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


BACKGROUND
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.


CONCLUSIONS
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.
Yang
Chi-Lin
CL
Institute of Biomedical Engineering, National Taiwan University, Taipei, Taiwan.
Yang
Been-Der
BD
Lin
Mu-Lien
ML
Wang
Yao-Hung
YH
Wang
Jaw-Lin
JL
D000328:Adult; D000368:Aged; D005260:Female; D005471:Fluoroscopy / Q000295:instrumentation / Q000379:methods* / Q000639:trends; D005727:Ganglia, Spinal / Q000000981:diagnostic imaging / Q000502:physiology / Q000601:surgery*; D006801:Humans; D017116:Low Back Pain / Q000503:physiopathology / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D038361:Neuronavigation / Q000295:instrumentation / Q000379:methods*; D014057:Tomography, X-Ray Computed / Q000295:instrumentation / Q000379:methods* / Q000639:trends; D004561:Transcutaneous Electric Nerve Stimulation / Q000295:instrumentation / Q000379:methods*