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/NCT05978362</url>
    </required_header>
    <id_info>
      <org_study_id>2022-A02629-34</org_study_id>
      <nct_id>NCT05978362</nct_id>
    </id_info>
    <brief_title>Value of Capsular Repair for Latarjet</brief_title>
    <acronym>CAP-LATARJET</acronym>
    <official_title>Prospective, Multicenter, Randomized Single-blind Study on the Interest of Capsular Repair in the Latarjet Operation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>GCS Ramsay Santé pour l'Enseignement et la Recherche</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>GCS Ramsay Santé pour l'Enseignement et la Recherche</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>
        The purpose of the study is to evaluate the occurrence of osteoarthritis (YES/NO) by&#xD;
        radiography.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a prospective, comparative, longitudinal, randomized, single-blind, multicenter&#xD;
        study.&#xD;
  &#xD;
        This study will validate preliminary results on a technique associating capsular repair with&#xD;
        abutment according to Latarjet in the treatment of shoulder instabilities. It may help reduce&#xD;
        the risk of osteoarthritis and thus allow patients to maintain a healthy, stable and painless&#xD;
        shoulder for longer.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">December 2034</completion_date>
    <primary_completion_date type="Anticipated">December 2034</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>prospective, comparative, longitudinal, randomized single-blind study</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>randomized single-blind study</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>occurrence of osteoarthritis</measure>
      <time_frame>10 years</time_frame>
      <description>Change from occurrence of osteoarthritis (YES/NO) on X-ray at 5 and 10 years, compared to inclusion X-ray using the Samilson-Prieto classification.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">86</enrollment>
    <condition>Shoulder Pain</condition>
    <arm_group>
      <arm_group_label>With capsular repair</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This technique consists of inserting the capsule during the operation according to Latarjet.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Without capsular repair</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Latarjet technique without capsular repair</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Latarjet technique</intervention_name>
      <description>Realization of a stop according to Latarjet</description>
      <arm_group_label>With capsular repair</arm_group_label>
      <arm_group_label>Without capsular repair</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patient, male or female, over the age of 18&#xD;
  &#xD;
            -  Patient with shoulder instability with risk factors for recurrence (ISIS score &gt; 3),&#xD;
               requiring surgical stabilization by abutment&#xD;
  &#xD;
            -  Affiliated patient or beneficiary of a social security scheme&#xD;
  &#xD;
            -  Patient having been informed and having given his free, informed and written consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patient with history of surgery for instability of the same shoulder&#xD;
  &#xD;
            -  Patient presenting contraindications to the realization of a postoperative scanner&#xD;
  &#xD;
            -  Patient whose physical and/or psychological health is severely impaired, which&#xD;
               according to the investigator may affect the compliance of the study participant&#xD;
  &#xD;
            -  Patient participating in another clinical research or in a period of exclusion from&#xD;
               another research still in progress at the time of inclusion&#xD;
  &#xD;
            -  Protected patient: adult under guardianship, curatorship or other legal protection,&#xD;
               deprived of liberty by judicial or administrative decision&#xD;
  &#xD;
            -  Pregnant, breastfeeding or parturient woman&#xD;
  &#xD;
            -  Patient hospitalized without consent.&#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>Geoffroy NOURISSAT, MD</last_name>
      <phone>768513650</phone>
      <phone_ext>+33</phone_ext>
      <email>gnourissat@wanadoo.fr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Clinique Maussins-Nollet</name>
        <address>
          <city>Paris</city>
          <zip>75019</zip>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Geoffroy NOURISSAT, MD</last_name>
        <phone>768513650</phone>
        <phone_ext>+33</phone_ext>
        <email>gnourissat@wanadoo.fr</email>
      </contact>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 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>Shoulder Pain</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/NCT05978362
  org study id: 2022-A02629-34
  nct id: NCT05978362
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of the study is to evaluate the occurrence of osteoarthritis (YES/NO) by
        radiography.
  This is a prospective, comparative, longitudinal, randomized, single-blind, multicenter
        study.
  
        This study will validate preliminary results on a technique associating capsular repair with
        abutment according to Latarjet in the treatment of shoulder instabilities. It may help reduce
        the risk of osteoarthritis and thus allow patients to maintain a healthy, stable and painless
        shoulder for longer.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: prospective, comparative, longitudinal, randomized single-blind study
  primary purpose: Treatment
  masking: Single (Participant)
  masking description: randomized single-blind study
  measure: occurrence of osteoarthritis
  time frame: 10 years
  description: Change from occurrence of osteoarthritis (YES/NO) on X-ray at 5 and 10 years, compared to inclusion X-ray using the Samilson-Prieto classification.
  arm group label: With capsular repair
  arm group type: Experimental
  description: This technique consists of inserting the capsule during the operation according to Latarjet.
  arm group label: Without capsular repair
  arm group type: Active Comparator
  description: Latarjet technique without capsular repair
  intervention type: Procedure
  intervention name: Latarjet technique
  description: Realization of a stop according to Latarjet
  arm group label: With capsular repair
  arm group label: Without capsular repair
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Geoffroy NOURISSAT, MD
  phone: 768513650
  phone ext: +33
  email: gnourissat@wanadoo.fr
  facility: 
  contact: 
  country: France
  responsible party type: Sponsor
  mesh term: Shoulder Pain