<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/NCT04427943</url>
  </required_header>
  <id_info>
    <org_study_id>S-20170108/69984</org_study_id>
    <nct_id>NCT04427943</nct_id>
  </id_info>
  <brief_title>Outcome After Revisions of Infected Knee Arthroplasties</brief_title>
  <acronym>RIKA</acronym>
  <official_title>Outcome After Revisions of Infected Knee Arthroplasties - a Prospective Multicenter Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Odense University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Odense University Hospital</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>
      A prospective multicenter cohort study on all types of revision knee arthroplasty procedures&#xD;
      performed due to infection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A prospective multicenter cohort study on all types of revision knee arthroplasty procedures&#xD;
      performed due to infection.&#xD;
&#xD;
      Most previous studies investigating outcomes after revisions of infected knee artrplasties&#xD;
      are single-center studies and retrospective. The study group has previously investigated&#xD;
      outcome of the surgical treatment of infected knee arthroplasties in Denmark based on&#xD;
      nationwide data from Danish registries. These studies revealed that the risk of treatment&#xD;
      failure causing re-revision or mortality was 30-40% in Denmark.&#xD;
&#xD;
      Based on these findings, an ongoing randomized controlled trial &quot;one-stage versus two-stage&#xD;
      revisions of the infected knee arthroplasty&quot; (ClinicalTrials.gov ID: NCT03435679) has been&#xD;
      initiated by the study group in Febuary 2018. It has been possible to include 20% of the&#xD;
      patients with surgically demanding periprosthetic knee infections from the including centres&#xD;
      in this randomized trial due to in- and exclusions criteria. Hence, the investigators wish to&#xD;
      include the remaining patients with periprosthetic knee joint infection in a prospective&#xD;
      cohort study in order to obtain high quality prospective data on function, quality of life&#xD;
      and complications after all types of surgical procedures performed due to periprosthetic knee&#xD;
      joint infection. Based on these data it will be possible to evaluate the surgical treatment&#xD;
      overall and it will be possible to evaluate whether the patients included in the randomized&#xD;
      trial are representative.&#xD;
&#xD;
      Study aim:&#xD;
&#xD;
      To present patient reported outcome and postoperative complications after all types of&#xD;
      surgical procedures performed due to periprosthetic knee infection. Furthermore, to analyze&#xD;
      the role of potential risk factors (patient comorbidity, microbiological diagnosis, surgical&#xD;
      intervention, antibiotic treatment, duration of symptoms) on outcome of the patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2020</start_date>
  <completion_date type="Anticipated">January 1, 2027</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2025</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>2 Years</target_duration>
  <primary_outcome>
    <measure>Change in Oxford Knee Score (Area Under Curve (AUC) from preoperatively to 12 months postoperatively)</measure>
    <time_frame>Measured preoperatively 6 weeks, 3, 6, 9, 12 months postoperatively</time_frame>
    <description>Change in Oxford Knee Score from preoperatively to 12 months postoperatively measured as Area Under Curve. Oxford Knee Score ranges from 0 to 48, 48 = best score.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Oxford Knee Score (Area Under Curve, AUC from preop. to 12 months postop.)</measure>
    <time_frame>Time Frame: Measured preoperatively, 6 weeks, 3, 6, 9, 12, 18 and 24 months postoperatively</time_frame>
    <description>Change in Oxford Knee Score from preoperatively to 24 months postoperatively measured as Area Under Curve. Oxford Knee Score ranges from 0 to 48, 48 = best score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in EuroQol five-dimensional descriptive system (EQ-5D-5L) from preop to 24 months postop.</measure>
    <time_frame>Measured preoperatively, 6 weeks, 3, 6, 9, 12, 18 and 24 months postoperatively.</time_frame>
    <description>Quality of life questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants re-revised (re-revision rate)</measure>
    <time_frame>2 year postoperatively</time_frame>
    <description>Number of patients re-revised due to infection and other causes within 2 years postoperatively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants dying (mortality rate)</measure>
    <time_frame>2 years postoperatively</time_frame>
    <description>Number of participants dying within 2 years posoperatively</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants readmitted (readmission rate)</measure>
    <time_frame>90 days postoperatively</time_frame>
    <description>Number of participant readmitted within 90 days postoperatively</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">350</enrollment>
