Carrozzo Alessandro, Pailhé Régis, Manchec Ophélie, Lustig Sebastien, Bérard Émilie, Cavaignac Etienne
Department of Orthopaedic Surgery Hôpital Pierre Paul Riquet, CHU de Toulouse Toulouse France.
Dipartimento di Scienze della Vita, della Salute e delle Professioni Sanitarie Università degli Studi "Link Campus University" Rome Italy.
J Exp Orthop. 2025 Sep 4;12(3):e70408. doi: 10.1002/jeo2.70408. eCollection 2025 Jul.
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.
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 ( = 3602) and non-navigated ( = 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.
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 ( = 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, = 0.036). PROM analyses were restricted to patients with both baseline and 5-year questionnaires ( = 470). The improvement of patient-reported functional outcomes at 5 years was not significantly different between groups ( = 0.893 after adjustment for potential confounders).
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 III, retrospective comparative study.
本研究旨在比较使用单一植入系统进行的导航全膝关节置换术（TKA）与非导航全膝关节置换术之间的植入物存活率、临床结果和影像学对线情况。
对使用单一植入系统为原发性骨关节炎进行的6078例TKA的前瞻性收集数据进行回顾性多中心分析。手术分为两组：导航组（n = 3602）和非导航组（n = 2476）。主要结局是植入物存活率。次要结局包括再次干预率、患者报告结局指标（PROMs，国际膝关节协会评分）和活动范围。
非导航组（98.9%；95%置信区间[CI]，98.2%-99.3%）和导航组（98.3%；95%CI，97.6%-98.8%）的五年植入物存活率相似（P = 0.505）。在对潜在混杂因素进行调整后，导航手术显示出排除感染后的手术再次干预风险略高（风险比1.42，95%CI：1.02-1.96，P = 0.036）。PROM分析仅限于同时拥有基线和五年问卷的患者（n = 470）。两组之间患者报告的五年功能结局改善情况无显著差异（对潜在混杂因素进行调整后P = 0.893）。
在植入物存活率方面，导航与传统器械TKA相当。在对混杂因素进行调整并排除感染性翻修后，导航手术显示出略高的再次手术风险。中期随访未观察到功能结局有显著优势。这些发现不支持在这种情况下常规使用导航有明确的临床益处。
III级，回顾性比较研究。
