<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/NCT04446676</url>
  </required_header>
  <id_info>
    <org_study_id>Gruca Teaching Hospital</org_study_id>
    <nct_id>NCT04446676</nct_id>
  </id_info>
  <brief_title>Impact of the Type of Stabilization in the Two-stage Knee Reimplantation on Reinfection - Prospective, Randomized Study.</brief_title>
  <official_title>Impact of the Type of Stabilization in the Two-stage Knee Reimplantation on Reinfection - Prospective, Randomized Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Prof A Gruca Teaching Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Prof A Gruca Teaching Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Participants after first-stage of knee infection reimplantation will be assign to one of two&#xD;
      groups: with stem vs. with sleeve. Investigators will check participants on clinical,&#xD;
      laboratory and reinfection signs. The main hypothesis is that better mechanical stability of&#xD;
      endoprosthesis with sleeves will support infection treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All participants will be treated because of periprosthetic joint infection of the knee, after&#xD;
      primary arthroplasty. All participants will be treated with two-stage protocol. In first&#xD;
      stage debridement and spacer implantation will be performed. After 6-week antibiotics, when&#xD;
      will be absent clinical or laboratory signs of reinfection, second stage will be performed.&#xD;
      All participants upon fulfillment all inclusion and exclusion criteria will sign informed&#xD;
      consent. With computer software patients will be randomized to one of two groups: with stem&#xD;
      vs. with sleeve. After operation all patients will get target antibiotics for 3 weeks.&#xD;
      Pre-operation and after on periodic controls will checked the Knee Society Score, The Western&#xD;
      Ontario and McMaster Universities Osteoarthritis Index(WOMAC), Visual Analogue Scale. After&#xD;
      2-year observation evaluation of reinfection rate will be performed in both groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 17, 2020</start_date>
  <completion_date type="Anticipated">January 2027</completion_date>
  <primary_completion_date type="Anticipated">July 2026</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>
    <intervention_model_description>Two groups with endoprosthesis stabilisation with stem or sleeve.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reinfection</measure>
    <time_frame>2 years</time_frame>
    <description>Rate of reinfection in both groups</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Loosening radiological signs</measure>
    <time_frame>2 years</time_frame>
    <description>Radiological evaluation of implant loosening with Modern Knee Society Radiographic Evaluation System</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Knee Society Score</measure>
    <time_frame>1 year</time_frame>
    <description>Clinical evaluation of patients after knee revision</description>
  </other_outcome>
  <other_outcome>
    <measure>The Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)</measure>
    <time_frame>1 year</time_frame>
    <description>Clinical evaluation of patients after knee revision</description>
  </other_outcome>
  <other_outcome>
    <measure>Visual Analogue Score</measure>
    <time_frame>1 year</time_frame>
    <description>Clinical evaluation of patients after knee revision</description>
  </other_outcome>
  <other_outcome>
    <measure>Alignment</measure>
    <time_frame>6 weeks</time_frame>
    <description>Radiological alignment of knee after operation in degrees</description>
  </other_outcome>
  <other_outcome>
    <measure>C-reactive protein</measure>
    <time_frame>1 year</time_frame>
    <description>After operation and at period controls (mg/l)</description>
  </other_outcome>
  <other_outcome>
    <measure>Erythrocyte sedimentation rate</measure>
    <time_frame>1 year</time_frame>
    <description>After operation and at period controls (mm/h)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Knee Infection</condition>
  <arm_group>
    <arm_group_label>Stem stabilization</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group of patients with stem endoprosthesis stabilization</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sleeve stabilization</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group of patients with sleeve endoprosthesis stabilization</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>stabilization with stem</intervention_name>
    <description>In both groups revision endoprosthesis of knee will be implanted with stem or sleeve stabilization.</description>
    <arm_group_label>Stem stabilization</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>stabilization with sleeve</intervention_name>
    <description>In both groups revision endoprosthesis of knee will be implanted with stem or sleeve stabilization.</description>
    <arm_group_label>Sleeve stabilization</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  second-stage of knee reimplantation&#xD;
&#xD;
          -  primary knee replacement in primary knee osteoarthritis&#xD;
&#xD;
          -  fulfillment of International Consensus Meeting 2018 infection criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  intraoperative bone defects Anderson Orthopedic Research Institute score &gt;II&#xD;
&#xD;
          -  autoimmune disease&#xD;
&#xD;
          -  diabetes&#xD;
&#xD;
          -  peripheral vascular disease&#xD;
&#xD;
          -  congenital or acquired immunodeficiencies&#xD;
&#xD;
          -  lack of pathogens after first-stage&#xD;
