<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/NCT04423835</url>
  </required_header>
  <id_info>
    <org_study_id>CQMU20200026</org_study_id>
    <nct_id>NCT04423835</nct_id>
  </id_info>
  <brief_title>Lateral Closing Wedge Osteotomy for Cubitus Varus Deformity in Children</brief_title>
  <official_title>Applying Paley's Principles to Lateral Closing Wedge Osteotomy for Cubitus Varus Deformity 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>
      Humeral osteotomy is the most effective method for evident cubitus varus correction in&#xD;
      children. Several osteotomy methods and fixation materials have been developed in the past.&#xD;
      By applying the principles of deformity correction described by Paley, the investigators&#xD;
      describe a novel corrective technique for cubitus varus involving lateral osteotomy using&#xD;
      Kirschner wires.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Supracondylar humerus fractures (SHFs) account for approximately 10% of all pediatric&#xD;
      fractures in children. Poorly treated SHFs can lead to the most common cubitus varus&#xD;
      deformity especially in patients treated conservatively. The cosmetic aspect of this&#xD;
      deformity is the main concern of patients, together with reduced remodeling ability.&#xD;
      Inevitably, surgery is the first choice for such patients. Several osteotomy techniques and&#xD;
      fixation materials have been developed in the last several decades. With the advent of&#xD;
      three-dimensional printing techniques and computed tomography reconstruction methods, more&#xD;
      accurate computing designs have been applied in the correction of cubitus varus. These&#xD;
      techniques make the surgery more complex and require the performance of computed tomography&#xD;
      (CT), resulting in high radiation exposure in children. Paley described the principles of&#xD;
      deformity correction that are widely used for the lower limbs. These principles represent an&#xD;
      alternative with easy application without the need of CT, with less occurrence of prominence&#xD;
      and good cosmetic outcome. According to the Paley principles, all the vertex of the&#xD;
      triangular osteotomy should site on the center of rotation of angulation (CORA) line, by&#xD;
      doing this, the gun-butt deformity was corrected perfectly. More importantly, they help to&#xD;
      accurately correct the anatomic axis of the upper limb. According to our knowledge, this is&#xD;
      the first study describes the lateral closing wedge osteotomy for correction cubitus varus&#xD;
      deformity in children by applying Paley's principles and fixation with K-wires.&#xD;
&#xD;
      Taken together, the investigators aimed at verifying the feasibility of Paley's principles&#xD;
      for deformity correction to treat cubitus varus in children.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2015</start_date>
  <completion_date type="Actual">January 1, 2020</completion_date>
  <primary_completion_date type="Actual">January 1, 2020</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>Elbow appearance</measure>
    <time_frame>3th month after surgery</time_frame>
    <description>elbows were evaluated using radiography and appearence</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">21</enrollment>
  <condition>Deformity; Bone</condition>
  <arm_group>
    <arm_group_label>lateral closing osteotomy for cubitus varus deformity</arm_group_label>
    <description>The osteotomy line of all patients was designed according to Paley's principles. The lateral incision was applied in all patients and the osteotomy lines were marked on the humerus with the assistance of C-arm radiographs.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Paley's Principle osteotomy</intervention_name>
    <description>. The osteotomy line of all patients was designed according to Paley's principles. The lateral incision was applied in all patients and the osteotomy lines were marked on the humerus with the assistance of C-arm radiographs. An isosceles triangle template was used for osteotomy, and the medial cortex was left intact. K-wires were used to fix the osteotomy laterally.</description>
    <arm_group_label>lateral closing osteotomy for cubitus varus deformity</arm_group_label>
    <other_name>Applying Paley's Principles to Lateral Closing Wedge Osteotomy</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All the patients were performed surgery between July 2015 and October 2017&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  surgery performed over 6 months after the occurrence of SHFs&#xD;
&#xD;
          -  difference in flexion angles of the affected and unaffected limbs of &gt;15 degrees&#xD;
&#xD;
          -  recovery of elbow function pre-ostomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  any other surgical approach used&#xD;
&#xD;
          -  consent not obtained from the patient's guardians&#xD;
&#xD;
          -  incomplete follow-up&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <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 6, 2020</study_first_submitted>
  <study_first_submitted_qc>June 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 8, 2020</last_update_submitted>
  <last_update_submitted_qc>June 8, 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>cubitus varus</keyword>
  <keyword>supracondylar humerus fracture</keyword>
  <keyword>osteotomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Congenital Abnormalities</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/NCT04423835
org study id: CQMU20200026
nct id: NCT04423835
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Humeral osteotomy is the most effective method for evident cubitus varus correction in
      children. Several osteotomy methods and fixation materials have been developed in the past.
      By applying the principles of deformity correction described by Paley, the investigators
      describe a novel corrective technique for cubitus varus involving lateral osteotomy using
      Kirschner wires.
Supracondylar humerus fractures (SHFs) account for approximately 10% of all pediatric
      fractures in children. Poorly treated SHFs can lead to the most common cubitus varus
      deformity especially in patients treated conservatively. The cosmetic aspect of this
      deformity is the main concern of patients, together with reduced remodeling ability.
      Inevitably, surgery is the first choice for such patients. Several osteotomy techniques and
      fixation materials have been developed in the last several decades. With the advent of
      three-dimensional printing techniques and computed tomography reconstruction methods, more
      accurate computing designs have been applied in the correction of cubitus varus. These
      techniques make the surgery more complex and require the performance of computed tomography
      (CT), resulting in high radiation exposure in children. Paley described the principles of
      deformity correction that are widely used for the lower limbs. These principles represent an
      alternative with easy application without the need of CT, with less occurrence of prominence
      and good cosmetic outcome. According to the Paley principles, all the vertex of the
      triangular osteotomy should site on the center of rotation of angulation (CORA) line, by
      doing this, the gun-butt deformity was corrected perfectly. More importantly, they help to
      accurately correct the anatomic axis of the upper limb. According to our knowledge, this is
      the first study describes the lateral closing wedge osteotomy for correction cubitus varus
      deformity in children by applying Paley's principles and fixation with K-wires.

      Taken together, the investigators aimed at verifying the feasibility of Paley's principles
      for deformity correction to treat cubitus varus in children.
observational model: Cohort
time perspective: Retrospective
measure: Elbow appearance
time frame: 3th month after surgery
description: elbows were evaluated using radiography and appearence
arm group label: lateral closing osteotomy for cubitus varus deformity
description: The osteotomy line of all patients was designed according to Paley's principles. The lateral incision was applied in all patients and the osteotomy lines were marked on the humerus with the assistance of C-arm radiographs.
intervention type: Procedure
intervention name: Paley's Principle osteotomy
description: . The osteotomy line of all patients was designed according to Paley's principles. The lateral incision was applied in all patients and the osteotomy lines were marked on the humerus with the assistance of C-arm radiographs. An isosceles triangle template was used for osteotomy, and the medial cortex was left intact. K-wires were used to fix the osteotomy laterally.
arm group label: lateral closing osteotomy for cubitus varus deformity
other name: Applying Paley's Principles to Lateral Closing Wedge Osteotomy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 3 Years
maximum age: 16 Years
healthy volunteers: No
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: Congenital Abnormalities
sharing ipd: No