SECTION
Biomechanics
CHAPTER
6 Anton E. Dmitriev
General Considerations of
Biomechanical Testing
INTRODUCTION
Spinal instrumentation has experienced rapid evolution over
the last 20 years, with the resulting variety of reconstructive
options significantly expanding the scope of spinal pathology
that can be successfully managed through surgical interven-
tion. Although different in design and surgical indication, most
currently available implants serve a common goal of stabilizing
the spine throughout the postoperative period while the bio-
logic arthrodesis matures into a successful fusion. However,
recent developments in the nonfusion technology have intro-
duced a new era of managing degenerative conditions through
motion preservation and retention of spinal flexibility. This
widely expanded armamentarium available to the spine special-
ist has allowed surgeons to address cases with evermore chal-
lenging biomechanical presentations. Therefore, rigorous
preclinical laboratory testing of spinal implants elucidating
their mechanical strength, fatigue and wear parameters, as well
as the vertebral anchoring potential is paramount. To that end,
significant efforts have been put forth by the biomechanical
research community, industry engineers, the American Society
for Testing and Materials (ASTM), and the Food and Drug
Administration (FDA) to standardize the biomechanical testing
protocols and preclinical evaluation of spinal implants.
BIOMECHANICAL TERMINOLOGY
AND ANALYZED PARAMETERS
General familiarity with the biomechanical concepts, terminol-
ogy, and parameters being analyzed is critical to understanding
and appreciating the relevant literature (Table 6.1). Aside from
the individual dissected vertebrae, a functional spinal unit
LWBK836_Ch06_p65-73.indd 65
II
(FSU) constitutes the smallest spinal segment that can be kine-
matically analyzed before and after a surgical manipulation. An
FSU, also known as a motion segment, is composed of any two
adjacent vertebrae, an intervening intervertebral disc, and the
interconnecting ligaments.21 Therefore, biomechanical testing
of a single FSU allows for a simplistic, however, precise defini-
tion of kinematic changes and quantification of the vertebral
stresses following a surgical intervention. According to Panjabi,15
each vertebra in an FSU represents a rigid body that can poten-
tially move in three translational (X,Y,Z) planes and about
three rotational axes (X,Y,Z) in relation to the other vertebra.
This motion accounts for the maximum of 6 degrees of free-
dom that a rigid body can move about in space. Vertebral
motion that is not impeded by the testing apparatus in any of
the 6 degrees of freedom is termed unconstrained. By conven-
tion, axial torsion is referred to as the rotations about the
 Y-axis, flexionextension occurs over the  X-axis, and lat-
eral bending takes place about the  Z-axis (Fig. 6.1). In the
laboratory setting, generating unconstrained loading of a sin-
gle FSU is technically easier due to the limited ranges of motion
(ROMs) in each of the loading planes. However, this approach
does not provide information on the biomechanical changes
occurring at the levels adjacent to a surgically manipulated seg-
ment. Furthermore, by definition, single FSU assessment pre-
cludes evaluation of multisegmental constructs that are often
required for proper management of a patients pathology.
Therefore, multisegmental spinal specimens must be utilized
to study the global effects of a surgical intervention.
Currently, segmental ROM is one of the most frequently
reported outcome measures in biomechanical studies.12 ROM
parameters can be easily translated to clinical practice as they
are often used to define a successful fusion on flexion
extension dynamic radiographs. Similarly, ROM is utilized as a
65
8/17/11 1:28:26 PM
 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
motion sparing procedures, where one can establish not only
the quantity but also the quality of the residual segmental
motion.8 Qualitative analysis of spinal motion includes map-
ping of the segments instantaneous axis of rotation (IAR), as
well as segregating the total segmental ROM into its two consti-
tutive regions: the neutral zone (NZ) and the elastic zone (EZ)
(ROM  NZ  EZ) (Table 6.1).
