Comparison of novel machine vision spinal image guidance system with existing 3D fluoroscopy-based navigation system: A randomized prospective study.

Abstract

Background context: The use of spinal image guidance systems (IGS) has increased patient safety, accuracy, operative efficiency, and reduced revision rates in pedicle screw placement procedures. Traditional intraoperative 3D fluoroscopy or CT imaging produces potentially harmful ionizing radiation and increases operative time to register the patient. An IGS, FLASH Navigation, uses machine vision through high resolution stereoscopic cameras and structured visible light to build a 3D topographical map of the patient's bony surface anatomy enabling navigation use without ionizing radiation.

Purpose: We aimed to compare FLASH navigation system to a widely used 3D fluoroscopic navigation (3D) platform by comparing radiation exposure and pedicle screw accuracy.

Design: A randomized prospective comparative cohort study of consecutive patients undergoing open posterior lumbar instrumented fusion.

Patient sample: Adults diagnosed with spinal pathology requiring surgical treatment and planning for open posterior lumbar fusion with pedicle screws implanted into 1-4 vertebral levels.

Outcome measures: Outcome measures included mean intraoperative fluoroscopy time and dose, mean CT dose length product (DLP) for preoperative and day 2 CT, pedicle screw accuracy by CT, estimated blood loss and revision surgery rate.

Methods: Consecutive patients were randomized 1:1 to FLASH or 3D and underwent posterior lumbar instrumented fusion. Radiation doses were recorded from pre- and postoperative CT and intraoperative 3D fluoroscopy. 2 independent blinded radiologists reviewed pedicle screw accuracy on CT.

Results: A total of 429 (n=210 FLASH, n=219 3D) pedicle screws were placed in 90 patients (n=45 FLASH, n=45 3D) over the 18-month study period. Mean age and indication for surgery were similar between both groups, with a non-significantly higher ratio of males in the 3D group. Mean intraoperative fluoroscopy time and doses were significantly reduced in FLASH compared to 3D (4.51±3.71s vs 79.6±23.0s, p<.001 and 80.9±68.1cGycm2 vs 3704.1±3442.4 cGycm2, p<.001, respectively). This represented a relative reduction of 94.3% in the total intraoperative radiation time and a 97.8% reduction in the total intraoperative radiation dose. Mean preoperative CT DLP and mean day 2 postoperative CT DLP were significantly reduced in FLASH compared to 3D (662.0±440.4mGy-cm vs 1008.9±616.3 mGy-cm, p<.001 and 577.9±294.3 mGy-cm vs 980.7±441.6 mGy-cm, p<.001, respectively). This represented relative reductions of 34.4% and 41.0% in the preoperative CT dose and postoperative total DLP, respectively. The FLASH group required an average of 1.2 registrations in each case with an average of 2447 (±961.3) data points registered with a mean registration time of 106s (±52.1). A rapid re-registration mechanism was utilized in 22% (n=10/45) of cases and took 22.7s (±11.3). Re-registration was used in 7% (n=3/45) in the 3D group. Pedicle screw accuracy was high in FLASH (98.1%) and 3D (97.3%) groups with no pedicle breach >2mm in either group (p<.001). EBL was not statistically different between the groups (p=.38). No neurovascular injuries occurred, and no patients required return to theatre for screw repositioning.

Conclusions: FLASH and 3D IGS demonstrate high accuracy for pedicle screw placement. FLASH showed significant reduction in intraoperative radiation time and dose with lower but non-significant blood loss. FLASH showed significant reduction in preoperative and postoperative radiation, but this may be associated to the lower number of males/females preponderance in this group. FLASH provides similar accuracy to contemporary IGS without requiring 3D-fluoroscopy or radiolucent operating tables. Reducing registration time and specialized equipment may reduce costs.