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SECTION

Biomechanics
II
CHAPTER

6 Anton E. Dmitriev

General Considerations of
Biomechanical Testing

INTRODUCTION (FSU) constitutes the smallest spinal segment that can be kine-
matically analyzed before and after a surgical manipulation. An
Spinal instrumentation has experienced rapid evolution over FSU, also known as a motion segment, is composed of any two
the last 20 years, with the resulting variety of reconstructive adjacent vertebrae, an intervening intervertebral disc, and the
options significantly expanding the scope of spinal pathology interconnecting ligaments.21 Therefore, biomechanical testing
that can be successfully managed through surgical interven- of a single FSU allows for a simplistic, however, precise defini-
tion. Although different in design and surgical indication, most tion of kinematic changes and quantification of the vertebral
currently available implants serve a common goal of stabilizing stresses following a surgical intervention. According to Panjabi,15
the spine throughout the postoperative period while the bio- each vertebra in an FSU represents a rigid body that can poten-
logic arthrodesis matures into a successful fusion. However, tially move in three translational (X,Y,Z) planes and about
recent developments in the nonfusion technology have intro- three rotational axes (X,Y,Z) in relation to the other vertebra.
duced a new era of managing degenerative conditions through This motion accounts for the maximum of 6 degrees of free-
motion preservation and retention of spinal flexibility. This dom that a rigid body can move about in space. Vertebral
widely expanded armamentarium available to the spine special- motion that is not impeded by the testing apparatus in any of
ist has allowed surgeons to address cases with evermore chal- the 6 degrees of freedom is termed unconstrained. By conven-
lenging biomechanical presentations. Therefore, rigorous tion, axial torsion is referred to as the rotations about the
preclinical laboratory testing of spinal implants elucidating  Y-axis, flexionextension occurs over the  X-axis, and lat-
their mechanical strength, fatigue and wear parameters, as well eral bending takes place about the  Z-axis (Fig. 6.1). In the
as the vertebral anchoring potential is paramount. To that end, laboratory setting, generating unconstrained loading of a sin-
significant efforts have been put forth by the biomechanical gle FSU is technically easier due to the limited ranges of motion
research community, industry engineers, the American Society (ROMs) in each of the loading planes. However, this approach
for Testing and Materials (ASTM), and the Food and Drug does not provide information on the biomechanical changes
Administration (FDA) to standardize the biomechanical testing occurring at the levels adjacent to a surgically manipulated seg-
protocols and preclinical evaluation of spinal implants. ment. Furthermore, by definition, single FSU assessment pre-
cludes evaluation of multisegmental constructs that are often
required for proper management of a patients pathology.
BIOMECHANICAL TERMINOLOGY Therefore, multisegmental spinal specimens must be utilized
AND ANALYZED PARAMETERS to study the global effects of a surgical intervention.
Currently, segmental ROM is one of the most frequently
General familiarity with the biomechanical concepts, terminol- reported outcome measures in biomechanical studies.12 ROM
ogy, and parameters being analyzed is critical to understanding parameters can be easily translated to clinical practice as they
and appreciating the relevant literature (Table 6.1). Aside from are often used to define a successful fusion on flexion
the individual dissected vertebrae, a functional spinal unit extension dynamic radiographs. Similarly, ROM is utilized as a
65

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66 Section II Biomechanics

TABLE 6.1 Relevant Biomechanical Terminology

Term Definition

Degrees of freedom (as The number of independent types of motion a rigid body can perform in
applicable to spinal space. A vertebra has a maximum of 6 degrees of freedom (three potential
motion) linear translations and three rotations)
Stress Is the load or force per unit area that develops on a plane surface within a
structure in response to externally applied loads
Strain Is the deformation that develops within a structure in response to externally
applied loads
Stiffness Is the slope of either the load/displacement or the stress/strain curves
Youngs modulus The modulus of elasticity, or the measure of the stiffness of a material.
Obtained by dividing a stress value in the elastic region of a stress/strain
curve by its corresponding strain value
Center of rotation (COR) A point within the body (or its hypothetical extension), which does not
move during a particular step in spinal motion. COR can be obtained by
tracking two points on the body from position A to B, then connecting the
corresponding points with straight lines and bisecting them at the center
with two normal lines. The point where they intersect is the COR, also
known as the instantaneous axis of rotation (IAR) for that step in motion
Neutral zone (NZ) A part of the range of motion of a joint through the neutral position until
the initial resistance (0.40.5 Nm)
Elastic zone (EZ) A part of the range of motion of a joint from the end of the NZ through the
end of physiologic nondestructive range of motion
Plastic zone (PZ) A part of the range of motion beyond the EZ where the joint will likely be
damaged

