Anda di halaman 1dari 91

A BIOMECHANICAL COMPARISON BETWEEN A BIOLOGICAL

INTERVERTEBRAL DISC AND SYNTHETIC INTERVERTEBRAL DISC

IMPLANTS UNDER COMPLEX LOADING: AN IN VITRO STUDY

A Thesis

Presented to

The Graduate Faculty of The University of Akron

In Partial Fulfillment

of the Requirements for the Degree

Master of Science

Snehal Chokhandre

August, 2007
A BIOMECHANICAL COMPARISON BETWEEN A BIOLOGICAL

INTERVERTEBRAL DISC AND SYNTHETIC INTERVERTEBRAL DISC

IMPLANTS UNDER COMPLEX LOADING: AN IN VITRO STUDY

Snehal Chokhandre

Thesis

Approved: Accepted:

____________________________ ____________________________
Advisor Dean of the College
Dr. Glen O. Njus Dr. George K. Haritos

____________________________ ____________________________
Committee Member Dean of the Graduate School
Dr.Stanley Rittgers Dr. George R. Newkome

____________________________ ____________________________
Department Chair Date
Dr. Daniel B. Sheffer

ii
ABSTRACT

This study aimed at evaluating the intervertebral disc implants for structural

properties in comparison with the biological intervertebral disc. We tried to understand

the load response of a cadaveric intervertebral disc structure under a physiologic complex

loading compared to its replacement and also the response of the cadaveric disc structure

to the current test standards for intervertebral implants.

Four cadaveric disc structures and four elastomeric intervertebral disc implants

(E-d) (Theken Disc, Akron, OH) were tested under modified ISO testing specifications

for replacements and also under single axis and coupled loads. The complex loading

included a combination of flexion-extension (6º,-3º), left and right lateral bending (2º,-

2º), axial rotation (2º,-2º) and axial compression (900-1700N). When tested under

modified ISO loading, the flexion-extension stiffness and axial rotation stiffness values

were found to be significantly different (p=0.0002 and p=0.0027, respectively) and no

significant difference was found between lateral bending stiffness values (p=0.9304).

When the two groups were tested under single axis loading, there was a

significant difference in the axial compression stiffness and axial rotation stiffness values

(p= 0.0067 and p=0.0027, respectively) and no significant difference was seen in the

flexion-extension stiffness and lateral bending stiffness values (p= 0.1092 and p=0.1348,

respectively). Under coupled loading of flexion-extension and lateral bending there was a

iii
significant difference in the lateral bending stiffness values between the two groups

(p=0.0485) but no significant difference was seen in the flexion-extension stiffness values

(p=0.1197).

Fatigue characteristics of the cadaveric intervertebral disc structures, E-d and a

pseudo Charite´ which was designed and fabricated similar to the Charite´ intervertebral

disc (Depuy Spine, Inc), were determined and compared. All the discs were fatigued

under modified ISO testing specifications. Stiffness values for single axis loadings and

disc heights were used for comparison and failure was characterized by a decrease in disc

height. The decrease in disc height at the given loading was considerably higher for the

cadaveric specimens and all the cadaveric disc structures failed due to fractures in the

vertebral bodies.

The study also aimed at evaluating the current testing standards for the

intervertebral disc implants as we put forth the argument that the actual biological

structure (intervertebral disc structure) itself would not survive the testing specifications

which its replacement is supposed to bear without failure.

iv
TABLE OF CONTENTS

Page

LIST OF TABLES…………………………………………………………………. viii

LIST OF FIGURES………………………………………………………………… x

CHAPTER

I. INTRODUCTION………………………………………………….…….. 1

1.1 Overview……….…………...……………………………………. 1

1.2 Objectives of the study………………………………………....... 5

1.3 Hypothesis…………………...…………………………………… 6

II. LITERATURE REVIEW…...……….…………………………………… 7

2.1 Structure and function of spine ………………………………….. 7

2.2 Mechanical loading of spine………………………….........…….. 10

2.2.1 Mechanical function………………………………………. 10

2.2.2 Mechanical damage………………………………………. 10

2.3 Lower back pain…………………………………………………. 11

2.4 Intervertebral disc..………………………….……………………. 12

2.4.1 Structure and function of intervertebral disc……………... 12

2.4.2 Intervertebral disc degeneration…………………………. 12

2.4.3 Association with pain…………………………………….. 14

v
2.5 Treatment options for lower back pain generated due to damaged
or degenerated disc ………………………………………………… 15

2.6 Disc Arthroplasty: Artificial intervertebral disc…………………… 17

2.7 Loads on the biological disc and the need to mimic them in the
replacements……………………………………………………… 20

III. METHODOLOGY……………….………………...…………………….. 22

3.1 Specimens ……………………………..………………………… 22

3.2 Sample size determination…………………….………….………. 23

3.3 Sample preparation…..…………………………...…..…………… 24

3.3.1 Cadaveric specimen……………………………….………. 24

3.3.2 Intervertebral disc implants………………………..……… 28

3.4 Biomechanical testing…………………………………………….. 29

3.4.1 Cadaveric specimens ……………………………………. 29

3.4.2 Intervertebral disc implants…….………………………… 32

3.5 Testing protocol………….…………………………………….….. 32

3.6 Data acquisition…………………………………………………… 34

3.7 Data analysis………………………………………………………. 35

3.8 Statistical analysis………………………………………………… 36

IV. RESULTS………………………...………………...…………………….. 37

4.1 Single and multi axial testing …………………………………….. 37

4.2 Fatigue test………………………………………………………… 56

4.3 Failure…………………………………………………………….. 60

vi
V. DISCUSSION 68

5.1 Overview……….…………..……..………………………………. 68

5.2 Single and multi axial testing……………………………………... 69

5.3 Fatigue characteristics comparisons………………………………. 72

5.4 Limitations of the study………………………………………….. 74

5.5 Future work………………………………………………………. 75

BIBLIOGRAPHY…………………………………………………..…….………. 76

vii
LIST OF TABLES

Table Page

2.1 Proposed designs for intervertebral disc prosthesis………………………. 18

2.2 Loads on spine…………………………………………………………….. 20

2.3 Testing parameters………………………………………………………… 21

4.1 Statistical results…………………………………………………………... 56

4.2 Axial stiffness comparison under fatigue…………………………………. 57

4.3 Flexion-extension (FE) stiffness comparison under fatigue………………. 57

4.4 Lateral bending (LB) stiffness comparison under fatigue………………… 57

4.5 Axial rotation (AR) stiffness comparison under fatigue………...………… 58

4.6 Shear forces comparison………………………………………..…………. 58

4.7 Disc height comparison under fatigue…………………………………….. 59

4.8 Summary of biomechanical testing of cadaveric disc L1L2 (October 30th,


2006) ……………………….……………………………………………... 61

4.9 Summary of biomechanical testing of cadaveric disc L1L2 (January 10th,


2007)………………………………………………………………………. 62

4.10 Summary of biomechanical testing of cadaveric disc L3L4 (February 20th,


2007)……………………………………………………………………….. 63

4.11 Summary of biomechanical testing of cadaveric disc L2L3 (March 19th,


2007)……………………………………………………………………….. 64

4.12 Summary of biomechanical testing of synthetic disc E-d1 (November 6th,


2006) …………………….……………...…………………………………. 65

viii
4.13 Summary of biomechanical testing of synthetic disc E-d2 (April 10th,
2007)…………...……. ……………………………………………….…. 65

4.14 Summary of biomechanical testing of synthetic disc E-d3 (April 10th,


2007)…………. ….…. …………………………………………….……. 66

4.15 Summary of biomechanical testing of synthetic disc E-d4 (April 10th,


2007)…………. ……. …………………………………………….……. 66

4.16 Summary of biomechanical testing of pseudo- Charite´ (April 10th, 2007) 67

ix
LIST OF FIGURES

Figure Page

1.1 A three dimensional coordinate system (according to ISO 2631)………… 5

2.1 Human spine ……………………………………………………………… 8

2.2 Motion segment ….………………………………………………………. 8

2.3 Spinal ligaments…...……………………………………………………… 9

2.4 Spinal cord and nerve roots………………………………………………. 9

2.5 Intervertebral disc…………………………………………………………. 13

3.1 Intact motion segment (Top view)……………………………..…………. 25

3.2 Intact motion segment (Side view)………………………………………... 25

3.3 Intact posterior region of the motion segment…………………………….. 25

3.4 After removal of the posterior region……………………………………... 25

3.5 Motion segment in alginate…………………….…………………………. 26

3.6 An alginate negative…………………….………………………………… 26

3.7 Alginate positive ……………………………..…………………………… 27

3.8 Final specimen of 5.1 cm………………………………………………….. 27

3.9 Specimen with one potted vertebral body and Steinman pin in other
vertebral body……………………….…………………………………..… 28

3.10 Specimen with both vertebral bodies potted in PMMA and ready for
testing ………………………………………………………………..…… 28

3.11 E-d (Theken Disc, Akron, OH) and pseudo Charite´ ……………………. 29

x
3.12 Cadaveric testing specimen………………………………………………. 30

3.13 Multi Axial Endura Tech Testing system…………………………………. 31

3.14 Temperature monitoring system…………………………………………... 31

3.15 Implant testing…………………………………………………………….. 32

3.16 Loading pattern for modified ISO………………………………………… 34

3.17 Data acquisition software…………………………………………………. 35

3.18 Typical graphs obtained from one of the data sets………………………... 35

4.1 Load – displacement graphs for Cadaveric Discs and Synthetic Implants.. 38

4.2 Axial Stiffness Comparison……………………………………………….. 39

4.3 Flexion –Extension Angle vs. Moment graphs for Cadaveric Discs and
Synthetic Implants E-d for Flexion-Extension with Static Compression……….. 40

4.4 Flexion- Extension Stiffness Comparison………………………………… 41

4.5 Flexion –Extension Angle vs. Moment graphs for Cadaveric Discs and
Synthetic Implants E-d for Flexion-Extension with Dynamic Compression…….. 42
4.6 Flexion-Extension Stiffness Comparison…………………………………. 43
4.7 Lateral Bending Angle vs. Moment graphs for Cadaveric Discs and Synthetic
Implants E-d for Lateral Bending with Static Compression…………………….. 44
4.8 Lateral Bending Stiffness Comparison……………………………………. 45
4.9 Flexion-Extension Angle vs. Moment graphs for the coupled loading of
Flexion-Extension, Lateral Bending with Dynamic Compression………. 46
4.10 Lateral Bending Angle vs. Moment graphs for the coupled loading of
Flexion-Extension, Lateral Bending with Dynamic Compression………. 47

4.11 Flexion-Extension and Lateral Bending Stiffness comparisons…………. 48

4.12 Axial Rotation Angle vs. Torque graphs for Axial Rotation with Static 49
Compression………………………………………………………………..
xi
4.13 Axial Rotation Stiffness Comparison…………………………………..…. 50

4.14 Flexion-Extension Angle vs. Moment graphs for Modified ISO………….. 52

4.15 Lateral Bending Angle vs. Moment graphs for Modified ISO……..….….. 53

4.16 Axial Rotation Angle vs. Moment graphs for Modified ISO…………….. 54

4.17 Stiffness Comparisons (Modified ISO)…………………………..……….. 55

4.18 Radiographs to assess damage to the cadaveric disc……………………… 60

xii
CHAPTER I

INTRODUCTION

This chapter provides an overview of the rationale behind conducting this study

with a brief description of the in vitro technique used followed by the goals, objectives

and the hypothesis.

1.1 Overview

Lower back pain continues to remain a major reason of morbidity around the

world. With an average incidence rate of 60%, about 2% of the work force in US has

compensable back injuries every year [23].Among the back related injuries, the lumbar

case increased from 39 to 47% in 2003. The annual cost of low back disability in US has

been estimated about 50 billion dollars [23, 17]. The healthcare expenditure on US is

very high and the prevalence in similar in men and women. About 1% of the US

population faces chronic disability due to back pain and 1% suffer temporary disability.

