<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/NCT03272373</url>
  </required_header>
  <id_info>
    <org_study_id>K.CR.I.G.16.34</org_study_id>
    <nct_id>NCT03272373</nct_id>
  </id_info>
  <brief_title>NexGen TM Tibia Clinical Outcomes Study</brief_title>
  <official_title>NexGen® TM Tibia Clinical Outcomes Study: Prospective Multicenter Study of the NexGen® TM Monoblock and Modular Tibias</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 study is to evaluate clinical performance for the commercially&#xD;
      available NexGen TM Monoblock Tibia and NexGen TM Modular Tibia used in primary cementless&#xD;
      tibia total knee arthroplasty.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, multicenter, non-randomized clinical study designed to facilitate the&#xD;
      collection and evaluation of radiographic parameters, pain and function, survival of the&#xD;
      device, and adverse event data. This clinical study will include the NexGen TM Monoblock&#xD;
      Tibia and NexGen TM Modular Tibia as 2 single-arms being analyzed separately.&#xD;
&#xD;
      The study will require each site to obtain IRB approval prior to study enrollment. All&#xD;
      potential study subjects will be required to participate in the Informed Consent Process.&#xD;
&#xD;
      All study subjects will undergo preoperative clinical evaluations prior to their cementless&#xD;
      tibia total knee arthroplasty. An immediate postoperative radiograph will be required.&#xD;
      Postoperative clinical follow-up and radiographic evaluations will be conducted at 6 weeks, 6&#xD;
      months, 1 year, and 2 years.&#xD;
&#xD;
      The primary endpoint of this study is to evaluate the clinical performance of the implant at&#xD;
      2 years postoperatively using radiographic parameters. Radiographs will be assessed for the&#xD;
      absence of progressive tibial radiolucencies, as defined in the radiographic protocol.&#xD;
&#xD;
      The secondary endpoints of this study will evaluate the clinical performance of the implant&#xD;
      at 2 years postoperatively, based upon:&#xD;
&#xD;
        -  No revisions for any reason&#xD;
&#xD;
        -  Oxford Knee Score &gt;38&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 3, 2017</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">May 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>2 single arms being analyzed separately</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Radiographic Parameters</measure>
    <time_frame>2 years</time_frame>
    <description>Radiograph assessments</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Oxford Knee Score</measure>
    <time_frame>2 years</time_frame>
    <description>The Oxford Knee Score assesses function and pain after total knee arthroplasty.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Revision Rate</measure>
    <time_frame>2 years</time_frame>
    <description>Rate of the number of revisions for any reason</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">132</enrollment>
  <condition>Osteoarthritis</condition>
  <condition>Rheumatoid Arthritis</condition>
  <condition>Traumatic Arthritis</condition>
  <condition>Polyarthritis</condition>
  <condition>Collagen Disorders and/or Avascular Necrosis of the Femoral Condyle</condition>
  <condition>Post-traumatic Loss of Joint Configuration</condition>
  <condition>Moderate Valgus, Varus, or Flexion Deformities</condition>
  <arm_group>
    <arm_group_label>Monoblock</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Subjects that receive the NexGen TM Monoblock Tibia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Modular</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Subjects that receive the NexGen TM Modular Tibia</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>NexGen TM Monoblock Tibia</intervention_name>
    <description>Primary cementless tibia total knee arthroplasty</description>
    <arm_group_label>Monoblock</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>NexGen TM Modular Tibia</intervention_name>
    <description>Primary cementless tibia total knee arthroplasty</description>
    <arm_group_label>Modular</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient is at least 18 years of age.&#xD;
&#xD;
          2. Patient qualifies for a primary cementless tibia total knee arthroplasty based on&#xD;
             physical exam and medical history, including diagnosis of severe knee pain and&#xD;
             disability due to at least one of the following:&#xD;
&#xD;
               1. Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.&#xD;
&#xD;
               2. Collagen disorders and/or avascular necrosis of the femoral condyle.&#xD;
&#xD;
               3. Post-traumatic loss of joint configuration, particularly when there is&#xD;
                  patellofemoral erosion, dysfunction or prior patellectomy.&#xD;
&#xD;
               4. Moderate valgus, varus, or flexion deformities.&#xD;
&#xD;
               5. The salvage of previously failed surgical attempts that did not include partial&#xD;
                  or total knee arthroplasty of the ipsilateral knee.&#xD;
&#xD;
          3. Patient has participated in the study-related Informed Consent process.&#xD;
&#xD;
          4. Patient is willing and able to provide written Informed Consent by signing and dating&#xD;
             the IRB approved Informed Consent Form.&#xD;
&#xD;
          5. Patient is willing and able to complete scheduled study procedures and follow-up&#xD;
             evaluations as described in the Informed Consent Form.&#xD;
&#xD;
          6. Independent of study participation, patient is a candidate for commercially available&#xD;
             cementless NexGen TM tibial knee component, implanted in accordance with product&#xD;
             labeling.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Previous history of infection in the affected joint.&#xD;
&#xD;
          2. Active local or systemic infection that may affect the prosthetic joint.&#xD;
&#xD;
          3. Insufficient bone stock on femoral or tibial surfaces.&#xD;
&#xD;
          4. Skeletal immaturity.&#xD;
&#xD;
          5. Neuropathic arthropathy.&#xD;
&#xD;
          6. Osteoporosis or any loss of musculature or neuromuscular disease that compromises the&#xD;
             affected limb.&#xD;
&#xD;
          7. A stable, painless arthrodesis in a satisfactory functional position.&#xD;
&#xD;
          8. Severe instability secondary to the absence of collateral ligament integrity.&#xD;
&#xD;
          9. Rheumatoid arthritis accompanied by an ulcer of the skin or a history of recurrent&#xD;
             breakdown of the skin.&#xD;
&#xD;
         10. Patient has previously received partial or total knee arthroplasty for the ipsilateral&#xD;
             knee.&#xD;
&#xD;
         11. Patient is currently participating in any other surgical intervention studies or pain&#xD;
             management studies.&#xD;
&#xD;
         12. Patient is known to be pregnant or considered a member of a protected population&#xD;
             (e.g., prisoner, mentally incompetent, etc.).&#xD;
&#xD;
         13. Patient has a known or suspected sensitivity or allergy to one or more of the implant&#xD;
             materials.&#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>Kacy Arnold, RN, MBA</last_name>
    <role>Study Director</role>
    <affiliation>Zimmer Biomet</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>LA BioMed at Harbor-UCLA Medical Center</name>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cornerstone Orthopaedics &amp; Sports Medicine, P.C.</name>
      <address>
        <city>Wheat Ridge</city>
        <state>Colorado</state>
        <zip>80033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Franciscan Health</name>
      <address>
        <city>Mooresville</city>
        <state>Indiana</state>
        <zip>46158</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry County Orthopedics and Sports Medicine</name>
      <address>
        <city>New Castle</city>
        <state>Indiana</state>
        <zip>47362</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Woods Mill Orthopedics, Ltd</name>
      <address>
        <city>Chesterfield</city>
        <state>Missouri</state>
        <zip>63017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pinehurst Surgical Clinic</name>
      <address>
        <city>Pinehurst</city>
        <state>North Carolina</state>
        <zip>28374</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>August 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>April 11, 2023</last_update_submitted>
  <last_update_submitted_qc>April 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 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>Arthritis</mesh_term>
    <mesh_term>Rheumatic Diseases</mesh_term>
    <mesh_term>Collagen Diseases</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>