follow-up assessment tool for total disc arthroplasty and other ative and adjacent levels is of particular importance when evalu-
motion sparing procedures, where one can establish not only ating total disc replacement (TDR) prostheses and other
the quantity but also the quality of the residual segmental motion preserving technology.9 Significant shifts in segmental
motion.8 Qualitative analysis of spinal motion includes map- IAR coupled with continued postoperative mobility can lead to
ping of the segments instantaneous axis of rotation (IAR), as excessive loading of the posterior elements, thus increasing the
well as segregating the total segmental ROM into its two consti- odds of progressive facet joint degeneration over time.
tutive regions: the neutral zone (NZ) and the elastic zone (EZ) Segmental NZ and EZ can be deduced from the total ROM
(ROM  NZ  EZ) (Table 6.1). by evaluating a corresponding load/displacement curve (Fig.
In the intact lumbar spine, flexionextension IAR forms an 6.2). NZ by definition represents spinal motion through a
ellipse in the posterior one third of the intervertebral disc region of no to minimal resistance offered by the joint.
space, overlying the superior end plate of the inferior body.11 Therefore, significant postoperative increase in the NZ range is
Information about the changes in the IAR location at the oper- representative of spinal instability. Following an instrumented
arthrodesis procedure, residual segmental ROM is rarely fully
eliminated; however, it should only consist of a limited EZ com-
ponent, with no sign of the NZ region on the load/displace-
ment graph. Spinal motion in the plastic zone is not applicable
to nondestructive multidirectional flexibility testing as it is
associated with ligamentous damage and loss of structural
integrity.
Segmental or construct stiffness is another measure of
postinstrumentation stability. Stiffness is a measure of resistance
by the construct in response to external loading or force. It
represents the slope of a load displacement curve and is usually
obtained within the elastic region of a curve. However, stiffness
of a construct is not a constant and tends to increase as the
applied forces rise.
Additional biomechanical parameters that are frequently
reported in the literature include implant and/or bony ele-
ment strain, nucleus pulposus pressure measured at the opera-
tive and the adjacent level disc spaces, and maximum load to
failure associated with either a full construct or one of its com-
Figure 6.1. Schematic representation of the XYZ coordinates in ponents (screw, hook, wire, etc.). Furthermore, preclinical
biomechanical testing. (Redrawn from White AA, Panjabi MM. Clini- evaluation of the motion preserving devices has to incorporate
cal biomechanics of the spine. Philadelphia, PA: Lippincott Williams data on implant wear characteristics obtained under continu-
& Wilkins, 1990.) ous cyclical loading conditions.

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Chapter 6 General Considerations of Biomechanical Testing 67

Figure 6.2. A typical load displacement curve with marked


boundaries for the neutral, elastic, and plastic zones (NZ, EZ, and
PZ, respectively). (Redrawn from White AA, Panjabi MM. Clinical
biomechanics of the spine. Philadelphia, PA: Lippincott Williams &
Wilkins, 1990.)

Figure 6.3. Lateral X-ray of a cervical spine instrumented with two


In nondestructive testing, implant strain has been used as a
miniature intradiscal pressure transducers at C3-C4 and C5-C6 levels.
predictive measure of the stress components distributed
through the device during cyclical or quasistatic loading (slow since the disc must remain intact) or the adjacent spinal motion
continuous loading about each of the three primary axes of segments (Fig. 6.3).
motion for two to three repetitive cycles). Strain gages generat-
ing these data can be mounted either within the implant of
interest or affixed to the surface of a longitudinal element IN VITRO BIOMECHANICAL TESTING MODELS
(rod). In addition, strain gages can be attached directly to the Human Cadaveric Model
surface of vertebral elements, including posterior laminas, facet
processes, or pedicles. These techniques help evaluate the The ultimate goal of in vitro biomechanics is to replicate clini-
extent of load sharing between the implant and the surround- cal spinal motion and loading conditions in a laboratory setting
ing bony structures. In turn, miniature intradiscal pressure (Tables 6.2 and 6.3). Proper simulation of these parameters
gages can be placed into the center of the disc nucleus through allows for a direct comparison of surgical instrumentation,
a small opening in the annular fibers. The data generated by reconstructive techniques, and instability patterns ensuing
these gages can serve as an estimate of the amount of load trans- posttrauma. Clinical biomechanics models utilize comparative
mitted through the anterior column either at the operative level responses of the surgically manipulated spine relative to its
(for posterior decompression/stabilization only procedures intact state. Sequential testing of an unaltered spine followed

