The Medacta International GMK Sphere Cementless Post-Marketing Surveillance Study

Medacta

Status: Enrolling

Conditions: Traumatic Arthritis; Arthritis; Avascular Necrosis; Poly-arthritis; Rheumatoid Arthritis

Treatments: Device: GMK Sphere cementless Knee Replacement

Study type: Observational

Funder types: Industry

Identifiers

NCT05003414

P02.014.26

Details and patient eligibility

About

This is a Post-Marketing Surveillance study of GMK Sphere cementless knee prosthesis.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• A disabled or severely disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis, poly-arthritis or avascular necrosis
• Patients between the age of 18 and 80 at the time of consent
• Listed for total knee replacement surgery.
• Patients who are willing and able to give informed written consent

Exclusion criteria

• Progressive local or systemic infection
• Muscular loss, neuromuscular disease or vascular deficiency of the affected limb, making the operation unjustifiable
• Severe instability secondary to advance destruction of condralar structures or loss of integrity of the medial or lateral ligament
• Those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems
• Patient whose BMI exceeds 40
• Any case not described in the inclusion criteria