<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/NCT03787329</url>
  </required_header>
  <id_info>
    <org_study_id>RD-106057</org_study_id>
    <nct_id>NCT03787329</nct_id>
  </id_info>
  <brief_title>Autologous Bone Marrow Concentration for Avascular Necrosis of Femoral Head</brief_title>
  <official_title>The Effect of Autologous Bone Marrow Concentration Combined With Core Decompression for Avascular Necrosis of Femoral Head</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pei-Yuan Lee, MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Aeon Biotechnology Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Show Chwan Memorial Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This study aims to evaluate the effect of bone marrow concentration on avascular necrosis of&#xD;
      femur head by comparing clinical and imaging outcomes between patients receiving core&#xD;
      decompression surgery with intraoperative bone marrow concentration and those receiving core&#xD;
      decompression surgery only.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Avascular necrosis (AVN) of femoral head is a progressive disease that predominantly affects&#xD;
      younger patients. Although the exact pathophysiology of AVN has not yet to be elucidated, the&#xD;
      disease is characterized by a vascular insult to the blood supply of the femoral head, which&#xD;
      can lead to collapse of the femoral head and subsequent degenerative changes. Mesenchymal&#xD;
      stem cells (MSCs) are pluripotent cells that can differentiate into multiple mesenchymal&#xD;
      tissues, including tenocytes, chondrocytes and osteoblasts, as well as being a source of&#xD;
      multiple growth factors to establish an environment conducive to soft and hard tissue&#xD;
      regeneration. As bone marrow concentration has high concentration of mesenchymal stem cells,&#xD;
      several studies have applied the autologous bone marrow concentration in halting the&#xD;
      progression of AVN of femoral head. However, a higher level of evidence for its use on&#xD;
      patients suffering from femoral head avascular necrosis has not been reported. This clinical&#xD;
      trial will evaluate and compare the eligible patients who undertake core decompression&#xD;
      surgery plus intraoperative bone marrow concentration with those who received core&#xD;
      decompression surgery only. All patients will be followed for one year and clinical and&#xD;
      imaging outcomes will be compared and analyzed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 14, 2017</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>3-month postoperative hip function evaluated by Harris Hip Score</measure>
    <time_frame>3-month postoperative</time_frame>
    <description>Hip function is evaluated using Harris Hip score. The survey has 10 question items and scores range from 0-100 with higher scores representing less dysfunction and better outcomes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>6-month postoperative hip function evaluated by Harris Hip Score</measure>
    <time_frame>6-month postoperative</time_frame>
    <description>Hip function is evaluated using Harris Hip Score. The survey has 10 question items and scores range from 0-100 with higher scores representing less dysfunction and better outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>12-month postoperative hip function evaluated by Harris Hip Score</measure>
    <time_frame>12-month postoperative</time_frame>
    <description>Hip function is evaluated using Harris Hip Score. The survey has 10 question items and scores range from 0-100 with higher scores representing less dysfunction and better outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>3-month postoperative degree of collapse evaluated by plain radiograph</measure>
    <time_frame>3-month postoperative</time_frame>
    <description>Degree of collapse is evaluated by plain radiograph</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6-month postoperative degree of collapse evaluated by plain radiograph</measure>
    <time_frame>6-month postoperative</time_frame>
    <description>Degree of collapse is evaluated by plain radiograph</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>12-month postoperative degree of collapse evaluated by plain radiograph</measure>
    <time_frame>12-month postoperative</time_frame>
    <description>Degree of collapse is evaluated by plain radiograph</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6-month postoperative degree of collapse evaluated by MRI</measure>
    <time_frame>6-month postoperative</time_frame>
    <description>Degree of collapse is evaluated by MRI</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Avascular Necrosis of Femur</condition>
  <condition>Bone Marrow</condition>
  <arm_group>
    <arm_group_label>Bone marrow concentration group</arm_group_label>
    <description>The patients receive core decompression surgery with bone marrow concentration.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Historical control group</arm_group_label>
    <description>The previous age-, gender-, and stage-matched patients who received core decompression surgery only.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Core decompression surgery with bone marrow concentration</intervention_name>
    <description>Core decompression surgery with bone marrow concentration</description>
    <arm_group_label>Bone marrow concentration group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Core decompression surgery</intervention_name>
    <description>Core decompression surgery only</description>
    <arm_group_label>Historical control group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        consecutive eligible patients who underwent core decompression combined with autologous&#xD;
        bone marrow stem cells treatment for avascular necrosis of the femoral head&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 30 and 60 years&#xD;
&#xD;
          -  With diagnosis of avascular necrosis of femoral head, Stage I - Stage III&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  With diagnosis of avascular necrosis of femoral head, Stage VI - Stage VI&#xD;
&#xD;
          -  With prior history of hip surgery&#xD;
&#xD;
          -  With current or prior history of trauma or infection at hip&#xD;
&#xD;
          -  Platelet count &lt; 50,000/µL&#xD;
&#xD;
          -  With current diagnosis of coagulopathy&#xD;
&#xD;
          -  With current or prior history of cancer&#xD;
&#xD;
          -  With current or prior history of hematological disease&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Patients who will not cooperate with one-year followup&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pei-Yuan Lee, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Show Chwan Memorial Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Chang-Han Chuang, MD</last_name>
    <phone>+886-975611794</phone>
    <email>skyman889@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Show Chwan Memorial Hospital</name>
      <address>
        <city>Changhua City</city>
        <state>Changhua</state>
        <zip>500</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chang-Han Chuang, MD</last_name>
      <phone>+886-975611794</phone>
      <email>skyman889@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>December 22, 2018</study_first_submitted>
  <study_first_submitted_qc>December 22, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>April 11, 2020</last_update_submitted>
  <last_update_submitted_qc>April 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Show Chwan Memorial Hospital</investigator_affiliation>
    <investigator_full_name>Pei-Yuan Lee, MD</investigator_full_name>
    <investigator_title>Superintendent</investigator_title>
  </responsible_party>
  <keyword>Femur Head Necrosis</keyword>
  <keyword>Mesenchymal Stromal Cells</keyword>
  <keyword>Bone Marrow</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteonecrosis</mesh_term>
    <mesh_term>Necrosis</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/NCT03787329
org study id: RD-106057
nct id: NCT03787329
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study aims to evaluate the effect of bone marrow concentration on avascular necrosis of
      femur head by comparing clinical and imaging outcomes between patients receiving core
      decompression surgery with intraoperative bone marrow concentration and those receiving core
      decompression surgery only.
