BIOMECHANICAL BEHAVIOUR OF CANCELLOUS BONE IN LUMBAR VERTEBRA...

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BIOMECHANICAL BEHAVIOUR OF CANCELLOUS BONE IN LUMBAR VERTEBRA BEFORE AND AFTER TOTAL DISK REPLACEMENT WITH PRODISC-L 1 A. Completo, 1 S. Silva, 1 I. Alcântara, 2 F. Fonseca, 1 A. Ramos, 1 C. Relvas, 1 J. Simões, 1 S. Meireles 1 Departamento de Engenharia Mecânica, Universidade de Aveiro; email: [email protected] 2 Serviço de Ortopedia – Hospitais da Universidade de Coimbra, Faculdade de Ciências da Saúde da Beira Interior SUMMARY The degenerative disc disease of the intervertebral disc occurs as part of normal aging and may be associated with pain. Clinical studies show an association between changed load patterns both in the disc and its adjacent vertebral body, with painful. If the pain becomes chronic, the total disc replacement is an option to preserve motion and eliminate the pain. However, the performance of total disc arthroplasty is not comparable with the high success of other arthroplasties. This suggests that failure to restore the normal loading pattern on implantation of a disc replacement could be a cause of lower clinical success rate. In the present study the variations of strain patterns in the cancellous bone of lumbar vertebra before and after disc replacement was studied using finite element models of natural and artificial disc Prodisc-L. The study results support the hypothesis that current implants fail to restore normal loading. The risk of failure of the intervertebral disc replacement does not seem to be related to the effect of "stress shielding", but due to the fatigue damage (stress fracture) of cancellous bone, due to great increase in the levels of strains of the implanted vertebra, relatively to the intact condition. INTRODUCTION There is significant evidence that changes in loading in the vertebral body and adjacent disc are associated with painful disc degeneration [1]. These studies suggest that a changed mechanical environment in disc and vertebra. Total disc replacement (TDR) is a surgical solution for painful degenerated disc and aims to restore mobility along with pain reduction. However, the clinical performance of TDR is not any better than fusion, and not comparable to the high success rate of other total joint replacements like hip and knee [2]. Currently the studies of disc replacement is mainly in the areas flexibility and stability, osseointegration and wear debris [3] but not in restitution of normal loading patterns. The incapacity to return normal loading conditions after disc replacement could be a issue leading to the clinical failures of the disc implants. In the case of a healthy normal disc, most of the disc behaves hydrostatically, except the outermost layers of the annulus. The nucleus transfers load uniformly over the vertebral endplates [4]. Deterioration of the disc causes structural changes and the hydrostatic region of disc becomes smaller, the nucleus loses its volume and annulus becomes stiffer. These changes affect the biomechanics of load transfer, as observed in vitro and in vivo studies [5]. In particular, presence of localized stress peaks is reported in the case of painful degenerated discs [6]. A change in the biomechanics of the disc will alter the pattern of load transfer in the vertebrae, especially in the adjacent vertebral endplate and cancellous bone. Degenerative changes to vertebral endplate and cancellous bone, as observed by MRI, are reported for painful, degenerated discs [1,7]. Hence the changed mechanical environment of the bone would result in structural changes such as bone remodeling or fatigue damage. We propose that an artificial disc that results in altered loading in them vertebral bone may lead to pain or damage in the bone, depending on the magnitude and pattern of loading. This could be a reason for the low clinical success rate of TDRs. The critical factor in the vertebra structure under the disc is the risk of failure of the supporting cancellous bone in compression. This study evaluates the extent to which one the most utilized modern TDR implants (Prodisc-L®) changes the normal loading pattern in the vertebral cancellous bone close to the disc relatively to the native condition, evaluating the risks of these changes, in terms of the changing the bone remodeling process and bone fatigue damage (stress fracture). METHODS Finite element models (Figure 1) of the intact and implanted structures of lumbar segments L4-L5 were built from CT- scans of human models, that were converted in 3D models with a image processing software package (ScanIP, Simpleware Ltd. Exeter, UK). The implant models were created with a CAD modelling package (Catia, Dassault- Systèms, France) after 3D digitalization with a 3-D laser scanner device (Roland LPX 250) (Figure 2). Figure 1: Finite element models of lumbar segment L4-L5 before and after disc replacement. Implanted Intact

