<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/NCT02196311</url>
  </required_header>
  <id_info>
    <org_study_id>H-34336</org_study_id>
    <nct_id>NCT02196311</nct_id>
  </id_info>
  <brief_title>Treatment Of Supracondylar Fractures Closed Reduction And Circular Ring External Fixation Versus Open Reduction and Internal Fixation</brief_title>
  <official_title>TREATMENT OF SUPRACONDYLAR FRACTURES IN ADOLESCENTS: CLOSED REDUCTION AND CIRCULAR RING EXTERNAL FIXATION VERSUS OPEN REDUCTION AND INTERNAL FIXATION</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baylor College of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Baylor College of Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients treated with circular external fixation will have better outcomes (as measured by&#xD;
      range of motion (ROM), alignment, outcome surveys) than those treated with open reduction and&#xD;
      internal fixation (ORIF).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to compare patients who undergo ORIF versus circular external&#xD;
      fixation for supracondylar humerus fractures in children ages 12-18. We are asking parental&#xD;
      permission to collect information about their child's injury, x-rays, obtain ROM measures,&#xD;
      collect input from questionnaires, and review other medical information relating to the&#xD;
      injury.&#xD;
&#xD;
      The study is NOT about randomizing subjects to treatment, rather we are asking permission to&#xD;
      keep track of the decisions that are made about our population's treatment and how it impacts&#xD;
      their recovery.&#xD;
&#xD;
      The eligibility criteria is subject's between 12 and 18 years, if supracondylar/periarticular&#xD;
      humerus fracture needed operative fixation, and the fracture is unable to be treated with&#xD;
      percutaneous skeletal fixation. Patients will be excluded if they have had a previous elbow&#xD;
      injury, Osteogenesis imperfecta or another fragile bone disease, elbow stiffness from another&#xD;
      cause, or any pre-existing arm weakness.&#xD;
&#xD;
      The outcome measures all enrolled subjects will complete are the QuickDASH and the Pediatric&#xD;
      and Adolescent Outcomes Instruments (PODCI). The QuickDASH is a shortened version of the DASH&#xD;
      (Disabilities of the Arm, Shoulder and Hand) Outcome Measure which is intended to measure&#xD;
      symptoms and functions in people with musculoskeletal disorders of the upper limb. The&#xD;
      QuickDASH is valid and reliable and is used for clinical and research purposes. The PODCI is&#xD;
      designed to assess patients overall health, pain and ability to participate in normal daily&#xD;
      activities in patients under 19 years of age. We will only distribute both questionnaires to&#xD;
      the subjects and we are not collecting parent perception.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    no patient recruited&#xD;
  </why_stopped>
  <start_date type="Actual">March 2014</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">December 2017</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>Range of motion (ROM), change is being assessed</measure>
    <time_frame>Initial post-op (first return visit to clinic after surgery), 6 (+/-) weeks, 3(+/-) months, 6 months, 1 year, and 2 years</time_frame>
    <description>Assessing ROM (elbow flexion/extension) in the initial post-operative period and long-term follow-up is an important outcome measure since it correlated with the ability to perform certain tasks with the arm (e.g. reaching head to shampoo/brush hair, reaching mouth to eat, etc.) The visit time frame as outlined above reflects the visits a child would typically return to clinic after surgery for a supracondylar fracture. Every visit will have a threshold of a few weeks to allow the family to return to clinic. These visits are all after the surgery has been performed. For example, the first or initial visit is the first time the patient will return to the hospital after surgery. At this visit the potential participant will be presented with the study materials and given the opportunity to participate. Should the participant participate the visits in the time frame will occur at the give interval.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Treatments, change is being assessed</measure>
    <time_frame>Initial post-op, 6 weeks, 3 months, 6 months, 1 year, and 2 years</time_frame>
    <description>Evaluating the various treatments for supracondylar humerus fractures, open reduction internal fixation and circular external fixation. The visit time frame as outlined above reflects the visits a child would typically return to clinic after surgery for a supracondylar fracture. Every visit will have a threshold of a few weeks to allow the family to return to clinic. These visits are all after the surgery has been performed. For example, the first or initial visit is the first time the patient will return to the hospital after surgery. At this visit the potential participant will be presented with the study materials and given the opportunity to participate. Should the participant participate the visits in the time frame will occur at the give interval.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Supracondylar Humerus Fractures</condition>
  <arm_group>
    <arm_group_label>Supracondylar humerus fractures</arm_group_label>
    <description>We are looking to compare open reduction internal fixation versus circular external fixation for supracondylar humerus fractures.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients at Texas Children Hospital will undergo either an open reduction with internal&#xD;
        fixation or a closed reduction and circular ring external fixation based on the operating&#xD;
        surgeon's preference. We do not plan on randomizing or assigning patients that present to&#xD;
        Texas Children's Hospital with a supracondylar humerus fracture. Children that consent to&#xD;
        participate will strictly continue their follow-up with the physician that performed the&#xD;
        surgery. Post-operative course will be noted, physical exam and x-rays followed and outcome&#xD;
        surveys obtained and measured intervals.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  12 and 18 years old&#xD;
&#xD;
          -  Supracondylar/periarticular humerus fracture needed operative fixation&#xD;
&#xD;
          -  Fracture is unable to be treated with percutaneous skeletal fixation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any previous elbow injury&#xD;
&#xD;
          -  Osteogenesis imperfecta or another fragile bone disease&#xD;
&#xD;
          -  Elbow stiffness from another cause&#xD;
&#xD;
          -  Any pre-existing arm weakness.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jaclyn F Hill, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Texas Children's Hospital &amp; Baylor College of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Texas Children's Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.texaschildrens.org/Locate/Departments-and-Services/Orthopedics/</url>
    <description>Texas Children's Hospital - Orthopedics Department</description>
  </link>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>July 16, 2014</study_first_submitted>
  <study_first_submitted_qc>July 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <last_update_submitted>November 9, 2020</last_update_submitted>
  <last_update_submitted_qc>November 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Baylor College of Medicine</investigator_affiliation>
    <investigator_full_name>Jaclyn Hill</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Supracondylar humerus fractures, external fixation, open reduction, and internal fixation.</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Humeral Fractures</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/NCT02196311
org study id: H-34336
nct id: NCT02196311
lead sponsor: 
has dmc: No
Patients treated with circular external fixation will have better outcomes (as measured by
      range of motion (ROM), alignment, outcome surveys) than those treated with open reduction and
      internal fixation (ORIF).
The purpose of this study is to compare patients who undergo ORIF versus circular external
      fixation for supracondylar humerus fractures in children ages 12-18. We are asking parental
      permission to collect information about their child's injury, x-rays, obtain ROM measures,
      collect input from questionnaires, and review other medical information relating to the
      injury.

