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Verasense传感器在导航反向肩关节置换术中的应用:对22例患者的初步临床前研究。

Use of Verasense sensor in navigated reverse shoulder arthroplasty: a preliminary and preclinical study on 22 patients.

作者信息

Tarallo Luigi, Morselli Milena, Donati Danilo, Mantovani Matteo, Catani Fabio

机构信息

Orthopaedic Department - University of Modena and Reggio Emilia, Modena, Italy.

Chief Research Officer, NCS Lab Srl, Carpi, Modena, Italy.

出版信息

Arch Orthop Trauma Surg. 2025 May 30;145(1):324. doi: 10.1007/s00402-025-05939-0.

Abstract

INTRODUCTION

Reverse total shoulder arthroplasty represents a helpful solution in restoring function and relieving pain for patients with several shoulder pathologies. However, the recovery of function for activities of daily living can be prolonged or incomplete. The reasons can be different. The aim of this work is to evaluate the causative relationship between the range of lateralization and the load distribution in movements simulating the daily life joint activities. We also collected data about the primary and final implant's lengthening and glenoid components (inclination, version, rotation and lateralization) and we compared them with load values measured during flexion-extension, internal-external rotation and during static positions: "over-the-head", "behind-back" and "cross-the-body".

MATERIALS AND METHODS

22 patients underwent reverse total shoulder arthroplasty implantation assisted by GPS navigation system (Exactech Inc, Gainesville, FL, USA). Preoperative data were collected by planning software. Intraoperative data were recorded using computer-assisted surgery; a wireless joint load sensor placed into the humeral trial insert was used to record joint load in real time while the RTSA was taken through passive motion.

RESULTS

Mean and the Standard Deviation of the force data for each movement and position have been evaluated. It has emerged that, preserving a final lateralisation from 18 to 22 mm, the average of force recorded, considering each movement and position, resulted between 11.8 and 22.5 lbf; the force on the glenoid's surface is influenced by the final lateralisation, the lengthening of the implant and the grade of abduction of the arm during the movement.

CONCLUSION

The data spread is consistent and narrow, especially for internal-external rotation and "behind-back" position. The limited number of patients did not allow the simultaneous analysis of multiple parameters and that limits our statistic results. Future trials should examine a broader range of patient-reported outcome measures and outcome variables including active range of motion kinematic data. This join load sensor could improve the understanding of how intraoperative joint load measurement may influence postoperative patient function and satisfaction. Future studies should integrate the post-operative follow-up in order to increase the knowledge about the causative relationship between intra-operative data and outcomes. This could improve the surgeon experience and his choices before and during the surgical act. This preliminary study evidenced a clear trend that can be statistically reinforced by enlarging the dataset.

摘要

引言

反式全肩关节置换术是恢复多种肩部疾病患者功能和缓解疼痛的有效方法。然而,日常生活活动功能的恢复可能会延长或不完全。原因可能多种多样。本研究的目的是评估在模拟日常生活关节活动的运动中,外展范围与负荷分布之间的因果关系。我们还收集了初次和最终植入物的延长以及关节盂组件(倾斜度、版本、旋转和外展)的数据,并将它们与在屈伸、内外旋转以及静态姿势(“过头”、“背后”和“过身体”)期间测量的负荷值进行比较。

材料与方法

22例患者在GPS导航系统(美国佛罗里达州盖恩斯维尔的Exactech公司)辅助下进行反式全肩关节置换术植入。术前数据通过规划软件收集。术中数据使用计算机辅助手术记录;在进行反式全肩关节置换术的被动运动时,将无线关节负荷传感器置于肱骨试验插入物中以实时记录关节负荷。

结果

评估了每个运动和姿势的力数据的平均值和标准差。结果表明,保持最终外展在18至22毫米之间,考虑到每个运动和姿势,记录的平均力在11.8至22.5磅力之间;关节盂表面的力受最终外展、植入物的延长以及运动期间手臂外展程度的影响。

结论

数据分布一致且狭窄,尤其是在内外旋转和“背后”姿势方面。患者数量有限不允许同时分析多个参数,这限制了我们的统计结果。未来的试验应检查更广泛的患者报告结局指标和结局变量,包括主动活动范围的运动学数据。这种关节负荷传感器可以增进对术中关节负荷测量如何影响术后患者功能和满意度的理解。未来的研究应纳入术后随访,以增加对术中数据与结局之间因果关系的认识。这可以改善外科医生的经验以及其在手术前和手术过程中的选择。这项初步研究证明了一个明显的趋势,通过扩大数据集可以在统计学上得到加强。

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