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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 Dr. Glen O. Njus

____________________________ Dean of the College Dr. George K. Haritos

____________________________ Committee Member Dr.Stanley Rittgers

____________________________ Dean of the Graduate School Dr. George R. Newkome

____________________________ Department Chair Dr. Daniel B. Sheffer

____________________________ Date

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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

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1197). 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. Stiffness values for single axis loadings and disc heights were used for comparison and failure was characterized by a decrease in disc height. Fatigue characteristics of the cadaveric intervertebral disc structures. All the discs were fatigued under modified ISO testing specifications. E-d and a pseudo Charite´ which was designed and fabricated similar to the Charite´ intervertebral disc (Depuy Spine.significant difference in the lateral bending stiffness values between the two groups (p=0. iv . Inc). were determined and compared. 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.0485) but no significant difference was seen in the flexion-extension stiffness values (p=0.

.1 1.2.. v . 2. 2... LIST OF FIGURES………………………………………………………………… CHAPTER I. 2.1 Structure and function of intervertebral disc……………. Hypothesis…………………. INTRODUCTION…………………………………………………. 1. 2.2 1.………….…………………….………...…………………………………… 2.4.………………………….. 2..... Intervertebral disc.…………………………………….……..…………………………………… 1 1 5 6 7 7 10 10 10 11 12 12 12 14 viii x LITERATURE REVIEW…. Objectives of the study……………………………………….......2 Structure and function of spine ………………………………….TABLE OF CONTENTS Page LIST OF TABLES…………………………………………………………………..4.2 Intervertebral disc degeneration………………………….1 2.4 Lower back pain………………………………………………….3 II..3 2.2 Mechanical damage……………………………………….4..3 Association with pain……………………………………...……..2. Mechanical loading of spine………………………….. Overview………. 2..1 Mechanical function………………………………………..

4 Biomechanical testing…………………………………………….………………………… 3... 4. METHODOLOGY………………..8 Statistical analysis………………………………………………… IV.7 Data analysis……………………………………………………….3 Failure…………………………………………………………….2..4. 3.2 Sample size determination……………………. RESULTS……………………….1 Cadaveric specimens …………………………………….3.…………… 3.…………...………………………… 3.6 Data acquisition…………………………………………………… 3.…………………….…………………….……………….. 3.. 3. 3.….……… 3... 3...………………………….……….3 Sample preparation…..……………….1 Specimens …………………………….1 Single and multi axial testing ……………………………………..….2 Fatigue test………………………………………………………… 4. 3. 15 17 20 22 22 23 24 24 28 29 29 32 32 34 35 36 37 37 56 60 vi .2 Intervertebral disc implants……..7 Loads on the biological disc and the need to mimic them in the replacements……………………………………………………… III.5 Treatment options for lower back pain generated due to damaged or degenerated disc ………………………………………………… 2..5 Testing protocol…………. 3. 4.1 Cadaveric specimen……………………………….4.2 Intervertebral disc implants………………………..………..6 Disc Arthroplasty: Artificial intervertebral disc…………………… 2.…………………………………….3.

76 vii .……….. 5.……. 5. 5..2 Single and multi axial testing……………………………………. 68 68 69 72 74 75 BIBLIOGRAPHY………………………………………………….V.3 Fatigue characteristics comparisons………………………………. 5..1 Overview……….4 Limitations of the study…………………………………………. DISCUSSION 5.……...……………………………….………….5 Future work………………………………………………………..

………… Shear forces comparison……………………………………….1 2.……………. Disc height comparison under fatigue…………………………………….6 4.4 4. Loads on spine……………………………………………………………..7 4. Summary of biomechanical testing of cadaveric disc L1L2 (January 10th.……………………………………………..LIST OF TABLES Table Page 2..3 4. 2006) ……………………. 2007)………………………………………………………………………. Summary of biomechanical testing of synthetic disc E-d1 (November 6th.5 4.9 62 4.3 4.8 Proposed designs for intervertebral disc prosthesis……………………….. 2007)………………………………………………………………………. Lateral bending (LB) stiffness comparison under fatigue………………… Axial rotation (AR) stiffness comparison under fatigue……….. 2006) ……………………….. Testing parameters………………………………………………………… Statistical results………………………………………………………….11 64 4.12 65 . Summary of biomechanical testing of cadaveric disc L3L4 (February 20th... Summary of biomechanical testing of cadaveric disc L2L3 (March 19th.. Flexion-extension (FE) stiffness comparison under fatigue……………….………………………………….1 4...…………. viii 18 20 21 56 57 57 57 58 58 59 61 4..10 63 4.2 4. 2007)………………………………………………………………………..2 2. Axial stiffness comparison under fatigue…………………………………. Summary of biomechanical testing of cadaveric disc L1L2 (October 30th.

2007) 65 4.Charite´ (April 10th. ……………………………………………. 2007)………….. …….…. Summary of biomechanical testing of synthetic disc E-d4 (April 10th. Summary of biomechanical testing of synthetic disc E-d3 (April 10th.….…….16 ix . ……………………………………………. ………………………………………………..13 Summary of biomechanical testing of synthetic disc E-d2 (April 10th.14 66 4.……. 2007)…………. Summary of biomechanical testing of pseudo.4. 2007)…………. ….15 66 67 4.…….

Intact posterior region of the motion segment……………………………. OH) and pseudo Charite´ …………………….5 3..9 A three dimensional coordinate system (according to ISO 2631)………… Human spine ……………………………………………………………… Motion segment …..………………………….7 3..……………………………………………………….3 2. Page 5 8 8 9 9 13 25 25 25 25 26 26 27 27 28 3..1 3..… Specimen with both vertebral bodies potted in PMMA and ready for testing ……………………………………………………………….3 3.………………………………… Alginate positive …………………………….2 3.…… E-d (Theken Disc.. Intervertebral disc………………………………………………………….10 28 29 3.…………. Akron.1 cm………………………………………………….2 2.1 2. Intact motion segment (Side view)……………………………………….4 2.…………………………………..6 3.11 x ....4 3.5 3. Motion segment in alginate……………………. After removal of the posterior region…………………………………….8 3. Intact motion segment (Top view)…………………………….……………………………………………………… Spinal cord and nerve roots………………………………………………. Specimen with one potted vertebral body and Steinman pin in other vertebral body……………………….…………………………… Final specimen of 5.. Spinal ligaments…..1 2. An alginate negative…………………….LIST OF FIGURES Figure 1.

Moment graphs for Cadaveric Discs and Synthetic Implants E-d for Flexion-Extension with Static Compression………. Axial Stiffness Comparison……………………………………………….3 Cadaveric testing specimen……………………………………………….8 4. 48 4...12 3. Lateral Bending Angle vs.17 3. 30 31 31 32 34 35 35 38 39 40 41 4. Loading pattern for modified ISO………………………………………… Data acquisition software………………………………………………….13 3.4 4....15 3.12 Axial Rotation Angle vs.. Lateral Bending with Dynamic Compression……….18 4. xi 49 . Torque graphs for Axial Rotation with Static Compression……………………………………………………………….6 4. Lateral Bending with Dynamic Compression……….2 4. Flexion –Extension Angle vs.1 4.5 4.7 Flexion. 42 43 Flexion-Extension Stiffness Comparison………………………………….3.. Moment graphs for Cadaveric Discs and Synthetic Implants E-d for Lateral Bending with Static Compression…………………….11 Flexion-Extension and Lateral Bending Stiffness comparisons…………. Lateral Bending Angle vs. Load – displacement graphs for Cadaveric Discs and Synthetic Implants. Moment graphs for Cadaveric Discs and Synthetic Implants E-d for Flexion-Extension with Dynamic Compression……. Moment graphs for the coupled loading of Flexion-Extension.. 44 45 4..14 3.10 47 4. Multi Axial Endura Tech Testing system………………………………….16 3. Typical graphs obtained from one of the data sets………………………..9 Lateral Bending Stiffness Comparison……………………………………. 46 4.. Implant testing……………………………………………………………. Moment graphs for the coupled loading of Flexion-Extension. Flexion-Extension Angle vs.Extension Stiffness Comparison………………………………… Flexion –Extension Angle vs. Temperature monitoring system………………………………………….

.15 4...…. Moment graphs for Modified ISO……………. Radiographs to assess damage to the cadaveric disc……………………… 50 52 53 54 55 60 xii .…..14 4. Moment graphs for Modified ISO…………. Flexion-Extension Angle vs. Axial Rotation Angle vs.16 4.13 4. Moment graphs for Modified ISO…….18 Axial Rotation Stiffness Comparison………………………………….17 4.….4.. Lateral Bending Angle vs..……….. Stiffness Comparisons (Modified ISO)………………………….

about 2% of the work force in US has compensable back injuries every year [23]. the intervertebral disc has been associated with it the most. objectives and the hypothesis.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. 1 . About 1% of the US population faces chronic disability due to back pain and 1% suffer temporary disability. the lumbar case increased from 39 to 47% in 2003. mainly because of the age –related deterioration. The changes in the intervertebral disc generally precede or coincide.1 Overview Lower back pain continues to remain a major reason of morbidity around the world. with other degenerative changes in the spine [8]. The healthcare expenditure on US is very high and the prevalence in similar in men and women. Even though almost every anatomical structure in the lower back has been implicated. 17]. Few of those who are disabled for more than six months have a chance of returning to work and after two years of disability. The annual cost of low back disability in US has been estimated about 50 billion dollars [23. their chances of reemployment almost vanish [23]. 1. With an average incidence rate of 60%.Among the back related injuries.