Cervical Spine: Representative Values of Human


TABLE 6.2
Intervertebral Motion*

Combined Flexion  One Side Lateral One Side Axial


Extension (X-Axis) Bending (Z-Axis) Rotation (Y-Axis)
Spinal Level Ave (Range) Ave (Range) Ave (Range)
C0-C1 25 5 5
C1-C2 20 5 40
C2-C3 10 (516) 10 (1120) 3 (010)
C3-C4 15 (726) 11 (915) 7 (310)
C4-C5 20 (1329) 11 (016) 7 (112)
C5-C6 20 (1329) 8 (016) 7 (212)
C6-C7 17 (626) 7 (017) 6 (210)
C7-T1 9 (47) 4 (017) 2 (07)

*Data taken from reference 1 (White and Panjabi).

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68 Section II Biomechanics

Lumbar Spine: Representative Values of Human


TABLE 6.3
Intervertebral Motion*

Combined Flexion  One Side Lateral One Side Axial


Extension (X-Axis) Bending (Z-Axis) Rotation (Y-Axis)
Spinal Level Ave (Range) Ave (Range) Ave (Range)
L1-L2 12 (516) 6 (38) 2 (13)
L2-L3 14 (818) 6 (310) 2 (13)
L3-L4 15 (617) 8 (412) 2 (13)
L4-L5 16 (921) 6 (39) 2 (13)
L5-S1 17 (1024) 3 (26) 1 (02)

*Data taken from reference 1 (White and Panjabi).

by a destabilized or an instrumented condition generate data approximates the human vertebral and disc space size and shape.
on the stabilizing potential of an arthrodesis construct or the The calf specimens are also more readily available and are sig-
maintenance of physiologic motion for nonfusion devices. nificantly cheaper than the human cadaver spines. Furthermore,
In the laboratory, human cadaveric specimens remain the Wilke et al25 investigated the kinematic properties of the calf tho-
standard model of in-vitro testing.12,16 Clinically, physiologic racic and lumbar regions and compared the data with previously
motion at each spinal level has been previously described.21 published results for the human cadaveric specimens. The
Similar motion parameters can be successfully replicated in the authors reported similarities in ROM, NZ, and stiffness between
laboratory setting; however, testing is usually limited to a specific the two models under axial rotation and lateral bending. The
spinal region of interest or a transition zone such as the cervico- flexionextension range was somewhat lower; however, still
thoracic or thoracolumbar junctions. Secondary to high flexibil- within the acceptable range. Furthermore, in a recent study by
ity, global ROM of a whole human spine usually exceeds the Riley et al19 the group reported similar motion trends at the
capacity of most currently available spine simulators. This is not L3-L4 level following destabilization and transpedicular fixation
a limitation of the cadaveric model but is a technical constraint in a calf and human models relative to their respective intact
that may hinder research efforts aimed at characterizing biome- conditions. However, comparison of the direct response to
chanics of extensive fusions, particularly, in severe deformity instrumentation revealed significant ROM differences between
applications. In addition, human cadaveric models present other the two models under axial rotation and lateral bending. Thus,
disadvantages. High specimen variability, limited supply, and despite concluding that calf spines offer a reasonable alternative
excessive cost constitute the main concerns associated with using to human tissue (due to similar motion trends following surgical
human material. Furthermore, cadaveric specimens often pres- manipulation), the authors advised to use caution when extrapo-
ent with progressive degenerative pathology and osteoporosis. lating calf spine data to clinical scenarios.
Therefore, radiographic and bone mineral density (BMD) In the cervical spinal region, the use of sheep and goat spines
screening are paramount in the pretesting phase. Lastly, strict has been previously reported. To validate the model Wilke
institutional guidelines for human tissue handling and disposal et al23,24 and later Kandziora et al14 undertook the challenge of
must be adhered to when using cadaveric material. comparing the biomechanical and anatomic parameters of the
sheep and human specimens. Wilke et al24 systematically evalu-
Animal Models ated the biomechanics of the whole sheep spine broken down
into individual motion segments. They then compared their data
In lieu of the aforementioned concerns, animal models, with human ROM values published by White and Panjabi.21
approximating human anatomical features and biomechanical Despite finding some ROM differences between the individual
parameters, have been explored and described. Spinal testing levels, the authors observed qualitative similarities in the cephal-
has been reported utilizing rabbit, canine, ovine, porcine, ocaudal trends as spinal motion changed from the cervical to
caprine, bovine, and nonhuman primate specimens. The main lumbar regions in both models. In Kandzioras work, the investi-
advantage of any of these animal species is the inherent within- gators performed a side-by-side comparison of the sheep and
group anatomic similarity, which yields highly reproducible human spine segmental kinematics and anatomic variability
data in the laboratory setting. However, significant differences through biomechanical testing and computed tomography imag-
do exist between the anatomic and biomechanical parameters ing.14 In concordance with previous studies, the group concluded
of the human and each of the above animal models; therefore, that sheep spine is a suitable model for cervical studies and high-
one must be cautious when attempting to directly translate in lighted the C3-C4 motion segment having the closest resem-
vitro animal data to clinical practice. blance to the corresponding human level.
The rabbit model has emerged as a commonly used vehicle
for studying the effects of bone graft substitutes, pharmacologic
agents, or wear particulate on the posterolateral arthrodesis. Synthetic Spine Model
Biomechanical characteristics of the rabbit lumbar spine have
been methodically described by Grauer et al.13 However, it is Human cadaveric and animal models enable analysis of the
not suitable for the in vitro assessment of spinal implants sec- mechanical behavior of spinal constructs in an acute postop-
ondary to the overall size of the animal spine. erative period. However, secondary to tissue degradation, it is
In contrast, the bovine thoracolumbar model has been widely impossible to simulate long-term prosthesis loading in a bio-
accepted for the biomechanical testing of spinal devices, as it logic specimen. Ashman et al7 estimated that prior to being

