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Scapular Positioning in Standing Position Using Sonography (3S)

Primary Purpose

Shoulder Osteoarthritis, Arthropathy Shoulder

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Scapular positioning in Standing position using Sonography
Sponsored by
University Hospital, Brest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Shoulder Osteoarthritis focused on measuring Reverse Shoulder Arthroplasty

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Major patients and agreeing to participate in the study after oral and written information.
  • Care course patients for a reverse shoulder arthroplasty on a native shoulder joint

Exclusion Criteria:

  • Patients under the age of 18
  • Patients refusing to participate in the study
  • Patients whose condition does not allow informed consent
  • Patients who are subject to legal protection (safeguarding of Justice, curatorship, guardianship), persons deprived of their liberty
  • Unaffiliated patients and non-beneficiaries of a health insurance plan

Sites / Locations

  • Brest, University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

shoulder localizer ultrasound

Arm 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.

Outcomes

Primary Outcome Measures

Study the location of the scapula in 3 dimensions for the patient in standing position
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.
Study the location of the scapula in 3 dimensions for the patient in standing position
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.
Study the location of the scapula in 3 dimensions for the patient in standing position
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.

Secondary Outcome Measures

Evaluating the accuracy of the device using a validation bench
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
Evaluating the accuracy of the device using a validation bench
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
Evaluating the accuracy of the device using a validation bench
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

Full Information

First Posted
October 29, 2019
Last Updated
June 25, 2020
Sponsor
University Hospital, Brest
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1. Study Identification

Unique Protocol Identification Number
NCT04449146
Brief Title
Scapular Positioning in Standing Position Using Sonography
Acronym
3S
Official Title
Scapular Positioning in Standing Position Using Sonography
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 2020 (Anticipated)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
July 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Osteoarthritis, Arthropathy Shoulder
Keywords
Reverse Shoulder Arthroplasty

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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).
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
shoulder localizer ultrasound
Arm Type
Experimental
Arm 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(s)
Scapular positioning in Standing position using Sonography
Intervention 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.
Primary Outcome Measure Information:
Title
Study the location of the scapula in 3 dimensions for the patient in standing position
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.
Time Frame
Day 1
Title
Study the location of the scapula in 3 dimensions for the patient in standing position
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.
Time Frame
Day1
Title
Study the location of the scapula in 3 dimensions for the patient in standing position
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.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Evaluating the accuracy of the device using a validation bench
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
Time Frame
Day 1
Title
Evaluating the accuracy of the device using a validation bench
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
Time Frame
Day 1
Title
Evaluating the accuracy of the device using a validation bench
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
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Major patients and agreeing to participate in the study after oral and written information. Care course patients for a reverse shoulder arthroplasty on a native shoulder joint Exclusion Criteria: Patients under the age of 18 Patients refusing to participate in the study Patients whose condition does not allow informed consent Patients who are subject to legal protection (safeguarding of Justice, curatorship, guardianship), persons deprived of their liberty Unaffiliated patients and non-beneficiaries of a health insurance plan
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hoel LETISSIER, Dr
Phone
689313164
Ext
+33
Email
hoel.letissier@chu-brest.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hoel LETISSIER, Dr
Organizational Affiliation
University Hospital, Brest
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brest, University Hospital
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hoel LETISSIER, Dr
Email
hoel.letissier@chu-brest.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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Scapular Positioning in Standing Position Using Sonography

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