Scapular Positioning in Standing Position Using Sonography (3S)

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).

Study Overview

• Status: Unknown
• Conditions: Shoulder Osteoarthritis; Arthropathy Shoulder
• Intervention / Treatment: Diagnostic test: Scapular positioning in Standing position using Sonography

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hoel LETISSIER, Dr; Phone Number: +33 689313164; Email: hoel.letissier@chu-brest.fr

Study Locations

• France
  • Brest, France, 29609
    • Brest, University Hospital
    • Contact: Hoel LETISSIER, Dr; Email: hoel.letissier@chu-brest.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: shoulder localizer ultrasound; 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.

Diagnostic test: Scapular positioning in Standing position using Sonography; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 1
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.	Day1
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.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day 1
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	Day 1
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	Day 1

Collaborators and Investigators

• Sponsor: University Hospital, Brest
• Investigators: Principal Investigator: Hoel LETISSIER, Dr, University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2020
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: October 29, 2019
• First Submitted That Met QC Criteria: June 25, 2020
• First Posted (Actual): June 26, 2020

Study Record Updates

• Last Update Posted (Actual): June 29, 2020
• Last Update Submitted That Met QC Criteria: June 25, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Reverse Shoulder Arthroplasty
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Joint Diseases
• Other Study ID Numbers: 3S (29BRC18.0239)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No