Enhancing total knee arthroplasty outcomes: the role of individualized femoral sagittal alignment in robotic-assisted surgery - A randomized controlled trial

Abstract Background Optimal sagittal alignment of the femoral prosthesis is critical to the success of total knee arthroplasty (TKA). While robotic-assisted TKA can improve alignment accuracy, the efficacy of default femoral alignment versus individualized alignment remains under scrutiny. This study aimed to compare the differences in prosthetic alignment, anatomical restoration, and clinical outcomes between individualized femoral sagittal alignment and default sagittal alignment in robotic-assisted TKA. Methods In a prospective randomised controlled trial, 113 patients (120 knees) underwent robotic-assisted TKA were divided into two groups: 61 with individualized femoral flexion (individualized alignment group) and 59 with default 3–5° flexion (default alignment group). The individualized alignment was based on the distal femoral sagittal anteverted angle (DFSAA), defined as the angle between the mechanical and distal anatomical axes of the femur. The radiographic and clinical outcomes were compared. Results Despite similar postoperative femoral flexion angles between groups (P = 0.748), the individualized alignment group exhibited significantly lower incidences of femoral prosthesis extension and higher rates of optimal 0–3° prosthesis flexion (9.8% vs. 27.1%, P = 0.014,78.7% vs. 55.9%, p = 0.008, respectively). The individualized alignment group also demonstrated more favourable changes in sagittal anatomy, with higher maintenance of postoperative anterior femoral offset within 1 mm (54.1% vs. 33.9%, P = 0.026) and posterior condylar offset within 1 mm and 2 mm (44.3% vs. 25.4%, p = 0.031,73.8% vs. 50.8%, p = 0.010, respectively). Although slight improvement in the Hospital for Special Surgery Knee Score (HSS) at three months was observed (P = 0.045), it did not reach a minimal clinically important difference. Conclusion Individualized tailoring of femoral sagittal alignment in robotic-assisted total knee arthroplasty (TKA) enhances prosthetic alignment and anatomical restoration, suggesting potential improvements in postoperative outcomes.