Scapular Positioning in Standing Position Using Sonography

NCT04449146 | Recruiting

• 1 other identifier: 3S (29BRC18.0239)
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Shoulder Osteoarthritis; Arthropathy Shoulder

Keywords

Reverse Shoulder Arthroplasty

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Evaluating the accuracy of the device using a validation bench

  Day 1

• Evaluating the accuracy of the device using a validation bench

  Day 1

• Evaluating the accuracy of the device using a validation bench

  Day 1

Study Arms (1)

shoulder localizer ultrasound

EXPERIMENTAL

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

Interventions

Scapular positioning in Standing position using Sonography DIAGNOSTIC_TEST

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.

shoulder localizer ultrasound

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

Brest, University Hospital

Brest, 29609, France

RECRUITING

Study Officials

• Hoel LETISSIER, Dr

  University Hospital, Brest

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hoel LETISSIER, Dr

CONTACT

689313164; hoel.letissier@chu-brest.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: October 29, 2019
• First Posted: June 26, 2020
• Study Start: August 31, 2022
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)