A Lateral Expandable Cage with Independently Adjustable Anterior and Posterior Heights Can Improve the Pressure Distribution at the Cage-Endplate Interface: A Biomechanics Study.

OBJECTIVE: To investigate how the expansion trajectory of a lateral expandable cage affects pressure distribution at the cage-endplate interface under well-controlled biomechanical loading conditions. METHODS: Three unique vertical height expansion trajectories used by clinically relevant lateral expandable cages were evaluated: craniocaudal, fixed-arc, and independently adjustable anterior and posterior height expansion. Two biomechanical loading scenarios were performed. The first scenario used custom bone foam test blocks to assess resultant pressure distribution at varying test block lordotic angles and expansion heights. The second scenario simulated expansion using synthetic spine units and compared the pressure distribution following expansion. RESULTS: For an expandable cage with craniocaudal expansion, the pressure distribution at the cage-endplate interface was found to depend heavily on the lordotic angle of the test block (P < 0.001), but not expansion height (P = 0.634). The greatest maximum pressure occurred at higher test block lordotic angles. For an expandable cage with fixed-arc expansion, the pressure distribution shifted anteriorly throughout expansion. In the simulated expansion trials, an expandable cage with adjustable anterior and posterior height expansion was found to improve the pressure distribution at the cage-endplate interface, reducing the maximum pressure measurements by 22% and 14% in the craniocaudal and fixed-arc expansion, respectively. CONCLUSIONS: Of the cage designs evaluated in this study, an expandable cage with independently adjustable anterior and posterior heights lowered the maximum pressure measured at the cage-endplate interface and alleviated the potential of cage edge loading, both of which are important considerations that are fundamental for a successful fusion procedure and the mitigation of implant subsidence risk.

Biomechanical comparison of subsidence performance among three modern porous lateral cage designs.

BACKGROUND: Cage subsidence remains a major complication after spinal surgery. The goal of this study was to compare the subsidence performance of three modern porous cage designs. METHODS: Three porous cages were evaluated: a porous titanium cage, a porous polyetheretherketone cage and a truss titanium cage. Mechanical testing was performed for each cage per the American Society for Testing and Materials F2077 and F2267 standards to evaluate cage stiffness and block stiffness, and per a novel clinically relevant dynamic subsidence testing method simulating cyclic spine loading during 3-months postoperatively to evaluate the subsidence displacement. FINDINGS: The porous polyetheretherketone cage demonstrated the lowest cage stiffness (21.0 ± 1.1 kN/mm), less than half of both titanium cages (truss titanium cage, 49.1 kN/mm; porous titanium cage, 43.6 kN/mm). The block stiffness was greatest for the porous titanium cage (2867.7 ± 105.3 N/mm), followed by the porous polyetheretherketone (2563.4 ± 72.9 N/mm) and truss titanium cages (2213.7 ± 21.8 N/mm). The dynamic subsidence displacement was greatest for the truss titanium cage, which was 1.5 and 2.5 times the subsidence displacement as the porous polyetheretherketone and porous titanium cages respectively. INTERPRETATIONS: Specific porous cage design plays a crucial role in the cage subsidence performance, to a greater degree than the selection of cage materials. A porous titanium cage with body lattice and microporous endplates significantly outperformed a truss titanium cage with a similar cage stiffness in subsidence performance, and a porous polyetheretherketone cage with half of its stiffness.

Choice of Spinal Interbody Fusion Cage Material and Design Influences Subsidence and Osseointegration Performance.