In the intact lumbar spine, flexionextension IAR forms an
ellipse in the posterior one third of the intervertebral disc
space, overlying the superior end plate of the inferior body.11
Information about the changes in the IAR location at the oper-
Figure 6.1. Schematic representation of the XYZ coordinates in
biomechanical testing. (Redrawn from White AA, Panjabi MM. Clini-
cal biomechanics of the spine. Philadelphia, PA: Lippincott Williams
& Wilkins, 1990.)
ative and adjacent levels is of particular importance when evalu-
ating total disc replacement (TDR) prostheses and other
motion preserving technology.9 Significant shifts in segmental
IAR coupled with continued postoperative mobility can lead to
excessive loading of the posterior elements, thus increasing the
odds of progressive facet joint degeneration over time.
Segmental NZ and EZ can be deduced from the total ROM
by evaluating a corresponding load/displacement curve (Fig.
6.2). NZ by definition represents spinal motion through a
region of no to minimal resistance offered by the joint.
Therefore, significant postoperative increase in the NZ range is
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-
ponents (screw, hook, wire, etc.). Furthermore, preclinical
evaluation of the motion preserving devices has to incorporate
data on implant wear characteristics obtained under continu-
ous cyclical loading conditions.

LWBK836_Ch06_p65-73.indd 66 8/17/11 1:28:28 PM

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

LWBK836_Ch06_p65-73.indd 67 8/17/11 1:28:29 PM

 68 Section II Biomechanics
Lumbar Spine: Representative Values of Human
TABLE 6.3
Intervertebral Motion*
Combined Flexion 
Extension (X-Axis)
Spinal Level Ave (Range)
L1-L2 12 (516)
L2-L3 14 (818)
L3-L4 15 (617)
L4-L5 16 (921)
L5-S1 17 (1024)
*Data taken from reference 1 (White and Panjabi).
by a destabilized or an instrumented condition generate data
on the stabilizing potential of an arthrodesis construct or the
maintenance of physiologic motion for nonfusion devices.
In the laboratory, human cadaveric specimens remain the
standard model of in-vitro testing.12,16 Clinically, physiologic
motion at each spinal level has been previously described.21
Similar motion parameters can be successfully replicated in the
laboratory setting; however, testing is usually limited to a specific
spinal region of interest or a transition zone such as the cervico-
thoracic or thoracolumbar junctions. Secondary to high flexibil-
ity, global ROM of a whole human spine usually exceeds the
capacity of most currently available spine simulators. This is not
a limitation of the cadaveric model but is a technical constraint
that may hinder research efforts aimed at characterizing biome-
chanics of extensive fusions, particularly, in severe deformity
applications. In addition, human cadaveric models present other
disadvantages. High specimen variability, limited supply, and
excessive cost constitute the main concerns associated with using
human material. Furthermore, cadaveric specimens often pres-
ent with progressive degenerative pathology and osteoporosis.
Therefore, radiographic and bone mineral density (BMD)
screening are paramount in the pretesting phase. Lastly, strict
institutional guidelines for human tissue handling and disposal
must be adhered to when using cadaveric material.
Animal Models
In lieu of the aforementioned concerns, animal models,
approximating human anatomical features and biomechanical
parameters, have been explored and described. Spinal testing
has been reported utilizing rabbit, canine, ovine, porcine,
caprine, bovine, and nonhuman primate specimens. The main
advantage of any of these animal species is the inherent within-
group anatomic similarity, which yields highly reproducible
data in the laboratory setting. However, significant differences
do exist between the anatomic and biomechanical parameters
of the human and each of the above animal models; therefore,
one must be cautious when attempting to directly translate in
vitro animal data to clinical practice.
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.
Biomechanical characteristics of the rabbit lumbar spine have
been methodically described by Grauer et al.13 However, it is
not suitable for the in vitro assessment of spinal implants sec-
ondary to the overall size of the animal spine.
In contrast, the bovine thoracolumbar model has been widely
accepted for the biomechanical testing of spinal devices, as it
LWBK836_Ch06_p65-73.indd 68
One Side Lateral One Side Axial
Bending (Z-Axis) Rotation (Y-Axis)
Ave (Range) Ave (Range)
6 (38) 2 (13)
6 (310) 2 (13)
8 (412) 2 (13)
6 (39) 2 (13)
3 (26) 1 (02)
approximates the human vertebral and disc space size and shape.
