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

Arthropathy

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria5

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 Criteria10

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.

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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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