MOTO Post-marketing Surveillance Study

NCT ID: NCT04072055

Last Updated: 2023-03-20

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-09-25
• Study Completion Date: 2023-03-16

Brief Summary

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.

Conditions

Osteonecrosis; Osteo Arthritis Knee

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

MOTO medial

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

MOTO Medial

Intervention Type: DEVICE

MOTO medial unicompartmental knee system

Interventions

MOTO Medial

MOTO medial unicompartmental knee system

Intervention Type: DEVICE

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medacta International SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

AZ Zeno Campus Knokke-Heist

Knokke-Heist, , Belgium

Clinique Saint-Joseph

Liège, , Belgium

Countries

Belgium

Other Identifiers

P02.021.01

Identifier Type: -

Identifier Source: org_study_id