The calf specimens are also more readily available and are sig-
nificantly cheaper than the human cadaver spines. Furthermore,
Wilke et al25 investigated the kinematic properties of the calf tho-
racic and lumbar regions and compared the data with previously
published results for the human cadaveric specimens. The
authors reported similarities in ROM, NZ, and stiffness between
the two models under axial rotation and lateral bending. The
flexionextension range was somewhat lower; however, still
within the acceptable range. Furthermore, in a recent study by
Riley et al19 the group reported similar motion trends at the
L3-L4 level following destabilization and transpedicular fixation
in a calf and human models relative to their respective intact
conditions. However, comparison of the direct response to
instrumentation revealed significant ROM differences between
the two models under axial rotation and lateral bending. Thus,
despite concluding that calf spines offer a reasonable alternative
to human tissue (due to similar motion trends following surgical
manipulation), the authors advised to use caution when extrapo-
lating calf spine data to clinical scenarios.
In the cervical spinal region, the use of sheep and goat spines
has been previously reported. To validate the model Wilke
et al23,24 and later Kandziora et al14 undertook the challenge of
comparing the biomechanical and anatomic parameters of the
sheep and human specimens. Wilke et al24 systematically evalu-
ated the biomechanics of the whole sheep spine broken down
into individual motion segments. They then compared their data
with human ROM values published by White and Panjabi.21
Despite finding some ROM differences between the individual
levels, the authors observed qualitative similarities in the cephal-
ocaudal trends as spinal motion changed from the cervical to
lumbar regions in both models. In Kandzioras work, the investi-
gators performed a side-by-side comparison of the sheep and
human spine segmental kinematics and anatomic variability
through biomechanical testing and computed tomography imag-
ing.14 In concordance with previous studies, the group concluded
that sheep spine is a suitable model for cervical studies and high-
lighted the C3-C4 motion segment having the closest resem-
blance to the corresponding human level.
Synthetic Spine Model
Human cadaveric and animal models enable analysis of the
mechanical behavior of spinal constructs in an acute postop-
erative period. However, secondary to tissue degradation, it is
impossible to simulate long-term prosthesis loading in a bio-
logic specimen. Ashman et al7 estimated that prior to being
8/17/11 1:28:30 PM
 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
Implant Constructs in a Vertebrectomy Model1
This document was the initial standard adopted by the ASTM
based on methodology described by Cunningham et al.10 In the
original study, the authors outlined the UHMWPE corpectomy
block model for the long-term dynamic testing of pedicle screw
constructs. The current procedure provides description of
three static (compression bending, tensile bending, and tor-
sion) and one dynamic (compression bending fatigue) tests
using the same synthetic model. Testing setup is outlined for
both the cervical and lumbar constructs. For the fatigue test-
ing, a maximum run-out force is established under which all
ASTM F207703 Test Methods for Intervertebral
Body Fusion Devices3
This test method outlines the procedure for establishing
mechanical strength of interbody spacers and cages in response
to axial compressive and shear forces as well as torsional
moments under static and dynamic loading protocols. For the
fatigue testing a polyacetal block assembly is used and the
implants are loaded to 5 million cycles, whereas in static load
applications (linear and torsional) a metal block assembly is
recommended. In addition, during all torsional testing a pre-
load of 100, 300, and 500 N for the cervical, thoracic, and lum-
bar spine, respectively, is advised (Fig. 6.6).

LWBK836_Ch06_p65-73.indd 69 8/17/11 1:28:30 PM

 70 Section II Biomechanics
Figure 6.5. ASTM 1717-04 Standard: lumbar corpectomy model
testing setup. (Redrawn from ASTM F1717-04 Standard Test Method
for Spinal Implant Constructs in a Vertebrectomy Model, 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
Fusion Device Under Static Axial Compression4
This testing standard was proposed for characterizing end plate
subsidence of nonbiologic interbody fusion devices in response
to axial compressive loading. The test is static in nature and is
applicable to the study of metallic implants only.
ASTM F234605 Standard Test Methods for Static and
Dynamic Characterization of Spinal Artificial Discs 5
Materials and methods for static and dynamic loading of an
artificial intervertebral disc are outlined in this protocol. The
overall testing setup and methodology is similar to the one
described in ASTM 207703 for the evaluation of an interverte-
bral fusion device. The main difference is the total number of
loading cycles that a prosthesis must endure without failing.
