Effect of an interspinous implant on loads in the lumbar spine.

Interspinous process implants are increasingly used to treat canal stenoses. Little information exists about the effects of implant height and stiffness on the biomechanical behavior of the lumbar spine. Therefore, a three-dimensional nonlinear finite element model of the osseoligamentous lumbar spine (L1 to L5) was created with a slightly degenerated disc at L3/L4. An interspinous implant was inserted at that segment. Implants with different heights and stiffnesses were studied. The model was loaded with the upper body weight and muscle forces to simulate walking and 25 degrees extension. Implant forces are influenced strongly by the height and negligibly by the elastic modulus of the implant. Intersegmental rotation at implant level is markedly reduced, while intradiscal pressure is slightly increased. Implant size and stiffness have only a minor effect on intradiscal pressure. The maximum von Mises stress in the vertebral arch is strongly increased by the implant.     

The viscoelastic standard nonlinear solid model: predicting the response of the lumbar intervertebral disk to low-frequency vibrations

Due to the mathematical complexity of current musculoskeletal spine models, there is a need for computationally efficient models of the intervertebral disk (IVD). The aim of this study is to develop a mathematical model that will adequately describe the motion of the IVD under axial cyclic loading as well as maintain computational efficiency for use in future musculoskeletal spine models. Several studies have successfully modeled the creep characteristics of the IVD using the three-parameter viscoelastic standard linear solid (SLS) model. However, when the SLS model is subjected to cyclic loading, it underestimates the load relaxation, the cyclic modulus, and the hysteresis of the human lumbar IVD. A viscoelastic standard nonlinear solid (SNS) model was used to predict the response of the human lumbar IVD subjected to low-frequency vibration. Nonlinear behavior of the SNS model was simulated by a strain-dependent elastic modulus on the SLS model. Parameters of the SNS model were estimated from experimental load deformation and stress-relaxation curves obtained from the literature. The SNS model was able to predict the cyclic modulus of the IVD at frequencies of 0.01 Hz, 0.1 Hz, and 1 Hz. Furthermore, the SNS model was able to quantitatively predict the load relaxation at a frequency of 0.01 Hz. However, model performance was unsatisfactory when predicting load relaxation and hysteresis at higher frequencies (0.1 Hz and 1 Hz). The SLS model of the lumbar IVD may require strain-dependent elastic and viscous behavior to represent the dynamic response to compressive strain.     

Finite element simulation of an artificial intervertebral disk using fiber reinforced laminated composite model

Degeneration of intervertebral disk (IVD) has been increased in recent years. The lumbar herniation can be cured using conservative and surgical procedures. Surgery is considered after failure of conservative treatment. Partial discectomy, fusion, and total disk replacement (TDR) are also common surgical treatments for degenerative disk disease. However, due to limitations and disadvantages of the current treatments, many studies have been carried out to approach the best design of mimicking natural disk. Recently, a new method of TDRs has been introduced using nature deformation of IVD by reinforced fibers of annulus fibrosis. Nonetheless, owing to limitations of experimental works on the human body, numerical studies of IVD may help to understand load transfer and biomechanical properties within the disks with reinforced fibers. In this study, a three-dimensional (3D) finite element model of the L2-L3 disk vertebrae unit with 12 vertical fibers embedded into annulus fibrosis was constructed. The IVD was subjected to compressive force, bending moment, and axial torsion. The most important parameters of disk failures were compared to that of experimental data. The results showed that the addition of reinforced fibers into the disk invokes a significant decrease of stress in the nucleus and annulus. The findings of this study may have implications not only for developing IVDs with reinforced fibers but also for the application of fiber reinforced IVD in orthopedics surgeries as a suitable implant.     

