Facet Arthrodesis with the FFX Device: One-Year Results from a Prospective Multicenter Study

Background Facet osteosynthesis can be performed to treat facet syndrome (FS) and reduce spinal instability following laminectomy in patients with lumbar spinal stenosis (LSS). The present study evaluated clinical and radiological outcomes following facet osteosynthesis with the FFX device.

Methods Patients with FS or LSS were prospectively enrolled in a single-arm, multicenter study. The device was placed at affected levels with or without concomitant posterior lumbar interbody fusion (PLIF) procedures. The visual analog scale (VAS) for back and leg pain and Oswestry Disability Index (ODI) were evaluated preoperatively and postoperatively. Computed tomography scans to assess fusion and migration were performed 1 year following surgery.

Results Fifty-three patients (26 men/27 women) with a mean age of 65.0 ± 9.6 years (range: 37–83 years) were enrolled. A total of 205 FFX devices were implanted with 15 patients undergoing concurrent PLIF procedures. There were no intraoperative or postoperative surgical complication reported, and no patient required revision surgery. Mean VAS leg and back pain scores significantly improved from 5.57 to 2.09 (P < .001) and 5.74 to 3.13 (P < .001), respectively, between the preoperative and 1 year follow-up assessments. Mean ODI scores also significantly improved from 44.7% to 24.0% (P < .001) during the same time period. Facet fusion occurred with 86.3% of device placements after 12 months. There was 1 (0.5%) asymptomatic device migration. Eight devices (3.9%) were considered misplaced.

Conclusions The use of the FFX device is associated with a significant reduction in both pain and disability following surgery with a high facet joint fusion rate.

Level of Evidence 4.

Clinical Relevance This is the first study reporting clinical experience using the FFX device to facilitate facet osteosynthesis. The ability of the device to relieve pain, reduce disability, and enhance lumbar facet fusion with a low rate of device misplacement and migration was demonstrated.