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. The loss of mobility may result in stiffness and loss of functional capacity. fusion impairs the normal motion and even though it may be considered a standard treatment in many instances. trauma can also lead to disc damage. flexibility and shock absorbing characteristics. etc. even paralysis. spinal cord compression. it is not enough to restore the nucleus to its original load sharing capacity [35. Degeneration may cause a lot of symptoms such as back pain. As the discs age. 19]. When the conservative measures fail and a damaged disc or segmental instability directly damages the neural elements or threatens to do so. 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. 2 . loss of muscle control and in extreme cases. The damaged disc may also lead to segmental instability. 32]. However. Besides age related deterioration.The degeneration of the intervertebral discs is a natural process. Even though it is effective in relieving pain caused by herniated disc. a number of issues develop. Decompression involves removal of the disc material that compresses the spinal nerve causing pain and sensory changes in the affected nerve. This compression of spinal nerves may result in pain. Intervertebral discs act in part as cushions that provide shock absorption between the vertebrae. With increasing age. operative intervention becomes necessary. the discs lose their elasticity. nerve root pathology. they shrink and therefore the disc height reduces and the space available for nerve roots and spinal cord also reduces [31].

Except a couple of artificial intervertebral disc designs. most of the designs are under clinical trials [31]. difficulties in fitting the implant and the size and weight of the implant make the design.g. development and surgical techniques a challenge. Very little to no current technology/ techniques. Biochemical problems. In determining the durability of the implant. 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. which intends to maintain the motion of the operative level by removing the damaged disc and limits the adjacent segment breakdown. The complex strains supported by the intervertebral disc make the implant development even more difficult.An alternative to spinal fusion is total disc replacement (spinal arthroplasty). durable and reliable structure. This is a current focal point in the European and North American surgical and industrial areas. as the spine undergoes 100 million flexion cycles during lifetime (not including the slight motion during breathing which is about 6 million a year). Further. which are still not being extensively used. Different loading conditions and motion controls must be considered too. have been used to study what is being replaced. the optimal life for the implant is found to be 30 million cycles and a minimum of 10 million cycles [26]. the current testing protocols given by American 3 . the focus has been on using current technology and techniques on the replacement. The vast majority of this information is decades old [26]. However. the information regarding the loads that it will be exposed to needs to be known.. For e. the development of an artificial intervertebral disc which would be an efficient. As the intervertebral disc is a complex anatomic and functional structure. is a challenge.

4 . As the motion preservation devices are gaining popularity.-3º). We tested the cadaveric disc structures and the synthetic intervertebral disc implants under the testing specifications provided by the ISO for artificial intervertebral discs. 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. The complex loading included a combination of flexion-extension (6º.-2º). Figure 1.1 gives an illustration of the coordinate system and the type of loads the specimens were subjected to. their preclinical mechanical testing is of prime importance to predict their in vivo safety and efficacy. left and right lateral bending (2º. the loads that spine undergoes during daily activities are still not completely known. much less understood. axial rotation (2º.society for testing and materials (ASTM) and the International Standards Organization (ISO) differ [15]. This study aimed at evaluating the intervertebral disc implants for structural properties in comparison with the biological intervertebral disc.-2º) and axial compression (900-1700N). Also.

To test the human cadaveric intervertebral discs under complex loads (modified ISO) in vitro. OH) and a Pseudo Charite´ (C-p) designed like Charite´ artificial intervertebral disc (DePuy Spine. the elastomeric intervertebral disc implant (Theken Disc. To compare the fatigue characteristics of the cadaveric disc structure. 3.2 Objectives of the study 1.) 5 . Akron.1 A three dimensional coordinate system (according to ISO 2631) [16] 1.Frontal Saggital Saggital Transverse Frontal Transverse Figure 1. 2. To make a biomechanical comparison of the performance of a cadaveric disc structure to that of the artificial intervertebral disc under ISO testing standards. Inc.

Akron. Akron.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. OH) with respect to transverse. saggital and frontal planes. 6 . OH) with respect to transverse. 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.1. saggital and frontal planes.

is curved slightly anteriorly.39]. provides structural support and bears the loads of head. obesity etc [39. An increased lordosis or kyphosis may be associated with a congenital problem. osteoporosis. the spine is composed of 24 vertebrae. 27. The lower back (lumbar spine) curves slightly anteriorly. poor posture. The spinal column provides body's main upright support. The normal curve of the neck and lower back is called lordosis while the normal curve of the thoracic spine is called kyphosis. Regardless of the activity there is always some type of load on the spine.1). The spine forms three curves. The thoracic spine (at the middle back) is curved posteriorly. sacral bones and the coccyx (Figure 2. 7 . neuromuscular problem. The cervical spine (at the neck). It keeps the upper body weight balanced evenly on pelvis. In humans. shoulders and the upper body [34. 12]. 12].CHAPTER II LITERATURE REVIEW 2.1 Structure and function of spine The human spine is a complex mechanical structure that is flexible. This puts minimal workload on the muscles to maintain the upright posture [34. suitably strong and stable. The spine protects the spinal cord and nerve roots.

39]. two superior facets. and the supraspinous ligaments [36.Intervertebral Disc Vertebral Body Facet Joint Nerve Root Pedicle Figure 2. they increase the time taken by the forces to reach the lower extremities while decreasing the force [36.2 Motion Segment [37] The term motion segment is that structure formed by two adjacent vertebrae associated ligaments. The facet joints resist axial rotation and the ligaments also work as motion limiters. interspinous and intertransverse ligaments. The bony projections at the back of the vertebra form the vertebral arch which consists of two pedicles and two laminae. two transverse processes.37]. The intervertebral discs act like shock absorbers to suppress impulsive forces transmitted by activities like jumping.1 Human Spine [37] Figure 2. The intersegmental ligaments include the ligamentum flavum. 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. 38. and intervertebral disc [Figure 2.2]. The intersegmental ligaments that hold many vertebrae together are the anterior and posterior longitudinal ligaments. 39. 8 .37]. and two inferior facets arise from the vertebral arch [36.

Any damage could lead to a sensory and motor function loss [36. 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. 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. 38]. any instability or excessive movement may lead to irritation or pinching of the nerve roots.Figure 2.3 Spinal Ligaments [37] Figure 2. 37. Instability leads to faster degeneration of the spine [34. 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.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. 27] 9 .

2 Mechanical loading of spine Irrespective of the activity there is always some kind of load on the spine.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]. Fatigue damage accumulates rapidly if spine is exposed to mechanical vibrations.2 Mechanical damage To investigate the failure mechanisms. The vertebral body is the first structure to fail in compression. 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. Rapid compressive forces can cause a burst fracture. In the lumbar region. The following section aims at discussing the mechanical function and damage due to inappropriate loading on the spine. [2] 2. Failure occurs at lower loads in fatigue and damage is mostly at the end plate. [2] The posterior intervertebral ligaments can resist 100N (posterior longitudinal ligament) to nearly 1kN for facet joint capsular ligaments. The combination and magnitude of loads change with activity.2. The facet joints resist horizontal forces acting perpendicular to their articular surfaces and limit the range of axial rotation.[18] The fibers in the interspinous and capsular ligaments are oriented and sized accordingly to resist forward bending movement. Fracture occurs in a single loading cycle 10 . They can resist shearing forces of about 2kN. the facet joints protect the discs from torsion and excess shear and the ligaments prevent excessive bending [2. 2.2.1 Mechanical function The intervertebral discs resist compressive forces mainly in upright posture. Compressive fatigue damage is more common due to the micro fractures.2.

Disc damage cannot be caused directly by compressive loading as the compressive loads have been found to affect the adjacent vertebral body. Facet joints are not well oriented to resist compressive forces. Over compressed spine can lead to disc rupture and pinching of nerve roots resulting in pain. With increase in age. poor physical condition. muscles weaken and discs lose flexibility and the ability to cushion the vertebrae. posture inappropriate for the activity being performed. The intervertebral disc and the facet joints resist extension and axial rotation and thus do not affect the ligaments much. 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 .with forces of approximately 2kN or in a response to cyclic forces between 380N to 760N [2].3 Lower back pain Lower back pain can occur due to several reasons. osteoporosis. [2]. strain or spasm in muscles or ligament can cause back pain. smoking. stress. the bone strength decreases. 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. weight gain during pregnancy. and poor sleeping position also may contribute to low back pain [35. 11]. With the disc narrowing of 1-3mm the loading on articular surfaces increases. A sprain. congenital abnormalities. The interspinous ligament is the first to rupture in hyperflexion. A 2º further extension is required to damage apophysial joint capsular ligament. 38]. obesity. Degenerative conditions like arthritis.

