<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/NCT01661998</url>
  </required_header>
  <id_info>
    <org_study_id>2009HSGF05</org_study_id>
    <nct_id>NCT01661998</nct_id>
  </id_info>
  <brief_title>Prospective Study of Motion Preservation Evaluation Below Fusions of the Spine in Adolescent Idiopathic Scoliosis</brief_title>
  <acronym>POM</acronym>
  <official_title>Motion Preservation Evaluation Below Fusions of the Spine in Adolescent Idiopathic Scoliosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Setting Scoliosis Straight Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>DePuy Spine</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Setting Scoliosis Straight Foundation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the relationship of A) The distal fusion level B)&#xD;
      The total length of fusion and the post-operative range of motion in the unfused vertebral&#xD;
      segments below the fusion in patients with Adolescent Idiopathic Scoliosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The motion behavior in the unfused segments of the spine following instrumentation is poorly&#xD;
      understood and the implications of hyper or hypo-mobility have not been clearly defined. The&#xD;
      purpose of this study is to evaluate the relationship of A) The distal fusion level B) The&#xD;
      total length of fusion and the post-operative range of motion in the unfused vertebral&#xD;
      segments below the fusion in patients with Adolescent Idiopathic Scoliosis to answer the&#xD;
      following specific clinical questions:&#xD;
&#xD;
        1. Further elucidate the motion behavior of the distal unfused spinal segments,&#xD;
           specifically:&#xD;
&#xD;
             1. Does motion differ at various post-operative time points (2 year post-op patients&#xD;
                versus 5 or 10 year post-op patients)?&#xD;
&#xD;
             2. Can predictive factors be identified with post-operative altered motion?&#xD;
&#xD;
        2. Further elucidate the relationship of the motion in the unfused spinal segments to the&#xD;
           lowest instrumented vertebrae.&#xD;
&#xD;
        3. Determine the relationship of the total length of fusion to the motion in the unfused&#xD;
           spinal segments (i.e. compare unfused motion in the distal unfused segments in Lenke 5/6&#xD;
           patients fused selectively (ThL/L only) versus nonselectively (TH and ThL/L)).&#xD;
&#xD;
        4. Determine the relationship between clinical examinations (i.e. reports of pain or&#xD;
           functional limitations) and patient reported outcomes (Health Related Quality of Life&#xD;
           Outcome Tools) to motion in the distal unfused segments.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2008</start_date>
  <completion_date type="Actual">December 2019</completion_date>
  <primary_completion_date type="Actual">December 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate post-operative range of motion in the unfused vertebral segments below the fusion in patients with Adolescent Idiopathic Scoliosis. Range of motion is assessed by side-bending to the left and to the right as well as bending forward.</measure>
    <time_frame>10 years</time_frame>
    <description>Data collected at patients 10 years visit.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">273</enrollment>
  <condition>Adolescent Idiopathic Scoliosis</condition>
  <arm_group>
    <arm_group_label>Harms Study Group</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who present to the investigator's clinic, who meet the inclusion criteria will be&#xD;
        offered enrollment in the study&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients presenting to the primary and co-investigator's facilities will be offered&#xD;
             inclusion into the study if they meet the following inclusion criteria:&#xD;
&#xD;
               -  Patient age &lt; 21 years&#xD;
&#xD;
               -  Male or female&#xD;
&#xD;
               -  Diagnosis of Adolescent Idiopathic Scoliosis&#xD;
&#xD;
               -  Any Lenke Classification type&#xD;
&#xD;
               -  Underwent surgical correction of the spinal deformity with a fusion&#xD;
&#xD;
               -  Are due for their 10 year post-operative visit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients will be excluded from study inclusion if they meet the following exclusion&#xD;
             criteria:&#xD;
&#xD;
               -  Neuromuscular co-morbidity&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter Newton, MD</last_name>
    <role>Study Director</role>
    <affiliation>Rady Children's Hospital San Deigo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rady Children's Hospital</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Scoliosis Associates &amp; NYU Hospital for Joint Diseases</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shriners Hospital for Children</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19140</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Canada</country>
  </removed_countries>
  <link>
    <url>http://hsg.settingscoliosisstraight.org/current-hsg-research/</url>
    <description>Setting Scoliosis Straight Website - highlighting the research of the Harms Study Group</description>
  </link>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>July 10, 2012</study_first_submitted>
  <study_first_submitted_qc>August 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 10, 2012</study_first_posted>
  <last_update_submitted>March 16, 2020</last_update_submitted>
  <last_update_submitted_qc>March 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Adolescent Idiopathic Scoliosis</keyword>
  <keyword>Spinal Deformity</keyword>
  <keyword>Treatment Outcomes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Scoliosis</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/NCT01661998
org study id: 2009HSGF05
nct id: NCT01661998
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to evaluate the relationship of A) The distal fusion level B)
      The total length of fusion and the post-operative range of motion in the unfused vertebral
      segments below the fusion in patients with Adolescent Idiopathic Scoliosis.
The motion behavior in the unfused segments of the spine following instrumentation is poorly
      understood and the implications of hyper or hypo-mobility have not been clearly defined. The
      purpose of this study is to evaluate the relationship of A) The distal fusion level B) The
      total length of fusion and the post-operative range of motion in the unfused vertebral
      segments below the fusion in patients with Adolescent Idiopathic Scoliosis to answer the
      following specific clinical questions:

        1. Further elucidate the motion behavior of the distal unfused spinal segments,
           specifically:

             1. Does motion differ at various post-operative time points (2 year post-op patients
                versus 5 or 10 year post-op patients)?

             2. Can predictive factors be identified with post-operative altered motion?

        2. Further elucidate the relationship of the motion in the unfused spinal segments to the
           lowest instrumented vertebrae.

        3. Determine the relationship of the total length of fusion to the motion in the unfused
           spinal segments (i.e. compare unfused motion in the distal unfused segments in Lenke 5/6
           patients fused selectively (ThL/L only) versus nonselectively (TH and ThL/L)).

        4. Determine the relationship between clinical examinations (i.e. reports of pain or
           functional limitations) and patient reported outcomes (Health Related Quality of Life
           Outcome Tools) to motion in the distal unfused segments.
observational model: Case-Control
time perspective: Prospective
measure: Evaluate post-operative range of motion in the unfused vertebral segments below the fusion in patients with Adolescent Idiopathic Scoliosis. Range of motion is assessed by side-bending to the left and to the right as well as bending forward.
time frame: 10 years
description: Data collected at patients 10 years visit.
arm group label: Harms Study Group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 21 Years
healthy volunteers: No
last name: Peter Newton, MD
role: Study Director
affiliation: Rady Children's Hospital San Deigo
facility: 
facility: 
facility: 
country: United States
country: Canada
url: http://hsg.settingscoliosisstraight.org/current-hsg-research/
description: Setting Scoliosis Straight Website - highlighting the research of the Harms Study Group
responsible party type: Sponsor
mesh term: Scoliosis