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BIOMECHANICAL BEHAVIOUR OF CANCELLOUS BONE IN LUMBAR VERTEBRA BEFORE AND AFTER

TOTAL DISK REPLACEMENT WITH PRODISC-L

1A. Completo,

1S. Silva,

1I. Alcântara,

2F. Fonseca,

1A. Ramos,

1C. Relvas,

1J. Simões,

1S. Meireles

1Departamento de Engenharia Mecânica, Universidade de Aveiro; email: [email protected]

2Serviço de Ortopedia – Hospitais da Universidade de Coimbra, Faculdade de Ciências da Saúde da Beira Interior

SUMMARY

The degenerative disc disease of the intervertebral disc occurs

as part of normal aging and may be associated with pain.

Clinical studies show an association between changed load

patterns both in the disc and its adjacent vertebral body, with

painful. If the pain becomes chronic, the total disc replacement

is an option to preserve motion and eliminate the pain.

However, the performance of total disc arthroplasty is not

comparable with the high success of other arthroplasties. This

suggests that failure to restore the normal loading pattern on

implantation of a disc replacement could be a cause of lower

clinical success rate. In the present study the variations of

strain patterns in the cancellous bone of lumbar vertebra

before and after disc replacement was studied using finite

element models of natural and artificial disc Prodisc-L. The

study results support the hypothesis that current implants fail

to restore normal loading. The risk of failure of the

intervertebral disc replacement does not seem to be related to

the effect of "stress shielding", but due to the fatigue damage

(stress fracture) of cancellous bone, due to great increase in

the levels of strains of the implanted vertebra, relatively to the

intact condition.

INTRODUCTION

There is significant evidence that changes in loading in the

vertebral body and adjacent disc are associated with painful

disc degeneration [1]. These studies suggest that a changed

mechanical environment in disc and vertebra. Total disc

replacement (TDR) is a surgical solution for painful

degenerated disc and aims to restore mobility along with pain

reduction. However, the clinical performance of TDR is not

any better than fusion, and not comparable to the high success

rate of other total joint replacements like hip and knee [2].

Currently the studies of disc replacement is mainly in the areas

flexibility and stability, osseointegration and wear debris [3]

but not in restitution of normal loading patterns. The

incapacity to return normal loading conditions after disc

replacement could be a issue leading to the clinical failures of

the disc implants. In the case of a healthy normal disc, most of

the disc behaves hydrostatically, except the outermost layers

of the annulus. The nucleus transfers load uniformly over the

vertebral endplates [4]. Deterioration of the disc causes

structural changes and the hydrostatic region of disc becomes

smaller, the nucleus loses its volume and annulus becomes

stiffer. These changes affect the biomechanics of load transfer,

as observed in vitro and in vivo studies [5]. In particular,

presence of localized stress peaks is reported in the case of

painful degenerated discs [6]. A change in the biomechanics

of the disc will alter the pattern of load transfer in the

vertebrae, especially in the adjacent vertebral endplate and

cancellous bone. Degenerative changes to vertebral endplate

and cancellous bone, as observed by MRI, are reported for

painful, degenerated discs [1,7]. Hence the changed

mechanical environment of the bone would result in structural

changes such as bone remodeling or fatigue damage. We

propose that an artificial disc that results in altered loading in

them vertebral bone may lead to pain or damage in the bone,

depending on the magnitude and pattern of loading. This could

be a reason for the low clinical success rate of TDRs. The

critical factor in the vertebra structure under the disc is the risk

of failure of the supporting cancellous bone in compression.

This study evaluates the extent to which one the most utilized

modern TDR implants (Prodisc-L®) changes the normal

loading pattern in the vertebral cancellous bone close to the

disc relatively to the native condition, evaluating the risks of

these changes, in terms of the changing the bone remodeling

process and bone fatigue damage (stress fracture).

METHODS Finite element models (Figure 1) of the intact and implanted

structures of lumbar segments L4-L5 were built from CT-

scans of human models, that were converted in 3D models

with a image processing software package (ScanIP,

Simpleware Ltd. Exeter, UK). The implant models were

created with a CAD modelling package (Catia, Dassault-

Systèms, France) after 3D digitalization with a 3-D laser

scanner device (Roland LPX 250) (Figure 2).

