<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/NCT04458961</url>
  </required_header>
  <id_info>
    <org_study_id>272334</org_study_id>
    <nct_id>NCT04458961</nct_id>
  </id_info>
  <brief_title>MIKROBE Management of Infected Knee Replacements-Obtaining Best Evidence</brief_title>
  <acronym>MIKROBE</acronym>
  <official_title>MIKROBE Management of Infected Knee Replacements-Obtaining Best Evidence A Feasibility Study for a Randomised Controlled Trial of One-stage or Two-stage Surgery for Prosthetic Knee Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Royal Devon and Exeter NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Exeter</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nuffield Orthopaedic Centre NHS Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Royal Devon and Exeter NHS Foundation Trust</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>
      Following a prosthetic knee joint infection, two types of operative approach can be&#xD;
      undertaken to treat the infection: a one-stage or two-stage revision operation. Both&#xD;
      approaches are widely used and are good at treating infection but we don't know which has the&#xD;
      best long-term outcomes for patients. This trial aims to assess the feasibility of conducting&#xD;
      a randomised controlled trial to evaluate whether treating a prosthetic knee infection with&#xD;
      one-stage revision surgery gives a better outcome than two-stage revision surgery in terms of&#xD;
      patient function and pain, and cost-effectiveness.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2021</start_date>
  <completion_date type="Anticipated">May 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">November 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>
    <masking_description>Blinding of participants and trial personnel will not be possible due to the nature of the intervention</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Ease of recruitment of participants</measure>
    <time_frame>20 months</time_frame>
    <description>Number of recruits compared to the number of potential participants.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Explaining the study</measure>
    <time_frame>20 months</time_frame>
    <description>Assessment of the process of explaining the study (explanation/recruitment/randomisation) between patients and surgeons via qualitative analysis of audio recording of pre-operative discussions about entering the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reasons for non-participation</measure>
    <time_frame>20 months</time_frame>
    <description>Qualitative analysis of semi-structured interviews with those patients who declined to participate in the trial.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient experience</measure>
    <time_frame>2 weeks after surgery</time_frame>
    <description>Experience and acceptability of the process of recruitment, randomisation and study participation via qualitative analysis of semi-structured interview.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgeon experience</measure>
    <time_frame>20 months</time_frame>
    <description>Experience of the process of recruitment, randomisation and study participation including thoughts about trial design via qualitative analysis of semi-structured interview after each patient surgery and at the end of the trial.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Protocol adherence</measure>
    <time_frame>20 months</time_frame>
    <description>Assessment of any deviations or violations to protocol that occur during the trial.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Healthcare resource utilisation</measure>
    <time_frame>20 months</time_frame>
    <description>Patient-reported questionnaire assessing heath and social resource use through an adapted questionnaire of the Client Service Receipt Inventory (CSRI) at 3 and 6 months post-operatively</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of two sites</measure>
    <time_frame>20 months</time_frame>
    <description>Recruitment and attrition rates at the two sites</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee injury and Osteoarthritis Outcome Score (KOOS) outcome and completion rates</measure>
    <time_frame>20 months</time_frame>
    <description>Patient-reported questionnaire assessing short-term and long-term symptoms and function in patients with knee injury to be administered pre-, 3 months and 6 months post-operatively</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxford Knee Score (OKS) outcome and completion rates</measure>
    <time_frame>20 months</time_frame>
    <description>Patient-reported questionnaire assessing function and pain after total knee replacement surgery to be administered pre-, 3 months and 6 months post-operatively</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ-5D-5L outcome and completion rates</measure>
    <time_frame>20 months</time_frame>
    <description>Patient-reported questionnaire assessing health-related quality of life to be administered pre-, 3 months and 6 months post-operatively</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Arthroplasty, Replacement, Knee</condition>
  <arm_group>
    <arm_group_label>One-stage</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Two-stage</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>One-stage</intervention_name>
    <description>A one-stage revision operation involves one operation to remove the joint, thoroughly cleaning the infected area and then implanting a new joint immediately.</description>
    <arm_group_label>One-stage</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Two-stage</intervention_name>
    <description>A two-stage revision operation involves two operations: the joint is removed in one operation, a temporary spacer device is inserted, then the infection is treated with antibiotics, and then a new joint is implanted in a second operation.</description>
    <arm_group_label>Two-stage</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults with prosthetic knee infection suitable for either one-stage or two-stage&#xD;
             revision surgery&#xD;
&#xD;
          -  Intra-operatively, all cases must have adequate soft-tissue coverage post debridement&#xD;
             to allow single or two stage revision surgery.&#xD;
&#xD;
          -  Case meets the International Consensus Meeting criteria for infection&#xD;
&#xD;
