Post Market Clinical Follow-up Study for Arthroplasty Shoulder System of FX Solutions at the Long Term

Summary

This study takes place in the framework of the Post-Market Clinical Follow-up of the FX Solutions Shoulder System. The goal of this PMCF study is to collect clinical data in order to confirm the safety and the performance at a long term and mainly the first two years of sales for each studied ranges.

Eligible patients who received the FX Solutions Shoulder System and are at about 7 years post-operative were contacted by the Investigator to explain the study, the retrospective collection and the prospective follow-up visit. Investigator also explain the analysis of the post-operative outcomes of the patient. During the call of the investigator, the patient was informed about the study's goal and about the data collection. The oral agreement of the patient was checked by the investigators in CRF with its signature. Then, an information form explaining the purpose of the data collection was provided to the patient by postmail.

The retrospective data were collected in a paper CRF via the medical file of patient.

Post-operative follow-up for all patients is limited to a teleconsultation intended to assess the patient's current condition and clinical outcomes.

Patient who are enrolled in the study shall be assigned a unique Subject Identification Number to de-identify their information.

Conditions

• Shoulder Disease
• Shoulder Fractures
• Shoulder Arthroplasty for Revision of Previous Treatment

Interventions

DEVICE

Shoulder Arthroplasty Surgery with HUMELOCK I & II® Anatomic Shoulder System

HUMELOCK II® is a new-generation of modular implant designed for the effective treatment of 3 or 4 part fractures of proximal humerus. The range of cases in which it can be used is wider than a simple reconstructive anatomical prosthesis. In fact, thanks to its anchoring plate, and if cephalic perfusion criteria are met, the modular nature of HUMELOCK II® means it is possible to retain the patient's native humeral head, even in cases of severe osteopenia. The HUMELOCK II® shoulder prosthesis allows the reconstruction of the shoulder joint as a result of a trauma (complex fracture of the proximal humerus, a common occurrence in severely injured shoulders. The HUMELOCK II® shoulder system may also be suitable for treating cases of failure of an existing shoulder prosthesis where a stem or other locking mechanism may be needed. The HUMELOCK II® shoulder prosthesis is a hemi shoulder and a total shoulder prosthesis.

DEVICE

Shoulder Arthroplasty Surgery with HUMELOCK II® Reversible System

HUMELOCK II® is a new-generation of modular implant designed for the effective treatment of 3 or 4 part fractures of proximal humerus. The HUMELOCK II® shoulder prosthesis allows the reconstruction of the shoulder joint as a result of a trauma (complex fracture of the proximal humerus). It is designed for use in complex shoulder reconstruction procedures in patients with stage 3 or 4 fragments in the proximal humerus - a common occurrence in severely injured shoulders. The HUMELOCK II® reversible system may also be suitable for treating cases of failure of an existing shoulder prosthesis where a stem or other locking mechanism may be needed. The HUMELOCK II reversible system is used when the rotator cuff is injured.

DEVICE

Shoulder Arthroplasty Surgery with HUMELOCK Reversed® Shoulder System

Humelock Reversed® is a new generation of reversed prosthesis, designed for numerous shoulder pathologies: ranging from offset arthritis to a complex cephalotuberosity fracture. A centric or eccentric glenosphere, tilted at 10°, centered on a variable length baseplate post and the position of which is guided by an intuitive adaptive instrumentation. A 145° prosthetic epiphysis allows the pillar of the scapula to be protected while maintaining optimum stability. The humeral implant is positioned naturally in the center of the epiphysis, preserving the remaining bone as much as possible. Options of locking or cementing will allow the surgeon to position the prosthetic stem at the required height, according to the patient's indication and anatomy. The surgery is called total shoulder arthroplasty. It is also indicated in a failed hemi-arthroplasty or a failed total arthroplasty. It is indicated for significant rupture of rotator cuff-tear (first surgery or revision surgery)

