<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/NCT03802656</url>
  </required_header>
  <id_info>
    <org_study_id>VBT120718</org_study_id>
    <nct_id>NCT03802656</nct_id>
  </id_info>
  <brief_title>Vertebral Body Tethering Treatment for Idiopathic Scoliosis</brief_title>
  <official_title>Safety and Feasibility of a Vertebral Body Tethering Technique for Pediatric Idiopathic Scoliosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ochsner Health System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ochsner Health System</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will determine whether vertebral body tethering is a safe and feasible method of&#xD;
      treatment for pediatric idiopathic scoliosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Scoliosis is a condition in which the spine is deformed by a curvature in the coronal plane.&#xD;
      It is generally associated with a twisting (axial plane) deformity as well. It can have a&#xD;
      variety of underlying etiologies and the etiology is used to classify the types of scoliosis.&#xD;
      Idiopathic scoliosis is sub-classified in two ways: by age of onset and by magnitude of&#xD;
      deformity. Curves between 10 and 25 degrees are considered mild. Curves between 25 and 50&#xD;
      degrees are classified as moderate. Curves greater than 50 degrees are termed severe. The&#xD;
      current standard of care for moderate scoliosis in patients with remaining growth is to&#xD;
      utilize a thoracolumbosacral orthosis (TLSO brace) to prevent progression of deformity. The&#xD;
      scientific evidence has supported the efficacy of this intervention in avoiding progression&#xD;
      of the Cobb angle to 50 degrees or more.&#xD;
&#xD;
      If treated with a TLSO brace, many idiopathic scoliosis patients would conceivably be&#xD;
      subjected to years of brace wear and the cost and psychological factors inherent therein.&#xD;
      Additional downsides of brace treatment include the potentially negative psychosocial impact&#xD;
      of wearing an external sign of deformity during adolescence, a key period of emotional&#xD;
      development. Prior research has identified negative psychosocial effects related to wearing a&#xD;
      brace in children.&#xD;
&#xD;
      Recent evidence has suggested that certain curve patterns will likely progress to 50 degrees&#xD;
      or more, despite treatment with a TLSO brace. Sanders, et al. demonstrated a correlation of&#xD;
      Cobb angle (greater than 35 degrees) and skeletal maturity (bone age 4 or less) to the risk&#xD;
      of progression to 50 degrees or more, despite TLSO bracing. The evidence supports that the&#xD;
      current practice of TLSO bracing is not an effective treatment to avoid progression to 50&#xD;
      degrees in these patients. It is on this population (thoracic Cobb angle greater than 35&#xD;
      degrees, bone age of 4 or less) that we intend to test the safety and feasibility of Anterior&#xD;
      Vertebral Body Tethering to avoid curve progression to 50 degrees.&#xD;
&#xD;
      The study intervention is surgical orthopedic implantation of the Anterior Vertebral Tether&#xD;
      Device, by way of thoracoscopic surgery under general anesthesia. The primary outcome&#xD;
      measures include assessments of safety of the insertion procedure and of the device, as well&#xD;
      as the secondary measure of feasibility by determining the ability to successfully implant&#xD;
      the investigational device.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Device is no longer investigational. It has been approved by the FDA as an HUD under HDE&#xD;
    H190005.&#xD;
  </why_stopped>
  <start_date type="Actual">June 24, 2019</start_date>
  <completion_date type="Actual">December 12, 2019</completion_date>
  <primary_completion_date type="Actual">December 12, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety: Incidence of Treatment-Emergent Adverse Events</measure>
    <time_frame>2 years after last subject's device implantation</time_frame>
    <description>Intraoperative and post-intervention medical events or signs and symptoms of complications arising after the start of study intervention will be captured. The event description, date of onset, end date, severity, and outcome will be documented. The frequencies, type, body system, severity, and relationship to the study intervention will also be summarized. A distinction will be made between those events which are &quot;device-related&quot; and &quot;non device-related&quot;.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Feasibility: Incidence of Successfully Implanted Tether Devices</measure>
    <time_frame>2 years after last subject's device implantation</time_frame>
