一种用于脊柱疾病的患者导航介入系统及其经皮脉冲射频刺激背根神经节的临床试验。

A patient-mount navigated intervention system for spinal diseases and its clinical trial on percutaneous pulsed radiofrequency stimulation of dorsal root ganglion.

机构信息

Institute of Biomedical Engineering, National Taiwan University, Taipei, Taiwan.

出版信息

Spine (Phila Pa 1976). 2010 Oct 1;35(21):E1126-32. doi: 10.1097/BRS.0b013e3181e11d73.

DOI:10.1097/BRS.0b013e3181e11d73

PMID:20838268

Abstract

STUDY DESIGN

Development of a patient-mount navigated intervention (PaMNI) system for spinal diseases. An in vivo clinical human trial was conducted to validate this system.

OBJECTIVE

To verify the feasibility of the PaMNI system with the clinical trial on percutaneous pulsed radiofrequency stimulation of dorsal root ganglion (PRF-DRG).

SUMMARY OF BACKGROUND DATA

Two major image guiding techniques, i.e., computed tomography (CT)-guided and fluoro-guided, were used for spinal intervention. The CT-guided technique provides high spatial resolution, and is claimed to be more accurate than the fluoro-guided technique. Nevertheless, the CT-guided intervention usually reaches higher radiograph exposure than the fluoro-guided counterpart. Some navigated intervention systems were developed to reduce the radiation of CT-guided intervention. Nevertheless, these systems were not popularly used due to the longer operation time, a new protocol for surgeons, and the availability of such a system.

METHODS

The PaMNI system includes 3 components, i.e., a patient-mount miniature tracking unit, an auto-registered reference frame unit, and a user-friendly image processing unit. The PRF-DRG treatment was conducted to find the clinical feasibility of this system.

RESULTS

The in vivo clinical trial showed that the accuracy, visual analog scale evaluation after surgery, and radiograph exposure of the PaMNI-guided technique are comparable to the one of conventional fluoro-guided technique, while the operation time is increased by 5 minutes.

CONCLUSION

Combining the virtues of fluoroscopy and CT-guided techniques, our navigation system is operated like a virtual fluoroscopy with augmented CT images. This system elevates the performance of CT-guided intervention and reduces surgeons' radiation exposure risk to a minimum, while keeping low radiation dose to patients like its fluoro-guided counterpart. The clinical trial of PRF-DRG treatment showed the clinical feasibility and efficacy of this system.

摘要

研究设计

开发一种用于脊柱疾病的患者导航介入（PaMNI）系统。进行了一项体内临床人体试验以验证该系统。

目的

通过经皮背根神经节脉冲射频刺激（PRF-DRG）的临床研究验证 PaMNI 系统的可行性。

背景资料总结

两种主要的图像引导技术，即计算机断层扫描（CT）引导和荧光引导，用于脊柱介入。CT 引导技术提供高空间分辨率，据称比荧光引导技术更准确。然而，CT 引导介入通常比荧光引导介入的射线曝光更高。已经开发了一些导航介入系统来降低 CT 引导介入的辐射。然而，由于操作时间更长、对外科医生的新协议以及此类系统的可用性，这些系统并未得到广泛应用。