<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/NCT04505579</url>
  </required_header>
  <id_info>
    <org_study_id>RAU2019-40S</org_study_id>
    <nct_id>NCT04505579</nct_id>
  </id_info>
  <brief_title>The Tether™ - Vertebral Body Tethering System Post Approval Study</brief_title>
  <official_title>The Tether™ - Vertebral Body Tethering System Post Approval Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zimmer Biomet</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Setting Scoliosis Straight Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Exponent, Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Zimmer Biomet</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_ppsd>Yes</is_ppsd>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is an opportunity to provide continued reasonable assurance of the safety and&#xD;
      probable benefit of The Tether HUD. The study will collect long term safety and efficacy&#xD;
      information from patients who have had their idiopathic scoliosis treated via anterior&#xD;
      vertebral body tethering (AVBT) with The Tether.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      While spinal fusion remains the standard surgical treatment for progressive idiopathic&#xD;
      scoliosis, concerns about the long-term effects of spinal fusion have led to the&#xD;
      investigation of growth-modulation techniques. Anterior Vertebral Body Tethering (AVBT) is&#xD;
      one such technique that utilizes growth modulation to remodel the shape of the vertebra and&#xD;
      straighten scoliotic curves in skeletally immature individuals. In this technique, screws are&#xD;
      inserted at each vertebral level for the length of the convex side of the curve. A strong&#xD;
      cord is connected through the screw tulip heads and used to initially straighten the curve as&#xD;
      each level is fixed with a set screw. Following surgery and during the growth period the&#xD;
      spine begins to remodel according to the Hueter-Volkmann Law, bone growth is relatively&#xD;
      inhibited in areas of increased pressure (convex or tethered side) and relatively stimulated&#xD;
      in areas of decreased pressure or tension (concave side). Following this principle, AVBT has&#xD;
      been shown to alter spinal growth with the potential to correct scoliosis while maintaining&#xD;
      spine flexibility.&#xD;
&#xD;
      The objective of the study is to assess the ongoing safety and probable benefit of The Tether&#xD;
      HUD which was approved by the FDA under an HDE. Subject enrollment and data collection will&#xD;
      be managed by the Harms Study Group (HSG) and Setting Scoliosis Straight Foundation (SSSF)&#xD;
      Registry. Institutions that are HSG members or affiliates, with Investigators/surgeons that&#xD;
      are trained and approved to perform surgeries with The Tether, will participate in the&#xD;
      registry. Ten sites from this group will be identified as study sites specific to this Tether&#xD;
      post-approval study (PAS). Consecutive subjects from these sites, that meet the eligibility&#xD;
      criteria of this study, will be flagged in the registry as the PAS cohort and the study&#xD;
      endpoints will be assessed across this population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 29, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2027</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2027</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>Rate of SAEs and device- &amp;/or procedure-related AEs</measure>
    <time_frame>AVBT surgery to five year post-op</time_frame>
    <description>The primary safety endpoint is the rate of Serious Adverse Events (SAEs) and device- and/or procedure-related Adverse Events (AEs)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of subjects with maintenance of the major Cobb angle less than or equal to 40 degrees at 60 months post-surgery</measure>
    <time_frame>AVBT surgery to five year post-op</time_frame>
    <description>The primary probable benefit endpoint is the percentage of patients with maintenance of the major Cobb angle less than or equal to 40 degrees at 60 months post-surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>AVBT surgery to five year post-op</time_frame>
    <description>Rates of overall Adverse Events; relatedness, severity, time to event</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reoperation</measure>
    <time_frame>AVBT surgery to five year post-op</time_frame>
    <description>Rates and types of reoperation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with new curves that develop above or below the tethered portion of the spine.</measure>
    <time_frame>AVBT surgery to five year post-op</time_frame>
