<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/NCT04495400</url>
  </required_header>
  <id_info>
    <org_study_id>STU 042018-004</org_study_id>
    <nct_id>NCT04495400</nct_id>
  </id_info>
  <brief_title>Percutaneous Screw Fixation vs. Open Fixation in the Treatment of Thoracolumbar Fractures</brief_title>
  <acronym>PrecScrew</acronym>
  <official_title>Percutaneous Screw Fixation vs. Open Fixation in the Treatment of Thoracolumbar Fractures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Texas Southwestern Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medtronic</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Texas Southwestern Medical Center</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>
      In this single-center retrospective study, the investigators will include all patients&#xD;
      admitted to Parkland Hospital who underwent surgical fixation of thoracolumbar fractures&#xD;
      between the years 2000 and 2017. The study investigators will gather demographic,&#xD;
      radiographic, and operative information. Patients will be matched according to demographic&#xD;
      information in a case-control style. The primary outcome of the study will be comparing the&#xD;
      clinical and radiographic outcomes of two surgical techniques in order to establish the best&#xD;
      treatment approach for this disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Thoracolumbar (TL) fractures occur in 8-15% of blunt trauma patients cared for in major&#xD;
      trauma centers. These fractures can be devastating and commonly occur in patients who endure&#xD;
      high-energy trauma (e.g. motor vehicle accidents). TL fractures occur mainly between T10 and&#xD;
      L2. The &quot;3 Column Model&quot; attempts to identify criteria that can predict instability of TL&#xD;
      fractures. This model divides the spine into anterior, middle, and posterior areas. Stability&#xD;
      is dependent on the integrity of two out of three of the columns. Major spine injuries are&#xD;
      those that involve mechanical or neurologic instability.&#xD;
&#xD;
      The four major types of injury include compression, burst, seat-belt, and&#xD;
      fracture-dislocation. Compression fractures account for 50-70% of all TL fractures and&#xD;
      usually consist of compression failure of the anterior column. Burst fractures comprise&#xD;
      approximately 14% of all TL injuries. These injuries usually involve compression of both the&#xD;
      anterior and posterior column. Seat-belt fractures (aka flexion-distraction fractures)&#xD;
      account for 10% of TL injuries and occur most commonly in patients who are wearing only the&#xD;
      lap belt (i.e. no chest belt) during motor vehicle trauma. These injuries typically involve&#xD;
      compression of the anterior column with distraction failure of both the middle and posterior&#xD;
      columns. Finally, the fracture-dislocation type fracture occurs with massive direct trauma to&#xD;
      the back, causing failure of all three columns and translational injury.&#xD;
&#xD;
      Patients with TL fractures may present with TL spine pain, midline TL spine tenderness, TL&#xD;
      spine bony deformity, or neurologic deficit. Oftentimes these patients were in high-velocity&#xD;
      traumatic scenarios, including falls from heights, crush injuries, motor vehicle crashes with&#xD;
      ejection, unenclosed vehicles (ex. motorcycles), or automobile versus pedestrian accidents.&#xD;
      Diagnosis is confirmed via computed tomography (CT) imaging or plain radiographs. CT imaging&#xD;
      is typically more accurate than plain radiographs but can be poor in certain subtypes of&#xD;
      injury. MRI can be utilized to assess the integrity of the ligaments and surrounding soft&#xD;
      tissues.&#xD;
&#xD;
      There is currently no universally accepted system for classifying the severity of TL&#xD;
      fractures. One proposed system is the Thoracolumbar injury classification and severity score&#xD;
      (TLICS). Points are awarded based on radiographic findings, neurologic status, and the&#xD;
      integrity of posterior ligamentous complex. The final numeric score is used to guide&#xD;
      treatment, with higher scores indicating need for surgery. Neurologic deficit favors surgery.&#xD;
&#xD;
      There is no clear consensus on the best treatment approach for TL fractures. For situations&#xD;
      where conservative management is decided (i.e. surgery is not required or is&#xD;
      contraindicated), patients are treated with recumbency and delayed ambulation in orthosis&#xD;
      with serial radiographs to determine need for further intervention. The surgical management&#xD;
      for more severe/unstable fractures usually involves posterior instrumentation with&#xD;
      percutaneous or open pedicle screw fixation.3 While the traditional open pedicle screw&#xD;
      fixation technique has demonstrated good radiologic and clinical outcomes, a minimally&#xD;
      invasive percutaneous approach has been increasingly used in recent years. The minimally&#xD;
      invasive technique potentially carries the advantage of less operative blood loss, shorter&#xD;
      operative time, smaller incisions, potentially less postoperative pain, and overall shorter&#xD;
      hospital stay. There are a few studies published in the literature, but more studies are&#xD;
      needed to establish the treatment modality that is the most efficacious and safe for these&#xD;
