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

Abstract

BackgroundPedicle 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 methodsA 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. ResultsA 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. ConclusionPlacement 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.

Evaluation of the Efficacy and Safety of FFX Facet Cages Compared to Pedicle Screw Fixation in Patients with Lumbar Spinal Stenosis: A Long-Term Study

“…A recent non-randomized, retrospective study compared mean operative time and estimated blood loss between patients undergoing posterior lumbar fusion surgery for LSS with either pedicle screw fixation or the FFX device. 16 The author reported that PS fixation was associated with significantly longer mean operative time compared to placement of the FFX device (152.5 ± 39.4 vs. 99.4 ± 44.0 minutes; p<0.001). Mean operative blood loss was also significantly greater for PS vs. FFX procedures (446.5 ± 272.0 vs. 251.0 ± 315.9 mL; p<0.001).…”

“…Previous studies have reported positive one-year outcomes associated with the placement of the FFX facet fixation device and reduced operative time and blood loss associated with the placement of the implant compared to placement of PS in patients with LSS. 15,16 A finite element simulation comparing the device with the PS placement suggests facet fusion leads to lower mechanical loads at the adjacent levels potentially lowering the risk of adjacent segment degeneration prior to fusion while providing equivalent stability once fusion is achieved. 17 In order to assess the long-term performance of the FFX device and to compare these outcomes with PS fixation, we conducted a hybrid retrospective-prospective study to evaluate clinical and radiological outcomes associated with single or multi-level use of these devices.…”

“…Previous studies have reported positive one-year outcomes associated with the placement of the FFX facet fixation device and reduced operative time and blood loss associated with the placement of the implant compared to placement of PS in patients with LSS. 15,16 A finite element simulation comparing the device with the PS placement suggests facet fusion leads to lower mechanical loads at the adjacent levels potentially lowering the risk of adjacent segment degeneration prior to fusion while providing equivalent stability once fusion is achieved. 17…”