Malham Gregory M, Wang Wenhai, McGuckin Joshua P, Mahoney Jonathan M, Biddau Dean T, Bucklen Brandon S
Neuroscience Institute, Epworth Hospital, Richmond, Victoria, Australia; Spine Surgery Research Foundation, Richmond, Victoria, Australia; School of Health Science, Swinburne University of Technology, Hawthorn, Victoria, Australia; Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Parkville, Victoria, Australia.
Musculoskeletal Education and Research Center, A Division of Globus Medical, Inc., Audubon, PA, USA.
Spine J. 2025 Jul;25(7):1564-1573. doi: 10.1016/j.spinee.2025.01.035. Epub 2025 Jan 30.
Lateral lumbar interbody fusion (LLIF) is a minimally invasive surgical technique that provides a wide footprint interbody cage for correction of lumbar coronal and sagittal deformity. Traditional spinal interbody fusion procedures utilize pedicle screws and rods for additional stability. An expandable lateral titanium interbody cage with an integrated lateral fixation (eLLIFp) device provides a stand-alone LLIF that is intended to function autonomously. This may reduce the complexity of the surgery and the potential risks associated with supplemental posterior instrumentation. The minimum-acceptable screw length to promote adequate biomechanical fixation and stability for a stand-alone eLLIFp has not been determined.
To investigate the effective ratio (of screw length/cage length) of a stand-alone eLLIFp construct that provides adequate biomechanical fixation and stability as compared to the eLLIFp with supplemental bilateral pedicle screw-rod fixation.
STUDY DESIGN/SETTING: In vitro cadaveric biomechanical testing and finite element modeling.
Eight fresh-frozen human cadaveric lumbar spine specimens (L2-5) were used.
Range-of-motion (ROM) measurements of intact and treated specimens with simulated stresses within the construct and surrounding bone during flexion-extension (FE), lateral bending (LB), and axial rotation (AR).
Specimens with similar age and DEXA scores were selected. ROM of intact specimens was measured before treatment with LLIF at L3-4. Specimens were treated with expandable lateral cages with integrated fixation (stand-alone eLLIFp) or eLLIFp with supplemental posterior fixation using bilateral pedicle screws and rods (eLLIFp + BPS). ROM was measured using a custom-built 6°-of-freedom motion simulator (±7.5Nm) and normalized as a percentage of intact. Four patient-specific lumbar functional spinal unit finite element models (FEMs) were developed, validated, and then instrumented with eLLIFp stand-alone devices. The integrated screw lengths were varied to achieve screw-to-cage length ratios of 0.6, 0.75 and 0.9. Stresses were compared among the constructs under a 7.5Nm pure moment load in FE, LB, and AR.
The stand-alone and posteriorly supplemented eLLIFp constructs were not sensitive to the ratio during FE and LB (with only a 4%-9% change in motion trends from low-to-high ratios, relative to intact). Independent of ratio, these constructs had minimal differences in FE and LB motion. However, during AR both constructs were sensitive to the ratio showing greater stability and less variability in performance with higher ratios (≥0.65). Regression analysis revealed that posteriorly supplemented eLLIFp constructs had a linear 13% reduction in AR motion as the ratio increased from low-to-high (p<.05). AR also imposed the highest stresses on the eLLIFp and these stresses increased with higher ratios (maximum stress 259MPa for ratio 0.9 during AR), yet implant failure was improbable because of the material properties of the titanium alloy used. Similarly, surrounding bone stresses were higher during AR and longer screws reduced these stresses (63MPa with a 0.6 ratio compared to 38MPa with a 0.9 ratio).
Independent of screw-to-cage length ratio, eLLIFp had comparable reduction of FE and LB motion with or without posterior fixation. For eLLIFp with and without posterior fixation, torsional performance and repeatability increased with screw-to-cage length ratio. Torsional stability was comparable between stand-alone eLLIFp with high ratios (≥0.65) and posteriorly supplemented eLLIFp with low ratios (0.55). However, a threshold screw-to-cage length ratio for optimizing the clinical performance of eLLIFp cannot be prescribed. Implant stress findings reinforced torsion as the critical loading condition. Surrounding bone stress decreased as the screw length increased, indicating the benefit of using longer screws. Surgeons using eLLIFp should consider longer screw lengths based on anatomical considerations.
eLLIFp cages can be used as a stand-alone device in appropriately selected patients. This avoids the morbidity and cost associated with futher supplemental posterior fixation. Surgeons using eLLIFp should consider using longer screws to optimize fixation.
