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

UnknownOBSERVATIONAL
Enrollment

416

Participants

Timeline

Start Date

April 7, 2022

Primary Completion Date

October 31, 2022

Study Completion Date

October 31, 2022

Conditions
Shoulder DiseaseShoulder FracturesShoulder 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

Trial Locations (20)

7620

RECRUITING

Centre Hospitalier de Dieppe, Dieppe

25000

RECRUITING

CHU Jean MINJOZ, Besançon

27000

RECRUITING

Clinique Bergouignan, Évreux

31600

RECRUITING

Clinique de l'Occitanie, Muret

35000

RECRUITING

Clinique Mutualiste la Sagesse, Rennes

35400

RECRUITING

Centre Hospitalier de St Malo, St-Malo

49800

RECRUITING

Clinique Saint Léonard, Trélazé

69001

RECRUITING

Clinique Saint Charles, Lyon

69300

RECRUITING

Infirmerie Protestante, Caluire-et-Cuire

71110

RECRUITING

Hopital privé Sainte Marie, Chalon-sur-Saône

73011

RECRUITING

CHMS Chambéry, Chambéry

75016

RECRUITING

Clinique Jouvenet, Paris

75020

RECRUITING

Clinique des Maussins, Paris

78300

RECRUITING

CHI Poissy - St Germain en Laye, Poissy

91480

RECRUITING

Hopital Privé Claude Gallien, Quincy-sous-Sénart

92160

RECRUITING

Hôpital Privé Antony, Antony

92400

RECRUITING

Clinique La Montagne, Courbevoie

98000

RECRUITING

Centre Hospitalier Princesse Grace, Monaco

01000

RECRUITING

Centre hospitalier Bourg en Bresse, Bourg-en-Bresse

RECRUITING

Clinique Convert, Bourg-en-Bresse

Sponsors

Lead Sponsor

All Listed Sponsors
lead

FX Solutions

INDUSTRY

NCT05284357 - Post Market Clinical Follow-up Study for Arthroplasty Shoulder System of FX Solutions at the Long Term | Biotech Hunter | Biotech Hunter