RecruitingNCT05459948

The Medacta GMK SpheriKA Post-Marketing Surveillance Study

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


Sponsor

Medacta International SA

Enrollment

281 participants

Start Date

Jul 30, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study follows patients who have received a specific type of total knee replacement implant (the Medacta GMK SpheriKA) to track how well it performs over time. It is a post-marketing surveillance study, meaning the implant is already approved and used in routine care — researchers are simply collecting data on real-world outcomes to ensure it continues to perform safely and effectively. You may be eligible if: - You are between 18 and 80 years old at the time of your knee surgery - You need a primary total knee replacement (your first knee replacement in that joint) - You have intact ligaments on both sides of the knee - You are willing to sign an informed consent form and attend follow-up visits You may NOT be eligible if: - You have inflammatory arthritis (such as rheumatoid arthritis) - Your BMI is greater than 40 - You have had a previous total or partial knee replacement in the same joint - You have had a high tibial osteotomy or femoral osteotomy (certain bone correction surgeries) - You have a neuromuscular or neurological disorder affecting your ability to use the knee - You have a systemic disease causing progressive bone loss - You are immunocompromised or on long-term steroids (more than 30 days) - You have poor bone quality or an active knee infection - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEGMK SpheriKA

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


Locations(4)

Centre de l'Arthrose

Mérignac, France

Clinique de l'Union

Saint-Jean, France

Humanitas Castelli

Bergamo, Italy

Gelenkzentrum Winterthur

Winterthur, Switzerland

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NCT05459948


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