<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/NCT01674764</url>
  </required_header>
  <id_info>
    <org_study_id>SCI-POEM</org_study_id>
    <nct_id>NCT01674764</nct_id>
  </id_info>
  <brief_title>Surgical Treatment for Spinal Cord Injury</brief_title>
  <acronym>SCI-POEM</acronym>
  <official_title>Prognostic Factors and Therapeutic Effects of Surgical Treatment for Traumatic Spinal Column Injury With Spinal Cord Injury: A Prospective, Observational European Multi-center Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AOSpine Europe</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AOSpine Europe</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Despite many years of research, an incomprehensible amount of scientific efforts worldwide&#xD;
      and billions of dollars invested, no effective therapy resulting in major neurological or&#xD;
      functional recovery is available to date for traumatic spinal cord injury (tSCI). Although&#xD;
      there is increasing experimental evidence from animal models that surgical decompression of&#xD;
      the spinal cord improves recovery after tSCI, clinical studies have not shown conclusive data&#xD;
      yet. The main explanations for this lack of convincing evidence are relatively small sample&#xD;
      sizes in previous studies, their predominantly retrospective nature, suboptimal measurement&#xD;
      methods for the assessment of neurological deficits, and inappropriate recording and&#xD;
      documentation of potential confounding factors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Although injuries to the spinal column represent a relatively small proportion of all&#xD;
      traumatic injuries, spinal injuries have one of the highest impacts on functional outcomes&#xD;
      and employment status. Even more than an injury of the spinal column, traumatic spinal cord&#xD;
      injury (tSCI) is a devastating disorder severely affecting patients' physical and&#xD;
      psychosocial well-being. The incidence of tSCI is estimated to be 11 to 53 new cases per&#xD;
      million population per year.&#xD;
&#xD;
      This is a multi-center, prospective, observational cohort study to evaluate if early (≤ 12&#xD;
      hours after the tSCI) surgical decom¬pression is superior to late (&gt; 12 hours and &lt; 14 days&#xD;
      after the tSCI) in improving neurologic motor outcomes in patients with acute traumatic&#xD;
      spinal cord injury.&#xD;
&#xD;
      The study will enroll 300 patients with anticipated 1:2 ratio of early vs. late surgery. This&#xD;
      CIP is not limited to cervical spinal cord injuries, does not consider a diagnostic MRI as&#xD;
      mandatory and will be conducted in a European setting where patients are generally&#xD;
      transported more swiftly to the treating institution when compared to other geographic&#xD;
      regions in the world.&#xD;
&#xD;
      Patients will be evaluated according to the schedule set forth in this CIP. The schedule&#xD;
      includes evaluations at pre-surgery, post-surgery, 72 hours post injury, 12 weeks ± 2 weeks;&#xD;
      6 months ± 30 days; 1 year ± 30 days. The enrollment period is expected to be approximately&#xD;
      36 months and subjects will be followed-up for 12 months for the evaluation of the primary&#xD;
      endpoint. The study duration is approximately 48 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2012</start_date>
  <completion_date type="Actual">October 2019</completion_date>
  <primary_completion_date type="Actual">October 2019</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 in American Spinal Injury Association Lower Extremities Motor Score (ASIALEMS) between pre-surgery and 1-year post-surgery FU</measure>
    <time_frame>Between pre-surgery and 1-year post-surgery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in American Spinal Injury Association Motor Score (ASIAMS) between pre-surgery and 1-year FU</measure>
    <time_frame>Pre-surgery and 1-year FU</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in American Spinal Injury Association Upper Extremities Motor Score (ASIAUEMS) between pre-surgery and 1-year FU</measure>
    <time_frame>Between pre-surgery and 1-year FU</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in American Spinal Injury Association Impairment Scale (AIS) between pre-surgery and 1-year FU</measure>
    <time_frame>Between pre-surgery and 1-year FU</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in American Spinal Injury Association Sensory Score (ASIASS) between pre-surgery and 1-year FU</measure>
    <time_frame>Between pre-surgery and 1-year FU</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spinal Cord Independency Measure (SCIM) at the 6-month and 1-year FU</measure>
