<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/NCT01672749</url>
  </required_header>
  <id_info>
    <org_study_id>EOS TROLLEY</org_study_id>
    <nct_id>NCT01672749</nct_id>
  </id_info>
  <brief_title>Evaluation of a Modern System to Allow for Growth in Children With Scoliosis Versus a Conventional Treatment</brief_title>
  <official_title>Evaluation of a Growth Guiding Construct vs. Standard Dual Growing Rods and VEPTR for the Treatment of Early Onset Scoliosis Patients: A Prospective Multi-center Cohort Study With a Matched Historical Control</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AO Innovation Translation Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AO Innovation Translation Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The foremost challenge when managing early onset scoliosis (curve deformity before the age of&#xD;
      10) is to prevent curve progression while maintaining growth of the spine. Current treatment&#xD;
      options require repetitive interventions as the spine and the child grow. This study will&#xD;
      compare two techniques of growth modulation: Standard dual growing rods versus the new Luqué&#xD;
      Trolley screws&#xD;
&#xD;
      Hypothesis: Patients treated with the DePuy Synthes TROLLEY system will undergo fewer&#xD;
      re-operations after 3 years of follow-up (FU) than patients included in the comparison group&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this clinical study is to show that the growth guiding construct with DePuy&#xD;
      Synthes TROLLEY Gliding Vehicles allows for less re-operations and for ongoing spinal growth&#xD;
      across an instrumented immature spine while preventing curve progression in early onset&#xD;
      scoliosis patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>June 2015</start_date>
  <completion_date type="Anticipated">April 2027</completion_date>
  <primary_completion_date type="Anticipated">June 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of re-operations</measure>
    <time_frame>3 years FU</time_frame>
    <description>Number of re-operations of the spine per patient in both groups after 3 years of FU</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sitting height</measure>
    <time_frame>10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Standing height</measure>
    <time_frame>10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiographic measurements</measure>
    <time_frame>10 years</time_frame>
    <description>Spine length: upper T1 to lower L5 end plates&#xD;
Chest length: upper T1 to Lower T12&#xD;
Instrumented spine length</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Curve / deformity type characteristics</measure>
    <time_frame>10 years</time_frame>
    <description>Lenke classification&#xD;
New EOS classification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events related to the procedure and/or device under investigation</measure>
    <time_frame>10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>10 years</time_frame>
    <description>EOS Questionnaire (EOSQ 24)&#xD;
Pediatric version of EQ-5D (EQ-5D-Y)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulmonary function:</measure>
    <time_frame>10 years</time_frame>
    <description>Forced vital capacity (FVC), actual [L] and predicted [%]&#xD;
Forced expiratory volume in 1 second (FEV1), actual [L] and predicted [%]&#xD;
Total lung capacity (TLC), actual [L] and predicted [%]&#xD;
Use and rate of assisted ventilation&#xD;
Residual volume (RV)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Growth potential</measure>
    <time_frame>10 years</time_frame>
    <description>Chronological age&#xD;
Bone age (based on radiograph of the hand)</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">51</enrollment>
  <condition>Early Onset Scoliosis</condition>
  <arm_group>
    <arm_group_label>Spine based dual growing rod or VEPTR</arm_group_label>
    <description>Patients treated with the TROLLEY system will be compared with patients from the Chest Wall and Spine Deformity Study Group (CWSDSG) and the Growing Spine Study Group (GSSG) treated with a spine based dual growing rod or the rib based Vertical Expandable Prosthetic Titanium Rib (VEPTR, Synthes North America). For each patient in the TROLLEY group a patient from each of the databases will be selected to be matched based on diagnosis, age, gender, and spine deformity classification.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TROLLEY system</arm_group_label>
    <description>Growth guiding construct using the DePuy Synthes TROLLEY Gliding Vehicles (GVs). The TROLLEY system is CE marked at the time of the study conduct.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Growth guiding construct using TROLLEY system</intervention_name>
    <description>Growth guiding construct using the DePuy Synthes TROLLEY Gliding Vehicles (GVs)</description>
    <arm_group_label>TROLLEY system</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Spine based dual growing rod or rib based VEPTR</intervention_name>
    <description>spine based dual growing rod or the rib based Vertical Expandable Prosthetic Titanium Rib (VEPTR, Synthes North America)</description>
    <arm_group_label>Spine based dual growing rod or VEPTR</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        One third of the patients will be recruited in designated investigation sites using the&#xD;
        TROLLEY system. For each trolley patient one to two comparative matched pairs will be&#xD;
        generated from mining the database of the Chest Wall and Spine Deformity Study Group&#xD;
        (CWSDSG) and the Growing Spine Study Group (GSSG).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 5 - 10 years&#xD;
&#xD;
          -  Diagnosis of Early Onset Scoliosis with any of the following etiologies:&#xD;
&#xD;
        Idiopathic Congenital Neuromuscular Syndromic Mesenchymal&#xD;
&#xD;
        - Significant growth potential defined by any of the following: pre peek growth velocity&#xD;
        bone age &lt; 10; open triradiate cartilage&#xD;
&#xD;
          -  An expected significant spinal deformity of more than 80 degrees at skeletal maturity&#xD;
&#xD;
          -  Signed informed consent as legally required (patient, parents, etc.)&#xD;
