xml: <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/NCT06042062</url>
    </required_header>
    <id_info>
      <org_study_id>202300966A3</org_study_id>
      <nct_id>NCT06042062</nct_id>
    </id_info>
    <brief_title>Clinical Evaluation of Infection Control to Knee Periprosthetic Joint Infection (PJI) -United Cellbrick Knee Spacer</brief_title>
    <official_title>Clinical Evaluation of Infection Control to Knee Periprosthetic Joint Infection (PJI) -United Cellbrick Knee Spacer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Chang Gung Memorial Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>United Orthopedic Corporation</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Chang Gung Memorial Hospital</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        A novel polyethylene-based knee spacer (United Cellbrick Knee Spacer), for the purpose of&#xD;
        infection control, was developed to enhance biomechanical safety and surgical convenience of&#xD;
        articulating knee spacers. In the present study, Commercially available cemented spacer were&#xD;
        compared to the novel United Cellbrick Knee Spacer in a practical setting to enhance our&#xD;
        understanding of the safety and performance of United Cellbrick Knee Spacer.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Two-stage exchange arthroplasty, which involves the removal of infected prostheses and&#xD;
        introduction of a temporary antibiotic-loaded cement spacers at the infection site, has been&#xD;
        widely accepted among treatment options. Antibiotic-loaded cement spacers facilitate in&#xD;
        maintaining joint space, limb length, soft tissue tension, and lengthening the period of&#xD;
        effective antibiotic release until infection control has been accomplished. Although&#xD;
        articulating knee spacers have demonstrated advantages in joint mobility and clinically&#xD;
        successful rates in infection control, issues relating to biomechanical safety contributed by&#xD;
        cement material characteristics have been noted. Surgeons had to implement alternative&#xD;
        methods for the construction of an intramedullary spacer to provide sufficient infection&#xD;
        control for deeper infection sites which could cause surgical inconveniences. A novel&#xD;
        polyethylene-based knee spacer, for the purpose of infection control, was developed to&#xD;
        enhance biomechanical safety and surgical convenience of articulating knee spacers. The&#xD;
        investigators aim to conduct a clinical study comparing the use of commercially available&#xD;
        cemented spacer to the United Cellbrick Knee Spacer in a practical setting to better&#xD;
        understand the safety and performance of United Cellbrick Knee Spacer and to enhance the&#xD;
        clinical confidence of surgeons. A total of 10 patients who are undergoing two-stage exchange&#xD;
        arthroplasty at Linkou Changgung Memorial Hospital will be recruited, including 5 patients in&#xD;
        the &quot;spacer&quot; group and 5 patients in the &quot;novel spacer&quot; group. Patients in the &quot;spacer&quot; group&#xD;
        will be receiving a full cement spacer (Stryker Simplex P) made of broad-acting antibiotics&#xD;
        (Vancomycin + Gentamicin) produced in the hospital. Patients in the &quot;novel spacer&quot; group will&#xD;
        be receiving United Cellbrick Knee Spacer, where the femoral and tibial spacers will be&#xD;
        filled with bone cement (Stryker Simplex P) with antibiotics (Vancomycin + Gentamicin).&#xD;
        Spacer survivorship defined as no removal or revision of any components as a result of&#xD;
        mechanical failure or complications will be analyzed. Blood tests, joint effusions, and x-ray&#xD;
        inspections will also be collected for analysis.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 1, 2023</start_date>
    <completion_date type="Anticipated">July 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2024</primary_completion_date>
    <study_type>Observational</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>
    <primary_outcome>
      <measure>Success Rate</measure>
      <time_frame>up to 6 months following surgery</time_frame>
      <description>Failure is defined as removal or revision of any components as a result of mechanical failure or complications.&#xD;
  Success is defined as implants that are successfully implanted without any failure for the duration of up to 180 days.&#xD;
  *Note: Spacers are temporarily implanted into patients for any two-stage arthroplasty. Hence, upon assessment by the surgeon, when the condition of the patients are ideal for the second-stage arthroplasty procedure, the surgeon will remove the spacer accordingly. Therefore, the timeframe for the spacer removal may happen anywhere before the duration of 180 days.&#xD;
