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Not yet recruitingNCT07819149SubPostEOSUpdated Sep 17, 2026

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

An interventional study of biplanar fluoroscopy EOS in Shoulder Arthroplasty, sponsored by GCS Ramsay Santé pour l'Enseignement et la Recherche. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.

Sponsored by GCS Ramsay Santé pour l'Enseignement et la Recherche · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
92
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Shoulder Arthroplasty
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
92 participants (estimated)

Study arms

  • Experimental
    Shoulder arthroplasty

    Procedure: biplanar fluoroscopy EOS

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.

05

What researchers measure

Primary outcomes

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

    between 0 and 100

    Time frame: one day

06

Study locations

1 site
  • Hôpital privé Jean Mermoz
    Lyon, 69008, France
07

Registry details

Key details

Study ID
NCT07819149
Lead sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
Responsible party
Sponsor
First posted
Sep 14, 2026
Start date
Sep 30, 2026 (estimated)
Primary completion
Jul 30, 2029 (estimated)
Completion
Jul 31, 2029 (estimated)
Last update
Sep 17, 2026

Study contacts

Jean-François Oudet, M.
Contact
jf.oudet@ecten.eu
0033683346567
Marie-Hélène Barba
Contact

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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