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Chapter 6 General Considerations of Biomechanical Testing 69

offloaded by a matured biologic fusion; an implant would have


endured over a million cycles of repeated loading. This esti-
mate was based on a 4-month postoperative window for a
maturing arthrodesis and an assumption that a patient loads a
construct every 5 seconds for 16 hours everyday.
In the laboratory, it would take more than 10 days of non-
stop loading of a single implant to reach the 1 million cycle
mark at a testing frequency of 1 Hz (1 cycle/sec). Obviously,
the specimens will begin to break down and degrade well before
the end of a testing cycle. Wilke and associates22 have experi-
mentally documented that cadaveric tissue degradation and
exposure to room temperature increases specimen flexibility
beyond 72 hours of testing. Therefore, several synthetic models
including ultra-high molecular weight polyethylene (UHMWPE)
and polyacetal blocks have been proposed to study the long-
term fatigue and wear parameters of spinal implants. Generally,
a device should be durable enough to withstand not only the
daily dynamic loading, but also the maximum static loads that it
may periodically experience (i.e., during heavy lifting, jump-
ing, etc). In an acute reconstructive scenario, it is challenging
to simulate implant failure prior to bone fracture; therefore,
synthetic models have also been useful in determining the ulti-
mate strength of spinal implants. Over the past decade the
ASTM society has developed a number of testing standards
(discussed below) utilizing the synthetic model that address the
long-term wear and ultimate strength parameters of spinal Figure 6.4. ASTM 1717-04 Standard: cervical corpectomy model
implants. Furthermore, these standards have now become testing setup. (Redrawn from ASTM F1717-04 Standard Test Method
the minimum requirements of the U.S. FDA for the mechani- for Spinal Implant Constructs in a Vertebrectomy Model, copyright
cal characterization of newly developed instrumentation. ASTM International, 100 Barr Harbor Drive, West Conshohocken, PA
Nonetheless, the synthetic block models are only sufficient for 19428.)
studying the mechanical properties of a device itself. They do
not provide information regarding the implants behavior
within a spinal construct, its stabilizing potential, bone inter-
face strength, and the possible effects on the adjacent spinal constructs can withstand 5 million cycles of continuous loading
segments. Therefore, one should be cautious when considering without failing (Figs. 6.4 and 6.5).
device efficacy based only on the synthetic model data.
ASTM F179897 (2003) Standard Guide for
Evaluating the Static and Fatigue Properties of
TESTING STANDARDIZATION Interconnection Mechanisms and Subassemblies
Used in Spinal Arthrodesis Implants2
ASTM STANDARDS
This standard was set forth to establish the mechanical strength
Following the rapid explosion of the spinal device market in of interconnecting mechanisms in spinal constructs. Various
the 1990s a number of implant-related construct failures have designs of implant interconnections can be tested under uni-
been reported. These mechanical insufficiencies have prompted axial static loading to failure or cyclical fatiguing at a maximum
the ASTM to outline a series of standardized testing protocols run-out load for a total of 2.5 million cycles. The maximum
that evaluate the ultimate strength, long-term performance, recommended static loading rate for this procedure was set at
and wear parameters of all new devices. The resulting standards 20 N/sec (25 mm/min) for linear loading or 25 Nm/min (25/
currently used by the FDA are summarized below: min) for torsional testing.

ASTM F171704 Standard Test Method for Spinal ASTM F207703 Test Methods for Intervertebral
Implant Constructs in a Vertebrectomy Model1 Body Fusion Devices3
This document was the initial standard adopted by the ASTM This test method outlines the procedure for establishing
based on methodology described by Cunningham et al.10 In the mechanical strength of interbody spacers and cages in response
original study, the authors outlined the UHMWPE corpectomy to axial compressive and shear forces as well as torsional
block model for the long-term dynamic testing of pedicle screw moments under static and dynamic loading protocols. For the
constructs. The current procedure provides description of fatigue testing a polyacetal block assembly is used and the
three static (compression bending, tensile bending, and tor- implants are loaded to 5 million cycles, whereas in static load
sion) and one dynamic (compression bending fatigue) tests applications (linear and torsional) a metal block assembly is
using the same synthetic model. Testing setup is outlined for recommended. In addition, during all torsional testing a pre-
both the cervical and lumbar constructs. For the fatigue test- load of 100, 300, and 500 N for the cervical, thoracic, and lum-
ing, a maximum run-out force is established under which all bar spine, respectively, is advised (Fig. 6.6).

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70 Section II Biomechanics

Figure 6.5. ASTM 1717-04 Standard: lumbar corpectomy model Figure 6.6. ASTM 2077-03 Standard: testing setup for evaluation
testing setup. (Redrawn from ASTM F1717-04 Standard Test Method of the intervertebral fusion devices. Of note, this setup is identical to
for Spinal Implant Constructs in a Vertebrectomy Model, copyright the one used in ASTM 2346-05 for evaluation of the total disc replace-
ASTM International, 100 Barr Harbor Drive, West Conshohocken, PA ment prostheses. (Redrawn from ASTM F2077-03 Test Methods for
19428.) Intervertebral Body Fusion Devices, copyright ASTM International,
100 Barr Harbor Drive, West Conshohocken, PA 19428.)

ASTM F226704 Standard Test Method for Measuring


Load-Induced Subsidence of an Intervertebral Body
fatigue component is outlined. In the lumbar spine, 1200 N of
Fusion Device Under Static Axial Compression4
axial preload are recommended with angular device rotations
This testing standard was proposed for characterizing end plate set for 20 under flexion/extension (combined), 15 for lateral
subsidence of nonbiologic interbody fusion devices in response bending (total), and 4 of combined left and right axial rota-
to axial compressive loading. The test is static in nature and is tion. As with other TDR testing standards, a total of 10 million
applicable to the study of metallic implants only. loading cycles are advised. In addition, the protocol encom-
passes device wear analysis using a testing medium weight loss
assessment methodology similar to the one described by
ASTM F234605 Standard Test Methods for Static and
Serhan et al.20
Dynamic Characterization of Spinal Artificial Discs 5
At the present moment the ASTM society continues to
Materials and methods for static and dynamic loading of an develop standardized methods of testing new technologies to
artificial intervertebral disc are outlined in this protocol. The keep up with the constantly evolving field of spinal implants.
overall testing setup and methodology is similar to the one Draft proposals that are undergoing current review are listed in
described in ASTM 207703 for the evaluation of an interverte- Table 6.4.
bral fusion device. The main difference is the total number of
loading cycles that a prosthesis must endure without failing.
NONDESTRUCTIVE MULTISEGMENTAL
Secondary to the prolonged functional expectancy for the
SPINE TESTING
device it is recommended to apply 10 million cycles during this
fatigue protocol. Similar to the ASTM-driven standardizations, the biomedical
research community is trying to establish guidelines for the bio-
mechanical testing of spinal constructs. One of the major draw-
ASTM F242305 Standard Guide for Functional,
backs of the earlier studies has been the vast difference in
Kinematic, and Wear Assessment of Total
testing methodologies employed by research centers world-
Disc Prostheses 6
wide. Currently, as a result of the ongoing efforts, several con-
The standard provides guidance for kinematic evaluation of sensus accepted loading protocols have been described for the
the cervical and lumbar TDR devices. Dynamic ROM for the nondestructive loading of multisegmental specimens:

