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/NCT05980442</url>
    </required_header>
    <id_info>
      <org_study_id>AAG-O-H-23032</org_study_id>
      <nct_id>NCT05980442</nct_id>
    </id_info>
    <brief_title>Comparative Study of Navigation-assisted OrthoPilot® Elite and Robotic-assisted MAKO® Total Knee Arthroplasty</brief_title>
    <acronym>ORMAK</acronym>
    <official_title>Randomized, Controlled, Single Center Observational Study to Compare the Safety and Performance of Navigation-assisted OrthoPilot® Elite and Robotic-assisted MAKO® Total Knee Arthroplasty</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Aesculap AG</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Aesculap AG</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Randomized, controlled, single center observational study to compare the safety and&#xD;
        performance of navigation-assisted OrthoPilot Elite and robotic-assisted MAKO total knee&#xD;
        arthroplasty (TKA). The aim of the study is the comparison of the clinical outcome between&#xD;
        navigated and robotic-assisted TKA. The hypothesis of the study is that both treatments&#xD;
        achieve similar results regarding functional and clinical aspects.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 2023</start_date>
    <completion_date type="Anticipated">June 2026</completion_date>
    <primary_completion_date type="Anticipated">June 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Functional outcome of the Knee Surgery measured by the Knee Society Score (KSS) (functional component)</measure>
      <time_frame>one year postoperatively</time_frame>
      <description>Functional result one year postoperatively measured with the functional component of the Knee Society Score (KSS). The KSS is an examiner-administrated standard clinical evaluation tool reporting results for patients undergoing TKA.&#xD;
  It separates findings in the operated knee (kKSS) score from findings related to the patient's function (fKSS), which might be affected by co-morbidities. The two sub-scores are reported separately ranging from 0 points (worst result) to 100 points (best results), as well as summarized score, total KSS. Final grading of total KSS results Scores of 160 to 200 will be rated as excellent, 140 to 159 as good, 120 to 139 as fair, and less than 120 as poor.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Survival of the implant components</measure>
      <time_frame>one year postoperatively</time_frame>
      <description>Kaplan-Meier Analysis is a standard statistical method to describe the survival of human subjects or medical products over a defined time period. The revision-free survival rate is the performance indicator of the product under investigation and confirms the clinical outcome of the knee prosthesis. Information on survival of the implant will be collected.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Clinical outcome of the Knee Surgery measured by the Knee Society Score (KSS) (clinical component)</measure>
      <time_frame>one year postoperatively</time_frame>
      <description>Functional result one year postoperatively measured with the functional component of the Knee Society Score (KSS). The KSS is an examiner-administrated standard clinical evaluation tool reporting results for patients undergoing TKA.&#xD;
  It separates findings in the operated knee (kKSS) score from findings related to the patient's function (fKSS), which might be affected by co-morbidities. The two sub-scores are reported separately ranging from 0 points (worst result) to 100 points (best results), as well as summarized score, total KSS. Final grading of total KSS results Scores of 160 to 200 will be rated as excellent, 140 to 159 as good, 120 to 139 as fair, and less than 120 as poor.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of Life [EQ-5D-5L]</measure>
      <time_frame>one year postoperatively</time_frame>
      <description>EQ-5D is a standardized 5-dimension (5D) 5-level (5L) measure of the health status and is developed by the EuroQol Group in order to have a simple and generic measure for clinical and economic assessment. Instructions for the user are directly included into the questionnaire and it consists of two pages. One cover five different dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression) and the other one the EQ visual Analogue Scale (EQ-VAS). The VAS scale records the self rated health status of the patient from the level &quot;the worst health you can imagine&quot; to &quot;the best health you can imagine&quot;.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anterior knee pain</measure>
      <time_frame>one year postoperatively</time_frame>
      <description>Anterior knee pain is used to evaluate the performance of the implantation and the implant itself. Rating is classified according to the description of Waters and Bentley in four dimensions: 0 (no pain), I (Mild pain that does not intrude on daily activities), II (Moderate pain that is a nuisance; patient not considering further surgery), III (Severe pain; Patient considering further surgery). The scoring is according to Feller et al. 0, 5, 10 and 15 points, respectively.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Comparison of Radiographic alignment</measure>
      <time_frame>one year postoperatively</time_frame>
      <description>Alignment (femoral-knee baseline angle, tibial-knee baseline angle, femoral-tibial angle (mechanical))</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Comparison of Radiographic status</measure>
      <time_frame>one year postoperatively</time_frame>
