measure: Incidence of treatment-emergent Adverse Events (safety)
  time frame: 10 years
  description: This will be assessed by recording the incidence and frequency of revisions, complications, and adverse events with particular focus on those that may be related to the study device.
  measure: Pain and Functional Performance - Oxford Hip Score
  time frame: 10 years
  description: "The Oxford Hip Score is patient-reported outcome instrument which contains 12 questions on activities of daily living that assess function and residual pain in patients undergoing total hip replacement surgery.
  Grading the Oxford Hip Score 0 to 19-May indicate severe hip arthritis... 20 to 29-May indicate moderate to severe hip arthritis... 30 to 39-May indicate mild to moderate hip arthritis... 40 to 48-May indicate satisfactory joint function..." Oxford Hip Score. (n.d.) Segen's Medical Dictionary. (2011). Retrieved August 19 2022 from https://medical-dictionary.thefreedictionary.com/Oxford+Hip+Score
  measure: Performance and Clinical Benefits - Harris Hip Score
  time frame: 10 years
  description: Patient Assessment: reported Harris Hip Score (if available)
  Harris Hip Score:
  The HHS is divided into three sections. The first section questions is about pain and its impact, which are answered by the patient or client. The second and third sections require the physiotherapist to assess the patient or client's hip joint and function.
  The HHS is a measure of dysfunction so the higher the score, the better the outcome for the individual. Results can be recorded and calculated online. The maximum score possible is 100. Results can be interpreted with the following: <70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent.
  measure: Performance and Clinical Benefits - Activity Level
  time frame: 10 years
  description: Patient Assessment: activity level
  Records patient's activity level on a 10-point scale from 'wholly inactive' to 'regularly particpates in impact sports.
  arm group label: Longevity IT Oblique Liners
  description: The Longevity IT Oblique liner was designed to provide variable joint anteversion and abduction.
  arm group label: Longevity IT Offset Liners
  description: The Longevity IT Offset liner was designed to lateralize the center of rotation of the cup.
  intervention type: Device
  intervention name: Total Hip Arthroplasty with Longevity IT Oblique Liners
  description: Primary or Revision Total Hip Arthroplasty using the Longevity IT Oblique liners according to the approved indications and compatible device.
  arm group label: Longevity IT Oblique Liners
  intervention type: Device
  intervention name: Total Hip Arthroplasty with Longevity IT Offset Liners
  description: Primary or Revision Total Hip Arthroplasty using the Longevity IT Offset liners according to the approved indications and compatible device.
  arm group label: Longevity IT Offset Liners
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Hillary Overholser
  role: Study Director
  affiliation: Zimmer Biomet
  last name: Abigail Fishel
  phone: 5745261765
  email: ABIGAIL.FISHEL@ZIMMERBIOMET.COM
  last name: Lynsey Boyle
  phone: 4125527111
  email: lynsey.boyle@zimmerbiomet.com
  responsible party type: Sponsor
  mesh term: Osteoarthritis
  mesh term: Joint Diseases
  mesh term: Slipped Capital Femoral Epiphyses
  mesh term: Necrosis
  sharing ipd: No