<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/NCT03826329</url>
  </required_header>
  <id_info>
    <org_study_id>2018-09-006CC</org_study_id>
    <nct_id>NCT03826329</nct_id>
  </id_info>
  <brief_title>Risk Factors of Second Surgery for Adjacent Segment Disease Following Anterior Cervical Discectomy and Fusion</brief_title>
  <acronym>2nd ACDF</acronym>
  <official_title>Risk Factors of Second Surgery for Adjacent Segment Disease Following Anterior Cervical Discectomy and Fusion: a 16-year Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taipei Veterans General Hospital, Taiwan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taipei Veterans General Hospital, Taiwan</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Although the incidence of second surgery for adjacent segment disease (ASD) after anterior&#xD;
      cervical discectomy and fusion (ACDF) has been reported, its risk factors remain elusive. Few&#xD;
      studies have had a sufficiently large number of patients, long follow-up time, and high&#xD;
      follow-up rate for investigation. To identify non-surgical risk factors of second surgery for&#xD;
      ASD following ACDF, the study used a national cohort with comprehensive follow-up.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All second ACDF surgery after one year from the first ACDF were identified as a consequence&#xD;
      of ASD that required another surgery. A multivariate competing risk survival model,&#xD;
      Kaplan-Meier survivorship, and average time to events were calculated.&#xD;
&#xD;
      2.1. Data source and ethical concerns The study used the National Health Insurance Research&#xD;
      Database (NHIRD), a national database containing 26 million administered insurants&#xD;
      accumulated from January 1997 to December 2013, provided by the National Health Research&#xD;
      Institutes of Taiwan. Due to the unique social-welfare health insurance system operated by&#xD;
      the government, it is mandatory for every resident in Taiwan to be enrolled. Thus, the NHIRD&#xD;
      has covered 99% of the population since its launch in 1996. The monopolistic national health&#xD;
      insurance also offers unrestricted access to any healthcare provider of the patients'&#xD;
      choices. The statistics, therefore, gathered by the NHIRD represent a sound cohort for&#xD;
      investigation of the natural course and subsequent management of diseases. It is particularly&#xD;
      good for studies that need longitudinal observation for repeat treatment (i.e. surgery for&#xD;
      ASD) because it allows for the capture of events, even though they may occur in multiple or&#xD;
      different institutes and hospitals. The universal coverage and comprehensive follow-up&#xD;
      provided a valuable chance to study ASD.&#xD;
&#xD;
      All the personal information had already undergone a de-identification and encryption&#xD;
      process. Individual and hospital identifiers are unique to the research database and&#xD;
      researchers therefore cannot trace individual patients or health service providers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 11, 2018</start_date>
  <completion_date type="Actual">November 30, 2018</completion_date>
  <primary_completion_date type="Actual">November 30, 2018</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>The date of re-operation (Second ACDF)</measure>
    <time_frame>from patient's index surgery to the end of follow-up (2013/12/31), 4.66 years in average</time_frame>
    <description>Patients were followed-up for the subsequent surgery (second ACDF) after their index operation (first ACDF). We used the hospitalization date of each admission record as the date of outcome (second ACDF). Each patient was followed-up from his index surgery (first ACDF) to re-operation (second ACDF), death, or end of follow-up (2013/12/31) which comes first.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">5565</enrollment>
  <condition>Spinal Fusion</condition>
  <arm_group>
    <arm_group_label>Study Cohort</arm_group_label>
    <description>The observational study included all patients who had been admitted for their first ACDF surgery during the 16-year span, began on January 1st, 1998 till the end of 2013, recorded in the NHIRD. The admission for cervical disc herniation and spondylosis were identified using the ICD9-CM diagnostic codes of 722.0, 722.4 and 722.71, while the surgery of ACDF was confirmed with the procedure codes of 80.51, 81.00 and 81.02 during the same hospitalization.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>observational study</intervention_name>
    <description>this is an observational study, there is no intervention in this study</description>
    <arm_group_label>Study Cohort</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study included all patients who had been admitted for their first ACDF surgery during&#xD;
        the 16-year span, began on January 1st, 1998 till the end of 2013, recorded in the NHIRD.&#xD;
        The admission for cervical disc herniation and spondylosis were identified using the&#xD;
        ICD9-CM diagnostic codes of 722.0, 722.4 and 722.71, while the surgery of ACDF was&#xD;
        confirmed with the procedure codes of 80.51, 81.00 and 81.02 during the same&#xD;
