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/NCT06038331</url>
    </required_header>
    <id_info>
      <org_study_id>SclerFIX-STT-TBF</org_study_id>
      <secondary_id>2023-A00790-45</secondary_id>
      <nct_id>NCT06038331</nct_id>
    </id_info>
    <brief_title>Use of a Treated, Devitalized and Sterile Umbilical Cord Amniotic Membrane in the Treatment of STT Osteoarthritis</brief_title>
    <official_title>Evaluation of the Treatment of Symptomatic Scaphotrapeziotrapezoidal (STT) Osteoarthritis With a Treated, Devitalized and Sterile Amniotic Membrane of Umbilical Cord Placed in Joint Interposition</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>TBF Genie Tissulaire</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>TBF Genie Tissulaire</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 aim of this open, prospective, multicenter trial is to evaluate the use of a sterile,&#xD;
        devitalized, processed umbilical cord amniotic membrane implant placed in joint interposition&#xD;
        in the treatment of STT osteoarthritis.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">October 2025</completion_date>
    <primary_completion_date type="Anticipated">October 2025</primary_completion_date>
    <phase>Phase 2</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>Decrease of the symptomatology related to the STT OA</measure>
      <time_frame>12 months</time_frame>
      <description>Quality of life related to STT OA evaluated using Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire (0 = no disability, 100 = most severe disability); a decrease of 25% of the score is expected between subject's inclusion and the 12-month postoperative visit</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Absence of inflammatory reactions and good local tolerance of the implant</measure>
      <time_frame>Through study completion (12 months)</time_frame>
      <description>No inflammatory reactions (oedema, erythema, necrosis, ulceration and/or delayed wound healing), no adverse effects or serious adverse effects.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Decrease of pain related to STT OA</measure>
      <time_frame>1 month, 3 months, 6 months, 12 months</time_frame>
      <description>Pain evaluated from 0 (no pain) to 10 (worst imaginable pain) on a visual analog scale (VAS)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Improvement of functional activities involving the thumb</measure>
      <time_frame>1 month, 3 months, 6 months, 12 months</time_frame>
      <description>Functional activities involving the thumb evaluated from 0 (best) to 56 (worst) using the Buffet score developed by the Besançon University Hospital</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Increase of thumb strength</measure>
      <time_frame>3 months, 6 months, 12 months</time_frame>
      <description>Thumb strength measured in kg by two-point pinch strength test using a pinch gauge</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Increase of grip strength</measure>
      <time_frame>3 months, 6 months, 12 months</time_frame>
      <description>Grip strength measured in kg by grip strength test using a dynamometer</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>No apparent joint space anomaly</measure>
      <time_frame>12 months</time_frame>
      <description>Joint space evaluated on radiography using Crosby's classification</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">14</enrollment>
    <condition>Osteoarthritis Hand</condition>
    <arm_group>
      <arm_group_label>SclerFIX-IP</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Treated, devitalised and sterile graft of umbilical cord amniotic membrane</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>SclerFIX-IP</intervention_name>
      <description>Decellularized, viro-inactivated, freeze-dried and sterile allogeneic graft of amniotic membrane of umbilical cord used as an interposition implant in the STT joint</description>
      <arm_group_label>SclerFIX-IP</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male or female; age between 18 and 75 years.&#xD;
  &#xD;
            -  Patient with symptomatic STT OA.&#xD;
  &#xD;
            -  Patient treated medically for functional signs for more than 3 months, without&#xD;
               improvement, justifying a surgical intervention.&#xD;
  &#xD;
            -  Patient with a QuickDash score &gt; 33 points (converted to 50%).&#xD;
  &#xD;
            -  Patient with wrist pain in front of the STT joint at rest = or &gt; 4/10 on VAS.&#xD;
  &#xD;
            -  Patient who received the study information and provided consent.&#xD;
  &#xD;
