Determination of Scapulothoracic and Glenohumeral Angles by Imaging in Patients After Shoulder Arthroplasty (SCAP-imag)

NCT ID: NCT06877936

Last Updated: 2025-03-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-29
• Study Completion Date: 2027-02-28

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.

Conditions

Arthropathy Shoulder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Reverse total shoulder arthroplasty surgery

Reverse total shoulder arthroplasty surgery performed by Dr. Lionel Neyton about 2 years prior to inclusion in the study

Group Type: EXPERIMENTAL

EOS exam

Intervention Type: PROCEDURE

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.

Questionnaires Constant et ASES

Intervention Type: OTHER

There will be 2 questionnaires : Constant and American Shoulder and Elbow Surgeons to determine their pain level and functional limitations.

Interventions

EOS exam

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.

Intervention Type: PROCEDURE

Questionnaires Constant et ASES

There will be 2 questionnaires : Constant and American Shoulder and Elbow Surgeons to determine their pain level and functional limitations.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ramsay Générale de Santé

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hopital privé Jean Mermoz

Lyon, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Lionel Neyton, Dr

Role: CONTACT

neyton.lionel@orange.fr

00334 37 53 00 57

Facility Contacts

Lionel Neyton, Dr

Role: primary

secretariat.scientifique@orthosanty.fr

04 37 53 00 57

Other Identifiers

2024-A01684-43

Identifier Type: -

Identifier Source: org_study_id