The preloading enhances the resistance to external forces and helps in dividing the compressive forces. In the cauda equina syndrome.12]. osteoporosis. A herniated. 2. If the ruptured disc presses the sciatic nerve which carries nerve fiber to legs. The following section discusses the structure and function of the intervertebral disc. spondylitis (severe inflammation of spinal joints) all lead to lower back pain in varying degrees. knee and foot it may cause low back pain combined with pain in legs. Spinal stenosis.12]. 2. Spinal degeneration may result in narrowing of spinal canal.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. of all the anatomical structures in the lumbar spine associated with the lower back pain.4. A severe condition can lead to loss of motor control loss in the legs. 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]. intervertebral disc has been associated with it the most and mainly due to age related deterioration and damage due to various reasons. This core is very hydrophilic and generates a tension on the annulus even when no external loading is present [26.4 Intervertebral Disc Intervertebral discs act as shock absorbers and to a certain extent motion limiters. Inarguably. The central core is made up of mucopolysacharide gel and proteoglycans and is called nucleus pulposus [26.12]. the possible causes and effects of degeneration and its association with pain. 12 . or ruptured disc can push into the space containing the spinal cord or the nerve root and results in pain. skeletal irregularities.Several conditions can cause lower back pain.

Annulus Fibrosus Nucleus Pulposus Lamellae Figure 2. And if natural healing does not occur. Due to accumulation of metabolic products.5 Intervertebral Disc 2. the center of rotation is constantly modified along two axes simultaneously. which results in back pain. [8. the proteoglycan material of the nucleus may migrate from the center to the periphery through the tear. There is generally a gradual decrease in the hydrophyllic proteoglycans and the associated water content [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.4.4]. 13 .5]. The nucleus dehydrates and shrinks resulting in load changes on the annulus. Degenerated discs result in compromised stability and increased motion between vertebrae [4]. The intervertebral disc provides a major part of its stability on its own [Figure 2. Radial tears may occur in the annulus. Thus.4]. This may mechanically deform the nerve root and result in a radicular pain [8.2 Intervertebral disc degeneration Degeneration of the intervertebral disc has been shown to be positively correlated with respect to age in humans. The collagen fiber arrangement in the annulus creates an efficient system to control and restrict rotation [26].The disc allows movement along and around three main axes. the pH changes with change in immunoglobulins and prostaglandins.

[8. Thus. 8] Disc herniation in a non degenerated disc can be due to abnormal loads. 2.3 Association with pain The exact role disc degeneration plays in the occurrence of low back pain is unclear . 14 .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. and lactic acid [21. Sensory information from the lumbar intervertebral discs is conducted to other spinal levels through the paravertebral sympathetic trunks [21] Therefore.26] Other factors that may lead to disc degeneration include smoking.4. exposure to whole body vibrations and heavy lifetime occupational and leisure physical loading [8. decompression of the nerve root is unlikely to reduce low back pain symptoms. Irritation of this nerve is thought to be one reason of axial back pain. substance P. secondary osteo. Furthermore. prostaglandin E.26] A genetic predisposition has also been implicated. Since the disc is not the only mobile structure of the functional unit . for e. the origin of pain in the functional unit is ill understood and is more complex than peripheral joints [8. Further. due to trauma. removal of the disc and denervation of the annulus is more likely to reduce discogenic pain than decompression alone.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.g. Male discs have been found to degenerate earlier than their age matched female counterparts.arthrosic modifications of the facet joints influence disc degeneration and vice versa. 26]. disc material has been shown to be a direct source of chemically irritative substances such as phospholipase A2.

several problems are associated with it. 31] This procedure is performed when there is a gross instability of motion segment resulting from a traumatic injury or degeneration [4. from annular tear to complete disc degeneration. 19]. 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. several treatment options have been tried over the years. acupuncture. Even though spinal fusion is extensively used. Anti-convulsants are used to treat certain type of nerve pain. Decompression involves removal of the disc material that compresses the spinal nerve causing pain and sensory changes in the affected nerve. [4. degenerated disc.2. The transfer of stress from the fused areas to the bordering non-fused areas may result in adjacent segment degeneration. Even though it is effective in relieving pain caused by herniated disc. 31]. In many patients 15 . operative intervention becomes necessary [19]. The loss of mobility from long segment fusions may result in stiffness and loss of functional capacity. 13]. Depending on the severity of the pain and the reason. 19. The technique is also used to abolish motion at a painful but stable.5 Treatment options for lower back pain generated due to damaged or degenerated disc Pain can occur at any stage of the degeneration process. it is not enough to restore the nucleus to its original load sharing capacity [35. Spinal manipulations. Fusion thus eliminates instability and helps in relieving pain. Fusion (arthrodesis) involves eliminating the motion between two or more vertebrae by using a bone grafting procedure and internal fixation system. Some antidepressants like amitriptyline and desipramine have been known to dull pain signals [35.

reduce the risk of facet damage. This involves replacing the entire damaged disc (nucleus and annulus) or the damaged nucleus depending on the need. 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 . The theoretical advantages of disc arthroplasty are prevention of adjacent segment disease. radiographic evidence of disc degeneration with varying degree of disc space collapse [13. and limit associated adjacent segment degeneration. protection of neural element by restoring disc height and shorter recovery time as patients would not recuperative period for fusion maturation [4. 13]. 14. 31]. surgery to correct all degenerative segments would often be too extensive and disabling [8. Nucleus replacements aim to restore the disc height and return the annular fibers to their natural length. 26. 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.6 Disc Arthroplasty: Artificial intervertebral disc Disc arthroplasty offers an alternative treatment. which would facilitate normal load distribution. including back and leg pain which is unresponsive to appropriate attempts at non-operative treatments.with multiple levels of mild degenerative disease.22]. that of alleviating pain while preserving the physiological motion.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. The indications for total disc replacement are similar to fusion. Disc arthroplasty alternatives are designed to preserve motion segments. 2.

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.place with an artificial disc. 17 . Table 2. Few of them have been tested in animal models and even fewer reached the clinical trial stage [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. the changing center of rotation at a given motion segment with changing position of the motion segment [6. Further. like.1 shows some of the designs that have been proposed over the years [26]. motion characteristics ) and are made of metal or polyethylene couples. there are several problems associated with the implant design.22]. Some attempt to combine both principles. the ability of the intervertebral disc to provide a complex combination of mobility and stability.14]. Since then several implants have been designed.e. The first disc arthroplasty attempt was performed with a steel ball endoprosthesis by Fernstorm in the late 1950s. presence of three joints at each level. Further.

painful and incompetent intervertebral discs with a prosthesis designed to restore normal disc height. but is becoming an increasingly more common intervention for patients.) and ProDisc-L (Synthes Spine) have received approval. and function.Table 2. Artificial disc replacement is considered experimental by the Food and Drug Administration (FDA). Charité (DePuy Spine. While artificial intervertebral discs have been used internationally for over 10 years. Other devices are currently under investigation in this country as 18 .1 Proposed designs for intervertebral disc prosthesis Year Researcher Intervertebral disc prosthesis design 1950 1973 1975 1978 1987 1991 1994 1995 2000 2000 Nechemson Stubstad et al. Froning Weber Downey Pisharodi Baumgartner Beer and Beer Bryan and Kunzler Gauchet Liquid Silicone rubber Reinforced elastic polymer disc Discoid bladder like implant Polyethylene structures with ceramic ovoid core Cushion made of silicon with inner core of fluid Hollow bag containing springs Elastic beads replacing nucleus Disc shaped screwed plates joined by springs Two threaded hollow half cylinders Two round plates and an intermediate deformable body Cervical and lumbar disc arthroplasty has reached the stage of clinical trials in United States. Inc. only two devices. The spinal arthroplasty techniques replace damaged.

part of the FDA process of approval [26.32]. Complex strains. Currently there are four different types of artificial discs that are undergoing either clinical. The structural.g.31.g. PDN® Prosthetic Disc Nucleus Elastic: e. Link SB Charite® disc. Composite: e. functional and pathogenic factors make the development of an artificial disc a challenge. Acroflex® Disc Mechanical: e. biochemical problems and surgical difficulties further demand an implant that is biocompatible and can withstand the long term complex mechanical demands. The different types are the following.g. Prodisc® Hydraulic: e. in-vivo or in-vitro evaluation.g. Maverick® Disc prosthesis Link SB Charite® disc Prodisc® 19 .

