Comparing the Efficacy of Radiation Free Machine-Vision Image-Guided Surgery With Traditional 2-Dimensional Fluoroscopy: A Randomized, Single-Center Study

Abstract

Background: Three-dimensional (3D) computer-assisted navigation (CAN) has emerged as a potential alternative to 2-dimensional (2D) fluoroscopy in the surgical placement of spinal instrumentation. Recently, 3D-CAN systems have improved significantly in their ability to provide real-time anatomical referencing while shortening the registration and set-up time. A novel system in navigation, Machine-Vision Image-Guided Surgery (MvIGS; 7D Surgical, Toronto, Canada) was cleared by the US Food and Drug Administration, but its potential benefits in reducing intra-operative radiation exposure to patients and enhancing surgical accuracy of pedicle screw placement are not fully known. Purpose: We sought to conduct a prospective, randomized, clinical study comparing the 3D-MvIGS spinal navigation system and 2D-fluoroscopy for pedicle screw insertion up to 3 levels (T10-S1) and for various measures of surgical efficacy. Methods: Sixty-two eligible patients were randomized to receive spine surgery using either the 3D-MvIGS group or the conventional 2D-fluoroscopy for pedicle screw fixation for the treatment of spinal stenosis and degenerative spondylolisthesis. Intra-operative parameters and procedure-related unintended protocol violations were recorded. Results: Operative time and estimated blood loss were not significantly different between groups. Radiation time and exposure to patients were significantly reduced in the 3D-MvIGS group. There was no difference between groups in pedicle screw placement accuracy (2D-fluoroscopy group, 96.6%; 3D-MvIGS group, 94.2%). There were no major complications or cases that required revision surgery. Conclusion: The 3D-MvIGS navigation system performed comparably with 2D-fluoroscopy in terms of pedicle screw placement accuracy and operative time. The 3D-MvIGS showed a significant reduction in radiation exposure to patients. In more complex cases or larger cohorts, the true value of greater anatomical visualization can be elucidated.

Automatic Registration and Error Color Maps to Improve Accuracy for Navigated Bone Tumor Surgery Using Intraoperative Cone-Beam CT

“…Some intraoperative CT systems provide automatic registration through the use of tracker markers affixed to the imaging device 42 ; further research is required to directly compare our method with these devices in terms of both registration accuracy and workflow efficiency. Alternatively, automatic registration techniques using optical technology, such as the Machine-vision Image Guided Surgery (MvIGS) system (7D Surgical), provide radiation-free scanning 43 but require bone exposure, which may be challenging in some settings (e.g., pelvic resection). Advantages associated with intraoperative CT imaging have recently been reported 44 , and as this becomes more widely available, our automatic registration method could be employed to improve surgical efficiency.…”

Novel Machine Vision Image Guidance System Significantly Reduces Procedural Time and Radiation Exposure Compared With 2-dimensional Fluoroscopy-based Guidance in Pediatric Deformity Surgery

“…15 This system has previously been studied in the adult population undergoing posterior spinal fusion in up to 4 levels and was found to reduce intraoperative radiation compared with both 2D-fluoroscopy-based navigation (2D fluoroscopy) and a different 3D navigation system. 16,17 The present study is the first study to compare intraoperative radiation emissions between machine vision navigation to 2D-fluoroscopy in a surgeon population performing spinal deformity correction surgery in a pediatric hospital. The objectives were to compare intraoperative radiation exposure and procedural operative time.…”

“…This system uses advanced optics combining a light projector with 2 stereoscopic video cameras to create a 3D map of the patient’s anatomy and correlates this information with preoperative computerized tomography (CT) 15. This system has previously been studied in the adult population undergoing posterior spinal fusion in up to 4 levels and was found to reduce intraoperative radiation compared with both 2D-fluoroscopy-based navigation (2D fluoroscopy) and a different 3D navigation system 16,17. The present study is the first study to compare intraoperative radiation emissions between machine vision navigation to 2D-fluoroscopy in a surgeon population performing spinal deformity correction surgery in a pediatric hospital.…”