<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/NCT01661959</url>
  </required_header>
  <id_info>
    <org_study_id>2007HSGAIS</org_study_id>
    <nct_id>NCT01661959</nct_id>
  </id_info>
  <brief_title>Adolescent Idiopathic Scoliosis Outcomes Database Registry</brief_title>
  <acronym>AIS</acronym>
  <official_title>Scoliosis Outcomes Database Registry</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>
    <collaborator>
      <agency>NuVasive</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 analyze the long-term outcomes of surgical treatment of&#xD;
      idiopathic scoliosis of all curve patterns treated by either anterior or posterior&#xD;
      procedures. In addition, to analyze the long-term outcomes of non-operative idiopathic&#xD;
      scoliosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. The first aim of this Database Registry is to maintain a prospective multicenter series&#xD;
           of patients treated surgically for adolescent idiopathic scoliosis. Patients from&#xD;
           multiple scoliosis centers around the U.S., as well as a center in Germany, will be&#xD;
           enrolled with comprehensive analysis of the curve pattern being treated, as well as the&#xD;
           type of surgery performed. The outcome of each surgical treatment will be analyzed. This&#xD;
           will allow the frequency of various curve types to be determined, as well as the&#xD;
           frequency of various surgical approaches utilized for each curve pattern.&#xD;
&#xD;
        2. The second aim is to determine if operative outcomes vary based on the surgical approach&#xD;
           utilized in scoliosis correction. In this analysis, it is anticipated that specific&#xD;
           approaches can be identified to be most appropriate for given scoliotic curve patterns.&#xD;
           In addition, the variations within individual curve patterns will be analyzed, as will&#xD;
           specific variations in the surgical approach (e.g., distal level of instrumentation,&#xD;
           hooks versus screws, hook patterns, etc).&#xD;
&#xD;
        3. The third aim is to develop an algorithm to guide surgical decision making based on a&#xD;
           scoliosis curve classification scheme that will allow the surgeon to provide the best&#xD;
           overall outcome (radiographic, functional, cosmetic) for a given patient with idiopathic&#xD;
           scoliosis.&#xD;
&#xD;
        4. The fourth aim is to evaluate the long-term outcomes of surgical intervention in this&#xD;
           patient population.&#xD;
&#xD;
        5. The fifth aim is to maintain a prospective multi-center series of patients with&#xD;
           idiopathic scoliosis who have not undergone surgical correction of their deformity. The&#xD;
           long-term outcome of this patient population will be compared with the surgical patient&#xD;
           population.&#xD;
&#xD;
        6. The sixth aim is to develop a guide to help clinicians make a decision for optimal&#xD;
           surgical treatment of AIS curves based on patient-specific 3D information.&#xD;
&#xD;
        7. Factors that may influence intra and post-operative course will also be evaluated. Of&#xD;
           particular interest are patient specific factors (curve size, pre op characteristics&#xD;
           such as blood work and PFT testing) and their influence on intra-operative blood loss.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date>January 2005</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Anticipated">December 2025</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>Change in radiographic outcome for surgical treatment of idiopathic scoliosis.</measure>
    <time_frame>25 years</time_frame>
    <description>Patients are followed up to 25 years post-op.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in clinical outcomes for surgical treatment of idiopathic scoliosis.</measure>
    <time_frame>25 years</time_frame>
    <description>Patients are followed up to 25 years post-op</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">10000</enrollment>
  <condition>Adolescent Idiopathic Scoliosis</condition>
  <arm_group>
    <arm_group_label>Non-Operative</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Operative</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 aged ≥ 10 and ≤ 21 years at time of enrollment,&#xD;
&#xD;
          -  male or female,&#xD;
&#xD;
          -  diagnosis of idiopathic scoliosis for which surgery is recommended to prevent&#xD;
             progression of the curvature or to correct trunk disfigurement.&#xD;
&#xD;
          -  Curve cobb of any magnitude - operative range&#xD;
&#xD;
          -  Spina bifida Oculta is permitted&#xD;
&#xD;
          -  Spondylolisthesis and Spondylolysis are permitted, as long as non-operative&#xD;
&#xD;
          -  Non-operative idiopathic scoliosis patients:&#xD;
&#xD;
               -  aged ≥ 10 and ≤ 21 years, male or female, curve cobb of ≥ 40º, for whom surgery&#xD;
                  has been offered and the patient has elected not to proceed with surgery.&#xD;
&#xD;
        OR&#xD;
&#xD;
        - OPTIONAL BY SITE: aged ≥ 10 and ≤ 21 years, male or female, Curve cobb ≥ 30º and&#xD;
        skeletally mature (with maturity defined as Age: girls &gt; 14 yrs; Boys &gt; 16 yrs and Risser&#xD;
        of ≥ 4 Plus one of the following: Girls 2+ yrs post menarchal, boys shaving regularly, no&#xD;
        height change in at least 6 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior spinal surgery&#xD;
&#xD;
          -  MRI abnormalities (including &gt; 4mm of Syrinx and/or Chiari malformation)&#xD;
&#xD;
          -  Neuromuscular or other serious co-morbidities&#xD;
&#xD;
          -  Thoracogenic or cardiogenic scoliosis&#xD;
&#xD;
          -  Associated syndrome or developmental delay&#xD;
&#xD;
          -  Unable or unwilling to firmly commit to returning for required follow-up visits&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter O Newton, MD</last_name>
    <role>Principal Investigator</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>Nemours Children's Clinic</name>
      <address>
        <city>Wilmington</city>
        <state>Delaware</state>
        <zip>19803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Miami Children's Hospital</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33155</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>John's Hopkins Medical Institute</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boston Children's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington Univ., St. Louis</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Physicians</name>
      <address>
        <city>Camden</city>
        <state>New Jersey</state>
        <zip>08103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Scoliosis Associates</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cincinnati Children's Hospital, Cincinnati, OH</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cincinnati Children's Hospital</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Childrens Hospital of Philadelphia</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</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>
    <facility>
      <name>CHU Saint-Justine Hospital</name>
      <address>
        <city>Montreal</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>British Columbia Children's Hospital</name>
      <address>
        <city>Vancouver</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Germany</country>
  </removed_countries>
  <link>
    <url>http://www.hsg.settingscoliosisstraight.org</url>
    <description>Harms Study Group</description>
  </link>
  <verification_date>April 2022</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>April 26, 2022</last_update_submitted>
  <last_update_submitted_qc>April 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Scoliosis</keyword>
  <keyword>Multi-center Database Registry</keyword>
  <keyword>Spinal Deformity</keyword>
  <keyword>Adolescent Idiopathic Scoliosis</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/NCT01661959
org study id: 2007HSGAIS
nct id: NCT01661959
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this study is to analyze the long-term outcomes of surgical treatment of
      idiopathic scoliosis of all curve patterns treated by either anterior or posterior
      procedures. In addition, to analyze the long-term outcomes of non-operative idiopathic
      scoliosis.
1. The first aim of this Database Registry is to maintain a prospective multicenter series
           of patients treated surgically for adolescent idiopathic scoliosis. Patients from
           multiple scoliosis centers around the U.S., as well as a center in Germany, will be
           enrolled with comprehensive analysis of the curve pattern being treated, as well as the
           type of surgery performed. The outcome of each surgical treatment will be analyzed. This
           will allow the frequency of various curve types to be determined, as well as the
           frequency of various surgical approaches utilized for each curve pattern.