    <time_frame>6-month and 1-year FU</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in quality of life using the Short version of the World Health Organization Quality-of-Life questionnaire (WHOQOL-BREF) between pre-injury and 1-year FU</measure>
    <time_frame>Pre-injury and 1-year FU</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of treatment related adverse events, as assessed by an independent evaluator</measure>
    <time_frame>Until the 1-year FU</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">297</enrollment>
  <condition>Acute Spinal Cord Injury of Traumatic Origin (tSCI)</condition>
  <arm_group>
    <arm_group_label>Early surgical intervention = Cohort 1</arm_group_label>
    <description>≤ 12 hours after the tSCI</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Late surgical intervention = Cohort 2</arm_group_label>
    <description>&gt; 12 hours and &lt; 14 days after the tSCI</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Early surgical intervention</intervention_name>
    <description>Open surgical stabilization and decompression (anterior, posterior or circumferential); and/or Closed reduction and external fixation</description>
    <arm_group_label>Early surgical intervention = Cohort 1</arm_group_label>
    <other_name>≤ 12 hours after the tSCI</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Late surgical intervention</intervention_name>
    <description>Open surgical stabilization and decompression (anterior, posterior or circumferential); and/or Closed reduction and external fixation</description>
    <arm_group_label>Late surgical intervention = Cohort 2</arm_group_label>
    <other_name>&gt; 12 hours and &lt; 14 days after the tSCI</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study will enroll 300 patients with anticipated 1:2 ratio of early vs. late surgery.&#xD;
        This CIP is not limited to cervical spinal cord injuries, does not consider a diagnostic&#xD;
        MRI as mandatory and will be conducted in a European setting where patients are generally&#xD;
        transported more swiftly to the treating institution when compared to other geographic&#xD;
        regions in the world.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 years and older&#xD;
&#xD;
          -  Diagnosis of blunt spinal column injury and spinal cord injury, including conus&#xD;
             medullaris and/or cauda equina injuries&#xD;
&#xD;
          -  Pre-surgery ASIA grade A, B, C or D&#xD;
&#xD;
          -  Less than 14 days between the injury and surgery&#xD;
&#xD;
          -  Ability to understand patient information / informed consent form&#xD;
&#xD;
          -  Willingness and ability to participate in the clinical investigation and FU procedures&#xD;
             (FUs)&#xD;
&#xD;
          -  Informed consent according to local legislations and applicable guidelines&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Traumatic brain injury: Glasgow Coma Scale (GCS) ≤ 13&#xD;
&#xD;
          -  Diagnosis of subclinical or clinical polyneuropathy (eg. presence of bilateral&#xD;
             impairment of strength, sensation, and/or deep tendon reflexes with symmetrical and&#xD;
             distal distribution and/or neurophysiological abnormalities)&#xD;
&#xD;
          -  Spinal cord injury caused by a penetrating injury&#xD;
&#xD;
          -  Non-traumatic or pathologic fractures or cord compression (eg, tumor or infection)&#xD;
&#xD;
          -  Unable to cooperate with physical examination (pre-operative, ≤ 2 weeks) because of&#xD;
             cognitive impairment, as assessed by the examiner&#xD;
&#xD;
          -  Previous spinal column or spinal cord injury&#xD;
&#xD;
          -  Diagnosis of spondyloarthropathy (inflammatory or non-inflammatory)&#xD;
&#xD;
          -  Morbid Obesity: Body Mass Index (BMI) &gt; 35&#xD;
&#xD;
          -  Any severe systemic disease that may have an influence on motor function (eg,&#xD;
             polyneuropathy)&#xD;
&#xD;
          -  ASA classification score ≥ 4&#xD;
&#xD;
          -  Recent history of substance abuse (ie, recreational drugs, alcohol) that would&#xD;
             preclude reliable assessment&#xD;
&#xD;
          -  Pregnancy at the time of inclusion&#xD;
&#xD;
          -  Prisoner&#xD;
&#xD;
          -  Participation in any other medical device or medicinal product study within the&#xD;
             previous month that could influence the results of the present study&#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>Allard JF Hosman, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical Co-Director Spine Unit, Radboud University Medical Centre, 6500 Nijmegen, The Netherlands</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical University Innsbruck</name>
