<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/NCT03289754</url>
  </required_header>
  <id_info>
    <org_study_id>16-001</org_study_id>
    <nct_id>NCT03289754</nct_id>
  </id_info>
  <brief_title>A Prospective Study to Evaluate the iTotal Knee and iPoly XE Tibial Inserts</brief_title>
  <official_title>A Prospective Study to Evaluate the ConforMIS iTotal® (CR) Knee Replacement System and iPoly XE Tibial Inserts</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ConforMIS, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ConforMIS, Inc.</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>
      This study is designed to evaluate the clinical outcomes of subjects who have recently&#xD;
      undergone surgery with the iTotal® Cruciate Retaining (CR) Total Knee Replacement System&#xD;
      (KRS) who have also had iPoly XE Tibial Inserts implanted.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is prospective and single-center. Subjects will be implanted with an iTotal® CR&#xD;
      Knee Replacement System in conjunction with an iPoly XE insert. The study will include a&#xD;
      minimum of 50 subjects and a maximum of 60 subjects at a single center. The study site will&#xD;
      be located in Germany. The study subjects will be followed for 10 years post implant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Decision of investigational team&#xD;
  </why_stopped>
  <start_date type="Actual">January 24, 2018</start_date>
  <completion_date type="Actual">June 9, 2022</completion_date>
  <primary_completion_date type="Actual">June 9, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline to 1-year in Knee Society Score</measure>
    <time_frame>1 year</time_frame>
    <description>Change in Knee Society Score from baseline (12 weeks post implantation) to 1 year post implantation. The Knee Society Score consists of three components: Objective Knee Score, Function Score, and Satisfaction Score.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline score in Knee Society Score at year 2</measure>
    <time_frame>2 years</time_frame>
    <description>Change in Knee Society Score from baseline (12 weeks post implantation) to 2 year post implantation. The Knee Society Score consists of three components: Objective Knee Score, Function Score, and Satisfaction Score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline score in Knee Society Score at year 5</measure>
    <time_frame>5 years</time_frame>
    <description>Change in Knee Society Score from baseline (12 weeks post implantation) to 5 year post implantation. The Knee Society Score consists of three components: Objective Knee Score, Function Score, and Satisfaction Score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline score in Knee Society Score at year 10</measure>
    <time_frame>10 years</time_frame>
    <description>Change in Knee Society Score from baseline (12 weeks post implantation) to 10 year post implantation. The Knee Society Score consists of three components: Objective Knee Score, Function Score, and Satisfaction Score.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>ConforMIS iTotal Knee with iPoly Insert</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The tibial insert being utilized in this study will be a highly-crosslinked, Vitamin-E enriched UHMWPE (iPoly XE) instead of traditional tibial inserts.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>iPoly XE tibial insert with ConforMIS iTotal KRS</intervention_name>
    <description>The implants are constructed to conform to the surface of the patient's femoral condyle and proximal tibia, replacing the damaged cartilage with a smooth articulating surface. The femoral component and tibial tray are manufactured from cobalt chromium molybdenum alloy. The tibial insert and patellar component are manufactured from ultra-high molecular weight polyethylene.</description>
    <arm_group_label>ConforMIS iTotal Knee with iPoly Insert</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Clinical condition included in the approved Indications For Use for the iTotal® CR&#xD;
&#xD;
          2. Osteoarthritis, as confirmed by the investigator's assessment of disease status at&#xD;
             screening visit that warrants a TKR procedure. Disease status is assessed by Clinical&#xD;
             and Radiographic assessment.&#xD;
&#xD;
          3. Willingness to participate in the clinical study, to give informed consent, and to&#xD;
             attend all follow-up visits&#xD;
&#xD;
          4. &gt; 18 years of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Simultaneous bilateral procedure required&#xD;
&#xD;
          2. BMI &gt; 40&#xD;
&#xD;
          3. Active malignancy (defined as a history of any invasive malignancy - except&#xD;
             non-melanoma skin cancer), unless patient has been treated with curative intent and&#xD;
             there have been no clinical signs or symptoms of the malignancy for at least 5 years&#xD;
&#xD;
          4. Poorly controlled diabetes&#xD;
&#xD;
          5. Neuromuscular conditions which prevent patient from participating in study activities&#xD;
&#xD;
          6. Active local or systemic infection&#xD;