      <description>potential presence of radiolucency at the interface between implant and bone on femoral and tibial components will be analyzed</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>(Serious) Adverse Events</measure>
      <time_frame>During the course of the study up to one year postoperatively</time_frame>
      <description>During the course of the study, any upcoming intra- or postoperative (serious) adverse device events or effects ((S)AE) related or not related to the product under investigation, will be documented. The total number of (S)AEs will be summarized and further evaluated by the sponsor and reported according to local legislation and necessity. Recorded complications will be categorized and analyzed in order to assess the safety of the investigational product.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">140</enrollment>
    <condition>Osteoarthritis, Knee</condition>
    <condition>Joint Diseases</condition>
    <condition>Rheumatoid Arthritis of Knee</condition>
    <condition>Posttraumatic Arthropathy</condition>
    <arm_group>
      <arm_group_label>OrthoPilot® Elite</arm_group_label>
      <description>navigated / computer assisted total knee replacement surgery</description>
    </arm_group>
    <arm_group>
      <arm_group_label>MAKO</arm_group_label>
      <description>robot assisted total knee replacement surgery</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Navigated total knee arthroplasty</intervention_name>
      <description>Total knee arthroplasty with Columbus® total knee endoprosthesis using the OrthoPilot® Elite navigation system</description>
      <arm_group_label>OrthoPilot® Elite</arm_group_label>
      <other_name>Columbus® total knee endoprosthesis</other_name>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Robot assisted total knee arthroplasty</intervention_name>
      <description>Total knee arthroplasty with Triathlon® total knee endoprosthesis using the MAKO® robot system</description>
      <arm_group_label>MAKO</arm_group_label>
      <other_name>Triathlon® total knee endoprosthesis</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients between 18 and 90 years of age having indication for a fixed-bearing total knee&#xD;
          endoprosthesis, without retropatellar arthrosis requiring patella resurfacing&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Indication for a TKA with a fixed-bearing total knee endoprosthesis&#xD;
  &#xD;
            -  Written informed consent for participating in the clinical study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patient age &lt;18 years and &gt;90 years&#xD;
  &#xD;
            -  Patient not willing to participate at the follow-up&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  retropatellar arthrosis requiring patella resurfacing&#xD;
  &#xD;
            -  American Society of Anaesthesiologists (ASA) Classification &gt;3&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>90 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Hans-Joachim Riesner, PD Dr. med.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Bundeswehr Krankenhaus Ulm</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Kristin Maier, Dr.</last_name>
      <phone>+49746195</phone>
      <email>info@aesculap.de</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Marius Selig</last_name>
      <phone>+49746195</phone>
      <email>info@aesculap.de</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Bundeswehr Krankenhaus Ulm</name>
        <address>
          <city>Ulm</city>
          <state>Baden-Württemberg</state>
          <zip>89081</zip>
          <country>Germany</country>
        </address>
      </facility>
      <contact>
        <last_name>Hans-Joachim Riesner, PD Dr. med.</last_name>
      </contact>
      <contact_backup>
        <last_name>Jörg Schneider, Dr. med.</last_name>
      </contact_backup>
      <investigator>
        <last_name>Hans-Joachim Riesner, PD Dr. med.</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Jörg Schneider, Dr. med.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Germany</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>computer assisted orthopedic surgery</keyword>
    <keyword>robotic assisted orthopedic surgery</keyword>
    <keyword>orthopedic navigation</keyword>
    <keyword>total knee arthroplasty</keyword>
    <keyword>total knee replacement</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Osteoarthritis, Knee</mesh_term>
      <mesh_term>Joint Diseases</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/NCT05980442
  org study id: AAG-O-H-23032
  nct id: NCT05980442
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Randomized, controlled, single center observational study to compare the safety and
        performance of navigation-assisted OrthoPilot Elite and robotic-assisted MAKO total knee
        arthroplasty (TKA). The aim of the study is the comparison of the clinical outcome between
        navigated and robotic-assisted TKA. The hypothesis of the study is that both treatments
        achieve similar results regarding functional and clinical aspects.
  observational model: Case-Control
  time perspective: Prospective
  measure: Functional outcome of the Knee Surgery measured by the Knee Society Score (KSS) (functional component)
  time frame: one year postoperatively
  description: Functional result one year postoperatively measured with the functional component of the Knee Society Score (KSS). The KSS is an examiner-administrated standard clinical evaluation tool reporting results for patients undergoing TKA.
