<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/NCT03275246</url>
  </required_header>
  <id_info>
    <org_study_id>CSE2017-01K</org_study_id>
    <nct_id>NCT03275246</nct_id>
  </id_info>
  <brief_title>Establish Implant Accuracy With X-PSI Knee System</brief_title>
  <acronym>X-PSI</acronym>
  <official_title>Establish Implant Accuracy With X-PSI Knee System - A Multi-center, Prospective, Non-controlled Post Market Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zimmer, GmbH</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>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this study is to establish the accuracy of the new X-PSI Knee System guides by&#xD;
      analyzing early postoperative (4-6 weeks) imaging data with regards to the mechanical&#xD;
      alignment and compare them with preoperative planning imaging data. Mechanical alignment in&#xD;
      the hip-knee-ankle (HKA) frontal plane with X-PSI Knee System will be measured and compared&#xD;
      with results reported in the literature using a conventional (non-guided) approach.&#xD;
&#xD;
      Hypothesis: The use of the new X-PSI Knee System achieves the same accuracy with respect to&#xD;
      mechanical alignment as with conventional instrumentation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patient-specific instruments (PSI) provide surgeons with an anatomically personalized surgery&#xD;
      tool. The newly developed and CE-marked X-PSI Knee System is based on long leg x-rays that&#xD;
      are used to generate a pre-operative 3D model of the knee. The total knee replacement surgery&#xD;
      will be planned according to this 3D model.&#xD;
&#xD;
      The aim of this multi-center, prospective, non-controlled post-market study is to&#xD;
      scientifically document the accuracy, cost-effectiveness and subsequent clinical performance&#xD;
      of the X-PSI Knee System. The X-PSI pin guides are designed to facilitate a more simplified,&#xD;
      efficient and customized TKA procedure compared to conventional, non-guided instrumentation.&#xD;
&#xD;
      To evaluate the accuracy of the X-PSI Knee System, early postoperative (4-6 weeks) imaging&#xD;
      data will be analysed with regards to the mechanical alignment (hip-knee-ankle angle) of the&#xD;
      leg and matched to preoperative planning imaging data. The X-PSI Knee System cohort will then&#xD;
      be compared with current literature (70% of cases within ±3 degrees) where patients were&#xD;
      conventionally operated with non-guided surgery. No control group will be studied.&#xD;
&#xD;
      The cost-effectiveness of the X-PSI Knee System will be evaluated with an efficiency matrix&#xD;
      to record OR set-up time, surgery time and post-processing time.&#xD;
&#xD;
      Clinical outcome data of the patients will be evaluated 4-6 weeks and 1 year post-surgery&#xD;
      with the help of patient questionnaires (VAS pain scale, EQ-5D and Oxford Knee Score), a&#xD;
      physical exam and the assessment of radiographs.&#xD;
&#xD;
      The study population will be compromised of males and females requiring total knee&#xD;
      arthroplasty and satisfy the inclusion/exclusion criteria. The study will last one (1) year&#xD;
      from the time of surgery. The collected data aim to improve the treatment and quality of life&#xD;
      of patients suffering from degenerative joint diseases. In addition, shorter surgery times&#xD;
      possibly result in reduced risk of infection, decreased time of anaesthesia and better&#xD;
      cost-effectiveness.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The clinical study was stopped due to very low enrolment numbers. Due to the very slow&#xD;
    enrolment, the goal of the study cannot be reached within a reasonable time frame.&#xD;
  </why_stopped>
  <start_date type="Actual">October 5, 2018</start_date>
  <completion_date type="Actual">November 17, 2020</completion_date>
  <primary_completion_date type="Actual">December 20, 2019</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mechanical Leg Alignment</measure>
    <time_frame>4-6 weeks post-surgery</time_frame>
    <description>Achievement of mechanical leg alignment in HKA frontal plane (± 3 degrees) with X-PSI Knee System is as accurate as with standard instrumentation at 4-6 weeks post operation. The X-PSI Knee System cohort will be compared with current literature (70% of cases within ± 3 degrees). No control group will be studied.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cost-effectiveness of the X-PSI Knee System Using an Efficiency Matrix</measure>
    <time_frame>During surgery, immediate pre- and post-surgery processing time</time_frame>
    <description>The cost-effectiveness of the X-PSI Knee System will be measured using an efficiency matrix where OR set-up time, surgery time and tray sterilization times will be collected and compared to conventional TKA procedures.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Patient Clinical Outcome Measure: Visual Analog Score Pain</measure>
    <time_frame>Baseline, 4-6 weeks and 1 year post-surgery</time_frame>
    <description>Obtain clincal outcome data on patients treated using the X-PSI Knee System in primary TKA procedures. The pain level will be measured using a 10 cm long scale indicating no pain (0) and worst imaginable pain (10).</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient Clinical Outcome Measure: Oxford Knee Score</measure>
