MOTO Post-marketing Surveillance Study

Study Overview
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Brief Summary
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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.

Official Title
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MOTO MEDIAL UNICOMPARTMENTAL KNEE ARTHROPLASTY: OPEN, PROSPECTIVE, MULTICENTRIC, OBSERVATIONAL STUDY

Conditions
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Osteonecrosis, Osteo Arthritis Knee

Intervention / Treatment
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* Device: MOTO Medial


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MOTO medial<br>Patients suitable fulfilling the standard criteria for the implantation of unicondylar implant. | Device: MOTO Medial<br>* MOTO medial unicompartmental knee system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prosthesis survival | survivorship analysis according to Kaplan-Meier method at 5 years after surgery | 5 years | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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UKA, Unicompartmental Knee Arthroplasty, antomic femoral component, anatomic tibial component