Calibration of hyperelastic material properties of the human lumbar intervertebral disc under fast dynamic compressive loads

Under fast dynamic loading conditions (e.g. high-energy impact), the load rate dependency of the intervertebral disc (IVD) material properties may play a crucial role in the biomechanics of spinal trauma. However, most finite element models (FEM) of dynamic spinal trauma uses material properties derived from quasi-static experiments, thus neglecting this load rate dependency. The aim of this study was to identify hyperelastic material properties that ensure a more biofidelic simulation of the IVD under a fast dynamic compressive load. A hyperelastic material law based on a first-order Mooney-Rivlin formulation was implemented in a detailed FEM of a L2-L3 functional spinal unit (FSU) to represent the mechanical behavior of the IVD. Bony structures were modeled using an elasto-plastic Johnson-Cook material law that simulates bone fracture while ligaments were governed by a viscoelastic material law. To mimic experimental studies performed in fast dynamic compression, a compressive loading velocity of 1 m/s was applied to the superior half of L2, while the inferior half of L3 was fixed. An exploratory technique was used to simulate dynamic compression of the FSU using 34 sets of hyperelastic material constants randomly selected using an optimal Latin hypercube algorithm and a set of material constants derived from quasi-static experiments. Selection or rejection of the sets of material constants was based on compressive stiffness and failure parameters criteria measured experimentally. The two simulations performed with calibrated hyperelastic constants resulted in nonlinear load-displacement curves with compressive stiffness (7335 and 7079 N/mm), load (12,488 and 12,473 N), displacement (1.95 and 2.09 mm) and energy at failure (13.5 and 14.7 J) in agreement with experimental results (6551 ± 2017 N/mm, 12,411 ± 829 N, 2.1 ± 0.2 mm and 13.0 ± 1.5 J respectively). The fracture pattern and location also agreed with experimental results. The simulation performed with constants derived from quasi-static experiments showed a failure energy (13.2 J) and a fracture pattern and location in agreement with experimental results, but a compressive stiffness (1580 N/mm), a failure load (5976 N) and a displacement to failure (4.8 mm) outside the experimental corridors. The proposed method offers an innovative way to calibrate the hyperelastic material properties of the IVD and to offer a more realistic simulation of the FSU in fast dynamic compression.     

Influence of the stiffness of bone defect implants on the mechanical conditions at the interface--a finite element analysis with contact

The study focused on the influence of the implant material stiffness on stress distribution and micromotion at the interface of bone defect implants. We hypothesized that a low-stiffness implant with a modulus closer to that of the surrounding trabecular bone would yield a more homogeneous stress distribution and less micromotion at the interface with the bony bed. To prove this hypothesis we generated a three-dimensional, non-linear, anisotropic finite element (FE) model. The FE model corresponded to a previously developed animal model in sheep. A prismatic implant filled a standardized defect in the load-bearing area of the trabecular bone beneath the tibial plateau. The interface was described by face-to-face contact elements, which allow press fits, friction, sliding, and gapping. We assumed a physiological load condition and calculated contact pressures, shear stresses, and shear movements at the interface for two implants of different stiffness (titanium: E=110GPa; composite: E=2.2GPa). The FE model showed that the stress distribution was more homogeneous for the low-stiffness implant. The maximum pressure for the composite implant (2.1 MPa) was lower than for the titanium implant (5.6 MPa). Contrary to our hypothesis, we found more micromotion for the composite (up to 6 microm) than for the titanium implant (up to 4.5 microm). However, for both implants peak stresses and micromotion were in a range that predicts adequate conditions for the osseointegration. This was confirmed by the histological results from the animal studies.     

A comparison between porcine,ovine, and bovine intervertebral disc anatomy and single lamella annulus fibrosus tensile properties