Secondary to the prolonged functional expectancy for the
device it is recommended to apply 10 million cycles during this
fatigue protocol.
ASTM F242305 Standard Guide for Functional,
Kinematic, and Wear Assessment of Total
Disc Prostheses 6
The standard provides guidance for kinematic evaluation of
the cervical and lumbar TDR devices. Dynamic ROM for the
LWBK836_Ch06_p65-73.indd 70
Figure 6.6. ASTM 2077-03 Standard: testing setup for evaluation
of the intervertebral fusion devices. Of note, this setup is identical to
the one used in ASTM 2346-05 for evaluation of the total disc replace-
ment prostheses. (Redrawn from ASTM F2077-03 Test Methods for
Intervertebral Body Fusion Devices, copyright ASTM International,
100 Barr Harbor Drive, West Conshohocken, PA 19428.)
fatigue component is outlined. In the lumbar spine, 1200 N of
axial preload are recommended with angular device rotations
set for 20 under flexion/extension (combined), 15 for lateral
bending (total), and 4 of combined left and right axial rota-
tion. As with other TDR testing standards, a total of 10 million
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
Serhan et al.20
At the present moment the ASTM society continues to
develop standardized methods of testing new technologies to
keep up with the constantly evolving field of spinal implants.
Draft proposals that are undergoing current review are listed in
Table 6.4.
NONDESTRUCTIVE MULTISEGMENTAL
SPINE TESTING
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-
backs of the earlier studies has been the vast difference in
testing methodologies employed by research centers world-
wide. Currently, as a result of the ongoing efforts, several con-
sensus accepted loading protocols have been described for the
nondestructive loading of multisegmental specimens:
8/17/11 1:28:31 PM
 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

LWBK836_Ch06_p65-73.indd 71 8/17/11 1:28:33 PM

 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
method of simulating the body weight that would be normally
transmitted through the spinal column. The main complica-
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-
leagues18 were able to overcome this phenomenon and devel-
oped a method of applying physiologic axial preloads (up to
1000 N) that does not induce spinal collapse. Nevertheless, this
concept, termed the follower preload, has only been validated
to work in the sagittal plane of spinal motion (flexion/
extension). The follower preload is applied through two bilat-
eral cables attached to the upper mount of the specimen and
running along the sides of a spine through specialized guides.
These guides are attached to each vertebral level and the cable
path through every anchor must be optimized in the antero-
posterior plane to coincide with each individual segments cen-
ter of rotation. Otherwise, inaccurate vector forces are trans-
mitted through the disc space, limiting segmental motion and
altering spinal alignment. For this reason and secondary to
the anatomic constraints for guide position in other planes, the
follower preload has only been deemed appropriate for the
flexion/extension mode of testing.
In summary, the quality of segmental motion with and with-
out preload is similar; therefore, comparative biomechanical
testing performed without preloading is still considered valid
even in the flexion/extension plane of motion.
Destructive Testing to Failure
In addition to the multidirectional flexibility analysis, a number
of studies can be performed to evaluate the maximum strength
of fixation afforded by a construct or an individual implant.
Figure 6.8. Biomechanical testing setup for C2 pedicle screw pull-
out showing actuator and thus the tensile force alignment with the
long axis of the screw.
Tensile pull-out testing of pedicle screws, laminar hooks, wires,
or interbody implants can provide information on the strength
of the bone/implant interface. These tests can be performed
with tensile forces oriented either in line with the long axis of
the implant (i.e., screw) or along the midsagittal plane of the
vertebra for posterior instrumentation assessment (Fig. 6.8).
In-line testing is the standard method of pull-out studies across
all implants, whereas parasagittal load direction simulates
forces exerted on a screw during forward bending or lifting
activities. This method takes into account both the implants
design and the surgical trajectory, as factors affecting the pull-out
resistance. Two additional parameters established to have predic-
tive value for implant failure are vertebral BMD and insertional
torque (IT) measured during screw placement. These assess-
ment tools have a direct clinical application as they can be
obtained pre-operatively (BMD) or during the surgery (IT).