&#xD;
          -  multi-bacterial infection&#xD;
&#xD;
          -  multidirectional instability&#xD;
&#xD;
          -  lack of patient consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paweł Bartosz</last_name>
    <role>Principal Investigator</role>
    <affiliation>Prof. A. Gruca Teaching Hospital in Otwock</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Paweł Bartosz</last_name>
    <phone>+48 793629685</phone>
    <email>pbartosz@vp.pl</email>
  </overall_contact>
  <location>
    <facility>
      <name>Gruca Teaching Hospital, Centre of Postgraduate Medical Centre</name>
      <address>
        <city>Otwock</city>
        <state>Mazowieckie</state>
        <zip>05-400</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Paweł Bartosz</last_name>
      <phone>+48 793629685</phone>
      <email>pbartosz@vp.pl</email>
    </contact>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>June 21, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>March 14, 2022</last_update_submitted>
  <last_update_submitted_qc>March 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Prof A Gruca Teaching Hospital</investigator_affiliation>
    <investigator_full_name>Bartosz Paweł</investigator_full_name>
    <investigator_title>M.D., Ph.D.</investigator_title>
  </responsible_party>
  <keyword>knee arthroplasty</keyword>
  <keyword>infection</keyword>
  <keyword>two-stage</keyword>
  <keyword>sleeve</keyword>
  <keyword>stem</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Reinfection</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Study protocol and Informed consent form will be shared</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>1 year</ipd_time_frame>
  </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/NCT04446676
org study id: Gruca Teaching Hospital
nct id: NCT04446676
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Participants after first-stage of knee infection reimplantation will be assign to one of two
      groups: with stem vs. with sleeve. Investigators will check participants on clinical,
      laboratory and reinfection signs. The main hypothesis is that better mechanical stability of
      endoprosthesis with sleeves will support infection treatment.
All participants will be treated because of periprosthetic joint infection of the knee, after
      primary arthroplasty. All participants will be treated with two-stage protocol. In first
      stage debridement and spacer implantation will be performed. After 6-week antibiotics, when
      will be absent clinical or laboratory signs of reinfection, second stage will be performed.
      All participants upon fulfillment all inclusion and exclusion criteria will sign informed
      consent. With computer software patients will be randomized to one of two groups: with stem
      vs. with sleeve. After operation all patients will get target antibiotics for 3 weeks.
      Pre-operation and after on periodic controls will checked the Knee Society Score, The Western
      Ontario and McMaster Universities Osteoarthritis Index(WOMAC), Visual Analogue Scale. After
      2-year observation evaluation of reinfection rate will be performed in both groups.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Two groups with endoprosthesis stabilisation with stem or sleeve.
primary purpose: Treatment
masking: Single (Investigator)
measure: Reinfection
time frame: 2 years
description: Rate of reinfection in both groups
measure: Loosening radiological signs
time frame: 2 years
description: Radiological evaluation of implant loosening with Modern Knee Society Radiographic Evaluation System
measure: Knee Society Score
time frame: 1 year
description: Clinical evaluation of patients after knee revision
measure: The Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)
time frame: 1 year
description: Clinical evaluation of patients after knee revision
measure: Visual Analogue Score
time frame: 1 year
description: Clinical evaluation of patients after knee revision
measure: Alignment
time frame: 6 weeks
description: Radiological alignment of knee after operation in degrees
measure: C-reactive protein
time frame: 1 year
description: After operation and at period controls (mg/l)
measure: Erythrocyte sedimentation rate
time frame: 1 year
description: After operation and at period controls (mm/h)
arm group label: Stem stabilization
arm group type: Active Comparator
description: Group of patients with stem endoprosthesis stabilization
arm group label: Sleeve stabilization
arm group type: Active Comparator
description: Group of patients with sleeve endoprosthesis stabilization
intervention type: Device
intervention name: stabilization with stem
description: In both groups revision endoprosthesis of knee will be implanted with stem or sleeve stabilization.
arm group label: Stem stabilization
intervention type: Device
intervention name: stabilization with sleeve
description: In both groups revision endoprosthesis of knee will be implanted with stem or sleeve stabilization.
arm group label: Sleeve stabilization
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Paweł Bartosz
role: Principal Investigator
affiliation: Prof. A. Gruca Teaching Hospital in Otwock
last name: Paweł Bartosz
phone: +48 793629685
email: pbartosz@vp.pl
facility: 
status: Recruiting
contact: 
country: Poland
responsible party type: Principal Investigator
investigator affiliation: Prof A Gruca Teaching Hospital
investigator full name: Bartosz Paweł
investigator title: M.D., Ph.D.
mesh term: Reinfection
sharing ipd: Yes
ipd description: Study protocol and Informed consent form will be shared
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd time frame: 1 year