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โ† Trials
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The Medacta GMK SpheriKA Post-Marketing Surveillance Study

Recruitingn/aAges 18 Years - 80 YearsAllMedacta International SA
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • GMK SpheriKA
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Where

4 sites
Centre de l'Arthrose
Mรฉrignac, France
Clinique de l'Union
Saint-Jean, France
Humanitas Castelli
Bergamo, Italy
Gelenkzentrum Winterthur
Winterthur, Switzerland
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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