Few of those who are disabled for more than six months have a chance of returning to

work and after two years of disability, their chances of reemployment almost vanish [23].

Even though almost every anatomical structure in the lower back has been

implicated, the intervertebral disc has been associated with it the most, mainly because of

the age –related deterioration. The changes in the intervertebral disc generally precede or

coincide, with other degenerative changes in the spine [8].

1
The degeneration of the intervertebral discs is a natural process. With increasing

age, the discs lose their elasticity, flexibility and shock absorbing characteristics.

Intervertebral discs act in part as cushions that provide shock absorption between the

vertebrae. Degeneration may cause a lot of symptoms such as back pain, nerve root

pathology, spinal cord compression, etc. As the discs age, they shrink and therefore the

disc height reduces and the space available for nerve roots and spinal cord also reduces

[31]. This compression of spinal nerves may result in pain, loss of muscle control and in

extreme cases, even paralysis. The damaged disc may also lead to segmental instability.

Besides age related deterioration, trauma can also lead to disc damage.

When the conservative measures fail and a damaged disc or segmental instability

directly damages the neural elements or threatens to do so, operative intervention

becomes necessary. Decompression involves removal of the disc material that

compresses the spinal nerve causing pain and sensory changes in the affected nerve. Even

though it is effective in relieving pain caused by herniated disc, it is not enough to restore

the nucleus to its original load sharing capacity [35, 19].

A standard protocol to alleviate pain from degenerated or herniated discs (may be

due to unnatural mechanical loadings) is the disc removal and fusion of the two adjacent

vertebrae. However, fusion impairs the normal motion and even though it may be

considered a standard treatment in many instances, a number of issues develop.

The loss of mobility may result in stiffness and loss of functional capacity. The

increased stresses on the adjacent non-fused areas due to the transfer of stresses from the

fused segments may lead to adjacent segment degeneration and/or remodeling [31, 32].

2
An alternative to spinal fusion is total disc replacement (spinal arthroplasty),

which intends to maintain the motion of the operative level by removing the damaged

disc and limits the adjacent segment breakdown. This is a current focal point in the

European and North American surgical and industrial areas. However, the focus has

been on using current technology and techniques on the replacement. Very little to no

current technology/ techniques, have been used to study what is being replaced. The vast

majority of this information is decades old [26].

As the intervertebral disc is a complex anatomic and functional structure, the

development of an artificial intervertebral disc which would be an efficient, durable and

reliable structure, is a challenge. The disc function is difficult to reproduce and the choice

of materials that will bear the loads is also of important consequence as the strains

supported by spine are different from those of peripheral joints. The complex strains

supported by the intervertebral disc make the implant development even more difficult.

For e.g., as the spine undergoes 100 million flexion cycles during lifetime (not including

the slight motion during breathing which is about 6 million a year), the optimal life for

the implant is found to be 30 million cycles and a minimum of 10 million cycles [26].

Biochemical problems, difficulties in fitting the implant and the size and weight of the

implant make the design, development and surgical techniques a challenge. Except a

couple of artificial intervertebral disc designs, which are still not being extensively used,

most of the designs are under clinical trials [31].

In determining the durability of the implant, the information regarding the loads

that it will be exposed to needs to be known. Different loading conditions and motion

controls must be considered too. Further, the current testing protocols given by American

3
society for testing and materials (ASTM) and the International Standards Organization

(ISO) differ [15]. Also, the loads that spine undergoes during daily activities are still not

completely known, much less understood.

As the motion preservation devices are gaining popularity, their preclinical

mechanical testing is of prime importance to predict their in vivo safety and efficacy.

This study aimed at evaluating the intervertebral disc implants for structural properties in

comparison with the biological intervertebral disc. We tried to understand the load

response of a cadaveric intervertebral disc structure under a physiologic complex loading

compared to its replacement and also the response of the cadaveric disc to the current test

standards for intervertebral implants.

We tested the cadaveric disc structures and the synthetic intervertebral disc

implants under the testing specifications provided by the ISO for artificial intervertebral

discs. The complex loading included a combination of flexion-extension (6º,-3º), left and

right lateral bending (2º,-2º), axial rotation (2º,-2º) and axial compression (900-1700N).

Figure 1.1 gives an illustration of the coordinate system and the type of loads the

specimens were subjected to.

4
Frontal Saggital

Frontal
Saggital

Transverse Transverse

Figure 1.1 A three dimensional coordinate system (according to ISO 2631) [16]

1.2 Objectives of the study

1. To make a biomechanical comparison of the performance of a cadaveric disc

structure to that of the artificial intervertebral disc under ISO testing standards.

2. To test the human cadaveric intervertebral discs under complex loads (modified

ISO) in vitro.

3. To compare the fatigue characteristics of the cadaveric disc structure, the

elastomeric intervertebral disc implant (Theken Disc, Akron, OH) and a Pseudo

Charite´ (C-p) designed like Charite´ artificial intervertebral disc (DePuy Spine,

Inc.)

5
1.3 Hypothesis

Null hypothesis (H0)

1) There are no statistical differences with respect to structural stiffness values

between human cadaveric discs compared to the elastomeric intervertebral disc

implant (Theken Disc, Akron, OH) with respect to transverse, saggital and frontal

planes.

Alternate hypothesis (H1)

1) There are statistical differences with respect to structural stiffness values between

human cadaveric discs compared to the elastomeric intervertebral disc implant

(Theken Disc, Akron, OH) with respect to transverse, saggital and frontal planes.

6
CHAPTER II

LITERATURE REVIEW

2.1 Structure and function of spine

The human spine is a complex mechanical structure that is flexible, suitably

strong and stable. Regardless of the activity there is always some type of load on the

spine. The spine protects the spinal cord and nerve roots, provides structural support

and bears the loads of head, shoulders and the upper body [34, 12]. It keeps the upper

body weight balanced evenly on pelvis. This puts minimal workload on the muscles

to maintain the upright posture [34, 12].

In humans, the spine is composed of 24 vertebrae, sacral bones and the coccyx

(Figure 2.1). The spinal column provides body's main upright support. The spine

forms three curves. The cervical spine (at the neck), is curved slightly anteriorly. The

thoracic spine (at the middle back) is curved posteriorly. The lower back (lumbar

spine) curves slightly anteriorly. The normal curve of the neck and lower back is

called lordosis while the normal curve of the thoracic spine is called kyphosis. An

increased lordosis or kyphosis may be associated with a congenital problem,

neuromuscular problem, poor posture, osteoporosis, obesity etc [39, 27,39].

7
Intervertebral Disc

Vertebral Body

Facet Joint
Nerve Root

Pedicle

Figure 2.1 Human Spine [37] Figure 2.2 Motion Segment [37]

The term motion segment is that structure formed by two adjacent vertebrae

associated ligaments, and intervertebral disc [Figure 2.2]. The intervertebral discs act like

shock absorbers to suppress impulsive forces transmitted by activities like jumping, they

increase the time taken by the forces to reach the lower extremities while decreasing the

force [36,37]. The bony projections at the back of the vertebra form the vertebral arch

which consists of two pedicles and two laminae. The spinal canal contains the spinal cord

and under each pedicle spinal nerves exit the spinal cord and pass through the foramina to

branch out to the body. The spinous process, two transverse processes, two superior

facets, and two inferior facets arise from the vertebral arch [36,37]. The facet joints resist

axial rotation and the ligaments also work as motion limiters. The intersegmental

ligaments include the ligamentum flavum, interspinous and intertransverse ligaments.

The intersegmental ligaments that hold many vertebrae together are the anterior and

posterior longitudinal ligaments, and the supraspinous ligaments [36, 39, 38,39].

8
Figure 2.3 Spinal Ligaments [37] Figure 2.4 Spinal Cord and Nerve Roots [37]

The spinal cord runs within the spinal canal from the brainstem to the first lumbar

vertebra and then the cord fibers separate to form cauda equina and then branch out to

legs and feet. The spinal cord works as a messenger between the brain and the rest of the

body by carrying motor messages from the brain to the body and relays sensory messages

from the body to the brain with the help of spinal nerves. Any damage could lead to a

sensory and motor function loss [36, 37, 38]. As the facet joints and disc allow the

movement between the two vertebrae and the foramens provides area for the nerve roots

to branch out from the spinal cord, any instability or excessive movement may lead to

irritation or pinching of the nerve roots. This generally results in pain and may increase

pressure on facet joints leading to inflammation and muscle spasms as the muscles try to

stop the segment movement. Instability leads to faster degeneration of the spine [34, 27]

9
2.2 Mechanical loading of spine

Irrespective of the activity there is always some kind of load on the spine. The

combination and magnitude of loads change with activity. The following section aims at

discussing the mechanical function and damage due to inappropriate loading on the spine.

2.2.1 Mechanical function

The intervertebral discs resist compressive forces mainly in upright posture, the

facet joints protect the discs from torsion and excess shear and the ligaments prevent

excessive bending [2,28] Nearly 20% of the compressive load falls on the facet joints but

this can go up to 70% if the intervertebral discs are degenerated and narrowed [40]. In the

lumbar region, The facet joints resist horizontal forces acting perpendicular to their

articular surfaces and limit the range of axial rotation. They can resist shearing forces of

about 2kN. [2] The posterior intervertebral ligaments can resist 100N (posterior

longitudinal ligament) to nearly 1kN for facet joint capsular ligaments.[18] The fibers in

the interspinous and capsular ligaments are oriented and sized accordingly to resist

forward bending movement. [2]

2.2.2 Mechanical damage

To investigate the failure mechanisms, dynamic loading tests are required so that

the elastic limit can be detected by loading the specimen rapidly and the non-reversible

deformation is real and not a viscous creep. The vertebral body is the first structure to fail

in compression. Failure occurs at lower loads in fatigue and damage is mostly at the end

plate. Compressive fatigue damage is more common due to the micro fractures. Fatigue

damage accumulates rapidly if spine is exposed to mechanical vibrations. Rapid

compressive forces can cause a burst fracture. Fracture occurs in a single loading cycle

10
with forces of approximately 2kN or in a response to cyclic forces between 380N to

760N [2].

Facet joints are not well oriented to resist compressive forces. With the disc

narrowing of 1-3mm the loading on articular surfaces increases. In the lumbar spine the

damage generally occurs in 1-3º of movement and the damage probably occurs in

subchondral bone behind the articular surface [2, 11].

The intervertebral disc and the facet joints resist extension and axial rotation and

thus do not affect the ligaments much. The interspinous ligament is the first to rupture in

hyperflexion. A 2º further extension is required to damage apophysial joint capsular

ligament. [2]. Disc damage cannot be caused directly by compressive loading as the

compressive loads have been found to affect the adjacent vertebral body. An

understanding of the mechanical loading of the lumbar spinal structures is important as

abnormal mechanical loading is one of the reasons of damaged spinal structures which

lead to lower back pain

2.3 Lower back pain

Lower back pain can occur due to several reasons. With increase in age, the bone

strength decreases, muscles weaken and discs lose flexibility and the ability to cushion

the vertebrae. A sprain, strain or spasm in muscles or ligament can cause back pain. Over

compressed spine can lead to disc rupture and pinching of nerve roots resulting in pain.

Degenerative conditions like arthritis, osteoporosis, congenital abnormalities, obesity,

smoking, weight gain during pregnancy, stress, poor physical condition, posture

inappropriate for the activity being performed, and poor sleeping position also may

contribute to low back pain [35, 38].