      patients.&#xD;
&#xD;
      At the University of Texas Southwestern (Parkland Hospital), the investigators evaluate and&#xD;
      treat a large population of patients with TL fractures. Previous trials in the literature&#xD;
      comparing open and percutaneous fixation of TL fractures have been series of ~100-200&#xD;
      patients. These studies have shown variable results, with many concluding similar outcome&#xD;
      results for the two surgical techniques. The purpose of this study is to compare a larger&#xD;
      number of patients (~500) who have undergone either surgical approach to determine the best&#xD;
      technique in terms of clinical and radiographic outcomes. The investigators believe this&#xD;
      study will provide neurosurgeons with invaluable information about the safety and efficacy of&#xD;
      different treatment modalities for TL fractures in this patient population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 23, 2018</start_date>
  <completion_date type="Actual">December 31, 2022</completion_date>
  <primary_completion_date type="Actual">September 19, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of Positive and Negative Clinical Outcomes based on hospital adverse events</measure>
    <time_frame>2000-2017</time_frame>
    <description>Hospital Adverse Events</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of positive and negative radiographic outcomes based on cobb angle of kyphosis and vertebral wedge angle</measure>
    <time_frame>2000-2017</time_frame>
    <description>Curvature of spine post-surgery</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">485</enrollment>
  <condition>Lumbar Vertebral Fracture</condition>
  <arm_group>
    <arm_group_label>Percutaneous Screw Fixation</arm_group_label>
    <description>Patients who have had a Percutaneous Screw fixation procedure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Open Fixation</arm_group_label>
    <description>Patients who have had an Open Fixation procedure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Thoracolumbar Fracture Fixation</intervention_name>
    <description>The is surgery is preformed on patients who have had a blunt trauma fractures between the T10 and the L2. The surgical management for more severe/unstable fractures usually involves posterior instrumentation with percutaneous or open pedicle screw fixation. While the traditional open pedicle screw fixation technique has demonstrated good radiologic and clinical outcomes, a minimally invasive percutaneous approach has been increasingly used in recent years.</description>
    <arm_group_label>Open Fixation</arm_group_label>
    <arm_group_label>Percutaneous Screw Fixation</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients from 200 to 2017 who have either had a Percutaneous fixation or an open fixation&#xD;
        for thoracolumbar fractures&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients with thoracolumbar fractures:&#xD;
&#xD;
          -  Who underwent open surgical fixation at Parkland Hospital&#xD;
&#xD;
          -  Who underwent percutaneous (minimally invasive) screw fixation at Parkland Hospital •&#xD;
             Age above 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age below 18&#xD;
&#xD;
          -  Bleeding disorders&#xD;
&#xD;
          -  Prior surgical fixation&#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>Salah Aoun, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Texas Southwestern Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Parkland Health and Hospital System</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>March 31, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <last_update_submitted>February 27, 2023</last_update_submitted>
  <last_update_submitted_qc>February 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Texas Southwestern Medical Center</investigator_affiliation>
    <investigator_full_name>Salah Aoun</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Spinal Fractures</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No IPD will be shared.</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/NCT04495400
org study id: STU 042018-004
nct id: NCT04495400
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this single-center retrospective study, the investigators will include all patients
      admitted to Parkland Hospital who underwent surgical fixation of thoracolumbar fractures
      between the years 2000 and 2017. The study investigators will gather demographic,
      radiographic, and operative information. Patients will be matched according to demographic
      information in a case-control style. The primary outcome of the study will be comparing the
      clinical and radiographic outcomes of two surgical techniques in order to establish the best
      treatment approach for this disease.
Thoracolumbar (TL) fractures occur in 8-15% of blunt trauma patients cared for in major
      trauma centers. These fractures can be devastating and commonly occur in patients who endure
      high-energy trauma (e.g. motor vehicle accidents). TL fractures occur mainly between T10 and
      L2. The "3 Column Model" attempts to identify criteria that can predict instability of TL
      fractures. This model divides the spine into anterior, middle, and posterior areas. Stability
      is dependent on the integrity of two out of three of the columns. Major spine injuries are
      those that involve mechanical or neurologic instability.

