<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/NCT04415814</url>
  </required_header>
  <id_info>
    <org_study_id>1123</org_study_id>
    <nct_id>NCT04415814</nct_id>
  </id_info>
  <brief_title>Unilateral Versus Bilateral Pedicle Screw Fixation for Lumbar Degenerative Diseases</brief_title>
  <official_title>Unilateral Versus Bilateral Pedicle Screw Fixation for Lumbar Degenerative Diseases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>I.M. Sechenov First Moscow State Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>I.M. Sechenov First Moscow State Medical University</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>
      Determining the treatment strategy for patients with degenerative diseases of the spine is&#xD;
      extremely difficult, without an accurate understanding of the nature of stress distribution&#xD;
      in the vertebral-motor segments of the spine, as well as biomechanical changes that are&#xD;
      associated with degenerative diseases of the spine. In this clinical study, we want to&#xD;
      compare the use of unilateral and bilateral transpedicular fixation for treating the patients&#xD;
      with degenerative diseases of the lumbar spine.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It is planned to use posterior stabilization without interbody fusion. In the postoperative&#xD;
      period, all the patients receive antibacterial and analgesic therapy. The early postoperative&#xD;
      period is spent in a hospital. Repeated appearances for control examinations (3, 6, 12&#xD;
      months) are provided for physical examination (EQ-5D, Oswestry Disability Index) and&#xD;
      performing radiographs or computed tomography (CT) of the spine. All patients undergo a&#xD;
      standard rehabilitation course.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">August 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>fusion rate of the operated spine segment</measure>
    <time_frame>in 3 months after surgery</time_frame>
    <description>Control CT/Radiography examination</description>
  </primary_outcome>
  <primary_outcome>
    <measure>fusion rate of the operated spine segment</measure>
    <time_frame>in 6 months after surgery</time_frame>
    <description>Control CT/Radiography examination</description>
  </primary_outcome>
  <primary_outcome>
    <measure>fusion rate of the operated spine segment</measure>
    <time_frame>in 12 months after surgery</time_frame>
    <description>Control CT/Radiography examination</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Fusion of Spine</condition>
  <arm_group>
    <arm_group_label>Group 1 (Unilateral Pedicle Screw Fixation)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will undergo stabilizing surgery on the lumbar spine for degenerative diseases of the spine. Pedicular screws will be installed unilaterally, which means on one side of the spinous processes. The system will be fixed with standard rod and blockers.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2 (Bilateral Pedicle Screw Fixation)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will undergo stabilizing surgery on the lumbar spine for degenerative diseases of the spine. Pedicular screws will be installed bilaterally, which means on the both sides of the spinous processes. The system will be fixed with standard rods and blockers.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Unilateral Pedicle Screw Fixation</intervention_name>
    <description>Pedicle screws are installed unilaterally on the one side of the vertebrae and fixed with rod</description>
    <arm_group_label>Group 1 (Unilateral Pedicle Screw Fixation)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Bilateral Pedicle Screw Fixation</intervention_name>
    <description>Pedicle screws are installed bilaterally on the both sides of the vertebrae and fixed with rods</description>
    <arm_group_label>Group 2 (Bilateral Pedicle Screw Fixation)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written informed consent of the patient to participate in the study;&#xD;
&#xD;
          -  Patients with degenerative diseases of the lumbar spine.&#xD;
&#xD;
          -  The opportunity for observation during the entire study period (12 months);&#xD;
&#xD;
          -  Mental adequacy, ability, willingness to cooperate and follow the doctor's&#xD;
             recommendations.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The refusal of a patient from surgery&#xD;
&#xD;
          -  The presence of contraindications to surgery&#xD;
&#xD;
          -  Severe forms of diabetes (glycosylated hemoglobin &gt;9%);&#xD;
&#xD;
          -  Blood diseases (thrombopenia, thrombocytopenia, anemia with Hb&lt; 90g\l);&#xD;