    <description>Determined by radiographic assessment, defined as a new curve development with Cobb angle measurement greater than or equal to 40 degrees.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with secondary curves that progress to the point of clinical significance.</measure>
    <time_frame>AVBT surgery to five year post-op</time_frame>
    <description>Determined by radiographic assessment, typically defined as an increase in secondary Cobb angle measurement greater than or equal to 10 degrees, or medical intervention/ intent to treat.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with device integrity failures including cord breakage and screw migration.</measure>
    <time_frame>AVBT surgery to five year post-op</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean (SD) and distributions of sagittal balance (mm) from pre-op through last visit</measure>
    <time_frame>Baseline to five year post-op</time_frame>
    <description>Sagittal balance is assessed on the lateral radiograph by measuring the difference (i.e. distance) between posterosuperior aspect of the S1 vertebral body and the plumb line.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean (SD) and distributions of lumbar lordosis (degrees) from pre-op through last visit.</measure>
    <time_frame>Baseline to five year post-op</time_frame>
    <description>Lumbar lordosis is defined as the angle at the intersection of lines perpendicular to lines parallel to the superior endplate of T12 and the superior endplate of S1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean score of Scoliosis Research Society 22r Patient Questionnaire</measure>
    <time_frame>Baseline to five year post-op</time_frame>
    <description>Self-reported outcomes of function, pain, self-image, mental health, and satisfaction. Mean score; 5 (Best) - 1 (Worst)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with compromised lung function</measure>
    <time_frame>Baseline to five year post-op</time_frame>
    <description>Comparison of the measured lung function (forced expiratory volume (FEV1), forced vital capacity (FVC) and FEV1/FVC) to predicted values, lower and upper limits of normal to determine if lung function is within the limits of the normal population.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement (degrees rotation) of trunk shape by scoliometer device. Mean (SD) [min, max] will be reported.</measure>
    <time_frame>Baseline to five year post-op</time_frame>
    <description>Measurements of trunk shape or rib hump will be collected preoperatively and at each follow-up visit. A standard scoliometer device will be used to measure the rib hump in the thoracic and/or lumbar regions of the spine, as applicable. The scoliometer is laid across the curve at right angles with the 0° mark at the spinous process and resting gently on the skin, not pressed down. The degrees of rotation are read and recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trunk flexibility as determined by distance (cm) of flexion and lateral bend using fingertip to floor method.</measure>
    <time_frame>Baseline to five year post-op</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Scoliosis Idiopathic</condition>
  <arm_group>
    <arm_group_label>Tether</arm_group_label>
    <description>Patients who have received The Tether HUD for treatment of idiopathic scoliosis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Anterior Vertebral Body Tethering</intervention_name>
    <description>Anterior Vertebral Body Tethering (AVBT) is a technique that utilizes growth modulation to remodel the shape of the vertebra and straighten scoliotic curves in skeletally immature individuals. In this technique, screws are inserted at each vertebral level for the length of the convex side of the curve. A strong cord is connected through the screw tulip heads and used to initially straighten the curve as each level is fixed with a set screw. Following surgery and during the growth period the spine begins to remodel according to the Hueter-Volkmann Law, bone growth is relatively inhibited in areas of increased pressure (convex or tethered side) and relatively stimulated in areas of decreased pressure or tension (concave side).</description>
    <arm_group_label>Tether</arm_group_label>
    <other_name>AVBT</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The Tether™ - Vertebral Body Tethering System is indicated for skeletally immature patients&#xD;
        that require surgical treatment to obtain and maintain correction of progressive idiopathic&#xD;
        scoliosis, with a major Cobb angle of 30 to 65 degrees whose osseous structure is&#xD;
        dimensionally adequate to accommodate screw fixation, as determined by radiographic&#xD;
        imaging. Patients should have failed bracing and/or be intolerant to brace wear.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of progressive idiopathic scoliosis&#xD;
