xml: <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/NCT06019572</url>
    </required_header>
    <id_info>
      <org_study_id>4-1712/2021</org_study_id>
      <nct_id>NCT06019572</nct_id>
    </id_info>
    <brief_title>Spine Trauma in the Elderly</brief_title>
    <official_title>Long-term Outcomes After Surgery for Subaxial Cervical Spine Injuries in Octogenarians, a Matched Controlled Analysis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Karolinska Institutet</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Karolinska Institutet</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>
        Our study aims at investigating short and long-term outcomes following surgery for subaxial&#xD;
        spine injuries in the elderly (octogenarian) population.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">April 1, 2023</start_date>
    <completion_date type="Actual">June 15, 2023</completion_date>
    <primary_completion_date type="Actual">June 1, 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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Postoperative complications</measure>
      <time_frame>30-day postoperative period</time_frame>
      <description>medical or surgical complications</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Mortality</measure>
      <time_frame>End of the study period (or end of data collection)</time_frame>
      <description>death</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">108</enrollment>
    <condition>Spine Injury</condition>
    <condition>Trauma</condition>
    <condition>Surgery</condition>
    <arm_group>
      <arm_group_label>Younger cohort (&lt;80 years)</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>octogenarians (≥80 years)</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Spine decompression and fixation surgery</intervention_name>
      <description>Surgery is performed by either an anterior or posterior approach. Anterior approach is performed with either discectomy or corpectomy accompanied fusion, while the posterior approach consist in a bilateral laminectomy accompanied by fusion.</description>
      <arm_group_label>Younger cohort (&lt;80 years)</arm_group_label>
      <arm_group_label>octogenarians (≥80 years)</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The study hospital is a publicly funded tertiary care center serving a region of&#xD;
          approximately 2.3 million inhabitants and the region's only level 1 trauma center. Patients&#xD;
          were identified through the surgical management software Orbit (Evry Healthcare Systems,&#xD;
          Solna, Sweden).&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All patients surgically treated for subaxial spine injuries between 2006 and 2018&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Missing records&#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>Karolinska University Hospital</name>
        <address>
          <city>Stockholm</city>
          <country>Sweden</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Sweden</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Karolinska Institutet</investigator_affiliation>
      <investigator_full_name>Adrian Elmi Terander</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Spinal Injuries</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06019572
  org study id: 4-1712/2021
  nct id: NCT06019572
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Our study aims at investigating short and long-term outcomes following surgery for subaxial
        spine injuries in the elderly (octogenarian) population.
  observational model: Cohort
  time perspective: Retrospective
  measure: Postoperative complications
  time frame: 30-day postoperative period
  description: medical or surgical complications
  measure: Mortality
  time frame: End of the study period (or end of data collection)
  description: death
  arm group label: Younger cohort (<80 years)
  arm group label: octogenarians (≥80 years)
  intervention type: Procedure
  intervention name: Spine decompression and fixation surgery
  description: Surgery is performed by either an anterior or posterior approach. Anterior approach is performed with either discectomy or corpectomy accompanied fusion, while the posterior approach consist in a bilateral laminectomy accompanied by fusion.
  arm group label: Younger cohort (<80 years)
  arm group label: octogenarians (≥80 years)
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: Sweden
  responsible party type: Principal Investigator
  investigator affiliation: Karolinska Institutet
  investigator full name: Adrian Elmi Terander
  investigator title: Associate Professor
  mesh term: Spinal Injuries