  The success rate will be represented as a percentage (%).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Vancomycin Concentration</measure>
      <time_frame>Day 1, 3, 7, up to 6 months following surgery</time_frame>
      <description>Vancomycin Concentration will be quantified utilizing Particle Enhanced Turbidimetric Inhibition Immunoassay. Blood samples (3mL) and joint effusion samples (5-10cc) will both be used to analyze the efficacy of vancomycin concentration (5-15ug/mL).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Gentamycin Concentration</measure>
      <time_frame>Day 1, 3, 7, up to 6 months following surgery</time_frame>
      <description>Gentamycin Concentration will be quantified utilizing Particle Enhanced Turbidimetric Inhibition Immunoassay. Blood samples (3mL) and joint effusion samples (5-10cc) will both be used to analyze the efficacy of gentamycin concentration (5-15ug/mL).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>C-reactive protein assessment</measure>
      <time_frame>Baseline, 7, up to 6 months following surgery</time_frame>
      <description>C-reactive protein assessment will be quantified utilizing turbidimetric-immunoassay. Blood samples (3mL) will be used to determine the level of inflammation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Bioassay of Antibiotic Activity of in Vitro Samples</measure>
      <time_frame>Day 1, 2, 3, 7</time_frame>
      <description>Bioassay of Antibiotic Activity of in Vitro Samples will be quantified utilizing aliquots of the samples and a modified microtube dilution bioassay. The following strains were selected as test organisms: Methicillin-susceptible Staphylococcus aureus (MSSA, ATCC 25923), Methicillin-resistant Staphylococcus aureus (MRSA, ATCC 43300), Staphylococcus epidermidis (ATCC 14990), Pseudomonas aeruginosa (P. aeruginosa, ATCC 27853) or Escherichia coli (E. coli, ATCC 25922). The in vitro samples were were inoculated with 105 colony forming units (CFUs) of bacteria per milliliter in 96-well culture dishes and incubated at 37 degree Celsius for 24 hours according to Hsu et al. The growth of bacteria associated with the different concentrations of antibiotics was compared visibly with each other and against the positive control (without antibiotic). The minimum inhibitory concentration of each antibiotic against each bacterium was determined by microtube dilution bioassay.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Spacer Complications</measure>
      <time_frame>Baseline, Day 0, up to 6 months following surgery</time_frame>
      <description>Any issues with spacer complications including allergic reactions, bone loss, joint stiffness, wound complications, recurrence or persistence of the infection, spacer fracture or dislocation, and side effects of local or systemic antibiotics will be recorded.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Knee; Infection, Joint</condition>
    <arm_group>
      <arm_group_label>&quot;Spacer&quot; group</arm_group_label>
      <description>The subjects who are assigned to Commercially available cement spacers in two-stage exchange arthroplasty.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>&quot;Novel spacer&quot; group</arm_group_label>
      <description>The subjects who are assigned to United Cellbrick Knee Spacer in two-stage exchange arthroplasty.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Two-stage exchange arthroplasty</intervention_name>
      <description>The indication for two-stage exchange arthroplasty is mainly periprosthetic joint infection.</description>
      <arm_group_label>&quot;Novel spacer&quot; group</arm_group_label>
      <arm_group_label>&quot;Spacer&quot; group</arm_group_label>
      <other_name>Two-stage revision arthroplasty</other_name>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Blood and Synovial Fluid Samples&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Patients who receive total knee arthroplasty with either a full cement spacer articlulated&#xD;
          by Stryker Simplex or Cellbrick knee spacer after August, 2023 at Chang Gung Memorial&#xD;
          Hospital, Linkou.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Patients who are older than 18 years old, suitable for temporary knee joint implants, and&#xD;
          will be undergoing treatment in Linkou Chang Gung Memorial Hospital who meet the following&#xD;
          criteria and have skeletally mature bones:&#xD;
  &#xD;
            1. who are diagnosed with infection before surgery and are expected to undergo two-stage&#xD;
               procedure for total knee replacement (TKR);&#xD;
  &#xD;
            2. Patients who are willing to use traditional mobility aids (such as crutches, walkers)&#xD;
               during implantation;&#xD;
  &#xD;
            3. The implantation time of the temporary knee implant shall not exceed 180 days.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients who are allergic to or have suffered from allergies to any component of the&#xD;