This project aimed to compare gross anatomical measures and biomechanical properties of single lamellae from the annulus fibrosus of ovine and porcine lumbar vertebrae, and bovine tail vertebrae. The morphology of the vertebrae of these species differ significantly both from each other and from human, yet how these differences alter biomechanical properties is unknown. Geometric parameters measured in this study included: 1) absolute and relative intervertebral (IVD) and vertebral body height and 2) absolute and relative intervertebral disc (IVD) anterior‐posterior (AP) and medial‐lateral (ML) widths. Single lamella tensile properties included toe‐region stress and stretch ratio, stiffness, and tensile strength. As expected, the bovine tail IVD revealed a more circular shape compared with both the ovine and porcine lumbar IVD. The bovine tail also had the largest IVD to vertebral body height ratio (due to having the highest absolute IVD height). Bovine tail lamellae were also found to be strongest and stiffest (in tension) while ovine lumbar lamellae were weakest and most compliant. Histological analysis revealed the greatest proportion of collagen in the bovine corroborating findings of increased strength and stiffness. The observed differences in anatomical shape, connective tissue composition, and tensile properties need to be considered when choosing an appropriate model for IVD research. J. Morphol. 277:244–251, 2016. © 2015 Wiley Periodicals, Inc.     

Palatal implant surgery effectiveness in treatment of obstructive sleep apnea: A numerical method with 3D patient-specific geometries

Obstructive sleep apnea (OSA) affects a large percentage of the population and is increasingly recognized as a major global health problem. One surgical procedure for OSA is to implant polyethylene (PET) material into the soft palate, but its efficacy remains to be discussed. In this study, we provide input to this topic based on numerical simulations. Three 3 dimensional (3D) soft palate finite element models including mouth-close and mouth-open cases were created based on three patient-specific computed tomography (CT) images. A simplified material modeling approach with the Neo-Hookean material model was applied, and nonlinear geometry was accounted for. Young’s modulus for the implant material was obtained from uniaxial tests, and the PET implant pillars were inserted to the 3D soft palate model. With the finite element model, we designed different surgical schemes and investigated their efficacy with respect to avoiding the soft palate collapse. Several pillar schemes were tested, including different placement directions, different placement positions, different settings for the radius and the array parameters of the implant pillars, and different Young’s moduli for the pillars. Based on our simulation results, the longitudinal-direction implant surgery improved the stiffness of the soft palate to a small degree, and implanting in the transverse direction was evaluated to be a good choice for improving the existing surgical scheme. In addition, the Young’s modulus of the polyethylene material implants has an influence on the reinforcement efficacy of the soft palate.     

A finite element model of the L4-L5 spinal motion segment: biomechanical compatibility of an interspinous device

The biomechanical compatibility of an interspinous device, used for the "dynamic stabilization" of a diseased spinal motion segment, was investigated. The behaviour of an implant made of titanium based alloy (Ti6Al4V) and that of an implant made of a super-elastic alloy (Ni-Ti) have been compared. The assessment of the biomechanical compatibility was achieved by means of the finite element method, in which suitable constitutive laws have been adopted for the annulus fibrosus and for the metal alloys. The model was aimed at simulating the healthy, the nucleotomized and the treated L4-L5 lumbar segment, subjected to compressive force and flexion-extension as well as lateral flexion moments. The computational model has shown that both the implants were able to achieve their main design purpose, which is to diminish the forces acting on the apophyseal joints. Nevertheless, the Ni-Ti implant has shown a more physiological flexural stiffness with respect to the Ti6Al4V implant, which exhibited an excessive stiffness and permanent strains (plastic strains), even under physiological loads. The computational models presented in this paper seems to be a promising tool able to predict the effectiveness of a biomedical device and to select the materials to be used for the implant manufacturing, within an engineering approach to the clinical problem of the spinal diseases.     

Confined compression experiments on bovine nucleus pulposus and annulus fibrosus: sensitivity of the experiment in the determination of compressive modulus and hydraulic permeability

