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

What this Trial Is About

Researchers are monitoring the performance of the GMK® SpheriKA Knee Prosthesis implanted using the kinematic alignment technique in patients who need a primary total knee replacement. This post-marketing surveillance study aims to collect clinical and radiological data to better understand how this device performs over time in people with arthropathy and knee replacement needs. Participants will receive the GMK® SpheriKA knee prosthesis through surgery using the kinematic alignment method. The study will follow patients from 6 weeks after surgery and then annually up to 10 years. During this time, various assessments including patient-reported outcomes, satisfaction questionnaires, radiological exams, and monitoring of adverse events will be collected at specific time points such as pre-operation, 6 weeks, 1, 2, 5, and 10 years. Participants will attend follow-up visits to complete questionnaires and undergo radiological imaging to evaluate joint function and alignment. The primary measure will be the Forgotten Joint Score (FJS), assessed from 6 weeks post-surgery through annual visits for up to 10 years. Researchers will also track safety and performance through adverse event reporting and imaging studies. The total participation duration may last up to 10 years to fully capture long-term outcomes and device performance.

The Medacta GMK SpheriKA Post-Marketing Surveillance Study