&#xD;
          -  Skeletally immature, based on both Risser (&lt;5) and Sanders (&lt;8) assessments&#xD;
&#xD;
          -  Major Cobb angle ≥30° and ≤65°&#xD;
&#xD;
          -  Osseous structure dimensionally adequate to accommodate screw fixation, as determined&#xD;
             by radiographic imaging&#xD;
&#xD;
          -  Failed or intolerant to bracing&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of any systemic infection, local infection, or skin compromise at the&#xD;
             surgical site&#xD;
&#xD;
          -  Prior spinal surgery at the level(s) to be treated&#xD;
&#xD;
          -  Documented poor bone quality, defined as a T-score -1.5 or less&#xD;
&#xD;
          -  Any other medical or surgical condition which would preclude the potential benefit of&#xD;
             spinal surgery, such as coagulation disorders, allergies to the implant materials, and&#xD;
             patient's unwillingness or inability to cooperate with post-operative care&#xD;
             instructions&#xD;
&#xD;
          -  Unwillingness, inability, or living situation (e.g. custody arrangements,&#xD;
             homelessness, detention) that would preclude ability to return to the study site for&#xD;
             follow-up visits as described in protocol and Informed Consent&#xD;
&#xD;
          -  Unwillingness to sign Informed Consent Form and participate in study procedures&#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_contact>
    <last_name>Adam J. Burnett, BS</last_name>
    <phone>9725229726</phone>
    <email>Adam.Burnett@zimmerbiomet.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Bryan McMahon, MS, RAC</last_name>
    <phone>3035331068</phone>
    <email>Bryan.McMahon@zimmerbiomet.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Missouri - Columbia</name>
      <address>
        <city>Columbia</city>
        <state>Missouri</state>
        <zip>65201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>July 20, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>December 2, 2020</last_update_submitted>
  <last_update_submitted_qc>December 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 4, 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>Scoliosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04505579
org study id: RAU2019-40S
nct id: NCT04505579
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is ppsd: Yes
is us export: Yes
This study is an opportunity to provide continued reasonable assurance of the safety and
      probable benefit of The Tether HUD. The study will collect long term safety and efficacy
      information from patients who have had their idiopathic scoliosis treated via anterior
      vertebral body tethering (AVBT) with The Tether.
While spinal fusion remains the standard surgical treatment for progressive idiopathic
      scoliosis, concerns about the long-term effects of spinal fusion have led to the
      investigation of growth-modulation techniques. Anterior Vertebral Body Tethering (AVBT) is
      one such technique that utilizes growth modulation to remodel the shape of the vertebra and
      straighten scoliotic curves in skeletally immature individuals. In this technique, screws are
      inserted at each vertebral level for the length of the convex side of the curve. A strong
      cord is connected through the screw tulip heads and used to initially straighten the curve as
      each level is fixed with a set screw. Following surgery and during the growth period the
      spine begins to remodel according to the Hueter-Volkmann Law, bone growth is relatively
      inhibited in areas of increased pressure (convex or tethered side) and relatively stimulated
      in areas of decreased pressure or tension (concave side). Following this principle, AVBT has
      been shown to alter spinal growth with the potential to correct scoliosis while maintaining
      spine flexibility.

      The objective of the study is to assess the ongoing safety and probable benefit of The Tether
      HUD which was approved by the FDA under an HDE. Subject enrollment and data collection will
      be managed by the Harms Study Group (HSG) and Setting Scoliosis Straight Foundation (SSSF)
      Registry. Institutions that are HSG members or affiliates, with Investigators/surgeons that
      are trained and approved to perform surgeries with The Tether, will participate in the
      registry. Ten sites from this group will be identified as study sites specific to this Tether
      post-approval study (PAS). Consecutive subjects from these sites, that meet the eligibility
      criteria of this study, will be flagged in the registry as the PAS cohort and the study
      endpoints will be assessed across this population.
