<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/NCT03257826</url>
  </required_header>
  <id_info>
    <org_study_id>HN04</org_study_id>
    <nct_id>NCT03257826</nct_id>
  </id_info>
  <brief_title>The Effect of Percutaneous Kirschner Wire Technique in Management of CPT Under One Year Old</brief_title>
  <official_title>The Effect of Percutaneous Kirschner Wire Technique in Management of Congenital Pseudarthrosis of Tibia Under One Year Old</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hunan Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Guangzhou Women and Children's Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shenzhen Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tongji Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Wuhan Union Hospital, China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Wuhan Women and Children's Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Foshan Hospital of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dalian Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Children's Hospital of Chongqing Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kunming Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hunan Children's Hospital</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>
      The aim of this study was to investigate the effect of percutaneous kirschner wire in&#xD;
      management of Congenital Pseudarthrosis of Tibia in children younger than 1 year of age. This&#xD;
      study was to determine the union rates of congenital pseudarthrosis in children operated&#xD;
      before 1 year of age to identify growth abnormalities in the affected limb ,including ankle&#xD;
      valgus,tibia valgus,and shortening.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Currently, the timing of surgery for congenital pseudarthrosis of the tibia is a&#xD;
      controversial issue. The investigators use percutaneous kirschner wire technique to manage&#xD;
      the Congenital Pseudarthrosis of Tibia in children younger than 1 year of age.To investigate&#xD;
      the effect of percutaneous kirschner wire in management of Congenital Pseudarthrosis of Tibia&#xD;
      in children younger than 1 year of age. Bone uion rate,average time of healing, ankle valgus,&#xD;
      limb length discrepancy, tibia axis alignment are recorded and evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 1, 2015</start_date>
  <completion_date type="Anticipated">December 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Primary union score (range,4-12 score)</measure>
    <time_frame>9 months post-operation</time_frame>
    <description>X ray score from tibia pseudarthrosis in anterior and posterior (AP )and lateral X ray. (&quot;RUST&quot; score:radiographic union scoring system for tibial fracture healing)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Refracture（Cortical discontinuity)</measure>
    <time_frame>0.5 , 1,2,3,4,5,6,7,8,9,10 years after the fracture is healed</time_frame>
    <description>Refracture was defined as an obvious fracture（Cortical discontinuity) on a plain radiograph,following the union at the site of the tibia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Residual Deformity-proximal tibia angulation(range,0°-90°)</measure>
    <time_frame>pre-operation and 0.5 , 1,2,3,4,5,6,7,8,9,10 years post-operation ]</time_frame>
    <description>measurement of the angulation of proximal tibia in anterior and posterior (AP )and lateral X ray.Proximal tibial valgus is created by the intersection of a line parallel to the proximal physis and another line along the axis of the proximal third of diaphysis in the tibia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Residual Deformity-Limb length discrepancy</measure>
    <time_frame>pre-operation and 0.5 , 1,2,3,4,5,6,7,8,9,10 years post-operation</time_frame>
    <description>measurement of the length difference of both tibia in AP and lateral X ray.Picture Archiving and Communication System (PACS) is used to measure the length of the tibia (The investigators measure the distance between the midpoint of the proximal tibial epiphyseal plate and the midpoint of distal tibia epiphyseal plate).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Residual Deformity-ankle valgus angulation(range,0°-90°)</measure>
    <time_frame>pre-operation and 0.5 , 1,2,3,4,5,6,7,8,9,10 years post-operation</time_frame>
    <description>measurement of the angulation between the distal tibia and ankle joint.Ankle valgus is assessed by the tibiotalar angle measured at the intersection of the mid-diaphyseal line of the tibia and a line drawn across the flat subchondral line of the talar dome.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Congenital Pseudarthrosis of Tibia</condition>
  <arm_group>
    <arm_group_label>surgery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Percutaneous Kirschner wire</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>kirschner wire</intervention_name>
    <description>retrograde percutaneous kirschner wire was applied to stabilize the tibia.</description>
    <arm_group_label>surgery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients did not undergo procedures&#xD;