    <time_frame>Baseline, 4-6 weeks and 1 year post-surgery</time_frame>
    <description>The Oxford Knee Score (OKS) is a 12-item patient-reported patient reported outcome specifically designed and developed to assess function and pain after total knee replacement (TKR) surgery (arthroplasty). The OKS provides a single summed score which reflects the severity of problems that the respondent has with their knee. Each question (item) is scored from 0 to 4 with 0 being the worst outcome and 4 being the best outcome. The scores are then summed to produce an overall score running from 0 (worst possible) to 48 (best outcome).</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient Clinical Outcome Measure: EQ-5D Visual Analogue Scale (VAS)</measure>
    <time_frame>Baseline, 4-6 weeks and 1 year post-surgery</time_frame>
    <description>Obtain clincal outcome data on patients treated using the X-PSI Knee System in primary TKA procedures. The EQ-5D VAS is a score to measure general quality of life. The general health state will be assessed on a patient self-reported Visual Analog Scale (VAS) where the endpoints are labelled 0 (worst imaginable health state) to 100 (best imaginable health state). The VAS is used as a quantitative measure of health outcome that reflects the patient's own judgement.</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient Clinical Outcome Measure: EQ-5D-3L Descriptive System</measure>
    <time_frame>Baseline, 4-6 weeks and 1 year post-surgery</time_frame>
    <description>The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <condition>Post-traumatic Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Total knee arthroplasty</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergoing total knee arthroplasty</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>X-PSI Knee System</intervention_name>
    <description>Patients are operated with X-PSI Knee System guides</description>
    <arm_group_label>Total knee arthroplasty</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient is 18 years of age or older.&#xD;
&#xD;
          -  Patient can follow the X-PSI Knee System imaging protocol as part of standard of care&#xD;
             procedures.&#xD;
&#xD;
          -  Patient gets TKA treatment which follows the criteria of the appropriate Instruction&#xD;
             for Use.&#xD;
&#xD;
          -  Patient is willing and able to cooperate in the required postoperative standard of&#xD;
             care.&#xD;
&#xD;
          -  Patient is willing and able to complete scheduled follow-up evaluations as described&#xD;
             in the Informed Consent.&#xD;
&#xD;
          -  Patient has participated in the study-related Informed Consent process and has signed&#xD;
             the Ethics Committee approved Informed Consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient is unwilling or unable to give consent or to comply with the follow-up&#xD;
             program.&#xD;
&#xD;
          -  Patient meets exclusion criteria of the appropriate Instruction for Use&#xD;
&#xD;
          -  Patients who have any condition which would in the judgement of the Investigator place&#xD;
             the patient at undue risk or interfere with the study. Any patient who is&#xD;
             institutionalized, or is a known drug abuser, a known alcoholic or anyone who cannot&#xD;
             understand what is required from them&#xD;
&#xD;
          -  Patient is known to be pregnant&#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>Oliver Schaetti, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Jr. Clinical Project Lead</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>HELIOS Kliniken Mittelweser GmbH</name>
      <address>
        <city>Nienburg</city>
        <zip>31582</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Knie Praxis Prof. Dr. Tibesku</name>
      <address>
        <city>Straubing</city>
        <zip>94315</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zuyderland Medical Park</name>
      <address>
        <city>Sittard</city>
        <zip>6162</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Bournemouth Hospital</name>
      <address>
        <city>Bournemouth</city>
        <zip>BH7 7DW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>Netherlands</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>August 24, 2017</study_first_submitted>
  <study_first_submitted_qc>September 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 7, 2017</study_first_posted>
  <results_first_submitted>May 10, 2021</results_first_submitted>
  <results_first_submitted_qc>September 8, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">October 6, 2021</results_first_posted>
  <last_update_submitted>September 8, 2021</last_update_submitted>
  <last_update_submitted_qc>September 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Primary total knee replacement</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 8, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/46/NCT03275246/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Total Knee Arthroplasty</title>
          <description>Patients undergoing total knee arthroplasty&#xD;