  It separates findings in the operated knee (kKSS) score from findings related to the patient's function (fKSS), which might be affected by co-morbidities. The two sub-scores are reported separately ranging from 0 points (worst result) to 100 points (best results), as well as summarized score, total KSS. Final grading of total KSS results Scores of 160 to 200 will be rated as excellent, 140 to 159 as good, 120 to 139 as fair, and less than 120 as poor.
  measure: Survival of the implant components
  time frame: one year postoperatively
  description: Kaplan-Meier Analysis is a standard statistical method to describe the survival of human subjects or medical products over a defined time period. The revision-free survival rate is the performance indicator of the product under investigation and confirms the clinical outcome of the knee prosthesis. Information on survival of the implant will be collected.
  measure: Clinical outcome of the Knee Surgery measured by the Knee Society Score (KSS) (clinical component)
  time frame: one year postoperatively
  description: Functional result one year postoperatively measured with the functional component of the Knee Society Score (KSS). The KSS is an examiner-administrated standard clinical evaluation tool reporting results for patients undergoing TKA.
  It separates findings in the operated knee (kKSS) score from findings related to the patient's function (fKSS), which might be affected by co-morbidities. The two sub-scores are reported separately ranging from 0 points (worst result) to 100 points (best results), as well as summarized score, total KSS. Final grading of total KSS results Scores of 160 to 200 will be rated as excellent, 140 to 159 as good, 120 to 139 as fair, and less than 120 as poor.
  measure: Quality of Life [EQ-5D-5L]
  time frame: one year postoperatively
  description: EQ-5D is a standardized 5-dimension (5D) 5-level (5L) measure of the health status and is developed by the EuroQol Group in order to have a simple and generic measure for clinical and economic assessment. Instructions for the user are directly included into the questionnaire and it consists of two pages. One cover five different dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression) and the other one the EQ visual Analogue Scale (EQ-VAS). The VAS scale records the self rated health status of the patient from the level "the worst health you can imagine" to "the best health you can imagine".
  measure: Anterior knee pain
  time frame: one year postoperatively
  description: Anterior knee pain is used to evaluate the performance of the implantation and the implant itself. Rating is classified according to the description of Waters and Bentley in four dimensions: 0 (no pain), I (Mild pain that does not intrude on daily activities), II (Moderate pain that is a nuisance; patient not considering further surgery), III (Severe pain; Patient considering further surgery). The scoring is according to Feller et al. 0, 5, 10 and 15 points, respectively.
  measure: Comparison of Radiographic alignment
  time frame: one year postoperatively
  description: Alignment (femoral-knee baseline angle, tibial-knee baseline angle, femoral-tibial angle (mechanical))
  measure: Comparison of Radiographic status
  time frame: one year postoperatively
  description: potential presence of radiolucency at the interface between implant and bone on femoral and tibial components will be analyzed
  measure: (Serious) Adverse Events
  time frame: During the course of the study up to one year postoperatively
  description: During the course of the study, any upcoming intra- or postoperative (serious) adverse device events or effects ((S)AE) related or not related to the product under investigation, will be documented. The total number of (S)AEs will be summarized and further evaluated by the sponsor and reported according to local legislation and necessity. Recorded complications will be categorized and analyzed in order to assess the safety of the investigational product.
  arm group label: OrthoPilot® Elite
  description: navigated / computer assisted total knee replacement surgery
  arm group label: MAKO
  description: robot assisted total knee replacement surgery
  intervention type: Device
  intervention name: Navigated total knee arthroplasty
  description: Total knee arthroplasty with Columbus® total knee endoprosthesis using the OrthoPilot® Elite navigation system
  arm group label: OrthoPilot® Elite
  other name: Columbus® total knee endoprosthesis
  intervention type: Device
  intervention name: Robot assisted total knee arthroplasty
  description: Total knee arthroplasty with Triathlon® total knee endoprosthesis using the MAKO® robot system
  arm group label: MAKO
  other name: Triathlon® total knee endoprosthesis
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 90 Years
  healthy volunteers: No
  last name: Hans-Joachim Riesner, PD Dr. med.
  role: Principal Investigator
  affiliation: Bundeswehr Krankenhaus Ulm
  last name: Kristin Maier, Dr.
  phone: +49746195
  email: info@aesculap.de
  last name: Marius Selig
  phone: +49746195
  email: info@aesculap.de
  facility: 
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  country: Germany
  responsible party type: Sponsor
  mesh term: Osteoarthritis, Knee
  mesh term: Joint Diseases
  sharing ipd: No