The rate of pull-out force application can be continuous or
incremental, with unique load and hold steps, which may
account for the stress-relaxation properties of the implant/bone
interface. In addition, prior to performing the tensile pull-out,
implants can be subjected to cyclical fatigue loading applied at
physiologic magnitudes in the cephalocaudal plane. This step
simulates potential chronic implant loosening or subsidence
(interbody devices) before a traumatic or sudden overload
event, resulting in the implant fixation failure.
Application of a destructive flexural moment to a multiseg-
mental construct can provide information on the overall
strength and the mode of failure for a certain method of

LWBK836_Ch06_p65-73.indd 72 8/17/11 1:28:41 PM


fixation. This becomes of particular interest when evaluating
anchor points at the proximal or distal end-vertebrae in a long-
segment reconstruction.
LIMITATIONS OF IN VITRO BIOMECHANICS
The current era of rapid expansion in the spinal device market
requires rigorous premarket evaluation before an implant can be
deemed safe and efficacious. The goals of in vitro testing are not
only to characterize the mechanical properties of an individual
implant/construct but also to outline its effects on the overall spi-
nal stability and motion following implantation through methodi-
cal replication of in vivo loads and conditions in a laboratory
setting, one can obtain a great volume of data that would help
predict the clinical success of a particular device, construct, or a
surgical technique. Furthermore, surgeons understanding of the
basic biomechanical principles of spinal instrumentation is para-
mount, as it aids in the proper planning of a procedure and
ensures that the approach and instrumentation of choice are bio-
mechanically adequate to sustain the long-term postoperative
loading.
Nonetheless, it is important to realize that even the most
sophisticated biomechanical testing setup is not capable of evalu-
ating the biologic responses of an organism to a surgical interven-
tion and a foreign body implantation. Certain reconstructions
that appear biomechanically superior in a laboratory may not be
clinically appropriate secondary to bulky design, low available vol-
ume for bony ingrowth, technically challenging surgical tech-
nique, or other factors. In addition, the optimum stiffness for a
device or a construct that creates the most favorable biomechani-
cal environment for the arthrodesis to mature is yet to be experi-
mentally elucidated. Furthermore, in vitro simulation of clinical
conditions is limited by the lack of spinal remodeling, soft-tissue
healing, bone formation, and prolonged in vivo loading.
These shortcomings can be overcome by conducting com-
prehensive animal studies; however, due to the extensive costs,
staff resources, and time commitment for these projects they
are often limited to the FDA mandated requirements. Moreover,
only randomized prospective clinical studies can generate
definitive data establishing the safety and effectiveness of a par-
ticular device or a treatment regimen. Nonetheless, despite the
limitations, with the expected changes in patient demographics
and the emergence of new technologies, biomechanical studies
will continue to play a first-stage role in the device and surgical
technique evaluation paradigm. Therefore, careful experimen-
tal design, planning, and adherence to the accepted testing
guidelines are imperative for the appropriate in vitro simulation
of varying clinical scenarios. Reproducible studies and testing
conditions will in turn enhance our ability to compare the
research data across institutions worldwide.
LWBK836_Ch06_p65-73.indd 73
Chapter 6 General Considerations of Biomechanical Testing 73
REFERENCES
1. ASTM Standard F1717, 2004, Standard Test Methods for Spinal Implant Constructs in a
Vertebrectomy Model. In, ASTM International, West Conshohocken, PA, www.astm.org.
2. ASTM Standard F1798, 1998 (2003), Standard Guide for Evaluating the Static and Fatigue
Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis
Implants. In, ASTM International, West Conshohocken, PA, www.astm.org.
3. ASTM Standard F2077, 2003, Test Methods For Intervertebral Body Fusion Devices. In,
ASTM International, West Conshohocken, PA, www.astm.org.
4. ASTM Standard F2267, 2004, Standard Test Method for Measuring Load Induced Subsid-
ence in an Intervertebral Body Fusion Device Under Static Axial Compression. In, ASTM
International, West Conshohocken, PA, www.astm.org.
