<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/NCT02257229</url>
  </required_header>
  <id_info>
    <org_study_id>032011-131</org_study_id>
    <nct_id>NCT02257229</nct_id>
  </id_info>
  <brief_title>Prospective Evaluation of Treatment for Clubfoot</brief_title>
  <official_title>Prospective Evaluation of Treatment for Clubfoot</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Texas Scottish Rite Hospital for Children</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Texas Scottish Rite Hospital for Children</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Specific aim:&#xD;
&#xD;
      To evaluate the outcome of infants who undergo one of two nonsurgical treatment interventions&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PURPOSE: The purpose of this project is to help orthopaedic surgeons better understand and&#xD;
      treat patients with a diagnosis of clubfoot. This proposed research will establish a protocol&#xD;
      for the collection of relevant clinical and functional outcome measures on our patients with&#xD;
      a diagnosis of clubfoot.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>August 2005</start_date>
  <completion_date type="Anticipated">September 2029</completion_date>
  <primary_completion_date type="Anticipated">September 2029</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>Degree of correction at initial brace wear</measure>
    <time_frame>2 months</time_frame>
    <description>Dimeglio scoring system will be used (score range from 0-20)</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">2500</enrollment>
  <condition>Clubfoot Deformity</condition>
  <arm_group>
    <arm_group_label>Surgical</arm_group_label>
    <description>Corrective Surgery only</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-Surgical</arm_group_label>
    <description>Correction with casting, braces, Physical therapy, other non-surgical methods</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-surgical + surgical</arm_group_label>
    <description>Correction with casting, braces, Physical therapy, other non-surgical methods subsequently followed by Corrective Surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Surgical</intervention_name>
    <description>Surgery only</description>
    <arm_group_label>Surgical</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Non-Surgical</intervention_name>
    <description>non-surgical methods such as, casting, bracing, physical therapy, and other.</description>
    <arm_group_label>Non-Surgical</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Non-surgical + surgical</intervention_name>
    <description>Combination of non-surgical methods subsequently followed by surgery</description>
    <arm_group_label>Non-surgical + surgical</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Primary care clinic&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with a diagnosis of clubfoot deformity&#xD;
&#xD;
          -  Spanish speaking patients will be eligible to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  All patients without a diagnosis of clubfoot&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anthony I Riccio, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Texas Scottish Rite Hospital for Children</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Rusty Hartman, MS</last_name>
    <phone>214-559-8371</phone>
    <email>rusty.hartman@tsrh.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jessica L Phillips, MPH</last_name>
    <phone>12145598562</phone>
    <email>jessica.laureano-phillips@tsrh.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Texas Scottish Rite Hospital for Children</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75219</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rusty Hartman, MS</last_name>
      <phone>214-559-8371</phone>
      <email>rusty.hartman@tsrh.org</email>
    </contact>
    <investigator>
      <last_name>Anthony I Riccio, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>September 22, 2014</study_first_submitted>
  <study_first_submitted_qc>October 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 6, 2014</study_first_posted>
  <last_update_submitted>April 10, 2023</last_update_submitted>
  <last_update_submitted_qc>April 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Texas Scottish Rite Hospital for Children</investigator_affiliation>
    <investigator_full_name>Anthony Riccio</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Clubfoot, deformity, correction, management, gait</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Clubfoot</mesh_term>
    <mesh_term>Talipes</mesh_term>
    <mesh_term>Equinus Deformity</mesh_term>
    <mesh_term>Foot Deformities</mesh_term>
    <mesh_term>Congenital Abnormalities</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Data will be collected at one site, only results of data analysis will be release in publishing. Data itself will not be shared.</ipd_description>
  </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/NCT02257229
org study id: 032011-131
nct id: NCT02257229
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Specific aim:

      To evaluate the outcome of infants who undergo one of two nonsurgical treatment interventions
PURPOSE: The purpose of this project is to help orthopaedic surgeons better understand and
      treat patients with a diagnosis of clubfoot. This proposed research will establish a protocol
      for the collection of relevant clinical and functional outcome measures on our patients with
      a diagnosis of clubfoot.
observational model: Cohort
time perspective: Prospective
measure: Degree of correction at initial brace wear
time frame: 2 months
description: Dimeglio scoring system will be used (score range from 0-20)
arm group label: Surgical
description: Corrective Surgery only
arm group label: Non-Surgical
description: Correction with casting, braces, Physical therapy, other non-surgical methods
arm group label: Non-surgical + surgical
description: Correction with casting, braces, Physical therapy, other non-surgical methods subsequently followed by Corrective Surgery
intervention type: Procedure
intervention name: Surgical
description: Surgery only
arm group label: Surgical
intervention type: Procedure
intervention name: Non-Surgical
description: non-surgical methods such as, casting, bracing, physical therapy, and other.
arm group label: Non-Surgical
intervention type: Procedure
intervention name: Non-surgical + surgical
description: Combination of non-surgical methods subsequently followed by surgery
arm group label: Non-surgical + surgical
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
healthy volunteers: No
last name: Anthony I Riccio, MD
role: Principal Investigator
affiliation: Texas Scottish Rite Hospital for Children
last name: Rusty Hartman, MS
phone: 214-559-8371
email: rusty.hartman@tsrh.org
last name: Jessica L Phillips, MPH
phone: 12145598562
email: jessica.laureano-phillips@tsrh.org
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Texas Scottish Rite Hospital for Children
investigator full name: Anthony Riccio
investigator title: Principal Investigator
mesh term: Clubfoot
mesh term: Talipes
mesh term: Equinus Deformity
mesh term: Foot Deformities
mesh term: Congenital Abnormalities
sharing ipd: No
ipd description: Data will be collected at one site, only results of data analysis will be release in publishing. Data itself will not be shared.