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/NCT06027697</url>
    </required_header>
    <id_info>
      <org_study_id>Subchondroplasty</org_study_id>
      <nct_id>NCT06027697</nct_id>
    </id_info>
    <brief_title>Prospective Evaluation of Subchondroplasty in Advanced Knee Osteoarthritis.</brief_title>
    <official_title>Prospective Evaluation of Subchondroplasty in Advanced Knee Osteoarthritis.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Clinique Paris-Bercy</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>CEISO</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
      <collaborator>
        <agency>ClinServ</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Clinique Paris-Bercy</source>
    <oversight_info>
      <has_dmc>No</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>
        The goal of this observational study is to evaluate the technique of subchondroplasty in&#xD;
        patients with advanced knee osteoarthritis.&#xD;
  &#xD;
        The main question it aims to answer is:&#xD;
  &#xD;
        • Does the subchondroplasty technique with the administration of AccuFill Porous Bone&#xD;
        Substitute Material (BSM) is effective in the relief of mechanical pain in patient with knee&#xD;
        osteoarthritis ?&#xD;
  &#xD;
        Participants will go under a minimally invasive surgery procedure (subchondroplasty) and&#xD;
        fulfil 3 validated questionnaires to assess pain, functional impairments and subjective&#xD;
        improvement.&#xD;
  &#xD;
        This study will be conducted for 4 years.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Background :&#xD;
  &#xD;
        The technique of subchondroplasty is recent and was created to follow the availability of&#xD;
        low-viscosity injectable phosphocalcic cement. It is aimed at osteoarthritic lesions and&#xD;
        proposes to treat subchondral disease associated with the process of osteoarthritic&#xD;
        degeneration, and which would be particularly painful in the support area.&#xD;
  &#xD;
        This technique seems interesting in terms of effectiveness with less risk since it is a&#xD;
        minimally invasive percutaneous procedure and it is systematically practiced on an outpatient&#xD;
        basis.&#xD;
  &#xD;
        In this context, the principal investigator has decided to conduct a long-term study for the&#xD;
        first time in France in order to collect clinical data and data on the safety profile of the&#xD;
        device.&#xD;
  &#xD;
        Design :&#xD;
  &#xD;
        This study is prospective, longitudinal, observational, single-arm, open monocentric and is a&#xD;
        post-market study.&#xD;
  &#xD;
        Intervention :&#xD;
  &#xD;
        As the current study is observational, the study will follow the usual standard of care.&#xD;
  &#xD;
        The participation of the patient can be divided in 2 parts :&#xD;
  &#xD;
          -  The first part is the treatment. After the inclusion of the patient, this latest will&#xD;
             undergo a minimally invasive surgery procedure (subchondroplasty) to receive the&#xD;
             treatment (AccuFill Porous Bone Substitute Material (BSM)).&#xD;
  &#xD;
          -  The second part is the follow-up visits. During this part the patient will follow a&#xD;
             appointment schedule with the doctor in order for the physicien to realised a clinical&#xD;
             examination and for the patient to fulfil the 3 validated questionnaires. These visits&#xD;
             will be spaced out over 4 years.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 2023</start_date>
    <completion_date type="Anticipated">September 2028</completion_date>
    <primary_completion_date type="Anticipated">December 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>Change from baseline (inclusion) in Patient-Reported Pain Scores on the Visual Analog Scale (VAS) to 3 months.</measure>
      <time_frame>Month 3</time_frame>
      <description>Visual Analog Scale (VAS) is a unidimensional measure of pain intensity, used to record patients' pain progression. It will helped the patient to assess the perceived mechanical knee pain on a horizontal, non-calibrated line of 10 cm, ranging from very low (0) to very high (10)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change from baseline (inclusion) in Patient-Reported Pain Scores on the Visual Analog Scale (VAS) to each visits</measure>
