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

NCT ID: NCT03806881

Last Updated: 2024-03-13

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 24 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2028-12-01

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Treatment group

Patients treated with a Glenius Glenoid Reconstruction System

reversed glenoid prothesis

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Glenius Glenoid Reconstruction system

Eligibility Criteria

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

• Pregnant patients
• Skeletally immature patients
• Prisoners

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

Sponsors

Materialise

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

AZ St-Elisabeth

Herentals, , Belgium

University Hospital Leuven - Traumatology

Leuven, , Belgium

University Hospital Leuven - Orthopedics

Leuven, , Belgium

Sint-Maartenskliniek

Nijmegen, , Netherlands

Countries

Belgium; Netherlands

Other Identifiers

SMAT009

Identifier Type: -

Identifier Source: org_study_id