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Chapter 6 General Considerations of Biomechanical Testing 71

Proposed New ASTM


TABLE 6.4 Standards (Under
Development)

Standard ID Name
WK453 Test Method for Static and Dynamic
Characterization of Spinal Artificial Discs
WK455 Test Method for Static and Fatigue Analysis of
Occipital-Cervical Spinal Implants
WK4863 Standard Guide for the Mechanical
Characterization of Lumbar Nuclear Devices
WK7479 Standard Test Method for the Functional,
Kinematic, and Wear Assessment of
Extra-Discal Spinal Motion Preserving Implants
WK8050 Guide for Functional, Kinematic, and Wear
Evaluation of Motion Preserving Total Facet
Prostheses

Stiffness Test Protocol11


According to this testing paradigm, one of the six rotational or
translational components of spinal motion is applied to a
specimen using displacement-controlled loading configura-
tion. The resulting moments, forces, and motion are measured
across the individual segments. However, this protocol is prone
to experimental error as the resulting motion is rarely uncon-
strained. The segmental axis of rotation must be user defined
and remains constant throughout the loading sequence; how-
ever, this response is not physiologic and is in conflict with the
concept of a shifting IAR described for spinal motion. Further-
more, this loading protocol requires that all coupled rotations
in the segment be blocked, which may result in an inadvertent
injury to the specimen during testing. Overall, the stiffness pro- Figure 6.7. A full lumbar spine L1-S1 setup for the multidirec-
tocol may not be the most appropriate for nondestructive eval- tional flexibility evaluation on a 6 degree-of-freedom spine simulator.
uation of multisegmental specimens. Note the infrared light emitting diodes (IRLEDs) attached to each
vertebral level that enable segmental ROM evaluation in a multi-FSU
specimen. In addition, intradiscal pressure is evaluated at L23 and
Flexibility Test Protocol12 L5S1 in this specimen via miniature transducers implanted in the
center of nucleus pulposus at those level (arrows).
Under this loading setup one of the three rotational moments
is applied to a specimen. Translational forces can also be
applied but are currently rarely reported. The resulting compo-
nents of segmental motion are measured in response to the tracking), reconstruction of the appropriate load/displacement
applied load. The rotational loads should be pure moments, curves is possible and enables precise characterization of inter-
which are equally distributed throughout each FSU in the spec- vertebral kinematics in terms of the total ROM, NZ, and EZ at
imen being analyzed. For the human cadaver, moments rang- each spinal level.
ing from 1.5 to 3 Nm are acceptable for the cervical region,
while the lumbar spine should be loaded to between 6 and 10
Hybrid Test Protocol11
Nm about each axis. According to Wilke et al,22 loading rates
ranging from 0.6 to 5.1/sec are adequate and result in similar The hybrid testing protocol has been recently adapted to
segmental ROMs. address the biomechanical changes (ROM, intradiscal pres-
In contrast to the stiffness protocol, a fixed axis of rotation sure, facet strain, etc.) occurring at levels adjacent to a surgical
and elimination of the coupled motions are not required. intervention. This protocol is specifically designed to evaluate
Therefore, the total number of the resulting degrees of freedom multisegmental specimens consisting of the whole spinal region
becomes a function of the testing apparatus, rather than the of interest (cervical, lumbar, etc.). Specimens are to be posi-
loading paradigm. Each of the three bending moments (axial tioned on a testing apparatus in the neutral orientation, after
rotation, flexion/extension, and lateral bending) are sequen- which unconstrained pure moments are applied using the stan-
tially applied at one end of the specimen while the other is fixed dard flexibility protocol. The spines global ROM is obtained
to an immobile or a free-sliding XZ platform (Fig. 6.7). for all loading planes and is then used as the displacement limit
Provided that segmental motion is recorded at each spinal that the testing apparatus must reach while evaluating all sub-
level independently (optoelectronic, radiographic, or magnetic sequent reconstructions in that particular specimen. Most

