<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/NCT03794622</url>
  </required_header>
  <id_info>
    <org_study_id>RD106049</org_study_id>
    <nct_id>NCT03794622</nct_id>
  </id_info>
  <brief_title>Autologous Bone Marrow Concentration for Femoral Shaft Fracture Union</brief_title>
  <official_title>The Effect of Autologous Bone Marrow Concentration on Femoral Shaft Fracture Union</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>
    <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 union of femoral shaft&#xD;
      fracture by comparing clinical and imaging outcomes between patients receiving Intramedullary&#xD;
      nail fixation with intraoperative bone marrow concentration and those receiving&#xD;
      Intramedullary nail fixation only.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Femoral shaft fracture is a common orthopaedic injury. Intramedullary nail is one of the&#xD;
      standard treatments. Its primary goal is to develop an osseous bridge between adjacent motion&#xD;
      segments to prevent motion, relieve pain, and facilitate bone union. Delayed union or&#xD;
      nonunion is common in femoral shaft fracture. Risk factors include comminuted fracture, open&#xD;
      fracture, smoking, diabetes and open reduction of fracture fixation. Mesenchymal stem cells&#xD;
      are pluripotent cells that can differentiate into multiple mesenchymal tissues, including&#xD;
      tenocytes, chondrocytes and osteoblasts, as well as being a source of multiple growth factors&#xD;
      to establish an environment conducive to soft and hard tissue regeneration. As bone marrow&#xD;
      concentration has high concentration of mesenchymal stem cells, some studies have shown that&#xD;
      autologous bone marrow concentration can improve bone healing. Therefore, the goal of this&#xD;
      study was to evaluate the effect of bone marrow concentration on union of femoral shaft&#xD;
      fracture.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 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>1-month postoperative degree of union evaluated by plain radiograph</measure>
    <time_frame>1-month postoperative</time_frame>
    <description>Degree of union evaluated by plain radiograph</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>2-month postoperative degree of union evaluated by plain radiograph</measure>
    <time_frame>2-month postoperative</time_frame>
    <description>Degree of union evaluated by plain radiograph</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>3-month postoperative degree of union evaluated by plain radiograph</measure>
    <time_frame>3-month postoperative</time_frame>
    <description>Degree of union evaluated by plain radiograph</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6-month postoperative degree of union evaluated by plain radiograph</measure>
    <time_frame>6-month postoperative</time_frame>
    <description>Degree of union evaluated by plain radiograph</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>12-month postoperative degree of union evaluated by plain radiograph</measure>
    <time_frame>12-month postoperative</time_frame>
    <description>Degree of union evaluated by plain radiograph</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Bone Marrow</condition>
  <condition>Femoral Shaft Fracture</condition>
  <arm_group>
    <arm_group_label>Bone marrow concentration group</arm_group_label>
    <description>Consecutive patients receive intramedullary nail fixation with bone marrow concentration.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Historical control group</arm_group_label>
    <description>Previous age- and gender-matched patients who receive intramedullary nail fixation only.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>intramedullary nail fixation with bone marrow concentration</intervention_name>
    <description>intramedullary nail fixation with bone marrow concentration</description>
    <arm_group_label>Bone marrow concentration group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>intramedullary nail fixation</intervention_name>
    <description>intramedullary nail fixation only</description>
    <arm_group_label>Historical control group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        consecutive eligible patients who underwent intramedullary nail fixation combined with&#xD;
        autologous bone marrow stem cells treatment for femoral shaft fracture&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  With recent diagnosis of femoral shaft fracture&#xD;
&#xD;
          -  Treated with intramedullary nail fixation&#xD;
&#xD;
          -  With one or more risk factors of non-union: comminuted fracture, open fracture,&#xD;
             smoking, obesity, diabetes, open reduction,&#xD;
&#xD;
          -  Age between 20 and 80 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Old femoral shaft fracture&#xD;
&#xD;
          -  With concurrent major trauma, ex. intracranial hemorrhage, pneumothorax, hemothorax,&#xD;
             internal bleeding.&#xD;
&#xD;
          -  With prior history of femoral surgery&#xD;
&#xD;
          -  With current or prior history of trauma or infection at femur&#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>20 Years</minimum_age>
    <maximum_age>80 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>Hsin-Chuan Chen, MD</last_name>
    <phone>+886975611139</phone>
    <email>henang0424@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Pei-Yuan Lee, MD</last_name>
  </overall_contact_backup>
  <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>Hsin-Chuan Chen, MD</last_name>
      <phone>+886975611139</phone>
      <email>henang0424@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>January 2, 2019</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 7, 2019</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>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Bone Marrow</keyword>
  <keyword>Mesenchymal Stromal Cells</keyword>
  <keyword>Femoral Shaft Fracture</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Femoral Fractures</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/NCT03794622
org study id: RD106049
nct id: NCT03794622
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This study aims to evaluate the effect of bone marrow concentration on union of femoral shaft
      fracture by comparing clinical and imaging outcomes between patients receiving Intramedullary
      nail fixation with intraoperative bone marrow concentration and those receiving
      Intramedullary nail fixation only.
Femoral shaft fracture is a common orthopaedic injury. Intramedullary nail is one of the
      standard treatments. Its primary goal is to develop an osseous bridge between adjacent motion
      segments to prevent motion, relieve pain, and facilitate bone union. Delayed union or
      nonunion is common in femoral shaft fracture. Risk factors include comminuted fracture, open
      fracture, smoking, diabetes and open reduction of fracture fixation. Mesenchymal stem cells
      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, some studies have shown that
      autologous bone marrow concentration can improve bone healing. Therefore, the goal of this
      study was to evaluate the effect of bone marrow concentration on union of femoral shaft
      fracture.
observational model: Case-Control
time perspective: Prospective
measure: 1-month postoperative degree of union evaluated by plain radiograph
time frame: 1-month postoperative
description: Degree of union evaluated by plain radiograph
measure: 2-month postoperative degree of union evaluated by plain radiograph
time frame: 2-month postoperative
description: Degree of union evaluated by plain radiograph
measure: 3-month postoperative degree of union evaluated by plain radiograph
time frame: 3-month postoperative
description: Degree of union evaluated by plain radiograph
measure: 6-month postoperative degree of union evaluated by plain radiograph
time frame: 6-month postoperative
description: Degree of union evaluated by plain radiograph
measure: 12-month postoperative degree of union evaluated by plain radiograph
time frame: 12-month postoperative
description: Degree of union evaluated by plain radiograph
arm group label: Bone marrow concentration group
description: Consecutive patients receive intramedullary nail fixation with bone marrow concentration.
arm group label: Historical control group
description: Previous age- and gender-matched patients who receive intramedullary nail fixation only.
intervention type: Other
intervention name: intramedullary nail fixation with bone marrow concentration
description: intramedullary nail fixation with bone marrow concentration
arm group label: Bone marrow concentration group
intervention type: Other
intervention name: intramedullary nail fixation
description: intramedullary nail fixation only
arm group label: Historical control group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Pei-Yuan Lee, MD
role: Study Chair
affiliation: Show Chwan Memorial Hospital
last name: Hsin-Chuan Chen, MD
phone: +886975611139
email: henang0424@gmail.com
last name: Pei-Yuan Lee, MD
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: Principal Investigator
mesh term: Fractures, Bone
mesh term: Femoral Fractures
sharing ipd: No