observational model: Cohort
time perspective: Prospective
measure: Rate of SAEs and device- &/or procedure-related AEs
time frame: AVBT surgery to five year post-op
description: The primary safety endpoint is the rate of Serious Adverse Events (SAEs) and device- and/or procedure-related Adverse Events (AEs)
measure: Percentage of subjects with maintenance of the major Cobb angle less than or equal to 40 degrees at 60 months post-surgery
time frame: AVBT surgery to five year post-op
description: The primary probable benefit endpoint is the percentage of patients with maintenance of the major Cobb angle less than or equal to 40 degrees at 60 months post-surgery
measure: Adverse Events
time frame: AVBT surgery to five year post-op
description: Rates of overall Adverse Events; relatedness, severity, time to event
measure: Reoperation
time frame: AVBT surgery to five year post-op
description: Rates and types of reoperation
measure: Number of participants with new curves that develop above or below the tethered portion of the spine.
time frame: AVBT surgery to five year post-op
description: Determined by radiographic assessment, defined as a new curve development with Cobb angle measurement greater than or equal to 40 degrees.
measure: Number of participants with secondary curves that progress to the point of clinical significance.
time frame: AVBT surgery to five year post-op
description: Determined by radiographic assessment, typically defined as an increase in secondary Cobb angle measurement greater than or equal to 10 degrees, or medical intervention/ intent to treat.
measure: Number of participants with device integrity failures including cord breakage and screw migration.
time frame: AVBT surgery to five year post-op
measure: Mean (SD) and distributions of sagittal balance (mm) from pre-op through last visit
time frame: Baseline to five year post-op
description: Sagittal balance is assessed on the lateral radiograph by measuring the difference (i.e. distance) between posterosuperior aspect of the S1 vertebral body and the plumb line.
measure: Mean (SD) and distributions of lumbar lordosis (degrees) from pre-op through last visit.
time frame: Baseline to five year post-op
description: Lumbar lordosis is defined as the angle at the intersection of lines perpendicular to lines parallel to the superior endplate of T12 and the superior endplate of S1.
measure: Mean score of Scoliosis Research Society 22r Patient Questionnaire
time frame: Baseline to five year post-op
description: Self-reported outcomes of function, pain, self-image, mental health, and satisfaction. Mean score; 5 (Best) - 1 (Worst)
measure: Number of participants with compromised lung function
time frame: Baseline to five year post-op
description: Comparison of the measured lung function (forced expiratory volume (FEV1), forced vital capacity (FVC) and FEV1/FVC) to predicted values, lower and upper limits of normal to determine if lung function is within the limits of the normal population.
measure: Measurement (degrees rotation) of trunk shape by scoliometer device. Mean (SD) [min, max] will be reported.
time frame: Baseline to five year post-op
description: Measurements of trunk shape or rib hump will be collected preoperatively and at each follow-up visit. A standard scoliometer device will be used to measure the rib hump in the thoracic and/or lumbar regions of the spine, as applicable. The scoliometer is laid across the curve at right angles with the 0° mark at the spinous process and resting gently on the skin, not pressed down. The degrees of rotation are read and recorded.
measure: Trunk flexibility as determined by distance (cm) of flexion and lateral bend using fingertip to floor method.
time frame: Baseline to five year post-op
arm group label: Tether
description: Patients who have received The Tether HUD for treatment of idiopathic scoliosis.
intervention type: Device
intervention name: Anterior Vertebral Body Tethering
description: Anterior Vertebral Body Tethering (AVBT) is a technique that utilizes growth modulation to remodel the shape of the vertebra and straighten scoliotic curves in skeletally immature individuals. In this technique, screws are inserted at each vertebral level for the length of the convex side of the curve. A strong cord is connected through the screw tulip heads and used to initially straighten the curve as each level is fixed with a set screw. Following surgery and during the growth period the spine begins to remodel according to the Hueter-Volkmann Law, bone growth is relatively inhibited in areas of increased pressure (convex or tethered side) and relatively stimulated in areas of decreased pressure or tension (concave side).
arm group label: Tether
other name: AVBT
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Adam J. Burnett, BS
phone: 9725229726
email: Adam.Burnett@zimmerbiomet.com
last name: Bryan McMahon, MS, RAC
phone: 3035331068
email: Bryan.McMahon@zimmerbiomet.com
facility: 
status: Recruiting
country: United States
responsible party type: Sponsor
mesh term: Scoliosis
sharing ipd: Undecided