Early Radiographic and Clinical Outcomes of Robotic-Arm-Assisted Versus Conventional TKA

Purpose: A robotic system was recently introduced to improve prosthetic alignment during total knee arthroplasty (TKA). The purpose of this multicenter prospective randomized controlled trial (RCT) study was to determine whether robotic-arm-assisted TKA improves the clinical and radiological outcomes in patients compared to conventional TKA. Methods: One hundred and thirty patients who underwent primary TKA were enrolled in this prospective, multicenter RCT conducted in 3 hospitals. Five patients were lost to follow-up at 6 weeks after surgery. Therefore, 125 patients (63 in the intervention group and 62 in the control group) remained in the final analysis. The primary outcome was the rate of patients whose mechanical axis of the femur was less than 3° deviated from the mechanical axis of the tibia evaluated by full-length weight-bearing X-rays of the lower limb at 6 weeks postoperatively. Secondary outcomes will include operation times, 6-week postoperative functional outcomes evaluated by the American Knee Society Score (KSS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), SF-36, adverse events (AEs) and serious adverse events (SAEs). Hypothesis: Robotic-arm-assisted TKA is safe and effective as demonstrated in this trial.