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.
We developed a miniature patient-mount navigated intervention system for spinal diseases. A clinical trial (percutaneous pulsed radiofrequency stimulation of dorsal root ganglion) was conducted to test the efficacy of this novel system.
From the *Institute of Biomedical Engineering, National Taiwan University, Taipei, Taiwan; †Taipei City Hospital Zhongxing Branch, Taipei, Taiwan; and ‡Department of Medical Imaging, National Taiwan University Hospital, Taipei, Taiwan.
Acknowledgment date: December 4, 2009. First revision date: February 10, 2010. Acceptance date: March 12, 2010.
The device(s)/drug(s) that is/are the subject of this manuscript is/are not FDA-approved for this indication and is/are not commercially available in the United States.
Institutional and Foundation funds were received in support of this work. No benefits in any form have been or will be received from a commercial party related directly or indirectly to the subject of this manuscript.
The authors Chi-Lin Yang and Been-Der Yang contributed equally to this paper.
Address correspondence and reprint requests to Jaw-Lin Wang, PhD, College of Medicine and Engineering, Institute of Biomedical Engineering and Department of Mechanical Engineering, National Taiwan University; Section 4, Roosevelt Road, Taipei 10617, Taiwan, ROC, Taiwan; E-mail: email@example.com