GMK SpheriKA: The first objective is to study the FJS of patients who were implanted a "GMK® SpheriKA" knee prosthesis using the kinematic alignment technique
Study summary
This is a Post-Marketing Surveillance of GMK SpheriKA knee stem prosthesis.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Primary objective will be evaluated with the Forgotten Joint score (FJS). — 6 weeks, from 1 to 10 years annually study the efficacy of the treatment to make the patient forget the presence of the artificial joint in everyday life.
The Forgotten Joint Score assessment consists of 12 questions and is scored on a 0-100 scale. The higher the score, the less the patient is aware of their affected joint when performing daily activities
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.
