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The Medacta GMK SpheriKA Post-Marketing Surveillance Study | Clinical Trials | Clareo Health

RECRUITING

The Medacta GMK SpheriKA Post-Marketing Surveillance Study

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

NCT05459948•Medacta International SA

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients willing to sign the informed consent.
•Patients able to comply with follow-up requirements, including postoperative weight-bearing restrictions and self-evaluations.
•Patients 18 - 80 years of age at the time of surgery.
•Patients requiring a primary total knee replacement (on label use).
•Patients with intact collateral ligaments.

Exclusion Criteria

•Patients with inflammatory arthritis.
•Morbidly obese patients, with a body mass index (BMI) \> 40.
•Patients with a history of total or unicompartmental reconstruction of the affected joint.
•Patients that have had a high tibial osteotomy or femoral osteotomy.
•Patients with neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
•Patients with a systemic or metabolic disorder leading to progressive bone deterioration.
•Patients that are immunologically compromised or receiving chronic steroids (\> 30 days).
•Patients whose bone stock is compromised due to disease or infection, unable to provide adequate support and/or fixation to the prosthesis.
•Patients with an active or suspected latent infection in or surrounding the knee joint.
•Pregnant or breastfeeding women.

Locations (4)

Centre de l'Arthrose

Mérignac, France

Clinique de l'Union

Saint-Jean, France

Humanitas Castelli

Bergamo, Italy

Gelenkzentrum Winterthur

Winterthur, Switzerland

Key Dates

Start Date

July 30, 2022

Primary Completion Date

May 1, 2035

Completion Date

May 1, 2035

Last Updated

September 29, 2025

Enrollment

281

ESTIMATED participants

Conditions

ArthropathyKnee Replacement

Interventions

GMK SpheriKA

DEVICE

Contacts

Arianna Girardi

CONTACT

+41 91 696 60 60 girardi@medacta.ch

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 29, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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The Medacta GMK SpheriKA Post-Marketing Surveillance Study

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