94. Machine vision image guided system in spinal fusion surgery: Early clinical experience

Abstract

<h3>BACKGROUND CONTEXT</h3> Computer-assisted navigation improves accuracy of pedicle screw placement. The machine vision image guided system (MvIGS), 7D Surgical, was developed to streamline surgical workflow and allow intraoperative navigation registration in seconds, without intraoperative radiation. This study presents the early clinical outcomes of spinal fusion with MvIGS. <h3>PURPOSE</h3> To identify outcomes of spinal fusion with intraoperative MvIGS use. <h3>STUDY DESIGN/SETTING</h3> Retrospective case series. <h3>PATIENT SAMPLE</h3> Adult patients who underwent spinal fusion with MvIGS at a single institution. <h3>OUTCOME MEASURES</h3> Primary outcome was postoperative complication. Secondary outcomes included readmissions, reoperations, and radiation exposure. <h3>METHODS</h3> Spinal fusion cases in adult patients (n=50) with intraoperative MvIGS at a single institution with three attending surgeons were reviewed. Baseline demographics, comorbidities, # fused levels, surgical indications, operative time, estimated blood loss (EBL), perioperative and 30-day complications, unplanned readmissions and reoperations were collected. Pre-, intra- and postoperative radiation exposure was totaled. <h3>RESULTS</h3> Across 50 patients, mean age was 61±17 years, and 44% were female. Mean ASA and CCI were 2.86±0.57 and 2.82±2.15, respectively. 24% had BMI >30, 6% actively used tobacco and 22% were diabetic. Indication for surgery included degenerative disease (33/50), deformity (1/50), tumor (5/50), infection (2/50) and trauma (9/50). Mean fusion length was 5.5±2.2 levels, and 12% (6/50) were revision cases. Mean operative time was 285±128 minutes and EBL was 544±601 mL. Most patients were discharged home (46%), skilled nursing facility (22%) or rehabilitation (24%). There were 7 (14%) complications, 4 (8%) readmissions and 2 (4%) reoperations. One reoperation was for a wound dehiscence, while the other was for lateral pedicle screw placement. Median total patient radiation exposure was 49.8±78.4mGy. Median registration time was 83±21s. <h3>CONCLUSIONS</h3> MvIGS is a safe and effective method of intraoperative navigation for spinal fusion surgery. The optical topographic imaging technology allows rapid registration and can be used for a variety of indications. <h3>FDA DEVICE/DRUG STATUS</h3> 7D Surgical System (Approved for this indication)