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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07819149
Acronym
SubPostEOS
Enrollment
92
Registered
2026-09-14
Start date
2026-09-30
Completion date
2029-07-31
Last updated
2026-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shoulder Arthroplasty

Brief 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. 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.

Interventions

PROCEDUREbiplanar fluoroscopy EOS

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.

Sponsors

GCS Ramsay Santé pour l'Enseignement et la Recherche
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Percentage of posterior subluxation of the humeral head measured in supine and upright positionsone daybetween 0 and 100

Countries

France

Contacts

CONTACTJean-François Oudet, M.
jf.oudet@ecten.eu0033683346567
CONTACTMarie-Hélène Barba

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 18, 2026