NCT03806881

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

Long Term Follow-up After Primary or Revision Shoulder Arthroplasty With a Patient- Specific Glenius Implant: A Prospective Cohort Study

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 24 (estimated)
• Sponsor: Materialise · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Arthroplasty, Replacement, Shoulder
• Glenoid Cavity
• Osteoarthritis of the Shoulder

Interventions

Type	Name	Description
DEVICE	reversed glenoid prothesis	All patients will undergo a primary or revision arthroplasty with Glenius according to the routine practice at the investigation site and will be followed at specified visiting moments, during which radiological and clinical data will be gathered.

Timeline

• Start date: 2019-07-01
• Primary completion: 2024-10-01
• Completion: 2028-12-01
• First posted: 2019-01-16
• Last updated: 2024-03-13

Locations

4 sites across 2 countries: Belgium, Netherlands