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Robotic-assisted total knee arthroplasty (rTKA) is being adopted rapidly, but data on its real-world safety compared with conventional TKA (cTKA) outside specialized centers are limited. The purpose of this study was to evaluate the association between rTKA and major surgical complications in a large, population-based cohort.

We conducted a propensity-score matched population-based cohort study of all adults undergoing primary rTKA versus cTKA for osteoarthritis in Ontario, Canada, from April 1, 2019, to October 31, 2023, with follow-up through October 31, 2024. Use of robotic assistance versus conventional instrumentation during primary TKA was identified for each case. During the study period, 74,359 TKAs were performed across 62 hospitals by 345 surgeons: 1,613 rTKAs and 72,746 cTKAs. The primary outcome was major surgical complications within one year, defined as a composite of revision arthroplasty, deep infection requiring surgery, or fracture requiring surgery. Outcomes were compared between matched groups using Cox proportional hazards regressions to estimate hazard ratios (HR) and absolute risk differences (ARD).

Robotic adoption increased from 1.7% of cases in 2019 to 5.8% in 2023 (P < 0.001). Compared to matched cTKA patients, those undergoing rTKA had a significantly higher rate of major complications within one year (2.0 versus 1.0%; ARD = 0.99% [95% confidence interval (CI), 0.25 to 1.73%]; HR = 2.01 [95% CI, 1.31 to 3.07]).

Adoption of rTKA in Ontario, Canada, was associated with an increased risk of major surgical complications as compared to cTKA. Further work is required to ensure implementation proceeds safely and that theoretical benefits of robotics translate into improved outcomes for patients.