xml: <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/NCT06005753</url>
    </required_header>
    <id_info>
      <org_study_id>BR11065157(04)</org_study_id>
      <nct_id>NCT06005753</nct_id>
    </id_info>
    <brief_title>Surgical Treatment of Injuries and Consequences of the Acetabulum</brief_title>
    <official_title>Improving the Surgical Treatment of Injuries and Consequences of Injuries of the Acetabulum</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>National Scientific Center of Traumatology and Orthopedics named after academician N.D. Batpenov</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>National Scientific Center of Traumatology and Orthopedics named after academician N.D. Batpenov</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>
        The aim of the program is to develop technologies for the diagnosis and treatment of injuries&#xD;
        and consequences of the pelvis.&#xD;
  &#xD;
        Purpose: to improve the technique of surgical treatment of acetabular fractures.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Tasks: Implementation of low-traumatic access to the acetabulum; introduction of a new&#xD;
        implant for osteosynthesis of complex acetabular fractures into clinical practice;&#xD;
        мathematical modeling of fixation of the acetabulum with a new implant; рublication of the&#xD;
        results of the work carried out The relevance of the use of new implants in orthopedics is&#xD;
        due to the problem of adaptation of implants in the body, especially with poor quality of&#xD;
        bone tissue. Currently, work is underway to improve the materials and shapes of implants, new&#xD;
        alloys are being studied, polymer implants are being introduced, but the problem of their&#xD;
        integration into bones remains. A promising direction in orthopedics is the creation of&#xD;
        implants as close as possible in their morphological shape and elasto-strength properties to&#xD;
        human bone. But the creation of an absolute copy of the bone structure from a metal alloy&#xD;
        leads to a weakening of its strength and loss of fixation stability, and subsequent lysis of&#xD;
        the adjacent bone tissue.&#xD;
  &#xD;
        All this indicates the need for further search for new, perhaps more promising and effective&#xD;
        ways to solve this problem.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">November 25, 2021</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</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>consolidation of fracture</measure>
      <time_frame>1 year follow-up</time_frame>
      <description>Evaluation of results using the radiological Matta criterion, the Harris Hip Score</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Acetabular Fracture</condition>
    <arm_group>
      <arm_group_label>Group A</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Surgical intervention group</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Ostheosynthesis of acetabular fractures</intervention_name>
      <description>The using of plate for fixation of acetabular fractures in surgical treatment</description>
      <arm_group_label>Group A</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  patients over 18 years of age&#xD;
  &#xD;
            -  patients with acetabular fractures undergoing surgery&#xD;
  &#xD;
            -  acetabular fractures according to the classification of Judet and Letournel&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  patients under 18 years of age&#xD;
  &#xD;
            -  posterior wall fracture according to the classification of Judet and Letournel&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Nagmet Mursalov, Phd</last_name>
      <phone>+77078553651</phone>
      <email>nagmet2007@mail.ru</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Nurgeldi Manap, Phd student</last_name>
      <phone>+77078088656</phone>
      <email>nurgeldi.manap@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Center of National Scientific center Of Traumatology and Orthopedics named after academician N.D. Batpenov</name>
        <address>
          <city>Astana</city>
          <zip>010000</zip>
          <country>Kazakhstan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Nagmet Mursalov, PhD</last_name>
        <phone>+77078553651</phone>
        <email>nagmet2007@mail.ru</email>
      </contact>
      <contact_backup>
        <last_name>Nurgeldi Manap, PhD student</last_name>
        <phone>+77078088656</phone>
        <email>nurgeldi.manap@gmail.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Kazakhstan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>National Scientific Center of Traumatology and Orthopedics named after academician N.D. Batpenov</investigator_affiliation>
      <investigator_full_name>Olzhas Bekarissov</investigator_full_name>
      <investigator_title>Chief of NSCTO</investigator_title>
    </responsible_party>
    <keyword>acetabulum</keyword>
    <keyword>osteosynthesis</keyword>
    <keyword>Stoppa approach</keyword>
    <keyword>fracture</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>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06005753
  org study id: BR11065157(04)
  nct id: NCT06005753
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The aim of the program is to develop technologies for the diagnosis and treatment of injuries
        and consequences of the pelvis.
  
        Purpose: to improve the technique of surgical treatment of acetabular fractures.
  Tasks: Implementation of low-traumatic access to the acetabulum; introduction of a new
        implant for osteosynthesis of complex acetabular fractures into clinical practice;
        мathematical modeling of fixation of the acetabulum with a new implant; рublication of the
        results of the work carried out The relevance of the use of new implants in orthopedics is
        due to the problem of adaptation of implants in the body, especially with poor quality of
        bone tissue. Currently, work is underway to improve the materials and shapes of implants, new
        alloys are being studied, polymer implants are being introduced, but the problem of their
        integration into bones remains. A promising direction in orthopedics is the creation of
        implants as close as possible in their morphological shape and elasto-strength properties to
        human bone. But the creation of an absolute copy of the bone structure from a metal alloy
        leads to a weakening of its strength and loss of fixation stability, and subsequent lysis of
        the adjacent bone tissue.
  
        All this indicates the need for further search for new, perhaps more promising and effective
        ways to solve this problem.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: consolidation of fracture
  time frame: 1 year follow-up
  description: Evaluation of results using the radiological Matta criterion, the Harris Hip Score
  arm group label: Group A
  arm group type: Experimental
  description: Surgical intervention group
  intervention type: Procedure
  intervention name: Ostheosynthesis of acetabular fractures
  description: The using of plate for fixation of acetabular fractures in surgical treatment
  arm group label: Group A
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Nagmet Mursalov, Phd
  phone: +77078553651
  email: nagmet2007@mail.ru
  last name: Nurgeldi Manap, Phd student
  phone: +77078088656
  email: nurgeldi.manap@gmail.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Kazakhstan
  responsible party type: Principal Investigator
  investigator affiliation: National Scientific Center of Traumatology and Orthopedics named after academician N.D. Batpenov
  investigator full name: Olzhas Bekarissov
  investigator title: Chief of NSCTO
  mesh term: Fractures, Bone
  sharing ipd: No