Kirchner Gregory J, Stambough Jeffrey B, Jimenez Emily, Mullen Kyle, Nikkel Lucas E
Department of Orthopaedics and Rehabilitation, Penn State Milton S. Hershey Medical Center, Hershey, PA, USA.
Department of Orthopaedic Surgery, University of Arkansas for Medical Sciences, Little Rock, AR, USA.
Clin Orthop Relat Res. 2025 Mar 1;483(3):431-438. doi: 10.1097/CORR.0000000000003330. Epub 2024 Nov 21.
Previously, we conducted a retrospective study of American Joint Replacement Registry (AJRR) data that examined the 2-year odds of revision between robotic-assisted and nonrobotic-assisted TKA, and we found no benefit to robotic assistance. However, proponents of robotic assistance have suggested that robot platforms confer more accurate bone cuts and precise implant sizing that might promote osteointegration of cementless implants by limiting micromotion at the bone-implant interface that could lead to aseptic loosening. Therefore, it seems important specifically to evaluate the odds of revision among patients with cementless implants only within our previous study population.
QUESTIONS/PURPOSES: (1) After controlling for potentially confounding variables, such as surgeon, institution, and patient comorbidity profile, was robotic assistance associated with a decreased odds of 2-year revision of cementless TKA for any reason compared with cementless TKAs performed without robotic assistance? (2) After again controlling for potentially confounding variables, was robotic assistance associated with a decreased odds of 2-year revision of cementless TKA for particular revision indications (such as aseptic loosening, infection, instability, or pain) compared with the cementless TKAs performed without robotic assistance?
Using the AJRR, a retrospective cohort of patients ≥ 65 years of age with osteoarthritis who underwent primary TKA with cementless femur and tibial components from January 2017 through March 2020 was identified. Procedures performed with hybrid fixation (cement only on the tibia but not on the femur, or vice versa) were excluded. The AJRR was selected because it is the largest arthroplasty registry in the world by annual procedure volume, and it contains a data linkage with inpatient and outpatient Medicare claims data to ensure near-complete 2-year follow-up. A total of 9220 patients were identified, and robotic assistance was used in 45% (4130) of procedures. Patient age did not differ between groups (72 ± 5 years versus 72 ± 5 years; p = 0.29). However, the robotic-assisted cohort had a slightly higher proportion of female patients (56% [2332 of 4130] versus 53% [2693 of 5090]; p = 0.002) and higher Charlson comorbidity index (CCI) (2.9 ± 0.9 versus 2.8 ± 0.9; p = 0.003). Therefore, a mixed-effects model was used to analyze the ORs for all-cause linked revision with robotic assistance and was adjusted for age, gender, CCI, surgeon, and institution. Subanalyses were performed on indications for revision. A power analysis demonstrated the ability to measure a difference as small as one-half SD between risk of revision within each cohort (specifically, moderate effect sizes based on Cohen d).
After controlling for potentially confounding variables, such as surgeon, location of surgery, and patient comorbidity profile, we found no difference regarding odds of all-cause revision between robotic-assisted and nonrobotic-assisted cementless TKA (OR of robotic-assisted versus nonrobotic-assisted cementless TKA 0.8 [95% CI 0.5 to 1.3]; p = 0.41). There were no differences in reasons for revision between robotic-assisted and nonrobotic-assisted cementless TKA, such as mechanical loosening (OR 3.2 [95% CI 0.8 to 12]; p = 0.09) and infection (OR 1.5 [95% CI 0.8 to 2.6]; p = 0.19).
We found no evidence that robotic assistance improves the odds of cementless implant survival free from revision at 2 years. Importantly, the differences in odds of revision beyond 2 years as a function of robotic assistance in cementless TKA remains unknown and warrants further population-level investigation, but until or unless robotic assistance proves its value in well-designed studies in terms of endpoints that patients can perceive (such as pain, function, or survivorship), we recommend against widespread adoption until further evidence becomes available. Additionally, we encourage surgeons and healthcare facilities using robotic assistance in cementless TKAs to study its impact on patient outcomes, if any.
Level III, therapeutic study.
此前，我们对美国关节置换登记处（AJRR）的数据进行了一项回顾性研究，该研究调查了机器人辅助与非机器人辅助全膝关节置换术（TKA）后2年翻修的几率，我们发现机器人辅助并无益处。然而，机器人辅助的支持者认为，机器人平台能进行更精确的截骨和更精准的假体尺寸测量，这可能通过限制骨-假体界面的微动来促进非骨水泥型假体的骨整合，而这种微动可能导致无菌性松动。因此，在我们之前的研究人群中，专门评估仅使用非骨水泥型假体患者的翻修几率似乎很重要。
问题/目的：（1）在控制了潜在的混杂变量，如外科医生、机构和患者合并症情况后，与未使用机器人辅助进行的非骨水泥型TKA相比，机器人辅助是否与非骨水泥型TKA因任何原因导致的2年翻修几率降低相关？（2）在再次控制潜在的混杂变量后，与未使用机器人辅助进行的非骨水泥型TKA相比，机器人辅助是否与因特定翻修指征（如无菌性松动、感染、不稳定或疼痛）导致的非骨水泥型TKA 2年翻修几率降低相关？
利用AJRR，确定了一个回顾性队列，其中≥65岁的骨关节炎患者在2017年1月至2020年3月期间接受了使用非骨水泥型股骨和胫骨组件的初次TKA。排除采用混合固定（仅在胫骨或仅在股骨上使用骨水泥）的手术。选择AJRR是因为它按年手术量计算是世界上最大的关节置换登记处，并且它包含与住院和门诊医疗保险索赔数据的链接，以确保近乎完整的2年随访。共识别出9220例患者，45%（4130例）的手术使用了机器人辅助。两组患者年龄无差异（72±5岁对72±5岁；p = 0.29）。然而，机器人辅助队列中女性患者比例略高（56%[4130例中的2332例]对53%[5090例中的2693例]；p = 0.002），Charlson合并症指数（CCI）也更高（2.9±0.9对2.8±0.9；p = 0.003）。因此，使用混合效应模型分析机器人辅助下全因相关翻修的比值比，并对年龄、性别、CCI、外科医生和机构进行了调整。对翻修指征进行了亚组分析。一项功效分析表明，能够检测到每个队列中翻修风险之间小至半个标准差的差异（具体而言，基于Cohen d的中等效应量）。
在控制了潜在的混杂变量，如外科医生、手术地点和患者合并症情况后，我们发现机器人辅助与非机器人辅助的非骨水泥型TKA全因翻修几率之间没有差异（机器人辅助与非机器人辅助的非骨水泥型TKA的比值比为0.8[95%可信区间0.5至1.3]；p = 0.41）。机器人辅助与非机器人辅助的非骨水泥型TKA的翻修原因没有差异，如机械性松动（比值比3.2[95%可信区间0.8至12]；p = 0.09）和感染（比值比1.5[95%可信区间0.8至2.6]；p = 0.19）。
我们没有发现证据表明机器人辅助能提高非骨水泥型假体2年无翻修存活的几率。重要的是，非骨水泥型TKA中机器人辅助超过2年的翻修几率差异仍然未知，值得进一步进行人群水平的研究，但在机器人辅助在精心设计的研究中就患者可感知的终点（如疼痛、功能或生存率）证明其价值之前或除非如此，我们建议在有更多证据之前不要广泛采用。此外，我们鼓励在非骨水泥型TKA中使用机器人辅助的外科医生和医疗机构研究其对患者结局的影响（如果有影响的话）。
III级，治疗性研究。