The biphasic material properties for nucleus pulposus tissue in confined compression have not been reported previously, and are required for a better understanding of intervertebral disc function and to provide material properties for use in finite-element models. The aims of this study were to determine linear and non-linear material properties for nucleus pulposus and annulus fibrosus tissues in confined compression, to define the influence of swelling conditions on these properties, and to determine the changes in the compressive modulus and hydraulic permeability induced by the repetition of the stress-relaxation experiment after a return to swelling pressure equilibrium. Specimens from caudal bovine nucleus and annulus were tested in confined compression stress-relaxation experiments and analyzed to quantify the compressive modulus and hydraulic permeability using linear and non-linear biphasic models. Our results suggested the use of confined swelling pre-test condition and non-linear biphasic model, which provided the material parameters with lowest relative variance and water content most representative of physiological conditions. Smaller compressive modulus and higher hydraulic permeability were obtained for the nucleus (H(A0)=0.31+/-0.04 MPa, k(0)=0.67+/-0.09 x 10(-15)m(4)/Ns) than for the annulus (H(A0)=0.74+/-0.13 MPa, k(0)=0.23+/-0.19 x 10(-15)m(4)/Ns), with relatively weak non-linearities. Strains up to 20% resulted in material properties that were significantly altered upon retesting. These altered material properties are an effort to quantify non-recoverable damage that occurs in disc tissue and suggest that in vivo exposure of disc tissues to low strain-rate and high-deformation loading conditions which outpace biological repair may result in altered mechanical behaviors.     

Biomechanical evaluation of a novel lumbosacral axial fixation device

BACKGROUND: Interbody arthrodesis is employed in the lumbar spine to eliminate painful motion and achieve stability through bony fusion. Bone grafts, metal cages, composite spacers, and growth factors are available and can be placed through traditional open techniques or minimally invasively. Whether placed anteriorly, posteriorly, or laterally, insertion of these implants necessitates compromise of the anulus--an inherently destabilizing procedure. A new axial percutaneous approach to the lumbosacral spine has been described. Using this technique, vertical access to the lumbosacral spine is achieved percutaneously via the presacral space. An implant that can be placed across a motion segment without compromise to the anulus avoids surgical destabilization and may be advantageous for interbody arthrodesis. The purpose of this study was to evaluate the in vitro biomechanical performance of the axial fixation rod, an anulus sparing, centrally placed interbody fusion implant for motion segment stabilization. METHOD OF APPROACH: Twenty-four bovine lumbar motion segments were mechanically tested using an unconstrainedflexibility protocol in sagittal and lateral bending, and torsion. Motion segments were also tested in axial compression. Each specimen was tested in an intact state, then drilled (simulating a transaxial approach to the lumbosacral spine), then with one of two axial fixation rods placed in the spine for stabilization. The range of motion, bending stiffness, and axial compressive stiffness were determined for each test condition. Results were compared to those previously reported for femoral ring allografts, bone dowels, BAK and BAK Proximity cages, Ray TFC, Brantigan ALIF and TLIF implants, the InFix Device, Danek TIBFD, single and double Harms cages, and Kaneda, Isola, and University plating systems. RESULTS: While axial drilling of specimens had little effect on stiffness and range of motion, specimens implanted with the axial fixation rod exhibited significant increases in stiffness and decreases in range of motion relative to intact state. When compared to existing anterior, posterior, and interbody instrumentation, lateral and sagittal bending stiffness of the axial fixation rod exceeded that of all other interbody devices, while stiffness in extension and axial compression were comparable to plate and rod constructs. Torsional stiffness was comparable to other interbody constructs and slightly lower than plate and rod constructs. CONCLUSIONS: For stabilization of the L5-S1 motion segment, axial placement of implants offers potential benefits relative to traditional exposures. The preliminary biomechanical data from this study indicate that the axial fixation rod compares favorably to other devices and may be suitable to reduce pathologic motion at L5-S1, thus promoting bony fusion.     

