<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/NCT03817632</url>
  </required_header>
  <id_info>
    <org_study_id>AAG-O-H-1708</org_study_id>
    <nct_id>NCT03817632</nct_id>
  </id_info>
  <brief_title>Orthopilot Elite Post-Market Clinical Follow-Up</brief_title>
  <official_title>Prospective, Multicenter, Observational, Comparative Clinical Trial on the Equivalence of Two Different OrthoPilot® Navigation System Generations Applied for Computer-assisted 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>
      Prospective, multicenter, observational, comparative clinical trial on the equivalence of two&#xD;
      different OrthoPilot® navigation system generations applied for computer-assisted total knee&#xD;
      arthroplasty&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is designed as a prospective, non-interventional, multicenter, comparative cohort&#xD;
      study. The product under investigation will be used in routine clinical practice and&#xD;
      according to the authorized Instructions for Use (IfU). Those data that are obtained in&#xD;
      routine clinical use will be documented in the Case Report Form (CRF).&#xD;
&#xD;
      The study design is based on a two-arms design. The patients for the both groups will be&#xD;
      recruited consecutively, starting with group A. The study will prove the equivalence of the&#xD;
      groups regarding the outcome of the postoperative lower limb alignment (mechanical leg axis)&#xD;
      and any deviation &gt;3° from neutral alignment is defined as an outlier.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2019</start_date>
  <completion_date type="Actual">October 29, 2022</completion_date>
  <primary_completion_date type="Actual">June 30, 2022</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>Rate of Lower Limb Alignment inside the range of 0±3°</measure>
    <time_frame>three months postoperatively</time_frame>
    <description>A postoperative lower limb alignment of the knee prosthesis in reference to the mechanical leg axis (3, 18) outside the range of ± 3° is defined as the outlier. The outlier rates will be used as the efficacy criterion for groups comparison</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Lower limb alignment of the knee prosthesis in reference to the mechanical leg axis</measure>
    <time_frame>3 months postoperatively</time_frame>
    <description>The outcome and function of a prosthesis is influenced by the postoperative alignment of the leg and the orientation in reference to the axis. Incorrect positioning can lead to an increased implant wear and functional limitations (23, 24). The aim of a postoperative alignment within 3° varus to 3° valgus will be assessed using long leg x-rays 3-4 months postoperatively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement of Knee Society Score (KSS)</measure>
    <time_frame>preoperatively and three months postoperatively</time_frame>
    <description>The KSS score is composed of two subgroups and has a maximum score of 200.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement of Oxford Knee Score (OKS)</measure>
    <time_frame>preoperatively and three months postoperatively</time_frame>
    <description>A patient-reported outcome instrument which contains 12 questions on activities of daily living that assess function and residual pain in patients undergoing total knee replacement (TKR) arthroplasty. Oxford Knee Score has a maximum of 48 points indicating satisfactory knee function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement of Quality of Life (EQ-5D-5L)</measure>
    <time_frame>preoperatively and three months postoperatively</time_frame>
    <description>The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).&#xD;
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Learning Curve</measure>
    <time_frame>Intraoperatively</time_frame>
    <description>The first 10 cases of each surgeon shall be excluded from the main analysis. The results of the first 10 cases (&quot;learning curve&quot;) shall be assessed separately and compared with the &quot;10 plus&quot; cases (&quot;routine cases&quot;) as a secondary learning curve analysis. The potential learning curve will be assessed measuring the intraoperative surgery time in reference to the already performed procedures of each surgeon</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraoperative handling of soft- and hardware components</measure>
    <time_frame>Intraoperatively</time_frame>
    <description>Aim of this study is also to document any upcoming problems or limitations the operating surgeon has with the new components of the OrthoPilot® Elite hardware system and the new software application TKA 6.0 for the implantation of primary total knee endoprosthesis. Intraoperatively documented results of the navigation system will be recorded and integrated into the final analysis. Potential problems or comments will be analysed descriptively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>(Serious) Adverse Device Effects</measure>
    <time_frame>up to 3 months postoperatively</time_frame>
    <description>As part of the follow-up examination, any upcoming (serious) adverse device events or effects related or not related to the product under investigation, will be documented in the dedicated Case Report Forms. Recorded complications will be categorized and analyzed in order to assess the safety of the OrthoPilot® navigation system</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">217</enrollment>
  <condition>Degenerative Osteoarthritis</condition>
  <condition>Rheumatoid Arthritis</condition>
  <condition>Posttraumatic Arthropathy</condition>
  <condition>Instability, Joint</condition>
  <condition>Stiffness of Knee, Not Elsewhere Classified</condition>
  <condition>Deformity of Knee</condition>
  <arm_group>
    <arm_group_label>A Standard</arm_group_label>
    <description>Computer assisted primary total knee replacement with OrthoPilot FS 101 navigation system and Software 5.1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B Elite</arm_group_label>
    <description>Computer assisted primary total knee replacement with OrthoPilot Elite navigation system and Software 6.0</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Computer assisted primary total knee replacement with OrthoPilot FS101 navigation system and Software 5.1</intervention_name>
    <description>Computer Assisted Total Knee Replacement with the OrthoPilot FS101 and the software TKA 5.1</description>
    <arm_group_label>A Standard</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Computer assisted primary total knee replacement with OrthoPilot Elite navigation system and Software 6.0</intervention_name>
    <description>Computer Assisted Total Knee Replacement with the with the OrthoPilot Elite and the software TKA 6.0</description>
