Osteo Arthritis Knee, Osteonecrosis
Conditions
Keywords
Unicompartmental Knee Arthroplasty, UKA, antomic femoral component, anatomic tibial component
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.
Interventions
DEVICEMOTO Medial
MOTO medial unicompartmental knee system
Sponsors
Medacta International SA
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prosthesis survival | 5 years | survivorship analysis according to Kaplan-Meier method at 5 years after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Belgium
Outcome results
None listed