      <address>
        <city>Innsbruck</city>
        <zip>6020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Institute of Emergency Medicine &quot;N.I. Pirogov&quot;</name>
      <address>
        <city>Sofia</city>
        <zip>1606</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teaching Hospital Sisiters of Charity</name>
      <address>
        <city>Zagreb</city>
        <zip>10000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôspital P. Wertheimer</name>
      <address>
        <city>Lyon</city>
        <zip>69500</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BG Unfallklinik Frankfurt</name>
      <address>
        <city>Frankfurt</city>
        <zip>60389</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Berufsgenossenschaftliche Unfallklinik Ludwigshafen</name>
      <address>
        <city>Ludwigshafen</city>
        <zip>67071</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mater Misericordiae University Hospital</name>
      <address>
        <city>Dublin</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Maggiore</name>
      <address>
        <city>Bologna</city>
        <zip>40133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico Umberto Primo</name>
      <address>
        <city>Rom</city>
        <zip>00161</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Medical Center St. Radboud</name>
      <address>
        <city>Nijmegen</city>
        <zip>6500 HB</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Medical Center Utrecht</name>
      <address>
        <city>Utrecht</city>
        <zip>3508 GA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spitalul &quot;Sfanta Treime&quot;</name>
      <address>
        <city>Iasi</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Center Vojvodina</name>
      <address>
        <city>Novi Sad</city>
        <zip>21000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gazi University Faculty of Medicine</name>
      <address>
        <city>Ankara</city>
        <zip>06000</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>King's College Hospital</name>
      <address>
        <city>London</city>
        <zip>SE5 9RS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queens's Medical Centre Campus</name>
      <address>
        <city>Nottingham</city>
        <zip>NG7 2UH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nuffield Orthopaedic Centre Headington</name>
      <address>
        <city>Oxford</city>
        <zip>OX3 7LD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Bulgaria</country>
    <country>Croatia</country>
    <country>France</country>
    <country>Germany</country>
    <country>Ireland</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>Romania</country>
    <country>Serbia</country>
    <country>Turkey</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>August 22, 2012</study_first_submitted>
  <study_first_submitted_qc>August 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2012</study_first_posted>
  <last_update_submitted>May 12, 2020</last_update_submitted>
  <last_update_submitted_qc>May 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 13, 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 Cord Injuries</mesh_term>
    <mesh_term>Wounds and Injuries</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/NCT01674764
org study id: SCI-POEM
nct id: NCT01674764
lead sponsor: 
has dmc: Yes
Despite many years of research, an incomprehensible amount of scientific efforts worldwide
      and billions of dollars invested, no effective therapy resulting in major neurological or
      functional recovery is available to date for traumatic spinal cord injury (tSCI). Although
      there is increasing experimental evidence from animal models that surgical decompression of
      the spinal cord improves recovery after tSCI, clinical studies have not shown conclusive data
      yet. The main explanations for this lack of convincing evidence are relatively small sample
      sizes in previous studies, their predominantly retrospective nature, suboptimal measurement
      methods for the assessment of neurological deficits, and inappropriate recording and
      documentation of potential confounding factors.
Although injuries to the spinal column represent a relatively small proportion of all
      traumatic injuries, spinal injuries have one of the highest impacts on functional outcomes
      and employment status. Even more than an injury of the spinal column, traumatic spinal cord
      injury (tSCI) is a devastating disorder severely affecting patients' physical and
      psychosocial well-being. The incidence of tSCI is estimated to be 11 to 53 new cases per
      million population per year.