Avascular necrosis (AVN) of femoral head is a progressive disease that predominantly affects
      younger patients. Although the exact pathophysiology of AVN has not yet to be elucidated, the
      disease is characterized by a vascular insult to the blood supply of the femoral head, which
      can lead to collapse of the femoral head and subsequent degenerative changes. Mesenchymal
      stem cells (MSCs) are pluripotent cells that can differentiate into multiple mesenchymal
      tissues, including tenocytes, chondrocytes and osteoblasts, as well as being a source of
      multiple growth factors to establish an environment conducive to soft and hard tissue
      regeneration. As bone marrow concentration has high concentration of mesenchymal stem cells,
      several studies have applied the autologous bone marrow concentration in halting the
      progression of AVN of femoral head. However, a higher level of evidence for its use on
      patients suffering from femoral head avascular necrosis has not been reported. This clinical
      trial will evaluate and compare the eligible patients who undertake core decompression
      surgery plus intraoperative bone marrow concentration with those who received core
      decompression surgery only. All patients will be followed for one year and clinical and
      imaging outcomes will be compared and analyzed.
observational model: Case-Control
time perspective: Prospective
measure: 3-month postoperative hip function evaluated by Harris Hip Score
time frame: 3-month postoperative
description: Hip function is evaluated using Harris Hip score. The survey has 10 question items and scores range from 0-100 with higher scores representing less dysfunction and better outcomes.
measure: 6-month postoperative hip function evaluated by Harris Hip Score
time frame: 6-month postoperative
description: Hip function is evaluated using Harris Hip Score. The survey has 10 question items and scores range from 0-100 with higher scores representing less dysfunction and better outcomes.
measure: 12-month postoperative hip function evaluated by Harris Hip Score
time frame: 12-month postoperative
description: Hip function is evaluated using Harris Hip Score. The survey has 10 question items and scores range from 0-100 with higher scores representing less dysfunction and better outcomes.
measure: 3-month postoperative degree of collapse evaluated by plain radiograph
time frame: 3-month postoperative
description: Degree of collapse is evaluated by plain radiograph
measure: 6-month postoperative degree of collapse evaluated by plain radiograph
time frame: 6-month postoperative
description: Degree of collapse is evaluated by plain radiograph
measure: 12-month postoperative degree of collapse evaluated by plain radiograph
time frame: 12-month postoperative
description: Degree of collapse is evaluated by plain radiograph
measure: 6-month postoperative degree of collapse evaluated by MRI
time frame: 6-month postoperative
description: Degree of collapse is evaluated by MRI
arm group label: Bone marrow concentration group
description: The patients receive core decompression surgery with bone marrow concentration.
arm group label: Historical control group
description: The previous age-, gender-, and stage-matched patients who received core decompression surgery only.
intervention type: Other
intervention name: Core decompression surgery with bone marrow concentration
description: Core decompression surgery with bone marrow concentration
arm group label: Bone marrow concentration group
intervention type: Other
intervention name: Core decompression surgery
description: Core decompression surgery only
arm group label: Historical control group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 30 Years
maximum age: 60 Years
healthy volunteers: No
last name: Pei-Yuan Lee, MD
role: Study Chair
affiliation: Show Chwan Memorial Hospital
last name: Chang-Han Chuang, MD
phone: +886-975611794
email: skyman889@gmail.com
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Sponsor-Investigator
investigator affiliation: Show Chwan Memorial Hospital
investigator full name: Pei-Yuan Lee, MD
investigator title: Superintendent
mesh term: Osteonecrosis
mesh term: Necrosis
sharing ipd: No