Long Term Follow-up After Primary or Revision Shoulder Arthroplasty With a Patient- Specific Glenius Implant

Materialise

Status

Invitation-only

Conditions

Osteoarthritis of the Shoulder

Glenoid Cavity

Arthroplasty, Replacement, Shoulder

Treatments

Device: reversed glenoid prothesis

Study type

Observational

Funder types

Industry

Identifiers

NCT03806881

SMAT009

Details and patient eligibility

About

This post-market follow-up study investigates improvement in clinical and radiological outcome after reversed total shoulder arthroplasty with the patient-specific Glenius Glenoid Reconstruction system

Full description

The Glenius glenoid implant is a solution for patients who need a reversed glenoid reconstruction (primary or revision) because of a severely damaged glenoid associated with severe bone loss. In these cases, standard reconstruction of the glenoid is not possible because of the lack of body support of the glenoid rim or columns.

The Glenius implant is custom-made prothesis: during pre-operative planning, the implant is designed based on a detailed 3D CT analysis of the defect with special reference to bone quality and the anatomy of the bone deficient glenoid. Optimized screw fixation trajectories are defined for each individual patient, which accommodate screws that are positioned and angled towards the best bone stock available in the glenoid/coracoid/scapula with each specific patient. The surgeon provides feedback on the the design and orientation of the implant needed to achieve the optimal inclination of the head and the position & offset of the joint's centre of rotation.

Because Glenius is a relatively new product and only for use in specific and complex cases of severy glenoid erosion, follow-up data on the clinical and radiological outcome are scarce. With this study we aim to collect long-term clinical and radiological follow-up data for patients treated with Glenius in a uniform, standardized way.

Enrollment

24 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

patients having primary or revision shoulder joint replacement with severe glenoid bone defects
Patient is 18 years of age or older
Patient can follow the Glenius system procedure that is standard of care
Patient is willing to cooperate in the required post-operative therapy
Patient has participated in the informed consent process and has signed the EC approved informed consent form

Exclusion criteria