<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/NCT02227537</url>
  </required_header>
  <id_info>
    <org_study_id>OG12-04-13</org_study_id>
    <nct_id>NCT02227537</nct_id>
  </id_info>
  <brief_title>Evaluation of the Providence Nighttime Brace for the Treatment of Adolescence Idiopathic Scoliosis</brief_title>
  <official_title>Evaluation of the Providence Nighttime Brace for the Treatment of Adolescence Idiopathic Scoliosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>OrthoGeorgia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>OrthoGeorgia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A multicenter, prospective, non-randomized, single-arm observational study evaluating the&#xD;
      Providence nighttime bracing system in patients diagnosed with adolescence idiopathic&#xD;
      scoliosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is designed as a multicenter, prospective, non-randomized, single arm&#xD;
      observational study. A temperature probe and data logger will be attached to the Providence&#xD;
      brace to monitor patient compliance wear time. Subjects will be blinded to temperature sensor&#xD;
      readings to maximize objectivity of brace wear.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">August 2016</completion_date>
  <primary_completion_date type="Anticipated">August 2016</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>Curve progression</measure>
    <time_frame>subjects will be followed up for a period of 24 months from their first visit after receiving the Providence nighttime bracing system</time_frame>
    <description>The percentage of patients who have ≤5o curve progression and the percentage of patients who have ≥6 o progression at maturity;&#xD;
The percentage of patients with curves exceeding 45o at maturity and the percentage who have had surgery recommended/undergone;&#xD;
2 year follow-up beyond maturity to determine the percentage of patients who subsequently undergo surgery.&#xD;
Routine follow-up visits will be scheduled 6 months apart (1st visit after brace fitting, 6, 12, 18 and 24 months) up to 24 months. At each of these visits, the patient will undergo a history &amp; physical, PA radiographs, Cobb Angle assessment, Adams Forward Bending test, Neurological examination, outcome questionnaire's, concomitant medications, and adverse event recordings.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Compliance</measure>
    <time_frame>subjects will be followed up for a period of 24 months from their first visit after receiving the Providence nighttime bracing system</time_frame>
    <description>A temperature data logger will record and monitor patient compliance of brace wear. To not create undue awareness to these recordings patients will be informed the temperature readings are being monitored for patient comfort and ease of brace wear. Reconciliation of data logger recordings will be conducted every 3 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functionality</measure>
    <time_frame>subjects will be followed up for a period of 24 months from their first visit after receiving the Providence nighttime bracing system</time_frame>
    <description>Both study subjects and their guardians will be asked to fill out an Adolescent Health Assessment. Based on the Version 2.0 Pediatrics-Parent/ Adolescent Outcomes Instrument also commonly referred to as the PODCI (&quot;Pediatric Outcomes Data Collection Instrument&quot;)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>physical health and personal image</measure>
    <time_frame>subjects will be followed up for a period of 24 months from their first visit after receiving the Providence nighttime bracing system</time_frame>
    <description>Both study subjects and their guardians will be asked to fill out an Adolescent Health Assessment. Based on the Version 2.0 Pediatrics-Parent/ Adolescent Outcomes Instrument also commonly referred to as the PODCI (&quot;Pediatric Outcomes Data Collection Instrument&quot;)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Adolescence Idiopathic Scoliosis</condition>
  <arm_group>
    <arm_group_label>Adolescence idiopathic scoliosis</arm_group_label>
    <description>Patients must be at least 10 years of age with a risser score of 0, 1, or 2</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Providence Nighttime Bracing System</intervention_name>
    <description>Providence Nighttime Bracing System</description>
    <arm_group_label>Adolescence idiopathic scoliosis</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Providence Nighttime Bracing System</intervention_name>
    <description>The Providence brace is a polypropylene plastic, acrylic framed, system designed to apply corrective forces to scoliatic curves achieving correction or reduction of scoliosis.</description>
    <arm_group_label>Adolescence idiopathic scoliosis</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        up to 100 adolescent male/female will be enrolled at up to 4 sites in the US. Patients must&#xD;
