Scapular Positioning in Standing Position Using Sonography

Shoulder Osteoarthritis Clinical Trial

— 3S  

Official title:

Scapular Positioning in Standing Position Using Sonography

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04449146
• Other study ID #: 3S (29BRC18.0239)
• Status: Recruiting
• Phase: N/A
• Start date: August 31, 2022
• Est. completion date: August 31, 2024

Study information

• Verified date: May 2024
• Source: University Hospital, Brest
• Contact: Hoel LETISSIER, Dr
• Phone: 689313164
• Email: hoel.letissier[@]chu-brest.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthropathy Shoulder
• Joint Diseases
• Osteoarthritis
• Shoulder Osteoarthritis

Intervention

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.

Locations

Country	Name	City	State
France	Brest, University Hospital	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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