Daily loads on spine can be summarized as follows: [15] Table 2. mainly compression. Studies have not focused much on how the disc performs under complex loads. should be known. The implant should be able to withstand the kind of loads the biological disc has to bear without failing [25. The optimal lifespan of the existing implants is only 30 million movements with a recommended minimum of 10 million. the type of the load the implant will be exposed to.18] So far the biological disc has been studied in isolated loading conditions. A few studies have focused on multidirectional properties of the disc [25. The parameters should be physiologically accurate. Different loading conditions and motion controls must also be considered.18] To determine the durability of the implant.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. So far for testing intervertebral disc implants.2.the test parameters are debatable.2 Loads on spine [15] 20 . But there is always some kind of coupled load on the disc.

shear motion profile [15]. The ISO parameters combine all the loading conditions together resulting in a cross. 21 . 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.The testing criteria provided by ASTM and ISO are considerably different (Table 1) and the motion paths generated by both are also different.

OH (E-d) were used for the biomechanical comparison with the cadaveric disc structures under multi axial loading. 3. an artificial intervertebral disc was prepared by 22 . Akron. For fatigue testing.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. Radiographs were obtained in mid saggital and oblique planes and were verified by an orthopedic surgeon to see if they were normal. 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).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. Intervertebral disc implants Elastomeric intervertebral disc implants by Theken Disc. The following content gives detailed information of how the study was conducted.

OH) required for test. OH which was based on the dimensions determined from the literature about the Charite´ artificial intervertebral disc implant (DePuy Spine. 30%. and. Inc).Theken Disc. 23 . the following formula was used. Values for above equation were: standard deviation of 10%.05. smallest true difference to be detected. 3. We named it pseudo Charite´. The sample size was found out to be 4. Akron. Akron. 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. n ≥ 2(σ / δ ) × (tα . significance level of 0.[ν ] + t2(1− P )[ν ] ) 2 2 Where. power of the test was taken as 90%.2 Sample size determination To determine the sample size of cadaveric specimens and elastomeric intervertebral disc implant E-d (Theken Disc.

3 Sample preparation The cadaveric specimens and the pseudo Charite´ needed preparation prior testing.1). 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. all the posterior elements including the lamina.2).3. cause of death and other information about the donors were not available to this author. Radiographs were obtained in mid saggital and oblique planes and were verified by an orthopedic surgeon to see if they were normal. They were kept hermetically frozen at -20 ºC and cool thawed prior to any work or biomechanical testing. gender. facet joints and pedicles were removed. 24 . leaving the anterior longitudinal ligament and the posterior longitudinal ligament intact (Figure 3.3. size. The elastomeric implants E-d did not need any fixture adaptations or preparation before testing. The samples were dissected from the intact spines. 3. fresh cadaveric specimens were used. All tissue work was conducted by suitably trained personnel.1 Cadaveric specimens For the test. The age. The following section discusses the sample preparation done for the study. Studies have shown that freezing and thawing at room temperature have little effect on the biomechanical behavior of the disc [16]. In each cadaveric specimen. All the muscle mass was removed (Figure 3. weight.

Figure 3. The removal was symmetric with respect to the centroidal transverse plane through the disc.1 cm. To achieve this. 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. anterior and posterior longitudinal ligaments and some part of the adjacent vertebral bodies intact and maintaining the height of the specimen at 5.3 Intact posterior region of the motion segment Figure 3. First an 25 .1 Intact motion segment (Top View) Figure 3. an intricate series of steps were taken. parallel cuts were made in the superior and inferior vertebral bodies in the transverse plane.4 After removal of the posterior region One objective was to keep the intervertebral disc. To achieve this.2 Intact motion segment (Side View) Figure 3.

2.6 Alginate negative 26 .5 and 3.8). such that the intersection of the disc and vertebral bodies was determined.7). another hypodermic needle was placed exactly halfway.5 Motion segment in alginate Figure 3. To cut the specimen such that the distance of the transverse planes in which the cuts were 2.55 cm distance on both the sides was determined and marked. Once the height of the disc was established. From this centrally placed needle. the height of the intervertebral disc was determined by prodding the specimen with a hypodermic needle without causing any damage to the tissue.55 cm on both sides from the transverse plane passing through the center of the disc. The next step was that of a positive made by pouring alginate into the negative impression (Figure 3. It was this negative that was actually used to rigidly hold the cadaveric specimen and appropriate cuts were made. Appropriate cuts in the vertebral bodies in the transverse plane were made using a Milwaukee saw (Figure 3.6). First. This positive was then used to get another negative though this time the negative was of polymethylmethacrylate (PMMA).impression of the spinal segment (after removing all the posterior parts) using alginate dental impression material was taken (Figure 3. Figure 3.

Attention was given so that the specimens were not torqued at odd angles during the preparatory phase.8 Final specimen of 5. To get the center of the specimen in transverse plane. Steinman pins were drilled in the vertebral bodies for proper load transmission in bending and torsion while testing (Figure 3.Figure 3. This was done to place and secure the potted specimen in the testing chamber which has a similar hole pattern. The center typically lied a centimeter from the posterior longitudinal ligament. so as to get a similar hole pattern in the PMMA which held the vertebral body.1 cm For fixation to the testing fixture each specimen was potted in PMMA.a PMMA powder/monomer mixture was poured in 27 . The specimen was placed such that the center of the specimen and the construct are overlapping. The center of both the vertebral bodies was determined in a similar fashion.7 Alginate positive Figure 3. 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. The vertebral bodies were embedded in PMMA using a circular potting construct.9].9). Machining was done on the holes to get the required hole diameter. Once the specimen was placed in the construct and secured . a circle was assumed on the disc and its center was determined [Figure 3.

2 Intervertebral disc implants: For comparison under multi axis by loading with human cadaveric disc structures. OH.10 Specimen with both vertebral bodies potted in PMMA and ready for testing 3. Akron. Figure 3. Akron. The specimens did not need any fixture adaptation prior to testing as testing fixtures were already available (Figure 3. Both vertebral bodies were potted in similar fashion (Figure 3. an artificial intervertebral disc was prepared by Theken Disc.11).10). were used. OH which was based on the dimensions determined from the literature about the 28 .9 Specimen with one potted vertebral body and Steinman pins in the other vertebral body Figure 3.the potting construct and allowed to set. four elastomeric disc implants by Theken Disc.3. For fatigue testing.

4 Biomechanical testing Biomechanical testing of all the specimens was done at Theken Disc.11). The cobalt chrome end plates were circular. Akron. Steinman pins were inserted in both the end plates before they were potted in PMMA (Figure 3.4.Charite´ artificial intervertebral disc implant (DePuy Spine. Figure 3. 3. OH. the two end plates were potted in PMMA following the protocol used for cadaveric discs. 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. Inc). (Figure 3. therefore we did not need to approximate the center. OH) and pseudo Charite´ 3.1 Cadaveric Specimen The testing chamber was built such that a temperature probe could be inserted to maintain the desired temperature. The specimens used and the testing equipment used are described in the following section.11 E-d (Theken Disc. Akron. As the implant consists of two cobalt chrome end plates and an intervening ultrahigh molecular weight polyethylene sliding core.12) 29 .

The spine simulator was capable of simulating all the loading components separately or in any combination. This included flexion. 3. left and right lateral bending moments. 30 . spine simulator (Figure.Posterior Chamber Anterior Chamber Specimen in Testing Figure 3.14). Shear forces could be measured by the system even though they could not be controlled.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.extension moments.12 Cadaveric Testing Specimens The testing set up would then be placed in a four independent axis prototype servo Pneumatic EnduraTEC Systems Corp. The spine simulator has a six axis load cell which measures the transmitted forces. left and right torsion and axial compression.

it was placed in the spine simulator such that the anterior region of the specimen was aligned with the flexion simulator. with minimal tilts in bending planes. (Figure 3.14 Temperature monitoring system 31 . The testing chamber was locked in the X-Y plane using a set of clamps and screws. Before locking.Once the specimen was fixed in the testing chamber.13 Multi-Axial EnduraTEC Testing System Figure 3. the bending moments were brought to a very low value. This was done once it was placed horizontally in the simulator.8) Figure 3.

5Hz with cyclic compression (300 – 700 N). The alignment and placement was done in a manner similar to the cadaveric specimens (Figure 3.3.25Hz with static compression (600 N).4.5 Testing protocol Spinal loading in vivo is complex and not very well understood. 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. -2û) at 0. Figure 3. All tests were started with an axial compression of 100 – 600 N at 0. two axis and multi axis loading conditions (per the ISO testing specifications). b) Flexion –extension (4û. Further the magnitudes vary from individual to individual depending on the type and extent of activity. age etc. -2û) at 0.25 Hz.2 Intervertebral disc implants The disc implants were also tested in the same system but they did not need temperature or moisture control.15 Implant testing 3.15). This was followed by a combination of coupled loads as follows: a) Flexion – extension (4û. 32 .

