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 < 0.0001) shorter surgeries (106 min compared to the literature data range of 185 - 240 min); significantly (p < 0.0001) shorter hospitalization (1.7 days compared to 4 - 19 days range). Mean estimated blood loss (EBL) was significantly lower (p < 0.001) (145 cm3 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.

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J. Maroon, J. Bost, D. LePere, S. Bost, L. Williams and A. Amos, "Clinical Evaluation of TruFUSE® Lumbar Facet Fusion System," Surgical Science, Vol. 4 No. 2, 2013, pp. 166-175. doi: 10.4236/ss.2013.42032.

Conflicts of Interest

The authors declare no conflicts of interest.


[1] R. A. Deyo, D. C. Cherkin, J. D. Loeser, et al., “Morbidity and Mortality in Association with Operations on the Lumbar Spine: The influence of Age, Diagnosis, and Procedure,” The Journal of Bone and Joint Surgery (American Volume), Vol. 74, No. 4, 1992, pp. 536-543.
[2] H. Moller and R. Hedlund, “Instrumented and Noninstrumented Postereolateral Fusion in Adult Spondylolisthesis,” Spine, Vol. 25, No. 13, 2000, pp. 1716-1721. doi:10.1097/00007632-200007010-00017
[3] F. B. Christensen, E. S. Hansen, M. Laursen, et al., “Long-Term Functional Outcome of Pedicle Screw Instrumentation as a Support for Postereolateral Spinal Fusion: Randomized Clinical Study with a 5-Year Follow-Up,” Spine, Vol. 27, No. 12, 2002, pp. 1269-1277. doi:10.1097/00007632-200206150-00006
[4] D. Dindo, N. Demartines and P. A. Clavien, “Classification of Surgical Complications: New Proposal with Evaluation in a Cohort of 6336 Patients and Results of Survey,” Annals of Surgery, Vol. 240, No. 2, 2004, pp. 205-213. doi:10.1097/
[5] R. A. Deyo, S. K. Mirza, B. I. Martin, et al., “Trends, Major Medical Complications and Charges Associated with Surgery for Lumbar Spinal Stenosis in Older Adults,” The Journal of the American Medical Association, Vol. 303, No. 13, 2010, pp. 1259-1265. doi:10.1001/jama.2010.338
[6] R. Johnsson, P. Axelsson and B. Stromqvist, “Posterolateral Lumbar Fusion Using Facet Joint Fixation with Biodegradable Rods: A Pilot Study,” European Spine Journal, Vol. 6, No. 2, 1997, pp. 144-148. doi:10.1007/BF01358748
[7] P. Fritzell, O. Hagg and A. Nordwall, “Complications in Lumbar Fusion Surgery for Chronic Low Back Pain: Comparison of Three Surgical Techniques Used in a Prospective Randomized Study. A Report from the Swedish Lumbar Spine Study Group,” European Spine Journal, Vol. 12, No. 2, 2003, pp. 178-189.
[8] D. N. Inamdar, M. Alagappan, L. Shyam, S. Devadoss and A. Devadoss, “Posterior Lumbar Interbody Fusion versus Intertransverse Fusion in the Treatment of Lumbar Spondylolisthesis,” The Journal of the Orthopaedic Surgery, Vol. 14, No. 1, 2006, pp. 21-26.
[9] K. T. Kim, S. H. Lee, Y. H. Lee, S. C. Bae and K. S. Suk, “Clinical Outcomes of 3 Fusion Methods through the Posterior Approach in the Lumbar Spine,” Spine, Vol. 31, No. 12, 2006, pp. 1351-1357. doi:10.1097/01.brs.0000218635.14571.55
[10] A. Hallet, J. S. Huntley and A. Gibson, “Foraminal Stenosis and Single-Level Degenerative Disc Disease,” Spine, Vol. 32, No. 13, 2007, pp. 1375-1380. doi:10.1097/BRS.0b013e318064520f
[11] S. Ohtori, T. Koshi, M. Yamashita, et al., “Single-Level Instrumented Posterolateral Fusion versus Non-Instrumented Anterior Interbody Fusion for Lumbar Spondylolisthesis: A Prospective Study with a 2-Year Follow-Up,” Journal of Orthopaedic Science, Vol. 16, No. 4, 2011, pp. 352-358. doi:10.1007/s00776-011-0088-5