      <time_frame>Week 3, Week 6, Month 6, Month 12, Month 24, Month 36, Month 48</time_frame>
      <description>Visual Analog Scale (VAS) is a unidimensional measure of pain intensity, used to record patients' pain progression. It will helped the patient to assess the perceived mechanical knee pain on a horizontal, non-calibrated line of 10 cm, ranging from very low (0) to very high (10).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline (inclusion) in International Knee Documentation Committee (IKDC) score to each visits</measure>
      <time_frame>Week 3, Week 6, Month 3, Month 6, Month 12, Month 24, Month 36, Month 48</time_frame>
      <description>IKDC is a subjective knee evaluation form to detect improvement or deterioration in symptoms, function and sports activities due to knee impairment.&#xD;
  This self-questionnaire is divided into three parts (symptoms, sports activities, function) and gives a score between 0 (worst) and 100 (best).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline (inclusion) for the Knee injury and Osteoarthritis Outcome Score (KOOS) to each visits</measure>
      <time_frame>Week 3, Week 6, Month 3, Month 6, Month 12, Month 24, Month 36, Month 48</time_frame>
      <description>KOOS is a knee-specific instrument, developed to assess the patient's opinion about their knee and associated problems. The KOOS evaluates both short-term and long-term consequences of knee injury.&#xD;
  It contains 42 items divided into five subscales:&#xD;
  KOOS Pain, KOOS Symptoms, Activities of Daily Living (KOOS ADL), Sport (KOOS Sport), and Quality of Life regarding the knee (KOOS QOL). Total scores can range from 0 to 100.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of adverse events</measure>
      <time_frame>Week 3, Week 6, Month 3, Month 6, Month 12, Month 24, Month 36, Month 48</time_frame>
      <description>To assess the rate of adverse events</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Radiography and MRI evolution of the knee lesions from baseline (inclusion) to 24 months</measure>
      <time_frame>Month 24</time_frame>
      <description>Morphologic evolution of knee joint on MRI and radiography</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of conversion to prosthetic replacement</measure>
      <time_frame>Month 12, Month 24, Month 36, Month 48</time_frame>
      <description>Rate of patient who have to undergo to prosthetic replacement</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">55</enrollment>
    <condition>Knee Osteoarthritis</condition>
    <arm_group>
      <arm_group_label>Subchondroplasty</arm_group_label>
      <description>AccuFill Porous Bone Substitute Material (BSM) will be administrated to the patient during a subchondroplasty procedure (treatment visit).&#xD;
  During the inclusion visit and the follow-up visits (Week 3, Week 6; Month 3, Month 6, Month 12, Month 24, Month 36, Month 48) the doctor will proceed the usual clinical exam and the patients will fulfil the validated questionnaires and scales to assess pain, functional impairments and subjective improvement.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>AccuFill® Porous Bone Substitute Material (BSM)</intervention_name>
      <description>The patient will undergo a minimally invasive surgery procedure (subchondroplasty) to receive the medical device AccuFill® Porous Bone Substitute Material (BSM).</description>
      <arm_group_label>Subchondroplasty</arm_group_label>
      <other_name>Subchondroplasty</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients who go for a consultation for refractory mechanical knees pain&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patient 18 years of age or older;&#xD;
  &#xD;
            -  Patient with a Body Mass Index ≤35 (BMI=kg/m2);&#xD;
  &#xD;
            -  Patient with Kellgren-Lawrence grade 3-4 Osteoarthritis, as reviewed on MRI and plain&#xD;
               radiography;&#xD;
  &#xD;
            -  Patient with knee bone marrow lesions confirmed by MRI result at least 3 months before&#xD;
               the intervention;&#xD;
  &#xD;
