<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/NCT04413565</url>
  </required_header>
  <id_info>
    <org_study_id>08.12.2016-71306642-050.01.04</org_study_id>
    <nct_id>NCT04413565</nct_id>
  </id_info>
  <brief_title>Infection Rate of One-Stage Bilateral TKR - One Surgeon Sequential vs. Two Surgeon Simultaneous: A Randomized Controlled Study</brief_title>
  <official_title>Infection Rate 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>
      The use of bilateral total knee replacements (TKR) is increasing with the number of patients&#xD;
      with bilateral end-stage knee osteoarthritis. Bilateral TKR can be performed in three&#xD;
      different ways: single-stage, two-team simultaneous bilateral TKR (two surgeons bilateral&#xD;
      TKR); single-stage, a sequential bilateral TKR (single surgeon bilateral TKR); and two-stage&#xD;
      bilateral TKR. Periprosthetic joint (PJI) infections are serious complications after TKR that&#xD;
      negatively affect the aimed outcome, decrease patient satisfaction, and increase morbidity&#xD;
      and mortality. The incidence of PJI is 1-2% and the number of cases is projected to grow as&#xD;
      the indications for TKR continue to increase. Investigators will prospectively compare the&#xD;
      incidence of periprosthetic joint infection between groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      924 knees (462 participants) will prospectively be randomized into 2 groups: two surgeons&#xD;
      bilateral TKA and single surgeon bilateral TKA. While 2 surgeons will perform simultaneous&#xD;
      total knee arthroplasty in the two surgeons' bilateral TKA group, one surgeon will perform&#xD;
      sequentially in the single surgeon bilateral TKA group. The primary outcome is to compare the&#xD;
      incidence of PJI between the groups. Secondary, logistic regression use to estimate the&#xD;
      effect of two surgeons bilateral TKA and single surgeon bilateral TKA on the likelihood of a&#xD;
      patient being infected.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 8, 2016</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">November 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>Infection incedence</measure>
    <time_frame>90 days</time_frame>
    <description>Early infection rates</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">413</enrollment>
  <condition>Infection Joint</condition>
  <condition>Joint Infection</condition>
  <condition>Arthroplasty Complications</condition>
  <arm_group>
    <arm_group_label>Two surgeon bilateral TKA group</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 surgeon bilateral TKA group</description>
    <arm_group_label>Two surgeon bilateral TKA group</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 without severe extra-articular deformities&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <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>May 2020</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>May 29, 2020</last_update_submitted>
  <last_update_submitted_qc>May 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 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>Infections</mesh_term>
    <mesh_term>Communicable Diseases</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/NCT04413565
org study id: 08.12.2016-71306642-050.01.04
nct id: NCT04413565
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The use of bilateral total knee replacements (TKR) is increasing with the number of patients
      with bilateral end-stage knee osteoarthritis. Bilateral TKR can be performed in three
      different ways: single-stage, two-team simultaneous bilateral TKR (two surgeons bilateral
      TKR); single-stage, a sequential bilateral TKR (single surgeon bilateral TKR); and two-stage
      bilateral TKR. Periprosthetic joint (PJI) infections are serious complications after TKR that
      negatively affect the aimed outcome, decrease patient satisfaction, and increase morbidity
      and mortality. The incidence of PJI is 1-2% and the number of cases is projected to grow as
      the indications for TKR continue to increase. Investigators will prospectively compare the
      incidence of periprosthetic joint infection between groups.
924 knees (462 participants) will prospectively be randomized into 2 groups: two surgeons
      bilateral TKA and single surgeon bilateral TKA. While 2 surgeons will perform simultaneous
      total knee arthroplasty in the two surgeons' bilateral TKA group, one surgeon will perform
      sequentially in the single surgeon bilateral TKA group. The primary outcome is to compare the
      incidence of PJI between the groups. Secondary, logistic regression use to estimate the
      effect of two surgeons bilateral TKA and single surgeon bilateral TKA on the likelihood of a
      patient being infected.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Infection incedence
time frame: 90 days
description: Early infection rates
arm group label: Two surgeon bilateral TKA group
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 surgeon bilateral TKA group
arm group label: Two surgeon bilateral TKA group
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: 18 Years
maximum age: N/A
healthy volunteers: No
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: Infections
mesh term: Communicable Diseases
sharing ipd: No