X-PSI Knee System: Patients are operated with X-PSI Knee System guides</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>The study was stopped before the patient reached the final 1 year follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Baseline data collected and reported for those participants that underwent surgery with X-PSI Knee System</population>
      <group_list>
        <group group_id="B1">
          <title>Total Knee Arthroplasty</title>
          <description>Patients undergoing total knee arthroplasty&#xD;
X-PSI Knee System: Patients are operated with X-PSI Knee System guides</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="3"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Germany</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mechanical Leg Alignment</title>
        <description>Achievement of mechanical leg alignment in HKA frontal plane (± 3 degrees) with X-PSI Knee System is as accurate as with standard instrumentation at 4-6 weeks post operation. The X-PSI Knee System cohort will be compared with current literature (70% of cases within ± 3 degrees). No control group will be studied.</description>
        <time_frame>4-6 weeks post-surgery</time_frame>
        <population>Mechanical alignment data were not collected from any participant.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Knee Arthroplasty</title>
            <description>Patients undergoing total knee arthroplasty&#xD;
X-PSI Knee System: Patients are operated with X-PSI Knee System guides</description>
          </group>
        </group_list>
        <measure>
          <title>Mechanical Leg Alignment</title>
          <description>Achievement of mechanical leg alignment in HKA frontal plane (± 3 degrees) with X-PSI Knee System is as accurate as with standard instrumentation at 4-6 weeks post operation. The X-PSI Knee System cohort will be compared with current literature (70% of cases within ± 3 degrees). No control group will be studied.</description>
          <population>Mechanical alignment data were not collected from any participant.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cost-effectiveness of the X-PSI Knee System Using an Efficiency Matrix</title>
        <description>The cost-effectiveness of the X-PSI Knee System will be measured using an efficiency matrix where OR set-up time, surgery time and tray sterilization times will be collected and compared to conventional TKA procedures.</description>
        <time_frame>During surgery, immediate pre- and post-surgery processing time</time_frame>
        <population>No data on cost-effectiveness and efficiency were collected from any participant.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Knee Arthroplasty</title>
            <description>Patients undergoing total knee arthroplasty&#xD;
X-PSI Knee System: Patients are operated with X-PSI Knee System guides</description>
          </group>
        </group_list>
        <measure>
          <title>Cost-effectiveness of the X-PSI Knee System Using an Efficiency Matrix</title>
          <description>The cost-effectiveness of the X-PSI Knee System will be measured using an efficiency matrix where OR set-up time, surgery time and tray sterilization times will be collected and compared to conventional TKA procedures.</description>
          <population>No data on cost-effectiveness and efficiency were collected from any participant.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Patient Clinical Outcome Measure: Visual Analog Score Pain</title>
        <description>Obtain clincal outcome data on patients treated using the X-PSI Knee System in primary TKA procedures. The pain level will be measured using a 10 cm long scale indicating no pain (0) and worst imaginable pain (10).</description>
        <time_frame>Baseline, 4-6 weeks and 1 year post-surgery</time_frame>
        <population>Data should be interpreted with caution, as too few participants were followed to assess endpoints (N=3 for baseline and 4-6 weeks; N=2 for 1 year)</population>
        <group_list>
          <group group_id="O1">
            <title>Total Knee Arthroplasty</title>
            <description>Patients undergoing total knee arthroplasty&#xD;
X-PSI Knee System: Patients are operated with X-PSI Knee System guides</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Clinical Outcome Measure: Visual Analog Score Pain</title>
          <description>Obtain clincal outcome data on patients treated using the X-PSI Knee System in primary TKA procedures. The pain level will be measured using a 10 cm long scale indicating no pain (0) and worst imaginable pain (10).</description>
          <population>Data should be interpreted with caution, as too few participants were followed to assess endpoints (N=3 for baseline and 4-6 weeks; N=2 for 1 year)</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.2" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4-6 weeks post-surgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.7" spread="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 year post-surgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Patient Clinical Outcome Measure: Oxford Knee Score</title>