        be at least 10 years of age. Participants who receive treatment must have been diagnosed&#xD;
        with adolescent idiopathic scoliosis without other significant spinal pathology.&#xD;
        Appropriate participant selection will be accomplished through the integration of clinical&#xD;
        and radiological parameters while ruling out other confounding sources of back pain or&#xD;
        curvature. Subjects will be included who demonstrate a Cobb angle between 25-40 degrees.&#xD;
        Participants must have radiographic evidence of a Risser grade of 0, 1, or 2. All chronic&#xD;
        disease process and other possible sources for spinal curvature will be excluded by&#xD;
        thorough history and physical examination.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject/guardian is able to provide informed consent and must sign the Institutional&#xD;
             Review Board approved Informed Consent Form;&#xD;
&#xD;
          -  Clinical/radiographic diagnosis of adolescence idiopathic scoliosis;&#xD;
&#xD;
          -  Male/female;&#xD;
&#xD;
          -  Skeletally immature (Risser grade 0, 1, or 2);&#xD;
&#xD;
          -  Cobb angle between 25-40 degrees;&#xD;
&#xD;
          -  Pre-menarchal or post-menarchal by no more than 1 year at the time of diagnosis;&#xD;
&#xD;
          -  Curve apex caudal to T6 vertebrae;&#xD;
&#xD;
          -  Physical and mental ability to adhere to bracing protocol;&#xD;
&#xD;
          -  Have agreed to refuse participation in another clinical trial for the duration of the&#xD;
             study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of previous surgical intervention or other invasive treatment for AIS;&#xD;
&#xD;
          -  History of orthotic treatment or other brace wear for the treatment of AIS;&#xD;
&#xD;
          -  Diagnosis of other musculoskeletal or developmental illness that might be responsible&#xD;
             for the spinal curvature;&#xD;
&#xD;
          -  Tumor or malignant tumor in the spine;&#xD;
&#xD;
          -  Inability to communicate clearly in the English language;&#xD;
&#xD;
          -  Subjects with a Risser score ≥ 3;&#xD;
&#xD;
          -  Plans to relocate within the next 2 years;&#xD;
&#xD;
          -  Any subject the Principle Investigator deems as an unfit candidate.&#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>William B Dasher, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>OrthoGeorgia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Eric D Lincoln, DO</last_name>
    <role>Principal Investigator</role>
    <affiliation>Georgia Pediatric Orthopaedics</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Winston R Jeshuran, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>OrthoGeorgia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Wayne Kelley, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>OrthoGeorgia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Randolph Devereaux, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mercer University School of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hamza H Awad, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mercer University School of Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Craig C Odum</last_name>
    <phone>478-254-5377</phone>
    <email>codum@orthoga.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Georgia Pediatric Orthopaedics</name>
      <address>
        <city>Macon</city>
        <state>Georgia</state>
        <zip>31201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Craig C Odum</last_name>
      <phone>478-254-5377</phone>
      <email>codum@orthoga.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>OrthoGeorgia</name>
      <address>
        <city>Macon</city>
        <state>Georgia</state>
        <zip>31201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Craig C Odum</last_name>
      <phone>478-254-5377</phone>
      <email>codum@orthoga.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>August 22, 2014</study_first_submitted>
  <study_first_submitted_qc>August 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2014</study_first_posted>
  <last_update_submitted>April 20, 2015</last_update_submitted>
  <last_update_submitted_qc>April 20, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 21, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>OrthoGeorgia</investigator_affiliation>
    <investigator_full_name>William Dasher, MD</investigator_full_name>
    <investigator_title>Orthopaedic Spine Surgeon</investigator_title>
  </responsible_party>
  <keyword>Adolescence Idiopathic Scoliosis</keyword>
  <keyword>nighttime Bracing</keyword>
  <keyword>Providence</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/NCT02227537
org study id: OG12-04-13
nct id: NCT02227537
lead sponsor: 
has dmc: No
A multicenter, prospective, non-randomized, single-arm observational study evaluating the
      Providence nighttime bracing system in patients diagnosed with adolescence idiopathic
      scoliosis.