      The study is NOT about randomizing subjects to treatment, rather we are asking permission to
      keep track of the decisions that are made about our population's treatment and how it impacts
      their recovery.

      The eligibility criteria is subject's between 12 and 18 years, if supracondylar/periarticular
      humerus fracture needed operative fixation, and the fracture is unable to be treated with
      percutaneous skeletal fixation. Patients will be excluded if they have had a previous elbow
      injury, Osteogenesis imperfecta or another fragile bone disease, elbow stiffness from another
      cause, or any pre-existing arm weakness.

      The outcome measures all enrolled subjects will complete are the QuickDASH and the Pediatric
      and Adolescent Outcomes Instruments (PODCI). The QuickDASH is a shortened version of the DASH
      (Disabilities of the Arm, Shoulder and Hand) Outcome Measure which is intended to measure
      symptoms and functions in people with musculoskeletal disorders of the upper limb. The
      QuickDASH is valid and reliable and is used for clinical and research purposes. The PODCI is
      designed to assess patients overall health, pain and ability to participate in normal daily
      activities in patients under 19 years of age. We will only distribute both questionnaires to
      the subjects and we are not collecting parent perception.
observational model: Cohort
time perspective: Prospective
measure: Range of motion (ROM), change is being assessed
time frame: Initial post-op (first return visit to clinic after surgery), 6 (+/-) weeks, 3(+/-) months, 6 months, 1 year, and 2 years
description: Assessing ROM (elbow flexion/extension) in the initial post-operative period and long-term follow-up is an important outcome measure since it correlated with the ability to perform certain tasks with the arm (e.g. reaching head to shampoo/brush hair, reaching mouth to eat, etc.) The visit time frame as outlined above reflects the visits a child would typically return to clinic after surgery for a supracondylar fracture. Every visit will have a threshold of a few weeks to allow the family to return to clinic. These visits are all after the surgery has been performed. For example, the first or initial visit is the first time the patient will return to the hospital after surgery. At this visit the potential participant will be presented with the study materials and given the opportunity to participate. Should the participant participate the visits in the time frame will occur at the give interval.
measure: Treatments, change is being assessed
time frame: Initial post-op, 6 weeks, 3 months, 6 months, 1 year, and 2 years
description: Evaluating the various treatments for supracondylar humerus fractures, open reduction internal fixation and circular external fixation. The visit time frame as outlined above reflects the visits a child would typically return to clinic after surgery for a supracondylar fracture. Every visit will have a threshold of a few weeks to allow the family to return to clinic. These visits are all after the surgery has been performed. For example, the first or initial visit is the first time the patient will return to the hospital after surgery. At this visit the potential participant will be presented with the study materials and given the opportunity to participate. Should the participant participate the visits in the time frame will occur at the give interval.
arm group label: Supracondylar humerus fractures
description: We are looking to compare open reduction internal fixation versus circular external fixation for supracondylar humerus fractures.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 12 Years
maximum age: 18 Years
healthy volunteers: No
last name: Jaclyn F Hill, MD
role: Principal Investigator
affiliation: Texas Children's Hospital & Baylor College of Medicine
facility: 
country: United States
url: http://www.texaschildrens.org/Locate/Departments-and-Services/Orthopedics/
description: Texas Children's Hospital - Orthopedics Department
responsible party type: Principal Investigator
investigator affiliation: Baylor College of Medicine
investigator full name: Jaclyn Hill
investigator title: Assistant Professor
mesh term: Fractures, Bone
mesh term: Humeral Fractures