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一项关于新型全流程机器人手臂辅助全髋关节置换术中假体定位准确性的前瞻性随机对照试验。

Prospective randomized controlled trial on the accuracy of prosthesis positioning in total hip arthroplasty assisted by a newly designed whole-process robotic arm.

作者信息

Wang Wenzhe, Zhang Zian, Wang Guanrong, Rong Chun, Xu Hao, Lu Xinzhe, Liu Yikai, Li Chenkai, Zhang Haining

机构信息

Department of Joint Surgery, The Affiliated Hospital of Qingdao University, Qingdao, 266000, Shandong, China.

Nursing Department of Operating Room, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, China.

出版信息

Int Orthop. 2023 Feb;47(2):413-419. doi: 10.1007/s00264-022-05501-2. Epub 2022 Jul 8.

Abstract

INTRODUCTION

The purpose of this article is to study whether the newly designed whole-process total hip arthroplasty (THA) robotic arm can improve the accuracy of prosthesis placement in THA.

METHOD

In this study, 72 patients undergoing THA were prospectively included and randomly divided into two groups. The experimental group was treated with THA assisted by a newly designed robotic arm. The control group received THA with conventional surgical methods. The imaging data were compared after operation.

RESULT

Compared with the conventional operation, the whole-process robotic arm can more accurately place the acetabular prosthesis in the anteversion safe zone of 5 ~ 25°, but in terms of the inclination angle, whether the reference is the safe zone of 30 ~ 50° or 30 ~ 45°, there is no statistical difference between the two groups. The average lower limb length discrepancy (LLLD) in the experimental group was 3.77 ± 8.31 mm longer than contralateral side, while the counterpart in the control group was 8.39 ± 9.11 mm, with significant difference (P = 0.029). The femoral prosthesis was fixed in neutral position in 35 (100%) cases in the experimental group and only 30 (83.3%) in the control group (P = 0.036). There was no significant difference in the recovery of hip offset, femoral anteversion, and canal fill ratio (CFR) between the two groups.

CONCLUSION

Robotic arm can improve the accuracy of anteversion of acetabular cup, restore the consistency of the length of lower limbs, and more accurately implant the femoral prosthesis to the neutral position in the coronal position.

CLINICAL TRIAL REGISTRATION NUMBER

ChiCTR2100044124 (date of registration: 2021-3-11).

摘要

引言

本文旨在研究新设计的全流程全髋关节置换术(THA)机器人手臂能否提高THA中假体植入的准确性。

方法

本研究前瞻性纳入72例行THA的患者,并随机分为两组。实验组采用新设计的机器人手臂辅助进行THA。对照组采用传统手术方法进行THA。术后比较影像学数据。

结果

与传统手术相比,全流程机器人手臂能更准确地将髋臼假体放置在5°至25°的前倾角安全区内,但在倾斜角度方面,无论参考的是30°至50°还是30°至45°的安全区,两组之间均无统计学差异。实验组平均下肢长度差异(LLLD)比对侧长3.77±8.31毫米,而对照组为8.39±9.11毫米,差异有统计学意义(P = 0.029)。实验组35例(100%)股骨假体固定于中立位,对照组仅30例(83.3%)(P = 0.036)。两组在髋关节偏移、股骨前倾角和髓腔填充率(CFR)恢复方面无显著差异。

结论

机器人手臂可提高髋臼杯前倾角的准确性,恢复下肢长度的一致性,并更准确地将股骨假体植入冠状位的中立位。

临床试验注册号

ChiCTR2100044124(注册日期:2021年3月11日)。

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