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

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.