&#xD;
          -  Patients with Crawford type IV CPT treated with Percutaneous Kirschner wire techniques&#xD;
&#xD;
          -  The age during surgery was less than 12 months old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with pseudarthrosis of tibia caused by trauma,infection, etc&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>12 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Haibo Mei, MD</last_name>
    <role>Study Director</role>
    <affiliation>Hunan Children's Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kun Liu, MD</last_name>
    <phone>008615084796158</phone>
    <email>lk998@sina.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Haibo Mei, MD</last_name>
    <phone>008613975197731</phone>
    <email>meihaibo@sina.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Kun Liu</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>417000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kun Liu, MD</last_name>
      <phone>008615084796158</phone>
      <email>lk998@sina.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>August 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>October 20, 2020</last_update_submitted>
  <last_update_submitted_qc>October 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>congenital pseudarthrosis of the tibia</keyword>
  <keyword>age of surgery</keyword>
  <keyword>Percutaneous Kirschner wire</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pseudarthrosis</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/NCT03257826
org study id: HN04
nct id: NCT03257826
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The aim of this study was to investigate the effect of percutaneous kirschner wire in
      management of Congenital Pseudarthrosis of Tibia in children younger than 1 year of age. This
      study was to determine the union rates of congenital pseudarthrosis in children operated
      before 1 year of age to identify growth abnormalities in the affected limb ,including ankle
      valgus,tibia valgus,and shortening.
Currently, the timing of surgery for congenital pseudarthrosis of the tibia is a
      controversial issue. The investigators use percutaneous kirschner wire technique to manage
      the Congenital Pseudarthrosis of Tibia in children younger than 1 year of age.To investigate
      the effect of percutaneous kirschner wire in management of Congenital Pseudarthrosis of Tibia
      in children younger than 1 year of age. Bone uion rate,average time of healing, ankle valgus,
      limb length discrepancy, tibia axis alignment are recorded and evaluated.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Primary union score (range,4-12 score)
time frame: 9 months post-operation
description: X ray score from tibia pseudarthrosis in anterior and posterior (AP )and lateral X ray. ("RUST" score:radiographic union scoring system for tibial fracture healing)
measure: Refracture（Cortical discontinuity)
time frame: 0.5 , 1,2,3,4,5,6,7,8,9,10 years after the fracture is healed
description: Refracture was defined as an obvious fracture（Cortical discontinuity) on a plain radiograph,following the union at the site of the tibia.
measure: Residual Deformity-proximal tibia angulation(range,0°-90°)
time frame: pre-operation and 0.5 , 1,2,3,4,5,6,7,8,9,10 years post-operation ]
description: measurement of the angulation of proximal tibia in anterior and posterior (AP )and lateral X ray.Proximal tibial valgus is created by the intersection of a line parallel to the proximal physis and another line along the axis of the proximal third of diaphysis in the tibia.
measure: Residual Deformity-Limb length discrepancy
time frame: pre-operation and 0.5 , 1,2,3,4,5,6,7,8,9,10 years post-operation
description: measurement of the length difference of both tibia in AP and lateral X ray.Picture Archiving and Communication System (PACS) is used to measure the length of the tibia (The investigators measure the distance between the midpoint of the proximal tibial epiphyseal plate and the midpoint of distal tibia epiphyseal plate).
measure: Residual Deformity-ankle valgus angulation(range,0°-90°)
time frame: pre-operation and 0.5 , 1,2,3,4,5,6,7,8,9,10 years post-operation
description: measurement of the angulation between the distal tibia and ankle joint.Ankle valgus is assessed by the tibiotalar angle measured at the intersection of the mid-diaphyseal line of the tibia and a line drawn across the flat subchondral line of the talar dome.
arm group label: surgery
arm group type: Experimental
description: Percutaneous Kirschner wire
intervention type: Device
intervention name: kirschner wire
description: retrograde percutaneous kirschner wire was applied to stabilize the tibia.
arm group label: surgery
criteria: 
gender: All
minimum age: 1 Month
maximum age: 12 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Haibo Mei, MD
role: Study Director
affiliation: Hunan Children's Hospital
last name: Kun Liu, MD
phone: 008615084796158
email: lk998@sina.com
last name: Haibo Mei, MD
phone: 008613975197731
email: meihaibo@sina.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Pseudarthrosis