<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/NCT03296228</url>
  </required_header>
  <id_info>
    <org_study_id>UW 16-208</org_study_id>
    <nct_id>NCT03296228</nct_id>
  </id_info>
  <brief_title>Comparison of Dynamic Radiographs in Determining Fusion Level in Adolescent Idiopathic Scoliosis Correction</brief_title>
  <official_title>Comparison of Dynamic Radiographs in Determining Fusion Level in Adolescent Idiopathic Scoliosis Correction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AO Foundation, AO Spine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </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>
      The purpose of this study is to identify the flexibility radiograph(s) that can most&#xD;
      accurately predict the curve behaviour after surgical correction of AIS. With these findings,&#xD;
      the investigators hope to give further guidance for the selection of fusion levels and to&#xD;
      incorporate different dynamic radiographs into the Lenke Classification, leading to a more&#xD;
      universal application that can consistently lead to good surgical and clinical outcome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Lenke Classification is the most widely-accepted classification for Adolescent Idiopathic&#xD;
      Scoliosis (AIS) in the world. Its recommendations for fusion of the minor curves depend on&#xD;
      its structurality. It defines a minor curve as structural if there is inflexibility on&#xD;
      side-bending more than 25 . However, a recent Delphi survey from a panel of experts in AIS&#xD;
      management showed that there was no consensus as to which type of dynamic radiograph was&#xD;
      optimal. Up to two thirds of the surgeons did not use side-bending as a routine, and hence&#xD;
      they cannot apply the Lenke Classification accurately in clinical practice nor follow its&#xD;
      recommendations for fusion.&#xD;
&#xD;
      Furthermore, the current classification does not give specific recommendations regarding the&#xD;
      selection of fusion levels and does not take into account the clinical appearance of the&#xD;
      patients which impact on treatment. Consequently, there are still controversies regarding the&#xD;
      Upper Instrumented Vertebra (UIV) and Lowest Instrumented Vertebra (LIV) selections, and&#xD;
      following the recommendations may not allow fusion of the least number of segments nor give&#xD;
      best clinical results eg shoulder balance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2016</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">May 1, 2018</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>Investigate the flexibility equivalence of different bending methods, and their predictability of the final outcome</measure>
    <time_frame>6 months to 9 months</time_frame>
    <description>To investigate the flexibility equivalence of different bending methods: supine side-bending, fulcrum bending (FB) and supine Halter traction without GA (awake), and their predictability of the final outcome</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incorporate these findings into the Lenke Classification of AIS</measure>
    <time_frame>6 months to 9 months</time_frame>
    <description>To incorporate these findings into the Lenke Classification of AIS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Give new recommendations for fusion levels according to the flexibility assessment</measure>
    <time_frame>6 months to 9 months</time_frame>
    <description>To give new recommendations for fusion levels according to the flexibility assessment</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">134</enrollment>
  <condition>Adolescent Idiopathic Scoliosis</condition>
  <arm_group>
    <arm_group_label>Hong Kong</arm_group_label>
    <description>Radiation: Flexibility Radiographs (supine, supine side-bend, FB)&#xD;
supine side-bending and fulcrum bending films</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Turkey</arm_group_label>
    <description>Radiation: Flexibility Radiographs (supine, supine side-bend, FB)&#xD;
Radiation: Flexibility Radiographs (awake traction)&#xD;
Radiation: Flexibility Radiographs (STUGA)&#xD;
supine side-bending, fulcrum bending films, awake traction and supine traction under GA</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Flexibility Radiographs (supine, supine side-bend, FB)</intervention_name>
    <description>Supine, supine side-bend, fulcrum bend</description>
    <arm_group_label>Hong Kong</arm_group_label>
    <arm_group_label>Turkey</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Flexibility Radiographs (awake traction)</intervention_name>
    <description>awake traction</description>
    <arm_group_label>Turkey</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Flexibility Radiographs (STUGA)</intervention_name>
    <description>supine traction under GA</description>
    <arm_group_label>Turkey</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study will be divided into two phases. In Phase 1, an exploratory pilot study will be&#xD;
        performed with up to 3 flexibility films done on the same patient in different spinal&#xD;
        centres which are in Hong Kong and Turkey.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients diagnosed with AIS who reach the threshold for surgical correction.&#xD;
&#xD;
          -  Patients aged 10 to 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Neuromuscular deformity&#xD;
&#xD;
          -  Prior fusion or spine surgery&#xD;
&#xD;
          -  Spinal tumor diagnosis&#xD;
&#xD;
          -  Congenital anomalies&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>18 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>Hamzaoglu A, Talu U, Tezer M, Mirzanli C, Domanic U, Goksan SB. Assessment of curve flexibility in adolescent idiopathic scoliosis. Spine (Phila Pa 1976). 2005 Jul 15;30(14):1637-42. doi: 10.1097/01.brs.0000170580.92177.d2.</citation>
    <PMID>16025034</PMID>
  </reference>
  <reference>
    <citation>Clements DH, Marks M, Newton PO, Betz RR, Lenke L, Shufflebarger H; Harms Study Group. Did the Lenke classification change scoliosis treatment? Spine (Phila Pa 1976). 2011 Jun 15;36(14):1142-5. doi: 10.1097/BRS.0b013e318207e9c4.</citation>
    <PMID>21358471</PMID>
  </reference>
  <reference>
    <citation>Cheh G, Lenke LG, Lehman RA Jr, Kim YJ, Nunley R, Bridwell KH. The reliability of preoperative supine radiographs to predict the amount of curve flexibility in adolescent idiopathic scoliosis. Spine (Phila Pa 1976). 2007 Nov 15;32(24):2668-72. doi: 10.1097/BRS.0b013e31815a5269.</citation>
    <PMID>18007242</PMID>
  </reference>
  <reference>
    <citation>Lenke LG, Betz RR, Harms J, Bridwell KH, Clements DH, Lowe TG, Blanke K. Adolescent idiopathic scoliosis: a new classification to determine extent of spinal arthrodesis. J Bone Joint Surg Am. 2001 Aug;83(8):1169-81.</citation>
    <PMID>11507125</PMID>
  </reference>
  <reference>
    <citation>Chow SC, Shao J, Wang H. Sample Size Calculations in Clinical Research. 2003. Marcel Dekker, New York</citation>
  </reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>September 22, 2017</study_first_submitted>
  <study_first_submitted_qc>September 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <last_update_submitted>May 5, 2020</last_update_submitted>
  <last_update_submitted_qc>May 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2020</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/NCT03296228
org study id: UW 16-208
nct id: NCT03296228
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to identify the flexibility radiograph(s) that can most
      accurately predict the curve behaviour after surgical correction of AIS. With these findings,
      the investigators hope to give further guidance for the selection of fusion levels and to
      incorporate different dynamic radiographs into the Lenke Classification, leading to a more
      universal application that can consistently lead to good surgical and clinical outcome.