        <description>The Oxford Knee Score (OKS) is a 12-item patient-reported patient reported outcome specifically designed and developed to assess function and pain after total knee replacement (TKR) surgery (arthroplasty). The OKS provides a single summed score which reflects the severity of problems that the respondent has with their knee. Each question (item) is scored from 0 to 4 with 0 being the worst outcome and 4 being the best outcome. The scores are then summed to produce an overall score running from 0 (worst possible) to 48 (best outcome).</description>
        <time_frame>Baseline, 4-6 weeks and 1 year post-surgery</time_frame>
        <population>Data should be interpreted with caution, as too few participants were followed to assess endpoints (N=3 for baseline and 4-6 weeks; N=2 for 1 year)</population>
        <group_list>
          <group group_id="O1">
            <title>Total Knee Arthroplasty</title>
            <description>Patients undergoing total knee arthroplasty&#xD;
X-PSI Knee System: Patients are operated with X-PSI Knee System guides</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Clinical Outcome Measure: Oxford Knee Score</title>
          <description>The Oxford Knee Score (OKS) is a 12-item patient-reported patient reported outcome specifically designed and developed to assess function and pain after total knee replacement (TKR) surgery (arthroplasty). The OKS provides a single summed score which reflects the severity of problems that the respondent has with their knee. Each question (item) is scored from 0 to 4 with 0 being the worst outcome and 4 being the best outcome. The scores are then summed to produce an overall score running from 0 (worst possible) to 48 (best outcome).</description>
          <population>Data should be interpreted with caution, as too few participants were followed to assess endpoints (N=3 for baseline and 4-6 weeks; N=2 for 1 year)</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.3" spread="6.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4-6 weeks post-surgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.3" spread="5.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 year post-surgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.0" spread="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Patient Clinical Outcome Measure: EQ-5D Visual Analogue Scale (VAS)</title>
        <description>Obtain clincal outcome data on patients treated using the X-PSI Knee System in primary TKA procedures. The EQ-5D VAS is a score to measure general quality of life. The general health state will be assessed on a patient self-reported Visual Analog Scale (VAS) where the endpoints are labelled 0 (worst imaginable health state) to 100 (best imaginable health state). The VAS is used as a quantitative measure of health outcome that reflects the patient's own judgement.</description>
        <time_frame>Baseline, 4-6 weeks and 1 year post-surgery</time_frame>
        <population>Data should be interpreted with caution, as too few participants were followed to assess endpoints (N=3 for baseline and 4-6 weeks; N=2 for 1 year)</population>
        <group_list>
          <group group_id="O1">
            <title>Total Knee Arthroplasty</title>
            <description>Patients undergoing total knee arthroplasty&#xD;
X-PSI Knee System: Patients are operated with X-PSI Knee System guides</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Clinical Outcome Measure: EQ-5D Visual Analogue Scale (VAS)</title>
          <description>Obtain clincal outcome data on patients treated using the X-PSI Knee System in primary TKA procedures. The EQ-5D VAS is a score to measure general quality of life. The general health state will be assessed on a patient self-reported Visual Analog Scale (VAS) where the endpoints are labelled 0 (worst imaginable health state) to 100 (best imaginable health state). The VAS is used as a quantitative measure of health outcome that reflects the patient's own judgement.</description>
          <population>Data should be interpreted with caution, as too few participants were followed to assess endpoints (N=3 for baseline and 4-6 weeks; N=2 for 1 year)</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.3" spread="24.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4-6 weeks post-surgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.3" spread="12.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 year post-surgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91.5" spread="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Patient Clinical Outcome Measure: EQ-5D-3L Descriptive System</title>
        <description>The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems.</description>
        <time_frame>Baseline, 4-6 weeks and 1 year post-surgery</time_frame>
        <population>Data should be interpreted with caution, as too few participants were followed to assess endpoints (N=3 for baseline and 4-6 weeks; N=2 for 1 year)</population>
        <group_list>
          <group group_id="O1">
            <title>Total Knee Arthroplasty</title>
            <description>Patients undergoing total knee arthroplasty&#xD;
X-PSI Knee System: Patients are operated with X-PSI Knee System guides</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Clinical Outcome Measure: EQ-5D-3L Descriptive System</title>
          <description>The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems.</description>