75Hz.25 Hz with dynamic (cyclic) compression (600 N). flexion –extension (4û.-3û) at 0.c) Lateral bending (-2û. An artificial intervertebral disc (pseudo-Charite´) was prepared by Theken Disc. torsion (-2û.16): flexion – extension (6û. 33 .25 Hz. Elastomeric intervertebral disc implant (Theken Disc.-2û) at 0. The number of cycles was large enough to get the appropriate data but not enough to damage the specimen. the specimens were again tested under axial compression (100N – 600N). Akron. 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.2û) at 0. cyclic compression (900 N – 1700 N). d) Lateral bending (-2û. -2û) at 0. For data analysis the last five cycles were typically chosen. -2û) at 0. In the end the specimens were tested under a modified ISO complex loading specification (Figure 3. The specimens were tested for 50±5 cycles for each loading. lateral bending (-2û.75 Hz.3û) with static compression at 0. After each two axes and /or multi axis loading test. e) Torsion (-3û. Akron.75.5 Hz.-2û) at 0. OH which was based on the dimensions determined from the literature about the Charite´ artificial intervertebral disc implant (DePuy Spine. The cadaveric specimens were fatigued under the ISO testing specifications until failure.25Hz with static compression (600 N). OH) (E-d) were also fatigued in similar fashion. Inc).

17) which was capable of determining the six motion components for the three dimensional relative motion between the two vertebral bodies.0 4.6 Data acquisition The spine simulator system was interfaced with a data acquisition and motion measurement system (Figure 3.0 Figure 3. 34 . The data acquisition system collected the data in real time. The relative motion between the two bodies was transformed to the local coordinate system and the errors were recorded throughout the test.0 axl rot lateral bending flex exten normalised force -4. temperature and errors. shear forces.16 Loading pattern for modified ISO 3. tilts. Along with the loads.Test 7 . This included the three translation and three rotational motions.ISO modified 8.0 0. it also measures and collected the moments.

0 Lateral Angle ( Deg.0 0. ( Nm) 20 10 0 -10 -20 -4 .0 4 . Angle ( ° ) T orque Angle ( ° ) Figure 3. flexion.17 Data Acquisition Software 3. . 2006 Flex. 10. were regressed (Figure 18).0 2 . displacement graph.L2 . 2006 6 3 0 -3 -6 -6. torque graph respectively . lateral bending angle vs.Jan.0 -2 .0 Rotat ion & Static Axial Loading.0 0.Jan.L1 . lateral bending stiffness and axial rotation stiffness values.0 3. 2007 Torque Mom.L1 .8 10.0 Displacement ( mm ) Lat Bend.extension stiffness. flexion -extension moment graph. Axial Comp. To calculate the axial stiffness.Figure 3.Nov. flexion-extension angle vs.-Ext. linear region of the last five loading and unloading cycles of the load vs.0 0 .-Ext. ( N-m ) 800 Force ( N ) 600 400 200 0 9. 10.Oct.0 -3.4 9. Mom.0 Flex.L1 L2 .0 3.L2 . .-ExDC.E-d1.7 Data Analysis Offline analysis was conducted using Microsoft Excel®. 2. 2007 Lateral Mom.6 9. 30.0 6. ) Flex. ( Nm) 8 4 0 -4 -3.18 Typical graphs obtained from one of the data sets 35 . lateral bending moment graph and axial rotation vs.

8 Statistical Analysis The statistical model assumed for this study was independent t-test. effect of one loading on the other and errors were also evaluated in the offline analysis. ‘i’ is 2. In order to prevent biasing effects due to loading. The disc type was taken as the independent variables and construct stiffness was taken as the dependant variable. To determine failure the disc height was recorded and monitored. Cary. 3. Failure was characterized by a constantly reducing disc height. 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. Statistical analysis using SAS software package (SAS Institute. After the fatigue tests. to evaluate the failure of the cadaveric specimens. 36 . the testing order within each specimen was randomized.) was performed. The means and standard deviations for each of the variables were also found. radiographs were taken. NC.Shear forces.

CHAPTER IV RESULTS 4.1 Single and multi-axial testing Following the methodology described in the earlier chapter. 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. Axial stiffness comparisons of the two groups with four specimens each were made. were tested.2).25 Hz). 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 . synthetic disc implants. four specimens from each group i.1).e. Initial Axial Compression All the specimens were tested under cyclic axial compression (100N to 600N. The specimen heights were recorded throughout the test and the changes were evaluated. cadaveric intervertebral disc structures and E-d. The load vs. The results of the tests were obtained for both the groups and were compared. The average axial stiffness values and standard deviations were calculated (Figure 4. at 0. All specimens were tested for 50 cycles of this loading.

Axial Compression (Cadaveric Specimens)
700 600 500
L1L2_Oct30 '06 L1L2_Jan10 '07 L2L3 Mar 19th '07 L3L4_Feb20th '07

Load (N)

400 300 200 100 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 E-d2 E-d3 E-d4

600 500

Load (N)

400 300 200

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 Cadaveric specimens n=4

Implants (E-d)

Axial Compression Stifness (N/mm)

2500

2000 n=4 1500

1000

500

0

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 flexionextension 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 L3L4 Feb 20th '07

Flexion -Extension moment (Nm)

10

0

-10

-20

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

Flexion -Extension angle (°)

Flexion-Extension, Static Compression (Implants E-d )
10 8 E-d1 E-d2 E-d3 E-d4

Flexion-Extension moment (Nm)

6 4 2 0 -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

78±0. Static Compression 3.4 Flexion-Extension Stiffness Comparison Flexion. the stiffness values were calculated by regressing the last five loading and unloading cycles of the angle – moment graphs (Figure 4.extension stiffness values were calculated like earlier stage and the means and standard deviations were calculated for both the groups. The flexion.0 2.03 Nm/degree (Figure 4.64 Nm/ degree and that of synthetic implants (E-d) was 1.58±0.6).Extension with Dynamic Compression All the specimens were tested under Flexion-Extension (4û. Like the earlier test.5 0. The axial rotation and lateral bending angles were maintained at 0º.0 0.-2û) at 0.5 n=4 Cadaveric specimens Flexion -Extension Stifness (Nm/°) 3.5 Implants (E-d) n=4 2.0 Figure 4.0 1.Flexion-Extension . 41 .25 Hz and a dynamic compression of 300 to 700 N.5).5 1. The mean flexion-extension stiffness for cadaveric specimens was 2.

Flexion-Extension, Dynamic Compression (Cadaveric Specimens)
20 L1L2 Oct 30th '06 L1L2 Jan 10th '07 L2L3 Mar 19th '07 L3L4 Feb 20th '07

Flexion-Extension moment (Nm)

15

10

5

0

-5

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

Flexion-Extension angle (°)

Flexion-Extension, Dynamic compression (Implants E-d)
8 E-d1 E-d2 E-d3 E-d4

6

Flexion -Extension moment (Nm)

4

2

0

-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 3.0 Cadaveric specimens

Flexion-Extension stifness (Nm/°)

2.5 n=4

Implants (E-d)

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

43

Lateral Bending ,Static Compression (Cadaveric specimens)
10 8 L1L2 Oct 30th '06 L1L2 Jan 10th '07 L2L2 Mar 19th '07 L3L4 Feb 20th '07

Lateral Bending moment (Nm)

6 4 2 0 -2 -4 -6 -8 -3 -2 -1 0 1 2 3

Lateral Bending angle (°)

Lateral Bending, Static Compression (Implants E-d)
12 10 8 E-d1 E-d2 E-d3 E-d4

Bending moment (Nm)

6 4 2 0 -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

The axial rotation angle was maintained at 0º for this test.Static Compression 4 Cadaveric specimens n=4 Implants (E-d) Lateral Bending stifness (Nm/°) 3 n=4 2 1 0 Figure 4.9±0. Lateral Bending with Dynamic Compression All the specimens were tested under a coupled loading of flexion-extension (4û.2 Nm/º.75 Hz and a dynamic axial compression of 300 to 700N (Figure 4.Extension. The mean lateral bending stiffness for the cadaveric specimens was found to be 2.61 Nm/º and that of synthetic implants (E-d) was found to be 1.11).2û) at 0.2û) at 0. The mean flexionextension stiffness for the cadaveric specimens was found to be 2.8 Lateral Bending Stiffness Comparison Flexion. 45 .Lateral Bending .9 and 4.52±0.25 Hz.45 Nm/º and that of synthetic implants (E-d) was found to be 3. lateral bending (2û. The flexion-extension stiffness and lateral bending stiffness values were calculated like earlier stages.4±0.10). The flexion – extension stiffness and lateral bending stiffness values were calculated for both the groups and the means and standard deviations were obtained.5 Nm/º (Figure 4.57±0.

Lateral Bending with Dynamic Compression 46 .9 Flexion Extension Angle vs. Moment graphs for the coupled loading of Flexion-Extension.Flexion-Extension (Cadaveric specimens) 15 L1L2 Oct 30th '06 L1L2 Jan 10th '07 L2L3 Mar 19th '07 L3L4 Feb 20th '07 Flexion-Extension moment (Nm) 10 5 0 -5 -10 -3 -2 -1 0 1 2 3 4 5 Flexion -Extension angle (°) Flexion-Extension (Implants E-d) 10 8 E-d1 E-d2 E-d3 E-d4 Flexion-Extension moment (Nm) 6 4 2 0 -2 -4 -6 -3 -2 -1 0 1 2 3 4 5 Flexion-Extension angle (°) Figure 4.

