Study Summary

220 patients with knee osteoarthritis scheduled for unilateral total knee arthroplasty (TKA) were included in this randomized study. After exclusions and loss to follow-up, 200 patients completed the follow-up and were included in the final analysis. Patients were randomized to undergo either handheld robotic-assisted TKA (Group R) or computer-assisted navigation TKA (Group C). The primary outcomes of interest were functional and radiological results. Functional outcomes included Knee Society Score (KSS), Knee Society Functional Score (KSFS), Western Ontario and McMaster University Osteoarthritis Index (WOMAC), Knee injury and Osteoarthritis Outcome Score (KOOS), High Flexion Knee Score (HFKS), Visual Analog Scale (VAS) pain score, and the Forgotten Joint Score (FJS-12). Radiological outcomes included hip–knee–ankle axis, coronal femoral and tibial angles, joint line, patellar thickness, and posterior offset. Secondary outcomes included extent of soft tissue releases, registration time, blood loss, complications, and error between planned and achieved bone cuts. Outcomes were assessed preoperatively and at 6 weeks, 3 months, 6 months, 1 year, and 2 years postoperatively. Overall, the results demonstrated that handheld robotic-assisted total knee arthroplasty required significantly fewer soft tissue releases and achieved greater accuracy of bone cuts compared with computer-assisted navigation. Although some functional and patient-reported scores favoured the robotic group at two years, none of these differences reached established clinically important difference thresholds.