Simulated-physiological loading conditions preserve biological and mechanical properties of caprine lumbar intervertebral discs in ex vivo culture

Low-back pain (LBP) is a common medical complaint and associated with high societal costs. Degeneration of the intervertebral disc (IVD) is assumed to be an important causal factor of LBP. IVDs are continuously mechanically loaded and both positive and negative effects have been attributed to different loading conditions.In order to study mechanical loading effects, degeneration-associated processes and/or potential regenerative therapies in IVDs, it is imperative to maintain the IVDs' structural integrity. While in vivo models provide comprehensive insight in IVD biology, an accompanying organ culture model can focus on a single factor, such as loading and may serve as a prescreening model to reduce life animal testing. In the current study we examined the feasibility of organ culture of caprine lumbar discs, with the hypothesis that a simulated-physiological load will optimally preserve IVD properties.Lumbar caprine IVDs (n = 175) were cultured in a bioreactor up to 21 days either without load, low dynamic load (LDL), or with simulated-physiological load (SPL). IVD stiffness was calculated from measurements of IVD loading and displacement. IVD nucleus, inner- and outer annulus were assessed for cell viability, cell density and gene expression. The extracellular matrix (ECM) was analyzed for water, glycosaminoglycan and total collagen content.IVD biomechanical properties did not change significantly with loading conditions. With SPL, cell viability, cell density and gene expression were preserved up to 21 days. Both unloaded and LDL resulted in decreased cell viability, cell density and significant changes in gene expression, yet no differences in ECM content were observed in any group.In conclusion, simulated-physiological loading preserved the native properties of caprine IVDs during a 21-day culture period. The characterization of caprine IVD response to culture in the LDCS under SPL conditions paves the way for controlled analysis of degeneration- and regeneration-associated processes in the future.     

Contribution of collagen fibers to the compressive stiffness of cartilaginous tissues

Cartilaginous tissues such as the intervertebral disk are predominantly loaded under compression. Yet, they contain abundant collagen fibers, which are generally assumed to contribute to tensile loading only. Fiber tension is thought to originate from swelling of the proteoglycan-rich nucleus. However, in aged or degenerate disk, proteoglycans are depleted, whereas collagen content changes little. The question then rises to which extend the collagen may contribute to the compressive stiffness of the tissue. We hypothesized that this contribution is significant at high strain magnitudes and that the effect depends on fiber orientation. In addition, we aimed to determine the compression of the matrix. Bovine inner and outer annulus fibrosus specimens were subjected to incremental confined compression tests up to 60 % strain in radial and circumferential direction. The compressive aggregate modulus was determined per 10 % strain increment. The biochemical composition of the compressed specimens and uncompressed adjacent tissue was determined to compute solid matrix compression. The stiffness of all specimens increased nonlinearly with strain. The collagen-rich outer annulus was significantly stiffer than the inner annulus above 20 % compressive strain. Orientation influenced the modulus in the collagen-rich outer annulus. Finally, it was shown that the solid matrix was significantly compressed above 30 % strain. Therefore, we concluded that collagen fibers significantly contribute to the compressive stiffness of the intervertebral disk at high strains. This is valuable for understanding the compressive behavior of collagen-reinforced tissues in general, and may be particularly relevant for aging or degenerate disks, which become more fibrous and less hydrated.     

Nucleus pulposus repair with cultured autologous elastic cartilage derived chondrocytes

Low back pain is one of the most common medical conditions in the Western world. Disc degeneration, an inevitable process of ageing, is one of the major causes of low back pain. Autologous chondrocyte transplantation (ACT) is an increasingly popular method of addressing pathological disorders of cartilage. The purpose of our study was to determine whether autologous chondrocytes from elastic cartilage could survive and synthesise a cartilage specific matrix in the intervertebral disc of rabbits. Sixteen lumbar intervertebral discs (IVD) of New Zealand White rabbits were analysed. In 6 IVD, the nucleus pulposus was evacuated and replaced with tissue engineered autologous chondrocytes from auricular cartilage. In the second group, only the nucleus pulposus was evacuated from 6 IVD, with no chondrocytes implantation. Four non-operated IVD were used as a control. Six months after the operation, the animals were euthanized and the IVD were analysed histologically. Autologous cartilage implants were well tolerated by the host for up to six months in vivo. There was only hyaline-like cartilage in the place of the nucleus pulposus. We could not detect any elastic fibres in the new cartilage matrix. In IVD from which only the nucleus pulposus was evacuated and no chondrocytes were implanted, just fibrous tissue was found instead of nucleus pulposus. The overall histological analysis of new cartilage produced after implantation in our study confirmed the hypothesis that ACT from auricular cartilage can be implanted into the IVD instead of the nucleus pulposus and that a significant percentage of implanted chondrocytes survive and produce hyaline-like cartilage.     

