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/NCT05966519</url>
    </required_header>
    <id_info>
      <org_study_id>CSA2022-29TDS</org_study_id>
      <nct_id>NCT05966519</nct_id>
    </id_info>
    <brief_title>ROSA Knee Intraoperative Planning Flexibility Study</brief_title>
    <acronym>IntraOP</acronym>
    <official_title>ROSA Knee Intraoperative Planning Flexibility on Japan Preferred Surgical Technique, A Single Center Prospective 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>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to verify that an orthopedic surgical assist robot (ROSA Knee&#xD;
        System) can provide intraoperative adjustment of osteotomy angle and volume for total knee&#xD;
        arthroplasty (TKA) based on feedbacks obtained from intraoperative soft tissue conditions. A&#xD;
        total 80 cases will be enrolled at one study site with a postoperative follow-up period of 2&#xD;
        years.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The objectives of the study are to document that ROSA Knee System can provide intraoperative&#xD;
        planning adjustment based on feedbacks obtained by laxity as well as gaps to locally&#xD;
        preferred surgeon's operative philosophy. This will also provide accuracy, intraoperative&#xD;
        soft tissue release as well as patient outcome on locally preferred surgical technique.&#xD;
  &#xD;
        The primary endpoint is defined as the mean absolute difference between X-Atlas image-based&#xD;
        pre-op plan &amp; intra-op final plan.&#xD;
  &#xD;
        The secondary endpoints include Kinematic Analysis, EuroQol 5 dimensions (EQ-5D),&#xD;
        Rehabilitation record, Knee Society Score (KSS) 2011, image assessment and Safety up to 2&#xD;
        years postoperatively.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 25, 2023</start_date>
    <completion_date type="Anticipated">February 25, 2027</completion_date>
    <primary_completion_date type="Anticipated">February 25, 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>The mean absolute difference between X-Atlas image based pre-op plan &amp; intra-op final plan</measure>
      <time_frame>Immediate post-operative</time_frame>
      <description>The mean absolute difference between X-Atlas image-based pre-op plan and intra-op final plan in order to demonstrate the ability of the system to allow for intra-operative adjustments</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Pain, range of knee motion and functional performance</measure>
      <time_frame>Preoperative, Postoperative 1.5 months (option), 3 months, 6 months, 12 months and 24 months</time_frame>
      <description>The Knee Society Score 2011, and Physical Exam to evaluate pain, range of knee motion and functional performance</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>QOL</measure>
      <time_frame>Preoperative, Postoperative 1.5 months (option), 3 months, 6 months, 12 months and 24 months</time_frame>
      <description>Subject quality-of-life will be measured by the EuroQol 5 dimensions 5-level (EQ-5D-5L)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rehabilitation record</measure>
      <time_frame>Preoperative, Postoperative 1.5 months (option), 3 months, 6 months, 12 months and 24 months</time_frame>
      <description>Recovery of patient will be assessed by prescribed Rehabilitation record and compliance</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Kinematic analysis</measure>
      <time_frame>Postoperative 12 months or 24 months</time_frame>
      <description>Kinematic analysis will be conducted to visualize postoperative knee motion</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Image review (CT/Radiograph)</measure>
      <time_frame>Preoperative, Discharge, Postoperative 1.5 months (option), 3 months, 6 months, 12 months and 24 months</time_frame>
      <description>Image review (CT/Radiograph) to assess the accuracy of the implant position, radiolucency, osteolysis, atrophy, hypertrophy, component migration, device fracture, heterotopic ossification, etc.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Osteo Arthritis Knee</condition>
    <condition>Rheumatoid Arthritis</condition>
    <arm_group>
      <arm_group_label>TKA with ROSA Knee</arm_group_label>
      <description>Total Knee Arthroplasty (TKA) is conducted using with robotic surgical assistant (ROSA) system</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Total Knee Replacement (TKR)</intervention_name>
      <description>Damaged cartilage of knee due to degenerative disease is replaced with metallic and plastic protheses</description>
      <arm_group_label>TKA with ROSA Knee</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The study population will comprise of males and females who require primary total knee&#xD;
          arthroplasty and satisfy the inclusion/exclusion criteria outlined in this section of the&#xD;
          protocol. In order to avoid potential selection bias, each Investigator will offer study&#xD;
          participation to each consecutive eligible patient presenting as a candidate for primary&#xD;
          total knee arthroplasty using the commercially available Zimmer Biomet total knee systems.&#xD;
          Eligible candidates who express interest in study participation will be offered Informed&#xD;
          Consent.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  20 years and over&#xD;
  &#xD;
            -  Skeletally matured&#xD;
  &#xD;
            -  Decision to have Total Knee Arthroplasty with ROSA Knee System being made&#xD;
               independently and prior to recruitment into study&#xD;
  &#xD;
            -  Willing and able to complete scheduled follow-up evaluations as described in the study&#xD;
               protocol&#xD;
  &#xD;
