As an emerging technology, functionally aligned robotic-assisted total knee arthroplasty (FA-RTKA) enables more precise osteotomy and prosthesis positioning through preoperative imaging modeling and intraoperative real-time navigation. Multiple studies have compared the clinical outcomes between FA-RTKA and mechanically aligned total knee arthroplasty (MA-TKA), yet the results remain inconsistent. It is necessary to conduct a meta-analysis to synthesize the existing evidence and investigate the differences in postoperative clinical outcomes between FA-RTKA and MA-TKA, thereby providing a more reliable basis for clinical decision-making.

We systematically searched four electronic databases (PubMed, Embase, Cochrane Library, and Web of Science). The inclusion criteria were controlled studies comparing the clinical outcomes between FA-RTKA and MA-TKA. The main outcomes were the Visual Analog Scale (VAS) score, Forgotten Joint Score (FJS), Knee Society Function Score (KSFS), Knee Society Knee Score (KSKS). Secondary outcome is the Range of Motion (ROM). All clinical outcomes were analyzed and evaluated using data from the final follow-up visit in each study.

A total of 11 studies involving 1,666 patients subjected to TKA were included, with 833 patients in the FA-TKA group and 833 in the MA-TKA group. No significant difference was observed in the VAS score and ROM at the final follow-up between the two groups. Statistically significant differences were found in all other clinical outcomes. Specifically, significant improvements were noted in the FJS (MD: 15.79, 95% CI: 6.02–25.57, P = 0.002), KSKS (MD: 2.36, 95% CI: 1.33–3.39, P < 0.00001), and KSFS (MD: 7.94, 95% CI: 1.47–14.42, P = 0.002).

Compared to MA-TKA, FA-RTKA demonstrated superior outcomes in joint function, stability, and patients’ subjective perception. In contrast, both techniques provided comparable pain relief.

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