MOTO Post-marketing Surveillance Study

Terminated

• Conditions: Osteo Arthritis Knee; Osteonecrosis
• Interventions: Device: MOTO Medial

• Registration Number: NCT04072055
• Lead Sponsor: Medacta International SA

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-26
• Study First Submitted QC: 2019-08-26
• Study First Posted: 2019-08-28
• Study Start: 2019-09-25
• Status Verified: 2023-03
• Primary Completion: 2023-03-16
• Study Completion: 2023-03-16
• Last Update Submitted: 2023-03-16
• Last Update Posted: 2023-03-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MOTO medial	MOTO Medial	Patients suitable fulfilling the standard criteria for the implantation of unicondylar implant.

Primary Outcome Measures

Name	Time	Method
Prosthesis survival	5 years	survivorship analysis according to Kaplan-Meier method at 5 years after surgery

Secondary Outcome Measures

Name	Time	Method
New Knee Society Score (KSS)	preoperative, 3 months, 1, 3 and 5 years	Functionality and symptom of operated knee will be evaluated by New KSS score
Radiological analysis	preoperative, postoperative, 3 months, 1, 3 and 5 years	Postoperative stability and fixation of the device will be assessed by standard radiological exams
Complication	up to 5 years	Intraoperative and postoperative complication will be collected during all duration of the study

Trial Locations

Locations (2)

Clinique Saint-Joseph; 🇧🇪 Liège, Belgium

AZ Zeno Campus Knokke-Heist; 🇧🇪 Knokke-Heist, Belgium