Gómez-Palomo Juan Miguel, Zamora-Mogollo Amparo, Tara-Abad Carmen, Diez-Izquierdo Marta, García-Vera Juan José, Martínez-Crespo Ana
Department of Orthopedic Surgery and Traumatology, Virgen de la Victoria University Hospital, Málaga, Spain.
Biomedical Research Institute of Málaga (IBIMA), Málaga, Spain.
Int Orthop. 2025 Aug 18. doi: 10.1007/s00264-025-06638-6.
Computer-assisted navigation in total knee arthroplasty (TKA) was developed to enhance implant positioning accuracy and optimize mechanical alignment. However, its impact on clinical outcomes remains controversial. This study aimed to evaluate the influence of navigation on functional and radiological outcomes, safety, and patient-reported quality of life at mid-term follow-up.
We conducted a retrospective single-center study including 190 patients who underwent primary TKA between 2015 and 2018, with a mean follow-up of 5.8 years. Ninety-five patients were operated on using optical computer navigation, while 95 underwent conventional instrumentation (sequential allocation). All surgeries were performed by the same two senior surgeons using mechanical alignment in both groups. Outcomes included the Hospital for Special Surgery (HSS) knee score, EQ-5D, SF-12, patient satisfaction, and radiographic alignment. Both univariate and multivariate analyses were performed using SPSS (v28.0/v29.0).
Patients in the navigated group achieved significantly greater improvement in HSS knee scores (mean increase 41.9 vs. 34.9 points; p = 0.043) and a higher proportion of clinically meaningful functional improvement (> 35-point HSS increase: 63.2% vs. 40.0%; p = 0.019) compared to the conventional group. Postoperative knee flexion was also better in the navigated group (118° vs. 113°; p = 0.048). No significant differences were observed in pain improvement (VAS), EQ-5D quality-of-life gain, or complication rates between groups. Navigation significantly reduced the number of outliers in component alignment (6.3% vs. 13.7% outside ± 3° from neutral), although this did not reach statistical significance (p = 0.068). On multivariate analysis, use of navigation was an independent predictor of superior functional improvement (odds ratio 2.65, 95% CI 1.38-5.12; p = 0.003), whereas other factors (age, sex, body mass index, diabetes, baseline HSS) were not significant.
Computer-assisted navigation in TKA was associated with greater mid-term functional improvement and improved prosthetic alignment, without increasing operative time or complications. Its implementation may be especially beneficial for enhancing stability and precision in mechanically aligned TKA. These findings should be interpreted with caution due to the retrospective design and mid-term follow-up duration.
Level III (retrospective comparative study).
全膝关节置换术（TKA）中的计算机辅助导航技术旨在提高植入物定位精度并优化机械对线。然而，其对临床结果的影响仍存在争议。本研究旨在评估中期随访时导航对功能和影像学结果、安全性以及患者报告的生活质量的影响。
我们进行了一项回顾性单中心研究，纳入了2015年至2018年间接受初次TKA的190例患者，平均随访5.8年。95例患者采用光学计算机导航进行手术，而95例患者接受传统器械手术（顺序分配）。两组所有手术均由同两位资深外科医生使用机械对线完成。结果包括特种外科医院（HSS）膝关节评分、EQ-5D、SF-12、患者满意度和影像学对线。使用SPSS（v28.0/v29.0）进行单变量和多变量分析。
与传统组相比，导航组患者的HSS膝关节评分改善更为显著（平均增加41.9分对34.9分；p = 0.043），且临床意义上功能改善的比例更高（HSS增加>35分：63.2%对40.0%；p = 0.019）。导航组术后膝关节屈曲也更好（118°对113°；p = 0.048）。两组在疼痛改善（VAS）、EQ-5D生活质量增益或并发症发生率方面未观察到显著差异。导航显著减少了组件对线中的异常值数量（与中立位±3°以外的比例为6.3%对13.7%），尽管未达到统计学意义（p = 0.068）。多变量分析显示，使用导航是功能改善更优的独立预测因素（优势比2.65，95%置信区间1.38 - 5.12；p = 0.003），而其他因素（年龄、性别、体重指数、糖尿病、基线HSS）不显著。
TKA中的计算机辅助导航与中期功能改善更大和假体对线改善相关，且不增加手术时间或并发症。其应用可能对增强机械对线TKA的稳定性和精度特别有益。由于本研究为回顾性设计且随访时间为中期，这些发现应谨慎解读。
III级（回顾性比较研究）。