          <population>Data should be interpreted with caution, as too few participants were followed to assess endpoints (N=3 for baseline and 4-6 weeks; N=2 for 1 year)</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline - patients reprting any problem (i.e some problems/ extreme problems) : Mobility</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline - patients reprting any problem (i.e some problems/ extreme problems) : Self-Care</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline - patients reprting any problem (i.e some problems/ extreme problems) : Usual Activities</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline - patients reprting any problem (i.e some problems/ extreme problems) : Pain/Discomfort</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline - patients reprting any problem (i.e some problems/ extreme problems) : Anxiety</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4- weeks post-surgery patients reprting any problem (i.e some problems/ extreme problems) : Mobility</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4- wks post-OP patients reprting any problem (i.e some problems/ extreme problems) : Self-Care</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4- wks post-OP patients reprting any problem (i.e some problems/ extreme problems): Usual Activities</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4- wks post-OP patients reprting any problem (i.e some problems/ extreme problems) : Pain/Discomfort</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4- wks post-OP patients reprting any problem (i.e some problems/ extreme problems) : Anxiety</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 year post-OP patients reprting any problem (i.e some problems/ extreme problems) : Mobility</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 year post-surgery patients reprting any problem (i.e some problems/ extreme problems) : Self-Care</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 year post-OP patients reprting any problem (i.e some problems/ extreme problems): Usual Activities</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 year post-OP patients reprting any problem (i.e some problems/ extreme problems) : Pain/Discomfort</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 year post-OP patients reprting any problem (i.e some problems/ extreme problems) : Anxiety</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 year starting from day of surgery</time_frame>
      <desc>Adverse Event data collected and reported for those participants that underwent surgery with X-PSI Knee System</desc>
      <group_list>
        <group group_id="E1">
          <title>Total Knee Arthroplasty</title>
          <description>Patients undergoing total knee arthroplasty&#xD;
X-PSI Knee System: Patients are operated with X-PSI Knee System guides</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The study was prematurely terminated due to slow enrloment. Only 3 subjects were operated with X-PSI. Out of the 3 subjects, 2 reached the final 1 year follow-up. Due to the very low number of subjects, no statistical analysis was conducted on the data.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Oliver Schaetti</name_or_title>
      <organization>Zimmer Biomet</organization>
      <phone>0041588548901</phone>
      <email>oliver.schaetti@zimmerbiomet.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03275246
org study id: CSE2017-01K
nct id: NCT03275246
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The goal of this study is to establish the accuracy of the new X-PSI Knee System guides by
      analyzing early postoperative (4-6 weeks) imaging data with regards to the mechanical
      alignment and compare them with preoperative planning imaging data. Mechanical alignment in
      the hip-knee-ankle (HKA) frontal plane with X-PSI Knee System will be measured and compared
      with results reported in the literature using a conventional (non-guided) approach.

      Hypothesis: The use of the new X-PSI Knee System achieves the same accuracy with respect to
      mechanical alignment as with conventional instrumentation.
Patient-specific instruments (PSI) provide surgeons with an anatomically personalized surgery
      tool. The newly developed and CE-marked X-PSI Knee System is based on long leg x-rays that
      are used to generate a pre-operative 3D model of the knee. The total knee replacement surgery
      will be planned according to this 3D model.

      The aim of this multi-center, prospective, non-controlled post-market study is to
      scientifically document the accuracy, cost-effectiveness and subsequent clinical performance
      of the X-PSI Knee System. The X-PSI pin guides are designed to facilitate a more simplified,
      efficient and customized TKA procedure compared to conventional, non-guided instrumentation.

      To evaluate the accuracy of the X-PSI Knee System, early postoperative (4-6 weeks) imaging
      data will be analysed with regards to the mechanical alignment (hip-knee-ankle angle) of the
      leg and matched to preoperative planning imaging data. The X-PSI Knee System cohort will then
      be compared with current literature (70% of cases within ±3 degrees) where patients were
      conventionally operated with non-guided surgery. No control group will be studied.

