<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/NCT01716936</url>
  </required_header>
  <id_info>
    <org_study_id>PR0056</org_study_id>
    <nct_id>NCT01716936</nct_id>
  </id_info>
  <brief_title>A Retrospective Review of Early Onset Spinal Deformity Patients Treated With the Ellipse MAGEC System</brief_title>
  <official_title>A Retrospective Multicenter Review of Early Onset Spinal Deformity Patients That Underwent Either a Primary or Revision Spinal Bracing Procedure With the Ellipse Technologies MAGEC Spinal Bracing and Distraction System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ellipse Technologies, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ellipse Technologies, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the safety profile and probable benefit of the&#xD;
      Ellipse Technologies Inc. MAGEC System in subjects with early onset spinal deformity&#xD;
      associated with thoracic insufficiency syndrome.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">January 2013</completion_date>
  <primary_completion_date type="Actual">January 2013</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Cobb Angle</measure>
    <time_frame>Baseline and 6, 12, 18 and 24 Months Postoperatively</time_frame>
    <description>Measured in Degrees</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Thoracic Spine Height</measure>
    <time_frame>Baseline and 6, 12, 18 and 24 Months Postoperatively</time_frame>
    <description>Measured in millimeters (mm)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Space Available for Lung</measure>
    <time_frame>Baseline and 6, 12, 18 and 24 Months Postoperatively</time_frame>
    <description>Measured as a percentage (%)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ocurrence of Procedure-Related Complications</measure>
    <time_frame>Baseline, Device Implant and 6, 12, 18 and 24 Months Postoperatively</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Occurrence of Adverse Events</measure>
    <time_frame>Baseline and 6, 12, 18 and 24 Months Postoperatively</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Coronal Balance</measure>
    <time_frame>Baseline and 6, 12, 18 and 24 Months Postoperatively</time_frame>
    <description>Measured in millimeters (mm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Sagittal Balance</measure>
    <time_frame>Baseline and 6, 12, 18 and 24 Months Postoperatively</time_frame>
    <description>Measured in millimeters (mm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of Subsequent surgical interventions following initial implantation</measure>
    <time_frame>Baseline and 6, 12, 18 and 24 Months Postoperatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Weight</measure>
    <time_frame>Baseline and 6, 12, 18 and 24 Months Postoperatively</time_frame>
    <description>Measured in kilograms (kg)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">54</enrollment>
  <condition>Thoracic Insufficiency Syndrome</condition>
  <arm_group>
    <arm_group_label>MAGEC Implant</arm_group_label>
    <description>All patients implanted with the MAGEC System will be reviewed for inclusion into this retrospective study.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All patients worldwide implanted with the Ellipse Technologies Spinal Bracing and&#xD;
        Distraction System (Invitation to Volunteer Non-Probability Sample).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Early onset spinal deformity with any etiology&#xD;
&#xD;
          -  Cobb angle measurement of 30 degrees or greater at the time of primary surgery&#xD;
&#xD;
          -  Thoracic spine height (T1 to T12) less than 22 cm at the time of primary surgery&#xD;
&#xD;
          -  Age less than 11 years old at the time of MAGEC implant&#xD;
&#xD;
          -  Implanted with the MAGEC system as either a primary or secondary revision spinal&#xD;
             bracing procedure&#xD;
&#xD;
          -  Patient has been implanted for a minimum of 6 months&#xD;
&#xD;
          -  Patient signs informed consent for the use of their personal private data&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient declines to sign informed consent for the use of their personal private data.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>11 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Behrooz A Akbarnia, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>San Diego Center for Spinal Disorders</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Cairo Public Hospital</name>
      <address>
        <city>Cairo</city>
        <zip>11559</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Helsinki</name>
      <address>
        <city>Helsinki</city>
        <zip>00029</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Turku University Hospital</name>
      <address>
        <city>Turku</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Hong Kong</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Rizzoli</name>
      <address>
        <city>Bologna</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bambin Gesu</name>
      <address>
        <city>Rome</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Starship Children's Hospital</name>
      <address>
        <city>Auckland</city>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ankara Gazi Universitesi Hastanesi</name>
      <address>
        <city>Ankara</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hacettepe University Hospital</name>
      <address>
        <city>Ankara</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florence Nightingale Hospital Ortopedi Bolumu</name>
      <address>
        <city>Istanbul</city>
        <zip>34403</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marmara Üniversitesi Eğt.ve Arş.Hastanesi</name>
      <address>
        <city>Istanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ege Sağlık Hastanesi</name>
      <address>
        <city>Izmir</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal National Orthopaedic Hospital NHS Trust</name>
      <address>
        <city>Stanmore</city>
        <state>Middlesex</state>
        <zip>HA7 4LP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of Wales</name>
      <address>
        <city>Cardiff</city>
        <zip>CF 14 4XW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Harley Street Clinic</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
    <country>Finland</country>
    <country>Hong Kong</country>
    <country>Italy</country>
    <country>New Zealand</country>
    <country>Turkey</country>
    <country>United Kingdom</country>
  </location_countries>
  <removed_countries>
    <country>France</country>
    <country>Germany</country>
  </removed_countries>
  <link>
    <url>http://www.ellipse-tech.com</url>
    <description>Ellipse Technologies, Inc. Website</description>
  </link>
  <verification_date>August 2013</verification_date>
  <study_first_submitted>September 19, 2012</study_first_submitted>
  <study_first_submitted_qc>October 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <last_update_submitted>August 13, 2013</last_update_submitted>
  <last_update_submitted_qc>August 13, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 15, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Thoracic Insufficiency Syndrome</keyword>
  <keyword>Early Onset Spinal Deformity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Congenital Abnormalities</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/NCT01716936
org study id: PR0056
nct id: NCT01716936
lead sponsor: 
has dmc: No
The purpose of this study is to determine the safety profile and probable benefit of the
      Ellipse Technologies Inc. MAGEC System in subjects with early onset spinal deformity
      associated with thoracic insufficiency syndrome.
observational model: Cohort
time perspective: Retrospective
measure: Change in Cobb Angle
time frame: Baseline and 6, 12, 18 and 24 Months Postoperatively
description: Measured in Degrees
measure: Change in Thoracic Spine Height
time frame: Baseline and 6, 12, 18 and 24 Months Postoperatively
description: Measured in millimeters (mm)
measure: Change in Space Available for Lung
time frame: Baseline and 6, 12, 18 and 24 Months Postoperatively
description: Measured as a percentage (%)
measure: Ocurrence of Procedure-Related Complications
time frame: Baseline, Device Implant and 6, 12, 18 and 24 Months Postoperatively
measure: Occurrence of Adverse Events
time frame: Baseline and 6, 12, 18 and 24 Months Postoperatively
measure: Change in Coronal Balance
time frame: Baseline and 6, 12, 18 and 24 Months Postoperatively
description: Measured in millimeters (mm)
measure: Change in Sagittal Balance
time frame: Baseline and 6, 12, 18 and 24 Months Postoperatively
description: Measured in millimeters (mm)
measure: Occurrence of Subsequent surgical interventions following initial implantation
time frame: Baseline and 6, 12, 18 and 24 Months Postoperatively
measure: Change in Weight
time frame: Baseline and 6, 12, 18 and 24 Months Postoperatively
description: Measured in kilograms (kg)
arm group label: MAGEC Implant
description: All patients implanted with the MAGEC System will be reviewed for inclusion into this retrospective study.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 11 Years
healthy volunteers: No
last name: Behrooz A Akbarnia, MD
role: Principal Investigator
affiliation: San Diego Center for Spinal Disorders
facility: 
facility: 
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country: Egypt
country: Finland
country: Hong Kong
country: Italy
country: New Zealand
country: Turkey
country: United Kingdom
country: France
country: Germany
url: http://www.ellipse-tech.com
description: Ellipse Technologies, Inc. Website
responsible party type: Sponsor
mesh term: Congenital Abnormalities