<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/NCT04500041</url>
  </required_header>
  <id_info>
    <org_study_id>00000</org_study_id>
    <nct_id>NCT04500041</nct_id>
  </id_info>
  <brief_title>Casting vs Bracing for Idiopathic Early-Onset Scoliosis</brief_title>
  <acronym>CVBT</acronym>
  <official_title>Casting vs Bracing for Idiopathic Early-Onset Scoliosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Iowa</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Orthopedic Research and Education Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Pediatric Spine Study Group</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Iowa</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Comparison of casting and bracing for the treatment of idiopathic early onset scoliosis&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study uses a multicenter, prospective hybrid research design, which will combine two&#xD;
      methods of treatment assignment (randomized and parent preference) and an embedded internal&#xD;
      pilot study for sample size re-estimation. Patients will be treated either with serial casts&#xD;
      or a full-time brace and followed until curve resolution, failure or palliation (neither&#xD;
      resolution nor failure after 2 years of treatment). Results of this study will provide&#xD;
      clinicians and families with evidence to support informed treatment decisions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 9, 2021</start_date>
  <completion_date type="Anticipated">September 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Treatment (casting or bracing) via randomized assignment OR based on family preference</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Study outcome is determined from serial radiographs. Radiographic readers will be blinded to the treatment assigned or received.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Curve Response</measure>
    <time_frame>on or before 24 months of treatment</time_frame>
    <description>Resolution - curve improvement to &lt;15 degrees (as measured on 2 consecutive radiographs)&#xD;
Failure&#xD;
Initial Cobb 20-50° (inclusive): curve progression of ≥20° resulting in a curve ≥50°&#xD;
Initial Cobb &gt;50°: curve progression of ≥20°&#xD;
Palliation - 2 years of treatment without resolution or failure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Health-related Quality of Life (HRQOL)</measure>
    <time_frame>on or before 24 months of treatment</time_frame>
    <description>Evaluation of patients' HRQOL as estimated by serial administrations of the Early Onset Scoliosis Questionnaire (EOSQ-24, completed by the parent at baseline and every 6 months, total score range 0-100, higher scores indicate higher level of HRQOL). Within and between treatment arm comparisons will be made.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Parent and Family Functioning</measure>
    <time_frame>on or before 24 months of treatment</time_frame>
    <description>Evaluation of patients' disease and treatment on parent and family function as estimated by serial administrations of the PedsQL Family Impact Module scores (PedsQL FIM, completed by the parent, total score range 0-100, higher scores indicate less negative impact). Within and between treatment arm comparisons will be made.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">440</enrollment>
  <condition>Scoliosis Idiopathic</condition>
  <condition>Early-Onset Scoliosis Deformity of Spine</condition>
  <arm_group>
    <arm_group_label>Casting</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will be treated with serial casting</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bracing</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will be treated with full-time orthotics (braces)</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Casting</intervention_name>
    <description>Use of casts applied using corrective maneuvers</description>
    <arm_group_label>Casting</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Bracing</intervention_name>
    <description>Use of full-time spinal orthosis</description>
    <arm_group_label>Bracing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Will enroll both patients with scoliosis and 1 of their parents/guardians&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
        Patient Inclusion&#xD;
&#xD;
          -  Diagnosis of idiopathic early-onset scoliosis&#xD;
&#xD;
          -  Child standing independently but not older than 3 years of age&#xD;
&#xD;
          -  20≤ Cobb angle ≤70° (largest structural curvature)&#xD;
&#xD;
          -  Rib-vertebral angle difference (RVAD) greater than 20 degrees or Rib Phase II&#xD;
&#xD;
          -  Parental consent to participate&#xD;
&#xD;
        Parent Inclusion&#xD;
&#xD;
          -  Parent or guardian of the minor subject&#xD;
&#xD;
          -  Consent to participate&#xD;
&#xD;
          -  Able to complete surveys&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patient Exclusion&#xD;
&#xD;
          -  Previous operative or non-operative treatment for idiopathic early-onset scoliosis&#xD;
&#xD;
          -  Not independently walking by 18 months of age or other signs/symptoms indicative of&#xD;
             developmental delay&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Months</minimum_age>
    <maximum_age>36 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stuart L Weinstein, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Iowa</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lori A Dolan, PhD</last_name>
    <phone>319-356-1075</phone>
    <email>lori-dolan@uiowa.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Arkansas Children's Hospital</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jennifer Ford</last_name>
      <email>fordjr@archildrens.org</email>
    </contact>
    <investigator>
      <last_name>David Bumpass, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Richard McCarthy, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Children's Hospital Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tyler Feddema</last_name>
      <email>tyler.feddema@childrenscolorado.org</email>
    </contact>
    <investigator>
      <last_name>Sumeet Garg, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Mark Erickson, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Nemours/Alfred I. duPont Hospital for Children</name>
      <address>
        <city>Wilmington</city>
        <state>Delaware</state>
        <zip>19803</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Petya Yorgova</last_name>
      <email>petya.yorgova@nemours.org</email>
    </contact>
    <investigator>
      <last_name>Suken Shah, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Children's Healthcare of Atlanta</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30342</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Numera Sachwani</last_name>
      <email>numera.sachwani@choa.org</email>
    </contact>
    <investigator>
      <last_name>Michael Schmidt, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Dennis Devito, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Nicholas Fletcher, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Joshua Murphy, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Lurie Children's Hospital of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jacob Wild</last_name>
      <email>jwild@luriehildrens.org</email>
    </contact>
    <investigator>
      <last_name>John Sarwark, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>John Grayhack, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Shriners Hospitals for Children - Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60707</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jennifer Schlotter</last_name>
      <email>jschottler@shrinenet.org</email>
    </contact>
    <investigator>
      <last_name>Purnendu Gupta, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Kim Hammerberg, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Michal Szczodry, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Riley's Hospital for Children at IU Healthcare</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Molly Moore</last_name>
      <email>momfreed@iupui.edu</email>
    </contact>
    <investigator>
      <last_name>Tyler Christman, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Iowa</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lori A Dolan, PhD</last_name>
      <phone>319-356-1075</phone>
      <email>lori-dolan@uiowa.edu</email>
    </contact>
    <investigator>
      <last_name>Stuart L Weinstein, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Lori A Dolan, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Joshua Holt, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gabrielle Reichard</last_name>
      <email>greicha1@jhmi.edu</email>
    </contact>
    <investigator>
      <last_name>Paul Sponseller, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Boston</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sydney Lee</last_name>
      <email>sydney.lee@childrens.harvard.edu</email>
    </contact>
    <investigator>
      <last_name>Timothy Hresko, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sahil Jha</last_name>
      <email>sahiljha@med.umich.edu</email>
    </contact>
    <investigator>
      <last_name>Ying Li, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Gillette Children's Specialty Healthcare</name>
      <address>
        <city>Saint Paul</city>
        <state>Minnesota</state>
        <zip>55101</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sara Morgan</last_name>
      <email>sarajmorgan@gillettechildrens.com</email>
    </contact>
    <investigator>
      <last_name>Daniel Miller, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Eduardo Beauchamp, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Tenner Guillaume, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Steven Koop, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Joseph Perra, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Walter Truong, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Children's Mercy Kansas City</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64108</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Julia Leamon</last_name>
      <email>jleamon@cmh.edu</email>
    </contact>
    <investigator>
      <last_name>Richard Schwend, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>John Anderson, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>St. Louis Children's Hospital/Washington University</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kirsten Brouillet</last_name>
      <email>kbrouillet@wustl.edu</email>
    </contact>
    <investigator>
      <last_name>Brian Kelly, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Scott Luhmann, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Morgan Stanley Children's Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Afrain Boby</last_name>
      <email>ab4789@cumc.columbia.edu</email>
    </contact>
    <investigator>
      <last_name>Benjamin Roye, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Michael Vitale, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Golisano Children's Hospital/University of Rochester</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Samantha Hoffman</last_name>
      <email>samantha_hoffman@urmc.rochester.edu</email>
    </contact>
    <investigator>
      <last_name>Susan Nelson, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Paul Rubery, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of North Carolina Chapel Hill</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27514</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Julie Titter</last_name>
      <email>julie_titter@med.unc.edu</email>
    </contact>
    <investigator>
      <last_name>James Sanders, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Doernbecher Children's Hospital / OHSU</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rebecca Smith</last_name>
      <email>smithreb@ohsu.edu</email>
    </contact>
    <investigator>
      <last_name>Matthew Halsey, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Scott Yang, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Shriners Hospitals for Children - Portland</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>David Louie</last_name>
      <email>david.louie@shrinenet.org</email>
    </contact>
    <investigator>
      <last_name>Michelle Welborn, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Daniel Bouton, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Leta Ashebo</last_name>
      <email>ashebol@chop.edu</email>
    </contact>
    <investigator>
      <last_name>Patrick Cahill, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Shriners Hospitals for Children - Philadelphia</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19140</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jason Woloff</last_name>
      <email>Jason.Woloff@shrinenet.org</email>
    </contact>
    <investigator>
      <last_name>Joshua Pahys, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Amir Samdani, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Pittsburgh</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15224</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Natalie Novak</last_name>
      <email>novakne@upmc.edu</email>
    </contact>
    <investigator>
      <last_name>Timothy Ward, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Patrick Bosch, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ozgur Dede, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Stephen Mendelson, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Campbell Clinic/Le Bonheur Children's Hospital</name>
      <address>
        <city>Germantown</city>
        <state>Tennessee</state>
        <zip>38138</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jonathan Rowland</last_name>
      <email>jrowland@uthsc.edu</email>
    </contact>
    <investigator>
      <last_name>Derek Kelly, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Brook Turner</last_name>
      <email>brooke.turner@vumc.org</email>
    </contact>
    <investigator>
      <last_name>Jeffrey Martus, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Gregory Mencio, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Texas Children's Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Callie Bridges</last_name>
      <email>csbridg2@texaschildrens.org</email>
    </contact>
    <investigator>
      <last_name>Brian Smith, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Benny Dahl, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Frank Gerow, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Darrell Hanson, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Virginia</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22903</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nancy McKnight</last_name>
      <email>hhz8fz@hscmail.mcc.virginia.eduginia.edu</email>
    </contact>
    <investigator>
      <last_name>Keith Bachmann, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Mark Abel, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Anuj Singla, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Seattle Children's Hospital</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98105</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Varakitsomboon Shing</last_name>
      <email>shing.varakitsomboon@seattlechildrens.org</email>
    </contact>
    <investigator>
      <last_name>Klane White, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nick Giebel</last_name>
      <email>ngiebel@mcw.edu</email>
    </contact>
    <investigator>
      <last_name>John Thometz, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Xue-Cheng Liu, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>British Columbia Children's Hospital</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6H 3N1</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Garshana Rajkumar</last_name>
      <email>garshana.rajkumar@cw.bc.ca</email>
    </contact>
    <contact_backup>
      <last_name>Sachini Jaysinghe</last_name>
      <email>sachini.jayasinghe1@cw.bc.ca</email>
    </contact_backup>
    <investigator>
      <last_name>Firoz Miyanji, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Christopher Reilly, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>IWK Health Centre</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3K 6R8</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Mandy Bouchard</last_name>
      <email>mandy.bouchard@iwk.nshealth.ca</email>
    </contact>
    <investigator>
      <last_name>Ron El-Hawary, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU Sainte-Justine</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H3T 1C5</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Isabelle Turgeon</last_name>
      <email>isabelle.turgeon.hsj@ssss.gouv.qc.ca</email>
    </contact>
    <investigator>
      <last_name>Stefan Parent, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Hong Kong</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Giselle Li</last_name>
      <email>gdli21@ortho.hku.hk</email>
    </contact>
    <investigator>
      <last_name>Kenneth Cheung, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jason Cheung, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Kenny Kwan, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Graham Shea, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Italian Scientific Spine Institute (ISICO)</name>
      <address>
        <city>Milano</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sabrina Donzelli</last_name>
      <email>sabrina.donzelli@isico.it</email>
    </contact>
    <investigator>
      <last_name>Stefano Negrini, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sabrina Donzelli, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Fabio Zaina, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Starship Child Health</name>
      <address>
        <city>Auckland</city>
        <country>New Zealand</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Emanuela Crua</last_name>
      <email>emanuela@abjs.co.nz</email>
    </contact>
    <investigator>
      <last_name>Haemish Crawford, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>National University Hospital</name>
      <address>
        <city>Singapore</city>
        <country>Singapore</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jeremy Chew</last_name>
      <email>Jeremy_JE_CHEW@nuhs.edu.sg</email>
    </contact>
    <investigator>
      <last_name>Hee Kit Wong, MBBS</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Loek Lim Lau, MBBS</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Acibadem Maslak Hospital</name>
      <address>
        <city>Istanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Tais Zulemyan</last_name>
      <email>tais.zulemyan@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Ahmet Alanay, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Yilgor Caglor, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Royal Orthopaedic Hospital</name>
      <address>
        <city>Birmingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Craig Pinner</last_name>
      <email>craig.pinner@nhs.net</email>
    </contact>
    <investigator>
      <last_name>Adrian Gardner, MB, FRCS</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Hong Kong</country>
    <country>Italy</country>
    <country>New Zealand</country>
    <country>Singapore</country>
    <country>Turkey</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>July 31, 2020</study_first_submitted>
  <study_first_submitted_qc>July 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>October 5, 2022</last_update_submitted>
  <last_update_submitted_qc>October 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Iowa</investigator_affiliation>
    <investigator_full_name>Stuart L. Weinstein, MD</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Cast</keyword>
  <keyword>Brace</keyword>
  <keyword>Spinal Orthosis</keyword>
  <keyword>Spinal Orthotic</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>Yes</sharing_ipd>
    <ipd_description>All study data (assessments and images) will reside in the Pediatric Spine Registry.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>after our planned analyses and publications are completed</ipd_time_frame>
    <ipd_access_criteria>Study data will be available to all CVBT investigators and Pediatric Spine Registry participants. Interested parties will prepare a proposal for consideration by the PI and the Pediatric Spine Study Group. If approved, the Pediatric Spine Registry staff will query the database and provide the required data for secondary analysis.</ipd_access_criteria>
  </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/NCT04500041
org study id: 00000
nct id: NCT04500041
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Comparison of casting and bracing for the treatment of idiopathic early onset scoliosis
This study uses a multicenter, prospective hybrid research design, which will combine two
      methods of treatment assignment (randomized and parent preference) and an embedded internal
      pilot study for sample size re-estimation. Patients will be treated either with serial casts
      or a full-time brace and followed until curve resolution, failure or palliation (neither
      resolution nor failure after 2 years of treatment). Results of this study will provide
      clinicians and families with evidence to support informed treatment decisions.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Treatment (casting or bracing) via randomized assignment OR based on family preference
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Study outcome is determined from serial radiographs. Radiographic readers will be blinded to the treatment assigned or received.
measure: Curve Response
time frame: on or before 24 months of treatment
description: Resolution - curve improvement to <15 degrees (as measured on 2 consecutive radiographs)
Failure
Initial Cobb 20-50° (inclusive): curve progression of ≥20° resulting in a curve ≥50°
Initial Cobb >50°: curve progression of ≥20°
Palliation - 2 years of treatment without resolution or failure
measure: Patient Health-related Quality of Life (HRQOL)
time frame: on or before 24 months of treatment
description: Evaluation of patients' HRQOL as estimated by serial administrations of the Early Onset Scoliosis Questionnaire (EOSQ-24, completed by the parent at baseline and every 6 months, total score range 0-100, higher scores indicate higher level of HRQOL). Within and between treatment arm comparisons will be made.
measure: Parent and Family Functioning
time frame: on or before 24 months of treatment
description: Evaluation of patients' disease and treatment on parent and family function as estimated by serial administrations of the PedsQL Family Impact Module scores (PedsQL FIM, completed by the parent, total score range 0-100, higher scores indicate less negative impact). Within and between treatment arm comparisons will be made.
arm group label: Casting
arm group type: Active Comparator
description: Subjects will be treated with serial casting
arm group label: Bracing
arm group type: Active Comparator
description: Subjects will be treated with full-time orthotics (braces)
intervention type: Procedure
intervention name: Casting
description: Use of casts applied using corrective maneuvers
arm group label: Casting
intervention type: Device
intervention name: Bracing
description: Use of full-time spinal orthosis
arm group label: Bracing
criteria: 
gender: All
minimum age: 12 Months
maximum age: 36 Months
healthy volunteers: No
last name: Stuart L Weinstein, MD
role: Principal Investigator
affiliation: University of Iowa
last name: Lori A Dolan, PhD
phone: 319-356-1075
email: lori-dolan@uiowa.edu
facility: 
status: Recruiting
contact: 
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status: Recruiting
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status: Recruiting
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status: Recruiting
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facility: 
status: Active, not recruiting
facility: 
status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
contact: 
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facility: 
status: Recruiting
contact: 
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investigator: 
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facility: 
status: Not yet recruiting
contact: 
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facility: 
status: Recruiting
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facility: 
status: Recruiting
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status: Not yet recruiting
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status: Recruiting
contact: 
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country: Canada
country: Hong Kong
country: Italy
country: New Zealand
country: Singapore
country: Turkey
country: United Kingdom
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Iowa
investigator full name: Stuart L. Weinstein, MD
investigator title: Professor
mesh term: Scoliosis
sharing ipd: Yes
ipd description: All study data (assessments and images) will reside in the Pediatric Spine Registry.
ipd info type: Study Protocol
ipd time frame: after our planned analyses and publications are completed
ipd access criteria: Study data will be available to all CVBT investigators and Pediatric Spine Registry participants. Interested parties will prepare a proposal for consideration by the PI and the Pediatric Spine Study Group. If approved, the Pediatric Spine Registry staff will query the database and provide the required data for secondary analysis.