腰椎侧方椎间融合术(LLIF)是一种微创手术技术,可提供一个宽大的椎间融合器以矫正腰椎冠状面和矢状面畸形。传统的脊柱椎间融合手术利用椎弓根螺钉和棒来提供额外的稳定性。一种带有集成侧向固定装置(eLLIFp)的可扩张钛制椎间融合器提供了一种独立的LLIF,旨在自主发挥作用。这可能会降低手术的复杂性以及与补充后路器械相关的潜在风险。尚未确定促进独立eLLIFp获得足够生物力学固定和稳定性所需的最小可接受螺钉长度。
研究与采用双侧椎弓根螺钉-棒补充固定的eLLIFp相比,能提供足够生物力学固定和稳定性的独立eLLIFp结构的有效率(螺钉长度/融合器长度)。
研究设计/场所:体外尸体生物力学测试和有限元建模。
使用了8个新鲜冷冻的人尸体腰椎标本(L2 - 5)。
在屈伸(FE)、侧弯(LB)和轴向旋转(AR)过程中,对完整标本以及模拟结构和周围骨骼应力作用下的处理后标本进行活动度(ROM)测量。
选择年龄和双能X线吸收法(DEXA)评分相似的标本。在L3 - 4节段进行LLIF治疗前测量完整标本的ROM。标本分别采用带有集成固定装置的可扩张侧方融合器(独立eLLIFp)或采用双侧椎弓根螺钉和棒进行补充后路固定的eLLIFp(eLLIFp + BPS)进行治疗。使用定制的6自由度运动模拟器(±7.5Nm)测量ROM,并将其归一化为完整标本的百分比。建立了4个患者特异性腰椎功能脊柱单元有限元模型(FEMs),进行验证,然后用独立的eLLIFp装置进行模拟。改变集成螺钉长度以实现螺钉与融合器长度比为0.6、0.75和0.9。在FE、LB和AR过程中,在7.5Nm纯弯矩载荷下比较各结构之间的应力。
在FE和LB过程中,独立的和后路补充的eLLIFp结构对该比例不敏感(相对于完整标本,从低比例到高比例运动趋势变化仅为4% - 9%)。与比例无关,这些结构在FE和LB运动中差异最小。然而,在AR过程中,两种结构对该比例都很敏感,较高比例(≥0.65)时表现出更高的稳定性和更小的性能变异性。回归分析显示,随着比例从低到高增加,后路补充的eLLIFp结构在AR运动中线性降低13%(p <.05)。AR也对eLLIFp施加了最高应力,并且这些应力随着比例升高而增加(AR过程中比例为0.9时最大应力为259MPa),但由于所用钛合金的材料特性,植入物不太可能失效。同样,AR过程中周围骨应力更高,更长的螺钉可降低这些应力(比例为0.6时为63MPa,比例为0.9时为38MPa)。
与有无后路固定无关,eLLIFp在FE和LB运动减少方面具有可比性。对于有无后路固定的eLLIFp,扭转性能和可重复性随螺钉与融合器长度比增加而提高。高比例(≥0.65)的独立eLLIFp与低比例(0.55)的后路补充eLLIFp之间的扭转稳定性相当。然而,无法规定优化eLLIFp临床性能的阈值螺钉与融合器长度比。植入物应力结果强化了扭转是关键加载条件。随着螺钉长度增加,周围骨应力降低,表明使用更长螺钉的益处。使用eLLIFp的外科医生应根据解剖学考虑因素考虑使用更长的螺钉。
eLLIFp融合器可在适当选择的患者中用作独立装置。这避免了与进一步补充后路固定相关的发病率和成本。使用eLLIFp的外科医生应考虑使用更长的螺钉以优化固定。