      The four major types of injury include compression, burst, seat-belt, and
      fracture-dislocation. Compression fractures account for 50-70% of all TL fractures and
      usually consist of compression failure of the anterior column. Burst fractures comprise
      approximately 14% of all TL injuries. These injuries usually involve compression of both the
      anterior and posterior column. Seat-belt fractures (aka flexion-distraction fractures)
      account for 10% of TL injuries and occur most commonly in patients who are wearing only the
      lap belt (i.e. no chest belt) during motor vehicle trauma. These injuries typically involve
      compression of the anterior column with distraction failure of both the middle and posterior
      columns. Finally, the fracture-dislocation type fracture occurs with massive direct trauma to
      the back, causing failure of all three columns and translational injury.

      Patients with TL fractures may present with TL spine pain, midline TL spine tenderness, TL
      spine bony deformity, or neurologic deficit. Oftentimes these patients were in high-velocity
      traumatic scenarios, including falls from heights, crush injuries, motor vehicle crashes with
      ejection, unenclosed vehicles (ex. motorcycles), or automobile versus pedestrian accidents.
      Diagnosis is confirmed via computed tomography (CT) imaging or plain radiographs. CT imaging
      is typically more accurate than plain radiographs but can be poor in certain subtypes of
      injury. MRI can be utilized to assess the integrity of the ligaments and surrounding soft
      tissues.

      There is currently no universally accepted system for classifying the severity of TL
      fractures. One proposed system is the Thoracolumbar injury classification and severity score
      (TLICS). Points are awarded based on radiographic findings, neurologic status, and the
      integrity of posterior ligamentous complex. The final numeric score is used to guide
      treatment, with higher scores indicating need for surgery. Neurologic deficit favors surgery.

      There is no clear consensus on the best treatment approach for TL fractures. For situations
      where conservative management is decided (i.e. surgery is not required or is
      contraindicated), patients are treated with recumbency and delayed ambulation in orthosis
      with serial radiographs to determine need for further intervention. The surgical management
      for more severe/unstable fractures usually involves posterior instrumentation with
      percutaneous or open pedicle screw fixation.3 While the traditional open pedicle screw
      fixation technique has demonstrated good radiologic and clinical outcomes, a minimally
      invasive percutaneous approach has been increasingly used in recent years. The minimally
      invasive technique potentially carries the advantage of less operative blood loss, shorter
      operative time, smaller incisions, potentially less postoperative pain, and overall shorter
      hospital stay. There are a few studies published in the literature, but more studies are
      needed to establish the treatment modality that is the most efficacious and safe for these
      patients.

      At the University of Texas Southwestern (Parkland Hospital), the investigators evaluate and
      treat a large population of patients with TL fractures. Previous trials in the literature
      comparing open and percutaneous fixation of TL fractures have been series of ~100-200
      patients. These studies have shown variable results, with many concluding similar outcome
      results for the two surgical techniques. The purpose of this study is to compare a larger
      number of patients (~500) who have undergone either surgical approach to determine the best
      technique in terms of clinical and radiographic outcomes. The investigators believe this
      study will provide neurosurgeons with invaluable information about the safety and efficacy of
      different treatment modalities for TL fractures in this patient population.
observational model: Case-Control
time perspective: Retrospective
measure: Rate of Positive and Negative Clinical Outcomes based on hospital adverse events
time frame: 2000-2017
description: Hospital Adverse Events
measure: Rate of positive and negative radiographic outcomes based on cobb angle of kyphosis and vertebral wedge angle
time frame: 2000-2017
description: Curvature of spine post-surgery
arm group label: Percutaneous Screw Fixation
description: Patients who have had a Percutaneous Screw fixation procedure.
arm group label: Open Fixation
description: Patients who have had an Open Fixation procedure.
intervention type: Procedure
intervention name: Thoracolumbar Fracture Fixation
description: The is surgery is preformed on patients who have had a blunt trauma fractures between the T10 and the L2. The surgical management for more severe/unstable fractures usually involves posterior instrumentation with percutaneous or open pedicle screw fixation. While the traditional open pedicle screw fixation technique has demonstrated good radiologic and clinical outcomes, a minimally invasive percutaneous approach has been increasingly used in recent years.
arm group label: Open Fixation
arm group label: Percutaneous Screw Fixation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Salah Aoun, MD
role: Principal Investigator
affiliation: University of Texas Southwestern Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Texas Southwestern Medical Center
investigator full name: Salah Aoun
investigator title: Assistant Professor
mesh term: Fractures, Bone
mesh term: Spinal Fractures
sharing ipd: No
ipd description: No IPD will be shared.