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72 Section II Biomechanics

importantly, the loading must still be induced by pure moments


and has to remain unconstrained throughout all testing
sequences. By forcing the spine to attain the same global ROM
as the intact specimen, one can assess the redistribution of
stresses and motions throughout the segments adjacent to a
surgically altered level.
The hybrid protocol works best when evaluating motion
preserving technology; however, it can also be applied to the
arthrodesis constructs. In the latter case, special attention has
to be paid to the overall forces exerted onto the specimen, as
they can rise substantially when testing multiple fused seg-
ments and may lead to inadvertent specimen damage.

Axial Preload
None of the in vitro testing methods can effectively replicate the
stabilizing properties of the axial musculature. Several groups
have described mechanically simulated muscle forces; however,
this significantly increases the complexity of the testing setup.
Furthermore, this technique also increases the potential for
additional experimental errors when attempting to replicate
the vector forces and magnitudes from one reconstruction to
the next within the same specimen.17 In addition, secondary to
the overall differences in patient size and fitness level, the role
of muscle forces on spinal stabilization can vary dramatically
between the individuals. Therefore, controversy still exists of
whether muscle force replication is an absolute necessity when
sequentially comparing different fixation techniques within the
same specimen.
Application of a compressive axial preload is another Figure 6.8. Biomechanical testing setup for C2 pedicle screw pull-
method of simulating the body weight that would be normally out showing actuator and thus the tensile force alignment with the
transmitted through the spinal column. The main complica- long axis of the screw.
tion with axial loading is the immediate buckling effect observed
in multisegmental spines even at the lowest load magnitudes
(50 N for the lumbar spine). However, Patwardhan and col- Tensile pull-out testing of pedicle screws, laminar hooks, wires,
leagues18 were able to overcome this phenomenon and devel- or interbody implants can provide information on the strength
oped a method of applying physiologic axial preloads (up to of the bone/implant interface. These tests can be performed
1000 N) that does not induce spinal collapse. Nevertheless, this with tensile forces oriented either in line with the long axis of
concept, termed the follower preload, has only been validated the implant (i.e., screw) or along the midsagittal plane of the
to work in the sagittal plane of spinal motion (flexion/ vertebra for posterior instrumentation assessment (Fig. 6.8).
extension). The follower preload is applied through two bilat- In-line testing is the standard method of pull-out studies across
eral cables attached to the upper mount of the specimen and all implants, whereas parasagittal load direction simulates
running along the sides of a spine through specialized guides. forces exerted on a screw during forward bending or lifting
These guides are attached to each vertebral level and the cable activities. This method takes into account both the implants
path through every anchor must be optimized in the antero- design and the surgical trajectory, as factors affecting the pull-out
posterior plane to coincide with each individual segments cen- resistance. Two additional parameters established to have predic-
ter of rotation. Otherwise, inaccurate vector forces are trans- tive value for implant failure are vertebral BMD and insertional
mitted through the disc space, limiting segmental motion and torque (IT) measured during screw placement. These assess-
altering spinal alignment. For this reason and secondary to ment tools have a direct clinical application as they can be
the anatomic constraints for guide position in other planes, the obtained pre-operatively (BMD) or during the surgery (IT).
follower preload has only been deemed appropriate for the The rate of pull-out force application can be continuous or
flexion/extension mode of testing. incremental, with unique load and hold steps, which may
In summary, the quality of segmental motion with and with- account for the stress-relaxation properties of the implant/bone
out preload is similar; therefore, comparative biomechanical interface. In addition, prior to performing the tensile pull-out,
testing performed without preloading is still considered valid implants can be subjected to cyclical fatigue loading applied at
even in the flexion/extension plane of motion. physiologic magnitudes in the cephalocaudal plane. This step
simulates potential chronic implant loosening or subsidence
(interbody devices) before a traumatic or sudden overload
Destructive Testing to Failure event, resulting in the implant fixation failure.
In addition to the multidirectional flexibility analysis, a number Application of a destructive flexural moment to a multiseg-
of studies can be performed to evaluate the maximum strength mental construct can provide information on the overall
of fixation afforded by a construct or an individual implant. strength and the mode of failure for a certain method of

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Chapter 6 General Considerations of Biomechanical Testing 73

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conditions will in turn enhance our ability to compare the


research data across institutions worldwide.

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