               implant, the bone cement used together or antibiotics.&#xD;
  &#xD;
            2. Patients who cannot perform two-stage knee replacement surgery due to decreased immune&#xD;
               response or other relevant clinical conditions.&#xD;
  &#xD;
            3. Patients who have not previously received total knee replacement surgery, and the&#xD;
               secondary infection is caused by trauma, septic arthritis or other surgery.&#xD;
  &#xD;
            4. sufficient support and / or fixation for implants due to disease, soft tissue defects,&#xD;
               bone defects or other relevant clinical conditions.&#xD;
  &#xD;
            5. Inability or unwillingness to return to hospital for evaluation.&#xD;
  &#xD;
            6. Cognitive function impairment makes the subject unable to answer questions or&#xD;
               cooperate with instructions.&#xD;
  &#xD;
            7. Other systemic comorbidities lead to severe impairment of the subject's mobility and&#xD;
               function.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Yu-Han Chang, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Chang Gung Memorial Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Yu-Han Chang, MD, PhD</last_name>
      <phone>886-3-3281200</phone>
      <phone_ext>2420</phone_ext>
      <email>yhchang@adm.cgmh.org.tw</email>
    </overall_contact>
    <location>
      <facility>
        <name>Department of Orthopedic Surgery at Linkou Changgung Memorial Hospital</name>
        <address>
          <city>Taoyuan</city>
          <zip>333</zip>
          <country>Taiwan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Yu-Han Chang, MD, PhD</last_name>
        <phone>886-3-3281200</phone>
        <phone_ext>2420</phone_ext>
        <email>yhchang@adm.cgmh.org.tw</email>
      </contact>
      <investigator>
        <last_name>Yu-Han Chang, MD, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Infection Control</keyword>
    <keyword>Two-Stage Exchange Arthroplasty</keyword>
    <keyword>Knee Spacer</keyword>
    <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>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06042062
  org study id: 202300966A3
  nct id: NCT06042062
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  A novel polyethylene-based knee spacer (United Cellbrick Knee Spacer), for the purpose of
        infection control, was developed to enhance biomechanical safety and surgical convenience of
        articulating knee spacers. In the present study, Commercially available cemented spacer were
        compared to the novel United Cellbrick Knee Spacer in a practical setting to enhance our
        understanding of the safety and performance of United Cellbrick Knee Spacer.
  Two-stage exchange arthroplasty, which involves the removal of infected prostheses and
        introduction of a temporary antibiotic-loaded cement spacers at the infection site, has been
        widely accepted among treatment options. Antibiotic-loaded cement spacers facilitate in
        maintaining joint space, limb length, soft tissue tension, and lengthening the period of
        effective antibiotic release until infection control has been accomplished. Although
        articulating knee spacers have demonstrated advantages in joint mobility and clinically
        successful rates in infection control, issues relating to biomechanical safety contributed by
        cement material characteristics have been noted. Surgeons had to implement alternative
        methods for the construction of an intramedullary spacer to provide sufficient infection
        control for deeper infection sites which could cause surgical inconveniences. A novel
        polyethylene-based knee spacer, for the purpose of infection control, was developed to
        enhance biomechanical safety and surgical convenience of articulating knee spacers. The
        investigators aim to conduct a clinical study comparing the use of commercially available
        cemented spacer to the United Cellbrick Knee Spacer in a practical setting to better
        understand the safety and performance of United Cellbrick Knee Spacer and to enhance the
        clinical confidence of surgeons. A total of 10 patients who are undergoing two-stage exchange
        arthroplasty at Linkou Changgung Memorial Hospital will be recruited, including 5 patients in
        the "spacer" group and 5 patients in the "novel spacer" group. Patients in the "spacer" group
        will be receiving a full cement spacer (Stryker Simplex P) made of broad-acting antibiotics
        (Vancomycin + Gentamicin) produced in the hospital. Patients in the "novel spacer" group will
        be receiving United Cellbrick Knee Spacer, where the femoral and tibial spacers will be
        filled with bone cement (Stryker Simplex P) with antibiotics (Vancomycin + Gentamicin).
