NCT05459948

The Medacta GMK SpheriKA Post-Marketing Surveillance Study

Medacta GMK® SpheriKA and Kinematic Alignment Technique Multicenter, Post-Market Outcome Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 281 (estimated)
• Sponsor: Medacta International SA · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: —

Summary

This is a Post-Marketing Surveillance of GMK SpheriKA knee stem prosthesis.

Detailed description

The aim of the current study is to collect clinical and radiological data to monitor the performances of the "GMK® SpheriKA" Knee Prosthesis implanted via the kinematic alignment technique.

Conditions

• Arthropathy
• Knee Replacement

Interventions

Type	Name	Description
DEVICE	GMK SpheriKA	The first objective is to study the FJS of patients who were implanted a "GMK® SpheriKA" knee prosthesis using the kinematic alignment technique

Timeline

• Start date: 2022-07-30
• Primary completion: 2035-05-01
• Completion: 2035-05-01
• First posted: 2022-07-15
• Last updated: 2025-09-29

Locations

4 sites across 3 countries: France, Italy, Switzerland