    <description>The feasibility of the vertebral body tethering device will analyzed based on successful implantation of the device. Implantation will be considered a failure if the device breaks/loosens after implantation, or if it overcorrects the spinal curve.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy: Comparison of Preoperative and Postoperative Cobb Angle</measure>
    <time_frame>2 years after last subject's device implantation</time_frame>
    <description>The exploratory therapeutic endpoint used for feasibility will be change in post-operative Cobb angle compared to pre-operative Cobb angle, measured on coronal radiograph of the spine.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Scoliosis</condition>
  <condition>Spinal Curvatures</condition>
  <condition>Spinal Diseases</condition>
  <condition>Bone Diseases</condition>
  <condition>Musculoskeletal Disease</condition>
  <condition>Adolescent Idiopathic Scoliosis</condition>
  <condition>Juvenile; Scoliosis</condition>
  <arm_group>
    <arm_group_label>Anterior Vertebral Body Tethering</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects who will be undergoing the anterior vertebral body tethering surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Anterior Vertebral Body Tethering</intervention_name>
    <description>Vertebral body tethering through anterior thoracoscopic approach under general anesthesia and fluoroscopic guidance.</description>
    <arm_group_label>Anterior Vertebral Body Tethering</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Males or females age 8 to 16 years old at time of enrollment (inclusive)&#xD;
&#xD;
          2. Diagnosis of idiopathic scoliosis&#xD;
&#xD;
          3. Sanders bone age of less than or equal to 4&#xD;
&#xD;
          4. Thoracic or thoracolumbar/lumbar curves of greater than or equal to 35 degrees and&#xD;
             less than or equal to 60 degrees from levels T4 through L3&#xD;
&#xD;
          5. Lenke classification of 1, 2, 3, 5, or 6&#xD;
&#xD;
          6. Patient has already been identified for and recommended to have surgical intervention&#xD;
&#xD;
          7. Spina bifida occulta is permitted&#xD;
&#xD;
          8. Spondylolysis or Spondylolisthesis is permitted, as long as it is non-operative, the&#xD;
             patient has not had any previous surgery for this, and no surgery is planned in the&#xD;
             future&#xD;
&#xD;
          9. Completed standard-of-care procedures as outlined in Section 5&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnancy (current)&#xD;
&#xD;
          2. Prior spinal or chest surgery&#xD;
&#xD;
          3. MRI abnormalities (including syrinx greater than 4mm, Chiari malformation, or tethered&#xD;
             cord)&#xD;
&#xD;
          4. Neuromuscular, thoracogenic, cardiogenic scoliosis, or any other non-idiopathic&#xD;
             scoliosis&#xD;
&#xD;
          5. Associated syndrome, including Marfan Disease or Neurofibromatosis&#xD;
&#xD;
          6. Sanders bone age greater than 4&#xD;
&#xD;
          7. Thoracic or thoracolumbar/lumbar curves less than 35 degrees or greater than 60&#xD;
             degrees&#xD;
&#xD;
          8. Compensatory curve greater than 35 degrees without intent to treat surgically&#xD;
&#xD;
          9. Unable or unwilling to firmly commit to returning for required follow-up visits&#xD;
&#xD;
         10. Investigator judgement that the subject/family may not be a candidate for the&#xD;
             intervention&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lawrence Haber, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ochsner Health System</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ochsner Health System- Jefferson Hwy</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>April 10, 2023</last_update_submitted>
  <last_update_submitted_qc>April 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Scoliosis</keyword>
  <keyword>Idiopathic Scoliosis</keyword>
  <keyword>Adolescent Idiopathic Scoliosis</keyword>
  <keyword>Vertebral Body Tethering</keyword>
  <keyword>growth modulation spine</keyword>
  <keyword>spine</keyword>
  <keyword>juvenile scoliosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Scoliosis</mesh_term>
    <mesh_term>Bone Diseases</mesh_term>
    <mesh_term>Musculoskeletal Diseases</mesh_term>
    <mesh_term>Spinal Diseases</mesh_term>
    <mesh_term>Spinal Curvatures</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03802656
org study id: VBT120718
nct id: NCT03802656
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
This study will determine whether vertebral body tethering is a safe and feasible method of
      treatment for pediatric idiopathic scoliosis.