11
Several conditions can cause lower back pain. A herniated, or ruptured disc can

push into the space containing the spinal cord or the nerve root and results in pain. In the

cauda equina syndrome, the disc material is pushed into spinal canal and compresses a

bundle of sacral and lumbar nerve roots and can result in permanent neurological

damage. [35]. If the ruptured disc presses the sciatic nerve which carries nerve fiber to

legs, knee and foot it may cause low back pain combined with pain in legs. A severe

condition can lead to loss of motor control loss in the legs. Spinal degeneration may

result in narrowing of spinal canal. Spinal stenosis, osteoporosis, skeletal irregularities,

spondylitis (severe inflammation of spinal joints) all lead to lower back pain in varying

degrees. Inarguably, of all the anatomical structures in the lumbar spine associated with

the lower back pain, intervertebral disc has been associated with it the most and mainly

due to age related deterioration and damage due to various reasons.

2.4 Intervertebral Disc

Intervertebral discs act as shock absorbers and to a certain extent motion limiters.

The following section discusses the structure and function of the intervertebral disc, the

possible causes and effects of degeneration and its association with pain.

2.4.1 Structure and function of intervertebral disc

The intervertebral disc is a mixed structure consisting of peripheral collagenous

bands called annulus fibrosus made of 15-20 concentric layers of alternating oblique

fibers [26,12]. The central core is made up of mucopolysacharide gel and proteoglycans

and is called nucleus pulposus [26,12]. This core is very hydrophilic and generates a

tension on the annulus even when no external loading is present [26,12]. The preloading

enhances the resistance to external forces and helps in dividing the compressive forces.

12
The disc allows movement along and around three main axes. Thus, the center of rotation

is constantly modified along two axes simultaneously. The intervertebral disc provides a

major part of its stability on its own [Figure 2.5]. The collagen fiber arrangement in the

annulus creates an efficient system to control and restrict rotation [26].

Annulus Fibrosus
Nucleus
Pulposus

Lamellae

Figure 2.5 Intervertebral Disc

2.4.2 Intervertebral disc degeneration

Degeneration of the intervertebral disc has been shown to be positively correlated

with respect to age in humans. There is generally a gradual decrease in the hydrophyllic

proteoglycans and the associated water content [8,4]. The nucleus dehydrates and shrinks

resulting in load changes on the annulus. Radial tears may occur in the annulus. And if

natural healing does not occur, the proteoglycan material of the nucleus may migrate

from the center to the periphery through the tear. [8,4] This may lead to further

delamination of the annulus and may results in back pain due to simulation of

sinuvertebral nerve. The nucleus may transgress all the layers of annulus resulting in a

herniation. This may mechanically deform the nerve root and result in a radicular pain

[8,4]. Due to accumulation of metabolic products, the pH changes with change in

immunoglobulins and prostaglandins, which results in back pain. Degenerated discs

result in compromised stability and increased motion between vertebrae [4].

13
The causes of disc degeneration are not well understood and also the clinical

variability makes it difficult to assess the risk for development of severe or earlier onset

of disc degeneration. Male discs have been found to degenerate earlier than their age

matched female counterparts. [8,26] Other factors that may lead to disc degeneration

include smoking, exposure to whole body vibrations and heavy lifetime occupational and

leisure physical loading [8,26] A genetic predisposition has also been implicated. Since

the disc is not the only mobile structure of the functional unit , secondary osteo- arthrosic

modifications of the facet joints influence disc degeneration and vice versa. Furthermore,

the origin of pain in the functional unit is ill understood and is more complex than

peripheral joints [8, 26].

2.4.3 Association with pain

The exact role disc degeneration plays in the occurrence of low back pain is

unclear .The reason why the intervertebral disc is considered the axial pain generator may

be because the posterior portion of the annulus fibrosus is innervated by fibers of the

sinuvertebral nerve which is a branch of the dorsal root ganglion. Irritation of this nerve

is thought to be one reason of axial back pain. Sensory information from the lumbar

intervertebral discs is conducted to other spinal levels through the paravertebral

sympathetic trunks [21] Therefore, decompression of the nerve root is unlikely to reduce

low back pain symptoms. Thus, removal of the disc and denervation of the annulus is

more likely to reduce discogenic pain than decompression alone. Further, disc material

has been shown to be a direct source of chemically irritative substances such as

phospholipase A2, prostaglandin E, substance P, and lactic acid [21, 8] Disc herniation in

a non degenerated disc can be due to abnormal loads, for e.g. due to trauma.

14
2.5 Treatment options for lower back pain generated due to damaged or degenerated disc

Pain can occur at any stage of the degeneration process, from annular tear to

complete disc degeneration. Depending on the severity of the pain and the reason, several

treatment options have been tried over the years. Anti-convulsants are used to treat

certain type of nerve pain. Some antidepressants like amitriptyline and desipramine have

been known to dull pain signals [35, 19]. Spinal manipulations, acupuncture, traction,

transcutaneous electrical stimulation have all been used to treat lower back pain. When

the conservative measures fail and segmental instability directly damages the neural

elements or threatens to do so, operative intervention becomes necessary [19].

Decompression involves removal of the disc material that compresses the spinal nerve

causing pain and sensory changes in the affected nerve. Even though it is effective in

relieving pain caused by herniated disc, it is not enough to restore the nucleus to its

original load sharing capacity [35, 19, 13].

Fusion (arthrodesis) involves eliminating the motion between two or more

vertebrae by using a bone grafting procedure and internal fixation system. [4, 31] This

procedure is performed when there is a gross instability of motion segment resulting from

a traumatic injury or degeneration [4, 31]. The technique is also used to abolish motion at

a painful but stable, degenerated disc. Fusion thus eliminates instability and helps in

relieving pain. Even though spinal fusion is extensively used, several problems are

associated with it. The loss of mobility from long segment fusions may result in stiffness

and loss of functional capacity. The transfer of stress from the fused areas to the

bordering non-fused areas may result in adjacent segment degeneration. In many patients

15
with multiple levels of mild degenerative disease, surgery to correct all degenerative

segments would often be too extensive and disabling [8, 31]. Disc arthroplasty

alternatives are designed to preserve motion segments, reduce the risk of facet damage,

and limit associated adjacent segment degeneration.

2.6 Disc Arthroplasty: Artificial intervertebral disc

Disc arthroplasty offers an alternative treatment, that of alleviating pain while

preserving the physiological motion. This involves replacing the entire damaged disc

(nucleus and annulus) or the damaged nucleus depending on the need. Nucleus

replacements aim to restore the disc height and return the annular fibers to their natural

length, which would facilitate normal load distribution. The theoretical advantages of

disc arthroplasty are prevention of adjacent segment disease, protection of neural element

by restoring disc height and shorter recovery time as patients would not recuperative

period for fusion maturation [4, 26, 14, 13].Total disc replacements would be used when

removal of all the sources of pain (including nucleus and annulus) becomes necessary

and healing is not possible in any way. Physiologic motion is complex and the prosthesis

should approximate the size and motion of a physiologic disc to avoid distraction or

overloading of the facet joints.

The indications for total disc replacement are similar to fusion, including back

and leg pain which is unresponsive to appropriate attempts at non-operative treatments,

radiographic evidence of disc degeneration with varying degree of disc space collapse

[13,22]. Other indications involve post laminotomy/ discotomy syndromes. It should be

avoided in patients with osteoporosis as a weaker bone would fail fast and anything

greater than grade I spondylolisthesis because an unstable segments cannot be held in

16
place with an artificial disc. Further, patients with significant canal stenosis or neural

compressive disease or pain related to significant scarring from previous surgery should

not be treated by disc replacement [13,22].

The first disc arthroplasty attempt was performed with a steel ball endoprosthesis

by Fernstorm in the late 1950s. Since then several implants have been designed. Few of

them have been tested in animal models and even fewer reached the clinical trial stage

[14]. Further, there are several problems associated with the implant design, like,

presence of three joints at each level, the ability of the intervertebral disc to provide a

complex combination of mobility and stability, the changing center of rotation at a given

motion segment with changing position of the motion segment [6,14].

Some prosthesis strive to reproduce the viscoelastic properties of the disc and are

made of silicones or polymers and some aim at reproducing the range of motion (i.e.

motion characteristics ) and are made of metal or polyethylene couples. Some attempt to

combine both principles. Table 2.1 shows some of the designs that have been proposed

over the years [26].

17
Table 2.1 Proposed designs for intervertebral disc prosthesis

Year Researcher Intervertebral disc prosthesis design

1950 Nechemson Liquid Silicone rubber

1973 Stubstad et al. Reinforced elastic polymer disc

1975 Froning Discoid bladder like implant

1978 Weber Polyethylene structures with ceramic ovoid core

1987 Downey Cushion made of silicon with inner core of fluid

1991 Pisharodi Hollow bag containing springs

1994 Baumgartner Elastic beads replacing nucleus

1995 Beer and Beer Disc shaped screwed plates joined by springs

2000 Bryan and Kunzler Two threaded hollow half cylinders

2000 Gauchet Two round plates and an intermediate deformable body

Cervical and lumbar disc arthroplasty has reached the stage of clinical trials in

United States. The spinal arthroplasty techniques replace damaged, painful and

incompetent intervertebral discs with a prosthesis designed to restore normal disc height,

and function. Artificial disc replacement is considered experimental by the Food and

Drug Administration (FDA), but is becoming an increasingly more common intervention

for patients. While artificial intervertebral discs have been used internationally for over

10 years, only two devices, Charité (DePuy Spine, Inc.) and ProDisc-L (Synthes Spine)

have received approval. Other devices are currently under investigation in this country as

18
part of the FDA process of approval [26,31,32]. The structural, functional and pathogenic

factors make the development of an artificial disc a challenge. Complex strains,

biochemical problems and surgical difficulties further demand an implant that is

biocompatible and can withstand the long term complex mechanical demands. Currently

there are four different types of artificial discs that are undergoing either clinical, in-vivo

or in-vitro evaluation. The different types are the following.

Composite: e.g. Link SB Charite® disc, Prodisc®

Hydraulic: e.g. PDN® Prosthetic Disc Nucleus

Elastic: e.g. Acroflex® Disc

Mechanical: e.g. Maverick® Disc prosthesis

Link SB Charite® disc Prodisc®

19
2.7 Loads on the biological disc and need to mimic them in the replacements

The spine undergoes approximately 100 million movements during an average

lifetime. The optimal lifespan of the existing implants is only 30 million movements with

a recommended minimum of 10 million. The implant should be able to withstand the

kind of loads the biological disc has to bear without failing [25,18]

So far the biological disc has been studied in isolated loading conditions, mainly

compression. But there is always some kind of coupled load on the disc. Studies have not

focused much on how the disc performs under complex loads. A few studies have

focused on multidirectional properties of the disc [25,18]

To determine the durability of the implant, the type of the load the implant will be

exposed to, should be known. Different loading conditions and motion controls must also

be considered. So far for testing intervertebral disc implants,the test parameters are

debatable. The parameters should be physiologically accurate. Daily loads on spine can

be summarized as follows: [15]

Table 2.2 Loads on spine [15]

20
The testing criteria provided by ASTM and ISO are considerably different (Table

1) and the motion paths generated by both are also different. The ISO parameters

combine all the loading conditions together resulting in a cross- shear motion profile [15].

Table 2.3 Testing parameters [15]

This study aims at understanding how the biological disc would perform under

complex loading conditions under which an artificial intervertebral disc implant is tested.

This would give us an insight on weather the biological disc can withstand the test

criteria set up for the artificial disc implants and also how it performs under complex or

coupled loads.

21
CHAPTER III

METHODOLOGY

Introduction

The objective of this study was to make a biomechanical comparison of the

human cadaveric disc and the synthetic intervertebral disc implants under multi axial

loading. The study also aimed at evaluating the performance of cadaveric disc under the

testing specifications prescribed for the replacement of the human disc by the

International Standards Organization (ISO). The following content gives detailed

information of how the study was conducted.

3.1 Specimens

Human cadaveric specimens

Standard radiographic tests were performed on the human cadaveric specimens to

ensure they were normal and did not have any fractures or any such structural damage.

Radiographs were obtained in mid saggital and oblique planes and were verified by an

orthopedic surgeon to see if they were normal.

