Abstract
BACKGROUND: A novel active robotic system for total knee arthroplasty (TKA) performs automated milling of bone surfaces. Study objectives were to assess system safety and effectiveness in a US population. METHODS: A multicenter clinical trial was conducted, following 115 patients for at least 6-months. A pre-defined list of robot-related adverse events was used to evaluate safety. Efficacy was assessed radiographically comparing planned versus achieved coronal limb alignment. RESULTS: No pre-defined adverse events occurred and postoperative limb alignment more than ±3° from plan occurred in 11.2 % of cases. CONCLUSION: Active robotics for TKA is safe and effective as demonstrated in this trial.