Comparative evaluation of the efficacy of robotic-assisted versus conventional total knee arthroplasty: a prospective randomized study

Introduction. Knee osteoarthritis is one of the most common causes of chronic pain and functional limitation in middle-aged and elderly individuals. Although total knee arthroplasty (TKA) is a well-established and effective procedure, up to 20 % of patients remain dissatisfied with surgical outcomes, primarily due to suboptimal component positioning and soft-tissue imbalance. Robotic-assisted systems aim to improve surgical precision and reproducibility of results; however, the clinical advantages of this approach over conventional techniques remain insufficiently substantiated. The purpose of the study. To compare the clinical and functional outcomes and safety of robotic-assisted versus conventional total knee arthroplasty in a prospective randomized trial with a 2-year follow-up. Materials and methods. A single-center, prospective, randomized study was conducted involving 100 patients (50 per group) with grade III–IV knee osteoarthritis according to the Kellgren–Lawrence classification. The study group underwent robotic-assisted TKA using the Cuvis Joint™ system, whereas the control group received conventional manual TKA. Functional outcomes were assessed preoperatively and at 2, 6, 12 and 24 months postoperatively using the IKDC, KSS, VAS, and Lequesne scales. Statistical analysis included the Mann–Whitney U test for continuous variables and Pearson’s χ² test for categorical data, with a significance threshold of p = 0.05. Results. Outcomes were evaluated in all 100 participants. On the IKDC scale, the robotic group showed significantly better results at 2 months (median 42 vs 36; p < 0.001), 6 months (55 vs 52; p = 0.001), and 12 months (68 vs 65; p = 0.001), with comparable results at 24 months (p = 0.141). The KSS scores remained higher in the robotic group throughout follow-up (p < 0.01). Pain intensity (VAS) and Lequesne index values were significantly lower in the robotic group from 2 months onward (p < 0.01). Median operative time was 95 minutes versus 60 minutes (p < 0.001), and intraoperative blood loss was 300 mL versus 250 mL (p = 0.022). No adverse events or complications were observed. Conclusion. Robotic-assisted total knee arthroplasty provides greater improvement in functional outcomes and pain reduction compared with conventional manual TKA, while maintaining a comparable safety profile. The observed increase in operative time and intraoperative blood loss reflects the learning curve effect and does not diminish the overall clinical efficacy of the technique. The findings support the feasibility and clinical relevance of implementing robotic technologies in arthroplasty of large joints (particularly, knee joints).