<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/NCT04477447</url>
  </required_header>
  <id_info>
    <org_study_id>AAG-O-H-2004</org_study_id>
    <nct_id>NCT04477447</nct_id>
  </id_info>
  <brief_title>PMCF Study on the Safety and Performance of CESPACE 3D</brief_title>
  <acronym>CATALINA</acronym>
  <official_title>Multicenter PMCF Study on the Safety and Performance of CESPACE 3D - A Prospective Study on Total Indications</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aesculap AG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aesculap AG</source>
  <brief_summary>
    <textblock>
      Prospective, pure data collection of all CeSPACE 3D patients in selected centers (not&#xD;
      interventional, multicenter)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 21, 2020</start_date>
  <completion_date type="Anticipated">June 2024</completion_date>
  <primary_completion_date type="Anticipated">June 2023</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>Change of Neck Specific Disability measured by Neck Disability Index (NDI)</measure>
    <time_frame>preoperative, 12 months postoperative</time_frame>
    <description>The NDI is designed to measure neck-specific disability. The questionnaire has 10 items to measure patient-reported disability secondary to neck pain and activities of daily living including personal care, lifting, reading, headaches, concentration, work status, driving, sleeping and recreation and patients rate their status from 0 (best) to 5 (worst imaginable). Individual item responses are summed to a total score, where 0 points indicate no activity limitations and 50 points indicate complete activity limitation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>JOA score</measure>
    <time_frame>preoperatively and at one follow-up- assessment after a minimum of one year postoperatively</time_frame>
    <description>The Japanese Orthopaedic Association (JOA) score is a widely used tool to assess the severity of clinical symptoms in patients with cervical compressive myelopathy. Motor function (Upper extremity/Lower extremity); Sensory (Upper extremity/lower extremity/trunk); Bladder function. The Score reaches a maximum of 17 and a Minimum of 0 points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain (VAS)</measure>
    <time_frame>preoperatively and at one follow-up- assessment after a minimum of one year postoperatively</time_frame>
    <description>The visual analogue scale (VAS) is a scale used to determine the pain intensity experienced by individuals. It consists of a line, approximately 10-15 cm in length, with the left side signifying no pain with a smiling face image and the right side signifying the worst pain ever with a frowning face image.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>development of EQ-5D-5L</measure>
    <time_frame>preoperatively and at one follow-up- assessment after a minimum of one year postoperatively</time_frame>
    <description>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. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. 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>development of radiological outcome</measure>
    <time_frame>preoperatively and at one follow-up- assessment after a minimum of one year postoperatively</time_frame>
    <description>if provided in the clinical standard; e.g. fusion, implant subsidence, implant migration)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of AE/SAEs</measure>
    <time_frame>preoperatively, intraoperatively and at one follow-up- assessment after a minimum of one year postoperatively</time_frame>
    <description>Rate of AE/SAEs during the postoperative course</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction with Treatment Outcome</measure>
    <time_frame>at one follow-up- assessment after a minimum of one year postoperatively</time_frame>
    <description>Patient satisfaction with Outcome of surgery documented in two aspects: is the Patient satisfied (four Point scale: very satisfied, satisfied, unsatisfied, very unsatisfied) and would the Patient like to undergo surgery again (yes, no, not willing to say)</description>
  </secondary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Degenerative Instability</condition>
  <condition>Spondylolisthesis</condition>
  <condition>Post-discectomy Syndrome</condition>
  <condition>Post-traumatic Instabilities</condition>
  <eligibility>
    <study_pop>
      <textblock>
        adult patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient is minimum 18 years old&#xD;
&#xD;
          -  Written informed consent for the documentation of clinical and radiological results&#xD;
&#xD;
          -  Patient's indication according to IFU&#xD;
&#xD;