&#xD;
          7. Immunocompromised&#xD;
&#xD;
          8. Fibromyalgia or other general body pain related condition&#xD;
&#xD;
          9. Rheumatoid arthritis or other forms of inflammatory joint disease&#xD;
&#xD;
         10. Loss of bone or musculature, osteonecrosis, neuromuscular or vascular compromise in&#xD;
             the area of the joint to be operated on, to an extent that the procedure is&#xD;
             unjustified&#xD;
&#xD;
         11. Diagnosed with or receiving treatment for Osteoporosis&#xD;
&#xD;
         12. Other physical disability affecting the hips, spine, or contralateral knee&#xD;
&#xD;
         13. Severe instability due to advanced loss of osteochondral structure&#xD;
&#xD;
         14. Prior arthroplasty of the affected knee, including High Tibial Osteotomy (HTO)&#xD;
&#xD;
         15. Compromised PCL or collateral ligament&#xD;
&#xD;
         16. Severe fixed valgus or varus deformity of &gt;15º&#xD;
&#xD;
         17. Extensor lag &gt; 15º&#xD;
&#xD;
         18. Fixed flexion contracture ≥ 15º&#xD;
&#xD;
         19. Unwilling or unable to comply with study requirements&#xD;
&#xD;
         20. Participation in another clinical study which would confound results&#xD;
&#xD;
         21. Allergy to any of the implant 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>Philipp Drees</last_name>
    <role>Principal Investigator</role>
    <affiliation>University- Mainz</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Medical Center of Johannes Gutenberg-University Mainz</name>
      <address>
        <city>Mainz</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>September 15, 2017</study_first_submitted>
  <study_first_submitted_qc>September 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 21, 2017</study_first_posted>
  <last_update_submitted>August 25, 2023</last_update_submitted>
  <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>knee implant</keyword>
  <keyword>osteoarthritis</keyword>
  <keyword>patient-specific</keyword>
  <keyword>knee osteoarthritis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</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/NCT03289754
org study id: 16-001
nct id: NCT03289754
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
This study is designed to evaluate the clinical outcomes of subjects who have recently
      undergone surgery with the iTotal® Cruciate Retaining (CR) Total Knee Replacement System
      (KRS) who have also had iPoly XE Tibial Inserts implanted.
The study is prospective and single-center. Subjects will be implanted with an iTotal® CR
      Knee Replacement System in conjunction with an iPoly XE insert. The study will include a
      minimum of 50 subjects and a maximum of 60 subjects at a single center. The study site will
      be located in Germany. The study subjects will be followed for 10 years post implant.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Change from Baseline to 1-year in Knee Society Score
time frame: 1 year
description: Change in Knee Society Score from baseline (12 weeks post implantation) to 1 year post implantation. The Knee Society Score consists of three components: Objective Knee Score, Function Score, and Satisfaction Score.
measure: Change from baseline score in Knee Society Score at year 2
time frame: 2 years
description: Change in Knee Society Score from baseline (12 weeks post implantation) to 2 year post implantation. The Knee Society Score consists of three components: Objective Knee Score, Function Score, and Satisfaction Score.
measure: Change from baseline score in Knee Society Score at year 5
time frame: 5 years
description: Change in Knee Society Score from baseline (12 weeks post implantation) to 5 year post implantation. The Knee Society Score consists of three components: Objective Knee Score, Function Score, and Satisfaction Score.
measure: Change from baseline score in Knee Society Score at year 10
time frame: 10 years
description: Change in Knee Society Score from baseline (12 weeks post implantation) to 10 year post implantation. The Knee Society Score consists of three components: Objective Knee Score, Function Score, and Satisfaction Score.
arm group label: ConforMIS iTotal Knee with iPoly Insert
arm group type: Experimental
description: The tibial insert being utilized in this study will be a highly-crosslinked, Vitamin-E enriched UHMWPE (iPoly XE) instead of traditional tibial inserts.
intervention type: Device
intervention name: iPoly XE tibial insert with ConforMIS iTotal KRS
description: The implants are constructed to conform to the surface of the patient's femoral condyle and proximal tibia, replacing the damaged cartilage with a smooth articulating surface. The femoral component and tibial tray are manufactured from cobalt chromium molybdenum alloy. The tibial insert and patellar component are manufactured from ultra-high molecular weight polyethylene.
arm group label: ConforMIS iTotal Knee with iPoly Insert
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Philipp Drees
role: Principal Investigator
affiliation: University- Mainz
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
sharing ipd: No