DEVICE

Shoulder Arthroplasty Surgery with EASYTECH® Anatomic Shoulder System

EASYTECH Anatomical Shoulder System is indicated for use in total shoulder replacement to treat a severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis. EASYTECH system is a new generation of modular implant designed for the reconstruction of the shoulder joint for treating cases of degenerative pathology. The surgery is called total shoulder arthroplasty. EASYTECH prosthesis is a stemless system of shoulder components. It is a bone-preserving implant. The anchor base provides primary stability to pulling-out thanks to peripheral pegs in the shape of fir trees and their asymmetric orientations ensure its rotational stability

DEVICE

Shoulder Arthroplasty Surgery with EASYTECH® Reversed System (Primary intention)

EASYTECH Reversed Shoulder System is indicated for primary total shoulder arthroplasty for the relief of pain and to improve function in patients with a massive and non-repairable rotator cuff tear. EASYTECH system is a new generation of modular implant designed for the reconstruction of the shoulder joint for treating cases of degenerative pathology. . EASYTECH prosthesis is a stemless system of shoulder components. It is a bone-preserving implant. The anchor base provides primary stability to pulling-out thanks to peripheral pegs in the shape of fir trees and their asymmetric orientations ensure its rotational stability. A centric or eccentric glenosphere, tilted at 10°, centered on a variable length baseplate post (compatible with positioning techniques), and the position of which is guided by an intuitive adaptive instrumentation

DEVICE

Shoulder Arthroplasty Surgery with EASYTECH® Reversible System (for revision only)

EASYTECH Reversible Shoulder System is indicated for revision total shoulder arthroplasty for the relief of pain and to improve function in patients with a massive and non-repairable rotator cuff tear. EASYTECH system is a new generation of modular implant designed for the reconstruction of the shoulder joint for treating cases of degenerative pathology. . EASYTECH prosthesis is a stemless system of shoulder components. It is a bone-preserving implant. The anchor base provides primary stability to pulling-out thanks to peripheral pegs in the shape of fir trees and their asymmetric orientations ensure its rotational stability. A centric or eccentric glenosphere, tilted at 10°, centered on a variable length baseplate post (compatible with positioning techniques), and the position of which is guided by an intuitive adaptive instrumentation.

DEVICE

Shoulder Arthroplasty Surgery with HUMERIS® Anatomic Shoulder System

The HUMERIS Shoulder system is intended to be used in adult patients with glenohumeral joint degenerative pathologies associated or not with rotator cuff arthropathy or tears when all other non-invasive treatments have failed to reduce the pain or improve the quality of life. The HUMERIS shoulder is a system of short stem.The technical characteristics of this implant have been designed based on computer simulations, correlated to results previously published in medical journals. A 145° prosthetic epiphysis allows the pillar of the scapula to be protected while maintaining optimum stability. The humeral implant is positioned naturally in the center of the epiphysis, preserving the remaining bone as much as possible.

DEVICE

Shoulder Arthroplasty Surgery with HUMERIS® Reversible Shoulder System

The HUMERIS Shoulder system is intended to be used in adult patients with glenohumeral joint degenerative pathologies associated or not with rotator cuff arthropathy or tears when all other non-invasive treatments have failed to reduce the pain or improve the quality of life. The HUMERIS shoulder is a system of short stem.The technical characteristics of this implant have been designed based on computer simulations, correlated to results previously published in medical journals, in order to avoid the disadvantages of traditional reverse prostheses. A centric or eccentric glenosphere, tilted at 10°, centered on a variable length baseplate post, the position of which is guided by an intuitive adaptive instrumentation.A 145° prosthetic epiphysis allows the pillar of the scapula to be protected while maintaining optimum stability.The humeral implant is positioned naturally in the center of the epiphysis, preserving the remaining bone as much as possible

Sponsors & Collaborators

• FX Solutions

  lead INDUSTRY

Principal Investigators

• Laurent OBERT, MD · CHU Jean MINJOZ

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-04-07

Primary Completion

2022-10-31

Completion

2022-10-31

FDA Device

Yes

Countries

• France
• Monaco

Study Locations