<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/NCT04441411</url>
  </required_header>
  <id_info>
    <org_study_id>NL67124.018.19</org_study_id>
    <secondary_id>NL8659</secondary_id>
    <nct_id>NCT04441411</nct_id>
  </id_info>
  <brief_title>Non Fusion Surgery in Adolescent Idiopathic Scoliosis Patients</brief_title>
  <acronym>NEMOST-AIS</acronym>
  <official_title>Non Fusion Surgery in Adolescent Idiopathic Scoliosis Patients Using the Nemost-AIS System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The primary objective of the study is to monitor the effectiveness of a minimal invasive&#xD;
      non-fusion double rod bipolar posterior spinal implant (Nemost growing domino) to correct the&#xD;
      scoliotic curve in growing patients suffering from progressive adolescent idiopathic&#xD;
      scoliosis (AIS) who have failed conservative treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Scoliosis is a complex three-dimensional deformity of the spine, which occurs primarily in&#xD;
      growing children and adolescents. In adolescent idiopathic scoliosis (AIS), the cause is&#xD;
      unknown. Children with severe and progressive scoliosis, if left untreated, are at risk of&#xD;
      rapid and severe spinal deformity progression, which can result in a decrease of pulmonary&#xD;
      function, poor cosmetic result and poor quality of life.&#xD;
&#xD;
      Treatment options in AIS depend on curve severity and remaining growth potential, and include&#xD;
      intensive brace treatment for smaller curvatures whereas surgical correction and spinal&#xD;
      fusion is advocated for more severe curves. Growing rods are used for severe early infantile&#xD;
      deformities or early onset scoliosis (EOS).&#xD;
&#xD;
      Bracing, by using a rigid plastic orthosis, is currently the primary therapy to prevent curve&#xD;
      progression in mild curves up to 45 degrees and skeletal immature patients. Most braces are&#xD;
      recommended to be worn for 18-23 hours per day during several years (until skeletal maturity&#xD;
      has been reached). This may cause a high level of physical discomfort and emotional and&#xD;
      psychological stress in these patients, and failure of brace treatment therefore is common.&#xD;
&#xD;
      Surgical therapy for AIS is recommended in severe progressive curvatures. Surgical treatment&#xD;
      includes correction of the spinal curvature by using multisegmental screw fixation and&#xD;
      posterior spinal fusion of the thoracolumbar spine. Complete posterior spinal fusion,&#xD;
      however, lacks the possibilities for future adaptation of natural changes in spinal balance&#xD;
      and posture.&#xD;
&#xD;
      Currently, growing rods systems are used as a posterior spinal implant to allow growth of the&#xD;
      spine and thorax and limit progression of the scoliosis in young patients with early onset&#xD;
      scoliosis. Growing rods systems are distractible spinal implants, with bipolar anchorage&#xD;
      fixations to the upper and lower part of the spine, using posterior spinal instrumentation&#xD;
      such as hooks and pedicle screws.&#xD;
&#xD;
      The Nemost growing system, developed by the EUROS Compagny, is a CE-marked commercial&#xD;
      available medical device for the treatment of early onset neuromuscular or early onset&#xD;
      idiopathic scoliosis. It is a non-fusion, growth enabling system with bipolar fixation&#xD;
      intended to be used with a posterior spinal instrumentation.&#xD;
&#xD;
      It is hypothesized that the use of a minimal invasive non-fusion bipolar posterior spinal&#xD;
      implant (Nemost growing domino) can both correct and brace the spine internally and adapt&#xD;
      balans and or distraction as the idiopathic scoliosis patient grows.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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>
    <intervention_model_description>Cohort study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Coronal balance (Correction of the primary curvature on radiograph</measure>
    <time_frame>2 years</time_frame>
    <description>Cobb angle (degrees)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>T1-S1 length on radiograph</measure>
    <time_frame>2 years</time_frame>
    <description>length (cm)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>instrument segment length on radiograph</measure>
    <time_frame>2 years</time_frame>
    <description>length (cm)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>(Serious) Adverse Event</measure>
    <time_frame>2 years</time_frame>
    <description>complications</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sagittal balance (thoracic kyphosis, lumbar lordosis, proximal and distal junctional angle)</measure>
    <time_frame>2 years</time_frame>
    <description>Cobb angle (degrees)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pelvic parameters (pelvic obliquity, sacral slope, pelvic incidence, pelvic tilt)</measure>
    <time_frame>2 years</time_frame>
    <description>degrees</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Vertebral rotation</measure>
    <time_frame>2 years</time_frame>
    <description>scoliometer assesment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Reported Outcome (PRO</measure>
    <time_frame>2 years</time_frame>
    <description>Scoliosis Research Society's-22 questionnaire</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">18</enrollment>
  <condition>Adolescent Idiopathic Scoliosis</condition>
  <arm_group>
    <arm_group_label>NEMOST-AIS</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>This study is designed as a cohort study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>NEMOST system</intervention_name>
    <description>Minimal invasive double rod posterior Non-Fusion Scoliosis Surgery</description>
    <arm_group_label>NEMOST-AIS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adolescent idiopathic scoliosis ;&#xD;
&#xD;
          -  Primary Cobb angle greater than 30°;&#xD;
&#xD;
          -  Failed non-operative treatment defined as progression of the curve greater than 5° per&#xD;
             year at any time;&#xD;
&#xD;
          -  Skeletally immature (Risser grade* ≤1 and Skeletal age of hand and wrist X-rays ≤14y);&#xD;
&#xD;
          -  In girl, either pre-menarchal or post-menarchal by no more than 1 year;&#xD;
&#xD;
          -  Age over 10 years;&#xD;
&#xD;
          -  Non rigid curve;&#xD;
&#xD;
          -  All Lenke type;&#xD;
&#xD;
          -  No previous spine surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-idiopathic scoliosis: musculoskeletal or neurologic conditions responsible for&#xD;
             cause of the spine curvature (i.e. neuromuscular, congenital or syndromic scoliosis);&#xD;
&#xD;
          -  History of previous spine surgery;&#xD;
&#xD;
          -  Risser sign &gt;1;&#xD;
&#xD;
          -  Disease or deformity likely to affect the stability of the device (i.e. inadequate&#xD;
             anatomy of pedicles, trauma or tumor in fixation region, severe osteoporosis, bone&#xD;
             destruction or poor bone quality);&#xD;
&#xD;
          -  Non-reductible scoliosis;&#xD;
&#xD;
          -  Known allergy or intolerance to one of the device material;&#xD;
&#xD;
          -  Acute or chronic infections, local or systemic;&#xD;
&#xD;
          -  Absence or insufficience of covering tissues;&#xD;
&#xD;
          -  Pathological obesity.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>BJ Van Royen, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>AmsterdamUMC</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>BJ Van Royen, MD, PhD</last_name>
    <phone>+31(0)5662672</phone>
    <email>bj.vanroyen@amsterdamumc.nl</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>AMC AmsterdamUMC</last_name>
    <phone>+31(0)205669111</phone>
    <email>amcfoundation@amc.nl</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>AmsterdamUMC, location AMC</name>
      <address>
        <city>Amsterdam</city>
        <state>NH</state>
        <zip>1105AZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dept of Orthopedics</last_name>
      <phone>+31(20)5662672</phone>
    </contact>
    <contact_backup>
      <last_name>Dept of orthopaedics</last_name>
      <phone>+31(20)5662672</phone>
    </contact_backup>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>June 18, 2020</last_update_submitted>
  <last_update_submitted_qc>June 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</investigator_affiliation>
    <investigator_full_name>BJ van Royen</investigator_full_name>
    <investigator_title>clinical professor, principal investigator</investigator_title>
  </responsible_party>
  <keyword>scoliosis</keyword>
  <keyword>nonfusion</keyword>
  <keyword>surgery</keyword>
  <keyword>fusionless</keyword>
  <keyword>idiopathic</keyword>
  <keyword>adolescent</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Scoliosis</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/NCT04441411
org study id: NL67124.018.19
secondary id: NL8659
nct id: NCT04441411
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The primary objective of the study is to monitor the effectiveness of a minimal invasive
      non-fusion double rod bipolar posterior spinal implant (Nemost growing domino) to correct the
      scoliotic curve in growing patients suffering from progressive adolescent idiopathic
      scoliosis (AIS) who have failed conservative treatment.
Scoliosis is a complex three-dimensional deformity of the spine, which occurs primarily in
      growing children and adolescents. In adolescent idiopathic scoliosis (AIS), the cause is
      unknown. Children with severe and progressive scoliosis, if left untreated, are at risk of
      rapid and severe spinal deformity progression, which can result in a decrease of pulmonary
      function, poor cosmetic result and poor quality of life.

