<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/NCT04417686</url>
  </required_header>
  <id_info>
    <org_study_id>2019-22</org_study_id>
    <secondary_id>2019-A00746-51</secondary_id>
    <nct_id>NCT04417686</nct_id>
  </id_info>
  <brief_title>ARTERIAL EMBOLIZATION OF PERSISTENT GENICULATE ARTERIES FOR CHRONIC PAIN MANAGEMENT AFTER TOTAL KNEE-REPLACEMENT ARTHROPLASTY(KNEE EMBOLISATION)</brief_title>
  <official_title>ARTERIAL EMBOLIZATION OF PERSISTENT GENICULATE ARTERIES FOR CHRONIC PAIN MANAGEMENT AFTER TOTAL KNEE-REPLACEMENT ARTHROPLASTY: A FEASIBILITY STUDY (KNEE EMBOLISATION)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique Hopitaux De Marseille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique Hopitaux De Marseille</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>
      Recent works in interventional radiology have shown interesting results in the treatment of&#xD;
      musculoskeletal inflammatory sites by arterial embolization. Supra-selective arterial&#xD;
      embolization has been successfully developed by Dr. Okuno (Japan) to manage moderate to&#xD;
      severe knee osteoarthritis. Also, inflammation of the surgical site mediated via geniculate&#xD;
      arteries is a major cause for persistent chronic post-operative gonalgia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hypothesis: Selective arterial embolization of persistent geniculate arteries could reduce&#xD;
      chronic post-operative gonalgia after TKA with minimally invasive approach.&#xD;
&#xD;
      Objective: To evaluate the feasibility of selective arterial embolization of persistent&#xD;
      geniculate arteries to reduce chronic post-operative gonalgia after TKA.&#xD;
&#xD;
      Material and methods: This study is a single-center, prospective, feasibility study. Patients&#xD;
      will be recruited after rheumatology consultation for chronic post-operative gonalgia, more&#xD;
      than 6 months after TKA for moderate to severe gonarthrosis. Eligible patients are adults&#xD;
      with moderate to severe chronic post-operative gonalgia (Visual Analysis Scale (VAS) &gt; 50mm)&#xD;
      and degraded life quality (assessed by SF36 score), despite at least 3 months of optimal&#xD;
      medical treatment. Non-inclusion criteria are mainly other rheumatologic or orthopedic severe&#xD;
      diseases, severe surgical complications. Under local anesthesia, with homolateral antegrade&#xD;
      femoral access, patient will undergo selective arterial embolization of persistent and&#xD;
      aberrant peri-prosthetic arteries using HydroPearl® 200µm Mircospheres. Follow-up&#xD;
      consultations will be scheduled at D1, M1, M3, M6 and M12. For a significance level of α=0.05&#xD;
      and power of 80% we require a cohort of 24 patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 22, 2021</start_date>
  <completion_date type="Anticipated">February 2024</completion_date>
  <primary_completion_date type="Anticipated">August 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>arterial embolization</measure>
    <time_frame>12 MONTHS</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>VAS pain score</measure>
    <time_frame>12MONTHS</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Western Ontario and Universities Osteroarthritis Index (WOMAC) score</measure>
    <time_frame>12MONTHS</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SF36 quality of life score</measure>
    <time_frame>12 MONTHS</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Musculoskeletal Inflammatory</condition>
  <arm_group>
    <arm_group_label>patient</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>arterial embolization</intervention_name>
    <description>arterial embolization of the geniculated arteries for reduction of pain after installation of total knee prosthesis</description>
    <arm_group_label>patient</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patient (male or female) aged 18-85&#xD;
&#xD;
          -  Suffering from moderate to severe chronic pain (EVA &gt; 50mm) more than 6 months after&#xD;
             total prosthetic knee replacement surgery for severe gonarthrosis with impact on&#xD;
             quality of life.&#xD;
&#xD;
          -  And having followed for at least 3 months a well-conducted conservative medical&#xD;
             treatment (anti-inflammatory, analgesic, masso-kinesiotherapy).&#xD;
&#xD;
          -  The patient may initially have had a single or bilateral replacement. The period of 6&#xD;
             months must be respected for each side, between the intervention and the inclusion for&#xD;
             homolateral pain.&#xD;
&#xD;
          -  Patient willing to participate in the study and with signed informed consent.&#xD;