This study is designed as a multicenter, prospective, non-randomized, single arm
      observational study. A temperature probe and data logger will be attached to the Providence
      brace to monitor patient compliance wear time. Subjects will be blinded to temperature sensor
      readings to maximize objectivity of brace wear.
observational model: Cohort
time perspective: Prospective
measure: Curve progression
time frame: subjects will be followed up for a period of 24 months from their first visit after receiving the Providence nighttime bracing system
description: The percentage of patients who have ≤5o curve progression and the percentage of patients who have ≥6 o progression at maturity;
The percentage of patients with curves exceeding 45o at maturity and the percentage who have had surgery recommended/undergone;
2 year follow-up beyond maturity to determine the percentage of patients who subsequently undergo surgery.
Routine follow-up visits will be scheduled 6 months apart (1st visit after brace fitting, 6, 12, 18 and 24 months) up to 24 months. At each of these visits, the patient will undergo a history & physical, PA radiographs, Cobb Angle assessment, Adams Forward Bending test, Neurological examination, outcome questionnaire's, concomitant medications, and adverse event recordings.
measure: Compliance
time frame: subjects will be followed up for a period of 24 months from their first visit after receiving the Providence nighttime bracing system
description: A temperature data logger will record and monitor patient compliance of brace wear. To not create undue awareness to these recordings patients will be informed the temperature readings are being monitored for patient comfort and ease of brace wear. Reconciliation of data logger recordings will be conducted every 3 months.
measure: Functionality
time frame: subjects will be followed up for a period of 24 months from their first visit after receiving the Providence nighttime bracing system
description: Both study subjects and their guardians will be asked to fill out an Adolescent Health Assessment. Based on the Version 2.0 Pediatrics-Parent/ Adolescent Outcomes Instrument also commonly referred to as the PODCI ("Pediatric Outcomes Data Collection Instrument")
measure: physical health and personal image
time frame: subjects will be followed up for a period of 24 months from their first visit after receiving the Providence nighttime bracing system
description: Both study subjects and their guardians will be asked to fill out an Adolescent Health Assessment. Based on the Version 2.0 Pediatrics-Parent/ Adolescent Outcomes Instrument also commonly referred to as the PODCI ("Pediatric Outcomes Data Collection Instrument")
arm group label: Adolescence idiopathic scoliosis
description: Patients must be at least 10 years of age with a risser score of 0, 1, or 2
intervention type: Device
intervention name: Providence Nighttime Bracing System
description: Providence Nighttime Bracing System
arm group label: Adolescence idiopathic scoliosis
intervention type: Device
intervention name: Providence Nighttime Bracing System
description: The Providence brace is a polypropylene plastic, acrylic framed, system designed to apply corrective forces to scoliatic curves achieving correction or reduction of scoliosis.
arm group label: Adolescence idiopathic scoliosis
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 10 Years
maximum age: 14 Years
healthy volunteers: No
last name: William B Dasher, MD
role: Principal Investigator
affiliation: OrthoGeorgia
last name: Eric D Lincoln, DO
role: Principal Investigator
affiliation: Georgia Pediatric Orthopaedics
last name: Winston R Jeshuran, MD
role: Principal Investigator
affiliation: OrthoGeorgia
last name: Wayne Kelley, MD
role: Principal Investigator
affiliation: OrthoGeorgia
last name: Randolph Devereaux, PhD
role: Principal Investigator
affiliation: Mercer University School of Medicine
last name: Hamza H Awad, MD, PhD
role: Principal Investigator
affiliation: Mercer University School of Medicine
last name: Craig C Odum
phone: 478-254-5377
email: codum@orthoga.org
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: OrthoGeorgia
investigator full name: William Dasher, MD
investigator title: Orthopaedic Spine Surgeon
mesh term: Scoliosis