Lateral Bending with Dynamic Compression 47 . Moment graphs for the coupled loading of Flexion-Extension.Lateral Bending (Cadaveric Specimens) 12 10 L1L2 Oct 30th '06 L1L2 Jan 10th '07 L2L3 Mar 19th '07 L3L4 Feb 20 '07 Lateral Bending moment (Nm) 8 6 4 2 0 -2 -4 -6 -3 -2 -1 0 1 2 3 Lateral Bending angle (°) Lateral Bending(Implants E-d) 12 10 E-d1 E-d2 E-d3 E-d4 Lateral Bending moment (Nm) 8 6 4 2 0 -2 -4 -6 -8 -3 -2 -1 0 1 2 3 Lateral Bending angle (°) Figure 4.10 Lateral Bending Angle vs.

48 .11 Flexion. The mean axial rotation stiffness for the cadaveric specimens was found to be 2.13 Nm/º (Figure 4.13).87±1.04 Nm/ º and that of synthetic implants (E-d) was found to be 1.25 Hz and a static compression of 500N and keeping the flexion-extension and lateral bending angles at 0û. The stiffness values were calculated for both the groups and the means and standard deviations were calculated. The flexion-extension and lateral bending angles were maintained at 0º for this test. The axial rotation or torsional stiffness was calculated by regressing the last five loading and unloading cycles of the angle – torque graphs (Figure 4.4±0.12).-3û) at 0.Flexion-Extension.Extension and Lateral Bending Stiffness Comparison Axial rotation with static compression The specimens were tested under axial rotation (3û. Lateral Bending with Dynamic Compression 5 Cadaveric specimens Implants (E-d) 4 Stiffness (Nm/°) 3 2 1 0 Flexion-Extension Lateral Bending Figure 4.

Axial Rotation.12 Axial Rotation Angle vs. Static Compression (Cadaveric specimens) 15 L1L2 Oct 30th '06 L1L2 Jan 10th '07 L2L3 Mar 19th '07 L3L4 Feb 20th '07 10 Axial Torque (Nm) 5 0 -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 E-d3 E-d4 4 Axial Torque (Nm) 2 0 -2 -4 -6 -4 -3 -2 -1 0 1 2 3 4 Axial Rotation angle (°) Figure 4. Torque graphs for Axial Rotation with Static Compression 49 .

75 Hz. 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.16). axial rotation (2û. 4.14.Axial Rotation .-2û) at 0. The complex loading was composed of flexion extension (6û. 50 .Static Compression 5 n=4 Cadaveric Specimens Axial Rotation Stiffness (Nm/°) 4 3 2 n=4 Implants (E-d) 1 0 Figure 4. lateral bending (2û.75 Hz and a dynamic axial compression of 900 to 1700N (Figures 4.5 Hz.15 and 4. an axial compression test was performed to make sure there was no structural damage.-2û) at 0.-3û) at 0.13 Axial Rotation Stiffness Comparison Testing under modified ISO specifications After every test mentioned above.

08 Nm/degree.23 Nm/degree and that of synthetic implants (E-d) was found to be 1.93±0.47±0. The mean lateral bending stiffness for the cadaveric specimens was found to be 2.(Figure 4.The mean flexion-extension stiffness for the cadaveric specimens was found to be 2.4±0. The mean axial rotation stiffness for the cadaveric specimens was found to be 2.64±0.17 Nm/degree.87 Nm/degree and that of synthetic implants (E-d) was found to be 2.69 Nm/degree and that of synthetic implants (E-d) was found to be 1.4±0.07 Nm/degree.17) 51 .2±0.

Flexion Extension. Moment graphs for Modified ISO 52 .14 Flexion Extension Angle vs. ISO (Cadaveric Specimens ) 20 Flexion-Extension moment (Nm) 10 L1L2 Oct 30th '06 L1L2 Jan 10th '07 L2L3 Mar 19th '07 L3L4 Feb 20th '07 0 -10 -20 -30 -4 -2 0 2 4 6 8 Flexion -Extension angle (°) Flexion-Extension (Implants E-d) 8 E-d1 E-d2 E-d3 E-d4 6 Flexion-Extension moment (Nm) 4 2 0 -2 -4 -6 -4 -2 0 2 4 6 8 Flexion -Extension angle (°) 4.

Lateral Bending . 06 L1L2 Jan 10th '07 L2L3 Mar 19th '07 L3L4 Feb 20th '07 10 Lateral Bending moment (Nm) 5 0 -5 -10 -15 -3 -2 -1 0 1 2 3 Lateral Bending angle (°) Lateral Bending (Implants E-d) 8 6 E-d1 E-d2 E-d3 E-d4 lateral Bending moment (Nm) 4 2 0 -2 -4 -6 -8 -3 -2 -1 0 1 2 3 Lateral Bending angle (°) Figure 4.ISO(Cadaveric Specimens) 15 L1L2 Oct 30th.15 Lateral Bending Angle vs. Moment graphs for Modified ISO 53 .

ISO (Cadaveric specimens) 8 6 4 L1L2 Oct 30th '06 L1L2 Jan 10th '07 L2L3 Mar 19th '07 L3L4 Feb 20th '07 Axial Torque (Nm) 2 0 -2 -4 -6 -8 -3 -2 -1 0 1 2 3 Axial Rotation angle (°) Axial Rotation (Implants) 4 3 2 E-d1 E-d2 E-d3 E-d4 Axial Torque (Nm) 1 0 -1 -2 -3 -4 -3 -2 -1 0 1 2 3 Axial Roation angle (°) Figure 4. Torque graphs for Modified ISO 54 .16 Axial Rotation Angle vs.Axial Rotation.

17 Stiffness Comparisons (Modified ISO) An independent t-test was performed using SAS software (SAS Institute. NC) on the results to evaluate whether the two groups were significantly different. All the results were also checked for possible outliers. For the test the synthetic and cadaveric disc types were taken as the independent variable and the axial stiffness as the dependent variable.1). 55 . No outliers were detected. Cary.05 (Table 4. The significance level of the test was taken as 0.ISO 4 n=4 n=4 3 n=4 n=4 Cadaveric Specimens Implants (E-d) Stiffness (Nm/°) 2 n=4 n=4 1 0 Flexion-Extension Lateral Bending Axial Rotation Figure 4.

AC FE.Table 4.0002 0. the Theken synthetic disc (E-d) and a pseudo Charite´ made by Theken Disc.5). The axial stiffness before and after the fatigue test were determined and compared.Significantly different. lateral bending stiffness and axial rotation stiffness before and after the test were evaluated for the three discs (Table 4.0485 0. Failure was characterized by a constant decrease in the height of the specimen.DC) LB ( FE.1 Statistical Results Loading AC FE.4.AC FE ( FE. One sample from each type was taken and fatigued under the modified ISO complex loading. The disc structures were fatigued under complex ISO loading specifications. The cadaveric discs were fatigued till they failed and failure was characterized by a constant decrease in disc height.9304 0.0027 0.0431 0. OH using the information available in literature about the Charite´ intervertebral disc implant by Depuy Spine Inc.DC) AR.LB.DC LB.SC FE ( Modified ISO) LB ( Modified ISO) AR ( Modified ISO) p-value 0. Akron.2. NS – Not significantly different 4.1348 0.1092 0. flexion-extension stiffness.0027 Result S NS S NS NS S S S NS S S.0067 0.LB. Changes in axial compression stiffness.1197 0.2 Fatigue test Fatigue comparisons were made between three structures: the cadaveric disc structures. 56 .

60 1.71 1.Charite LB Stiffness Initial (Nm/º) 2.86 3.21 1.Charite Initial Axial Stiffness (N/mm) 1791 2188 5783 After Fatigue (N/mm) 1065 (1500 cycles ) 2079 (1500 cycles ) 5431 (1500 cycles) % Difference 41% 5% 8% Table 4.61 2.23 FE Stiffness Final (Nm/º) 2.24 Specimen L1L2 Jan 10th E-d 3 Pseudo-Charite Table 4.Table 4.06 57 .55 2.50 2.) E-d 3 (Theken Disc) Pseudo.80 1.3 Flexion-Extension (FE) Stiffness comparison under fatigue FE Stiffness Initial (Nm/º) 3.2 Axial stiffness comparison under fatigue Disc Structures L1L2 Tested-Jan 10th (Cad.04 LB Stiffness Final (Nm/º) 3.4 Lateral Bending (LB) Stiffness comparison under fatigue Specimen L1L2 Jan 10th E-d 3 Pseudo.

5 -3.Lateral Shear Initial (N) -5.8 -5.Lateral Shear Final (N) 1.03 AR Stiffness Final (Nm/º) 2.5 -3.0 Max.04 Specimen L1L2 Jan 10th E-d 3 Pseudo.Charite´ Max.43 1.Table 4.AP Shear Final (N) -60. A comparison of the shear forces before and after the fatigue test is as given below (Table 4.4 Specimen L1L2 Jan 10th E-d 3 Pseudo.6).30 0.AP Shear Initial (N) 14.0 -5.Charite 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.1 1. Table 4.0 Max.6 -0.2 58 .Charite´ Max.6 Shear forces comparison Specimen L1L2 Jan 10th E-d 3 Pseudo.7 -4.5 Axial Rotation (AR) Stiffness comparison under fatigue AR Stiffness Initial (Nm/º) 4.50 0.03 1.6 0.

