The Medacta GMK SpheriKA Post-Marketing Surveillance Study

Medacta

Status: Enrolling

Conditions: Knee Replacement; Arthropathy

Treatments: Device: GMK SpheriKA

Study type: Observational

Funder types: Industry

Identifiers

NCT05459948

P.02.025.02

Details and patient eligibility

About

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

Full 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.

Enrollment: 281 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.