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

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.