5. ASTM Standard F2346, 2005, Standard Test Methods for Static and Dynamic Characteriza-
tion of Spinal Artificial Discs. In, ASTM International, West Conshohocken, PA, www.astm.
org.
6. ASTM Standard F2423, 2005, Standard Guide for Functional, Kinematic, and Wear Assess-
ment of Total Disc Prostheses. In, ASTM International, West Conshohocken, PA, www.astm.
org.
7. Ashman RB, Bechtold JE, Edwards WT, Johnston CE II, McAfee PC, Tencer AF. In vitro
spinal arthrodesis implant mechanical testing protocols. J Spinal Disord 1989;2:274281.
8. Auerbach JD, Wills BP, McIntosh TC, Balderston RA. Evaluation of spinal kinematics fol-
lowing lumbar total disc replacement and circumferential fusion using in vivo fluoroscopy.
Spine 2007;32:527536.
9. Cunningham BW, Gordon JD, Dmitriev AE, Hu N, McAfee PC. Biomechanical evaluation
of total disc replacement arthroplasty: an in vitro human cadaveric model. Spine
2003;28:S110S117.
10. Cunningham BW, Sefter JC, Shono Y, McAfee PC. Static and cyclical biomechanical analysis
of pedicle screw spinal constructs. Spine 1993;18:16771688.
11. Goel VK, Panjabi MM. Roundtables in spine surgery; spine biomechanics; evaluation of
motion preservation devices and relevant terminology, vol 1. St. Louis, MO: Quality Medi-
cal Publishing, 2005.
12. Goel VK, Panjabi MM, Patwardhan AG, Dooris AP, Serhan H. Test protocols for evaluation
of spinal implants. J Bone Joint Surg Am 2006;88(Suppl 2):103109.
13. Grauer JN, Erulkar JS, Patel TC, Panjabi MM. Biomechanical evaluation of the New
Zealand white rabbit lumbar spine: a physiologic characterization. Eur Spine J 2000;9:
250255.
14. Kandziora F, Pflugmacher R, Scholz M, et al. Comparison between sheep and human cervi-
cal spines: an anatomic, radiographic, bone mineral density, and biomechanical study.
Spine 2001;26:10281037.
15. Panjabi MM. Biomechanical evaluation of spinal fixation devices: I. A conceptual frame-
work. Spine 1988;13:11291134.
16. Panjabi MM. Cervical spine models for biomechanical research. Spine 1998;23:2684
2700.
17. Panjabi MM, Miura T, Cripton PA, Wang JL, Nain AS, DuBois C. Development of a system
for in vitro neck muscle force replication in whole cervical spine experiments. Spine 2001;
26:22142219.
18. Patwardhan AG, Havey RM, Carandang G, et al. Effect of compressive follower preload on
the flexion-extension response of the human lumbar spine. J Orthop Res 2003;21:
540546.
19. Riley LH III, Eck JC, Yoshida H, Koh YD, You JW, Lim TH. A biomechanical comparison of
calf versus cadaver lumbar spine models. Spine 2004;29:E217E220.
20. Serhan HA, Dooris AP, Parsons ML, Ares PJ, Gabriel SM. In vitro wear assessment of the
Charite artificial disc according to ASTM recommendations. Spine 2006;31:19001910.
21. White AA, Panjabi MM. Clinical biomechanics of the spine. Philadelphia, PA: Lippincott
Williams & Wilkins, 1990.
22. Wilke HJ, Jungkunz B, Wenger K, Claes LE. Spinal segment range of motion as a function
of in vitro test conditions: effects of exposure period, accumulated cycles, angular-
deformation rate, and moisture condition. Anat Rec 1998;251:1519.
23. Wilke HJ, Kettler A, Claes LE. Are sheep spines a valid biomechanical model for human
spines? Spine 1997;22:23652374.
24. Wilke HJ, Kettler A, Wenger KH, Claes LE. Anatomy of the sheep spine and its comparison
to the human spine. Anat Rec 1997;247:542555.
25. Wilke HJ, Krischak ST, Wenger KH, Claes LE. Load-displacement properties of the thora-
columbar calf spine: experimental results and comparison to known human data. Eur
Spine J 1997;6:129137.
8/17/11 1:28:46 PM