<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/NCT04449146</url>
  </required_header>
  <id_info>
    <org_study_id>3S (29BRC18.0239)</org_study_id>
    <nct_id>NCT04449146</nct_id>
  </id_info>
  <brief_title>Scapular Positioning in Standing Position Using Sonography</brief_title>
  <acronym>3S</acronym>
  <official_title>Scapular Positioning in Standing Position Using Sonography</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Brest</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Brest</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 objective of this study is to analyse the positioning of the scapula in standing position&#xD;
      and compared to the supine position (CT scan) in 3 dimensions (3 rotations of the scapula)&#xD;
      using a non-radiant, portable system, combining an ultrasound probe with marker and a camera&#xD;
      integrated into a Tablet for the three-dimensional location of the marker (probe).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a mono-center trial. Patients in the process of pre-operative care of a reverse&#xD;
      shoulder arthroplasty (CT Scan already available as part of the care course in supine&#xD;
      position) will be offered the study. A localizer ultrasound will be performed during surgical&#xD;
      consultation or the day before the surgery in standing position (duration: 1/2 day). This&#xD;
      consultation takes place during the course of the surgical consultation or when the patient&#xD;
      is admitted the day before his surgical procedure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 2020</start_date>
  <completion_date type="Anticipated">July 2022</completion_date>
  <primary_completion_date type="Anticipated">July 2022</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>
    <intervention_model_description>This is mono-center study. Patients in the process of preoperative care of a Reverse Shoulder Arthroplasty (CT Scan already available as part of the extended care course) will be offered the study. A localizer ultrasound will be performed during surgical consultation or the day before the surgical procedure in standing position (duration: 1/2 day).</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Study the location of the scapula in 3 dimensions for the patient in standing position</measure>
    <time_frame>Day 1</time_frame>
    <description>descriptive statistics of the population : mean and standard deviation of the 3 rotations of the scapula in each plane of reference coronal plane expressed in degree.&#xD;
Comparison with the supine position and analysis of any differences.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Study the location of the scapula in 3 dimensions for the patient in standing position</measure>
    <time_frame>Day1</time_frame>
    <description>descriptive statistics of the population : mean and standard deviation of the 3 rotations of the scapula in each plane of reference axial plane expressed in degree.&#xD;
Comparison with the supine position and analysis of any differences.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Study the location of the scapula in 3 dimensions for the patient in standing position</measure>
    <time_frame>Day 1</time_frame>
    <description>descriptive statistics of the population : mean and standard deviation of the 3 rotations of the scapula in each plane of reference sagittal plane expressed in degree.&#xD;
Comparison with the supine position and analysis of any differences.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluating the accuracy of the device using a validation bench</measure>
    <time_frame>Day 1</time_frame>
    <description>Validation of the device using a biomechanical bench. The rotation will be assessed in coronal plane in degree. The differences between the measurements of the biomechanical bench will be compared to the measurements validation bench to assess the mean error and standard deviation of the ultrasound device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluating the accuracy of the device using a validation bench</measure>
    <time_frame>Day 1</time_frame>
    <description>Validation of the device using a biomechanical bench. The rotation will be assessed in axial plane in degree. The differences between the measurements of the biomechanical bench will be compared to the measurements validation bench to assess the mean error and standard deviation of the ultrasound device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluating the accuracy of the device using a validation bench</measure>
    <time_frame>Day 1</time_frame>
    <description>Validation of the device using a biomechanical bench. The rotation will be assessed in sagittal plane in degree. The differences between the measurements of the biomechanical bench will be compared to the measurements validation bench to assess the mean error and standard deviation of the ultrasound device</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Shoulder Osteoarthritis</condition>
  <condition>Arthropathy Shoulder</condition>
  <arm_group>
    <arm_group_label>shoulder localizer ultrasound</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The localizer ultrasound of the shoulder is performed on an unclothed patient (at the shoulders) and comes to locate bony landmarks using the ultrasound probe as a Transcutaneous localizer. The Protocol plans to acquire different landmarks on the scapula: lower angle, coracoid, scapula spine and bilateral acromioclavicular joint (definition of the coronal plan). These acquisitions are carried out by the probe connected to a Tablet (Microsoft surface Pro 3) which allows to locate the probe and by extension of the probe the location of the points selected by ultrasound.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Scapular positioning in Standing position using Sonography</intervention_name>
    <description>The localizer ultrasound of the shoulder is performed in an unclothed patient (at the shoulders) and comes to locate bony landmarks using the ultrasound probe as a Transcutaneous localizer.</description>
    <arm_group_label>shoulder localizer ultrasound</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Major patients and agreeing to participate in the study after oral and written&#xD;
             information.&#xD;
&#xD;
          -  Care course patients for a reverse shoulder arthroplasty on a native shoulder joint&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients under the age of 18&#xD;
&#xD;
          -  Patients refusing to participate in the study&#xD;
&#xD;
          -  Patients whose condition does not allow informed consent&#xD;
&#xD;
          -  Patients who are subject to legal protection (safeguarding of Justice, curatorship,&#xD;
             guardianship), persons deprived of their liberty&#xD;
&#xD;
          -  Unaffiliated patients and non-beneficiaries of a health insurance plan&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hoel LETISSIER, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Brest</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hoel LETISSIER, Dr</last_name>
    <phone>689313164</phone>
    <phone_ext>+33</phone_ext>
    <email>hoel.letissier@chu-brest.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Brest, University Hospital</name>
      <address>
        <city>Brest</city>
        <zip>29609</zip>
        <country>France</country>
      </address>
    </facility>
    <contact>
      <last_name>Hoel LETISSIER, Dr</last_name>
      <email>hoel.letissier@chu-brest.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>October 29, 2019</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 26, 2020</study_first_posted>
  <last_update_submitted>June 25, 2020</last_update_submitted>
  <last_update_submitted_qc>June 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Reverse Shoulder Arthroplasty</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Joint Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04449146
org study id: 3S (29BRC18.0239)
nct id: NCT04449146
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to analyse the positioning of the scapula in standing position
      and compared to the supine position (CT scan) in 3 dimensions (3 rotations of the scapula)
      using a non-radiant, portable system, combining an ultrasound probe with marker and a camera
      integrated into a Tablet for the three-dimensional location of the marker (probe).