OBJECTIVE: The objective of the study was to quantify the effect of cage material (titanium-alloy vs. polyetheretherketone or PEEK) and design (porous vs. solid) on subsidence and osseointegration. METHODS: Three lateral cages (solid PEEK, solid titanium, and 3-dimension-printed porous titanium cages) were evaluated for cage stiffness, subsidence compression stiffness, and dynamic subsidence displacement under simulated postoperative spine loading. Dowel-shaped implants made of grit-blasted solid titanium alloy (solid titanium) and porous titanium were fabricated using commercially available processes. Samples were processed for mechanical push-out testing and polymethylmethacrylate histology following an established ovine bone implantation model. RESULTS: The solid titanium cage exhibited the greatest stiffness (57.1 ± 0.6 kN/mm), followed by the porous titanium cage (40.4 ± 0.3 kN/mm) and the solid PEEK cage (37.1 ± 1.2 kN/mm). In the clinically relevant dynamic subsidence, the porous titanium cage showed the least amount of subsidence displacement (0.195 ± 0.012 mm), significantly less than that of the solid PEEK cage (0.328 ± 0.020 mm) and the solid titanium cage (0.538 ± 0.027 mm). Bony on-growth was noted histologically on all implant materials; however, only the porous titanium supported bony ingrowth with marked quantities of bone formed within the interconnected pores through 12 weeks. Functional differences in osseointegration were noted between groups during push-out testing. The porous titanium showed the highest maximum shear stress at 12 weeks and was the only group that demonstrated significant improvement (4-12 weeks). CONCLUSIONS: The choice of material and design is critical to cage mechanical and biological performances. A porous titanium cage can reduce subsidence risk and generate biological stability through bone on-growth and ingrowth.

Subsidence and fusion performance of a 3D-printed porous interbody cage with stress-optimized body lattice and microporous endplates - a comprehensive mechanical and biological analysis.

BACKGROUND CONTEXT: Cage subsidence remains a serious complication after spinal fusion surgery. Novel porous designs in the cage body or endplate offer attractive options to improve subsidence and osseointegration performance. PURPOSE: To elucidate the relative contribution of a porous design in each of the two major domains (body and endplates) to cage stiffness and subsidence performance, using standardized mechanical testing methods, and to analyze the fusion progression via an established ovine interbody fusion model to support the mechanical testing findings. STUDY DESIGN/SETTING: A comparative preclinical study using standardized mechanical testing and established animal model. METHODS: To isolate the subsidence performance contributed by each porous cage design feature, namely the stress-optimized body lattice (vs. a solid body) and microporous endplates (vs. smooth endplates), four groups of cages (two-by-two combination of these two features) were tested in: (1) static axial compression of the cage (per ASTM F2077) and (2) static subsidence (per ASTM F2267). To evaluate the progression of fusion, titanium cages were created with a microporous endplate and internal lattice architecture analogous to commercial implants used in subsidence testing and implanted in an endplate-sparing, ovine intervertebral body fusion model. RESULTS: The cage stiffness was reduced by 16.7% by the porous body lattice, and by 16.6% by the microporous endplates. The porous titanium cage with both porous features showed the lowest stiffness with a value of 40.4±0.3 kN/mm (Mean±SEM) and a block stiffness of 1976.8±27.4 N/mm for subsidence. The body lattice showed no significant impact on the block stiffness (1.4% reduction), while the microporous endplates decreased the block stiffness significantly by 24.9% (p<.0001). All segments implanted with porous titanium cages were deemed rigidly fused by manual palpation, except one at 12 weeks, consistent with robotic ROM testing and radiographic and histologic observations. A reduction in ROM was noted from 12 to 26 weeks (4.1±1.6° to 2.2±1.4° in lateral bending, p<.05; 2.1±0.6° to 1.5±0.3° in axial rotation, p<.05); and 3.3±1.6° to 1.9±1.2° in flexion extension, p=.07). Bone in the available void improved with time in the central aperture (54±35% to 83±13%, p<.05) and porous cage structure (19±26% to 37±21%, p=.15). CONCLUSIONS: Body lattice and microporous endplates features can effectively reduce the cage stiffness, therefore reducing the risk of stress shielding and promoting early fusion. While body lattice showed no impact on block stiffness and the microporous endplates reduced the block stiffness, a titanium cage with microporous endplates and internal lattice supported bone ingrowth and segmental mechanical stability as early as 12 weeks in ovine interbody fusion. CLINICAL SIGNIFICANCE: Porous titanium cage architecture can offer an attractive solution to increase the available space for bone ingrowth and bridging to support successful spinal fusion while mitigating risks of increased subsidence.

Supplementary delta-rod configurations provide superior stiffness and reduced rod stress compared to traditional multiple-rod configurations after pedicle subtraction osteotomy: a finite element study.

