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Shoulder ArthroplastySubPostEOSNCT07819149

Assessment of Posterior Subluxation of the Humeral Head Using Biplanar Imaging in the Upright Position in Patients Scheduled for Total Shoulder Arthroplasty

A study testing biplanar fluoroscopy EOS in people with Shoulder Arthroplasty, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

Total shoulder replacement is now recognized as a reliable and effective therapeutic option for the treatment of various degenerative joint conditions. Over time, clinical outcomes have significantly improved, both in terms of patient satisfaction and pain relief and functional recovery. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Shoulder Arthroplasty
What is being tested?
biplanar fluoroscopy EOS
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
92 participants
Where
1 siteFrance
Study dates
30 Sep 2026to 31 Jul 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Major
  • Scheduled for shoulder arthroplasty
  • Having undergone a CT scan of the shoulder scheduled for arthroplasty prior to the operation
  • Patient having signed an informed consent form
  • Patient affiliated with a social security scheme or beneficiary of such a scheme, according to Article L.1124-1 of the Public Health Code

Who cannot join

  • Contraindications from surgeons
  • Contraindication to EOS® examination
  • Anthropometry incompatible with EOS® examination
  • Scheduled for shoulder arthroplasty due to : fracture, sequelae of a fracture, history of glenoid graft
  • History of fracture of the humerus, scapula, or clavicle
  • Vulnerable and/or protected individual: adult under guardianship, curatorship, or other legal protection, deprived of liberty by judicial or administrative decision
  • Pregnant, breastfeeding, or postpartum woman

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jean-François Oudet, M. contact

0033683346567

jf.oudet@ecten.eu

Marie-Hélène Barba contact

France1 site
  • Hôpital privé Jean Mermoz

    Lyon, 69008

    Lionel Neyton, Dr, 0437530057 ext. 0033, neyton.lionel@orange.fr

Other trials in France

About this study

Total shoulder replacement is now recognized as a reliable and effective therapeutic option for the treatment of various degenerative joint conditions. Over time, clinical outcomes have significantly improved, both in terms of patient satisfaction and pain relief and functional recovery. Anatomical total shoulder replacement (TSR) has become the gold standard for pathologies such as glenohumeral osteoarthritis with an intact rotator cuff, with an estimated incidence of 12.5 cases per 100,000 patients, while reverse total shoulder replacement, intended primarily for pathologies of massive, irreparable rotator cuff tears, has an estimated incidence of 19.3 cases per 100,000 patients. These surgical approaches restore shoulder mobility, particularly during elevation movements, while significantly reducing pain.

However, loosening of the glenoid implant remains one of the main complications observed after total shoulder arthroplasty (TSA), often associated with increased pain, impaired function, and decreased overall patient satisfaction. Analysis of the explanted glenoid components frequently reveals posterior wear of the glenoid, which is closely correlated with the phenomenon of loosening. Among the factors likely to contribute to this complication, the rate of preoperative posterior subluxation of the humeral head has been identified as a major determinant of clinical outcomes in acetabular impingement (AIM), due to the progressive postoperative recurrence of this subluxation and its deleterious mechanical effects on the glenoid. Furthermore, the rate of posterior subluxation of the humeral head wa historically calculated from 2D CT scans obtained preoperatively. More recently, the limitations of the 2D approach have been highlighted, thus giving way to quantification using 3D reconstructions from the preoperative CT scan. However, whether for the 2D or 3D approach, the CT scan is performed while the patient is lying on their back. Although they did not directly quantify the posterior subluxation of the humeral head, showed, in healthy individuals, that the kinematics of the shoulder (i.e., glenohumeral angle) and more specifically the translation of the humeral head relative to the glenoid were different depending on whether the participant was lying down or standing. Considering that the majority of daily human activities are performed with the torso upright, it is crucial to determine whether the estimated rate of posterior subluxation of the humeral head and shoulder kinematics (i.e., glenohumeral angles) measured in the supine position accurately reflects the actual measurements when the patient is standing. One reason for this discrepancy could be the difficulty in measuring the rate of posterior subluxation of the humeral head and shoulder kinematics in the upright position. Standard motion analysis methods using video systems are not precise enough to measure these parameters, particularly due to soft tissue artifacts. Conversely, biplanar fluoroscopy or low-dose imaging (EOS®) are the gold standard for measuring shoulder kinematics with accuracy on the order of degrees and millimeters. However, no study to date has quantified the rate of posterior humeral head subluxation and shoulder kinematics in patients in an upright position.

The main objective of this study is to evaluate the influence of position, namely supine versus upright, on the quantification of posterior subluxation of the humeral head in patients scheduled for total shoulder replacement.

Being tested
biplanar fluoroscopy EOS

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • biplanar fluoroscopy EOSProcedure or surgery

    It involves taking a biplanar radiographic image (2 x-rays) of the operated side. Patients stand in the booth with their arms at their sides.

    Before the EOS scan, a preview image will be taken to verify the correct patient positioning.

Study groups in NCT07819149
Study groupRoleWhat they receive
Shoulder arthroplastyExperimentalNot described
Receives: Procedure: biplanar fluoroscopy EOS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of posterior subluxation of the humeral head measured in supine and upright positions

    between 0 and 100

    Measured: one day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2026
  2. Study start30 Sep 2026 (estimated)
  3. Primary completion30 Jul 2029 (estimated)
  4. Study completion31 Jul 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
92 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07819149
Sponsor's protocol ID
2026-A00569-42
Acronym
SubPostEOS
Status last verified
Sep 2026
First submitted
8 Sep 2026
Last updated
17 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing biplanar fluoroscopy EOS in people with Shoulder Arthroplasty, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jean-François Oudet, M. (0033683346567, jf.oudet@ecten.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of posterior subluxation of the humeral head measured in supine and upright positions (time frame: one day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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