An interventional study of EOS exam and Questionnaires Constant et ASES in Arthropathy Shoulder, sponsored by Ramsay Générale de Santé. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-14.
Sponsored by Ramsay Générale de Santé · Not applicable, Interventional, and Other
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.
Ramsay Générale de Santé is the lead sponsor of 42 studies on the registry; 10 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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Reverse total shoulder arthroplasty surgery performed by Dr. Lionel Neyton about 2 years prior to inclusion in the study
Procedure: EOS exam · Other: Questionnaires Constant et ASES
The EOS procedure will consist of taking 3 x-rays per side (6 in total) while the patient is standing (oriented at 35° to the x-ray) with the arm in position 0°, then at 45° and finally at 90° elevation in the frontal plane for 20 seconds per position.
There will be 2 questionnaires : Constant and American Shoulder and Elbow Surgeons to determine their pain level and functional limitations.
Kinematics evaluation
The evaluation of kinematics will be done through the quantification of the scapulothoracic and glenohumeral angles.
Time frame: one month
Scapulohumeral rhythm
Scapulohumeral rhythm on the operated side and on the contralateral side.
Time frame: one month
Constant score on the operated side and the contralateral side.
Constant score
Time frame: one month
ASES score
ASES score on the operated side and the contralateral side.
Time frame: one month
Started Jan 2025 (actual). Primary completion is estimated for Jan 2026, 12 months after the start.
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