PURPOSE: The biomechanical performance of conventional multi-rod configurations (satellite rods and accessory rods) in pedicle subtraction osteotomies has been previously studied in vitro and using finite element models (FEM). Delta and delta-cross rods are innovative multi-rod configurations where the rod bends were placed only in its proximal and distal extremities in order to obtain a dorsal translation of the central part of the rod respect to the most angulated area of the main rods. However, the biomechanical properties of the delta and delta-cross rods have not been investigated. This study used FEM to analyze the effect of delta-rod configurations on the stiffness and primary rod stress reduction in multiple-rod constructs after pedicle subtraction osteotomy. METHODS: The global range of motion in the spine and the magnitude and distribution of the von Mises stress in the rods were studied using a spine finite element model described previously. A follower load of 400 N along with moments of 7.5 N in flexion/extension, lateral bending, and axial rotation were tested on the spine model. Initial breakage was created on the rod based on the maximum stress location. The post-breakage models were tested under flexion. RESULTS: Delta and delta-cross rods reduced more range of motion (up to 45% more reduction) and reduced more primary rod stress than other previously tested rod configurations (up to 48% more reduction). After initial rod fracture occurred, delta and delta-cross rods also had less range of motion (up to 23.6% less) and less rod von Mises stress (up to 81.2% less) than other rod configurations did. CONCLUSIONS: Delta and delta-cross rods have better biomechanical performance than satellite rods and accessory rods in pedicle subtraction osteotomies in terms of construct stiffness and rod stress reduction. After the initial rod breakage occurred, the delta and delta-cross rods could minimize the loss of fixation, which have less rod stress and greater residual stiffness than other rod configurations do. Based on this FEA study, delta-rod configurations show more favorable biomechanical behavior than previously described multi-rod configurations. These slides can be retrieved under Electronic Supplementary Material.

Effective modulus of the human intervertebral disc and its effect on vertebral bone stress.

The mechanism of vertebral wedge fractures remains unclear and may relate to typical variations in the mechanical behavior of the intervertebral disc. To gain insight, we tested 16 individual whole discs (between levels T8 and L5) from nine cadavers (mean±SD: 66±16 years), loaded in compression at different rates (0.05-20.0% strain/s), to measure a homogenized "effective" linear elastic modulus of the entire disc. The measured effective modulus, and average disc height, were then input and varied parametrically in micro-CT-based finite element models (60-µm element size, up to 80 million elements each) of six T9 human vertebrae that were virtually loaded to 3° of moderate forward-flexion via a homogenized disc. Across all specimens and loading rates, the measured effective modulus of the disc ranged from 5.8 to 42.7MPa and was significantly higher for higher rates of loading (p<0.002); average disc height ranged from 2.9 to 9.3mm. The parametric finite element analysis indicated that, as disc modulus increased and disc height decreased across these ranges, the vertebral bone stresses increased but their spatial distribution was largely unchanged: most of the highest stresses occurred in the central trabecular bone and endplates, and not anteriorly. Taken together with the literature, our findings suggest that the effective modulus of the human intervertebral disc should rarely exceed 100MPa and that typical variations in disc effective modulus (and less so, height) minimally influence the spatial distribution but can appreciably influence the magnitude of stress within the vertebral body.

Vertebral fragility and structural redundancy.

The mechanisms of age-related vertebral fragility remain unclear, but may be related to the degree of "structural redundancy" of the vertebra; ie, its ability to safely redistribute stress internally after local trabecular failure from an isolated mechanical overload. To better understand this issue, we performed biomechanical testing and nonlinear micro-CT-based finite element analysis on 12 elderly human thoracic ninth vertebral bodies (age 76.9 ± 10.8 years). After experimentally overloading the vertebrae to measure strength, we used nonlinear finite element analysis to estimate the amount of failed tissue and understand the failure mechanisms. We found that the amount of failed tissue per unit bone mass decreased with decreasing bone volume fraction (r(2) = 0.66, p < 0.01). Thus, for the weak vertebrae with low bone volume fraction, overall failure of the vertebra occurred after failure of just a tiny proportion of the bone tissue (<5%). This small proportion of failed tissue had two sources: the existence of fewer vertically oriented load paths to which load could be redistributed from failed trabeculae; and the vulnerability of the trabeculae in these few load paths to undergo bending-type failure mechanisms, which further weaken the bone. Taken together, these characteristics suggest that diminished structural redundancy may be an important aspect of age-related vertebral fragility: vertebrae with low bone volume fraction are highly susceptible to collapse because so few trabeculae are available for load redistribution if the external loads cause any trabeculae to fail.

Prediction of new clinical vertebral fractures in elderly men using finite element analysis of CT scans.

Vertebral strength, as estimated by finite element analysis of computed tomography (CT) scans, has not yet been compared against areal bone mineral density (BMD) by dual-energy X-ray absorptiometry (DXA) for prospectively assessing the risk of new clinical vertebral fractures. To do so, we conducted a case-cohort analysis of 306 men aged 65 years and older, which included 63 men who developed new clinically-identified vertebral fractures and 243 men who did not, all observed over an average of 6.5 years. Nonlinear finite element analysis was performed on the baseline CT scans, blinded to fracture status, to estimate L1 vertebral compressive strength and a load-to-strength ratio. Volumetric BMD by quantitative CT and areal BMD by DXA were also evaluated. We found that, for the risk of new clinical vertebral fracture, the age-adjusted hazard ratio per standard deviation change for areal BMD (3.2; 95% confidence interval [CI], 2.0-5.2) was significantly lower (p < 0.005) than for strength (7.2; 95% CI, 3.6-14.1), numerically lower than for volumetric BMD (5.7; 95% CI, 3.1-10.3), and similar for the load-to-strength ratio (3.0; 95% CI, 2.1-4.3). After also adjusting for race, body mass index (BMI), clinical center, and areal BMD, all these hazard ratios remained highly statistically significant, particularly those for strength (8.5; 95% CI, 3.6-20.1) and volumetric BMD (9.4; 95% CI, 4.1-21.6). The area-under-the-curve for areal BMD (AUC = 0.76) was significantly lower than for strength (AUC = 0.83, p = 0.02), volumetric BMD (AUC = 0.82, p = 0.05), and the load-to-strength ratio (AUC = 0.82, p = 0.05). We conclude that, compared to areal BMD by DXA, vertebral compressive strength and volumetric BMD consistently improved vertebral fracture risk assessment in this cohort of elderly men.

Influence of vertical trabeculae on the compressive strength of the human vertebra.

Vertebral strength, a key etiologic factor of osteoporotic fracture, may be affected by the relative amount of vertically oriented trabeculae. To better understand this issue, we performed experimental compression testing, high-resolution micro-computed tomography (µCT), and micro-finite-element analysis on 16 elderly human thoracic ninth (T(9)) whole vertebral bodies (ages 77.5 ± 10.1 years). Individual trabeculae segmentation of the µCT images was used to classify the trabeculae by their orientation. We found that the bone volume fraction (BV/TV) of just the vertical trabeculae accounted for substantially more of the observed variation in measured vertebral strength than did the bone volume fraction of all trabeculae (r(2) = 0.83 versus 0.59, p < .005). The bone volume fraction of the oblique or horizontal trabeculae was not associated with vertebral strength. Finite-element analysis indicated that removal of the cortical shell did not appreciably alter these trends; it also revealed that the major load paths occur through parallel columns of vertically oriented bone. Taken together, these findings suggest that variation in vertebral strength across individuals is due primarily to variations in the bone volume fraction of vertical trabeculae. The vertical tissue fraction, a new bone quality parameter that we introduced to reflect these findings, was both a significant predictor of vertebral strength alone (r(2) = 0.81) and after accounting for variations in total bone volume fraction in multiple regression (total R(2) = 0.93). We conclude that the vertical tissue fraction is a potentially powerful microarchitectural determinant of vertebral strength.

Contribution of the intra-specimen variations in tissue mineralization to PTH- and raloxifene-induced changes in stiffness of rat vertebrae.

