Functional alignment in robotic total knee arthroplasty provides favourable outcomes and minimal early revisions: A systematic review and meta‐analysis

Abstract Purpose Functional alignment (FA) has emerged as a personalised alignment strategy in total knee arthroplasty (TKA), enabled by robotic‐assisted technology. Although early clinical results are encouraging, evidence remains heterogeneous and long‐term safety is uncertain. This systematic review aimed to evaluate functional outcomes, and early revision risk of robotic‐assisted TKA performed under FA principles with a minimum follow‐up of two years. Methods This review was conducted according to PRISMA guidelines and registered in PROSPERO (CRD420251134340). PubMed/MEDLINE and Scopus were searched up to August 2025. Eligible studies included adult patients undergoing robotic‐assisted primary TKA with FA, reporting outcomes at ≥2 years' follow‐up. Data on demographics, robotic system, implant type, patient‐reported outcome measures (PROMs), range of motion (ROM), complications, and revision rates were extracted. Risk of bias was assessed using ROB 2 and ROBINS‐I. A random‐effects single‐arm meta‐analysis of pooled proportions was performed for early aseptic revision risk. Results Twenty studies (5155 TKAs) were included, with a weighted mean follow‐up of 2.5 years. All procedures were performed using the image‐based robotic system. Postoperative PROMs were consistently high: Knee Society Score (KSS) Knee 92.4–94.5, KSS Function 91.4–93.4, and FJS 74.8–77.5. Kujala scores indicated minimal anterior knee pain (88.1–93.2). ROM improved from a mean preoperative flexion of 119.3° to 123°–124.8°. Complications were infrequent, most commonly stiffness requiring manipulation under anaesthesia. Across all cohorts, 18 aseptic revisions were reported (pooled proportion 0.35%, 95% CI 0.23–0.55). The single‐arm meta‐analysis of pooled proportions showed a negligible pooled early revision risk (rounded to 0.00; 95% CI 0.00–0.01; I² = 0%). Outcomes were comparable across age, gender, fixation type, and implant constraint, although obese patients accounted for all mechanical failures. Conclusion Robotic‐assisted TKA performed under FA principles yields favourable short‐ to mid‐term functional outcomes and a low rate of early aseptic revision. Level of Evidence Level III, systematic review and meta‐analysis.