    <arm_group_label>B Elite</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        adult patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion: Inclusion Criteria:&#xD;
&#xD;
          -  Patients with indication for Total Knee Arthroplasty using the Aesculap OrthoPilot®&#xD;
             navigation system and a corresponding primary implant&#xD;
&#xD;
          -  Dated and signed informed consent&#xD;
&#xD;
        Exclusion: Exclusion Criteria&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Patients &lt; 18 years&#xD;
&#xD;
          -  Patients unable to participate at the follow-up examination (physically, mentally)&#xD;
&#xD;
          -  Previous joint replacement at the indexed knee&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Universitätsklinikum Carl Gustav Carus</name>
      <address>
        <city>Dresden</city>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uniklinikum Freiburg</name>
      <address>
        <city>Freiburg</city>
        <zip>79106</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Schönkliniken Klinikum Eilbek</name>
      <address>
        <city>Hamburg</city>
        <zip>22081</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>January 23, 2019</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>January 13, 2023</last_update_submitted>
  <last_update_submitted_qc>January 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Navigation</keyword>
  <keyword>Computer Assisted Orthopedic Surgery</keyword>
  <keyword>OrthoPilot®</keyword>
  <keyword>Total Knee Arthroplasty</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Joint Instability</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/NCT03817632
org study id: AAG-O-H-1708
nct id: NCT03817632
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Prospective, multicenter, observational, comparative clinical trial on the equivalence of two
      different OrthoPilot® navigation system generations applied for computer-assisted total knee
      arthroplasty
The study is designed as a prospective, non-interventional, multicenter, comparative cohort
      study. The product under investigation will be used in routine clinical practice and
      according to the authorized Instructions for Use (IfU). Those data that are obtained in
      routine clinical use will be documented in the Case Report Form (CRF).

      The study design is based on a two-arms design. The patients for the both groups will be
      recruited consecutively, starting with group A. The study will prove the equivalence of the
      groups regarding the outcome of the postoperative lower limb alignment (mechanical leg axis)
      and any deviation >3° from neutral alignment is defined as an outlier.
observational model: Cohort
time perspective: Prospective
measure: Rate of Lower Limb Alignment inside the range of 0±3°
time frame: three months postoperatively
description: A postoperative lower limb alignment of the knee prosthesis in reference to the mechanical leg axis (3, 18) outside the range of ± 3° is defined as the outlier. The outlier rates will be used as the efficacy criterion for groups comparison
measure: Lower limb alignment of the knee prosthesis in reference to the mechanical leg axis
time frame: 3 months postoperatively
description: The outcome and function of a prosthesis is influenced by the postoperative alignment of the leg and the orientation in reference to the axis. Incorrect positioning can lead to an increased implant wear and functional limitations (23, 24). The aim of a postoperative alignment within 3° varus to 3° valgus will be assessed using long leg x-rays 3-4 months postoperatively.
measure: Improvement of Knee Society Score (KSS)
time frame: preoperatively and three months postoperatively
description: The KSS score is composed of two subgroups and has a maximum score of 200.
measure: Improvement of Oxford Knee Score (OKS)
time frame: preoperatively and three months postoperatively
description: A patient-reported outcome instrument which contains 12 questions on activities of daily living that assess function and residual pain in patients undergoing total knee replacement (TKR) arthroplasty. Oxford Knee Score has a maximum of 48 points indicating satisfactory knee function
measure: Improvement of Quality of Life (EQ-5D-5L)
time frame: preoperatively and three months postoperatively
description: The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
measure: Learning Curve
time frame: Intraoperatively
description: The first 10 cases of each surgeon shall be excluded from the main analysis. The results of the first 10 cases ("learning curve") shall be assessed separately and compared with the "10 plus" cases ("routine cases") as a secondary learning curve analysis. The potential learning curve will be assessed measuring the intraoperative surgery time in reference to the already performed procedures of each surgeon
measure: Intraoperative handling of soft- and hardware components
time frame: Intraoperatively
description: Aim of this study is also to document any upcoming problems or limitations the operating surgeon has with the new components of the OrthoPilot® Elite hardware system and the new software application TKA 6.0 for the implantation of primary total knee endoprosthesis. Intraoperatively documented results of the navigation system will be recorded and integrated into the final analysis. Potential problems or comments will be analysed descriptively.
measure: (Serious) Adverse Device Effects
time frame: up to 3 months postoperatively
description: As part of the follow-up examination, any upcoming (serious) adverse device events or effects related or not related to the product under investigation, will be documented in the dedicated Case Report Forms. Recorded complications will be categorized and analyzed in order to assess the safety of the OrthoPilot® navigation system
arm group label: A Standard
description: Computer assisted primary total knee replacement with OrthoPilot FS 101 navigation system and Software 5.1
arm group label: B Elite
description: Computer assisted primary total knee replacement with OrthoPilot Elite navigation system and Software 6.0
intervention type: Device
intervention name: Computer assisted primary total knee replacement with OrthoPilot FS101 navigation system and Software 5.1
description: Computer Assisted Total Knee Replacement with the OrthoPilot FS101 and the software TKA 5.1
arm group label: A Standard
intervention type: Device
intervention name: Computer assisted primary total knee replacement with OrthoPilot Elite navigation system and Software 6.0
description: Computer Assisted Total Knee Replacement with the with the OrthoPilot Elite and the software TKA 6.0
arm group label: B Elite
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
facility: 
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Joint Instability