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/NCT03272373
org study id: K.CR.I.G.16.34
nct id: NCT03272373
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The objective of this study is to evaluate clinical performance for the commercially
      available NexGen TM Monoblock Tibia and NexGen TM Modular Tibia used in primary cementless
      tibia total knee arthroplasty.
This is a prospective, multicenter, non-randomized clinical study designed to facilitate the
      collection and evaluation of radiographic parameters, pain and function, survival of the
      device, and adverse event data. This clinical study will include the NexGen TM Monoblock
      Tibia and NexGen TM Modular Tibia as 2 single-arms being analyzed separately.

      The study will require each site to obtain IRB approval prior to study enrollment. All
      potential study subjects will be required to participate in the Informed Consent Process.

      All study subjects will undergo preoperative clinical evaluations prior to their cementless
      tibia total knee arthroplasty. An immediate postoperative radiograph will be required.
      Postoperative clinical follow-up and radiographic evaluations will be conducted at 6 weeks, 6
      months, 1 year, and 2 years.

      The primary endpoint of this study is to evaluate the clinical performance of the implant at
      2 years postoperatively using radiographic parameters. Radiographs will be assessed for the
      absence of progressive tibial radiolucencies, as defined in the radiographic protocol.

      The secondary endpoints of this study will evaluate the clinical performance of the implant
      at 2 years postoperatively, based upon:

        -  No revisions for any reason

        -  Oxford Knee Score >38
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: 2 single arms being analyzed separately
primary purpose: Treatment
masking: None (Open Label)
measure: Radiographic Parameters
time frame: 2 years
description: Radiograph assessments
measure: Oxford Knee Score
time frame: 2 years
description: The Oxford Knee Score assesses function and pain after total knee arthroplasty.
measure: Revision Rate
time frame: 2 years
description: Rate of the number of revisions for any reason
arm group label: Monoblock
arm group type: Other
description: Subjects that receive the NexGen TM Monoblock Tibia
arm group label: Modular
arm group type: Other
description: Subjects that receive the NexGen TM Modular Tibia
intervention type: Device
intervention name: NexGen TM Monoblock Tibia
description: Primary cementless tibia total knee arthroplasty
arm group label: Monoblock
intervention type: Device
intervention name: NexGen TM Modular Tibia
description: Primary cementless tibia total knee arthroplasty
arm group label: Modular
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kacy Arnold, RN, MBA
role: Study Director
affiliation: Zimmer Biomet
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Rheumatic Diseases
mesh term: Collagen Diseases
mesh term: Necrosis
sharing ipd: No