Intervertebral disc implants

Elastomeric intervertebral disc implants by Theken Disc, Akron, OH (E-d) were

used for the biomechanical comparison with the cadaveric disc structures under multi

axial loading. For fatigue testing, an artificial intervertebral disc was prepared by

22
Theken Disc, Akron, OH which was based on the dimensions determined from

the literature about the Charite´ artificial intervertebral disc implant (DePuy Spine, Inc).

We named it pseudo Charite´.

3.2 Sample size determination

To determine the sample size of cadaveric specimens and elastomeric

intervertebral disc implant E-d (Theken Disc, Akron, OH) required for test, the following

formula was used.

n ≥ 2(σ / δ ) × (tα ,[ν ] + t2(1− P )[ν ] )


2 2

Where, n : number of replications / sample size


σ : true standard deviation
δ : smallest true difference to be detected
ν : degrees of freedom of sample standard deviation
α : significance level
P : desired probability that a difference will be found to be significant
Power of the test
T : two tailed t-table value.
Values for above equation were: standard deviation of 10%; significance level of

0.05; power of the test was taken as 90%; and, smallest true difference to be detected,

30%. The sample size was found out to be 4.

23
3.3 Sample preparation

The cadaveric specimens and the pseudo Charite´ needed preparation prior

testing. The elastomeric implants E-d did not need any fixture adaptations or preparation

before testing. The following section discusses the sample preparation done for the study.

3.3.1 Cadaveric specimens

For the test, fresh cadaveric specimens were used. They were kept hermetically

frozen at -20 ºC and cool thawed prior to any work or biomechanical testing. Studies

have shown that freezing and thawing at room temperature have little effect on the

biomechanical behavior of the disc [16]. Radiographic tests were performed on the

human cadaveric specimens to ensure they were normal and did not have any fractures or

any such structural damage. Radiographs were obtained in mid saggital and oblique

planes and were verified by an orthopedic surgeon to see if they were normal. The age,

gender, weight, size, cause of death and other information about the donors were not

available to this author.

The samples were dissected from the intact spines. All the muscle mass was

removed (Figure 3.1). In each cadaveric specimen, all the posterior elements including

the lamina, facet joints and pedicles were removed, leaving the anterior longitudinal

ligament and the posterior longitudinal ligament intact (Figure 3.2). All tissue work was

conducted by suitably trained personnel.

24
Figure 3.1 Intact motion segment Figure 3.2 Intact motion segment
(Top View) (Side View)

Figure 3.3 Intact posterior region Figure 3.4 After removal of the
of the motion segment posterior region

One objective was to keep the intervertebral disc, anterior and posterior

longitudinal ligaments and some part of the adjacent vertebral bodies intact and

maintaining the height of the specimen at 5.1 cm. To achieve this, parallel cuts were

made in the superior and inferior vertebral bodies in the transverse plane. The removal

was symmetric with respect to the centroidal transverse plane through the disc.

Considerable portions of the vertebral bodies were removed such that the remaining

region could be used to hold the specimen in place and the intervertebral disc takes most

of the loads while testing. To achieve this, an intricate series of steps were taken. First an

25
impression of the spinal segment (after removing all the posterior parts) using alginate

dental impression material was taken (Figure 3.5 and 3.6). The next step was that of a

positive made by pouring alginate into the negative impression (Figure 3.7). This positive

was then used to get another negative though this time the negative was of

polymethylmethacrylate (PMMA). It was this negative that was actually used to rigidly

hold the cadaveric specimen and appropriate cuts were made. To cut the specimen such

that the distance of the transverse planes in which the cuts were 2.55 cm on both sides

from the transverse plane passing through the center of the disc. First, the height of the

intervertebral disc was determined by prodding the specimen with a hypodermic needle

without causing any damage to the tissue, such that the intersection of the disc and

vertebral bodies was determined. Once the height of the disc was established, another

hypodermic needle was placed exactly halfway. From this centrally placed needle, 2.55

cm distance on both the sides was determined and marked. Appropriate cuts in the

vertebral bodies in the transverse plane were made using a Milwaukee saw (Figure 3.8).

Figure 3.5 Motion segment in alginate Figure 3.6 Alginate negative

26
Figure 3.7 Alginate positive Figure 3.8 Final specimen of 5.1 cm

For fixation to the testing fixture each specimen was potted in PMMA. The

vertebral bodies were embedded in PMMA using a circular potting construct. The

specimen was placed such that the center of the specimen and the construct are

overlapping. To get the center of the specimen in transverse plane, a circle was assumed

on the disc and its center was determined [Figure 3.9]. The center typically lied a

centimeter from the posterior longitudinal ligament. The center of both the vertebral

bodies was determined in a similar fashion.

The base plate of the potting construct had a particular hole pattern in which

small brass rods were placed before PMMA was poured in the assembly, so as to get a

similar hole pattern in the PMMA which held the vertebral body. This was done to place

and secure the potted specimen in the testing chamber which has a similar hole pattern.

Machining was done on the holes to get the required hole diameter.

Attention was given so that the specimens were not torqued at odd angles during

the preparatory phase. Steinman pins were drilled in the vertebral bodies for proper load

transmission in bending and torsion while testing (Figure 3.9). Once the specimen was

placed in the construct and secured ,a PMMA powder/monomer mixture was poured in

27
the potting construct and allowed to set. Both vertebral bodies were potted in similar

fashion (Figure 3.10).

Figure 3.9 Specimen with one potted vertebral body and Steinman pins in the other
vertebral body

Figure 3.10 Specimen with both vertebral bodies potted in PMMA and ready for testing

3.3. 2 Intervertebral disc implants:


For comparison under multi axis by loading with human cadaveric disc structures,

four elastomeric disc implants by Theken Disc, Akron, OH, were used. The specimens

did not need any fixture adaptation prior to testing as testing fixtures were already

available (Figure 3.11).

For fatigue testing, an artificial intervertebral disc was prepared by Theken Disc,

Akron, OH which was based on the dimensions determined from the literature about the

28
Charite´ artificial intervertebral disc implant (DePuy Spine, Inc). As the implant consists

of two cobalt chrome end plates and an intervening ultrahigh molecular weight

polyethylene sliding core, the two end plates were potted in PMMA following the

protocol used for cadaveric discs. The cobalt chrome end plates were circular, therefore

we did not need to approximate the center. Steinman pins were inserted in both the end

plates before they were potted in PMMA (Figure 3.11).

Figure 3.11 E-d (Theken Disc, Akron, OH) and pseudo Charite´

3.4 Biomechanical testing

Biomechanical testing of all the specimens was done at Theken Disc, Akron, OH.

The specimens used and the testing equipment used are described in the following

section.

3.4.1 Cadaveric Specimen

The testing chamber was built such that a temperature probe could be inserted to

maintain the desired temperature. The potted cadaveric specimens were fixed in the

testing chamber and kept moist by immersion in Ringers solution and maintained at 37 ûC

throughout the experiment. (Figure 3.12)

29
Posterior Chamber Anterior Chamber Specimen in Testing

Figure 3.12 Cadaveric Testing Specimens

The testing set up would then be placed in a four independent axis prototype servo

Pneumatic EnduraTEC Systems Corp. spine simulator (Figure. 3.13) with an engaged

active temperature control system with the help of which the temperature was maintained

at 37ûC throughout the cadaveric specimen testing (Figure 3.14).

The spine simulator has a six axis load cell which measures the transmitted forces.

The spine simulator was capable of simulating all the loading components separately or

in any combination. This included flexion- extension moments, left and right lateral

bending moments, left and right torsion and axial compression. Shear forces could be

measured by the system even though they could not be controlled.

30
Once the specimen was fixed in the testing chamber, it was placed in the spine

simulator such that the anterior region of the specimen was aligned with the flexion

simulator. The testing chamber was locked in the X-Y plane using a set of clamps and

screws. This was done once it was placed horizontally in the simulator, with minimal tilts

in bending planes. Before locking, the bending moments were brought to a very low

value. (Figure 3.8)

Figure 3.13 Multi-Axial EnduraTEC Testing System

Figure 3.14 Temperature monitoring system

31
3.4.2 Intervertebral disc implants

The disc implants were also tested in the same system but they did not need

temperature or moisture control. The alignment and placement was done in a manner

similar to the cadaveric specimens (Figure 3.15).

Figure 3.15 Implant testing

3.5 Testing protocol

Spinal loading in vivo is complex and not very well understood. Further the

magnitudes vary from individual to individual depending on the type and extent of

activity, age etc. The objective was to evaluate the cadaveric disc structure under the

testing specifications for the disc replacement while also evaluating the structural

characteristics of the cadaveric discs and the synthetic implants.

The specimens were tested in all the individual, two axis and multi axis loading

conditions (per the ISO testing specifications). All tests were started with an axial

compression of 100 – 600 N at 0.25 Hz. This was followed by a combination of coupled

loads as follows:

a) Flexion – extension (4û, -2û) at 0.25Hz with static compression (600 N).

b) Flexion –extension (4û, -2û) at 0.5Hz with cyclic compression (300 – 700 N).

32
c) Lateral bending (-2û,-2û) at 0.25Hz with static compression (600 N).

d) Lateral bending (-2û, -2û) at 0.75 Hz, flexion –extension (4û, -2û) at 0.25 Hz with

dynamic (cyclic) compression (600 N).

e) Torsion (-3û- 3û) with static compression at 0.25 Hz.

In the end the specimens were tested under a modified ISO complex loading

specification (Figure 3.16): flexion – extension (6û,-3û) at 0.5 Hz, lateral bending (-2û,-

2û) at 0.75Hz, torsion (-2û,-2û) at 0.75, cyclic compression (900 N – 1700 N). After each

two axes and /or multi axis loading test, the specimens were again tested under axial

compression (100N – 600N). The specimens were tested for 50±5 cycles for each

loading, so that the first few cycles could be taken as preconditioning and the results

would not be affected by the initial viscoelasticity of the specimen. The number of cycles

was large enough to get the appropriate data but not enough to damage the specimen. For

data analysis the last five cycles were typically chosen.

The cadaveric specimens were fatigued under the ISO testing specifications until

failure. Elastomeric intervertebral disc implant (Theken Disc, Akron, OH) (E-d) were

also fatigued in similar fashion. An artificial intervertebral disc (pseudo-Charite´) was

prepared by Theken Disc, Akron, OH which was based on the dimensions determined

from the literature about the Charite´ artificial intervertebral disc implant (DePuy Spine,

Inc).

33
Test 7 - ISO modified
8.0

axl rot
4.0 lateral bending
flex exten
0.0 normalised force

-4.0

Figure 3.16 Loading pattern for modified ISO

3.6 Data acquisition

The spine simulator system was interfaced with a data acquisition and motion

measurement system (Figure 3.17) which was capable of determining the six motion

components for the three dimensional relative motion between the two vertebral bodies.

This included the three translation and three rotational motions. The relative motion

between the two bodies was transformed to the local coordinate system and the errors

were recorded throughout the test. The data acquisition system collected the data in real

time. Along with the loads, it also measures and collected the moments, shear forces,

tilts, temperature and errors.

34
Figure 3.17 Data Acquisition Software

3.7 Data Analysis

Offline analysis was conducted using Microsoft Excel®. To calculate the axial

stiffness, flexion- extension stiffness, lateral bending stiffness and axial rotation stiffness

values, linear region of the last five loading and unloading cycles of the load vs.

displacement graph, flexion-extension angle vs. flexion -extension moment graph, lateral

bending angle vs. lateral bending moment graph and axial rotation vs. torque graph

respectively , were regressed (Figure 18).