          -  Patients having had a Debridement, Anti-biotic and Implant Retained procedure&#xD;
             previously or washout/biopsy only of an infected TKR are suitable&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable or unwilling to undergo either treatment&#xD;
&#xD;
          -  Lacking capacity to consent to research&#xD;
&#xD;
          -  Refusal to consent to study for any reason&#xD;
&#xD;
          -  Re-revision of prosthetic knee infection if first revision was for infection&#xD;
&#xD;
          -  Presence of tuberculosis infection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrew Toms, FRCS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Royal Devon and Exeter NHS Foundation Trust</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Amy McAndrew, PhD</last_name>
    <phone>+44 (0)1392 724070</phone>
    <email>a.mcandrew@exeter.ac.uk</email>
  </overall_contact>
  <location>
    <facility>
      <name>Princess Elizabeth Orthopaedic Centre, Royal Devon and Exeter NHS Trust (RD&amp;E NHSFT)</name>
      <address>
        <city>Exeter</city>
        <state>Devon</state>
        <zip>EX2 5DW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <contact>
      <last_name>Andrew Toms</last_name>
      <phone>01392 403562</phone>
      <email>andrewtoms@nhs.net</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Nuffiels Orthopaedic Centre (NOC)</name>
      <address>
        <city>Oxford</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <contact>
      <last_name>Abtin Alvand</last_name>
      <email>abtin.alvand@oxfordkneegroup.com</email>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>January 28, 2021</last_update_submitted>
  <last_update_submitted_qc>January 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Arthropathy</keyword>
  <keyword>Arthropathy Related to Infection</keyword>
  <keyword>Arthropathy of Knee Joint</keyword>
  <keyword>One-stage</keyword>
  <keyword>Two-stage</keyword>
  <keyword>Infection</keyword>
  <keyword>Prosthetic joint infection</keyword>
  <!-- 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/NCT04458961
org study id: 272334
nct id: NCT04458961
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Following a prosthetic knee joint infection, two types of operative approach can be
      undertaken to treat the infection: a one-stage or two-stage revision operation. Both
      approaches are widely used and are good at treating infection but we don't know which has the
      best long-term outcomes for patients. This trial aims to assess the feasibility of conducting
      a randomised controlled trial to evaluate whether treating a prosthetic knee infection with
      one-stage revision surgery gives a better outcome than two-stage revision surgery in terms of
      patient function and pain, and cost-effectiveness.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
masking description: Blinding of participants and trial personnel will not be possible due to the nature of the intervention
measure: Ease of recruitment of participants
time frame: 20 months
description: Number of recruits compared to the number of potential participants.
measure: Explaining the study
time frame: 20 months
description: Assessment of the process of explaining the study (explanation/recruitment/randomisation) between patients and surgeons via qualitative analysis of audio recording of pre-operative discussions about entering the study.
measure: Reasons for non-participation
time frame: 20 months
description: Qualitative analysis of semi-structured interviews with those patients who declined to participate in the trial.
measure: Patient experience
time frame: 2 weeks after surgery
description: Experience and acceptability of the process of recruitment, randomisation and study participation via qualitative analysis of semi-structured interview.
measure: Surgeon experience
time frame: 20 months
description: Experience of the process of recruitment, randomisation and study participation including thoughts about trial design via qualitative analysis of semi-structured interview after each patient surgery and at the end of the trial.
measure: Protocol adherence
time frame: 20 months
description: Assessment of any deviations or violations to protocol that occur during the trial.
measure: Healthcare resource utilisation
time frame: 20 months
description: Patient-reported questionnaire assessing heath and social resource use through an adapted questionnaire of the Client Service Receipt Inventory (CSRI) at 3 and 6 months post-operatively
measure: Comparison of two sites
time frame: 20 months
description: Recruitment and attrition rates at the two sites
measure: Knee injury and Osteoarthritis Outcome Score (KOOS) outcome and completion rates
time frame: 20 months
description: Patient-reported questionnaire assessing short-term and long-term symptoms and function in patients with knee injury to be administered pre-, 3 months and 6 months post-operatively
measure: Oxford Knee Score (OKS) outcome and completion rates
time frame: 20 months
description: Patient-reported questionnaire assessing function and pain after total knee replacement surgery to be administered pre-, 3 months and 6 months post-operatively
measure: EQ-5D-5L outcome and completion rates
time frame: 20 months
description: Patient-reported questionnaire assessing health-related quality of life to be administered pre-, 3 months and 6 months post-operatively
arm group label: One-stage
arm group type: Active Comparator
arm group label: Two-stage
arm group type: Active Comparator
intervention type: Procedure
intervention name: One-stage
description: A one-stage revision operation involves one operation to remove the joint, thoroughly cleaning the infected area and then implanting a new joint immediately.
arm group label: One-stage
intervention type: Procedure
intervention name: Two-stage
description: A two-stage revision operation involves two operations: the joint is removed in one operation, a temporary spacer device is inserted, then the infection is treated with antibiotics, and then a new joint is implanted in a second operation.
arm group label: Two-stage
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Andrew Toms, FRCS
role: Principal Investigator
affiliation: Royal Devon and Exeter NHS Foundation Trust
last name: Amy McAndrew, PhD
phone: +44 (0)1392 724070
email: a.mcandrew@exeter.ac.uk
facility: 
contact: 
facility: 
contact: 
country: United Kingdom
responsible party type: Sponsor