            -  Patients with degenerative knee pathology at the prosthetic stage (outdated medical&#xD;
               treatments), with a frontal deformity of less than 12°, (and wishing to avoid or delay&#xD;
               the prosthetic procedure as much as possible) / goniometry);&#xD;
  &#xD;
            -  Patient with unbearable mechanical pain with a walking perimeter limited at 500 m&#xD;
  &#xD;
            -  Patient with non-surgical treatment failure (infiltration of Platelet Rich Plasma&#xD;
               (PRP), corticoids, acid hyaluronic);&#xD;
  &#xD;
            -  Patient who agrees to participate in the study and who signed the informed&#xD;
               non-opposition form;&#xD;
  &#xD;
            -  Patient physically and mentally willing and able, in the Investigator's opinion at the&#xD;
               time of enrolment, to be compliant with the protocol including all follow-up visits,&#xD;
               survey completion, weight- bearing restrictions, and post-operative rehabilitation;&#xD;
  &#xD;
            -  Patient with social protection.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patient with a Body Mass Index &gt; 35 (BMI=kg/m2);&#xD;
  &#xD;
            -  Patient with inflammatory rheumatic pathologies;&#xD;
  &#xD;
            -  Patient with frontal deformities (varus, valgus) of more than 12°;&#xD;
  &#xD;
            -  Patient with degenerative pathologies at the operative stage but likely to benefit&#xD;
               from a conservative intervention (osteotomy), except if the knee is centred;&#xD;
  &#xD;
            -  Patient with stiff knees (more than 20° of flexum and/or less than 90° of flexion);&#xD;
  &#xD;
            -  Patient with painful severe femoro-patellar osteoarthritis;&#xD;
  &#xD;
            -  Patient with contraindications for Magnetic Resonance Imaging (MRI);&#xD;
  &#xD;
            -  Patient with history of systemic diseases which could contribute to secondary&#xD;
               arthropathies (e.g., sickle cell disease, hemochromatosis, or autoimmune disease);&#xD;
  &#xD;
            -  Patient with history of cognitive-behavioural disorders that could interact with&#xD;
               assessment by self-questionnaire;&#xD;
  &#xD;
            -  Patient with local or general infection or suspicion of infection;&#xD;
  &#xD;
            -  Patient with severe coagulation disorders;&#xD;
  &#xD;
            -  Patient with primary bone tumour in the knee area,&#xD;
  &#xD;
            -  Patient with undercurrent serious pathology with life expectance &lt; 2 years;&#xD;
  &#xD;
            -  Female patient of childbearing age that are known to be pregnant during inclusion&#xD;
               visit or wishing to become pregnant before treatment;&#xD;
  &#xD;
            -  Patient who has forfeited their freedom by administrative or legal award, or is under&#xD;
               guardianship or under limited judicial protection;&#xD;
  &#xD;
            -  Patient participating in another interventional clinical trial or testing an&#xD;
               experimental drug within 30 days of inclusion in the study;&#xD;
  &#xD;
            -  Patients who cannot read or write French&#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_contact>
      <last_name>Guy Mylle, Dr</last_name>
      <phone>01 44 01 01 02</phone>
      <email>guymylle@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Clinique Paris Bercy</name>
        <address>
          <city>Charenton-le-Pont</city>
          <zip>94220</zip>
          <country>France</country>
        </address>
      </facility>
      <investigator>
        <last_name>Guy Mylle, Dr</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Knee osteoarthritis</keyword>
    <keyword>Subchondroplasty</keyword>
    <keyword>Knee mechanical pain</keyword>
    <keyword>AccuFill Porous Bone Substitute Material</keyword>
    <keyword>Minimally invasive surgical procedure</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Osteoarthritis</mesh_term>
      <mesh_term>Osteoarthritis, Knee</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/NCT06027697
  org study id: Subchondroplasty
  nct id: NCT06027697
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational study is to evaluate the technique of subchondroplasty in
        patients with advanced knee osteoarthritis.
  