Only one specimen was compared from each type. The Charite´ disc is already undergoing clinical trials and has been approved by the FDA after clearing the testing criteria.3 Disp.The fatigue failure comparison between the three disc types was based on the change in disc height before and after the fatigue test.(mm) Initial 9.10 L1L2 Jan 10th E-d 3 PseudoCharite The synthetic discs E-d have been tested under ISO fatigue test protocol for 7M cycles without failure at Theken Disc. Table 4. 59 .41 (1500 cycles) 17. The values are taken from the axial compression tests before and after the fatigue tests.6 17.23 (1500 cycles) Change in height (mm) 5. Akron.22 0.17 0.574 (1500 cycles) 9.7 Disc height comparison under fatigue Specimen Disp. (mm) Post Fatigue 4. Change in height was recorded after the fatigue test was run on all the three specimens.75 9. OH.

Fracture Figure 4. radiographs were taken and a bony failure was detected. The failure of the biological disc structure was characterized by a consistent decrease in specimen height.18 Radiographs to access damage to the cadaveric disc 60 . which characterized the structural failure. One objective of the study was to evaluate whether the actual biological disc which is going to be replaced by the implant.4. To determine the kind of failure the structure had undergone.3 Failure The ISO standards expect the implants to last for 10 million cycles of the complex loading without failure. would last under the testing specifications.

4 Result tables Table 4. ( mm ) 8.Lateral Bending with Static Compression LBFEC.38 ISOb AC 1674.95 2.90 1. (Nm/°) / / / 2.Axial Rotation with Static Compression ISOb.72 Stable Min.97 2. Stiff.41 2.22 2.Flexion.8 to 4.35 0.65 L1-L2: Human Flex-Ext Stiff. * For Table 4.14 0.70 / 1.18 0.69 1.Axial Compression 61 . 30th.00 1.62 8.06 2.90 2.92 1. 2006) Oct 30th and 31st .70 8.65 2.16 0.15 AC.84 1.87 Lateral Stiff.39 8.19 1.13 1.Modified ISO AC.11 0.Extension with Dynamic Compression LBSC.15 0.69 2.83 1.8 Summary of biomechanical testing of Cadaveric disc L1L2 (October.48 8. Flexion-Extension with Dynamic Compression ARSC.07 0.67 / 2. ( mm ) 9.Lateral Bending.47 8.92 / Stable Max. (Nm/°) / 1.21 0.88 8.60 8. (N/mm) AC FESC FEDC LBSC LBFEC ARSC 1428.22 / 2.4.23 8.51 8.34 8.Axial Compression FESC.28 1.Flexion-Extension with Static Compression FEDC.36 1.51 2.14 0.04 3.96 / Axial Rot.74 / * Highlighted row values in ISOb were used for calculations.10 0.21 0. 2006 Axial Stiff.35 δ ( mm ) 0. (Nm/°) / / / / / 2.24 2.

31 4. 2007) Jan.22 3.24 9.68 3.55 0.29 9.28 0.51 9.34 9.20 / 3.56 2.86 3.06 0.99 2.65 0.71 / Lateral Stiff.11 / 2.23 5.29 2.03 4. 10. 2007 Axial Stiff.63 0.11 9.14 / 2.57 Stable Min. ( mm ) 9.63 5.21 3.05 9. (Nm/°) / / / 2. (N/mm) AC FESC FEC LBSC LBFEC TSC FELBTC ISOb 17 AC 1065.48 9.45 * Highlighted row values in ISOb were used for calculations.Table 4.13 δ ( mm ) 0.61 / Axial Rot.65 2.43 / Stable Max.11 4.38 1791.36 9.72 2. (Nm/°) / 3.23 0.82 2.14 0. Stiff.27 9.9 Summary of biomechanical testing of Cadaveric disc L1L2 ( January 10th.38 L1-L2: Human Flx-Ext Stiff.88 3.46 6.05 3. 62 .11 0.23 0.75 9. ( mm ) 9.48 9. (Nm/°) / / / / / 4.43 9.98 4.11 0.56 4.

53 3.10 Summary of biomechanical testing of Cadaveric disc L3L4 ( February 20th.06 3.21 / Axial Rot.21 3.71 / 3. FESC FE DC LB SC FE LB DC AR SC ISOb 1294 / 2272 L3-L4: Human Flx-Ext Stiff.72 2. 63 .32 3.5 3.07 8.Table 4.05 1.98 2. (Nm/°) / / / / / / 2.85 2.32 0.85 7.17 0.56 2.46 3.82 0.28 3.91 8.25 0.28 0.33 0.73 2. 2007 Axial Stiff.03 3.6 Stable Min.97 3.94 3.97 7.85 2.31 0.24 0. (Nm/°) / 1. (N/mm) AC.37 0.65 Lateral Stiff.34 0.18 8.04 7.8 7.39 0. Stiff.17 δ ( mm ) 0.83 2.41 2.56 3.61 / 2.07 2.8 7.75 4.28 0. 2007) Feb 20th and 21st. (Nm/°) / / / 2.07 3.4 2.03 4.25 3.73 2.91 / Stable Max.6 2.53 7.97 2.37 5.76 8.32 2.35 3.17 5.43 AC 809 / * Highlighted row values in ISOb were used for calculations.45 5.19 3. ( mm ) 7.11 4.66 0.59 2.64 4. ( mm ) 8.

(Nm/°) / / / 2.00 2.80 9. 2007 Axial Stiff.11 2.06 9. ( mm ) 9.03 8.60 Stable Max.01 1.50 2.11 Summary of biomechanical testing of Cadaveric disc L2L3 (March 19th.90 2.70 2.06 9.19 0.16 0.85 10.06 1. ( mm ) 10.44 9.43 2.83 Stable Min.20 / / 1.22 1.35 9.84 9. 64 . 11 1449.43 3.19 1. (Nm/°) / / / / / 1.82 / 2.00 L2 L3 Human Flx-Ext Stiff.29 0.80 7.00 7.00 9.87 9.26 1.76 / / 2.23 ISOb 18 * Highlighted row values in ISOb were used for calculations.03 Axial Rot Stiff.60 d ( mm ) 0.20 10.68 9.64 10.90 9.31 Lateral Stiff.19 2. (Nm/°) / 2. (N/mm) AC FESC FEDC LBDC FELBDC ARSC Axial Comp.95 8.23 1.70 / 3.33 0.22 0. 2007) March 19th .49 1.73 7.86 9.64 8.41 0.Table 4.

45 1.91 9.16 65 . (Nm/°) / / / / / 1. (Nm/°) / 1.68 2.36 Stable Max.5 0. (N/mm) AC FE SC FE DC LB SC FE LB DC AR SC ISOb 2207 Flx-Ext Stiff.22 0.3 0.12 0.15 0.74 / 1.59 9.44 9. 2007) April 10th and 11th.37 9.74 8.66 8.34 7.96 8.26 0.72 3. ( mm ) 9. 2006) Nov 06.25 1.65 8.02 0.43 Lateral Stiff. (Nm/°) / / / 2.36 Stable Max.59 8.2 Stable Min.39 0.07 0.59 Flx-Ext Stiff. ( mm ) 9.2 Lateral Stiff.39 δ ( mm ) 0.75 8.71 / 2. Stiff.Table 4. ( mm ) 8. (Nm/°) / / / / / 1.24 8.63 8.25 Axial Stiff.1 0.52 9.76 1. (N/mm) AC FE SC FE DC LB SC FE LBDC AR SC ISOb 1964.37 9.65 1.62 8.35 Table 4.75 / 1. Stiff. (Nm/°) / / / 2. 2007 E-d2 Axial Rot.62 7.55 Stable Min.81 8.14 Axial Stiff.78 8.53 9.03 1.22 0.64 8.85 δ ( mm ) 0.83 / 2. (Nm/°) / 1.12 Summary of biomechanical testing of Synthetic disc E-d1 (November 6th.46 7.85 / 1. ( mm ) 8.2006 E-d1 Axial Rot.13 Summary of biomechanical testing of Synthetic disc E-d2 ( April 10th.69 / 1.28 9.66 9.