&#xD;
          -  Willingness and ability of the patient to participate in the clinical investigation&#xD;
             including imaging and FU procedures&#xD;
&#xD;
          -  Willingness and ability of the parents to support the patient in his/her study&#xD;
             participation&#xD;
&#xD;
          -  Ability of the patient and parents to understand the content of the patient&#xD;
             information / informed consent form and participate in the clinical investigation&#xD;
&#xD;
          -  Signed informed consent by patient / parent(s)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Curve magnitude and rigidity: Cobb greater than 100 degrees or bends less than 50&#xD;
             degrees&#xD;
&#xD;
          -  Prior spinal surgery&#xD;
&#xD;
          -  Skeletal maturity&#xD;
&#xD;
          -  Any not medically managed severe systemic disease&#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>5 Years</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean Ouellet, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>McGill University Health Science Centre, Montreal, Canada</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpitaux Universitaires de Genève</name>
      <address>
        <city>Genève</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen's Medical Centre</name>
      <address>
        <city>Nottingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sheffield Children's Hospital</name>
      <address>
        <city>Sheffield</city>
        <zip>S10 2TH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
    <country>United Kingdom</country>
  </location_countries>
  <removed_countries>
    <country>Canada</country>
  </removed_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>August 22, 2012</study_first_submitted>
  <study_first_submitted_qc>August 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2012</study_first_posted>
  <last_update_submitted>August 26, 2022</last_update_submitted>
  <last_update_submitted_qc>August 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Scoliosis [MESH]</keyword>
  <keyword>Pediatrics [MESH]</keyword>
  <keyword>Early onset</keyword>
  <keyword>Growth guidance</keyword>
  <keyword>Growing rod</keyword>
  <keyword>Trolley</keyword>
  <keyword>Dual growing rod technique</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Scoliosis</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/NCT01672749
org study id: EOS TROLLEY
nct id: NCT01672749
lead sponsor: 
has dmc: Yes
The foremost challenge when managing early onset scoliosis (curve deformity before the age of
      10) is to prevent curve progression while maintaining growth of the spine. Current treatment
      options require repetitive interventions as the spine and the child grow. This study will
      compare two techniques of growth modulation: Standard dual growing rods versus the new Luqué
      Trolley screws

      Hypothesis: Patients treated with the DePuy Synthes TROLLEY system will undergo fewer
      re-operations after 3 years of follow-up (FU) than patients included in the comparison group
The purpose of this clinical study is to show that the growth guiding construct with DePuy
      Synthes TROLLEY Gliding Vehicles allows for less re-operations and for ongoing spinal growth
      across an instrumented immature spine while preventing curve progression in early onset
      scoliosis patients.
observational model: Cohort
time perspective: Prospective
measure: Number of re-operations
time frame: 3 years FU
description: Number of re-operations of the spine per patient in both groups after 3 years of FU
measure: Sitting height
time frame: 10 years
measure: Standing height
time frame: 10 years
measure: Radiographic measurements
time frame: 10 years
description: Spine length: upper T1 to lower L5 end plates
Chest length: upper T1 to Lower T12
Instrumented spine length
measure: Curve / deformity type characteristics
time frame: 10 years
description: Lenke classification
New EOS classification
measure: Adverse Events related to the procedure and/or device under investigation
time frame: 10 years
measure: Quality of life
time frame: 10 years
description: EOS Questionnaire (EOSQ 24)
Pediatric version of EQ-5D (EQ-5D-Y)
measure: Pulmonary function:
time frame: 10 years
description: Forced vital capacity (FVC), actual [L] and predicted [%]
Forced expiratory volume in 1 second (FEV1), actual [L] and predicted [%]
Total lung capacity (TLC), actual [L] and predicted [%]
Use and rate of assisted ventilation
Residual volume (RV)
measure: Growth potential
time frame: 10 years
description: Chronological age
Bone age (based on radiograph of the hand)
arm group label: Spine based dual growing rod or VEPTR
description: Patients treated with the TROLLEY system will be compared with patients from the Chest Wall and Spine Deformity Study Group (CWSDSG) and the Growing Spine Study Group (GSSG) treated with a spine based dual growing rod or the rib based Vertical Expandable Prosthetic Titanium Rib (VEPTR, Synthes North America). For each patient in the TROLLEY group a patient from each of the databases will be selected to be matched based on diagnosis, age, gender, and spine deformity classification.
arm group label: TROLLEY system
description: Growth guiding construct using the DePuy Synthes TROLLEY Gliding Vehicles (GVs). The TROLLEY system is CE marked at the time of the study conduct.
intervention type: Device
intervention name: Growth guiding construct using TROLLEY system
description: Growth guiding construct using the DePuy Synthes TROLLEY Gliding Vehicles (GVs)
arm group label: TROLLEY system
intervention type: Device
intervention name: Spine based dual growing rod or rib based VEPTR
description: spine based dual growing rod or the rib based Vertical Expandable Prosthetic Titanium Rib (VEPTR, Synthes North America)
arm group label: Spine based dual growing rod or VEPTR
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 5 Years
maximum age: 10 Years
healthy volunteers: No
last name: Jean Ouellet, MD
role: Principal Investigator
affiliation: McGill University Health Science Centre, Montreal, Canada
facility: 
facility: 
facility: 
country: Switzerland
country: United Kingdom
country: Canada
responsible party type: Sponsor
mesh term: Scoliosis