Comparison of Operative Time and Blood Loss With the FFX® Device Versus Pedicle Screw Fixation During Surgery for Lumbar Spinal Stenosis: A Retrospective Cohort Study.

Background Pedicle screw (PS) placement can be associated with soft tissue damage and blood loss. The study objective was to evaluate differences in operative time and blood loss between PS fixation and an implantable facet fusion device in patients undergoing lumbar fusion surgery. Materials and methods A retrospective analysis was performed on patients undergoing lumbar fusion surgery with PS fixation or the lumbar Facet FiXation (FFX) device. Procedures were performed by the same surgeon at a single institution. The PS group included patients from 2016 and the FFX group included patients from 2018. Variables including age, sex, levels operated on, operative time, and operative blood loss were collected. Results A total of 70 patients were included in the study. Twenty-eight in the PS arm and 42 in the FFX arm. The PS group had a mean age of 67.5 ± 9.3 years compared to 70.4 ± 11.5 years for the FFX group. The PS group had a higher percentage of females (57.1%) versus the FFX group (31.0%); p = 0.025. Mean number of levels operated on were similar between the PS and FFX groups (2.3 ± 1 .1 vs. 2.2 ± 1.0, respectively; p = 0.89). Mean operative time was significantly longer for the PS group versus the FFX group (152.5 ± 39.4 vs. 99.4 ± 44.0 minutes; p < 0.001). Mean operative blood loss was significantly greater for the PS group versus the FFX group (446.5 ± 272.0 vs. 251.0 ± 315.9 mL; p < 0.01). Differences were independent of the number of levels operated on. Conclusion Placement of the FFX device is associated with a significant reduction in operative time and blood loss compared to PS fixation in patients undergoing spinal fusion surgery.