The LANCET robotic system can improve surgical efficiency in total hip arthroplasty: A prospective randomized, multicenter, parallel-controlled clinical trial

IF 5.9 1区 医学 Q1 ORTHOPEDICS Journal of Orthopaedic Translation Pub Date : 2024-03-01 DOI:10.1016/j.jot.2023.12.004
Zhihong Xu , Senlin Chai , Dongyang Chen , Weijun Wang , Jin Dai , Xiaofeng Zhang , Jianghui Qin , Kai Song , Xinhua Li , Jing Han , Qing Chang , Miaofeng Zhang , Chenxi Xue , Jun Lu , Lidong Wu , Yunfeng Yao , Lan Li , Qing Jiang
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Abstract

Objective

To evaluate the accuracy and safety of the LANCET robotic system, a robot arm assisted operation system for total hip arthroplasty via a multicenter clinical randomized controlled trial.

Methods

A total of 116 patients were randomized into two groups: LANCET robotic arm assisted THA group (N = 58) and the conventional THA group (N = 58). General information about the patients was collected preoperatively. Operational time and bleeding were recorded during the surgery. The position of the acetabular prosthesis was evaluated by radiographs one week after surgery and compared with preoperative planning. Harris score, hip mobility, prosthesis position and angle and complications were compared between the two groups at three months postoperatively.

Results

None of the 111 patients who ultimately completed the 3-month follow-up experienced adverse events such as hip dislocation and infection during follow-up. In the RAA group, 52 (92.9 %) patients were located in the Lewinnek safe zone and 49 (87.5 %) patients were located in the Callanan safe zone. In the control group were 47 (85.5 %) and 44 (80.0 %) patients, respectively. In the RAA group, 53 (94.6 %) patients had a postoperative acetabular inclination angle and 51 (91.1 %) patients had an acetabular version angle within a deviation of 5° from the preoperative plan. These numbers were significantly higher than those of the control group, which consisted of 42 (76.4 %) and 34 (61.8 %) patients respectively. There were no significant differences between the two groups of subjects in terms of general condition, intraoperative bleeding, hip mobility, and adverse complications.

Conclusion

The results of this prospective randomized, multicenter, parallel-controlled clinical study demonstrated that the LANCET robotic system leads conventional THA surgery in accuracy of acetabular cup placement and does not differ from conventional THA surgery in terms of postoperative hip functional recovery and complications.

The translational potential of this article

In the past, the success rate of total hip arthroplasty (THA) relied heavily on the surgeon's experience. As a result, junior doctors needed extensive training to become proficient in this technique. However, the introduction of surgical robots has significantly improved this situation. By utilizing robotic assistance, both junior and senior doctors can perform THA quickly and efficiently. This advancement is crucial for the widespread adoption of THA, as patients can now receive surgical treatment in local facilities instead of overwhelming larger hospitals and straining medical resources. Moreover, the development of surgical robots with fully independent intellectual property rights holds immense value in overcoming the limitations of high-end medical equipment. This aligns with the objectives outlined in the 14th Five Year Plan for National Science and Technology Strategy.

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LANCET 机器人系统可提高全髋关节置换术的手术效率:前瞻性随机、多中心、平行对照临床试验
目的 通过多中心临床随机对照试验,评估全髋关节置换术的机械臂辅助操作系统LANCET机器人系统的准确性和安全性:LANCET机械臂辅助全髋关节置换术组(58例)和传统全髋关节置换术组(58例)。术前收集患者的一般信息。术中记录手术时间和出血量。术后一周通过X光片评估髋臼假体的位置,并与术前计划进行比较。术后三个月,对两组患者的Harris评分、髋关节活动度、假体位置和角度以及并发症进行比较。结果在最终完成三个月随访的111名患者中,没有一人在随访期间发生髋关节脱位和感染等不良事件。在 RAA 组中,52 例(92.9%)患者位于 Lewinnek 安全区,49 例(87.5%)患者位于 Callanan 安全区。对照组分别有 47 名(85.5%)和 44 名(80.0%)患者。在 RAA 组中,53(94.6%)名患者的术后髋臼倾斜角度和 51(91.1%)名患者的髋臼翻转角度与术前计划偏差在 5° 以内。这些数字明显高于对照组,对照组患者分别为 42 人(76.4%)和 34 人(61.8%)。两组受试者在一般情况、术中出血、髋关节活动度和不良并发症方面无明显差异。结论这项前瞻性随机、多中心、平行对照临床研究的结果表明,LANCET 机器人系统在髋臼杯置入的准确性方面领先于传统的 THA 手术,并且在术后髋关节功能恢复和并发症方面与传统的 THA 手术没有差异。因此,初级医生需要接受大量培训才能熟练掌握这项技术。然而,手术机器人的引入大大改善了这一状况。通过使用机器人辅助,初级和高级医生都能快速高效地完成 THA 手术。这一进步对于 THA 的广泛应用至关重要,因为患者现在可以在当地的医疗机构接受手术治疗,而不必去大医院就医,也不会造成医疗资源的紧张。此外,具有完全自主知识产权的手术机器人的开发在克服高端医疗设备的局限性方面具有巨大价值。这与《国家科技战略 "十四五 "规划》提出的目标不谋而合。
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来源期刊
Journal of Orthopaedic Translation
Journal of Orthopaedic Translation Medicine-Orthopedics and Sports Medicine
CiteScore
11.80
自引率
13.60%
发文量
91
审稿时长
29 days
期刊介绍: The Journal of Orthopaedic Translation (JOT) is the official peer-reviewed, open access journal of the Chinese Speaking Orthopaedic Society (CSOS) and the International Chinese Musculoskeletal Research Society (ICMRS). It is published quarterly, in January, April, July and October, by Elsevier.
期刊最新文献
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