        The main question it aims to answer is:
  
        • Does the subchondroplasty technique with the administration of AccuFill Porous Bone
        Substitute Material (BSM) is effective in the relief of mechanical pain in patient with knee
        osteoarthritis ?
  
        Participants will go under a minimally invasive surgery procedure (subchondroplasty) and
        fulfil 3 validated questionnaires to assess pain, functional impairments and subjective
        improvement.
  
        This study will be conducted for 4 years.
  Background :
  
        The technique of subchondroplasty is recent and was created to follow the availability of
        low-viscosity injectable phosphocalcic cement. It is aimed at osteoarthritic lesions and
        proposes to treat subchondral disease associated with the process of osteoarthritic
        degeneration, and which would be particularly painful in the support area.
  
        This technique seems interesting in terms of effectiveness with less risk since it is a
        minimally invasive percutaneous procedure and it is systematically practiced on an outpatient
        basis.
  
        In this context, the principal investigator has decided to conduct a long-term study for the
        first time in France in order to collect clinical data and data on the safety profile of the
        device.
  
        Design :
  
        This study is prospective, longitudinal, observational, single-arm, open monocentric and is a
        post-market study.
  
        Intervention :
  
        As the current study is observational, the study will follow the usual standard of care.
  
        The participation of the patient can be divided in 2 parts :
  
          -  The first part is the treatment. After the inclusion of the patient, this latest will
             undergo a minimally invasive surgery procedure (subchondroplasty) to receive the
             treatment (AccuFill Porous Bone Substitute Material (BSM)).
  
          -  The second part is the follow-up visits. During this part the patient will follow a
             appointment schedule with the doctor in order for the physicien to realised a clinical
             examination and for the patient to fulfil the 3 validated questionnaires. These visits
             will be spaced out over 4 years.
  observational model: Cohort
  time perspective: Prospective
  measure: Change from baseline (inclusion) in Patient-Reported Pain Scores on the Visual Analog Scale (VAS) to 3 months.
  time frame: Month 3
  description: Visual Analog Scale (VAS) is a unidimensional measure of pain intensity, used to record patients' pain progression. It will helped the patient to assess the perceived mechanical knee pain on a horizontal, non-calibrated line of 10 cm, ranging from very low (0) to very high (10)
  measure: Change from baseline (inclusion) in Patient-Reported Pain Scores on the Visual Analog Scale (VAS) to each visits
  time frame: Week 3, Week 6, Month 6, Month 12, Month 24, Month 36, Month 48
  description: Visual Analog Scale (VAS) is a unidimensional measure of pain intensity, used to record patients' pain progression. It will helped the patient to assess the perceived mechanical knee pain on a horizontal, non-calibrated line of 10 cm, ranging from very low (0) to very high (10).
  measure: Change from baseline (inclusion) in International Knee Documentation Committee (IKDC) score to each visits
  time frame: Week 3, Week 6, Month 3, Month 6, Month 12, Month 24, Month 36, Month 48
  description: IKDC is a subjective knee evaluation form to detect improvement or deterioration in symptoms, function and sports activities due to knee impairment.
  This self-questionnaire is divided into three parts (symptoms, sports activities, function) and gives a score between 0 (worst) and 100 (best).
  measure: Change from baseline (inclusion) for the Knee injury and Osteoarthritis Outcome Score (KOOS) to each visits
  time frame: Week 3, Week 6, Month 3, Month 6, Month 12, Month 24, Month 36, Month 48
  description: KOOS is a knee-specific instrument, developed to assess the patient's opinion about their knee and associated problems. The KOOS evaluates both short-term and long-term consequences of knee injury.
  It contains 42 items divided into five subscales:
  KOOS Pain, KOOS Symptoms, Activities of Daily Living (KOOS ADL), Sport (KOOS Sport), and Quality of Life regarding the knee (KOOS QOL). Total scores can range from 0 to 100.
  measure: Rate of adverse events
  time frame: Week 3, Week 6, Month 3, Month 6, Month 12, Month 24, Month 36, Month 48
  description: To assess the rate of adverse events
  measure: Radiography and MRI evolution of the knee lesions from baseline (inclusion) to 24 months
  time frame: Month 24
  description: Morphologic evolution of knee joint on MRI and radiography
  measure: Rate of conversion to prosthetic replacement
  time frame: Month 12, Month 24, Month 36, Month 48
  description: Rate of patient who have to undergo to prosthetic replacement
  arm group label: Subchondroplasty
  description: AccuFill Porous Bone Substitute Material (BSM) will be administrated to the patient during a subchondroplasty procedure (treatment visit).
  During the inclusion visit and the follow-up visits (Week 3, Week 6; Month 3, Month 6, Month 12, Month 24, Month 36, Month 48) the doctor will proceed the usual clinical exam and the patients will fulfil the validated questionnaires and scales to assess pain, functional impairments and subjective improvement.
  intervention type: Device
  intervention name: AccuFill® Porous Bone Substitute Material (BSM)
  description: The patient will undergo a minimally invasive surgery procedure (subchondroplasty) to receive the medical device AccuFill® Porous Bone Substitute Material (BSM).
  arm group label: Subchondroplasty
  other name: Subchondroplasty
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Guy Mylle, Dr
  phone: 01 44 01 01 02
  email: guymylle@gmail.com
  facility: 
  investigator: 
  country: France
  responsible party type: Sponsor
  mesh term: Osteoarthritis
  mesh term: Osteoarthritis, Knee