Multicentre GMK UNI Anatomical Cementless Study - FR

Medacta

Status: Active, not recruiting

Conditions: Revision Surgery; Avascular Necrosis of the Femoral Condyle; Osteoarthritis of the Knee

Study type: Observational

Funder types: Industry

Identifiers

NCT06715917

P02.018.02

Details and patient eligibility

About

Unicompartmental Knee Arthroplasty (UKA) is the principal surgical alternative to Total Knee Arthroplasty (TKA) in patients with end-stage unicompartmental tibiofemoral osteoarthritis (OA) of the knee. The current post-marketing surveillance study aims to monitor GMK-UNI monocompartmental knee prosthesis performances over a 10-year time period.

Enrollment: 249 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients presenting with disease that meets the indications for use for Medacta implants included in this study (on-label use);
• Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to the patient's surgery;
• Patient's age between 18 and 75 years old;
• Patients must be willing to comply with the pre and postoperative evaluation schedule.

Exclusion criteria

• Patients with one or more medical conditions identified as a contraindication defined by the labelling on any Medacta implants used in this study;
• Any patient who cannot or will not provide informed consent for participation in the study;
• Patients who need a revision surgery
• Patients unable to understand and take action;
• Any case not described in the inclusion criteria;
• Patients aged under 18 years;
• Patients aged over 75 years;