      The cost-effectiveness of the X-PSI Knee System will be evaluated with an efficiency matrix
      to record OR set-up time, surgery time and post-processing time.

      Clinical outcome data of the patients will be evaluated 4-6 weeks and 1 year post-surgery
      with the help of patient questionnaires (VAS pain scale, EQ-5D and Oxford Knee Score), a
      physical exam and the assessment of radiographs.

      The study population will be compromised of males and females requiring total knee
      arthroplasty and satisfy the inclusion/exclusion criteria. The study will last one (1) year
      from the time of surgery. The collected data aim to improve the treatment and quality of life
      of patients suffering from degenerative joint diseases. In addition, shorter surgery times
      possibly result in reduced risk of infection, decreased time of anaesthesia and better
      cost-effectiveness.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Mechanical Leg Alignment
time frame: 4-6 weeks post-surgery
description: Achievement of mechanical leg alignment in HKA frontal plane (± 3 degrees) with X-PSI Knee System is as accurate as with standard instrumentation at 4-6 weeks post operation. The X-PSI Knee System cohort will be compared with current literature (70% of cases within ± 3 degrees). No control group will be studied.
measure: Cost-effectiveness of the X-PSI Knee System Using an Efficiency Matrix
time frame: During surgery, immediate pre- and post-surgery processing time
description: The cost-effectiveness of the X-PSI Knee System will be measured using an efficiency matrix where OR set-up time, surgery time and tray sterilization times will be collected and compared to conventional TKA procedures.
measure: Patient Clinical Outcome Measure: Visual Analog Score Pain
time frame: Baseline, 4-6 weeks and 1 year post-surgery
description: Obtain clincal outcome data on patients treated using the X-PSI Knee System in primary TKA procedures. The pain level will be measured using a 10 cm long scale indicating no pain (0) and worst imaginable pain (10).
measure: Patient Clinical Outcome Measure: Oxford Knee Score
time frame: Baseline, 4-6 weeks and 1 year post-surgery
description: The Oxford Knee Score (OKS) is a 12-item patient-reported patient reported outcome specifically designed and developed to assess function and pain after total knee replacement (TKR) surgery (arthroplasty). The OKS provides a single summed score which reflects the severity of problems that the respondent has with their knee. Each question (item) is scored from 0 to 4 with 0 being the worst outcome and 4 being the best outcome. The scores are then summed to produce an overall score running from 0 (worst possible) to 48 (best outcome).
measure: Patient Clinical Outcome Measure: EQ-5D Visual Analogue Scale (VAS)
time frame: Baseline, 4-6 weeks and 1 year post-surgery
description: Obtain clincal outcome data on patients treated using the X-PSI Knee System in primary TKA procedures. The EQ-5D VAS is a score to measure general quality of life. The general health state will be assessed on a patient self-reported Visual Analog Scale (VAS) where the endpoints are labelled 0 (worst imaginable health state) to 100 (best imaginable health state). The VAS is used as a quantitative measure of health outcome that reflects the patient's own judgement.
measure: Patient Clinical Outcome Measure: EQ-5D-3L Descriptive System
time frame: Baseline, 4-6 weeks and 1 year post-surgery
description: The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems.
arm group label: Total knee arthroplasty
arm group type: Experimental
description: Patients undergoing total knee arthroplasty
intervention type: Device
intervention name: X-PSI Knee System
description: Patients are operated with X-PSI Knee System guides
arm group label: Total knee arthroplasty
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Oliver Schaetti, PhD
role: Study Chair
affiliation: Jr. Clinical Project Lead
facility: 
facility: 
facility: 
facility: 
country: Germany
country: Netherlands
country: United Kingdom
responsible party type: Sponsor
mesh term: Osteoarthritis
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The study was prematurely terminated due to slow enrloment. Only 3 subjects were operated with X-PSI. Out of the 3 subjects, 2 reached the final 1 year follow-up. Due to the very low number of subjects, no statistical analysis was conducted on the data.
point of contact: 