Axial Comp. - L1 - L2 - Jan. 10, 2007 Lat Bend- L1 - L2 - Oct. 30, 2006
Lateral Mom. ( N-m )

800 6
600 3
Force ( N )

400 0
200 -3
0 -6
9.4 9.6 9.8 10.0 -6.0 -3.0 0.0 3.0

Displacement ( mm ) Lateral Angle ( Deg. )

Flex.-ExDC. - E-d1- Nov. 2, 2006 Rotat ion & Static Axial Loading- L1 -
L2 - Jan. 10, 2007
Flex.-Ext. Mom. ( N-

8
Torque Mom. ( N-

20
4
10
m)

0
m)

0
-4 -10
-20
-3.0 0.0 3.0 6.0 -4 .0 -2 .0 0 .0 2 .0 4 .0

Flex.-Ext. Angle ( ° ) T orque Angle ( ° )

Figure 3.18 Typical graphs obtained from one of the data sets

35
Shear forces, effect of one loading on the other and errors were also evaluated in

the offline analysis. To determine failure the disc height was recorded and monitored.

Failure was characterized by a constantly reducing disc height. After the fatigue tests, to

evaluate the failure of the cadaveric specimens, radiographs were taken.

3.8 Statistical Analysis

The statistical model assumed for this study was independent t-test. The model is

Yij = µ + τi + εij
Where: Yij: dependent variable (output)
µ : Underlying mean of all groups
τi : treatment
εij : Random error
In this study, ‘i’ is 2. In order to prevent biasing effects due to loading, the testing

order within each specimen was randomized. The disc type was taken as the independent

variables and construct stiffness was taken as the dependant variable. Statistical analysis

using SAS software package (SAS Institute, Cary, NC.) was performed. The means and

standard deviations for each of the variables were also found.

36
CHAPTER IV

RESULTS

4.1 Single and multi-axial testing

Following the methodology described in the earlier chapter, four specimens from

each group i.e. cadaveric intervertebral disc structures and E-d, synthetic disc implants,

were tested. The results of the tests were obtained for both the groups and were

compared.

Initial Axial Compression

All the specimens were tested under cyclic axial compression (100N to 600N, at

0.25 Hz). All specimens were tested for 50 cycles of this loading. The load vs.

displacement graphs were plotted and the axial stiffness values were calculated by

regressing the last five loading and unloading cycles for all the specimens (Figure 4.1).

The specimen heights were recorded throughout the test and the changes were evaluated.

Axial stiffness comparisons of the two groups with four specimens each were made. The

average axial stiffness values and standard deviations were calculated (Figure 4.2). The

average axial stiffness for cadaveric discs was 1490± 212 N/mm and that for synthetic

implants (E-d) was 2454±320 N/mm.

37
Axial Compression (Cadaveric Specimens)

700
L1L2_Oct30 '06
L1L2_Jan10 '07
600 L2L3 Mar 19th '07
L3L4_Feb20th '07
500

400
Load (N)

300

200

100

0
7.5 8.0 8.5 9.0 9.5 10.0 10.5

Displacement (mm)

Axial Compression (Implants E-d)

700

E-d1
600 E-d2
E-d3
E-d4
500

400
Load (N)

300

200

100

0
8.6 8.8 9.0 9.2 9.4 9.6 9.8

Displacement (mm)

Figure 4.1 Load – Displacement graphs for Cadaveric Discs and Synthetic Implants E-d

38
Axial Compression

3000
Implants (E-d)
n=4
Cadaveric specimens
2500
Axial Compression Stifness (N/mm)

2000
n=4

1500

1000

500

Figure 4.2 Axial Stiffness Comparison

Flexion – Extension with Static Compression

The specimens were tested under Flexion- Extension (4û,-2û) at 0.25 Hz. and a

static compression of 500 N. The Flexion- Extension moments were recorded and the

graphs of the angles vs. moments were plotted (Figure 4.3).The flexion-extension

stiffness was calculated by regressing the last five cycles of the graphs for all the eight

specimens. The flexion-extension stiffness values were calculated for all specimens and

the means and standard deviations were calculated for both the groups. The mean flexion-

extension stiffness for cadaveric specimens was 2.44 ±0.71 Nm/º and that of synthetic

implants (E-d) was 1.77±0.09 Nm/º (Figure 4.4).Throughout this test, the axial rotation

and lateral bending angles were maintained at 0º.

39
Flexion Extension , Static Compression (Cadaveric specimens)

20

L1L2 Oct 30th '06


L1L2 Jan 10th '07
L2L3 Mar 19th '07

Flexion -Extension moment (Nm)


10
L3L4 Feb 20th '07

-10

-20

-30
-3 -2 -1 0 1 2 3 4 5

Flexion -Extension angle (°)

Flexion-Extension, Static Compression (Implants E-d )

10
E-d1
8 E-d2
E-d3
Flexion-Extension moment (Nm)

E-d4
6

-2

-4

-6
-3 -2 -1 0 1 2 3 4 5

Flexion-Extension angle (°)

Figure 4.3. Flexion –Extension Angle vs. Moment graphs for Cadaveric Discs and Synthetic
Implants E-d for Flexion-Extension with Static Compression

40
Flexion-Extension , Static Compression

3.5

Cadaveric specimens
n=4
3.0

Flexion -Extension Stifness (Nm/°)


2.5
Implants (E-d)

n=4
2.0

1.5

1.0

0.5

0.0

Figure 4.4 Flexion-Extension Stiffness Comparison

Flexion- Extension with Dynamic Compression

All the specimens were tested under Flexion-Extension (4û,-2û) at 0.25 Hz and a

dynamic compression of 300 to 700 N. Like the earlier test, the stiffness values were

calculated by regressing the last five loading and unloading cycles of the angle – moment

graphs (Figure 4.5). The flexion- extension stiffness values were calculated like earlier

stage and the means and standard deviations were calculated for both the groups. The

mean flexion-extension stiffness for cadaveric specimens was 2.58±0.64 Nm/ degree and

that of synthetic implants (E-d) was 1.78±0.03 Nm/degree (Figure 4.6). The axial rotation

and lateral bending angles were maintained at 0º.

41
Flexion-Extension, Dynamic Compression (Cadaveric Specimens)

20
L1L2 Oct 30th '06
L1L2 Jan 10th '07
15 L2L3 Mar 19th '07

Flexion-Extension moment (Nm)


L3L4 Feb 20th '07

10

-5

-10
-3 -2 -1 0 1 2 3 4 5

Flexion-Extension angle (°)

Flexion-Extension, Dynamic compression (Implants E-d)

E-d1
6 E-d2
E-d3
Flexion -Extension moment (Nm)

E-d4
4

-2

-4

-6
-2 -1 0 1 2 3 4 5

Flexion-Extension angle (°)

Figure 4.5. Flexion –Extension Angle vs. Moment graphs for Cadaveric Discs and Synthetic
Implants E-d for Flexion-Extension with Dynamic Compression

42
Flexion-Extension ,Dynamic Compression

3.5

n=4 Cadaveric specimens


3.0

Flexion-Extension stifness (Nm/°)


2.5
Implants (E-d)

2.0 n=4

1.5

1.0

0.5

0.0

Figure 4.6 Flexion-Extension Stiffness Comparison

Lateral Bending with Static Compression

All the specimens (cadaveric and E-d) were tested under left-right lateral bending

(2û,-2û) at 0.25 Hz and a static axial compression of 500N. The lateral bending stiffness

values were calculated from the lateral bending angle vs lateral bending moment graphs

for all the specimens (Figure 4.7). The stiffness values were calculated for both the

groups and the means and standard deviation values were also calculated for both the

groups. The mean lateral bending stiffness for cadaveric specimens was 2.48±0.37 Nm/ º

and that of synthetic implants (E-d) was 2.9±0.4 Nm/ º (Figure 4.8). The flexion-

extension and axial rotation angles were maintained at 0º during this test.

43
Lateral Bending ,Static Compression (Cadaveric specimens)

10

L1L2 Oct 30th '06


8 L1L2 Jan 10th '07
L2L2 Mar 19th '07
6
Lateral Bending moment (Nm)
L3L4 Feb 20th '07

-2

-4

-6

-8
-3 -2 -1 0 1 2 3

Lateral Bending angle (°)

Lateral Bending, Static Compression (Implants E-d)

12
E-d1
10
E-d2
E-d3
8
E-d4
6
Bending moment (Nm)

-2

-4

-6

-8
-3 -2 -1 0 1 2 3

Lateral Bending angle (°)

Figure 4.7 Lateral Bending Angle vs. Moment graphs for Cadaveric Discs and Synthetic
Implants E-d for Lateral Bending with Static Compression

44
Lateral Bending ,Static Compression

4
Cadaveric specimens

n=4 Implants (E-d)

Lateral Bending stifness (Nm/°)


3 n=4

Figure 4.8 Lateral Bending Stiffness Comparison

Flexion- Extension, Lateral Bending with Dynamic Compression

All the specimens were tested under a coupled loading of flexion-extension

(4û- 2û) at 0.25 Hz, lateral bending (2û- 2û) at 0.75 Hz and a dynamic axial

compression of 300 to 700N (Figure 4.9 and 4.10). The flexion-extension stiffness

and lateral bending stiffness values were calculated like earlier stages. The flexion –

extension stiffness and lateral bending stiffness values were calculated for both the

groups and the means and standard deviations were obtained. The mean flexion-

extension stiffness for the cadaveric specimens was found to be 2.52±0.61 Nm/º and

that of synthetic implants (E-d) was found to be 1.9±0.2 Nm/º. The mean lateral

bending stiffness for the cadaveric specimens was found to be 2.57±0.45 Nm/º and

that of synthetic implants (E-d) was found to be 3.4±0.5 Nm/º (Figure 4.11). The

axial rotation angle was maintained at 0º for this test.

45
Flexion-Extension (Cadaveric specimens)

15

L1L2 Oct 30th '06


L1L2 Jan 10th '07
10 L2L3 Mar 19th '07

Flexion-Extension moment (Nm)


L3L4 Feb 20th '07

-5

-10
-3 -2 -1 0 1 2 3 4 5

Flexion -Extension angle (°)

Flexion-Extension (Implants E-d)

10
E-d1
8 E-d2
E-d3
Flexion-Extension moment (Nm)

E-d4
6

-2

-4

-6
-3 -2 -1 0 1 2 3 4 5

Flexion-Extension angle (°)

Figure 4.9 Flexion Extension Angle vs. Moment graphs for the coupled loading of
Flexion-Extension, Lateral Bending with Dynamic Compression

46
Lateral Bending (Cadaveric Specimens)

12
L1L2 Oct 30th '06
10 L1L2 Jan 10th '07
L2L3 Mar 19th '07
8 L3L4 Feb 20 '07
Lateral Bending moment (Nm)

-2

-4

-6
-3 -2 -1 0 1 2 3

Lateral Bending angle (°)

Lateral Bending(Implants E-d)

12

10 E-d1
E-d2
8 E-d3
Lateral Bending moment (Nm)

E-d4
6

-2

-4

-6

-8
-3 -2 -1 0 1 2 3

Lateral Bending angle (°)

Figure 4.10 Lateral Bending Angle vs. Moment graphs for the coupled loading of
Flexion-Extension, Lateral Bending with Dynamic Compression

47
Flexion-Extension, Lateral Bending with Dynamic Compression

Cadaveric specimens
Implants (E-d)
4
Stiffness (Nm/°)

0
Flexion-Extension Lateral Bending

Figure 4.11 Flexion- Extension and Lateral Bending Stiffness Comparison

Axial rotation with static compression

The specimens were tested under axial rotation (3û,-3û) at 0.25 Hz and a static

compression of 500N and keeping the flexion-extension and lateral bending angles at 0û.

The axial rotation or torsional stiffness was calculated by regressing the last five loading

and unloading cycles of the angle – torque graphs (Figure 4.12). The stiffness values

were calculated for both the groups and the means and standard deviations were

calculated. The mean axial rotation stiffness for the cadaveric specimens was found to be

2.87±1.04 Nm/ º and that of synthetic implants (E-d) was found to be 1.4±0.13 Nm/º

(Figure 4.13). The flexion-extension and lateral bending angles were maintained at 0º for

this test.