This is a mono-center trial. Patients in the process of pre-operative care of a reverse
      shoulder arthroplasty (CT Scan already available as part of the care course in supine
      position) will be offered the study. A localizer ultrasound will be performed during surgical
      consultation or the day before the surgery in standing position (duration: 1/2 day). This
      consultation takes place during the course of the surgical consultation or when the patient
      is admitted the day before his surgical procedure.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: This is mono-center study. Patients in the process of preoperative care of a Reverse Shoulder Arthroplasty (CT Scan already available as part of the extended care course) will be offered the study. A localizer ultrasound will be performed during surgical consultation or the day before the surgical procedure in standing position (duration: 1/2 day).
primary purpose: Diagnostic
masking: None (Open Label)
measure: Study the location of the scapula in 3 dimensions for the patient in standing position
time frame: Day 1
description: descriptive statistics of the population : mean and standard deviation of the 3 rotations of the scapula in each plane of reference coronal plane expressed in degree.
Comparison with the supine position and analysis of any differences.
measure: Study the location of the scapula in 3 dimensions for the patient in standing position
time frame: Day1
description: descriptive statistics of the population : mean and standard deviation of the 3 rotations of the scapula in each plane of reference axial plane expressed in degree.
Comparison with the supine position and analysis of any differences.
measure: Study the location of the scapula in 3 dimensions for the patient in standing position
time frame: Day 1
description: descriptive statistics of the population : mean and standard deviation of the 3 rotations of the scapula in each plane of reference sagittal plane expressed in degree.
Comparison with the supine position and analysis of any differences.
measure: Evaluating the accuracy of the device using a validation bench
time frame: Day 1
description: Validation of the device using a biomechanical bench. The rotation will be assessed in coronal plane in degree. The differences between the measurements of the biomechanical bench will be compared to the measurements validation bench to assess the mean error and standard deviation of the ultrasound device
measure: Evaluating the accuracy of the device using a validation bench
time frame: Day 1
description: Validation of the device using a biomechanical bench. The rotation will be assessed in axial plane in degree. The differences between the measurements of the biomechanical bench will be compared to the measurements validation bench to assess the mean error and standard deviation of the ultrasound device
measure: Evaluating the accuracy of the device using a validation bench
time frame: Day 1
description: Validation of the device using a biomechanical bench. The rotation will be assessed in sagittal plane in degree. The differences between the measurements of the biomechanical bench will be compared to the measurements validation bench to assess the mean error and standard deviation of the ultrasound device
arm group label: shoulder localizer ultrasound
arm group type: Experimental
description: The localizer ultrasound of the shoulder is performed on an unclothed patient (at the shoulders) and comes to locate bony landmarks using the ultrasound probe as a Transcutaneous localizer. The Protocol plans to acquire different landmarks on the scapula: lower angle, coracoid, scapula spine and bilateral acromioclavicular joint (definition of the coronal plan). These acquisitions are carried out by the probe connected to a Tablet (Microsoft surface Pro 3) which allows to locate the probe and by extension of the probe the location of the points selected by ultrasound.
intervention type: Diagnostic Test
intervention name: Scapular positioning in Standing position using Sonography
description: The localizer ultrasound of the shoulder is performed in an unclothed patient (at the shoulders) and comes to locate bony landmarks using the ultrasound probe as a Transcutaneous localizer.
arm group label: shoulder localizer ultrasound
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Hoel LETISSIER, Dr
role: Principal Investigator
affiliation: University Hospital, Brest
last name: Hoel LETISSIER, Dr
phone: 689313164
phone ext: +33
email: hoel.letissier@chu-brest.fr
facility: 
contact: 
country: France
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Joint Diseases
sharing ipd: No