何去何从?比较机器人辅助全髋关节置换术中三种不同手术方法的放射学效果。

Expert review of medical devices Pub Date : 2024-04-01 Epub Date: 2024-03-29 DOI:10.1080/17434440.2024.2334932
Zhang Xianzuo, Shen Xianyue, Abasi Maimaitiabula, Zhang Zian, Zhang Haining, Yang Bo, Zhu Chen
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摘要

目的评估机器人辅助手术全髋关节置换术(RAS-THA)中使用三种不同方法放置髋臼组件的准确性和精确度:本研究是一项多中心随机对照试验的二次分析,该试验比较了 Trex RS Hip 1.0 机器人导航系统在不同手术方法中的应用。从2021年6月到2022年7月,145名患者在三家中国医疗中心接受了治疗。终末期关节疾病患者被随机分配到机器人导航系统组或对照组。对髋臼组件的定位进行影像学评估,并使用均方根误差(RMSE)测量配准精度:结果:总体 RMSE 为 0.72 mm(SD = 0.24 mm),表明无论采用哪种手术方法,准确性都是一致的。各组的内翻差异显著(P = 0.001)。侧位 RAS-THA 显示出更高的精确度。RAS直接前方入路(DAA)组的旋转中心水平距离偏差最小(0.89 ± 1.14 mm,p = 0.0014),腿长偏差最小(2.41 ± 1.17 mm)。RAS DAA方法也产生了更一致的结果:结论:在 THA 中使用机器人辅助,尤其是通过 DAA 方法,可提高髋臼组件定位的准确性和精确度。各种手术方法一致的注册准确性证实了这些方法在 THA 中的可靠性。临床试验注册:www.clinicaltrials.gov 识别码为 ChiCTR2100044124。
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Which way forward? Comparing radiological outcomes using three different surgical approaches in robotic assisted total hip arthroplasty.

Objectives: To assess the accuracy and precision of acetabular component placement in robot-assisted surgery total hip arthroplasty (RAS-THA) using three different approaches.

Methods: This study is a secondary analysis from a multicenter, randomized controlled trial comparing the Trex RS Hip 1.0 robot navigation system across different surgical approaches. It involved 145 patients treated at three Chinese medical centers from June 2021 to July 2022. Patients with end-stage joint disease were randomly assigned to either the RAS or control group. Acetabular component positioning was evaluated radiographically, and registration accuracy was measured using Root Mean Square Error (RMSE).

Results: The overall RMSE was 0.72 mm (SD = 0.24 mm), indicating consistent accuracy regardless of surgical approach. Significant variations in anteversion were noted across groups (p = 0.001). Lateral RAS-THA showed enhanced precision. The RAS Direct Anterior Approach (DAA) group had the least deviation in the rotation center's horizontal distance (0.89 ± 1.14 mm, p = 0.0014) and minimal leg length discrepancy (2.41 ± 1.17 mm). The RAS DAA approach also produced more consistent results.

Conclusion: Robotic assistance in THA, especially via the DAA approach, enhances the accuracy and precision of acetabular component positioning. Consistent registration accuracy across various surgical approaches confirms the reliability of these methods for THA.

Clinical trial registration: www.clinicaltrials.gov identifier is ChiCTR2100044124.

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