  <condition>Periprosthetic Knee Infection</condition>
  <arm_group>
    <arm_group_label>RIKA cohort</arm_group_label>
    <description>patients with periprosthetic knee joint infection scheduled for revision knee arthroplasty surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>revision surgery</intervention_name>
    <description>The intervention is the planned revision surgery according to local guidelines.</description>
    <arm_group_label>RIKA cohort</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with periprosthetic knee joint infection requiring revision surgery.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical signs of periprosthetic knee joint infection and indication for revision&#xD;
             surgery&#xD;
&#xD;
          -  Speak and understand Danish and have given informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participation in &quot;one-stage versus two-stage revisions of the infected knee&#xD;
             arthroplasty&quot;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Martin Lindberg-Larsen, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Odense University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Martin Lindberg-Larsen, MD, PhD</last_name>
    <phone>0045 25213900</phone>
    <email>martin.lindberg-larsen@rsyd.dk</email>
  </overall_contact>
  <location>
    <facility>
      <name>Aalborg University Hospital</name>
      <address>
        <city>Aalborg</city>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andreas Kappel, MD</last_name>
      <phone>004520604629</phone>
      <email>andreas.kappel@rn.dk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Bispebjerg Hospital</name>
      <address>
        <city>Copenhagen</city>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jens Bagger, MD</last_name>
      <phone>21603580</phone>
      <email>jens.bagger@regionh.dk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hvidovre</name>
      <address>
        <city>Copenhagen</city>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kirill Gromov</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Rigshospitalet</name>
      <address>
        <city>Copenhagen</city>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Anders Odgaard, MD, PhD</last_name>
      <phone>0045 27478245</phone>
      <email>anders.odgaard@regionh.dk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Horsens Hospital</name>
      <address>
        <city>Horsens</city>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jeppe Lange, MD, PhD</last_name>
      <phone>0045 26853290</phone>
      <email>jeppe.lange@clin.au.dk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Næstved Hospital</name>
      <address>
        <city>Næstved</city>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Henrik Schrøder, MD</last_name>
      <phone>0045 50567163</phone>
      <email>hemsc@regionsjaelland.dk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Odense Universitets Hospital</name>
      <address>
        <city>Odense</city>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Martin Lindberg-Larsen, MD, PhD</last_name>
      <phone>0045 25213900</phone>
      <email>martin.lindberg-larsen@rsyd.dk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Vejle Hospital</name>
      <address>
        <city>Vejle</city>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thomas Bruno Lind-Hansen, MD, PhD</last_name>
      <phone>0045 22289260</phone>
      <email>Thomas.Bruno.Lind-Hansen@rsyd.dk</email>
    </contact>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <results_reference>
    <citation>Lindberg-Larsen M, Pitter FT, Voldstedlund M, Schroder HM, Bagger J. Microbiological diagnosis in revision of infected knee arthroplasties in Denmark. Infect Dis (Lond). 2017 Nov-Dec;49(11-12):824-830. doi: 10.1080/23744235.2017.1350878. Epub 2017 Jul 8.</citation>
    <PMID>28691647</PMID>
  </results_reference>
  <results_reference>
    <citation>Lindberg-Larsen M, Jorgensen CC, Bagger J, Schroder HM, Kehlet H. Revision of infected knee arthroplasties in Denmark. Acta Orthop. 2016 Aug;87(4):333-8. doi: 10.3109/17453674.2016.1148453. Epub 2016 Feb 22.</citation>
    <PMID>26900908</PMID>
  </results_reference>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>January 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>August 26, 2021</last_update_submitted>
  <last_update_submitted_qc>August 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Odense University Hospital</investigator_affiliation>
    <investigator_full_name>Martin Lindberg-Larsen</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>infection</keyword>
  <keyword>knee arthroplasty</keyword>
  <keyword>surgical treatment</keyword>
  <keyword>patient reported outcome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04427943
org study id: S-20170108/69984
nct id: NCT04427943
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A prospective multicenter cohort study on all types of revision knee arthroplasty procedures
      performed due to infection.
A prospective multicenter cohort study on all types of revision knee arthroplasty procedures
      performed due to infection.

