<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/NCT04424498</url>
  </required_header>
  <id_info>
    <org_study_id>CQMU20200016</org_study_id>
    <nct_id>NCT04424498</nct_id>
  </id_info>
  <brief_title>Treatment of Displaced Radial Neck Combined With Olecranon Fractures</brief_title>
  <official_title>Absorbable Rods and Kirschner Wires for the Treatment of Displaced Radial Neck Combined With Olecranon Fractures in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital of Chongqing Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Children's Hospital of Chongqing Medical University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aimed to evaluate the outcomes of using absorbable rods and Kirschner Wires&#xD;
      technique for severe displaced radial neck fractures combined with olecranon fractures in&#xD;
      children.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The most common fracture in children is the elbow fracture, and the three most common elbow&#xD;
      fractures are supracondylar, lateral condylar, and medial epicondylar fractures. Elbow&#xD;
      fractures are easy to diagnose and the treatment modalities are studied often. However,&#xD;
      proximal radius fractures, which include radial neck and head fractures, remain challenging&#xD;
      to diagnose and manage. In addition, proximal radius fractures are often combined with other&#xD;
      fractures, most commonly, an olecranon fracture. Most radial neck fractures can be treated&#xD;
      conservatively if the displacement is less than 3 mm and the angle is less than 30º. However,&#xD;
      for severe Judet type III and type IV radial neck fractures, surgery is inevitable.&#xD;
&#xD;
      This study focused on radial neck fractures combined with an olecranon fracture. In this&#xD;
      study, absorbable rods were used for fixation of radial head fractures, and with no need for&#xD;
      removal of the inner fixation, we performed anatomy reduction via the same incision with&#xD;
      direct vision of the olecranon, and we were able to fix the fractures with Kirschner wires&#xD;
      (K-wires). In this retrospective study, we aimed to evaluate a treatment method for severe&#xD;
      displaced radial neck combined with olecranon fractures in children using a Boyd incision,&#xD;
      absorbable rods, and K-wires.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2019</start_date>
  <completion_date type="Actual">December 1, 2019</completion_date>
  <primary_completion_date type="Actual">December 1, 2019</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Mayo Elbow Performance Index score</measure>
    <time_frame>3th month after surgery</time_frame>
    <description>MEPI results were categorized as follows: &gt;90 points, excellent; 81-90 points, good; 61-80 points, fair; and &lt;60 points, poor.</description>
  </primary_outcome>
  <enrollment type="Actual">31</enrollment>
  <condition>Child</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Absorbable Rods and Kirschner Wires</intervention_name>
    <description>A Boyd incision was applied in all patients; olecranon fractures were reduced first and fixed with Kirschner wires. Then, the displaced radial neck fractures were reduced and fixed using absorbable rods.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Medical records of patients who attended our hospital between Jan 2012 and Dec 2016 were&#xD;
        retrospectively reviewed.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  open reduction of severe radial neck fractures combined with an olecranon fractures in&#xD;
             the same elbow&#xD;
&#xD;
          -  fixation performed using absorbable rods and K-wires&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  single radial head fractures or single olecranon fractures&#xD;
&#xD;
          -  fixation performed with bands&#xD;
&#xD;
          -  old fractures,&#xD;
&#xD;
          -  Boyd incision was not used,&#xD;
&#xD;
          -  guardians did not agree with the surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>13 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yuxi Su, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's hospital of Chongqing Medical Univeristy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Hospital of Chongqing Medical University</name>
      <address>
        <city>Chongqing</city>
        <state>Chongqing</state>
        <zip>400014</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 9, 2020</last_update_submitted>
  <last_update_submitted_qc>June 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Children's Hospital of Chongqing Medical University</investigator_affiliation>
    <investigator_full_name>Yuxi Su</investigator_full_name>
    <investigator_title>Vice professor</investigator_title>
  </responsible_party>
  <keyword>Kirschner wires</keyword>
  <keyword>Absorbable rods</keyword>
  <keyword>Radial neck fracture</keyword>
  <keyword>Olecranon fracture</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Olecranon Fracture</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04424498
org study id: CQMU20200016
nct id: NCT04424498
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study aimed to evaluate the outcomes of using absorbable rods and Kirschner Wires
      technique for severe displaced radial neck fractures combined with olecranon fractures in
      children.
The most common fracture in children is the elbow fracture, and the three most common elbow
      fractures are supracondylar, lateral condylar, and medial epicondylar fractures. Elbow
      fractures are easy to diagnose and the treatment modalities are studied often. However,
      proximal radius fractures, which include radial neck and head fractures, remain challenging
      to diagnose and manage. In addition, proximal radius fractures are often combined with other
      fractures, most commonly, an olecranon fracture. Most radial neck fractures can be treated
      conservatively if the displacement is less than 3 mm and the angle is less than 30º. However,
      for severe Judet type III and type IV radial neck fractures, surgery is inevitable.

      This study focused on radial neck fractures combined with an olecranon fracture. In this
      study, absorbable rods were used for fixation of radial head fractures, and with no need for
      removal of the inner fixation, we performed anatomy reduction via the same incision with
      direct vision of the olecranon, and we were able to fix the fractures with Kirschner wires
      (K-wires). In this retrospective study, we aimed to evaluate a treatment method for severe
      displaced radial neck combined with olecranon fractures in children using a Boyd incision,
      absorbable rods, and K-wires.
observational model: Cohort
time perspective: Retrospective
measure: Mayo Elbow Performance Index score
time frame: 3th month after surgery
description: MEPI results were categorized as follows: >90 points, excellent; 81-90 points, good; 61-80 points, fair; and <60 points, poor.
intervention type: Procedure
intervention name: Absorbable Rods and Kirschner Wires
description: A Boyd incision was applied in all patients; olecranon fractures were reduced first and fixed with Kirschner wires. Then, the displaced radial neck fractures were reduced and fixed using absorbable rods.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 3 Years
maximum age: 13 Years
healthy volunteers: No
last name: Yuxi Su, M.D.
role: Principal Investigator
affiliation: Children's hospital of Chongqing Medical Univeristy
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Children's Hospital of Chongqing Medical University
investigator full name: Yuxi Su
investigator title: Vice professor
mesh term: Olecranon Fracture
sharing ipd: No