Scapular Positioning in Standing Position Using Sonography

Not Applicable

Recruiting

• Conditions: Shoulder Osteoarthritis; Arthropathy Shoulder
• Interventions: Diagnostic Test: Scapular positioning in Standing position using Sonography

• Registration Number: NCT04449146
• Lead Sponsor: University Hospital, Brest

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.

Study Timeline

• Study First Submitted: 2019-10-29
• Study First Submitted QC: 2020-06-25
• Study First Posted: 2020-06-26
• Study Start: 2022-08-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-12
• Primary Completion: 2026-08-31
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
shoulder localizer ultrasound	Scapular positioning in Standing position using Sonography	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.

Primary Outcome Measures

Name	Time	Method
Study the location of the scapula in 3 dimensions for the patient in standing position	Day 1	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

Name	Time	Method
Evaluating the accuracy of the device using a validation bench	Day 1	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

Trial Locations

Locations (1)

Brest, University Hospital; 🇫🇷 Brest, France