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新型七轴机器人辅助全髋关节置换系统的学习曲线:一项随机对照试验。

The learning curve of a novel seven-axis robot-assisted total hip arthroplasty system: a randomized controlled trial.

机构信息

Department of Orthopedics, West China Hospital, Orthopedic Research Institute, Sichuan University, Chengdu, China.

Department of Orthopedics, Chengdu Second People's Hospital, Chengdu, China.

出版信息

BMC Musculoskelet Disord. 2024 Apr 30;25(1):342. doi: 10.1186/s12891-024-07474-2.

Abstract

BACGROUND

The aim of this study was to assess the learning curve of a novel seven-axis robot-assisted total hip arthroplasty (RaTHA) system.

METHODS

A total of 59 patients who underwent unilateral total hip arthroplasty at our institution from June 2022 to September 2022 were prospectively included in the study. In this randomized controlled clinical trial, robot-assisted THA (RaTHA) and Conventional THA (CoTHA) were performed using cumulative sum (CUSUM) analysis to evaluate the learning curve of the RaTHA system. The demographic data, preopera1tive clinical data, duration of operation, postoperative Harris Hip Score (HHS), postoperative Western Ontario and McMaster Universities Arthritis Index (WOMAC) score, and duration of operation between the learning stage and the proficiency stage of the RaTHA group were compared between the two groups.

RESULTS

The average duration of operation of the RaTHA group was increased by 34.73 min compared with the CoTHA group (104.26 ± 19.33 vs. 69.53 ± 18.38 min, p < 0.01). The learning curve of the RaTHA system can be divided into learning stage and proficiency stage, and the former consists of the first 13 cases by CUSUM analysis. In the RaTHA group, the duration of operation decreased by 29.75 min in the proficiency stage compared to the learning stage (121.12 ± 12.84 vs.91.37 ± 12.92, p < 0.01).

CONCLUSIONS

This study demonstrated that the surgical team required a learning curve of 13 cases to become proficient using the RaTHA system. The duration of operation, total blood loss, and drainage gradually shortened (decreased) with the learning curve stage, and the differences were statistically significant.

TRIAL REGISTRATION

Number: ChiCTR2200061630, Date: 29/06/2022.

摘要

背景

本研究旨在评估一种新型七轴机器人辅助全髋关节置换术(RaTHA)系统的学习曲线。

方法

本研究前瞻性纳入了 2022 年 6 月至 9 月在我院行单侧全髋关节置换术的 59 例患者。在这项随机对照临床试验中,使用累积和(CUSUM)分析评估 RaTHA 系统的学习曲线,机器人辅助 THA(RaTHA)和常规 THA(CoTHA)分别进行。比较两组患者的一般资料、术前临床资料、手术时间、术后 Harris 髋关节评分(HHS)、术后 Western Ontario 和 McMaster 大学骨关节炎指数(WOMAC)评分,以及 RaTHA 组学习阶段和熟练阶段的手术时间。

结果

RaTHA 组的手术时间平均增加 34.73 分钟,明显高于 CoTHA 组(104.26±19.33 分钟比 69.53±18.38 分钟,p<0.01)。RaTHA 系统的学习曲线可分为学习阶段和熟练阶段,前者通过 CUSUM 分析由前 13 例组成。在 RaTHA 组,熟练阶段的手术时间较学习阶段缩短了 29.75 分钟(121.12±12.84 分钟比 91.37±12.92 分钟,p<0.01)。

结论

本研究表明,使用 RaTHA 系统,手术团队需要 13 例才能达到熟练水平。手术时间、总失血量和引流量随着学习曲线阶段的进展逐渐缩短(减少),差异具有统计学意义。

试验注册

编号:ChiCTR2200061630,日期:2022 年 6 月 29 日。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b898/11061987/b1e13fb4f99f/12891_2024_7474_Figa_HTML.jpg

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