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/NCT06012656</url>
    </required_header>
    <id_info>
      <org_study_id>P01.005.10</org_study_id>
      <nct_id>NCT06012656</nct_id>
    </id_info>
    <brief_title>Prospective Study for the Evaluation of the Cementless Anatomic Femoral Stem Minimax -Launay</brief_title>
    <official_title>Prospective, Multricentre, Non Controlled, Non-randomized, Open Study for the Evaluation of the Cementless Anatomic Femoral Stem MiniMAX</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Medacta International SA</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Medacta International SA</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>
        This is a post-marketing surveillance on MiniMAX Stem&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">January 2, 2019</start_date>
    <completion_date type="Anticipated">January 2, 2031</completion_date>
    <primary_completion_date type="Anticipated">January 2, 2029</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>Survival Rate</measure>
      <time_frame>10 years</time_frame>
      <description>Kaplan Meier method</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Functional evaluation</measure>
      <time_frame>Pre-op, 3 months, 1, 3, 5, 10 years</time_frame>
      <description>Harris Hip Score (HHS): the HHS is a measure of dysfunction so the higher the score, the better the outcome for the individual. The maximum score possible is 100. Results can be interpreted with the following: &lt;70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluation of patient satisfaction</measure>
      <time_frame>Pre-op, 3 months, 1, 3, 5, 10 years</time_frame>
      <description>HOOS (hip disability and osteoarthritis outcome score) questionnaire: HOOS is a questionnaire intended to be used to assess patient's opinion about their hip and associated problems, and to evaluate their symptoms and functional limitations during a therapeutic process.The interval score ranges from 0 to 100 where 0 represents total hip disability and 100 represents perfect hip health.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluation of the stem fixation</measure>
      <time_frame>Pre-op, 3 months, 1, 3, 5, 10 years</time_frame>
      <description>Radiographic evaluation to assess the osteointegration of the stem, the implant positioning, radiolucent lines.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluation of the general and thigh pain</measure>
      <time_frame>Pre-op, 3 months, 1, 3, 5, 10 years</time_frame>
      <description>Echelle Visuelle Analogique (EVA) and pain location. Interpretation of the EVA scale: no pain 0, low pain 1-3, moderate pain 4-6, severe pain 7-9, extreme pain 10.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of adverse events</measure>
      <time_frame>Surgery, Immediate post-op, 3 months, 1, 3, 5, 10 years</time_frame>
      <description>Intraoperative and postoperative complications</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluation of the stability of the stem</measure>
      <time_frame>Pre-op, 3 months, 1, 3, 5, 10 years</time_frame>
      <description>Radiographic evaluation to assess the osteointegration of the stem, the implant positioning, radiolucent lines.</description>
    </secondary_outcome>
    <enrollment type="Actual">100</enrollment>
    <condition>Primary Osteoarthritis</condition>
    <condition>Secondary Osteoarthritis</condition>
    <condition>Traumatic Arthritis</condition>
    <condition>Rheumatoid Arthritis</condition>
    <condition>Congenital Hip Dysplasia</condition>
    <condition>Avascular Necrosis</condition>
    <condition>Fracture; Femur, Head</condition>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>MiniMAX</intervention_name>
      <description>Total or Partial Hip Arthroplasty</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The sample size of 100 patients has been defined based on the literature data to guarantee&#xD;
          a sufficient number of patients for the evaluation of the performance of the prosthesis,&#xD;
          taking into account a 10% of lost patients (dead or lost at follow-up).&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patient with a clinical condition requiring THA&#xD;
  &#xD;
            2. Patient receiving a MiniMAX® stem&#xD;
  &#xD;
            3. Patient aged more than 18 years&#xD;
  &#xD;
            4. Patient having a Social Insurance or a similar protection regime&#xD;
  &#xD;
            5. Patient eligible for an AMIS procedure&#xD;
  &#xD;
            6. Patient able to follow the study requirements&#xD;
  &#xD;
            7. Patients who are willing to give informed written consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patient with local or systemic infection&#xD;
  &#xD;
            2. Participation to biomedical research&#xD;
  &#xD;
            3. Patient whose BMI exceeds 40&#xD;
  &#xD;
            4. Patient with less than 18 years&#xD;
  &#xD;
            5. Protected adults&#xD;
  &#xD;
            6. Vulnerable person according to article L1121-6 of the Code de la Santè Publique.&#xD;
  &#xD;
            7. Pregnant or lactating woman&#xD;
  &#xD;
            8. Patient unable to express his/ her opinion about the participation to the study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Centre Clinical Angouleme Soyaux</name>
        <address>
          <city>Soyaux</city>
          <zip>16800</zip>
          <country>France</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</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>Arthritis</mesh_term>
      <mesh_term>Osteoarthritis</mesh_term>
      <mesh_term>Hip Dislocation</mesh_term>
      <mesh_term>Developmental Dysplasia of the Hip</mesh_term>
      <mesh_term>Hip Dislocation, Congenital</mesh_term>
      <mesh_term>Necrosis</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/NCT06012656
  org study id: P01.005.10
  nct id: NCT06012656
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This is a post-marketing surveillance on MiniMAX Stem
  observational model: Cohort
  time perspective: Prospective
  measure: Survival Rate
  time frame: 10 years
  description: Kaplan Meier method
  measure: Functional evaluation
  time frame: Pre-op, 3 months, 1, 3, 5, 10 years
  description: Harris Hip Score (HHS): the HHS is a measure of dysfunction so the higher the score, the better the outcome for the individual. The maximum score possible is 100. Results can be interpreted with the following: <70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent.
  measure: Evaluation of patient satisfaction
  time frame: Pre-op, 3 months, 1, 3, 5, 10 years
  description: HOOS (hip disability and osteoarthritis outcome score) questionnaire: HOOS is a questionnaire intended to be used to assess patient's opinion about their hip and associated problems, and to evaluate their symptoms and functional limitations during a therapeutic process.The interval score ranges from 0 to 100 where 0 represents total hip disability and 100 represents perfect hip health.
  measure: Evaluation of the stem fixation
  time frame: Pre-op, 3 months, 1, 3, 5, 10 years
  description: Radiographic evaluation to assess the osteointegration of the stem, the implant positioning, radiolucent lines.
  measure: Evaluation of the general and thigh pain
  time frame: Pre-op, 3 months, 1, 3, 5, 10 years
  description: Echelle Visuelle Analogique (EVA) and pain location. Interpretation of the EVA scale: no pain 0, low pain 1-3, moderate pain 4-6, severe pain 7-9, extreme pain 10.
  measure: Incidence of adverse events
  time frame: Surgery, Immediate post-op, 3 months, 1, 3, 5, 10 years
  description: Intraoperative and postoperative complications
  measure: Evaluation of the stability of the stem
  time frame: Pre-op, 3 months, 1, 3, 5, 10 years
  description: Radiographic evaluation to assess the osteointegration of the stem, the implant positioning, radiolucent lines.
  intervention type: Device
  intervention name: MiniMAX
  description: Total or Partial Hip Arthroplasty
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: France
  responsible party type: Sponsor
  mesh term: Arthritis
  mesh term: Osteoarthritis
  mesh term: Hip Dislocation
  mesh term: Developmental Dysplasia of the Hip
  mesh term: Hip Dislocation, Congenital
  mesh term: Necrosis