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