&#xD;
          -  The unwillingness of the patient to conscious cooperation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alexey Lychagin, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>IM Sechenov University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Vadim Cherepanov, MD, PhD</last_name>
    <phone>+79166548850</phone>
    <email>cvg_cherepanov@mail.ru</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ivan Vyazankin, MD</last_name>
    <phone>+79163770457</phone>
    <email>vzvzvzvan@mail.ru</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Sechenov University</name>
      <address>
        <city>Moscow</city>
        <zip>119991</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vadim Cherepanov, professor</last_name>
      <phone>+79166548850</phone>
      <email>cvg_cherepanov@mail.ru</email>
    </contact>
    <contact_backup>
      <last_name>Ivan Vyazankin</last_name>
      <phone>+79163770457</phone>
      <email>vzvzvzvan@mail.ru</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>May 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>September 24, 2020</last_update_submitted>
  <last_update_submitted_qc>September 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>degenerative spine</keyword>
  <keyword>unilateral fixation of the spine</keyword>
  <keyword>fusion of the lumbar spine</keyword>
  <keyword>posterior stabilization</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/NCT04415814
org study id: 1123
nct id: NCT04415814
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Determining the treatment strategy for patients with degenerative diseases of the spine is
      extremely difficult, without an accurate understanding of the nature of stress distribution
      in the vertebral-motor segments of the spine, as well as biomechanical changes that are
      associated with degenerative diseases of the spine. In this clinical study, we want to
      compare the use of unilateral and bilateral transpedicular fixation for treating the patients
      with degenerative diseases of the lumbar spine.
It is planned to use posterior stabilization without interbody fusion. In the postoperative
      period, all the patients receive antibacterial and analgesic therapy. The early postoperative
      period is spent in a hospital. Repeated appearances for control examinations (3, 6, 12
      months) are provided for physical examination (EQ-5D, Oswestry Disability Index) and
      performing radiographs or computed tomography (CT) of the spine. All patients undergo a
      standard rehabilitation course.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: fusion rate of the operated spine segment
time frame: in 3 months after surgery
description: Control CT/Radiography examination
measure: fusion rate of the operated spine segment
time frame: in 6 months after surgery
description: Control CT/Radiography examination
measure: fusion rate of the operated spine segment
time frame: in 12 months after surgery
description: Control CT/Radiography examination
arm group label: Group 1 (Unilateral Pedicle Screw Fixation)
arm group type: Experimental
description: Patients will undergo stabilizing surgery on the lumbar spine for degenerative diseases of the spine. Pedicular screws will be installed unilaterally, which means on one side of the spinous processes. The system will be fixed with standard rod and blockers.
arm group label: Group 2 (Bilateral Pedicle Screw Fixation)
arm group type: Active Comparator
description: Patients will undergo stabilizing surgery on the lumbar spine for degenerative diseases of the spine. Pedicular screws will be installed bilaterally, which means on the both sides of the spinous processes. The system will be fixed with standard rods and blockers.
intervention type: Procedure
intervention name: Unilateral Pedicle Screw Fixation
description: Pedicle screws are installed unilaterally on the one side of the vertebrae and fixed with rod
arm group label: Group 1 (Unilateral Pedicle Screw Fixation)
intervention type: Procedure
intervention name: Bilateral Pedicle Screw Fixation
description: Pedicle screws are installed bilaterally on the both sides of the vertebrae and fixed with rods
arm group label: Group 2 (Bilateral Pedicle Screw Fixation)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Alexey Lychagin, MD, PhD
role: Study Chair
affiliation: IM Sechenov University
last name: Vadim Cherepanov, MD, PhD
phone: +79166548850
email: cvg_cherepanov@mail.ru
last name: Ivan Vyazankin, MD
phone: +79163770457
email: vzvzvzvan@mail.ru
facility: 
status: Recruiting
contact: 
contact backup: 
country: Russian Federation
responsible party type: Sponsor
sharing ipd: No