48
Axial Rotation, Static Compression (Cadaveric specimens)

15

L1L2 Oct 30th '06


L1L2 Jan 10th '07
10 L2L3 Mar 19th '07
L3L4 Feb 20th '07

5
Axial Torque (Nm)

-5

-10

-15
-4 -3 -2 -1 0 1 2 3 4

Axial Roation angle (°)

Axial Rotation, Static Compression (Implants E-d)

6
E-d1
E-d2
4 E-d3
E-d4

2
Axial Torque (Nm)

-2

-4

-6
-4 -3 -2 -1 0 1 2 3 4

Axial Rotation angle (°)

Figure 4.12 Axial Rotation Angle vs. Torque graphs for Axial Rotation with Static
Compression

49
Axial Rotation ,Static Compression

Cadaveric Specimens
n=4
Axial Rotation Stiffness (Nm/°) 4

2 Implants (E-d)
n=4

Figure 4.13 Axial Rotation Stiffness Comparison

Testing under modified ISO specifications

After every test mentioned above, an axial compression test was performed to

make sure there was no structural damage. The test under ISO specifications was

performed at the end of the experiment when it was established that the specimens

were not damaged in any way after the earlier tests and no changes in the axial

compression values were observed.

The complex loading was composed of flexion extension (6û,-3û) at 0.5 Hz, lateral

bending (2û,-2û) at 0.75 Hz, axial rotation (2û,-2û) at 0.75 Hz and a dynamic axial

compression of 900 to 1700N (Figures 4.14, 4.15 and 4.16).

50
The mean flexion-extension stiffness for the cadaveric specimens was found to

be 2.64±0.23 Nm/degree and that of synthetic implants (E-d) was found to be

1.4±0.17 Nm/degree. The mean lateral bending stiffness for the cadaveric specimens

was found to be 2.47±0.87 Nm/degree and that of synthetic implants (E-d) was found

to be 2.4±0.08 Nm/degree. The mean axial rotation stiffness for the cadaveric

specimens was found to be 2.93±0.69 Nm/degree and that of synthetic implants (E-d)

was found to be 1.2±0.07 Nm/degree.(Figure 4.17)

51
Flexion Extension, ISO (Cadaveric Specimens )

20
L1L2 Oct 30th '06
L1L2 Jan 10th '07
L2L3 Mar 19th '07
10 L3L4 Feb 20th '07

Flexion-Extension moment (Nm)


0

-10

-20

-30
-4 -2 0 2 4 6 8

Flexion -Extension angle (°)

Flexion-Extension (Implants E-d)

E-d1
6 E-d2
E-d3
Flexion-Extension moment (Nm)

E-d4
4

-2

-4

-6
-4 -2 0 2 4 6 8

Flexion -Extension angle (°)

4.14 Flexion Extension Angle vs. Moment graphs for Modified ISO

52
Lateral Bending ,ISO(Cadaveric Specimens)

L1L2 Oct 30th, 06


15
L1L2 Jan 10th '07
L2L3 Mar 19th '07
L3L4 Feb 20th '07
10
Lateral Bending moment (Nm)

-5

-10

-15
-3 -2 -1 0 1 2 3

Lateral Bending angle (°)

Lateral Bending (Implants E-d)

8
E-d1
6 E-d2
E-d3
E-d4
lateral Bending moment (Nm)

-2

-4

-6

-8
-3 -2 -1 0 1 2 3

Lateral Bending angle (°)

Figure 4.15 Lateral Bending Angle vs. Moment graphs for Modified ISO

53
Axial Rotation,ISO (Cadaveric specimens)

8
L1L2 Oct 30th '06
6 L1L2 Jan 10th '07
L2L3 Mar 19th '07
L3L4 Feb 20th '07
4
Axial Torque (Nm)

-2

-4

-6

-8
-3 -2 -1 0 1 2 3

Axial Rotation angle (°)

Axial Rotation (Implants)

E-d1
3 E-d2
E-d3
2 E-d4
Axial Torque (Nm)

-1

-2

-3

-4
-3 -2 -1 0 1 2 3

Axial Roation angle (°)

Figure 4.16 Axial Rotation Angle vs. Torque graphs for Modified ISO

54
ISO

4
n=4 Cadaveric Specimens
n=4 Implants (E-d)

3 n=4
n=4
Stiffness (Nm/°)

2
n=4
n=4

0
Flexion-Extension Lateral Bending Axial Rotation

Figure 4.17 Stiffness Comparisons (Modified ISO)

An independent t-test was performed using SAS software (SAS Institute, Cary,

NC) on the results to evaluate whether the two groups were significantly different. For

the test the synthetic and cadaveric disc types were taken as the independent variable and

the axial stiffness as the dependent variable. The significance level of the test was taken

as 0.05 (Table 4.1). All the results were also checked for possible outliers. No outliers

were detected.

55
Table 4.1 Statistical Results

Loading p-value Result


AC 0.0067 S
FE,AC 0.1092 NS
FE,DC 0.0431 S
LB,AC 0.1348 NS
FE ( FE,LB,DC) 0.1197 NS
LB ( FE,LB,DC) 0.0485 S
AR,SC 0.0027 S
FE ( Modified ISO) 0.0002 S
LB ( Modified ISO) 0.9304 NS
AR ( Modified ISO) 0.0027 S

S- Significantly different, NS – Not significantly different

4.2 Fatigue test

Fatigue comparisons were made between three structures: the cadaveric disc

structures, the Theken synthetic disc (E-d) and a pseudo Charite´ made by Theken Disc,

Akron, OH using the information available in literature about the Charite´ intervertebral

disc implant by Depuy Spine Inc. The disc structures were fatigued under complex ISO

loading specifications. Failure was characterized by a constant decrease in the height of

the specimen.

One sample from each type was taken and fatigued under the modified ISO

complex loading. The axial stiffness before and after the fatigue test were determined and

compared. The cadaveric discs were fatigued till they failed and failure was

characterized by a constant decrease in disc height. Changes in axial compression

stiffness, flexion-extension stiffness, lateral bending stiffness and axial rotation stiffness

before and after the test were evaluated for the three discs (Table 4.2- 4.5).

56
Table 4.2 Axial stiffness comparison under fatigue

Initial Axial
Disc Structures Stiffness After Fatigue (N/mm) % Difference
(N/mm)
L1L2 Tested-Jan
10th (Cad.) 1791 1065 (1500 cycles ) 41%
E-d 3 (Theken
Disc) 2188 2079 (1500 cycles ) 5%

Pseudo- Charite 5783 5431 (1500 cycles) 8%

Table 4.3 Flexion-Extension (FE) Stiffness comparison under fatigue

FE Stiffness FE Stiffness
Specimen
Initial Final
(Nm/º) (Nm/º)
L1L2 Jan 10th 3.21 2.71
E-d 3 1.80 1.60
Pseudo-Charite 1.23 1.24

Table 4.4 Lateral Bending (LB) Stiffness comparison under fatigue

LB Stiffness LB Stiffness
Specimen
Initial Final
(Nm/º) (Nm/º)
L1L2 Jan 10th 2.86 3.61
E-d 3 3.55 2.50
Pseudo- Charite 2.04 2.06

57
Table 4.5 Axial Rotation (AR) Stiffness comparison under fatigue

AR Stiffness AR Stiffness
Specimen Initial Final
(Nm/º) (Nm/º)
L1L2 Jan 10th 4.03 2.43
E-d 3 1.50 1.30
Pseudo- Charite 0.03 0.04

The maximum anterior-posterior (AP) shear force and lateral shear force values

were determined from the axial compression tests before and after the fatigue tests were

conducted on the specimens. A comparison of the shear forces before and after the

fatigue test is as given below (Table 4.6).

Table 4.6 Shear forces comparison

Specimen Max.AP Shear Max.AP Shear


Initial (N) Final (N)
L1L2 Jan 10th 14.6 -60.8
E-d 3 -0.5 -5.0
Pseudo- Charite´ -3.0 -5.4

Max.Lateral Max.Lateral
Specimen Shear Shear
Initial (N) Final (N)
L1L2 Jan 10th -5.7 1.5
E-d 3 -4.1 -3.6
Pseudo- Charite´ 1.0 0.2

58
The fatigue failure comparison between the three disc types was based on the

change in disc height before and after the fatigue test. Change in height was recorded

after the fatigue test was run on all the three specimens. The values are taken from the

axial compression tests before and after the fatigue tests. Only one specimen was

compared from each type.

Table 4.7 Disc height comparison under fatigue

Change
Specimen Disp.(mm) Disp. (mm)
in height
Initial Post Fatigue
(mm)
4.574 (1500
L1L2 Jan 10th 9.75 cycles) 5.17
9.41 (1500
9.6
E-d 3 cycles) 0.22
Pseudo- 17.23 (1500
17.3 0.10
Charite cycles)

The synthetic discs E-d have been tested under ISO fatigue test protocol for 7M

cycles without failure at Theken Disc, Akron, OH. The Charite´ disc is already

undergoing clinical trials and has been approved by the FDA after clearing the testing

criteria.

59
4.3 Failure

The ISO standards expect the implants to last for 10 million cycles of the complex

loading without failure. One objective of the study was to evaluate whether the actual

biological disc which is going to be replaced by the implant, would last under the testing

specifications. The failure of the biological disc structure was characterized by a

consistent decrease in specimen height. To determine the kind of failure the structure had

undergone, radiographs were taken and a bony failure was detected, which characterized

the structural failure.

Fracture

Figure 4.18 Radiographs to access damage to the cadaveric disc

60
4.4 Result tables

Table 4.8 Summary of biomechanical testing of Cadaveric disc L1L2 (October. 30th,
2006)

Oct 30th and 31st , 2006 L1-L2: Human

Axial
Axial Flex-Ext Lateral Stable Stable
Rot.
Stiff. Stiff. Stiff. Stiff. Max. Min. δ
(N/mm) (Nm/°) (Nm/°) (Nm/°) ( mm ) ( mm ) ( mm )

AC 1428.65 / / / 9.23 8.88 0.35


FESC 1.83 / / 8.70 8.60 0.11
FEDC 1.70 / / 8.62 8.51 0.10
LBSC / 2.24 / 8.47 8.39 0.07
LBFEC 1.67 2.22 / 8.48 8.34 0.15
ARSC / / 2.36 8.41 8.22 0.18
2.51 2.04 1.95 2.90 2.69 0.21
2.69 3.06 2.19 2.13 1.92 0.21
ISOb
2.65 2.97 1.90 1.28 1.14 0.14
2.87 2.96 1.92 1.00 0.84 0.16
AC 1674.74 / / / 1.72 1.35 0.38

* Highlighted row values in ISOb were used for calculations.

* For Table 4.8 to 4.15

AC- Axial Compression

FESC- Flexion-Extension with Static Compression

FEDC- Flexion- Extension with Dynamic Compression

LBSC- Lateral Bending with Static Compression

LBFEC- Lateral Bending, Flexion-Extension with Dynamic Compression

ARSC- Axial Rotation with Static Compression

ISOb- Modified ISO

AC- Axial Compression

61
Table 4.9 Summary of biomechanical testing of Cadaveric disc L1L2 ( January 10th,
2007)

Jan. 10, 2007 L1-L2: Human

Axial
Axial Flx-Ext Lateral Stable Stable
Rot.
Stiff. Stiff. Stiff. Stiff. Max. Min. δ
(N/mm) (Nm/°) (Nm/°) (Nm/°) ( mm ) ( mm ) ( mm )

AC 1791.38 / / / 9.75 9.48 0.28


FESC 3.21 / / 9.11 9.05 0.06
FEC 3.20 / / 9.48 9.36 0.11
LBSC / 2.86 / 9.43 9.29 0.14
LBFEC 3.11 3.14 / 9.51 9.27 0.23
TSC / / 4.03 9.34 9.24 0.11
FELBTC 2.82 2.99 4.05 9.46 9.23 0.23
2.56 2.88 3.29 6.63 5.98 0.65
ISOb 17 2.65 3.22 2.72 5.31 4.68 0.63
2.71 3.61 2.43 4.11 3.56 0.55
AC 1065.38 / / / 4.57 4.13 0.45

* Highlighted row values in ISOb were used for calculations.