Mechanical behavior of a new biphasic calcium phosphate bone graft

The aim of this study was to create a new porous calcium phosphate implant for use as a synthetic bone graft substitute. Porous bioceramic was fabricated using a foam-casting method. By using polyurethane foam and a slurry containing hydroxyapatite-dicalcium phosphate powder, water, and additives, a highly porous structure (66 ± 5%) was created. The porous specimens possess an elastic modulus of 330 ± 32 MPa and a compressive strength of 10.3 ± 1.7 MPa. The X-ray diffraction patterns show hydroxyapatite and beta-pyrophosphate phases after sintering. A rabbit model was developed to evaluate the compressive strength and elastic modulus of cancellous bone defects treated with these porous synthetic implants. The compressive mechanical properties became weaker until the second month post implantation. After the second month, these properties increased slightly and remained higher than control values. New bone formed on the outside surface and on the macropore walls of the specimens, as osteoids and osteoclasts were evident two months postoperatively. Considering these properties, these synthetic porous calcium phosphate implants could be applicable as cancellous bone substitutes.     

Influence of experimental protocols on the mechanical properties of the intervertebral disc in unconfined compression

The lack of standardization in experimental protocols for unconfined compression tests of intervertebral discs (IVD) tissues is a major issue in the quantification of their mechanical properties. Our hypothesis is that the experimental protocols influence the mechanical properties of both annulus fibrosus and nucleus pulposus. IVD extracted from bovine tails were tested in unconfined compression stress-relaxation experiments according to six different protocols, where for each protocol, the initial swelling of the samples and the applied preload were different. The Young's modulus was calculated from a viscoelastic model, and the permeability from a linear biphasic poroviscoelastic model. Important differences were observed in the prediction of the mechanical properties of the IVD according to the initial experimental conditions, in agreement with our hypothesis. The protocol including an initial swelling, a 5% strain preload, and a 5% strain ramp is the most relevant protocol to test the annulus fibrosus in unconfined compression, and provides a permeability of 5.0 ± 4.2e(-14)m(4)/N[middle dot]s and a Young's modulus of 7.6 ± 4.7 kPa. The protocol with semi confined swelling and a 5% strain ramp is the most relevant protocol for the nucleus pulposus and provides a permeability of 10.7 ± 3.1 e(-14)m(4)/N[middle dot]s and a Young's modulus of 6.0 ± 2.5 kPa.     

Statistical factorial analysis on the poroelastic material properties sensitivity of the lumbar intervertebral disc under compression,flexion and axial rotation

A statistical factorial analysis approach was conducted on a poroelastic finite element model of a lumbar intervertebral disc to analyse the influence of six material parameters (permeabilities of annulus, nucleus, trabecular vertebral bone, cartilage endplate and Young's moduli of annulus and nucleus) on the displacement, fluid pore pressure and velocity fields. Three different loading modes were investigated: compression, flexion and axial rotation. Parameters were varied considering low and high levels in agreement with values found in the literature for both healthy and degenerated lumbar discs. Results indicated that annulus stiffness and cartilage endplate permeability have a strong effect on the overall fluid- and solid-phase responses in all loading conditions studied. Nucleus stiffness showed its main relevance in compression while annulus permeability influenced mainly the annular pressure field. This study confirms the permeability's central role in biphasic modelling and highlights for the lumbar disc which experiments of material property characterization should be performed. Moreover, such sensitivity study gives important guidelines in poroelastic material modelling and finite element disc validation.     

Mechano-acoustic determination of Young's modulus of articular cartilage

The compressive stiffness of an elastic material is traditionally characterized by its Young's modulus. Young's modulus of articular cartilage can be directly measured using unconfined compression geometry by assuming the cartilage to be homogeneous and isotropic. In isotropic materials, Young's modulus can also be determined acoustically by the measurement of sound speed and density of the material. In the present study, acoustic and mechanical techniques, feasible for in vivo measurements, were investigated to quantify the static and dynamic compressive stiffness of bovine articular cartilage in situ. Ultrasound reflection from the cartilage surface, as well as the dynamic modulus were determined with the recently developed ultrasound indentation instrument and compared with the reference mechanical and ultrasound speed measurements in unconfined compression (n=72). In addition, the applicability of manual creep measurements with the ultrasound indentation instrument was evaluated both experimentally and numerically. Our experimental results indicated that the sound speed could predict 47% and 53% of the variation in the Young's modulus and dynamic modulus of cartilage, respectively. The dynamic modulus, as determined manually with the ultrasound indentation instrument, showed significant linear correlations with the reference Young's modulus (r(2)=0.445, p<0.01, n=70) and dynamic modulus (r(2)=0.779, p<0.01, n=70) of the cartilage. Numerical analyses indicated that the creep measurements, conducted manually with the ultrasound indentation instrument, were sensitive to changes in Young's modulus and permeability of the tissue, and were significantly influenced by the tissue thickness. We conclude that acoustic parameters, i.e. ultrasound speed and reflection, are indicative to the intrinsic mechanical properties of the articular cartilage. Ultrasound indentation instrument, when further developed, provides an applicable tool for the in vivo detection of cartilage mechano-acoustic properties. These techniques could promote the diagnostics of osteoarthrosis.     

Mechanical study of spinal interbody implants--characteristics and limits of standardized testing]

Spinal interbody fusion has proved to be a useful procedure for the surgical stabilization of spinal segments, for which fusion cases made of metal or reinforced polymers are increasingly being used. For the mechanical testing of spinal interbody implants, a test setup has been developed on the basis of an ASTM proposal. Initially, testing of lumbar fusion cages made of CFRP (carbon fibre reinforced polymer) was carried out. The implants (UNION Cages, Medtronic Sofamor Danek), which are characterised by their radiolucency on radiography, NMR and CT scans, have a cube-shaped body with three table-tracks on the under and upper surfaces. The cages were tested at different loads. Modifications of the proposed standardized method were carried out to enable implementation of implant-oriented testing. The tested cages were shown to have adequate axial compression, shear and torsional strengths with regard to the implant body. The maximum axial compression force tolerated by the table-tracks was less than the maximal potential loading of the lumbar spine, and, with account being taken of implant design, consequences with regard to surgical technique were drawn. As dictated by the geometry of the table-tracks, parallel grooves have to be made intra-operatively in the vertebral end plates. Axial compressive loads then act on the implant body, and the table-tracks are protected from damage. To avoid in vivo failure, the tested cages should be implanted only when this specific surgical technique is employed. Using supplementary anterior or posterior instrumentation, in vivo failure of the table-tracks under physiological spinal loading is not to be expected.     

Variability in the properties of silicone gel breast implants.

Several generations of silicone gel breast implants have been produced by implant manufacturers. The primary material usually viewed as the base material in the manufacture of implants is polydimethylsiloxane. Polymeric reactions are notorious for their variability and nonuniformity. The elastomer used in different types of implants can have vastly different properties. Furthermore, the material properties associated with a particular type of implant can vary considerably from one lot to the next. Considering the various designs, styles, and manufacturing techniques associated with silicone gel implants, knowledge of the original properties of the implants before implantation is important in determining the effects of aging in vivo. This study was conducted to investigate differences in key mechanical and chemical properties of silicone gel breast implant materials. The two types of implants chosen for analysis were Silastic I and Silastic II control implants. Material property data were determined for both types of controls and significant differences were found in their values. Lot-to-lot variability was also investigated and found to be significant.