Figure 1: Finite element models of lumbar segment L4-L5

before and after disc replacement.

Implanted Intact

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The meshing of the models was done using FE meshing

software HyperMesh-v8.0 (Altair-Engineering, USA). Non-

linear finite element analyses were performed with ABAQUS

(6.7-1). The bone-implant and was modelled with a surface-to-

surface contact algorithm and augmented Lagrange

formulation method with a coefficient of friction of 0.3.

Figure 2: Photo (left) and 3D model (Right) of artificial disc

Prodisc-L® (Synthes GmbH, Suisse) tail 27x34.5.

The material properties (Table 1) used are those referenced by

the manufacturer of implant and from bone and natural disk

taken from literature [8,9].

Table 1: Material properties used in finite element models.

Material Elastic modulus

(MPa)

Poisson ratio

(νννν)

Metal disc (CrCoMo) 214x103 0,30

Disc insert (UHMWPE) 725 0,38

Cortical bone 12x103 0,30

Cancellous bone 110 0,25

Nucleus 1,5 0,49

Annulus 4,2 0,45

The same load-case was applied ant the intact an implanted

lumbar segments models. For this load-case a axial load of

700 N (1 to 2.5 times body weight in walking) [10] was

applied at the upper surface of L4 vertebra while L5 vertebra

was constrained at bottom surface. Comparative analysis of

the peak and patterns of minimal principal cancellous bone

strains under the native and prosthetic disk were made.

RESULTS AND DISCUSSION

The patterns of the minimal principal cancellous bone strains

under the native and prosthetic disk are presented in Figure 3.

The strain patterns in intact condition reveals a uniform strain

distribution with a mean value around -150 µstrain, while the

strain pattern in implanted condition reveals a strain

concentration at the nucleus of the vertebra next to the keel of

prosthesis. The peak value of the minimal principal strains (Ɛ2)

at the implanted case was -976 µstrain, this value represents an

increase of 10 times the strain value of intact condition

(-96 µstrain) in the same localization. The critical factor in the

vertebra structure is the risk of failure of the supporting

cancellous bone in compression. Thus, the risk of failure of

the intervertebral disc replacement does not seem to be related

to the effect of "stress shielding", and then, with bone

resorption. Rather, if risk exists, its due to the fatigue damage

(stress fracture) of cancellous bone, due to great increase in

the level of strains in the prosthetic vertebrae relatively to the

intact condition. However, this risk seems low for the load

levels (walking) used in this study. However, in cases where

the physiological activities significantly increase the load on

the prosthetic vertebra and if they are repetitive, the risk of

stress fracture in cancellous bone may be present.

Figure 3: View from top (bottom) and transverse cut (upper)

patterns of minimal principal strains (Ɛ2) in cancellous bone of

L5 vertebra.

CONCLUSIONS

A brief message based on the results of this study is that a

patient subject to TDR arthroplasty, should avoid efforts that

go beyond a normal physiological activity especially if they

are repetitive.

ACKNOWLEDGEMENTS Acknowledgments to Fundação para a Ciencia e Tecnologia

through PTDC/EME-PME/103578/2008.

REFERENCES

1. van Dieen JH, et al. Medical Hypotheses. 53:246, 1999.

2. Blumenthal S, et al.. Spine. 30:1565-1569, 2005

3. Cunningham BW, et al.. Spine. 28: 2003.

4. Adams MA, et al. Journal Biomechanics. 38:1972,2005.

5. McNally DS, et al. Spine. 17:66, 1992.

6. McNally DS, et al. Spine. 21:2580, 1996.

7. Albert HB, et al. Medical Hypotheses . 70:361, 2008.

8. Ferguson SJ, et al. Journal Biomechanics. 37:213, 2004.

9. Kumar N, et al. Spine. 30:1731, 2005.

10. Cappozzo, A. Journal of Orthopaedic Research. 1: 292,

1983.

-1000 -900 -800 -700 -600 -500 -400 -300 -200 -100

0

Implanted Intact Ɛ2

(x10-6

m/m)