62
Table 4.10 Summary of biomechanical testing of Cadaveric disc L3L4 ( February 20th,
2007)

Feb 20th and


21st, 2007 L3-L4: Human

Axial
Axial Flx-Ext Lateral Rot. Stable Stable
Stiff. Stiff. Stiff. Stiff. Max. Min. δ
(N/mm) (Nm/°) (Nm/°) (Nm/°) ( mm ) ( mm ) ( mm )

AC. 1294 / / / 8.18 7.85 0.33


FESC / 1.85 / / 8.04 7.8 0.24
FE DC 2272 2.61 / / 7.97 7.8 0.17
LB SC / 2.72 / 7.91 7.53 0.39
FE LB DC 2.56 2.71 / 8.07 7.76 0.31
AR SC 3.4 / / 8.45 8.17 0.28
ISOb 2.98 3.46 2.97 5.37 5.11 0.25
2.73 3.35 2.73 5.03 4.75 0.28
2.53 3.19 2.56 4.64 4.32 0.32
3.07 3.21 2.41 4.28 3.94 0.34
2.83 3.06 2.32 3.97 3.6 0.37
2.59 3.03 2.05 3.5 2.85 0.66
2.65 3.21 1.91 3.07 2.25 0.82
AC 809 / / / 3.6 3.17 0.43

* Highlighted row values in ISOb were used for calculations.

63
Table 4.11 Summary of biomechanical testing of Cadaveric disc L2L3 (March 19th,
2007)

March 19th , 2007 L2 L3 Human

Axial Flx-Ext Lateral Axial Rot Stable Stable


Stiff. Stiff. Stiff. Stiff. Max. Min. d
(N/mm) (Nm/°) (Nm/°) (Nm/°) ( mm ) ( mm ) ( mm )

AC 1449.00 / / / 10.20 9.87 0.33


FESC 2.90 / / 10.00 9.80 0.19
FEDC 2.82 / / 9.84 9.68 0.16
LBDC / 2.11 / 9.86 9.44 0.41
FELBDC 2.76 2.20 / 9.85 9.64 0.22
ARSC / / 1.70 10.35 10.06 0.29
Axial Comp. 11 / / / 9.90 9.64 0.26
2.50 1.49 3.43 9.06 8.00 1.06
2.43 1.19 3.00 9.03 7.80 1.23
ISOb 18
2.19 1.01 2.70 8.95 7.73 1.22
2.31 1.03 2.60 8.83 7.60 1.23

* Highlighted row values in ISOb were used for calculations.

64
Table 4.12 Summary of biomechanical testing of Synthetic disc E-d1 (November 6th,
2006)

Nov 06,2006 E-d1

Axial
Axial Flx-Ext Lateral Rot. Stable Stable
Stiff. Stiff. Stiff. Stiff. Max. Min. δ
(N/mm) (Nm/°) (Nm/°) (Nm/°) ( mm ) ( mm ) ( mm )

AC 1964.59 / / / 8.96 8.66 0.3


FE SC 1.65 / / 8.75 8.65 0.1
FE DC 1.75 / / 8.78 8.62 0.15
LB SC / 2.68 / 8.74 8.24 0.5
FE LBDC 1.69 2.83 / 8.81 8.59 0.22
AR SC / / 1.25 8.64 8.62 0.02
ISOb 1.2 2.36 1.14 8.2 7.85 0.35

Table 4.13 Summary of biomechanical testing of Synthetic disc E-d2 ( April 10th, 2007)

April 10th and 11th,


2007 E-d2

Axial
Axial Flx-Ext Lateral Rot. Stable Stable
Stiff. Stiff. Stiff. Stiff. Max. Min. δ
(N/mm) (Nm/°) (Nm/°) (Nm/°) ( mm ) ( mm ) ( mm )

AC 2207 / / / 9.59 9.37 0.22


FE SC 1.76 / / 9.44 9.37 0.07
FE DC 1.74 / / 9.46 9.34 0.12
LB SC / 2.72 / 7.91 7.52 0.39
FE LB DC 1.85 3.71 / 9.53 9.28 0.26
AR SC / / 1.45 9.66 9.63 0.03
ISOb 1.43 2.36 1.25 9.55 8.39 1.16

65
Table 4.14 Summary of biomechanical testing of Synthetic disc E-d3 (April 10th, 2007)

April 10th and 11th,


2007 E-d3

Axial
Axial Flx-Ext Lateral Rot. Stable Stable
Stiff. Stiff. Stiff. Stiff. Max. Min. δ
(N/mm) (Nm/°) (Nm/°) (Nm/°) ( mm ) ( mm ) ( mm )

AC 2721.36 / / / 9.57 9.52 0.05


FE SC 1.86 / / 9.52 9.43 0.09
FE DC 1.8 / / 9.51 9.39 0.12
LB SC / 2.86 / 9.6 9.1 0.5
FE LB DC 2.23 3.13 / 9.63 9.36 0.27
AR SC / / 1.41 9.42 9.4 0.02
ISOb 2.18 3.33 1.47 9.6 9.35 0.24
AC 1.66 2.59 1.29 8.89 8.53 0.36

Table 4.14 Summary of biomechanical testing of Synthetic disc E-d3 ( April 10th, 2007)

April 10th and 11th,


2007 E-d4

Axial
Axial Flx-Ext Lateral Rot. Stable Stable
Stiff. Stiff. Stiff. Stiff. Max. Min. δ
(N/mm) (Nm/°) (Nm/°) (Nm/°) ( mm ) ( mm ) ( mm )

AC 2187.93 / / / 9.64 9.42 0.23


FE SC 1.8 / / 9.45 9.45 0
FE DC 1.78 / / 9.48 9.34 0.14
LB SC / 3.55 / 9.55 9.05 0.49
FE LB DC 2 3.85 / 9.57 9.3 0.27
AR SC / / 1.5 9.39 9.37 0.02
ISOb 1.57 2.51 1.29 8.82 8.4 0.43
AC / / / 9.42 9.18 0.24

66
Table 4.15: Summary of biomechanical testing of pseudo- Charite ( February 20th, 2007)

Feb 20th 2007 Pseudo Charite

Axial
Axial Flx-Ext Lateral Rot. Stable Stable
Stiff. Stiff. Stiff. Stiff. Max. Min. δ
(N/mm) (Nm/°) (Nm/°) (Nm/°) ( mm ) ( mm ) ( mm )

AC 19928.5 / / / 8.33 8.27 0.06


FE SC 0.92 / / 8.36 8.23 0.13
FE DC 0.96 / / 8.35 8.23 0.12
LB SC / / 0.52 8.37 8.25 0.12
FE LB DC 0.92 0.48 / 8.43 8.18 0.25
AR SC / / 0.03 8.29 8.29 0
ISOb 0.9 0.43 0.04 8.4 8.08 0.32
AC / / / 8.3 8.25 0.05

67
CHAPTER V

DISCUSSION

5.1 Overview

An intervertebral disc implant is expected to allow normal physiologic motion

and permit the spine to regulate its motion instead of spinal motion adapting to the

implant. The implant should address the in vivo loading conditions, and it should resist

wear and material delamination [30].

This study aims at evaluating two implants against the biological disc structure

that they are designed to replace. It is an attempt to assess whether the structural

properties of one of the implants (E-d) are comparable to the actual cadaveric disc

structures so as to get an idea of how well the implant could mimic the structural

properties of an actual disc structure. The comparison is also made between the cadaveric

disc structure and two implant designs on the basis of fatigue characteristics, which

essentially focuses on finding out the durability of the implant against the biological

structure under the recommended loading. The study also aims at evaluating the ISO

testing specifications for the intervertebral disc implants. We believe that they are so

demanding that even the actual biological disc structure would fail under such loadings.

Thus, expecting an implant to pass these tests would perhaps lead to more robust designs

but it could also lead to possible rejection of some good implant designs that may not last

as long under the test environment as the ISO standards require.


68
5.2 Single and multi-axial tests

The objective of these tests was to make a comparison between the groups under

complex modified ISO loading. We started the test with single axis loading and then

introduced one type of load at every step of the testing protocol. The structural properties

of the two groups were compared for all the single and multi-axis tests.

Axial compression

The cadaveric discs and the implants E-d were tested under a cyclic compression

of 100-600N at 0.25 Hz. The axial stiffness of the two groups was significantly different

(p =0.0067). The average value for the cadaveric disc structures was found to be 1490±

212 N/mm and that of the implant was 2454±320 N/mm. The higher value of the mean

axial stiffness for the implants might be because one of the implants was mistakenly

tested under a smaller range of axial compression which led to a higher value of axial

stiffness for that specimen.

Flexion-Extension loading, lateral bending loading and axial rotation loading with static

compression

When the specimens were tested under flexion-extension (4º,-2º), lateral bending

(2º,2º) and axial rotation (2º, 2º) individually with a static compression of 500N, there

was no significant difference detected between the flexion-extension stiffness values for

the flexion-extension loading with static compression (p =0.1092) and lateral bending

stiffness values for the lateral bending with static compression test (p=0.1348) for the two

groups. There was a significant difference in the axial rotation stiffness values for the

axial rotation with static compression test (p=0.0027). The mean flexion-extension

stiffness for cadaveric specimens was 2.44 ±0.71 Nm/º and that of synthetic implants (E-

69
d) was 1.77±0.09 Nm/º. The mean lateral bending stiffness for cadaveric specimens was

2.48±0.37 Nm/ º and that of synthetic implants (E-d) was 2.9±0.4 Nm/º. The mean axial

rotation stiffness for the cadaveric specimens was found to be 2.8±1.04 Nm/º and that of

synthetic implants (E-d) was found to be 1.4±0.13 Nm/º. The loading characteristics for

all the three loadings were similar for the two groups.

Therefore, based on these results we conclude that the two disc types behave

similarly under flexion-extension and lateral bending and there behavior is different in

axial rotation. In other words, the implants mimic the structural properties of the

cadaveric discs in flexion extension and lateral bending.

Flexion –extension loading with dynamic compression

The flexion-extension stiffness values were significantly different for the two

groups (p=0.0431). The mean flexion-extension stiffness for cadaveric specimens was

2.58±0.64 Nm/º and that of synthetic implants (E-d) was 1.78±0.03 Nm/º. Based on the

results we conclude that the implants could not mimic the structural properties of the

cadaveric discs under the given loading.

Flexion- extension, lateral bending with dynamic compression

In the coupled loading with flexion – extension (4º,-2º), lateral bending (2º,-2º)

and axial compression (300-700N), there was no significant difference in the flexion –

extension stiffness values between the two groups (p=0.1197). However, there was a

significant difference in the lateral bending stiffness values (p= 0.0485). Under a coupled

load, the two disc types behave differently.

70
Complex modified ISO loading

The complex loading was consisted of flexion extension (6˚,-3˚) at 0.5 Hz, lateral

bending (2˚,-2˚) at 0.75 Hz, axial rotation (2˚,-2˚) at 0.75 Hz and a dynamic axial

compression of 900 to 1700N. Under the modified ISO loading specifications the flexion

–extension stiffness values for the two groups were determined to be significantly

different (p = 0.0002). The axial rotation stiffness values for the two groups were also

significantly different (p= 0.0027). The lateral bending stiffness values were comparable

for the two groups. The loading characteristics for flexion-extension were a little skewed

but that could not have affected the stiffness value determination as the slope of the linear

region of the loading and unloading cycles was considered for stiffness value

determination. The mean flexion-extension stiffness for the cadaveric specimens was

found to be 2.64±0.23 Nm/º and that of synthetic implants (E-d) was found to be

1.4±0.17 Nm/º. The mean lateral bending stiffness for the cadaveric specimens was found

to be 2.47±0.87 Nm/º and that of the synthetic implants (E-d) was found to be 2.4±0.08

Nm/º. The mean axial rotation stiffness for the cadaveric specimens was found to be

2.93±0.69 Nm/º and that of synthetic implants (E-d) was found to be 1.2±0.07 Nm/º.