            -  Member or beneficiary of a national health insurance plan.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnant or breastfeeding woman; woman without effective contraception.&#xD;
  &#xD;
            -  Patient with functional rhizarthrosis that has not been stabilized or treated&#xD;
               medically or surgically.&#xD;
  &#xD;
            -  Patient with signs of neuropathy with functional disorders such as hyperesthesia.&#xD;
  &#xD;
            -  Patient with uncontrolled epilepsy or neuropathy that contraindicates locoregional&#xD;
               anesthesia.&#xD;
  &#xD;
            -  Person confined by a judicial or administrative decision.&#xD;
  &#xD;
            -  Adult subjected to legal protection measures or unable to provide his/her consent.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Laurence BARNOUIN, MD</last_name>
      <phone>4 72 68 69 09</phone>
      <phone_ext>+33</phone_ext>
      <email>laurence.barnouin@tbf-lab.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Justine BOSC, MSc</last_name>
      <phone>4 72 68 69 11</phone>
      <phone_ext>+33</phone_ext>
      <email>justine.bosc@tbf-lab.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Institut Chirurgical de la Main et du Membre Supérieur (ICMMS)</name>
        <address>
          <city>Lyon</city>
          <zip>69006</zip>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Lionel ERHARD, MD</last_name>
        <email>lionel.erhard@institut-chirurgical.com</email>
      </contact>
      <investigator>
        <last_name>Lionel ERHARD, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 4, 2023</study_first_submitted>
    <study_first_submitted_qc>September 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>ScaphoTrapezioTrapezoid OsteoArthritis (STT OA)</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Osteoarthritis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06038331
  org study id: SclerFIX-STT-TBF
  secondary id: 2023-A00790-45
  nct id: NCT06038331
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this open, prospective, multicenter trial is to evaluate the use of a sterile,
        devitalized, processed umbilical cord amniotic membrane implant placed in joint interposition
        in the treatment of STT osteoarthritis.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Decrease of the symptomatology related to the STT OA
  time frame: 12 months
  description: Quality of life related to STT OA evaluated using Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire (0 = no disability, 100 = most severe disability); a decrease of 25% of the score is expected between subject's inclusion and the 12-month postoperative visit
  measure: Absence of inflammatory reactions and good local tolerance of the implant
  time frame: Through study completion (12 months)
  description: No inflammatory reactions (oedema, erythema, necrosis, ulceration and/or delayed wound healing), no adverse effects or serious adverse effects.
  measure: Decrease of pain related to STT OA
  time frame: 1 month, 3 months, 6 months, 12 months
  description: Pain evaluated from 0 (no pain) to 10 (worst imaginable pain) on a visual analog scale (VAS)
  measure: Improvement of functional activities involving the thumb
  time frame: 1 month, 3 months, 6 months, 12 months
  description: Functional activities involving the thumb evaluated from 0 (best) to 56 (worst) using the Buffet score developed by the Besançon University Hospital
  measure: Increase of thumb strength
  time frame: 3 months, 6 months, 12 months
  description: Thumb strength measured in kg by two-point pinch strength test using a pinch gauge
  measure: Increase of grip strength
  time frame: 3 months, 6 months, 12 months
  description: Grip strength measured in kg by grip strength test using a dynamometer
  measure: No apparent joint space anomaly
  time frame: 12 months
  description: Joint space evaluated on radiography using Crosby's classification
  arm group label: SclerFIX-IP
  arm group type: Experimental
  description: Treated, devitalised and sterile graft of umbilical cord amniotic membrane
  intervention type: Biological
  intervention name: SclerFIX-IP
  description: Decellularized, viro-inactivated, freeze-dried and sterile allogeneic graft of amniotic membrane of umbilical cord used as an interposition implant in the STT joint
  arm group label: SclerFIX-IP
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Laurence BARNOUIN, MD
  phone: 4 72 68 69 09
  phone ext: +33
  email: laurence.barnouin@tbf-lab.com
  last name: Justine BOSC, MSc
  phone: 4 72 68 69 11
  phone ext: +33
  email: justine.bosc@tbf-lab.com
  facility: 
  contact: 
  investigator: 
  country: France
  responsible party type: Sponsor
  mesh term: Osteoarthritis
  sharing ipd: No