Improved surgical accuracy in total knee arthroplasty using the ROSA® knee system: A randomised‐controlled unblinded trial

Abstract Purpose Robotic‐assisted total knee arthroplasty (RATKA) has been connected to improved surgical precision and implant alignment compared to conventional TKA (CTKA), with limited evidence from randomised‐controlled trials (RCT) and a large range of different systems on the market. Consequently, this study aimed to compare RATKA using the ROSA® knee system and CTKA in a prospective RCT for surgical as well as patient‐reported outcomes. Methods Seventy‐seven patients undergoing TKA were prospectively included in this monocentric, unblinded RCT. All patients had a minimum follow‐up of 1 year. Primary endpoints were postoperative implant alignment accuracy and patient‐reported outcomes using the Oxford knee score (OKS) and quality of life scoring (EQ‐5D‐5L). Secondary outcomes included range of motion, blood loss, length of stay, return to work and physiotherapy needs. Statistical analysis included multivariable regression with significance set at p 3°; <−3° from the mechanical axis) compared to CTKA (38% vs. 18%, p = 0.047). Both groups had comparable postoperative improvement in patient‐reported outcomes (OKS Δ prepost 18.0 vs. 17.7, p = 0.902; EQ‐5D‐5L Δ prepost 0.21 vs. 0.25, p = 0.089). Regression analysis identified preoperative OKS ( b = 0.57, p < 0.001) and cruciate‐retaining implant bearing ( b = 5.42, p = 0.043) as significant predictors of improved postoperative outcome. Conclusions RATKA using the ROSA® knee system improves implant positioning and radiological alignment compared to CTKA with similar short‐term clinical outcomes. Future research should focus on long‐term RCT data to determine whether the improved accuracy of RATKA results in superior implant survival and reduced revision rates. Level of Evidence Level II, prospective comparative study.