The Lenke Classification is the most widely-accepted classification for Adolescent Idiopathic
      Scoliosis (AIS) in the world. Its recommendations for fusion of the minor curves depend on
      its structurality. It defines a minor curve as structural if there is inflexibility on
      side-bending more than 25 . However, a recent Delphi survey from a panel of experts in AIS
      management showed that there was no consensus as to which type of dynamic radiograph was
      optimal. Up to two thirds of the surgeons did not use side-bending as a routine, and hence
      they cannot apply the Lenke Classification accurately in clinical practice nor follow its
      recommendations for fusion.

      Furthermore, the current classification does not give specific recommendations regarding the
      selection of fusion levels and does not take into account the clinical appearance of the
      patients which impact on treatment. Consequently, there are still controversies regarding the
      Upper Instrumented Vertebra (UIV) and Lowest Instrumented Vertebra (LIV) selections, and
      following the recommendations may not allow fusion of the least number of segments nor give
      best clinical results eg shoulder balance.
observational model: Cohort
time perspective: Prospective
measure: Investigate the flexibility equivalence of different bending methods, and their predictability of the final outcome
time frame: 6 months to 9 months
description: To investigate the flexibility equivalence of different bending methods: supine side-bending, fulcrum bending (FB) and supine Halter traction without GA (awake), and their predictability of the final outcome
measure: Incorporate these findings into the Lenke Classification of AIS
time frame: 6 months to 9 months
description: To incorporate these findings into the Lenke Classification of AIS
measure: Give new recommendations for fusion levels according to the flexibility assessment
time frame: 6 months to 9 months
description: To give new recommendations for fusion levels according to the flexibility assessment
arm group label: Hong Kong
description: Radiation: Flexibility Radiographs (supine, supine side-bend, FB)
supine side-bending and fulcrum bending films
arm group label: Turkey
description: Radiation: Flexibility Radiographs (supine, supine side-bend, FB)
Radiation: Flexibility Radiographs (awake traction)
Radiation: Flexibility Radiographs (STUGA)
supine side-bending, fulcrum bending films, awake traction and supine traction under GA
intervention type: Radiation
intervention name: Flexibility Radiographs (supine, supine side-bend, FB)
description: Supine, supine side-bend, fulcrum bend
arm group label: Hong Kong
arm group label: Turkey
intervention type: Radiation
intervention name: Flexibility Radiographs (awake traction)
description: awake traction
arm group label: Turkey
intervention type: Radiation
intervention name: Flexibility Radiographs (STUGA)
description: supine traction under GA
arm group label: Turkey
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 10 Years
maximum age: 18 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: Hamzaoglu A, Talu U, Tezer M, Mirzanli C, Domanic U, Goksan SB. Assessment of curve flexibility in adolescent idiopathic scoliosis. Spine (Phila Pa 1976). 2005 Jul 15;30(14):1637-42. doi: 10.1097/01.brs.0000170580.92177.d2.
PMID: 16025034
citation: Clements DH, Marks M, Newton PO, Betz RR, Lenke L, Shufflebarger H; Harms Study Group. Did the Lenke classification change scoliosis treatment? Spine (Phila Pa 1976). 2011 Jun 15;36(14):1142-5. doi: 10.1097/BRS.0b013e318207e9c4.
PMID: 21358471
citation: Cheh G, Lenke LG, Lehman RA Jr, Kim YJ, Nunley R, Bridwell KH. The reliability of preoperative supine radiographs to predict the amount of curve flexibility in adolescent idiopathic scoliosis. Spine (Phila Pa 1976). 2007 Nov 15;32(24):2668-72. doi: 10.1097/BRS.0b013e31815a5269.
PMID: 18007242
citation: Lenke LG, Betz RR, Harms J, Bridwell KH, Clements DH, Lowe TG, Blanke K. Adolescent idiopathic scoliosis: a new classification to determine extent of spinal arthrodesis. J Bone Joint Surg Am. 2001 Aug;83(8):1169-81.
PMID: 11507125
citation: Chow SC, Shao J, Wang H. Sample Size Calculations in Clinical Research. 2003. Marcel Dekker, New York
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