            -  Has participated in the informed consent process and is willing and able to sign an&#xD;
               Institutional Review Board (IRB)/Ethics Committee (EC) approved informed consent form&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Has serious bone defect(s), which require(s) metallic augment, synthetic bone or&#xD;
               allograft&#xD;
  &#xD;
            -  Is septic, has an active infection or has osteomyelitis at the affected joint&#xD;
  &#xD;
            -  Has vascular insufficiency, muscular atrophy at the implant site or neuromuscular&#xD;
               disease which might jeopardize the outcome of the surgery&#xD;
  &#xD;
            -  Has any concomitant disease which is likely to jeopardize the functioning or success&#xD;
               of the implant&#xD;
  &#xD;
            -  Is known to be pregnant&#xD;
  &#xD;
            -  Is a prisoner, known alcohol or drug abuser or mentally incompetent or unable to&#xD;
               understand what participation in this study entails&#xD;
  &#xD;
            -  Has a known sensitivity or allergy to one or more of the implanted materials&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Yasuharu Nakashima</last_name>
      <role>Principal Investigator</role>
      <affiliation>Kyushu University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Noriko Sugawara</last_name>
      <phone>+81-3-6402-6600</phone>
      <email>noriko.sugawara@zimmerbiomet.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Kyushu University Hospital</name>
        <address>
          <city>Fukuoka</city>
          <zip>812-8582</zip>
          <country>Japan</country>
        </address>
      </facility>
      <contact>
        <last_name>Shinya Kawahara</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Japan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>July 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 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>Arthritis</mesh_term>
      <mesh_term>Osteoarthritis</mesh_term>
      <mesh_term>Osteoarthritis, Knee</mesh_term>
    </condition_browse>
    <!-- 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/NCT05966519
  org study id: CSA2022-29TDS
  nct id: NCT05966519
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  The purpose of this study is to verify that an orthopedic surgical assist robot (ROSA Knee
        System) can provide intraoperative adjustment of osteotomy angle and volume for total knee
        arthroplasty (TKA) based on feedbacks obtained from intraoperative soft tissue conditions. A
        total 80 cases will be enrolled at one study site with a postoperative follow-up period of 2
        years.
  The objectives of the study are to document that ROSA Knee System can provide intraoperative
        planning adjustment based on feedbacks obtained by laxity as well as gaps to locally
        preferred surgeon's operative philosophy. This will also provide accuracy, intraoperative
        soft tissue release as well as patient outcome on locally preferred surgical technique.
  
        The primary endpoint is defined as the mean absolute difference between X-Atlas image-based
        pre-op plan & intra-op final plan.
  
        The secondary endpoints include Kinematic Analysis, EuroQol 5 dimensions (EQ-5D),
        Rehabilitation record, Knee Society Score (KSS) 2011, image assessment and Safety up to 2
        years postoperatively.
  observational model: Case-Only
  time perspective: Prospective
  measure: The mean absolute difference between X-Atlas image based pre-op plan & intra-op final plan
  time frame: Immediate post-operative
  description: The mean absolute difference between X-Atlas image-based pre-op plan and intra-op final plan in order to demonstrate the ability of the system to allow for intra-operative adjustments
  measure: Pain, range of knee motion and functional performance
  time frame: Preoperative, Postoperative 1.5 months (option), 3 months, 6 months, 12 months and 24 months
  description: The Knee Society Score 2011, and Physical Exam to evaluate pain, range of knee motion and functional performance
  measure: QOL
  time frame: Preoperative, Postoperative 1.5 months (option), 3 months, 6 months, 12 months and 24 months
  description: Subject quality-of-life will be measured by the EuroQol 5 dimensions 5-level (EQ-5D-5L)
  measure: Rehabilitation record
  time frame: Preoperative, Postoperative 1.5 months (option), 3 months, 6 months, 12 months and 24 months
  description: Recovery of patient will be assessed by prescribed Rehabilitation record and compliance
  measure: Kinematic analysis
  time frame: Postoperative 12 months or 24 months
  description: Kinematic analysis will be conducted to visualize postoperative knee motion
  measure: Image review (CT/Radiograph)
  time frame: Preoperative, Discharge, Postoperative 1.5 months (option), 3 months, 6 months, 12 months and 24 months
  description: Image review (CT/Radiograph) to assess the accuracy of the implant position, radiolucency, osteolysis, atrophy, hypertrophy, component migration, device fracture, heterotopic ossification, etc.
  arm group label: TKA with ROSA Knee
  description: Total Knee Arthroplasty (TKA) is conducted using with robotic surgical assistant (ROSA) system
  intervention type: Device
  intervention name: Total Knee Replacement (TKR)
  description: Damaged cartilage of knee due to degenerative disease is replaced with metallic and plastic protheses
  arm group label: TKA with ROSA Knee
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Yasuharu Nakashima
  role: Principal Investigator
  affiliation: Kyushu University
  last name: Noriko Sugawara
  phone: +81-3-6402-6600
  email: noriko.sugawara@zimmerbiomet.com
  facility: 
  contact: 
  country: Japan
  responsible party type: Sponsor
  mesh term: Arthritis
  mesh term: Osteoarthritis
  mesh term: Osteoarthritis, Knee