        hospitalization.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients who had been admitted for their first ACDF surgery during the 16-year span,&#xD;
             began on January 1st, 1998 till the end of 2013, recorded in the NHIRD&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  any re-operation (i.e. ACDF) within 365 days from the indexed date of the first ACDF&#xD;
             were excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yu-Chun Chen</last_name>
    <role>Principal Investigator</role>
    <affiliation>Taipei Veterans General Hospital, Taiwan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yu-Chun Chen</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 27, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>January 30, 2019</last_update_submitted>
  <last_update_submitted_qc>January 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Taipei Veterans General Hospital, Taiwan</investigator_affiliation>
    <investigator_full_name>vghtpe user</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Adjacent segment disease (ASD)</keyword>
  <keyword>Second surgery</keyword>
  <keyword>Anterior cervical discectomy and fusion (ACDF)</keyword>
  <keyword>Risk factors</keyword>
  <keyword>Cohort study</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The PI have no right to share the data</ipd_description>
  </patient_data>
  <!-- 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/NCT03826329
org study id: 2018-09-006CC
nct id: NCT03826329
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Although the incidence of second surgery for adjacent segment disease (ASD) after anterior
      cervical discectomy and fusion (ACDF) has been reported, its risk factors remain elusive. Few
      studies have had a sufficiently large number of patients, long follow-up time, and high
      follow-up rate for investigation. To identify non-surgical risk factors of second surgery for
      ASD following ACDF, the study used a national cohort with comprehensive follow-up.
All second ACDF surgery after one year from the first ACDF were identified as a consequence
      of ASD that required another surgery. A multivariate competing risk survival model,
      Kaplan-Meier survivorship, and average time to events were calculated.

      2.1. Data source and ethical concerns The study used the National Health Insurance Research
      Database (NHIRD), a national database containing 26 million administered insurants
      accumulated from January 1997 to December 2013, provided by the National Health Research
      Institutes of Taiwan. Due to the unique social-welfare health insurance system operated by
      the government, it is mandatory for every resident in Taiwan to be enrolled. Thus, the NHIRD
      has covered 99% of the population since its launch in 1996. The monopolistic national health
      insurance also offers unrestricted access to any healthcare provider of the patients'
      choices. The statistics, therefore, gathered by the NHIRD represent a sound cohort for
      investigation of the natural course and subsequent management of diseases. It is particularly
      good for studies that need longitudinal observation for repeat treatment (i.e. surgery for
      ASD) because it allows for the capture of events, even though they may occur in multiple or
      different institutes and hospitals. The universal coverage and comprehensive follow-up
      provided a valuable chance to study ASD.

      All the personal information had already undergone a de-identification and encryption
      process. Individual and hospital identifiers are unique to the research database and
      researchers therefore cannot trace individual patients or health service providers.
observational model: Cohort
time perspective: Retrospective
measure: The date of re-operation (Second ACDF)
time frame: from patient's index surgery to the end of follow-up (2013/12/31), 4.66 years in average
description: Patients were followed-up for the subsequent surgery (second ACDF) after their index operation (first ACDF). We used the hospitalization date of each admission record as the date of outcome (second ACDF). Each patient was followed-up from his index surgery (first ACDF) to re-operation (second ACDF), death, or end of follow-up (2013/12/31) which comes first.
arm group label: Study Cohort
description: The observational study included all patients who had been admitted for their first ACDF surgery during the 16-year span, began on January 1st, 1998 till the end of 2013, recorded in the NHIRD. The admission for cervical disc herniation and spondylosis were identified using the ICD9-CM diagnostic codes of 722.0, 722.4 and 722.71, while the surgery of ACDF was confirmed with the procedure codes of 80.51, 81.00 and 81.02 during the same hospitalization.
intervention type: Other
intervention name: observational study
description: this is an observational study, there is no intervention in this study
arm group label: Study Cohort
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Yu-Chun Chen
role: Principal Investigator
affiliation: Taipei Veterans General Hospital, Taiwan
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Taipei Veterans General Hospital, Taiwan
investigator full name: vghtpe user
investigator title: Principal Investigator
sharing ipd: No
ipd description: The PI have no right to share the data