<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/NCT04489394</url>
  </required_header>
  <id_info>
    <org_study_id>AAG-O-H-1901</org_study_id>
    <nct_id>NCT04489394</nct_id>
  </id_info>
  <brief_title>Quintex® Follow-up After One Year Minimum</brief_title>
  <acronym>Quintex</acronym>
  <official_title>Prospective Follow-up Study of the Aesculap Quintex® Anterior Cervical Plating System After a Minimum of One Year</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 study, not randomised, non-interventional, monocentric, investigating an intended&#xD;
      patient cohort of 60 patients already operated on the cervical spine due to degenerative disc&#xD;
      disease of the cervical spine down to the first thoracolumbar VBR (C2-T1), who received a&#xD;
      Quintex plate for stabilisation&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 11, 2019</start_date>
  <completion_date type="Actual">February 18, 2020</completion_date>
  <primary_completion_date type="Actual">February 18, 2020</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical Results measured by Neck Disability Index (NDI)</measure>
    <time_frame>One retrospective visit, between one and approx. five years post-op.</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>Neck and arm pain</measure>
    <time_frame>One retrospective visit, between one and approx. five years post-op.</time_frame>
    <description>Visual analogue scale for pain: 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>Patient satisfaction</measure>
    <time_frame>One retrospective visit, between one and approx. five years post-op.</time_frame>
    <description>Patient satisfaction with Outcome of surgery documented in two aspects: is the Patient satisfied (four Point scale:&#xD;
very satisfied, satisfied, unsatisfied, very unsatisfied) and would the Patient like to undergo surgery again (yes, no, not willing to say)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life measured by EQ-5D-5L</measure>
    <time_frame>One retrospective visit, between one and approx. five years post-op.</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>Dysphagia assessment</measure>
    <time_frame>One retrospective visit, between one and approx. five years post-op.</time_frame>
    <description>Bazaz score: The Bazaz Dysphagia Score is one criterion used to define dysphagia; it classifies dysphagia as severe, moderate, mild, or none</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>One retrospective visit, between one and approx. five years post-op.</time_frame>
    <description>Adverse Events and Serious Adverse Events, reoperations and revisions rates</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative Need for Pain medication</measure>
    <time_frame>One retrospective visit, between one and approx. five years post-op.</time_frame>
    <description>The patient's Need for Pain Medication is measured by the WHO (World Health Organization) analgesic ladder</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiological outcome from standard x-rays</measure>
    <time_frame>One retrospective visit, between one and approx. five years post-op.</time_frame>
    <description>Radiologically: Fusion status, plate position, pot. migration of screws and plate, radiolucent lines</description>
  </secondary_outcome>
  <enrollment type="Actual">60</enrollment>
  <condition>Degenerative Disc Disease</condition>
  <condition>Spondylolisthesis</condition>
  <condition>Trauma</condition>
  <condition>Spinal Stenosis</condition>
  <condition>Deformity of Spine</condition>
  <condition>Pseudoarthrosis of Spine</condition>
  <condition>Cervical Spondylosis</condition>
  <condition>Instability; Back</condition>
  <eligibility>
    <study_pop>
      <textblock>
        adult patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - all patients who received a Quintex® Anterior Cervical Plate since 2014 until approx. end&#xD;
        2018 (minimum Follow-up is one year) in the study center&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient informed consent not signed&#xD;
&#xD;
          -  Patients living outside a radius of 80 km around the study center&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Katholisches Klinikum Koblenz</name>
      <address>
        <city>Koblenz</city>
        <zip>56073</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>July 28, 2020</last_update_submitted>
  <last_update_submitted_qc>July 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Stenosis</mesh_term>
    <mesh_term>Intervertebral Disc Degeneration</mesh_term>
    <mesh_term>Spondylolisthesis</mesh_term>
    <mesh_term>Spondylosis</mesh_term>
    <mesh_term>Pseudarthrosis</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/NCT04489394
org study id: AAG-O-H-1901
nct id: NCT04489394
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Prospective study, not randomised, non-interventional, monocentric, investigating an intended
      patient cohort of 60 patients already operated on the cervical spine due to degenerative disc
      disease of the cervical spine down to the first thoracolumbar VBR (C2-T1), who received a
      Quintex plate for stabilisation
observational model: Cohort
time perspective: Retrospective
measure: Clinical Results measured by Neck Disability Index (NDI)
time frame: One retrospective visit, between one and approx. five years post-op.
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: Neck and arm pain
time frame: One retrospective visit, between one and approx. five years post-op.
description: Visual analogue scale for pain: 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: Patient satisfaction
time frame: One retrospective visit, between one and approx. five years post-op.
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)
measure: Quality of life measured by EQ-5D-5L
time frame: One retrospective visit, between one and approx. five years post-op.
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: Dysphagia assessment
time frame: One retrospective visit, between one and approx. five years post-op.
description: Bazaz score: The Bazaz Dysphagia Score is one criterion used to define dysphagia; it classifies dysphagia as severe, moderate, mild, or none
measure: Complications
time frame: One retrospective visit, between one and approx. five years post-op.
description: Adverse Events and Serious Adverse Events, reoperations and revisions rates
measure: Postoperative Need for Pain medication
time frame: One retrospective visit, between one and approx. five years post-op.
description: The patient's Need for Pain Medication is measured by the WHO (World Health Organization) analgesic ladder
measure: Radiological outcome from standard x-rays
time frame: One retrospective visit, between one and approx. five years post-op.
description: Radiologically: Fusion status, plate position, pot. migration of screws and plate, radiolucent lines
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Spinal Stenosis
mesh term: Intervertebral Disc Degeneration
mesh term: Spondylolisthesis
mesh term: Spondylosis
mesh term: Pseudarthrosis