          -  Patient is not pregnant&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Patient is not willing or able to participate at the follow-up examination&#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>Stefan Nikolaus Kroppenstedt, Dr. med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Abteilung für Wirbelsäulenchirurgie Sana Kliniken Sommerfeld</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Francis Kilian, Dr. med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Katholisches Klinikum Koblenz</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Stefan Maenz, Dr.</last_name>
    <phone>+49-7461-95-0</phone>
    <email>stefan.maenz@aesculap.de</email>
  </overall_contact>
  <location>
    <facility>
      <name>Katholisches Klinikum Koblenz</name>
      <address>
        <city>Koblenz</city>
        <zip>56073</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Francis Kilian, Dr. med.</last_name>
    </contact>
    <contact_backup>
      <last_name>Bernhard Bruchmann, Dr.</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Sana Kliniken Sommerfeld</name>
      <address>
        <city>Kremmen</city>
        <zip>16766</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Stefan Nikolaus Kroppenstedt, Dr. med.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</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>Cervical Vertebrae;</keyword>
  <keyword>Spondylolisthesis;</keyword>
  <keyword>Treatment Outcome;</keyword>
  <keyword>Interbody Fusion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spondylolisthesis</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/NCT04477447
org study id: AAG-O-H-2004
nct id: NCT04477447
lead sponsor: 
Prospective, pure data collection of all CeSPACE 3D patients in selected centers (not
      interventional, multicenter)
observational model: Cohort
time perspective: Prospective
measure: Change of Neck Specific Disability measured by Neck Disability Index (NDI)
time frame: preoperative, 12 months postoperative
description: The NDI is designed to measure neck-specific disability. The questionnaire has 10 items to measure patient-reported disability secondary to neck pain and activities of daily living including personal care, lifting, reading, headaches, concentration, work status, driving, sleeping and recreation and patients rate their status from 0 (best) to 5 (worst imaginable). Individual item responses are summed to a total score, where 0 points indicate no activity limitations and 50 points indicate complete activity limitation.
measure: JOA score
time frame: preoperatively and at one follow-up- assessment after a minimum of one year postoperatively
description: The Japanese Orthopaedic Association (JOA) score is a widely used tool to assess the severity of clinical symptoms in patients with cervical compressive myelopathy. Motor function (Upper extremity/Lower extremity); Sensory (Upper extremity/lower extremity/trunk); Bladder function. The Score reaches a maximum of 17 and a Minimum of 0 points.
measure: Pain (VAS)
time frame: preoperatively and at one follow-up- assessment after a minimum of one year postoperatively
description: The visual analogue scale (VAS) is a scale used to determine the pain intensity experienced by individuals. It consists of a line, approximately 10-15 cm in length, with the left side signifying no pain with a smiling face image and the right side signifying the worst pain ever with a frowning face image.
measure: development of EQ-5D-5L
time frame: preoperatively and at one follow-up- assessment after a minimum of one year postoperatively
description: 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. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. 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: development of radiological outcome
time frame: preoperatively and at one follow-up- assessment after a minimum of one year postoperatively
description: if provided in the clinical standard; e.g. fusion, implant subsidence, implant migration)
measure: Rate of AE/SAEs
time frame: preoperatively, intraoperatively and at one follow-up- assessment after a minimum of one year postoperatively
description: Rate of AE/SAEs during the postoperative course
measure: Patient Satisfaction with Treatment Outcome
time frame: at one follow-up- assessment after a minimum of one year postoperatively
description: Patient satisfaction with Outcome of surgery documented in two aspects: is the Patient satisfied (four Point scale: very satisfied, satisfied, unsatisfied, very unsatisfied) and would the Patient like to undergo surgery again (yes, no, not willing to say)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stefan Nikolaus Kroppenstedt, Dr. med.
role: Principal Investigator
affiliation: Abteilung für Wirbelsäulenchirurgie Sana Kliniken Sommerfeld
last name: Francis Kilian, Dr. med.
role: Principal Investigator
affiliation: Katholisches Klinikum Koblenz
last name: Stefan Maenz, Dr.
phone: +49-7461-95-0
email: stefan.maenz@aesculap.de
facility: 
status: Not yet recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
investigator: 
country: Germany
responsible party type: Sponsor
mesh term: Spondylolisthesis