      This is a multi-center, prospective, observational cohort study to evaluate if early (≤ 12
      hours after the tSCI) surgical decom¬pression is superior to late (> 12 hours and < 14 days
      after the tSCI) in improving neurologic motor outcomes in patients with acute traumatic
      spinal cord injury.

      The study will enroll 300 patients with anticipated 1:2 ratio of early vs. late surgery. This
      CIP is not limited to cervical spinal cord injuries, does not consider a diagnostic MRI as
      mandatory and will be conducted in a European setting where patients are generally
      transported more swiftly to the treating institution when compared to other geographic
      regions in the world.

      Patients will be evaluated according to the schedule set forth in this CIP. The schedule
      includes evaluations at pre-surgery, post-surgery, 72 hours post injury, 12 weeks ± 2 weeks;
      6 months ± 30 days; 1 year ± 30 days. The enrollment period is expected to be approximately
      36 months and subjects will be followed-up for 12 months for the evaluation of the primary
      endpoint. The study duration is approximately 48 months.
observational model: Cohort
time perspective: Prospective
measure: Change in American Spinal Injury Association Lower Extremities Motor Score (ASIALEMS) between pre-surgery and 1-year post-surgery FU
time frame: Between pre-surgery and 1-year post-surgery
measure: Change in American Spinal Injury Association Motor Score (ASIAMS) between pre-surgery and 1-year FU
time frame: Pre-surgery and 1-year FU
measure: Change in American Spinal Injury Association Upper Extremities Motor Score (ASIAUEMS) between pre-surgery and 1-year FU
time frame: Between pre-surgery and 1-year FU
measure: Change in American Spinal Injury Association Impairment Scale (AIS) between pre-surgery and 1-year FU
time frame: Between pre-surgery and 1-year FU
measure: Change in American Spinal Injury Association Sensory Score (ASIASS) between pre-surgery and 1-year FU
time frame: Between pre-surgery and 1-year FU
measure: Spinal Cord Independency Measure (SCIM) at the 6-month and 1-year FU
time frame: 6-month and 1-year FU
measure: Change in quality of life using the Short version of the World Health Organization Quality-of-Life questionnaire (WHOQOL-BREF) between pre-injury and 1-year FU
time frame: Pre-injury and 1-year FU
measure: Rate of treatment related adverse events, as assessed by an independent evaluator
time frame: Until the 1-year FU
arm group label: Early surgical intervention = Cohort 1
description: ≤ 12 hours after the tSCI
arm group label: Late surgical intervention = Cohort 2
description: > 12 hours and < 14 days after the tSCI
intervention type: Procedure
intervention name: Early surgical intervention
description: Open surgical stabilization and decompression (anterior, posterior or circumferential); and/or Closed reduction and external fixation
arm group label: Early surgical intervention = Cohort 1
other name: ≤ 12 hours after the tSCI
intervention type: Procedure
intervention name: Late surgical intervention
description: Open surgical stabilization and decompression (anterior, posterior or circumferential); and/or Closed reduction and external fixation
arm group label: Late surgical intervention = Cohort 2
other name: > 12 hours and < 14 days after the tSCI
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Allard JF Hosman, MD, PhD
role: Principal Investigator
affiliation: Medical Co-Director Spine Unit, Radboud University Medical Centre, 6500 Nijmegen, The Netherlands
facility: 
facility: 
facility: 
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facility: 
facility: 
facility: 
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country: Austria
country: Bulgaria
country: Croatia
country: France
country: Germany
country: Ireland
country: Italy
country: Netherlands
country: Romania
country: Serbia
country: Turkey
country: United Kingdom
responsible party type: Sponsor
mesh term: Spinal Cord Injuries
mesh term: Wounds and Injuries