Thus, the two groups have different structural properties under complex modified ISO

loading. From the nature of the graphs for different loadings it can be seen that all the

implants behaved fairly similarly as expected while the cadaveric specimens showed

variability. In certain cases where there was a sudden change in the moment values,

which could be attributed to a protruded bone spur.

Therefore, on the basis of the results that we obtained from this study, we

conclude that there are statistical differences with respect to structural stiffness values

71
between the two groups with respect to transverse and saggital planes. No significant

difference was found in the stiffness values in the frontal planes when tested under ISO

specifications. On this basis, we reject the null hypothesis.

5.3 Fatigue characteristics comparison

One specimen from each of the three groups was tested under fatigue to

compare the durability of the three disc structures under the given modified ISO loading

specification. The axial stiffness and disc height dropped considerably for the biological

disc after nearly 1500 cycles of complex modified ISO loading. However, the stiffness

values and disc heights for the implants (both E-d and pseudo Charite´) remained

comparatively unaffected at similar loading cycles. This implies that the cadaveric discs

were weaker compared to the implants and could not withstand the loading conditions.

For testing the cadaveric specimens large portions of vertebral bodies were removed

because the testing equipments could only accommodate specimens with a height less

than 5.1 mm. This modification accelerated the early failure of the cadaveric disc

structure as the bony region failed first. Using intact vertebral bodies with larger test

grips would perhaps allow the specimens last longer than the average 1500 cycles at

which all the cadaveric specimens failed.

Another possible reason that might have been instrumental in an early failure of

the cadaveric disc structure might be the testing standards. We do not have enough

knowledge of the type of physiological loads the spine has to withstand but perhaps they

are too extreme as compared to the actual physiological loadings. If the implants pass this

test, they may be robust designs. But it also raises a question about the ISO testing

standards because if the biological structure failed at a very small percentage of the

72
expected life (i.e. number of cycles) of the implant under testing environment, then

perhaps the testing specifications are too demanding and this may lead to rejection of

some good designs which may not last for the specified time under the testing conditions.

Failure was characterized by decreased height of the specimen. The cadaveric

disc structures failed very early and even though the intervertebral disc material did not

seem to fail, the disc structure collapsed due to the bony structure failure. A similar

failure was observed in all the cadaveric specimens. The bony vertebral bodies could not

bear the extreme loadings and experienced fracture due to fatigue.

Since other biological structures like facet joints, ligaments etc. would be present

in real life situations and the loads would be distributed among all the spinal structures,

the assumption that the intervertebral disc should bear such high loads as specified by the

ISO is questionable. Another question that this study raised is do we really need such a

robust implant? If other biological structures begin to deteriorate with age, would the

normal implant change the load distribution in other spinal structures? Testing the

cadaveric disc structures under ISO specifications gave us an insight into how much and

what kinds of loads (i.e. individually or in a combination) the intervertebral disc structure

can bear. Comparison with the available in vivo loading information can provide a better

understanding of the loads the biological structure can withstand.

The pseudo Charite´ proved superior to the other two disc structures in both axial

stiffness and axial shift comparison. A possible reason for this is that the design of the

pseudo Charite´ is different compared to the other two disc structures which share a

similar basic design. The difference in the material properties and the different design

might have contributed to the more robust structure of the pseudo Charite´.

73
5.4 Limitations of the study

The results of this study should be considered in light of the following limitations:

• The limited number of cadaveric specimens was an important issue. Increasing

the number of specimens and including more segments from different donors

would give us a better understanding of the performance of the cadaveric discs

as the variability in the properties was high among the small group that was

studied.

• As discs from different vertebral levels were used, there could be a difference in

the segment material properties, even though the author does not have any

references to support this speculation. If segments from different levels could be

tested and compared, we might be able to understand if the results were affected

due to variation in material properties.

• The information regarding the age of the donors was not available to the author.

The age of the specimens could possibly have an effect on the results. Since

with specimens taken from old donors, there is a possibility that degeneration

had already set in.

• The information regarding the bone mineral density was not available to the

author. If any of the cadaveric specimens was osteoporotic, it might have

affected the results. Testing the specimens for bone mineral density could help

us understand the results better.

• The radiographs shown after were not taken immediately at failure as we used

the drop in disc height as our criteria and observed it until we were sure that the

74
discs had failed. Therefore, we could not determine the specific bony region

where the failure might possibly have set in.

• We could not allow the specimen height of more than 5.1 cm due to the design

of the testing equipment and, thus, had to remove a considerable part of the

bones. This might have caused the cadaveric specimens to fail at a lower range

of cycles.

5.5 Future work

These limitations should be considered when designing the studies in the future,

and a few suggestions are:

• Designing 3D finite element models for the biological intervertebral disc

structures so that and the implants can facilitate the study of the performance of

these discs without actually performing the experiments. This would also aid in

changing the loading conditions and finding their effect on the different disc

designs. The effects due to variability of properties in cadaveric specimens

could be eliminated using a 3D model.

• A prior knowledge of the age, bone mineral density etc. would help in selecting

the appropriate cadaveric specimens for testing.

• The results obtained would be more reliable if discs from a single vertebral level

would be used.

75
BIBLIOGRAPHY

1. Adams M, Hutton W. The effect of posture on the role of the apophysial joints in
resisting intervertebral compressive force. Journal of bone joint surgery. 1980; 62-
B; 358-62.

2. Adams M, Dolan P. Recent advances in lumber spine mechanics and their clinical
significance. Clinical Biomechanics Vol. 10, No. 1, pp 3-19, 1995.

3. Adams M, & Dolan P. Spine Biomechanics. Journal of Biomechanics 38 (2005)


1972- 1983.

4. Bao Q, McCillen G, Higham P, Dumbleton J, Yuan H. The artificial disc: theory,


design and materials. Biomaterials. 1996 Vol. 17 No. 12.

5. Bibby S, Jones A, Lee B, Yu J, Urban G. ‘The pathophysiology of the


intervertebral disc’ , Joint Bone Spine 2001 ; 68 : 537-42

6. Blumenthal S, Ohnmeiss D, Guyer R, Hochschuler S, McAfee P, Garcia R, Salib


R, Yuan H, Bertagnoli R, Bryan V. Artificial intervertebral discs and beyond : a
North American spine society annual meeting symposium The Spine Journal 2
(2002) 460-463.

7. Broom N. Biomechanics of load bearing of the intervertebral disc: an


experimental and finite element model. Medical Engineering and Physics. Vol.
19, No. 2. pp 145- 156, 1997.

8. Cassinelli E, Kang J. Current understanding of lumbar disc degeneration.


Operative Techniques in Orthopedics. Vol. 10, No 4 (October), 2000: pp 254 -
262.

9. Cunningham B. Basic scientific considerations in total disc arthroplasty. The


Spine Journal 4 (2004) 219S -230S.

10. Denoziere G, Ku D. Biomechanical comparison between fusion of two vertebrae


and implantation of an artificial intervertebral disc. Journal of Biomechanics 39
(2006) 766-775.

76
11. Dunlop R, Adams M, Hutton W. Disc space narrowing and lumbar facet joints.
Journal of Bone Joint Surgery 1984; 66-B 706-10.

12. Ebraheim N, Hassan A, Lee M, Xu R. Functional Anatomy of Lumbar spine.


Seminars in pain medicine. 2: 131: 137, 2004.

13. Freeman B, Davenport J. Total disc replacement in the lumbar spine: a systematic
review of the literature. European Spine Journal (2006) 15 (Suppl. 3): S439-S447.

14. Gamradt S, Wang J. Lumbar disc arthroplasty. The Spine Journal 5 (2005) 95-
103.

15. Hannen M. Wear properties of UHMWPE in CHARITE artificial intervertebral


disc Mechanics of contact and lubrication, MTM G230. Department of
mechanical and industrial engineering. Northeastern University. Spring 2006.

16. Hilke W, Wegner L. Testing criteria for spinal implants: recommendations for the
standardization on in vitro stability testing of spinal implants. European Spine
Journal (1998) 7: 148-154

17. Kent M, Keating J. Epdemiology of low back pain in primary care. Chiropractic
and Osteopathy 2005, 13:13 doi:10.1186/1746-1340-13-13

18. Kotani Y, Cunningham B, Abumi K, Dmitreiv A, Hu N, Ito M, Shikinami Y,


McAfee C, Minami A. Multidirectional flexibility analysis of anterior and
posterior artificial disc reconstruction: In vitro human cadaveric spine model.
European Spine Journal. (2006) 15: 1511- 1520.

19. Lotz J. The biomechanics of prevention and treatment for low back pain: 2nd
international workshop. Clinical Biomechanics 14 (1999) 220-223.

20. MacLean J, Owen J, Iatridis J. Role of endplates in contributing to compression


behaviors of motion segments and intervertebral discs. Journal of Biomechanics
40 (2007) 55- 63.

21. Patel A,Welch W. Posterior lumbar interbody fusion with metal cages: current
techniques. Operative Techniques in Orthopedics. Vol. 10, No. 4 (October) 2000.
pp 311-319.

22. Petersilge C. Lumbar disc replacement .Seminars in Musculoskeletal Radiology/


Volume 10, No.1 2006.

23. Sadoughi A. Low back pain, Seminars in Anesthesia, Perioperative Medicine and
Pain, Vol. 22 No.3 (September) 2003, pp- 159-167.

77
24. Shikinami Y, Kotani Y, Cunningham B, Abumi K, Kaneda K. A biomimetic
artificial disc with improved mechanical properties compared to biological
intervertebral discs. Advanced Functional Materials. 2004. 14, No 11, November.

25. Spenciner D, Greene D, Paiva J, Palumbo M, Crisco J. The multidirectional


bending properties of the human lumbar intervertebral disc. The Spine Journal 6
(2006) 248- 257.

26. Szpalski M, Gunzburg R, Mayer M. Spine arthroplasty: a historical review.


European Spine Journal (2002) 11 (Suppl. 2): S65-S84.

27. Tortora G, Grabowski S. Principles of Anatomy and Physiology, tenth edition


,2003.

28. Yoganandan N, Myklebust B, Wilson R, et al. Functional biomechanics of the


thoracolumabar vertebral cortex. Clinical Biomechanics. 1988; 3: 11-18.

29. Yu C, Tsai K, Hu W, Lin R, Song H, Chang G. Geometric and morphological


changes of the intervertebral disc under fatigue testing. Clinical Biomechanics 18
(2003) S3-S9.

30. Zigler J. Lumbar spine arthroplasty using ProDisc II The Spine Journal 4 (2004)
260S -267S.

31. www.spinemd.com/artificialdisc.htm; online link. [Dated May 2007]

32. http://www.mitr.p.lodz.pl/biomat/discs.html; online link [Dated May 2007]

33. http://www.regence.com/trgmedpol/surgery/sur127.html; online link [Dated May


2007]

34. Spinal Anatomy Health Information - SofamorDanek_com.htm; online link


[Dated May 2007]

35. http://www.ninds.nih.gov/disorders/backpain/detail_backpain.htm; online link


[Dated May 2007]

36. http://www.neurosurgeon.org/pem/pdf/20040418_SpineAnatomyandSpineGenera
l.pdf 05/25/07; online link [Dated May 2007]

37. http://www.mayfieldclinic.com/PE-AnatSpine.htm; online link [Dated May 2007]

38. http://www.spineuniverse.com/displayarticle.php/article1393.html; online link


[Dated May 2007]

78
39. http://bone-muscle.health-cares.net/lordosis-causes.php; online link [Dated July ,
2007]

40. http://bone-muscle.health-cares.net/kyphosis-causes.php; online link [Dated July,


2007]

79