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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
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.
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
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).
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.)
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
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