        Spacer survivorship defined as no removal or revision of any components as a result of
        mechanical failure or complications will be analyzed. Blood tests, joint effusions, and x-ray
        inspections will also be collected for analysis.
  observational model: Cohort
  time perspective: Prospective
  measure: Success Rate
  time frame: up to 6 months following surgery
  description: Failure is defined as removal or revision of any components as a result of mechanical failure or complications.
  Success is defined as implants that are successfully implanted without any failure for the duration of up to 180 days.
  *Note: Spacers are temporarily implanted into patients for any two-stage arthroplasty. Hence, upon assessment by the surgeon, when the condition of the patients are ideal for the second-stage arthroplasty procedure, the surgeon will remove the spacer accordingly. Therefore, the timeframe for the spacer removal may happen anywhere before the duration of 180 days.
  The success rate will be represented as a percentage (%).
  measure: Vancomycin Concentration
  time frame: Day 1, 3, 7, up to 6 months following surgery
  description: Vancomycin Concentration will be quantified utilizing Particle Enhanced Turbidimetric Inhibition Immunoassay. Blood samples (3mL) and joint effusion samples (5-10cc) will both be used to analyze the efficacy of vancomycin concentration (5-15ug/mL).
  measure: Gentamycin Concentration
  time frame: Day 1, 3, 7, up to 6 months following surgery
  description: Gentamycin Concentration will be quantified utilizing Particle Enhanced Turbidimetric Inhibition Immunoassay. Blood samples (3mL) and joint effusion samples (5-10cc) will both be used to analyze the efficacy of gentamycin concentration (5-15ug/mL).
  measure: C-reactive protein assessment
  time frame: Baseline, 7, up to 6 months following surgery
  description: C-reactive protein assessment will be quantified utilizing turbidimetric-immunoassay. Blood samples (3mL) will be used to determine the level of inflammation.
  measure: Bioassay of Antibiotic Activity of in Vitro Samples
  time frame: Day 1, 2, 3, 7
  description: Bioassay of Antibiotic Activity of in Vitro Samples will be quantified utilizing aliquots of the samples and a modified microtube dilution bioassay. The following strains were selected as test organisms: Methicillin-susceptible Staphylococcus aureus (MSSA, ATCC 25923), Methicillin-resistant Staphylococcus aureus (MRSA, ATCC 43300), Staphylococcus epidermidis (ATCC 14990), Pseudomonas aeruginosa (P. aeruginosa, ATCC 27853) or Escherichia coli (E. coli, ATCC 25922). The in vitro samples were were inoculated with 105 colony forming units (CFUs) of bacteria per milliliter in 96-well culture dishes and incubated at 37 degree Celsius for 24 hours according to Hsu et al. The growth of bacteria associated with the different concentrations of antibiotics was compared visibly with each other and against the positive control (without antibiotic). The minimum inhibitory concentration of each antibiotic against each bacterium was determined by microtube dilution bioassay.
  measure: Spacer Complications
  time frame: Baseline, Day 0, up to 6 months following surgery
  description: Any issues with spacer complications including allergic reactions, bone loss, joint stiffness, wound complications, recurrence or persistence of the infection, spacer fracture or dislocation, and side effects of local or systemic antibiotics will be recorded.
  arm group label: "Spacer" group
  description: The subjects who are assigned to Commercially available cement spacers in two-stage exchange arthroplasty.
  arm group label: "Novel spacer" group
  description: The subjects who are assigned to United Cellbrick Knee Spacer in two-stage exchange arthroplasty.
  intervention type: Device
  intervention name: Two-stage exchange arthroplasty
  description: The indication for two-stage exchange arthroplasty is mainly periprosthetic joint infection.
  arm group label: "Novel spacer" group
  arm group label: "Spacer" group
  other name: Two-stage revision arthroplasty
  Blood and Synovial Fluid Samples
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Yu-Han Chang, MD, PhD
  role: Principal Investigator
  affiliation: Chang Gung Memorial Hospital
  last name: Yu-Han Chang, MD, PhD
  phone: 886-3-3281200
  phone ext: 2420
  email: yhchang@adm.cgmh.org.tw
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: Taiwan
  responsible party type: Sponsor
  mesh term: Infections
  mesh term: Communicable Diseases