Navigated versus non‐navigated total knee arthroplasty: A large single‐implant cohort analysis of clinical outcomes and survivorship

Abstract Purpose The aim of this study was to compare implant survival, clinical outcomes and radiographic alignment between navigated and non‐navigated total knee arthroplasty (TKA) performed with a single implant system. Methods A retrospective multicenter analysis of prospectively collected data from 6078 TKAs performed for primary osteoarthritis using a single implant system was performed. Procedures were divided into two groups: navigated (n = 3602) and non‐navigated (n = 2476). The primary outcome was implant survival. Secondary outcomes included re‐intervention rates, patient‐reported outcomes measures (PROMs, International Knee Society scores), and range of motion. Results Five‐year implant survival was similar between the non‐navigated (98.9%; 95% confidence interval [CI], 98.2%–99.3%) and navigated (98.3%; 95% CI, 97.6%–98.8%) groups (p = 0.505). After adjustment for potential confounders, navigated procedures showed a slightly higher risk of surgical reintervention excluding infection (hazard ratio 1.42, 95% CI: 1.02–1.96, p = 0.036). PROM analyses were restricted to patients with both baseline and 5‐year questionnaires (n = 470). The improvement of patient‐reported functional outcomes at 5 years was not significantly different between groups (p = 0.893 after adjustment for potential confounders). Conclusions Navigation was equivalent to conventional instrumentation TKA with respect to implant survival. After adjusting for confounders and excluding septic revisions, navigated procedures showed a slightly higher reoperation risk. No significant advantage in functional outcomes was observed at mid‐term follow‐up. These findings do not support a clear clinical benefit for routine use of navigation in this setting. Level of Evidence Level III, retrospective comparative study.