MOTO Post-marketing Surveillance Study

Medacta

Status: Terminated

Conditions: Osteonecrosis; Osteo Arthritis Knee

Treatments: Device: MOTO Medial

Study type: Observational

Funder types: Industry

Identifiers

NCT04072055

P02.021.01

Details and patient eligibility

About

The prospective, multicentric, observational study has the aims to monitor the performance of the MOTO medial unicompartmental knee system in the treatment of patients with knee disease requiring a UKA. 150 patients will be recruited in 18 months and will be reviewed until 5 years follow-up visit after surgery. The primary objective of the study is to evaluate the prosthesis survival at 5 years.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with unicompartmental tibiofemoral osteoarthritis (OA) of the knee that meet the indications for use of Medacta implant included in this study (on-label use);
• Patients suffering from unilateral osteoarthritis or osteonecrosis of a single knee compartment;
• Frontal deformity < 10° (evaluated on weight-bearing long-axis x-rays);
• Flexion contracture < 10°;
• Intact ligaments;
• Patients willing and able to provide written informed consent for participation in the study;
• Patient's age over 18 years old;
• Patient with BMI < 40 kg/m2;
• Patients willing to comply with the pre and post-operative evaluation schedule.

Exclusion criteria

• Patients with one or more medical conditions identified as a contraindication in 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 who had previously undergone high tibial osteotomy or anterior cruciate ligament (ACL) reconstruction;
• Patients with BMI ≥ 40 kg/m2;
• Patients unable to understand and take action;
• Any case not described in the inclusion criteria.

Trial design

150 participants in 1 patient group

MOTO medial

Description:

Patients suitable fulfilling the standard criteria for the implantation of unicondylar implant.

Treatment:

Device: MOTO Medial