title: Novel spinal instrumentation to enhance osteogenesis and fusion: a preliminary study.
abstract: OBJECTIVE Instrumented spinal fusion continues to exhibit high failure rates in patients undergoing multilevel lumbar fusion or pseudarthrosis revision; with Grade II or higher spondylolisthesis; or in those possessing risk factors such as obesity, tobacco use, or metabolic disorders. Direct current (DC) electrical stimulation of bone growth represents a unique surgical adjunct in vertebral fusion procedures, yet existing spinal fusion stimulators are not optimized to enhance interbody fusion. To develop an advanced method of applying DC electrical stimulation to promote interbody fusion, a novel osteogenic spinal system capable of routing DC through rigid instrumentation and into the vertebral bodies was fabricated. A pilot study was designed to assess the feasibility of osteogenic instrumentation and compare the ability of osteogenic instrumentation to promote successful interbody fusion in vivo to standard spinal instrumentation with autograft. METHODS Instrumented, single-level, posterior lumbar interbody fusion (PLIF) with autologous graft was performed at L4-5 in adult Toggenburg/Alpine goats, using both osteogenic spinal instrumentation (plus electrical stimulation) and standard spinal instrumentation (no electrical stimulation). At terminal time points (3 months, 6 months), animals were killed and lumbar spines were explanted for radiographic analysis using a SOMATOM Dual Source Definition CT Scanner and high-resolution Microcat II CT Scanner. Trabecular continuity, radiodensity within the fusion mass, and regional bone formation were examined to determine successful spinal fusion. RESULTS Quantitative analysis of average bone density in pedicle screw beds confirmed that electroactive pedicle screws used in the osteogenic spinal system focally enhanced bone density in instrumented vertebral bodies. Qualitative and quantitative analysis of high-resolution CT scans of explanted lumbar spines further demonstrated that the osteogenic spinal system induced solid bony fusion across the L4-5 disc space as early as 6 weeks postoperatively. In comparison, inactive spinal instrumentation with autograft was unable to promote successful interbody fusion by 6 months postoperatively. CONCLUSIONS Results of this study demonstrate that novel osteogenic spinal instrumentation supports interbody fusion through the focal delivery of DC electrical stimulation. With further technical development and scientific/clinical validation, osteogenic spinal instrumentation may offer a unique alternative to biological scaffolds and pharmaceutical adjuncts used in spinal fusion procedures.
authors.affiliation: Department of Biomedical Engineering, and.|Department of Neurosurgery, Washington University School of Medicine, St. Louis, Missouri.
authors.forename: Matthew R
authors.initials: MR
authors.lastname: MacEwan
authors.affiliation: Division of Comparative Medicine, Washington University; and.
authors.forename: Michael R
authors.initials: MR
authors.lastname: Talcott
authors.affiliation: Department of Biomedical Engineering, and.
authors.forename: Daniel W
authors.initials: DW
authors.lastname: Moran
authors.affiliation: Department of Biomedical Engineering, and.|Department of Neurosurgery, Washington University School of Medicine, St. Louis, Missouri.
authors.forename: Eric C
authors.initials: EC
authors.lastname: Leuthardt
mesh_terms: D000818:Animals; D064592:Autografts; D004599:Electric Stimulation Therapy / Q000295:instrumentation / Q000379:methods*; D005240:Feasibility Studies; D005260:Female; D006041:Goats; D008159:Lumbar Vertebrae / Q000000981:diagnostic imaging / Q000601:surgery; D010012:Osteogenesis / Q000502:physiology; D065289:Pedicle Screws; D010865:Pilot Projects; D011897:Random Allocation; D013123:Spinal Fusion / Q000295:instrumentation / Q000379:methods*; D013997:Time Factors; D014057:Tomography, X-Ray Computed; D014182:Transplantation, Autologous / Q000295:instrumentation / Q000379:methods; D016896:Treatment Outcome
keywords: AP = anteroposterior; BMP = bone morphogenetic protein; DC = direct current; LR = left-right; direct current; electrical stimulation; instrumentation; interbody fusion; lumbar; osteogenic