<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/NCT04434690</url>
  </required_header>
  <id_info>
    <org_study_id>71306642-050.01.04</org_study_id>
    <nct_id>NCT04434690</nct_id>
  </id_info>
  <brief_title>Radiologic Results of One-Stage Bilateral TKR - One Surgeon Sequential vs. Two Surgeon Simultaneous: A Randomized Controlled Study</brief_title>
  <official_title>Radiologic Results of One-Stage Bilateral TKR - One Surgeon Sequential vs. Two Surgeon Simultaneous: A Randomized Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bezmialem Vakif University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bezmialem Vakif University</source>
  <oversight_info>
    <has_dmc>No</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>
      Many surgeons and patients prefer bilateral total knee arthroplasty (TKA) under one&#xD;
      anesthesia as single-stage administration. A single-stage bilateral TKA can be performed in&#xD;
      two different ways: single-stage, two-team simultaneous bilateral TKA (two surgeons bilateral&#xD;
      TKA), and single-stage, a sequential bilateral TKA (single surgeon bilateral TKA). The&#xD;
      purpose of this study is to evaluate the radiological results in the single-stage bilateral&#xD;
      TKA in terms of two surgeons bilateral TKA and single surgeon bilateral TKA.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Investigators will enroll 136 participants with primary bilateral symptomatic knee&#xD;
      osteoarthritis that will refractory to conservative treatment who will undergo bilateral TKA&#xD;
      under single anaesthesia after 15.06.2020. Investigators will include patients who were less&#xD;
      than 75 years old, with no history of malignancy, without severe extra-articular deformities,&#xD;
      and without the systemic inflammatory disease, severe cardiac insufficiency, and morbid&#xD;
      obesity (&gt;40 kg/m2 or 35 or more and experiencing obesity-related health conditions). An&#xD;
      informed consent form will be obtained from all patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Anticipated">October 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">October 30, 2020</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Radiological examination</measure>
    <time_frame>14days</time_frame>
    <description>Coronal and Sagittal Alignment</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Gonarthrosis; Primary</condition>
  <arm_group>
    <arm_group_label>Simultaneous</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2 surgeons will perform simultaneous total knee arthroplasty in this group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Single surgeon bilateral TKA group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>One surgeon will perform sequentially tptal knee arthroplasty in this group</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Simultaneous bilateral total knee arthroplasty</intervention_name>
    <description>Two surgeons bilateral TKA group</description>
    <arm_group_label>Simultaneous</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Sequenced bilateral TKA</intervention_name>
    <description>Single surgeon bilateral TKA group</description>
    <arm_group_label>Single surgeon bilateral TKA group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Primary bilateral knee osteoarthritis with refractory to conservative treatment Patients&#xD;
        who accept participation in the research and the randomization&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        no history of malignancy less than 75 years old without severe extra-articular deformities&#xD;
        severe cardiac insufficiency and morbid obesity without systemic inflammatory diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Orkhan Aliyev, MD</last_name>
    <phone>+90 505 991 71 19</phone>
    <email>orkhanaliyev@outlook.com.tr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Bezmialem Vakif University</name>
      <address>
        <city>Istanbul</city>
        <state>Fatih</state>
        <zip>34000</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Orkhan Aliyev</last_name>
      <phone>05059917419</phone>
      <email>orkhanaliyev@outlook.com.tr</email>
    </contact>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 13, 2020</study_first_submitted>
  <study_first_submitted_qc>June 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>June 13, 2020</last_update_submitted>
  <last_update_submitted_qc>June 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bezmialem Vakif University</investigator_affiliation>
    <investigator_full_name>Orkhan Aliyev</investigator_full_name>
    <investigator_title>MD, Resident Doctor in Orthopaedic Surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis, Knee</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/NCT04434690
org study id: 71306642-050.01.04
nct id: NCT04434690
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Many surgeons and patients prefer bilateral total knee arthroplasty (TKA) under one
      anesthesia as single-stage administration. A single-stage bilateral TKA can be performed in
      two different ways: single-stage, two-team simultaneous bilateral TKA (two surgeons bilateral
      TKA), and single-stage, a sequential bilateral TKA (single surgeon bilateral TKA). The
      purpose of this study is to evaluate the radiological results in the single-stage bilateral
      TKA in terms of two surgeons bilateral TKA and single surgeon bilateral TKA.
Investigators will enroll 136 participants with primary bilateral symptomatic knee
      osteoarthritis that will refractory to conservative treatment who will undergo bilateral TKA
      under single anaesthesia after 15.06.2020. Investigators will include patients who were less
      than 75 years old, with no history of malignancy, without severe extra-articular deformities,
      and without the systemic inflammatory disease, severe cardiac insufficiency, and morbid
      obesity (>40 kg/m2 or 35 or more and experiencing obesity-related health conditions). An
      informed consent form will be obtained from all patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Radiological examination
time frame: 14days
description: Coronal and Sagittal Alignment
arm group label: Simultaneous
arm group type: Experimental
description: 2 surgeons will perform simultaneous total knee arthroplasty in this group.
arm group label: Single surgeon bilateral TKA group
arm group type: Active Comparator
description: One surgeon will perform sequentially tptal knee arthroplasty in this group
intervention type: Procedure
intervention name: Simultaneous bilateral total knee arthroplasty
description: Two surgeons bilateral TKA group
arm group label: Simultaneous
intervention type: Procedure
intervention name: Sequenced bilateral TKA
description: Single surgeon bilateral TKA group
arm group label: Single surgeon bilateral TKA group
criteria: 
gender: All
minimum age: 35 Years
maximum age: 75 Years
healthy volunteers: No
last name: Orkhan Aliyev, MD
phone: +90 505 991 71 19
email: orkhanaliyev@outlook.com.tr
facility: 
status: Recruiting
contact: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Bezmialem Vakif University
investigator full name: Orkhan Aliyev
investigator title: MD, Resident Doctor in Orthopaedic Surgery
mesh term: Osteoarthritis, Knee
sharing ipd: No