Larrainzar-Garijo Ricardo, Molanes-López Elisa M, Cañones-Martín Miguel, Murillo-Vizuete David, Valencia-Santos Natalia, Garcia-Bogalo Raul, Corella-Montoya Fernando
Orthopedic and Trauma Department, Hospital Universitario Infanta Leonor, C/ Gran Via Este 80, 28031 Madrid, Spain.
Departamento Cirugía, Facultad de Medicina, Universidad Complutense Madrid, Madrid, Spain.
Indian J Orthop. 2022 Jun 22;56(8):1439-1448. doi: 10.1007/s43465-022-00666-9. eCollection 2022 Aug.
The purpose of this study is to determine whether the use of a surgical navigation system in total knee replacement (TKR) enables beginner and intermediate surgeons to achieve clinical PROM outcomes as good as those conducted by expert surgeons in the long term.
We enrolled 100 consecutive patients whose total navigated knee arthroplasty (TKA) was performed in our institution from 2008 to 2010. According to the principal surgeon's surgical experience, the patients were divided into three groups: (1) beginner surgeons, with no more than 30 previous knee replacement performances, (2) intermediate surgeons, with more than 30 but not more than 300, and (3) expert surgeons, with more than 300 knee replacements. Demographic data collected on the cohort included gender, laterality, age, and body mass index (BMI). The outcome measures assessed were Forgotten Joint Score (FJS), implant positioning, limb alignment, and prosthesis survival rate. A margin of equivalence of ± 18.5 points in the FJS scale was prespecified in terms of the minimal clinically important difference (MCID) to compare the FJS results obtained in the long period between the groups of interest.
The mean follow-up was 11.10 ± 0.78, 10.86 ± 0.66, and 11.30 ± 0.74 years, respectively, for each of the groups. The long-term FJS mean score was 80.86 ± 21.88, 81.36 ± 23.87, and 90.48 ± 14.65 for each group. The statistical analysis proved noninferiority and equivalence in terms of the FJS results reported in the long term by patients in Groups 1 or 2 compared to those in Group 3. More specifically, it has been proved that the mean difference between groups is within the interval of equivalence defined in terms of the MCID. The overall prostheses survival rate was 93.7%.
Navigated assisted TKA, under expert guidance, can be as effective when performed by beginner or intermediate surgeons as performed by senior surgeons regarding the accuracy of implant positioning, limb alignment, and long-term clinical outcome.
本研究旨在确定在全膝关节置换术（TKR）中使用手术导航系统是否能使初级和中级外科医生在长期内取得与专家外科医生相当的临床患者报告结局测量（PROM）结果。
我们纳入了2008年至2010年在我们机构连续接受全膝关节置换术（TKA）的100例患者。根据主刀医生的手术经验，将患者分为三组：（1）初级外科医生，既往膝关节置换手术不超过30例；（2）中级外科医生，既往膝关节置换手术超过30例但不超过300例；（3）专家外科医生，既往膝关节置换手术超过300例。收集的队列人口统计学数据包括性别、患侧、年龄和体重指数（BMI）。评估的结局指标包括遗忘关节评分（FJS）、植入物位置、肢体对线和假体生存率。在FJS量表中预先设定了±18.5分的等效性界限，以比较不同组在长期内获得的FJS结果的最小临床重要差异（MCID）。
每组的平均随访时间分别为11.10±0.78年、10.86±0.66年和11.30±0.74年。每组的长期FJS平均得分分别为80.86±21.88、81.36±23.87和90.48±14.65。统计分析证明，与第3组相比，第1组或第2组患者长期报告的FJS结果在非劣效性和等效性方面。更具体地说，已证明组间平均差异在根据MCID定义的等效区间内。总体假体生存率为93.7%。
在专家指导下，导航辅助TKA在植入物定位准确性、肢体对线和长期临床结局方面，由初级或中级外科医生进行时与高级外科医生进行时同样有效。
