Robotic-assisted Versus Conventional Total Knee Arthroplasty

The objective of this clinical trial is to measure the effectiveness and safety of the ROSA® Knee System in assisting surgeons with bone resections and implant positioning optimization through early clinical and radiographic outcomes compared with conventional surgical instrumentation in total knee arthroplasty (TKA).

Inclusion criteria

• Patient is age between 18 and 85 years old, inclusive;
• Patient qualifies for a primary TKA based on the investigator's clinical judgement;
• Patient is a candidate for commercially available Persona® Knee Joint Prosthese which is compatible with the ROSA® Knee System;
• Patient is willing and able to provide written Informed Consent.

Exclusion criteria

• Patient planning to receive bilateral TKA surgery within 3 months;
• Patient who has undergone revision surgery for partial or total knee arthroplasty of the ipsilateral knee；
• Bone tumor patient who has undergone bilateral TKA;
• Stable, painless ipsilateral knee arthrodesis within a satisfactory function and position;
• Patient who has received partial or total knee arthroplasty for the contralateral knee within 6 months prior to scheduled primary TKA;
• Patient has active, local infection or previous intra-articular infection in the affected joint;
• Insufficient bone stock on femoral or tibial surfaces;
• Skeletal immaturity;
• Osteomalacia or any metabolic disorder which may impair bone formation;
• Patient has neurologic disorders (e.g. Stroke);
• Patient hs diseases that could lead to prosthesis instability, failure of prosthesis fixation or postoperative complications (e.g. Arthrodesis, Scoliosis, Lumbar Stenosis)
• Patient has a hip pathology with significant bone loss (e.g. avascular necrosis of the femoral head with collapse, severe dysplasia of the femoral head or the acetabulum);
• Patient has hip pathology severely limiting range of motion (e.g. arthrodesis, severe contractures, chronic severe dislocation);
• Patients with severe knee instability caused by incomplete collateral ligaments, cruciate ligaments, and posterolateral structural injury;
• Rheumatoid arthritis accompanied by an ulcer of the skin or history of recurrent breakdown of the skin;
• Patient has severe angular knee deformity of >20° varus or >20° valgus;
• Patient has a known or suspected sensitivity or allergy to one or more of the implant materials;
• Patient has other contraindications specified by the implant manufacturer;
• Patient is pregnant or considered a member of a protected population (e.g. prisoner, mentally incompetent);
• In the past 1 month participated in or is participating in clinical trials related to other drugs and medical devices;
• Any other conditions that the investigator considers inappropriate for participation in this trial.