<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/NCT01666860</url>
  </required_header>
  <id_info>
    <org_study_id>2010/740</org_study_id>
    <nct_id>NCT01666860</nct_id>
  </id_info>
  <brief_title>Long-term Follow-up of the Anterior Lumbar Interbody Fusion Procedure.</brief_title>
  <official_title>Long-term Follow-up of the Anterior Lumbar Interbody Fusion Procedure.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Ghent</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Ghent</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      During the period 1989-1999, a number of patients underwent an ALIF-procedure. Anterior&#xD;
      Lumbar Interbody Fusion procedure (ALIF) is a type of lumbar spinal fusion. The approach of&#xD;
      the lumbar region is by incision of the abdominal wall. The intervertebral disc is removed&#xD;
      and replaced by a bone graft. These patients form the population of this study. The goal of&#xD;
      this study is to evaluate their current medical condition and to determine the clinical&#xD;
      outcome.&#xD;
&#xD;
      The clinical result will be stipulated by means of standardized questionnaires (VAS-score,&#xD;
      Oswestry low Back Pain Questionnaire and SF-36)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2010</start_date>
  <completion_date type="Actual">July 2011</completion_date>
  <primary_completion_date type="Actual">March 2011</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>A clinical evaluation before an Anterior Lumbar Interbody Fusion procedure.</measure>
    <time_frame>Baseline</time_frame>
    <description>The clinical result will be stipulated by means of standardized questionnaires.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>A clinical evaluation after an Anterior Lumbar Interbody Fusion procedure.</measure>
    <time_frame>5 years after the operation</time_frame>
    <description>The clinical result will be stipulated by means of standardized questionnaires.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Union of the vertebrae.</measure>
    <time_frame>1 day (At the standard follow up consultation)</time_frame>
    <description>Standard post operative X-ray.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">56</enrollment>
  <condition>Anterior Lumbar Interbody Fusion Procedure</condition>
  <arm_group>
    <arm_group_label>Anterior Lumbar Interbody Fusion procedure</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Anterior Lumbar Interbody Fusion procedure</intervention_name>
    <arm_group_label>Anterior Lumbar Interbody Fusion procedure</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who have an Anterior Lumbar Interbody Fusion Procedure as treatment for&#xD;
        degenerative disc disease.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  An Anterior Lumbar Interbody Fusion procedure between 1999 and 2005&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#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>Bart Poffyn, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Ghent</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ghent University Hospital</name>
      <address>
        <city>Ghent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <link>
    <url>http://www.uzgent.be</url>
    <description>Related Info</description>
  </link>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 14, 2012</study_first_submitted>
  <study_first_submitted_qc>August 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 16, 2012</study_first_posted>
  <last_update_submitted>August 16, 2012</last_update_submitted>
  <last_update_submitted_qc>August 16, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 17, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>anterior lumbar interbody fusion</keyword>
  <!-- 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/NCT01666860
org study id: 2010/740
nct id: NCT01666860
lead sponsor: 
has dmc: No
During the period 1989-1999, a number of patients underwent an ALIF-procedure. Anterior
      Lumbar Interbody Fusion procedure (ALIF) is a type of lumbar spinal fusion. The approach of
      the lumbar region is by incision of the abdominal wall. The intervertebral disc is removed
      and replaced by a bone graft. These patients form the population of this study. The goal of
      this study is to evaluate their current medical condition and to determine the clinical
      outcome.

      The clinical result will be stipulated by means of standardized questionnaires (VAS-score,
      Oswestry low Back Pain Questionnaire and SF-36)
observational model: Cohort
time perspective: Prospective
measure: A clinical evaluation before an Anterior Lumbar Interbody Fusion procedure.
time frame: Baseline
description: The clinical result will be stipulated by means of standardized questionnaires.
measure: A clinical evaluation after an Anterior Lumbar Interbody Fusion procedure.
time frame: 5 years after the operation
description: The clinical result will be stipulated by means of standardized questionnaires.
measure: Union of the vertebrae.
time frame: 1 day (At the standard follow up consultation)
description: Standard post operative X-ray.
arm group label: Anterior Lumbar Interbody Fusion procedure
intervention type: Procedure
intervention name: Anterior Lumbar Interbody Fusion procedure
arm group label: Anterior Lumbar Interbody Fusion procedure
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Bart Poffyn, MD
role: Principal Investigator
affiliation: University Hospital, Ghent
facility: 
country: Belgium
url: http://www.uzgent.be
description: Related Info
responsible party type: Sponsor