Functional alignment is associated with increased incidence of pre-balance, reduced soft-tissue release, and...

This study aimed to compare two alignment strategies in the same patient undergoing simultaneous bilateral robotic-assisted TKA (SB-RATKA): mechanical alignment (MA), the gold-standard, and functional alignment (FA), a balance-driven, personalized alignment strategy. The outcome measures included quantitative assessment of soft-tissue release, incidence of knee balance, and post-operative pain. This was a prospective, self-controlled, randomized-controlled trial involving 72 patients who underwent SB-RATKA using the MAKO® robotic system with comparable grades of deformity and pain in both knees. 65 patients were finally included with one alignment strategy done per knee, with the patients blinded to the strategy used. The study recorded the additional soft-tissue releases required, incidence of pre-balance, and daily post-operative VAS pain scores. The mean age of the study population was 57.95 years, with a female preponderance (N = 53, 81.6%). MA group had significantly more medial compartment tightness in both flexion (MA-15.6 ± 1.8; FA-17 ± 1.3) and extension (MA-14.9 ± 1.9; FA-17 ± 1.1) (p < 0.0001) compared to the FA group after dynamic balancing. 66% of knees in the FA group (N = 43) achieved pre-balance compared to 32.3% in the MA group (N = 21) (p < 0.0001). VAS scores showed a significant reduction in pain in the FA group up to 72 h post-surgery (p < 0.0001). The requirement for posteromedial release (PM), posterior capsular (PC) release, tibial reduction osteotomy (TRO), and superficial MCL pie crusting (sMCL) were significantly lower in FA (PM-22, PC-13, TRO-8, sMCL-2) compared to MA (PM-44, PC-29, TRO-18, sMCL-8). Functional alignment strategy consistently resulted in a higher incidence of knee balance with a significant reduction in soft-tissue releases and immediate post-operative pain when compared to MA in the same patient undergoing SB-RATKA. Therapeutic Level 1.