        2. The second aim is to determine if operative outcomes vary based on the surgical approach
           utilized in scoliosis correction. In this analysis, it is anticipated that specific
           approaches can be identified to be most appropriate for given scoliotic curve patterns.
           In addition, the variations within individual curve patterns will be analyzed, as will
           specific variations in the surgical approach (e.g., distal level of instrumentation,
           hooks versus screws, hook patterns, etc).

        3. The third aim is to develop an algorithm to guide surgical decision making based on a
           scoliosis curve classification scheme that will allow the surgeon to provide the best
           overall outcome (radiographic, functional, cosmetic) for a given patient with idiopathic
           scoliosis.

        4. The fourth aim is to evaluate the long-term outcomes of surgical intervention in this
           patient population.

        5. The fifth aim is to maintain a prospective multi-center series of patients with
           idiopathic scoliosis who have not undergone surgical correction of their deformity. The
           long-term outcome of this patient population will be compared with the surgical patient
           population.

        6. The sixth aim is to develop a guide to help clinicians make a decision for optimal
           surgical treatment of AIS curves based on patient-specific 3D information.

        7. Factors that may influence intra and post-operative course will also be evaluated. Of
           particular interest are patient specific factors (curve size, pre op characteristics
           such as blood work and PFT testing) and their influence on intra-operative blood loss.
observational model: Case-Control
time perspective: Prospective
measure: Change in radiographic outcome for surgical treatment of idiopathic scoliosis.
time frame: 25 years
description: Patients are followed up to 25 years post-op.
measure: Change in clinical outcomes for surgical treatment of idiopathic scoliosis.
time frame: 25 years
description: Patients are followed up to 25 years post-op
arm group label: Non-Operative
arm group label: Operative
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 10 Years
maximum age: 21 Years
healthy volunteers: No
last name: Peter O Newton, MD
role: Principal Investigator
affiliation: Rady Children's Hospital San Deigo
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
country: United States
country: Germany
url: http://www.hsg.settingscoliosisstraight.org
description: Harms Study Group
responsible party type: Sponsor
mesh term: Scoliosis