      Treatment options in AIS depend on curve severity and remaining growth potential, and include
      intensive brace treatment for smaller curvatures whereas surgical correction and spinal
      fusion is advocated for more severe curves. Growing rods are used for severe early infantile
      deformities or early onset scoliosis (EOS).

      Bracing, by using a rigid plastic orthosis, is currently the primary therapy to prevent curve
      progression in mild curves up to 45 degrees and skeletal immature patients. Most braces are
      recommended to be worn for 18-23 hours per day during several years (until skeletal maturity
      has been reached). This may cause a high level of physical discomfort and emotional and
      psychological stress in these patients, and failure of brace treatment therefore is common.

      Surgical therapy for AIS is recommended in severe progressive curvatures. Surgical treatment
      includes correction of the spinal curvature by using multisegmental screw fixation and
      posterior spinal fusion of the thoracolumbar spine. Complete posterior spinal fusion,
      however, lacks the possibilities for future adaptation of natural changes in spinal balance
      and posture.

      Currently, growing rods systems are used as a posterior spinal implant to allow growth of the
      spine and thorax and limit progression of the scoliosis in young patients with early onset
      scoliosis. Growing rods systems are distractible spinal implants, with bipolar anchorage
      fixations to the upper and lower part of the spine, using posterior spinal instrumentation
      such as hooks and pedicle screws.

      The Nemost growing system, developed by the EUROS Compagny, is a CE-marked commercial
      available medical device for the treatment of early onset neuromuscular or early onset
      idiopathic scoliosis. It is a non-fusion, growth enabling system with bipolar fixation
      intended to be used with a posterior spinal instrumentation.

      It is hypothesized that the use of a minimal invasive non-fusion bipolar posterior spinal
      implant (Nemost growing domino) can both correct and brace the spine internally and adapt
      balans and or distraction as the idiopathic scoliosis patient grows.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Cohort study
primary purpose: Treatment
masking: None (Open Label)
measure: Coronal balance (Correction of the primary curvature on radiograph
time frame: 2 years
description: Cobb angle (degrees)
measure: T1-S1 length on radiograph
time frame: 2 years
description: length (cm)
measure: instrument segment length on radiograph
time frame: 2 years
description: length (cm)
measure: (Serious) Adverse Event
time frame: 2 years
description: complications
measure: Sagittal balance (thoracic kyphosis, lumbar lordosis, proximal and distal junctional angle)
time frame: 2 years
description: Cobb angle (degrees)
measure: Pelvic parameters (pelvic obliquity, sacral slope, pelvic incidence, pelvic tilt)
time frame: 2 years
description: degrees
measure: Vertebral rotation
time frame: 2 years
description: scoliometer assesment
measure: Patient Reported Outcome (PRO
time frame: 2 years
description: Scoliosis Research Society's-22 questionnaire
arm group label: NEMOST-AIS
arm group type: Other
description: This study is designed as a cohort study.
intervention type: Device
intervention name: NEMOST system
description: Minimal invasive double rod posterior Non-Fusion Scoliosis Surgery
arm group label: NEMOST-AIS
criteria: 
gender: All
minimum age: 10 Years
maximum age: 17 Years
healthy volunteers: No
last name: BJ Van Royen, MD, PhD
role: Principal Investigator
affiliation: AmsterdamUMC
last name: BJ Van Royen, MD, PhD
phone: +31(0)5662672
email: bj.vanroyen@amsterdamumc.nl
last name: AMC AmsterdamUMC
phone: +31(0)205669111
email: amcfoundation@amc.nl
facility: 
status: Recruiting
contact: 
contact backup: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
investigator full name: BJ van Royen
investigator title: clinical professor, principal investigator
mesh term: Scoliosis
sharing ipd: No