Clinical Evaluation of TruFUSE® Lumbar Facet Fusion System

Introduction: The TruFUSE lumbar facet fusion system is a unique allograft milled bone dowel used to fuse facet joints. We evaluated subjects undergoing TruFUSE fusion for stable grade I spondylolisthesis and stenosis comparing operative time, length of stay, blood loss and outcome to a similar literature-based cohort of patients undergoing pedicle screw fusion (PSF). Methods: From 2009 to 2011, 41 subjects (17 M,24 F, aver. age 69.5 yr) underwent TruFUSE facet fusion along with transverse process bone fusion and laminectomy. Length of stay, operative time, blood loss and outcomes were compared to eight literature-based cohort that analyzed similar parameters following pedicle screw fusion. Results: The 41 subjects’ mean operative time for laminectomy, transverse process fusion and TruFUSE facet fusion was 106 min, with a mean blood loss of145 cm3, and a mean hospital stay of 1.7 days (77% one day). A follow-up at average six months, 33 (80%) subjects reported subjective outcomes of “excellent” or “somewhat improved”, four (10%) “unchanged” and four (10%) “worse”. Flexion and extension radiographs showed 39 of the 41 patients (95%) had spinal stability at an average six months post-op and all (100%) had signs of early fusion. Discussion: TruFUSE subjects had significantly (p - 19 days range). Mean estimated blood loss (EBL) was significantly lower (p 3 compared to321 cm3 and1082 cm3 range for PSF). Subjective outcome and radiographic stability were comparable between groups. Conclusion: This comparison using the TruFUSE lumbar facet fusion system demonstrates improvements in length of stay, surgical blood loss, and operative time in our selected patient population compared to several published lumbar pedicle screw fusion systems outcomes. There may be potential economic benefits as a result of these improvements.