[12] T. Koshi, S. Ohtori, M. Suzuki, et al., “Uni- and Bi-Lateral Instrumented Posterolateral Fusion of the Lumbar Spine with Local Bone Grafting: A Prospective Study with a 2-Year Follow-Up,” Spine, Vol. 36, No. 26, 2011, pp. E1744-E1748.
[13] S. Ohtori, M. Suzuki, M. Takaso, et al., “Single-Level Instrumented Posterolateral Fusion of the Lumbar Spine with a Local Bone Graft versus an Iliac Crest Bone Graft: A Prospective, Randomized Study with a 2-Year Follow-Up,” European Spine Journal, Vol. 20, No. 4, 2011, pp. 635-639. doi:10.1007/s00586-010-1656-7
[14] S. M. Mardjetko, P. J. Connolly and S. Shott, “Degenerative Lumbar Spondylolisthesis: A Meta-Analysis of Literature 1979-1993,” Spine, Vol. 19, No. 20, 2004, pp. 2256-2265. doi:10.1097/00007632-199410151-00002
[15] G. W. Wood, R. J. Boyd, T. A. Carothers, et al., “The Effect of Pedicle Screw/Plate Fixation on Lumbar/Lumbosacral Autogenous Bone Graft Fusions in Patients with Degenerative Disc Disease,” Spine, Vol. 20, No. 7, 1995, pp. 819-830. doi:10.1097/00007632-199504000-00017
[16] H. G. Deen, D. S. Fenton and T. J. Lamer, “Minimally Invasive Procedures for Disorders of the Lumbar Spine,” Mayo Clinic Proceedings, Vol. 78, No. 10, 2003, pp. 1249-1256. doi:10.4065/78.10.1249
[17] R. I. Riesenburger and C. A. David, “Lumbar Microdiscectomy and Microendoscopic Discectomy,” Minimally Invasive Therapy & Allied Technologies, Vol. 15, No. 5, 2006, pp. 267-270. doi:10.1080/13645700600958432
[18] C. K. Lee and N. A. Langrana, “Review of Spinal Fusion for Degenerative Disc Disease: Need for an Alternative Treatment Approach of Disc Arthroplasty,” The Spine Journal, Vol. 4, No. 6, 2004, pp. 173-176. doi:10.1016/j.spinee.2004.07.002
[19] D. B. Pateder and E. Benzel, “Noninstrumented Facet Fusion in Patients Undergoing Lumbar Laminectomy for Degenerative Spondylolisthesis,” Journal of Surgical Orthopadic Advances, Vol. 19, No. 3, 2010, pp. 153-158.
[20] W. M. Johnson, “The Use of the TruFUSE Structural Facet Joint Fusion Allograft in Conjunction with a Lumbar Laminectomy,” 2011.
[21] W. M. Johnson, “Understanding the Morphology of Lumbar Facets and Its Correlation to the TruFUSE? Facet Joint Fusion Procedure,” 2011.
[22] A. E. Brodsky, E. S. Kovalsky and M. A. Khalil, “Correlation of Radiologic Assessment of Lumbar Spine Fusions with Surgical Exploration,” Spine, Vol. 16, No. 6S, 1991, pp. 261-265. doi:10.1097/00007632-199106001-00017
[23] A. Abla, H. El Kadi, J. Bost, J. C. Maroon and M. Wert, “Evaluation of Spondylolisthesis after Lumbar Laminectomy,” Contemporary Neurosurgery, Vol. 26, 2004, pp. 1-6.
[24] W. A. Abdu, J. D. Lurie, K. F. Spratt, et al., “Degenerative Spondylolisthesis: Does Fusion Method Influence Outcome? Four-Year Results of the Spine Patient Outcomes Research Trial,” Spine, Vol. 34, No. 21, 2009, pp. 2351-2360. doi:10.1097/BRS.0b013e3181b8a829
[25] O. Schwarzenbach, U. Beremann, B. Jost, et al., “Accuracy of Computer-Assisted Pedicle Screw Placement: An in Vivo Computed Tomography Analysis,” Spine, Vol. 22, No. 4, 1997, pp. 452-458. doi:10.1097/00007632-199702150-00020
[26] F. Asgarzadie and L. T. Khoo, “Minimally Invasive Operative Management for Lumbar Spinal Stenosis: Overview of Early and Long-Term Outcomes,” Orthopedic Clinics of North America, Vol. 38, No. 3, 2007, pp. 387-399. doi:10.1016/j.ocl.2007.02.006
[27] S. D. Candrilli and J. A. Mauskopf, “How Much Does a Hospital Day Cost?” The 11th Annual International Meeting of the International Society for Pharmacoeconomics and Outcomes Research, Philadelphia, 20-24 May 2006.

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