The intra-specimen spatial variation in mineralization of bone tissue can be changed by drug treatments that alter bone remodeling. However, the contribution of such changes to the overall biomechanical effect of a treatment on bone strength is not known. To provide insight into this issue, we used a rat model to determine the effects of ovariectomy, parathyroid hormone, and raloxifene (vs. sham) on the contribution of spatial variations in mineralization to treatment-induced changes in vertebral stiffness. Mineral density was measured from 6-microm voxel-sized quantitative micro-CT scans. Whole-vertebral and trabecular stiffness values were estimated using finite element analysis of these micro-CT scans, first including all intra-specimen variations in mineral density in the model and then excluding such variations by using a specimen-specific average density throughout each specimen. As expected, we found appreciable effects of treatment on overall bone stiffness, the effect being greater for the trabecular compartment (up to 52% reduction vs. sham, p<0.0001) than the whole vertebra (p=0.055). Intra-specimen mean mineralization was not changed with treatment but the intra-specimen variation in mineralization was, although the effect was small (4%). Intra-specimen spatial variations in mineralization accounted for 10-12% and 5-6% of overall stiffness of the trabecular compartment and whole vertebral body, respectively. However, after accounting for all treatment effects on bone geometry and trabecular microstructure, any treatment effects due to changes in mineralization were negligible (<2%), although statistically detectable (p<0.02). We conclude that, despite a role in the general biomechanical behavior of bone, the spatial variations in tissue mineralization, as measured by quantitative micro-CT, did not appreciably contribute to ovariectomy-, PTH-, or raloxifene-induced changes in stiffness of the whole bone or the trabecular compartment in these rat vertebrae.

Role of trabecular microarchitecture in whole-vertebral body biomechanical behavior.

The role of trabecular microarchitecture in whole-vertebral biomechanical behavior remains unclear, and its influence may be obscured by such factors as overall bone mass, bone geometry, and the presence of the cortical shell. To address this issue, 22 human T(9) vertebral bodies (11 female; 11 male; age range: 53-97 yr, 81.5 +/- 9.6 yr) were scanned with microCT and analyzed for measures of trabecular microarchitecture, BMC, cross-sectional area, and cortical thickness. Sixteen of the vertebrae were biomechanically tested to measure compressive strength. To estimate vertebral compressive stiffness with and without the cortical shell for all 22 vertebrae, two high-resolution finite element models per specimen-one intact model and one with the shell removed-were created from the microCT scans and virtually compressed. Results indicated that BMC and the structural model index (SMI) were the individual parameters most highly associated with strength (R(2) = 0.57 each). Adding microarchitecture variables to BMC in a stepwise multiple regression model improved this association (R(2) = 0.85). However, the microarchitecture variables in that regression model (degree of anisotropy, bone volume fraction) differed from those when BMC was not included in the model (SMI, mean trabecular thickness), and the association was slightly weaker for the latter (R(2) = 0.76). The finite element results indicated that the physical presence of the cortical shell did not alter the relationships between microarchitecture and vertebral stiffness. We conclude that trabecular microarchitecture is associated with whole-vertebral biomechanical behavior and that the role of microarchitecture is mediated by BMC but not by the cortical shell.

Gap junctions and osteoblast-like cell gene expression in response to fluid flow.

Bone formation occurs in vivo in response to mechanical stimuli, but the signaling pathways involved remain unclear. The ability of bone cells to communicate with each other in the presence of an applied load may influence the overall osteogenic response. The goal of this research was to determine whether inhibiting cell-to-cell gap junctional communication between bone-forming cells would affect the ensemble cell response to an applied mechanical stimulus in vitro. In this study, we investigated the effects of controlled oscillatory fluid flow (OFF) on osteoblastic cells in the presence and the absence of a gap-junction blocker. MC3T3-E1 Clone 14 cells in a monolayer were exposed to 2 h of OFF at a rate sufficient to create a shear stress of 20 dyne/cm(2) at the cell surface, and changes in steady-state mRNA levels for a number of key proteins known to be involved in osteogenesis were measured. Of the five proteins investigated, mRNA levels for osteopontin (OPN) and osteocalcin were found to be significantly increased 24 h postflow. These experiments were repeated in the presence of 18 beta-glycyrrhetinic acid (BGA), a known gap-junction blocker, to determine whether gap-junction intercellular communication is necessary for this response. We found that the increase in OPN mRNA levels is not observed in the presence of BGA, suggesting that gap junctions are involved in the signaling process. Interestingly, enzyme linked immunosorbent assay data showed that levels of secreted OPN protein increased 48 h postflow and that this increase was unaffected by the presence of intact gap junctions.