一项前瞻性随机对照试验：一种新型膝关节置换术机器人系统具有更好的放射学结果和同等的临床功能。

IF 2 3区医学 Q2 ORTHOPEDICS

International Orthopaedics Pub Date : 2025-04-23 DOI:10.1007/s00264-025-06523-2

Xiao Geng, Ziyang Dong, Jiazheng Chen, Mengqiang Tian, Yongqing Wang, Yiming Ren, Zhihui Zhao, Yipu Zhang, Xinguang Wang, Cheng Wang, Zijian Li, Hua Tian

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引用次数: 0

摘要

目的：本研究旨在评估机器人辅助全膝关节置换术的早期临床和影像学结果，并确定新型机器人系统的骨切除和植入物定位的效率和安全性。方法：在三家医院进行的这项前瞻性、多中心随机对照试验中，纳入了144例原发性TKA患者。5例患者术后6周未随访。因此，139例患者（RA TKA组73例，CI TKA组66例）仍留在最终分析中。主要结局是术后12周下肢全长负重x光片评估的患者术后对齐与计划偏差小于3°的比例。次要结果包括组件的冠状面和矢状面对齐、手术时间、出血量、12周活动范围（ROM）、12周术后功能结果和满意度（由美国膝关节学会评分（KSS）、西安大略省和麦克马斯特大学骨关节炎指数（WOMAC）和不良事件（ae）评估）。结果：术后12周，我们发现RA TKA组的x线透视率明显更高(90.4% vs. 59.1%；结论：本试验表明，新型机器人辅助TKA在骨切除和种植体定位方面更安全，更精确。

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Better radiological outcomes but equal clinical function of a novel knee arthroplasty robot system: a prospective randomized controlled trial.

Purpose: This study aimed to evaluate the early clinical and radiological outcomes of robot assisted total knee arthroplasty, and to determine the efficiency and safety of its bone resection and implant positioning of the novel robot system.

Methods: 144 patients who underwent primary TKA were enrolled in this prospective, multicenter RCT conducted in three hospitals. five patients were lost to follow-up at six weeks after surgery. Therefore, 139 patients (73 in the RA TKA group and 66 in the CI TKA group) remained in the final analysis. The primary outcome was the rate of patients whose postoperative alignment was less than 3° deviated from the planned evaluated by full-length weight-bearing X-rays of the lower limb at 12 weeks postoperatively. Secondary outcomes included coronal and sagittal alignment of the components, operation times, blood loss, 12-week range of motion(ROM), 12-week postoperative functional outcomes and satisfaction evaluated by the American Knee Society Score (KSS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and adverse events (AEs).

Results: At 12 weeks postoperatively, we found the rate of radiographic inliers was significantly higher in the RA TKA group (90.4% vs. 59.1%; p < 0.05). The difference between planned and postoperative frontal femoral component (FFC) angle, frontal tibia component (FTC) angle and lateral femoral component (LFC) angle are significantly smaller in the RA TKA group (p < 0.05). The operation time was significantly longer in the RA TKA group than in the CI TKA group (133.01 vs. 92.33 min; p < 0.05). There was no significant difference in blood loss, 12-week ROM, 12-week postoperative functional outcomes and satisfaction evaluated by KSS and WOMAC scores. There were no AEs or SAEs that were determined to be "related" to the robotic system.

Conclusion: The novel robot assisted TKA is safe and more precise in bone resection and implant positioning as demonstrated in this trial.

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来源期刊

International Orthopaedics 医学-整形外科

CiteScore

5.50

自引率

7.40%

发文量

360

审稿时长

1 months

期刊介绍： International Orthopaedics, the Official Journal of the Société Internationale de Chirurgie Orthopédique et de Traumatologie (SICOT) , publishes original papers from all over the world. The articles deal with clinical orthopaedic surgery or basic research directly connected with orthopaedic surgery. International Orthopaedics will also link all the members of SICOT by means of an insert that will be concerned with SICOT matters. Finally, it is expected that news and information regarding all aspects of orthopaedic surgery, including meetings, panels, instructional courses, etc. will be brought to the attention of the readers. Manuscripts submitted for publication must contain a statement to the effect that all human studies have been approved by the appropriate ethics committee and have therefore been performed in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki. It should also be stated clearly in the text that all persons gave their informed consent prior to their inclusion in the study. Details that might disclose the identity of the subjects under study should be omitted. Reports of animal experiments must state that the "Principles of laboratory animal care" (NIH publication No. 85-23, revised 1985) were followed, as well as specific national laws (e.g. the current version of the German Law on the Protection of Animals) where applicable. The editors reserve the right to reject manuscripts that do not comply with the above-mentioned requirements. The author will be held responsible for false statements or for failure to fulfil the above-mentioned requirements.