<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/NCT03244969</url>
  </required_header>
  <id_info>
    <org_study_id>hematoma-2017</org_study_id>
    <nct_id>NCT03244969</nct_id>
  </id_info>
  <brief_title>Bone Healing Study</brief_title>
  <official_title>Study of the Granulation Tissue Formation in the Early Fracture Hematoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kazan Federal University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kazan Federal University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the research is to identify structural tissue changes in the early fracture&#xD;
      hematomas.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The fracture hematomas obtained during reconstructive bone surgery from patients with bone&#xD;
      fractures will be examined. Histological methods and ultra-thin sections for electron&#xD;
      microscopy will be used to identify structural tissue changes in the granulation tissue in&#xD;
      different period of time after bone fracture. Immunohistochemical analysis will be performed&#xD;
      to estimate the dynamic of proliferation, differentiation and cell migration during&#xD;
      granulation and reticulofibrosis bone tissues development.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Study was registered in another clinicaltrials.gov entry&#xD;
  </why_stopped>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Anticipated">November 2017</completion_date>
  <primary_completion_date type="Anticipated">October 2017</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Granulation tissue formation</measure>
    <time_frame>23 days</time_frame>
  </primary_outcome>
  <enrollment type="Actual">0</enrollment>
  <condition>Bone Fracture</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with fractures of the upper and lower extremities underwent surgical bone&#xD;
        recunstruction.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with fractures of the upper and lower extremities&#xD;
&#xD;
          -  Patients for whom the surgical bone reconstruction are indicated&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>84 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Igor Plaksa</name>
      <address>
        <city>Moscow</city>
        <zip>119333</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <last_update_submitted>August 31, 2021</last_update_submitted>
  <last_update_submitted_qc>August 31, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kazan Federal University</investigator_affiliation>
    <investigator_full_name>Mikhail Mavlikeev</investigator_full_name>
    <investigator_title>aspirant of the morphology department</investigator_title>
  </responsible_party>
  <keyword>Hematoma fracture, angiogenesis, bone formation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT03244969
org study id: hematoma-2017
nct id: NCT03244969
lead sponsor: 
has dmc: No
The aim of the research is to identify structural tissue changes in the early fracture
      hematomas.
The fracture hematomas obtained during reconstructive bone surgery from patients with bone
      fractures will be examined. Histological methods and ultra-thin sections for electron
      microscopy will be used to identify structural tissue changes in the granulation tissue in
      different period of time after bone fracture. Immunohistochemical analysis will be performed
      to estimate the dynamic of proliferation, differentiation and cell migration during
      granulation and reticulofibrosis bone tissues development.
observational model: Cohort
time perspective: Prospective
measure: Granulation tissue formation
time frame: 23 days
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 84 Years
healthy volunteers: No
facility: 
country: Russian Federation
responsible party type: Principal Investigator
investigator affiliation: Kazan Federal University
investigator full name: Mikhail Mavlikeev
investigator title: aspirant of the morphology department
mesh term: Fractures, Bone
sharing ipd: Yes