(Nm/°) / 1.64 9.35 8.55 3. 2007 E-d3 Axial Rot.6 8.59 Stable Max.4 9. ( mm ) 9.51 9. (N/mm) AC FE SC FE DC LB SC FE LB DC AR SC ISOb AC 2721.49 0.42 9.86 1.02 0.6 9.05 0.45 9.57 9.5 1.36 9. (Nm/°) / / / / / 1.8 1. (N/mm) AC FE SC FE DC LB SC FE LB DC AR SC ISOb AC 2187.14 0.53 δ ( mm ) 0.33 2.1 9.66 Lateral Stiff.85 / 2.86 3.09 0.13 / 3.8 / 2.42 Stable Min.27 0. (Nm/°) / / / 2.51 / Stable Max. ( mm ) 9.34 9.18 δ ( mm ) 0.02 0.57 9.55 9.52 9.05 9. (Nm/°) / / / / / 1.24 66 .12 0. Stiff.48 9.37 8. (Nm/°) / 1.29 Axial Stiff.29 / Axial Stiff. 2007 E-d4 Axial Rot.45 9.39 8.47 1.36 Table 4. 2007) April 10th and 11th.63 9.93 Flx-Ext Stiff.42 9. Stiff.52 9.43 0.57 / Lateral Stiff.4 9.3 9.36 Flx-Ext Stiff.14 Summary of biomechanical testing of Synthetic disc E-d3 (April 10th. ( mm ) 9.Table 4.41 1.27 0.14 Summary of biomechanical testing of Synthetic disc E-d3 ( April 10th.78 / 2 / 1.23 / 2.24 0. (Nm/°) / / / 3.39 9.18 1.43 9.82 9. 2007) April 10th and 11th.5 0. ( mm ) 9.23 0 0.89 Stable Min.

(Nm/°) / / / 0.32 0. (Nm/°) / / / / 0.08 8.03 0.4 8.92 0.35 8.23 8.13 0.12 0.5 Flx-Ext Stiff.48 / 0.96 / 0.29 8.9 / Lateral Stiff.92 / 0.29 8. (N/mm) AC FE SC FE DC LB SC FE LB DC AR SC ISOb AC 19928.52 / 0.27 8. (Nm/°) / 0. Stiff.04 / Axial Stiff.3 Stable Min. ( mm ) 8.43 8.18 8.25 8.23 8.43 / Stable Max.15: Summary of biomechanical testing of pseudo. 2007) Feb 20th 2007 Pseudo Charite Axial Rot.36 8. ( mm ) 8.Charite ( February 20th.33 8.05 67 .37 8.12 0.Table 4.25 0 0.06 0.25 δ ( mm ) 0.

which essentially focuses on finding out the durability of the implant against the biological structure under the recommended loading. The comparison is also made between the cadaveric disc structure and two implant designs on the basis of fatigue characteristics. Thus. 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 implant should address the in vivo loading conditions. The study also aims at evaluating the ISO testing specifications for the intervertebral disc implants. 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. This study aims at evaluating two implants against the biological disc structure that they are designed to replace. We believe that they are so demanding that even the actual biological disc structure would fail under such loadings.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. 68 . and it should resist wear and material delamination [30].CHAPTER V DISCUSSION 5.

We started the test with single axis loading and then introduced one type of load at every step of the testing protocol. The mean flexion-extension stiffness for cadaveric specimens was 2. 2º) individually with a static compression of 500N.1092) and lateral bending stiffness values for the lateral bending with static compression test (p=0. 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. There was a significant difference in the axial rotation stiffness values for the axial rotation with static compression test (p=0.71 Nm/º and that of synthetic implants (E69 . Axial compression The cadaveric discs and the implants E-d were tested under a cyclic compression of 100-600N at 0. there was no significant difference detected between the flexion-extension stiffness values for the flexion-extension loading with static compression (p =0. The axial stiffness of the two groups was significantly different (p =0.0027).1348) for the two groups.-2º).0067). 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.44 ±0. The structural properties of the two groups were compared for all the single and multi-axis tests. lateral bending loading and axial rotation loading with static compression When the specimens were tested under flexion-extension (4º.5.25 Hz.2 Single and multi-axial tests The objective of these tests was to make a comparison between the groups under complex modified ISO loading.2º) and axial rotation (2º. Flexion-Extension loading. lateral bending (2º.

the implants mimic the structural properties of the cadaveric discs in flexion extension and lateral bending.d) was 1.4 Nm/º.9±0. Under a coupled load.1197).4±0.58±0.04 Nm/º and that of synthetic implants (E-d) was found to be 1. 70 .48±0.0485).-2º).64 Nm/º and that of synthetic implants (E-d) was 1. The mean flexion-extension stiffness for cadaveric specimens was 2. 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.0431). The mean lateral bending stiffness for cadaveric specimens was 2. The loading characteristics for all the three loadings were similar for the two groups. In other words.8±1.-2º) and axial compression (300-700N).77±0. the two disc types behave differently. there was a significant difference in the lateral bending stiffness values (p= 0.03 Nm/º.78±0. 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.09 Nm/º. However.37 Nm/ º and that of synthetic implants (E-d) was 2. lateral bending with dynamic compression In the coupled loading with flexion – extension (4º. there was no significant difference in the flexion – extension stiffness values between the two groups (p=0. Therefore. lateral bending (2º. The mean axial rotation stiffness for the cadaveric specimens was found to be 2.13 Nm/º. Flexion –extension loading with dynamic compression The flexion-extension stiffness values were significantly different for the two groups (p=0.

2±0.47±0.75 Hz. The mean flexion-extension stiffness for the cadaveric specimens was found to be 2.69 Nm/º and that of synthetic implants (E-d) was found to be 1.75 Hz and a dynamic axial compression of 900 to 1700N. axial rotation (2˚.-2˚) at 0.87 Nm/º and that of the synthetic implants (E-d) was found to be 2. Under the modified ISO loading specifications the flexion –extension stiffness values for the two groups were determined to be significantly different (p = 0.4±0. 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. lateral bending (2˚.17 Nm/º.4±0. Thus.5 Hz. on the basis of the results that we obtained from this study. Therefore. which could be attributed to a protruded bone spur. the two groups have different structural properties under complex modified ISO loading.07 Nm/º.23 Nm/º and that of synthetic implants (E-d) was found to be 1.-3˚) at 0. In certain cases where there was a sudden change in the moment values. The lateral bending stiffness values were comparable for the two groups. 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.08 Nm/º. The axial rotation stiffness values for the two groups were also significantly different (p= 0.-2˚) at 0.0002). The mean axial rotation stiffness for the cadaveric specimens was found to be 2.Complex modified ISO loading The complex loading was consisted of flexion extension (6˚.93±0.0027). we conclude that there are statistical differences with respect to structural stiffness values 71 . The mean lateral bending stiffness for the cadaveric specimens was found to be 2.64±0.

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. On this basis.between the two groups with respect to transverse and saggital planes. However. 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. If the implants pass this test. Another possible reason that might have been instrumental in an early failure of the cadaveric disc structure might be the testing standards. they may be robust designs. we reject the null hypothesis.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. 5. 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. No significant difference was found in the stiffness values in the frontal planes when tested under ISO specifications. The axial stiffness and disc height dropped considerably for the biological disc after nearly 1500 cycles of complex modified ISO loading. This implies that the cadaveric discs were weaker compared to the implants and could not withstand the loading conditions. the stiffness values and disc heights for the implants (both E-d and pseudo Charite´) remained comparatively unaffected at similar loading cycles. 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 . This modification accelerated the early failure of the cadaveric disc structure as the bony region failed first.1 mm.

individually or in a combination) the intervertebral disc structure can bear. 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. 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.e. the assumption that the intervertebral disc should bear such high loads as specified by the ISO is questionable. 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. 73 .expected life (i. the disc structure collapsed due to the bony structure failure. ligaments etc. Since other biological structures like facet joints. Another question that this study raised is do we really need such a robust implant? If other biological structures begin to deteriorate with age. Comparison with the available in vivo loading information can provide a better understanding of the loads the biological structure can withstand. Failure was characterized by decreased height of the specimen. would be present in real life situations and the loads would be distributed among all the spinal structures. 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. The pseudo Charite´ proved superior to the other two disc structures in both axial stiffness and axial shift comparison. number of cycles) of the implant under testing environment. The difference in the material properties and the different design might have contributed to the more robust structure of the pseudo Charite´. The cadaveric disc structures failed very early and even though the intervertebral disc material did not seem to fail.

Testing the specimens for bone mineral density could help us understand the results better. The age of the specimens could possibly have an effect on the results. we might be able to understand if the results were affected due to variation in material properties. it might have affected the results. If any of the cadaveric specimens was osteoporotic. • The information regarding the bone mineral density was not available to the author. even though the author does not have any references to support this speculation.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. • 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 .5. If segments from different levels could be tested and compared. • The information regarding the age of the donors was not available to the author. Since with specimens taken from old donors. 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. there is a possibility that degeneration had already set in. • As discs from different vertebral levels were used. there could be a difference in the segment material properties.

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. thus. bone mineral density etc. • The results obtained would be more reliable if discs from a single vertebral level would be used.1 cm due to the design of the testing equipment and.discs had failed. would help in selecting the appropriate cadaveric specimens for testing. This might have caused the cadaveric specimens to fail at a lower range of cycles. • A prior knowledge of the age. had to remove a considerable part of the bones. 75 . 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. we could not determine the specific bony region where the failure might possibly have set in. Therefore. 5. • We could not allow the specimen height of more than 5.5 Future work These limitations should be considered when designing the studies in the future.

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