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Recruiting NCT04449146

Scapular Positioning in Standing Position Using Sonography

No phase Interventional Shoulder Osteoarthritis Arthropathy Shoulder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Scapular positioning in Standing position using Sonography.
Who it may be relevant to
Registry conditions: Shoulder Osteoarthritis, Arthropathy Shoulder. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Study the location of the scapula in 3 dimensions for the patient in standing position [Time frame: Day 1]
  • Study the location of the scapula in 3 dimensions for the patient in standing position [Time frame: Day1]
  • Study the location of the scapula in 3 dimensions for the patient in standing position [Time frame: Day 1]
Secondary outcome measures (3)
  • Evaluating the accuracy of the device using a validation bench [Time frame: Day 1]
  • Evaluating the accuracy of the device using a validation bench [Time frame: Day 1]
  • Evaluating the accuracy of the device using a validation bench [Time frame: Day 1]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

France · 1 center
  • Brest, University Hospital — Brest

Identifiers

NCT: NCT04449146 · 3S (29BRC18.0239)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