      Most previous studies investigating outcomes after revisions of infected knee artrplasties
      are single-center studies and retrospective. The study group has previously investigated
      outcome of the surgical treatment of infected knee arthroplasties in Denmark based on
      nationwide data from Danish registries. These studies revealed that the risk of treatment
      failure causing re-revision or mortality was 30-40% in Denmark.

      Based on these findings, an ongoing randomized controlled trial "one-stage versus two-stage
      revisions of the infected knee arthroplasty" (ClinicalTrials.gov ID: NCT03435679) has been
      initiated by the study group in Febuary 2018. It has been possible to include 20% of the
      patients with surgically demanding periprosthetic knee infections from the including centres
      in this randomized trial due to in- and exclusions criteria. Hence, the investigators wish to
      include the remaining patients with periprosthetic knee joint infection in a prospective
      cohort study in order to obtain high quality prospective data on function, quality of life
      and complications after all types of surgical procedures performed due to periprosthetic knee
      joint infection. Based on these data it will be possible to evaluate the surgical treatment
      overall and it will be possible to evaluate whether the patients included in the randomized
      trial are representative.

      Study aim:

      To present patient reported outcome and postoperative complications after all types of
      surgical procedures performed due to periprosthetic knee infection. Furthermore, to analyze
      the role of potential risk factors (patient comorbidity, microbiological diagnosis, surgical
      intervention, antibiotic treatment, duration of symptoms) on outcome of the patients.
observational model: Cohort
time perspective: Prospective
measure: Change in Oxford Knee Score (Area Under Curve (AUC) from preoperatively to 12 months postoperatively)
time frame: Measured preoperatively 6 weeks, 3, 6, 9, 12 months postoperatively
description: Change in Oxford Knee Score from preoperatively to 12 months postoperatively measured as Area Under Curve. Oxford Knee Score ranges from 0 to 48, 48 = best score.
measure: Change in Oxford Knee Score (Area Under Curve, AUC from preop. to 12 months postop.)
time frame: Time Frame: Measured preoperatively, 6 weeks, 3, 6, 9, 12, 18 and 24 months postoperatively
description: Change in Oxford Knee Score from preoperatively to 24 months postoperatively measured as Area Under Curve. Oxford Knee Score ranges from 0 to 48, 48 = best score.
measure: Change in EuroQol five-dimensional descriptive system (EQ-5D-5L) from preop to 24 months postop.
time frame: Measured preoperatively, 6 weeks, 3, 6, 9, 12, 18 and 24 months postoperatively.
description: Quality of life questionnaire
measure: Number of participants re-revised (re-revision rate)
time frame: 2 year postoperatively
description: Number of patients re-revised due to infection and other causes within 2 years postoperatively.
measure: Number of participants dying (mortality rate)
time frame: 2 years postoperatively
description: Number of participants dying within 2 years posoperatively
measure: Number of participants readmitted (readmission rate)
time frame: 90 days postoperatively
description: Number of participant readmitted within 90 days postoperatively
arm group label: RIKA cohort
description: patients with periprosthetic knee joint infection scheduled for revision knee arthroplasty surgery
intervention type: Procedure
intervention name: revision surgery
description: The intervention is the planned revision surgery according to local guidelines.
arm group label: RIKA cohort
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Martin Lindberg-Larsen, MD, PhD
role: Principal Investigator
affiliation: Odense University Hospital
last name: Martin Lindberg-Larsen, MD, PhD
phone: 0045 25213900
email: martin.lindberg-larsen@rsyd.dk
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Denmark
citation: Lindberg-Larsen M, Pitter FT, Voldstedlund M, Schroder HM, Bagger J. Microbiological diagnosis in revision of infected knee arthroplasties in Denmark. Infect Dis (Lond). 2017 Nov-Dec;49(11-12):824-830. doi: 10.1080/23744235.2017.1350878. Epub 2017 Jul 8.
PMID: 28691647
citation: Lindberg-Larsen M, Jorgensen CC, Bagger J, Schroder HM, Kehlet H. Revision of infected knee arthroplasties in Denmark. Acta Orthop. 2016 Aug;87(4):333-8. doi: 10.3109/17453674.2016.1148453. Epub 2016 Feb 22.
PMID: 26900908
responsible party type: Principal Investigator
investigator affiliation: Odense University Hospital
investigator full name: Martin Lindberg-Larsen
investigator title: Principal investigator
mesh term: Infections
sharing ipd: Undecided