A Prospective Clinical Investigation of Robotic-assisted TKA With Skywalker and Evolution Medial Pivot Knee

What this Trial Is About

Researchers are evaluating the safety and performance of robotic-assisted total knee arthroplasty (RA-TKA) using the Skywalker device combined with the Evolution Medial Pivot (eMP) knee. The study aims to compare this approach with conventional manual instrumentations for eMP knees and non-medial pivot total knee arthroplasties, focusing on accuracy, learning curve, postoperative function, and safety. This prospective trial includes patients with various joint diseases or deformities who meet specific eligibility criteria. Participants will receive either robotic-assisted total knee replacement with the Skywalker device and eMP knee or conventional total knee arthroplasty performed manually. The study includes a cohort of learning curve cases for surgeons adopting the Skywalker system. Comparisons will be made retrospectively with patients who had eMP knees with conventional instruments or non-medial pivot total knee arthroplasties. The study evaluates surgical accuracy, alignment, and kinematics at various postoperative time points. During the study, participants will undergo multiple assessments including functional scores like the Forgotten Joint Score (FJS) and Oxford Knee Score (OKS) at intervals up to 12 months, as well as range of motion evaluations and kinematic analysis using radiostereometric analysis (RSA). Safety monitoring includes tracking surgical revisions, interventions, and serious adverse events requiring hospitalization. The learning curve of surgeons will be assessed based on surgical times. Participants must be independent and ambulatory and able to comply with follow-up visits and evaluations over the study period.

l Investigation of Robotic-assisted TKA (RA-TKA) With Skywalker and Evolution Medial Pivot Knee (eMP Knee)