Abstract
PURPOSE: In total knee arthroplasty (TKA), implants are increasingly aligned based on emerging patient-specific alignment strategies, such as unrestricted kinematic alignment (KA), according to their constitutional limb alignment (phenotype alignment), which results in a large proportion of patients having a hip-knee angle (HKA) outside the safe range of ± 3° to 180° traditionally considered in the mechanical alignment strategy. The aim of this systematic review is to investigate whether alignment outside the safe zone of ± 3° is associated with a higher revision rate and worse clinical outcome than alignment within this range. METHODS: A systematic literature search was conducted in PubMed, Embase, Cochrane and World of Science, with search terms including synonyms and plurals for "total knee arthroplasty", "alignment", "outlier", "malalignment", "implant survival" and "outcome". Five studies were identified with a total number of 927 patients and 952 implants. The Oxford Knee Score (OKS) and the WOMAC were used to evaluate the clinical outcome. The follow-up period was between 6 months and 10 years. RESULTS: According to HKA 533 knees were aligned within ± 3°, 47 (8.8%) were varus outliers and 121 (22.7%) were valgus outliers. No significant differences in clinical outcomes were found between implants positioned within ± 3° and varus and valgus outliers. Likewise, no significant differences were found regarding revision rates and implant survival. CONCLUSION: The universal use of the "safe zone" of ± 3° derived from the mechanical alignment strategy is hardly applicable to modern personalised alignment strategies in the light of current literature. However, given the conflicting evidence in the literature on the risks of higher revision rates and poorer clinical outcomes especially with greater tibial component deviation, the lack of data on the outcomes of more extreme alignments, and regarding the use of implants for KA TKA that are actually designed for mechanical alignment, there is an urgent need for research to define eventual evidence-based thresholds for new patient-specific alignment strategies, not only for HKA but also for FMA and TMA, also taking into account the preoperative phenotype and implant design. It is of utmost clinical relevance for the application of modern alignment strategies to know which native phenotypes may be reproduced with a TKA. LEVEL OF EVIDENCE: IV.