Actively Recruiting
The Medacta GMK SpheriKA Post-Marketing Surveillance Study
Led by Medacta International SA · Updated on 2025-09-29
281
Participants Needed
4
Research Sites
665 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Post-Marketing Surveillance of GMK SpheriKA knee stem prosthesis.
CONDITIONS
Official Title
The Medacta GMK SpheriKA Post-Marketing Surveillance Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Centre de l'Arthrose
Mérignac, France
Actively Recruiting
2
Clinique de l'Union
Saint-Jean, France, 31240
Actively Recruiting
3
Humanitas Castelli
Bergamo, Italy
Actively Recruiting
4
Gelenkzentrum Winterthur
Winterthur, Switzerland
Actively Recruiting
Research Team
A
Arianna Girardi
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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