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NCT Number: NCT04449146

Scapular Positioning in Standing Position Using Sonography

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).

Recruiting

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brest, University Hospital

Brest, 29609, France

Location status: Recruiting

Location contact

Hoel LETISSIER, Dr

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: Day 1

    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.

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

    Time frame: Day1

    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.

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

    Time frame: 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 outcomes

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

    Time frame: Day 1

    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

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

    Time frame: Day 1

    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

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

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Hoel LETISSIER, Dr

CONTACT

[email protected]

689313164 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Acronym: 3S

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jun 26, 2020
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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