Scoliosis is a condition in which the spine is deformed by a curvature in the coronal plane.
      It is generally associated with a twisting (axial plane) deformity as well. It can have a
      variety of underlying etiologies and the etiology is used to classify the types of scoliosis.
      Idiopathic scoliosis is sub-classified in two ways: by age of onset and by magnitude of
      deformity. Curves between 10 and 25 degrees are considered mild. Curves between 25 and 50
      degrees are classified as moderate. Curves greater than 50 degrees are termed severe. The
      current standard of care for moderate scoliosis in patients with remaining growth is to
      utilize a thoracolumbosacral orthosis (TLSO brace) to prevent progression of deformity. The
      scientific evidence has supported the efficacy of this intervention in avoiding progression
      of the Cobb angle to 50 degrees or more.

      If treated with a TLSO brace, many idiopathic scoliosis patients would conceivably be
      subjected to years of brace wear and the cost and psychological factors inherent therein.
      Additional downsides of brace treatment include the potentially negative psychosocial impact
      of wearing an external sign of deformity during adolescence, a key period of emotional
      development. Prior research has identified negative psychosocial effects related to wearing a
      brace in children.

      Recent evidence has suggested that certain curve patterns will likely progress to 50 degrees
      or more, despite treatment with a TLSO brace. Sanders, et al. demonstrated a correlation of
      Cobb angle (greater than 35 degrees) and skeletal maturity (bone age 4 or less) to the risk
      of progression to 50 degrees or more, despite TLSO bracing. The evidence supports that the
      current practice of TLSO bracing is not an effective treatment to avoid progression to 50
      degrees in these patients. It is on this population (thoracic Cobb angle greater than 35
      degrees, bone age of 4 or less) that we intend to test the safety and feasibility of Anterior
      Vertebral Body Tethering to avoid curve progression to 50 degrees.

      The study intervention is surgical orthopedic implantation of the Anterior Vertebral Tether
      Device, by way of thoracoscopic surgery under general anesthesia. The primary outcome
      measures include assessments of safety of the insertion procedure and of the device, as well
      as the secondary measure of feasibility by determining the ability to successfully implant
      the investigational device.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Safety: Incidence of Treatment-Emergent Adverse Events
time frame: 2 years after last subject's device implantation
description: Intraoperative and post-intervention medical events or signs and symptoms of complications arising after the start of study intervention will be captured. The event description, date of onset, end date, severity, and outcome will be documented. The frequencies, type, body system, severity, and relationship to the study intervention will also be summarized. A distinction will be made between those events which are "device-related" and "non device-related".
measure: Feasibility: Incidence of Successfully Implanted Tether Devices
time frame: 2 years after last subject's device implantation
description: The feasibility of the vertebral body tethering device will analyzed based on successful implantation of the device. Implantation will be considered a failure if the device breaks/loosens after implantation, or if it overcorrects the spinal curve.
measure: Efficacy: Comparison of Preoperative and Postoperative Cobb Angle
time frame: 2 years after last subject's device implantation
description: The exploratory therapeutic endpoint used for feasibility will be change in post-operative Cobb angle compared to pre-operative Cobb angle, measured on coronal radiograph of the spine.
arm group label: Anterior Vertebral Body Tethering
arm group type: Experimental
description: Subjects who will be undergoing the anterior vertebral body tethering surgery.
intervention type: Device
intervention name: Anterior Vertebral Body Tethering
description: Vertebral body tethering through anterior thoracoscopic approach under general anesthesia and fluoroscopic guidance.
arm group label: Anterior Vertebral Body Tethering
criteria: 
gender: All
minimum age: 8 Years
maximum age: 16 Years
healthy volunteers: No
last name: Lawrence Haber, MD
role: Principal Investigator
affiliation: Ochsner Health System
facility: 
country: United States
responsible party type: Sponsor
mesh term: Scoliosis
mesh term: Bone Diseases
mesh term: Musculoskeletal Diseases
mesh term: Spinal Diseases
mesh term: Spinal Curvatures
sharing ipd: No