<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/NCT02228538</url>
  </required_header>
  <id_info>
    <org_study_id>13-003</org_study_id>
    <nct_id>NCT02228538</nct_id>
  </id_info>
  <brief_title>Total Knee Arthroplasty Functional Outcomes Study Research Design</brief_title>
  <official_title>Total Knee Arthroplasty Functional Outcomes Study Research Design</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ConforMIS, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ochsner Health System</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>ConforMIS, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to obtain patient oriented and clinically oriented physical&#xD;
      function outcomes both pre-operatively and post-operatively in patients receiving a total&#xD;
      knee arthroplasty.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study aims to use up to 75 patients at 3 centers to determine a baseline short-term&#xD;
      post-operative physical function status of patients undergoing a total knee arthroplasty&#xD;
      through patient and clinically based assessments. The KOOS score will collect data on the&#xD;
      patient's physical function, stiffness and pain. The BERG balance, TUG, and TUDS tests will&#xD;
      be used quantitatively to assess the patient's ability to conduct activities of daily living&#xD;
      like walking for an extended period of time, standing from a seated position, and maintaining&#xD;
      balance while performing a series of actions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Not enough subject participation&#xD;
  </why_stopped>
  <start_date>October 2013</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">May 2015</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>Timed Functional Tests at 6 weeks</measure>
    <time_frame>6 weeks post-op</time_frame>
    <description>Assess patient functional outcomes over time. Comparing times from pre-op to post op of patients performing the same functional tests.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Timed Functional testing at 6 months</measure>
    <time_frame>6 months post op</time_frame>
    <description>Assess patient functional outcomes over time. Comparing times from pre-op to post op of patients performing the same functional tests.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Timed Functional Testing at 1 year</measure>
    <time_frame>1 year post-op</time_frame>
    <description>Assess patient functional outcomes over time. Comparing times from pre-op to post op of patients performing the same functional tests.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Outcome questionnaires at 6 weeks</measure>
    <time_frame>6 weeks post-op</time_frame>
    <description>Assess knee pain and function scores over time. Comparing questionnaire scores from pre-op to post op of patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Outcome questionnaires at 6 months</measure>
    <time_frame>6 months post-op</time_frame>
    <description>Assess knee pain and function scores over time. Comparing questionnaire scores from pre-op to post op of patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Outcome questionnaires at 1 year</measure>
    <time_frame>1 year post op</time_frame>
    <description>Assess knee pain and function scores over time. Comparing questionnaire scores from pre-op to post op of patients.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">7</enrollment>
  <condition>Osteoarthritis of the Knee</condition>
  <arm_group>
    <arm_group_label>Total knee arthroplasty patients</arm_group_label>
    <description>ConforMIS iTotal (CR) knee implant system and off-the-shelf knee implant systems from various manufacturers</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Total knee arthroplasty patients</intervention_name>
    <description>ConforMIS iTotal (CR) knee implant system &amp; off-the-shelf standard knee implant system from various manufacturers</description>
    <arm_group_label>Total knee arthroplasty patients</arm_group_label>
    <other_name>knee replacement</other_name>
    <other_name>joint replacement</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Total knee arthroplasty patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient is male or non-pregnant female age 18 years or older at time of study&#xD;
&#xD;
          -  Patient is a candidate for a total knee arthroplasty&#xD;
&#xD;
          -  Patient is willing and able to comply with postoperative scheduled clinical and&#xD;
             radiographic evaluations and rehabilitation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a primary diagnosis other than osteoarthritis of the knee as determined&#xD;
             by an orthopedic surgeon&#xD;
&#xD;
          -  Patients who have had any previous lower extremity procedure&#xD;
&#xD;
          -  Patients with a BMI greater than or equal to 40&#xD;
&#xD;
          -  Patients with an active infection within the affected knee joint&#xD;
&#xD;
          -  Patients with a neuromuscular or neurosensory deficiency that may limit the ability of&#xD;
             the patient to evaluate the safety and efficacy of the device&#xD;
&#xD;
          -  Patients diagnosed with systemic disease or metabolic disorder leading to progressive&#xD;
             bone deterioration (e.g. Lupus Erythematosus, Paget's disease)&#xD;
&#xD;
          -  Patients immunologically suppressed or receiving chronic steroids in excess of normal&#xD;
             physiological requirements (e.g. greater than 30 days)&#xD;
&#xD;
          -  Patients with a known sensitivity to device materials&#xD;
&#xD;
          -  Non-English speaking patients&#xD;
&#xD;
          -  Patient is a prisoner&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Deryk Jones, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ochsner Heath System</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ochsner Clinic Foundation</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>June 5, 2014</study_first_submitted>
  <study_first_submitted_qc>August 27, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2014</study_first_posted>
  <last_update_submitted>September 20, 2016</last_update_submitted>
  <last_update_submitted_qc>September 20, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 21, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>total knee arthroplasty</keyword>
  <keyword>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>
  <!-- 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/NCT02228538
org study id: 13-003
nct id: NCT02228538
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to obtain patient oriented and clinically oriented physical
      function outcomes both pre-operatively and post-operatively in patients receiving a total
      knee arthroplasty.
This study aims to use up to 75 patients at 3 centers to determine a baseline short-term
      post-operative physical function status of patients undergoing a total knee arthroplasty
      through patient and clinically based assessments. The KOOS score will collect data on the
      patient's physical function, stiffness and pain. The BERG balance, TUG, and TUDS tests will
      be used quantitatively to assess the patient's ability to conduct activities of daily living
      like walking for an extended period of time, standing from a seated position, and maintaining
      balance while performing a series of actions.
observational model: Cohort
time perspective: Prospective
measure: Timed Functional Tests at 6 weeks
time frame: 6 weeks post-op
description: Assess patient functional outcomes over time. Comparing times from pre-op to post op of patients performing the same functional tests.
measure: Timed Functional testing at 6 months
time frame: 6 months post op
description: Assess patient functional outcomes over time. Comparing times from pre-op to post op of patients performing the same functional tests.
measure: Timed Functional Testing at 1 year
time frame: 1 year post-op
description: Assess patient functional outcomes over time. Comparing times from pre-op to post op of patients performing the same functional tests.
measure: Outcome questionnaires at 6 weeks
time frame: 6 weeks post-op
description: Assess knee pain and function scores over time. Comparing questionnaire scores from pre-op to post op of patients.
measure: Outcome questionnaires at 6 months
time frame: 6 months post-op
description: Assess knee pain and function scores over time. Comparing questionnaire scores from pre-op to post op of patients.
measure: Outcome questionnaires at 1 year
time frame: 1 year post op
description: Assess knee pain and function scores over time. Comparing questionnaire scores from pre-op to post op of patients.
arm group label: Total knee arthroplasty patients
description: ConforMIS iTotal (CR) knee implant system and off-the-shelf knee implant systems from various manufacturers
intervention type: Device
intervention name: Total knee arthroplasty patients
description: ConforMIS iTotal (CR) knee implant system & off-the-shelf standard knee implant system from various manufacturers
arm group label: Total knee arthroplasty patients
other name: knee replacement
other name: joint replacement
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Deryk Jones, MD
role: Principal Investigator
affiliation: Ochsner Heath System
facility: 
country: United States
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee