<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/NCT03298256</url>
  </required_header>
  <id_info>
    <org_study_id>UW 15-493</org_study_id>
    <nct_id>NCT03298256</nct_id>
  </id_info>
  <brief_title>Three-dimensional Effects of Bracing in Adolescent Idiopathic Scoliosis</brief_title>
  <official_title>Three-dimensional Effects of Bracing in Adolescent Idiopathic Scoliosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Hong Kong</source>
  <oversight_info>
    <has_dmc>No</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>
      This study intends to investigate the three dimensional (3D) effect of bracing on the&#xD;
      adolescent idiopathic scoliosis (AIS). In particular, it will look at the relationship&#xD;
      between frontal deformity correction and changes in the sagittal profile and apical vertebral&#xD;
      rotation (AVR) during bracing. The investigators hypothesise that if the thoracic frontal&#xD;
      deformity can be controlled with bracing, there will be spontaneous correction of the&#xD;
      sagittal plane and rotation deformity through coupling.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Scoliosis is a 3D deformity of the spine with curvatures occurring in three planes.&#xD;
&#xD;
      The efficacy of bracing in correcting the frontal deformity is now well-accepted after the&#xD;
      Bracing in Adolescent Idiopathic Scoliosis Trial (BRAIST). Restoration of the sagittal&#xD;
      alignment is one of the fundamental goals in scoliosis treatment. The investigators have&#xD;
      previously demonstrated on fulcrum bending radiographs that there is coupling between the&#xD;
      frontal deformity, thoracic kyphosis and apical vertebral derotation. The investigators'&#xD;
      findings suggest that there may be natural coupling of the frontal and sagittal deformities&#xD;
      towards &quot;self-normalisation&quot; during correction of the curves. The effect of bracing on the&#xD;
      sagittal alignment and 3D deformity in scoliosis is currently not well-understood. If there&#xD;
      is a tendency for the natural curve behaviour to return towards a more normal sagittal&#xD;
      alignment, then bracing may exert a similar effect on the 3D profile. Understanding how the&#xD;
      3D deformity is affected by bracing allows further insight into curve progression and brace&#xD;
      effectiveness.&#xD;
&#xD;
      Few studies in the literature have addressed the sagittal profile and 3D correction by&#xD;
      bracing. Of those, the findings were based on vertebral reconstructions obtained from&#xD;
      CT-scan, finite element analysis modelling, or studying the changes in the rib cage rotation.&#xD;
      However, the investigators propose to measure the 3D profile using the modern EOS ® system,&#xD;
      which allows biplanar radiography and 3D calculations and a more accurate measurement of&#xD;
      vertebral wedging.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2015</start_date>
  <completion_date type="Actual">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">May 31, 2019</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>Compare change in three dimensional (3D) effect of bracing on the adolescent idiopathic scoliosis (AIS) using the EOS Imaging System</measure>
    <time_frame>Follow-up to 3 years</time_frame>
    <description>To compare change in full length, orthogonal anteroposterior and lateral X-rays in a standardised standing position after the brace is applied, and at intervals of no fewer than 6 months until the brace is weaned off, or if surgical intervention is required</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measure health-related quality of life outcome by the 22-item Scoliosis Research Society questionnaire (SRS-22) of patients with adolescent idiopathic scoliosis (AIS)</measure>
    <time_frame>Follow-up to 3 years</time_frame>
    <description>To compare change in the health-related quality of life outcome of patients with adolescent idiopathic scoliosis (AIS) by the 22-item Scoliosis Research Society questionnaire (SRS-22), with the minimum score of 22 to the maximum score of 110. Higher score means better health outcome</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">53</enrollment>
  <condition>Adolescent Idiopathic Scoliosis</condition>
  <arm_group>
    <arm_group_label>Lenke type 1 AIS</arm_group_label>
    <description>Patients will be given a new prescription for a custom made Boston type thoracic-lumbo- sacral-orthosis (TLSO) braces. All patients will undergo low dose biplanar X-rays using the EOS ® machine system.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>EOS X-rays</intervention_name>
    <description>Full length, orthogonal anteroposterior and lateral X-rays will be taken simultaneously in a standardised standing position, with arms folded anteriorly in 45 degrees . All radiographs will include C7 proximally and the femoral heads distally. 3D reconstruction of the spine can be performed. X-rays will be repeated after the brace is applied, and at intervals of no fewer than 6 months until the brace is weaned off, or if surgical intervention is required. Coronal, sagittal and axial parameters will be calculated from the reconstruction. 3D vertebral wedging will be calculated in the posterofrontal, sagittal and diagonal planes at the apex, 3 superior and 3 inferior vertebrae, as described by Scherrer et al. Changes in the pre- and post-bracing and follow-up parameters can be calculated.</description>
    <arm_group_label>Lenke type 1 AIS</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study will be conducted in the Department of Orthopaedics and Traumatology, The&#xD;
        University of Hong Kong.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -Diagnosis of Lenke type 1 AIS who fulfil the normal criteria for bracing&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  if the aetiology of the scoliosis is not idiopathic&#xD;
&#xD;
          -  does not belong to Lenke type 1&#xD;
&#xD;
          -  previous treatment with a brace&#xD;
&#xD;
          -  severe presentation requiring surgical intervention&#xD;
&#xD;
          -  unavailable for regular follow-up&#xD;
&#xD;
          -  parents are unable to give informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dr Kenny Kwan, BMBCh(Oxon)</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Hong Kong</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duchess of Kent Children's Hospital</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <reference>
    <citation>Weinstein SL, Dolan LA, Wright JG, Dobbs MB. Effects of bracing in adolescents with idiopathic scoliosis. N Engl J Med. 2013 Oct 17;369(16):1512-21. doi: 10.1056/NEJMoa1307337. Epub 2013 Sep 19.</citation>
    <PMID>24047455</PMID>
  </reference>
  <reference>
    <citation>Luk KD, Cheung WY, Wong Y, Cheung KM, Wong YW, Samartzis D. The predictive value of the fulcrum bending radiograph in spontaneous apical vertebral derotation in adolescent idiopathic scoliosis. Spine (Phila Pa 1976). 2012 Jul 1;37(15):E922-6. doi: 10.1097/BRS.0b013e31824f108f.</citation>
    <PMID>22744400</PMID>
  </reference>
  <reference>
    <citation>Luk KD, Vidyadhara S, Lu DS, Wong YW, Cheung WY, Cheung KM. Coupling between sagittal and frontal plane deformity correction in idiopathic thoracic scoliosis and its relationship with postoperative sagittal alignment. Spine (Phila Pa 1976). 2010 May 15;35(11):1158-64. doi: 10.1097/BRS.0b013e3181bb49f3.</citation>
    <PMID>20118836</PMID>
  </reference>
  <reference>
    <citation>Parent S, Labelle H, Skalli W, de Guise J. Vertebral wedging characteristic changes in scoliotic spines. Spine (Phila Pa 1976). 2004 Oct 15;29(20):E455-62. doi: 10.1097/01.brs.0000142430.65463.3a.</citation>
    <PMID>15480123</PMID>
  </reference>
  <reference>
    <citation>Masharawi Y, Salame K, Mirovsky Y, Peleg S, Dar G, Steinberg N, Hershkovitz I. Vertebral body shape variation in the thoracic and lumbar spine: characterization of its asymmetry and wedging. Clin Anat. 2008 Jan;21(1):46-54. doi: 10.1002/ca.20532.</citation>
    <PMID>17729333</PMID>
  </reference>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>September 25, 2017</study_first_submitted>
  <study_first_submitted_qc>September 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 2, 2017</study_first_posted>
  <last_update_submitted>May 21, 2022</last_update_submitted>
  <last_update_submitted_qc>May 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Dr. Kenny Kwan</investigator_full_name>
    <investigator_title>Clinical Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>AIS</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/NCT03298256
org study id: UW 15-493
nct id: NCT03298256
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study intends to investigate the three dimensional (3D) effect of bracing on the
      adolescent idiopathic scoliosis (AIS). In particular, it will look at the relationship
      between frontal deformity correction and changes in the sagittal profile and apical vertebral
      rotation (AVR) during bracing. The investigators hypothesise that if the thoracic frontal
      deformity can be controlled with bracing, there will be spontaneous correction of the
      sagittal plane and rotation deformity through coupling.
Scoliosis is a 3D deformity of the spine with curvatures occurring in three planes.

      The efficacy of bracing in correcting the frontal deformity is now well-accepted after the
      Bracing in Adolescent Idiopathic Scoliosis Trial (BRAIST). Restoration of the sagittal
      alignment is one of the fundamental goals in scoliosis treatment. The investigators have
      previously demonstrated on fulcrum bending radiographs that there is coupling between the
      frontal deformity, thoracic kyphosis and apical vertebral derotation. The investigators'
      findings suggest that there may be natural coupling of the frontal and sagittal deformities
      towards "self-normalisation" during correction of the curves. The effect of bracing on the
      sagittal alignment and 3D deformity in scoliosis is currently not well-understood. If there
      is a tendency for the natural curve behaviour to return towards a more normal sagittal
      alignment, then bracing may exert a similar effect on the 3D profile. Understanding how the
      3D deformity is affected by bracing allows further insight into curve progression and brace
      effectiveness.

      Few studies in the literature have addressed the sagittal profile and 3D correction by
      bracing. Of those, the findings were based on vertebral reconstructions obtained from
      CT-scan, finite element analysis modelling, or studying the changes in the rib cage rotation.
      However, the investigators propose to measure the 3D profile using the modern EOS ® system,
      which allows biplanar radiography and 3D calculations and a more accurate measurement of
      vertebral wedging.
observational model: Cohort
time perspective: Prospective
measure: Compare change in three dimensional (3D) effect of bracing on the adolescent idiopathic scoliosis (AIS) using the EOS Imaging System
time frame: Follow-up to 3 years
description: To compare change in full length, orthogonal anteroposterior and lateral X-rays in a standardised standing position after the brace is applied, and at intervals of no fewer than 6 months until the brace is weaned off, or if surgical intervention is required
measure: Measure health-related quality of life outcome by the 22-item Scoliosis Research Society questionnaire (SRS-22) of patients with adolescent idiopathic scoliosis (AIS)
time frame: Follow-up to 3 years
description: To compare change in the health-related quality of life outcome of patients with adolescent idiopathic scoliosis (AIS) by the 22-item Scoliosis Research Society questionnaire (SRS-22), with the minimum score of 22 to the maximum score of 110. Higher score means better health outcome
arm group label: Lenke type 1 AIS
description: Patients will be given a new prescription for a custom made Boston type thoracic-lumbo- sacral-orthosis (TLSO) braces. All patients will undergo low dose biplanar X-rays using the EOS ® machine system.
intervention type: Radiation
intervention name: EOS X-rays
description: Full length, orthogonal anteroposterior and lateral X-rays will be taken simultaneously in a standardised standing position, with arms folded anteriorly in 45 degrees . All radiographs will include C7 proximally and the femoral heads distally. 3D reconstruction of the spine can be performed. X-rays will be repeated after the brace is applied, and at intervals of no fewer than 6 months until the brace is weaned off, or if surgical intervention is required. Coronal, sagittal and axial parameters will be calculated from the reconstruction. 3D vertebral wedging will be calculated in the posterofrontal, sagittal and diagonal planes at the apex, 3 superior and 3 inferior vertebrae, as described by Scherrer et al. Changes in the pre- and post-bracing and follow-up parameters can be calculated.
arm group label: Lenke type 1 AIS
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 10 Years
maximum age: 14 Years
healthy volunteers: No
last name: Dr Kenny Kwan, BMBCh(Oxon)
role: Principal Investigator
affiliation: The University of Hong Kong
facility: 
country: Hong Kong
citation: Weinstein SL, Dolan LA, Wright JG, Dobbs MB. Effects of bracing in adolescents with idiopathic scoliosis. N Engl J Med. 2013 Oct 17;369(16):1512-21. doi: 10.1056/NEJMoa1307337. Epub 2013 Sep 19.
PMID: 24047455
citation: Luk KD, Cheung WY, Wong Y, Cheung KM, Wong YW, Samartzis D. The predictive value of the fulcrum bending radiograph in spontaneous apical vertebral derotation in adolescent idiopathic scoliosis. Spine (Phila Pa 1976). 2012 Jul 1;37(15):E922-6. doi: 10.1097/BRS.0b013e31824f108f.
PMID: 22744400
citation: Luk KD, Vidyadhara S, Lu DS, Wong YW, Cheung WY, Cheung KM. Coupling between sagittal and frontal plane deformity correction in idiopathic thoracic scoliosis and its relationship with postoperative sagittal alignment. Spine (Phila Pa 1976). 2010 May 15;35(11):1158-64. doi: 10.1097/BRS.0b013e3181bb49f3.
PMID: 20118836
citation: Parent S, Labelle H, Skalli W, de Guise J. Vertebral wedging characteristic changes in scoliotic spines. Spine (Phila Pa 1976). 2004 Oct 15;29(20):E455-62. doi: 10.1097/01.brs.0000142430.65463.3a.
PMID: 15480123
citation: Masharawi Y, Salame K, Mirovsky Y, Peleg S, Dar G, Steinberg N, Hershkovitz I. Vertebral body shape variation in the thoracic and lumbar spine: characterization of its asymmetry and wedging. Clin Anat. 2008 Jan;21(1):46-54. doi: 10.1002/ca.20532.
PMID: 17729333
responsible party type: Principal Investigator
investigator affiliation: The University of Hong Kong
investigator full name: Dr. Kenny Kwan
investigator title: Clinical Assistant Professor
mesh term: Scoliosis
sharing ipd: No