NCT05215600

Anaverse™ Glenoid System and Its Instrumentation

Anaverse™ Glenoid System and Its Instrumentation - Retrospective and Prospective, Non-Controlled Post Market Clinical Follow-Up Study

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: —

Summary

The objectives of this study are to confirm safety, performance and clinical benefits of the Anaverse™ Glenoid System and its instrumentation by analysis of standard scoring systems, radiographs and adverse event records.

Detailed description

The safety of the system will be assessed by monitoring the frequency and incidence of adverse events. The performance and clinical benefits will be evaluated by assessment of the overall pain and functional performance, survival, and radiographic parameters of all enrolled study subjects. The primary endpoint is defined by the survival of the implant system at 2 years which is based on removal or intended removal of the Anaverse™ Glenoid System baseplate and will be determined by using the Kaplan Meier method.

Conditions

• Rotator Cuff Injuries
• Shoulder Pain
• Arthropathy
• Arthroplasty Complications

Interventions

Type	Name	Description
DEVICE	Anaverse Shoulder System	Reverse Shoulder Arthroplasty

Timeline

• Start date: 2022-05-06
• Primary completion: 2024-04-23
• Completion: 2024-04-23
• First posted: 2022-01-31
• Last updated: 2025-04-08
• Results posted: 2025-03-20

Locations

1 site across 1 country: Switzerland