<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/NCT04425369</url>
  </required_header>
  <id_info>
    <org_study_id>CQMU20200017</org_study_id>
    <nct_id>NCT04425369</nct_id>
  </id_info>
  <brief_title>Iliac Crest Bone Graft Harvesting for Pediatric Pelvic Osteotomy</brief_title>
  <official_title>Comparison of the Inner Side and Two-sided Approaches for Iliac Crest Bone Graft Harvesting for Pediatric Pelvic Osteotomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yuxi Su</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Children's Hospital of Chongqing Medical University</source>
  <oversight_info>
    <has_dmc>No</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>
      The iliac crest is one of the most commonly used bone graft sources, especially in pediatric&#xD;
      pelvic osteotomy operations for developmental dysplasia of the hip (DDH) and&#xD;
      Legg-Calve-Perthes disease. In this study, we aimed to identify the effects of inner side and&#xD;
      two-sided approaches for iliac crest bone harvesting on post-surgery ilium growth in&#xD;
      children.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Autogenous bone grafting is still the gold standard and most effective method for treatment&#xD;
      of non-union and bone defects due to congenital disease and infection. Despite the&#xD;
      development of bone engineering, none of the allogeneic bone products can match the&#xD;
      osteoinductive, osteoconductive, and immunogenic properties of autogenous bone. The iliac&#xD;
      crest is one of the most harvested sites other than the fibula, ribs, and ulna. An iliac&#xD;
      crest bone graft (ICBG) can supply a larger amount of cortical and cancellous bone than&#xD;
      grafts from other donor sites. Pelvic osteotomy is widely used for treating developmental&#xD;
      dysplasia of the hip (DDH) and Legg-Calve-Perthes disease. Tricortical structural bone such&#xD;
      as that in the ilium is needed to stabilize the pelvis after osteotomy, and the anterior and&#xD;
      posterior iliac crest are the two most used graft donor sites. When surgery is planned in the&#xD;
      prone position, such as that for posterior spinal fusion, surgeons generally prefer to adopt&#xD;
      the posterior approach for ICBG procedures. In supine position surgeries such as pelvic&#xD;
      osteotomy for DDH or Legg-Calve-Perthes disease, surgeons prefer the anterior approach for&#xD;
      ICBG procedures. There are many studies on iliac bone growth and complications after ICBG&#xD;
      procedures. Most of the studies demonstrated good outcomes and few complications. However,&#xD;
      according to our literature review, none of the previous studies used the iliac bone for&#xD;
      transplantation in pelvic osteotomy. In this study, we compared the results between an inner&#xD;
      table harvest site and an inner-outer table harvest site for ICBG used to maintain stability&#xD;
      in pelvic osteotomy.&#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>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Radiographic parameters were evaluated on anteroposterior pelvic radiographs</measure>
    <time_frame>3th month after surgery</time_frame>
    <description>The growth areas were measured by GE healthcare-Centricity RIS CE V3.0 software (General Electric Company). The areas was calculated as mm2.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time for the totally recovery of iliac defect</measure>
    <time_frame>through study completion, an average of 6 months</time_frame>
    <description>the time was calculated from the surgery to the time totally recovery of iliac defect by days</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">47</enrollment>
  <condition>Child</condition>
  <condition>Osteotomy</condition>
  <arm_group>
    <arm_group_label>inner side approaches for iliac crest bone graft</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>An anterior approach was used to expose the inner table of the ilium.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>two-sided approaches for iliac crest bone graft</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>both sides of the ilium were totally exposed of the ilium.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>two-sided approaches for iliac crest bone graft</intervention_name>
    <description>Only one side of the ilium was exposed when surgery.</description>
    <arm_group_label>two-sided approaches for iliac crest bone graft</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  the patients who performed iliac crest bone graft and pelvic osteotomy at the same&#xD;
             time&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  they had a history of pelvic osteotomy or iliac crest bone graft surgery, bilateral&#xD;
             hip disease or congenital bone dysplasia, or were lost to follow-up.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 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 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>Sponsor-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>pelvic osteotomy</keyword>
  <keyword>developmental dysplasia of the hip</keyword>
  <keyword>iliac crest bone graft</keyword>
  <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/NCT04425369
org study id: CQMU20200017
nct id: NCT04425369
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The iliac crest is one of the most commonly used bone graft sources, especially in pediatric
      pelvic osteotomy operations for developmental dysplasia of the hip (DDH) and
      Legg-Calve-Perthes disease. In this study, we aimed to identify the effects of inner side and
      two-sided approaches for iliac crest bone harvesting on post-surgery ilium growth in
      children.
Autogenous bone grafting is still the gold standard and most effective method for treatment
      of non-union and bone defects due to congenital disease and infection. Despite the
      development of bone engineering, none of the allogeneic bone products can match the
      osteoinductive, osteoconductive, and immunogenic properties of autogenous bone. The iliac
      crest is one of the most harvested sites other than the fibula, ribs, and ulna. An iliac
      crest bone graft (ICBG) can supply a larger amount of cortical and cancellous bone than
      grafts from other donor sites. Pelvic osteotomy is widely used for treating developmental
      dysplasia of the hip (DDH) and Legg-Calve-Perthes disease. Tricortical structural bone such
      as that in the ilium is needed to stabilize the pelvis after osteotomy, and the anterior and
      posterior iliac crest are the two most used graft donor sites. When surgery is planned in the
      prone position, such as that for posterior spinal fusion, surgeons generally prefer to adopt
      the posterior approach for ICBG procedures. In supine position surgeries such as pelvic
      osteotomy for DDH or Legg-Calve-Perthes disease, surgeons prefer the anterior approach for
      ICBG procedures. There are many studies on iliac bone growth and complications after ICBG
      procedures. Most of the studies demonstrated good outcomes and few complications. However,
      according to our literature review, none of the previous studies used the iliac bone for
      transplantation in pelvic osteotomy. In this study, we compared the results between an inner
      table harvest site and an inner-outer table harvest site for ICBG used to maintain stability
      in pelvic osteotomy.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Radiographic parameters were evaluated on anteroposterior pelvic radiographs
time frame: 3th month after surgery
description: The growth areas were measured by GE healthcare-Centricity RIS CE V3.0 software (General Electric Company). The areas was calculated as mm2.
measure: Time for the totally recovery of iliac defect
time frame: through study completion, an average of 6 months
description: the time was calculated from the surgery to the time totally recovery of iliac defect by days
arm group label: inner side approaches for iliac crest bone graft
arm group type: No Intervention
description: An anterior approach was used to expose the inner table of the ilium.
arm group label: two-sided approaches for iliac crest bone graft
arm group type: Experimental
description: both sides of the ilium were totally exposed of the ilium.
intervention type: Procedure
intervention name: two-sided approaches for iliac crest bone graft
description: Only one side of the ilium was exposed when surgery.
arm group label: two-sided approaches for iliac crest bone graft
criteria: 
gender: All
minimum age: 2 Years
maximum age: 16 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Children's Hospital of Chongqing Medical University
investigator full name: Yuxi Su
investigator title: Vice professor
sharing ipd: No