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.
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.
Marie-Hélène Barba contact
France1 site
Hôpital privé Jean Mermoz
Lyon, 69008
Lionel Neyton, Dr, 0437530057 ext. 0033, neyton.lionel@orange.fr
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.
- Conditions
- Shoulder Arthroplasty
- 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 group | Role | What they receive |
|---|---|---|
| Shoulder arthroplasty | Experimental | Not described Receives: Procedure: biplanar fluoroscopy EOS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted14 Sep 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Jul 2029 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder ArthroplastyStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Posterior Subluxation of the Humeral Head Using Biplanar Imaging in the Upright Position in Patients Scheduled for Total Shoulder Arthroplasty
- ClinicalTrials.gov ID
- NCT07819149
- Acronym / sponsor ID
- SubPostEOS / 2026-A00569-42
- Conditions
- Shoulder Arthroplasty
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 30 Jul 2029 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 14 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Shoulder arthroplasty | Experimental | Procedure: biplanar fluoroscopy EOS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biplanar fluoroscopy EOSIt 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. | Procedure or surgery | Shoulder arthroplasty |
Primary outcome
Percentage of posterior subluxation of the humeral head measured in supine and upright positions
Time frame: one day
between 0 and 100
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marie-Hélène Barba contact
1 site in 1 country: see every site and its status.
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.