&#xD;
          -  Patient willing to undergo post-operative monitoring for one year.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Orthopaedic or rheumatological pathologies:&#xD;
&#xD;
          -  Rheumatoid arthritis&#xD;
&#xD;
          -  Psoriatic rheumatism&#xD;
&#xD;
          -  Spondylarthropathies&#xD;
&#xD;
          -  History of primary or secondary bone tumor, in remission or active.&#xD;
&#xD;
          -  Myeloma&#xD;
&#xD;
          -  Operational criteria:&#xD;
&#xD;
          -  Infection of the surgical site&#xD;
&#xD;
          -  Re-operation&#xD;
&#xD;
          -  Severe bleeding&#xD;
&#xD;
          -  Use of turnstile per-operative&#xD;
&#xD;
          -  Wound of popliteal artery&#xD;
&#xD;
          -  Diabetic patient&#xD;
&#xD;
          -  Comorbidities:&#xD;
&#xD;
          -  General condition responsible for objective hemostasis disorder (hemophilia,&#xD;
             Willebrand disease, thrombocytopenia) and anticoagulant treatments.&#xD;
&#xD;
          -  Pads 100 G/L&#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>EMILIE GARRIDO PRADALIE</last_name>
    <role>Study Director</role>
    <affiliation>Assistance Publique Hopitaux De Marseille</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>vincent VIDAL</last_name>
    <email>vincent.vidal@ap-hm.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Assistance Publique Hopitaux de Marseille</name>
      <address>
        <city>Marseille</city>
        <zip>13354</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <email>drci@ap-hm.fr</email>
    </contact>
    <investigator>
      <last_name>vinent vidal</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>August 5, 2021</last_update_submitted>
  <last_update_submitted_qc>August 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Pain</mesh_term>
  </condition_browse>
  <!-- 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/NCT04417686
org study id: 2019-22
secondary id: 2019-A00746-51
nct id: NCT04417686
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Recent works in interventional radiology have shown interesting results in the treatment of
      musculoskeletal inflammatory sites by arterial embolization. Supra-selective arterial
      embolization has been successfully developed by Dr. Okuno (Japan) to manage moderate to
      severe knee osteoarthritis. Also, inflammation of the surgical site mediated via geniculate
      arteries is a major cause for persistent chronic post-operative gonalgia.
Hypothesis: Selective arterial embolization of persistent geniculate arteries could reduce
      chronic post-operative gonalgia after TKA with minimally invasive approach.

      Objective: To evaluate the feasibility of selective arterial embolization of persistent
      geniculate arteries to reduce chronic post-operative gonalgia after TKA.

      Material and methods: This study is a single-center, prospective, feasibility study. Patients
      will be recruited after rheumatology consultation for chronic post-operative gonalgia, more
      than 6 months after TKA for moderate to severe gonarthrosis. Eligible patients are adults
      with moderate to severe chronic post-operative gonalgia (Visual Analysis Scale (VAS) > 50mm)
      and degraded life quality (assessed by SF36 score), despite at least 3 months of optimal
      medical treatment. Non-inclusion criteria are mainly other rheumatologic or orthopedic severe
      diseases, severe surgical complications. Under local anesthesia, with homolateral antegrade
      femoral access, patient will undergo selective arterial embolization of persistent and
      aberrant peri-prosthetic arteries using HydroPearl® 200µm Mircospheres. Follow-up
      consultations will be scheduled at D1, M1, M3, M6 and M12. For a significance level of α=0.05
      and power of 80% we require a cohort of 24 patients.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: arterial embolization
time frame: 12 MONTHS
measure: VAS pain score
time frame: 12MONTHS
measure: Western Ontario and Universities Osteroarthritis Index (WOMAC) score
time frame: 12MONTHS
measure: SF36 quality of life score
time frame: 12 MONTHS
arm group label: patient
arm group type: Experimental
intervention type: Procedure
intervention name: arterial embolization
description: arterial embolization of the geniculated arteries for reduction of pain after installation of total knee prosthesis
arm group label: patient
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: EMILIE GARRIDO PRADALIE
role: Study Director
affiliation: Assistance Publique Hopitaux De Marseille
last name: vincent VIDAL
email: vincent.vidal@ap-hm.fr
facility: 
status: Recruiting
contact: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Chronic Pain