Clinical trial NCT06877936: Determination of Scapulothoracic and Glenohumeral Angles by Imaging in Patients After Shoulder Arthroplasty (SCAP-imag)
Official title: Determination of Scapulothoracic and Glenohumeral Angles by Imaging in Patients After Shoulder Arthroplasty
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Arthropathy Shoulder
Lead sponsor: Ramsay Générale de Santé
Sponsor class: OTHER
First posted: 2025-03-14
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The shoulder is a site particularly affected by osteoarthritis since it affects up to 7% of the population aged over 65. To deal with osteoarthritis, total shoulder prosthesis is an increasingly used solution. Among the different types of total shoulder prostheses, the majority of surgical procedures involve the use of a reverse total shoulder prosthesis. This type of prosthesis modifies the anatomy of the shoulder in order to ensure better stability and mobility of the shoulder in patients while also compensating for potential significant lesions of certain deep muscles of the shoulder joint (i.e., rotator cuff).

Reverse prostheses have good short-term results but these are impaired in longer term with a Constant functional score of around 70% at 10 years and a survival rate of 70% after 20 years. Problems of bone conflicts between the scapula and the humerus can also be observed on these reverse total shoulder prostheses with variable rates from 4.6% to 47.3% depending on the position of the prosthesis.

In order to minimize the risk of complications, several tools are available to surgeons to optimize the positioning of the prosthesis. Planning software can be used to plan the kinematics of the shoulder after arthroplasty and quantify shoulder movements by 1/ estimating the scapulothoracic and glenohumeral angles, and 2/ determining the scapulohumeral rhythm (i.e., joint coordination index evaluating the relative contribution of these two joints to the total elevation of the arm). This prediction allows the surgeon to adapt the size, shape and position of the implants to each patient in order to ensure optimal shoulder kinematics, namely a maximum amplitude without bone conflicts (contacts) between the scapula and the humerus.

The main objective of this study is to evaluate the influence of a reverse shoulder arthroplasty on shoulder kinematics at 2 years postoperatively in comparison with the non-operated contralateral limb.


Eligibility criteria: Inclusion Criteria:

* Major
* Reverse total shoulder arthroplasty surgery performed by Dr. Lionel Neyton (Jean Mermoz Private Hospital,69008 Lyon) 24±3 months prior to inclusion in the study.
* Have had a CT scan of the operated shoulder prior to the operation
* Patient having signed informed consent
* Patient affiliated to a social security scheme or beneficiary of such a scheme, according to Article L.1124-1 of the Public Health Code

Exclusion Criteria:

* Contraindication to the EOS® examination
* Anthropometry incompatible with the production of EOS images
* Pregnant, parturient, breastfeeding women
* Have a history of fracture at the level of the humerus, scapula or clavicle
* Have a history of surgery on the shoulder or contralateral upper limb to the limb with the prosthesis
* Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision

Primary outcomes:
measure: Kinematics evaluation
timeFrame: one month
Secondary outcomes:
measure: Scapulohumeral rhythm
timeFrame: one month
measure: Constant score on the operated side and the contralateral side.
timeFrame: one month
measure: ASES score
timeFrame: one month
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hopital privé Jean Mermoz
Study officials:
References: