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CHAPTER 5/CLINICAL SPINAL INSTABILITY / 53
different animals, three graded spinal injuries (inter­spinous and supraspinous ligament transections, laminec­tomy, and facetectomy) at the C4-5 level were studied by functional flexion-extension stereoradiographs for up to 24 weeks (17,18). In these in vivo animal experiments, contrary to expectations, the spine at the injury site became more stable (even compared with the intact spine) as measured by standardized functional X-ray studies during the healing period (Fig. 5-3). Although the facetectomy resulted in the largest increase in motion acutely, it also produced the largest decrease in motion in vivo. At 6 weeks after the injury, the range of motion (ROM) decreased from 23 degrees preoperatively to 5 degrees postoperatively. These findings are suppor ted by studies using a canine (19) and a porcine model (20). In the later study, explanation was provided for the decreased motion. At 3 months post facetectomy, we found hypertrophy of the facet joints, which limited the range of motion.
Degeneration
For an in-depth description of degeneration, please see
Chapter 3.
The spine degenerates with age; this is a normal process that results in altered mechanical characteristics. It also may lead to low back problems. Kirkaldy-Willis (6) provided a classification of degeneration of the spine based on three stages.
Stage 1. Dysfunction. This includes low back pain with
nonspecific syndrome. The facet capsule may be lax
and disc degeneration is of grade 1 to 2 on a scale of 1
to 4.
FIG. 5-3. Average intervertebral range of motion at the injury site as a function of healing time. The injury was bilateral facetectomy at C4-5 in a canine model. The injury was unprotected during the entire healing phase, and the motion measurements were made using functional flexion-e xtension stereoradiographs.(From Panjabi M, P elk er K, Crisco J, et al. Biomechanics of healing of posterior cervical spinal injuries in canine model. Spine 1988;13:803–807.)
Stage 2. Instability. This is marked by increased facet
joint laxity and moderate disc degeneration (grades 2 to 3). Clinical syndrome can be identified, and the instability can be measured by functional X-ray stud­ies.
Stage 3. Restabilization. This is characterized by fibrosis
in posterior joints and osteophytic formations leading to decreased overall motion. Disc generation has reached the final stage (g rades 3 to 4).
A recent study has confirmed the biomechanical aspects of the preceding hypothesis using an intraopera­tive instrumented lamina spreader (21). It consisted of an electric motor, which spread the adjacent laminae, and the strain gauges attached to the spreader legs, which measured the force applied. Based on a study of nearly 300 patients and 650 FSUs intraoperatively, we conclude the following. The average stiffness reaches its peak of 120 N/mm at about 25 years of age, decreases thereafter to less than 20 N/mm at about 55 years, and then increases once more to about 80 N/mm above the age of 60 (Fig. 5-4). The stiffness seems to have an inverse rela­tionship to the disc degeneration and range of motion.
The degeneration effect on the mechanical properties of the spine is specific and direction dependent. Several parameters may be obtained from load-displacement curves of a lumbar spine specimen to quantify the mechanical properties. These are: the neutral zone (NZ), representing “looseness” of the specimen; the elastic zone (EZ), which may equate with elastic deformation; and the range of motion (Fig. 5-5). Another parameter is the neutral zone ratio (NZR), equal to NZ divided by ROM. In a study using fresh cadaveric lumbosacral spine specimens, intervertebral flexion-extension, lateral bend­ing, and axial rotation were measured and plotted against disc degeneration grade (22). In flexion-extension, there was some tendency for ROM to decrease and NZ to increase. The lateral bending showed significant decrease in ROM and significant increase in NZR. In axial rotation there were significant changes in ROM, which decreased, and in NZ and NZR, both of which increased.
The preceding knowledge has been obtained mostly from in vitro experiments. The general degeneration of the spine, seen on X-ray films as decreased disc height, deformed end plates, and osteophyte formation, has not been found to be a reliable predictor of subsequent low back pain. On the other hand, evidence suggests that increased disc degeneration carries a signif icantly higher risk of low back problems (23). During discography , 23% of patients with nondegenerated discs reported pain, and 77% felt either pressure only or no pain at all. On the other hand, among patients with a severely degenerated annulus, 90% reported pain during discography, whereas only 10% felt no pain or simply some pressure. Thus, a significant relationship seems to exist between disc degeneration and low back pain, even though it may not
54 /SECTION I/BASIC SCIENCE
FIG. 5-4. Functional spinal unit (FSU) stiffness distribution with age. (From Brown MD, Holmes DC, Heiner AD, et al. Intraoperative measurement of lumbar spine motion segment stiffness. Spine 2002;27(9):954–958.)
be a one-to-one correspondence. This and similar in vivo studies provide a link to the in vitro biomechanical stud- ies, by which the mechanical characteristics of the spine and the clinical symptoms of low back pain may be related.
Role of Spinal Muscles
The understanding of the primary role of musculature
in providing spinal stability and the extent to which the
FIG. 5-5. Load-displacement curve of a spine specimen.The measurements for neutral zone (NZ), elastic zone (EZ), and range of motion (ROM) are obtained from the curve.
musculature contributes to pain production, modulation, and prevention is not well understood. Muscle dysfunc­tion may result from muscle weakness, in the form of decreased strength or endurance, and possibly from a dis­turbance in the neuromuscular control system, in the form of altered recruitment patterns. Muscle spasm and pain may be indicators of muscular overload owing to the reduced efficiency in weakened passive structures of the spinal system. As described, muscles form an important subsystem of the overall spinal stabilizing system.
A lumbo-sacral (L1-sacrum) spinal column that is devoid of musculature is a mechanically unstable struc­ture, with a load-carrying capacity of less than 90 N (or 20 pounds) (24). However, with properly coordinated muscle action, the spine can sustain large loads, which is exemplified by the action of weight lifters. In the past, the complexity of the muscular anatomy and physiology hin­dered the development of biomechanical models for studying the stabilizing role of muscle, as well as various passive components of the spine (e.g., ligaments, discs, vertebrae, and facet joints). Detailed morphologic and biomechanical analyses of the lumbar musculature are now available (25–27). The spinal muscles may be con­ceptualized as local (intersegmental) and global (multi­segmental), which helps us to understand their functions of stabilizing the spine and producing motion (28,29). Advanced mathematical models are helping us to better understand the instability (30).
A modeling study based on radiographs from normal subjects was performed to determine the effects of flex­ion on the forces exerted by the lumbar muscles (27). The
CHAPTER 5/CLINICAL SPINAL INSTABILITY / 55
act of flexing caused substantial elongation of many mus­cle fascicles, which consequently reduced the maximum active tension they could exert. Consequently, it was found that the compressive forces and moments exerted by the back muscles in full flexion are not signif icantly different from those in the upright posture. However, major changes in shear forces were found, particularly at L5-S1, where there was a re versal from a net anterior to a net posterior force. These shear forces must be consid­ered when prescribing therapeutic exercise, particularly in patients with translatory instability in the lower lumbar and lumbosacral region.
Using an anatomically detailed biomechanical model, the role of the lumbar erector spinae musculature in off­setting the anterior shear forces on L4-5 (58 to 324 N) and upper body mass during different dynamic lifts (squat and stoop) were studied (31,32). They found that, during the squat lift, the maximum peak forces supported by the f acet joints and possibly the disc remained rela­tively constant at approximately 200 N, regardless of the load mass. When comparing the two different lifting styles, the stoop lift, which produced a more flexed lum­bar spine than did the squat lift, and had greater contri­butions from the passive lumbar structures (e.g., liga­mentous strain), although the peak moments provided by these tissues were less than 60 nm.
The effects of simulated intersegmental muscle forces on spinal instability in an in vitro experiment have been investigated (33). In flexion loading, range of motion increased and neutral zone decreased with the application of muscle forces, whereas both variables decreased in extension loading. Similar observations have been made in an in vivo investigation using a porcine model to study alterations in segmental kinematics as a result of injury to the passive stabilizing components and stimulation of the lumbar musculature (34). When compared with the un­stimulated situation, stimulation of the paraspinal mus­cles produced significantly greater range of motion in sagittal rotation and shear translation in the L3-4 motion segment after injuries to the disc or facet joints. Although it increased the range of motion, the increased muscular activity also stabilized the injured motion segment. This stabilization was indicated by a reduction in the abrupt changes in the pattern of motion for sagittal rotation dur­ing the transitional phase between dynamic flexion and extension (neutral region).
Electromyographic signals of the paraspinal and ab­dominal muscles have been studied both in normal sub­jects and in patients with low back pain. Some studies have sho wn that the electromyographic patterns displayed some abnormalities in patients with low back pain com­pared with the normal group (35–37). Also, the flexion­relaxation phenomenon of the erector spinae muscle group is absent in some patients with acute low back pain but returns after the pain has gone. The flexion-relaxation phenomenon is the myoelectric silence at approximately
two thirds of maximum flexion angle, at which the load moment is carried by the soft tissues (e.g., ligaments, fas­cia, and passive elongated muscle) (38,39). It is now believed that intra-abdominal pressure stabilizes the spine (40).
However, studies show diverging results as to whether increased intra-abdominal pressure loads or unloads the spine (30,41,42). The muscles not only apply loads and provide stability, but also help control the posture and movement (5). In a study of low back patients and healthy controls, patients demonstrated poorer balance control while sitting on an unstable hemisphere and had longer reaction times to sudden horizontal loadings (43).
DIAGNOSTIC METHODS Roentgenographic Motion Studies
Besides the grades of disc degeneration, which are related to a greater risk of low back pain, other motion and posture measures can be obtained from radiographs or computed tomography or MRI images. Functional radiographs (e.g., a pair of radiographs taken, generally, at the extremes of a motion in a certain plane) form the basis of most clinical studies of motion. Knutsson (44) was probably the f irst to indicate a relationship between excessive anteroposterior translation seen on flexion­extension radiographs and low back problems. In another study, patients with low back pain were examined in lat­eral bending, and centers of rotation were calculated for various positions of the lumbar spine. An increased area occupied by the locus of the centers of rotation at a par­ticular level w as found to be directly related to the pain at that level (45). In another study, motions were measured from lateral radiographs taken in three specified postures (46). Normal patients were found to be different from the patients with spondylosis in translation and rotation and in coupling between these motions.
The spinal movements of patients with low back pain who are suspected of having instability ma y not al w a ys be greater in magnitude. It is known clinically, quantif ied using stereoradiographic analysis, that patients with low back pain have restricted flexion-extension intervertebral motion. The total flexion (L1-S1) of about 50 degrees in normal individuals decreases to less than 20 degrees in patients with low back pain and nerve root tension signs (47). Associated with the restricted flexion-extension spinal motion are increased coupled motions (i.e., lateral bends and axial rotations). The coupled motion is defined as the associated motion produced during the main motion (e.g., lateral bending or axial rotation produced during flexion). Theoretically, there are up to f ive cou­pled motions for every main motion. Both observations may be explained by the fact that spinal instability resulted in activation of the muscular system. Increased muscle forces restricted the overall motion of the spine
56 /SECTION I/BASIC SCIENCE
and at the same time, owing to muscle imbalance, resulted in asymmetric spinal movements (e.g., out-of­sagittal plane coupled motion during flexion-extension). Functional flexion-extension X-ray studies were per­formed passively on a patient population that was subdi­vided into different groups having similar pathologic conditions (48). When compared with a normal popula­tion, all patients exhibited less motion, except for high­performance athletes who showed more motion com­pared to the controls. Therefore, it was concluded that a kinematic analysis of the lumbar spine using passiv e flex­ion-extension was not a clinically useful method.
Inferior-superior loading using functional X-ray e xam­inations also has been investigated as a measure of spinal instability (49,50). The motion was measured at two extremes of motion obtained by (a) spinal traction (sus­pending the individual from his or her hands); and (2) compression (using a weighted backpack during stand­ing). Anteroposterior translation measurements were taken from lateral X-ray films of patients who had spondylolisthetic or retrospondylolisthetic displacement. In accordance with the severity of symptoms, the patients were divided into the following groups: (a) asymptomatic patients; (b) those with moderate symptoms and (c) patients with severe symptoms. The degree of primary anterior slip was almost equal in the three groups, but the translator movement differed signif icantly among them, as follows: 0.7, 5.2, and 7.5 mm, respectively.
Stereoradiographic techniques have been used to ana­lyze three degrees-of-freedom sagittal plane motion (sagittal rotation, antero-posterior translation, and infe­rior-superior translation) in patients with low back pain and suspected segmental spinal instability (51). The aver­age angular ROM in patients at the unaf fected level (9.67 degrees) was not different from that at the affected level (8.45 degrees). The same was true for antero-posterior shear translation values, which were 1.54 and 0.92 mm, respectively. However, the ratio (i.e., coupled shear trans­lation divided by the flexion angle) was significantly dif­ferent (+0.18 versus 0.13 mm/degree) at the unaffected and affected levels, respectively. The retrodisplacement (anterior-to-posterior translation during flexion from extended position) was associated with the restricted motion, especially for sagittal plane rotations of less than 5 degrees, but was not correlated with the specif ic clini­cally unstable levels.
In a recent study, three-dimensional coupled motions were measured in low back pain patients (52). The patients were asked to move in three planes (sagittal, transverse, and frontal) while the intervertebral motions of pedicle screws inserted into the vertebrae above and below the suspected painful level were measured. During flexion-extension, there w ere small out of plane rotations. During axial rotation there was considerable v ariability in the coupled motions. The same was true for the lateral bending. The authors concluded that in contrast to well-
defined in vivo and in vitro coupling patterns observed in the controls, the low back pain patients showed signifi­cantly greater variability. The inherent coupling pattern of the osseoligamentous spine was modified by the al­tered muscle pattern or pain.
Other Measures of Instability
Measurement of ROM, especiall y flexion-extension, is easy in vivo. For this reason, the ROM has been used often as an indicator of instability (4). Unfortunately, the ROM is not related to clinical instability, as exemplified by a young gymnast who may have extensive ROM but no clinical symptoms of instability (3). Further, the mea­surement of the ROM is affected by voluntary effort that the subject applies at the time of examination and motion limitation because of pain. Thus, investigating other mea­sures of motion as possible indicators of instability has merit.
One such variable is the neutral zone, w hich represents looseness of the spinal column around the neutral posi­tion. Support for the coupled motions concept is provided by an in vivo study, which documented the presence of these motions in patients with suspected clinical instabil­ity (47). The neutral zone has been studied only in vitro. The increase in the neutral zone was found to be associ­ated with disc degeneration and its decrease was related to simulated muscle force application (22,33). No direct clinical evidence is yet available. Because both measures are generally smaller in magnitude compared with the ROM, new and more accurate diagnostic methods are needed. In a recent study using ultrasound Doppler effect, the neutral zones of the sacroiliac joint have been mea­sured in subjects without pain (53). Future studies with low back pain patients using this technique will be in­teresting to see if the neutral zone concept is clinically useful.
Using an intervertebral motion device for continuously measuring sagittal plane motion in the human lumbar spine, the intervertebral motion, along with the overall trunk angle, was measured dynamically during standing flexion-extension, both in normal subjects in patients sus­pected of having clinical instability in a lumbar motion segment (39). There exists a characteristic pattern of motion during flexion-extension for normal lumbar motion segments and patients (Fig. 5-6). The main f ind­ings were the follo wing. Motion w as significantly less, by at least 50%, in patients compared to the controls. A 78% reduction in muscle activity at full flexion (flexion relax­ation) occurred in controls, whereas only a 13% reduc­tion was found in patients. These observations were explained by hypothesizing that the neuromuscular con­trol system provides acti v e stabilization needed to protect the injured or diseased passive structures from move­ments that may cause pain, similar to the stabilization concepts proposed by Panjabi (5).
FIG. 5-6. Segmental kinematics (sagittal rotation) and myo­electric experimental data during a flexion-extension (F-E) cycle from the L4-5 motion segment plotted as a function of trunk F-E angle for a control and a patient. (Neutral standing position = trunk F-E angle = 0 degrees. Root mean square of the right-side erector spinae myoelectric activity (RMS EMG).) (From Kaigle AM, Wessberg P, Hansson T. Muscular and kinematic behavior of the lumbar spine during flexion­extension. J Spinal Disord 1998;11(2):163–174.)
TREATMENTS
Spinal instability is treated clinically by diverse con­servative methods, some of w hich seem to be parado xic. Both the flexion exercises, which strengthen abdominal muscles, and the extension exercises, which strengthen back muscles, have been effective (54). To increase spinal stability co-contraction of both the front and back muscles is needed (55). This may be the explanation for the effectiveness of both the flexion and extension exer­cises. Rotational exercises have been found to be effec­tive in patients who did not respond to other treatments (56). In addition to strengthening the spinal muscles, improving muscle coordination is important in enhanc­ing spinal stability (5). Muscle stabilization has been advocated and shown to be effective in treating back pain patients (57). Various fusion techniques are re­ported to have clinical success (3).
CHAPTER 5/CLINICAL SPINAL INSTABILITY / 57
FUTURE RESEARCH
Several aspects of spinal instability need to be investi­gated from the biomechanical viewpoint. A short list is provided.
1. By means of in vitro simulations (using human cadaveric material), in vivo animal models, and mathematical models, investigate the role of inter­segmental (deep) as well as multisegmental (superfi­cial) muscles in providing spinal stability.
2. Develop techniques that measure the dynamic inter­vertebral motion continuously.
3. Using in vivo animal models, study the role of heal- ing and adaptation after injury in altering the spinal stability.
4. Develop new and more accurate diagnostic methods for determining abnormalities of coupled motion, neutral zones, and other motion variables, w hich ma y help to provide more sensitive and specific measure­ments of spinal instability than are presently avail­able.
5. Conduct clinical studies (prospective, double b lind , and controlled) that correlate carefully obtained measures of instability of intervertebral motions (representing spinal column) and muscle function (representing neu­romuscular control) with the clinical symptoms. These studies may help to bridge the gap between instability indicators and clinical symptoms.
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18. Wetzel FT, Panjabi MM, Pelker RR. Biomechanics of the rabbit cervi­cal spine as a function of component transection. J Orthop Res 1989;7: 723–727.
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20. Kaigle AM, Holm SH, Hansson TH. Kinematic behavior of the porcine lumbar spine: a chronic lesion model. Spine 1997;22(24):2796–2806.
21. Brown MD, Holmes DC, Heiner AD, et al. Intraoperative measurement of lumbar spine motion segment stiffness. Spine 2002;27(9):954–958.
22. Mimura M, Panjabi MM, Oxland TR, et al. Disc degeneration affects the multidirectional flexibility of the lumbar spine. Spine 1994;19(12): 1371–1380.
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CHAPTER 6

Spinal Instrumentation

Vijay K. Goel, Manohar M. Panjabi, Huroshi Kuroki, Setti S. Rengachary, D. McGowan, and N. Ebraheim
In recent years, surgeons have well-accepted surgical sta­bilization and fusion of the spine using instrumentation. Accordingly, the number of available devices for use by a surgeon has increased (1–4). The types and complexity of procedures (e.g., posterior, anterior, interbody) (3) have produced novel design challenges, requiring sophisti­cated testing protocols (3). In addition, most contempo­rary implant issues of stabilization and fusion of the spine are mostly mechanical in nature (4). [Biologic factors related to the adaptive nature of living tissue further complicate mechanical characterization (3,5,6).] Accord­ingly, researchers have designed various methods of test­ing to assess the mechanical nature of the spine and implants, both as separate and united entities. These eval­uation regimens have produced valuable information and have led to the design and de v elopment of state-of-the-art systems. The most eff icient way to describe the biome­chanical issues relating to stabilization and fusion in the thoracolumbar region is to group the literature that con­cerns the major testing modalities. Results of specific studies are presented to show the type of information pro­vided by the various testing methods.
CLINICAL SCOPE AND OBJECTIVE OF SPINAL FUSION
Low back pain is responsible for approximately 14% of visits to physicians that do not in v olve pree xisting con­ditions (2). Others have estimated 70% of the population in the United States has experienced back pain in their lives, leading to surgical intervention of the lumbar spine in 4% of the population (2). Surgical treatments most often promote fusion of the painful segments, with an estimated 25% of the 280,000 operations involving the lumbar spine (4,7).
The objective of spinal fusion is to eliminate pain and allow the patient to resume normal activities. Elimination of relative motion between the affected joints often
reduces this type of segmental pain. Spinal fusion is also performed to prevent or correct deformity (3) and stabi­lize the spine after trauma. Pathologic degeneration of the bony elements, intervertebral disc, and soft tissues are also indicators for fusion (3). Although intervertebral disc conditions seem to account for a significant propor­tion of the lesions leading to fusion, other indications include segmental instability, both degenerative and iatrogenic, and failed previous surgery. Although the aforementioned indications are commonly cited in the lit­erature as grossly appropriate, there is considerable debate as to the degree of the lesion that indicates fusion (8).
Properly applied, spinal instrumentation maintains alignment and shares spinal loads until a solid, consoli­dated fusion is achieved. As instrumentation procedures have become increasingly popular, the number of avail­able fixation systems has grown. With few exceptions, these hardware systems are used in combination with bone grafting procedures, and may be augmented by external bracing systems.
BIOMECHANICAL EVALUATION OF INSTRUMENTATION PERFORMANCE
Spinal implants typically follow loosely standardized testing sequelae during the design and development stage and in preparation for clinical use. The design and devel­opment phase goal, from a biomechanical standpoint, seeks to characterize and define the geometric consider­ations and load-bearing environment to which the implant will be subjected. Various testing modalities exist that elucidate which components may need to be redesigned. Not including the testing protocols for indi­vidual components of a device, plastic vertebrae (corpec­tomy) models are one of the first-stage tests that involve placing the assembled device on plastic vertebral compo­nents in an attempt to pinpoint which component of the
59
60 /SECTION I/BASIC SCIENCE
assembled device may be the weakest mechanical link in the worst case scenario, vertebrectomy. The in vivo effec­tiveness of the device may be limited by its attachment to the vertebrae (fixation). Thus, testing of the implant-bone interface is critical in determining the fixation of the device to biologic tissue. Construct testing on cadaveric specimens provides information about the effectiveness of the device in reducing intervertebral motion across the affected and adjacent segments during quasi-physiologic loading. Animal studies provide insight with respect to the long-term biologic effects of implantation. Analytic modeling, such as the finite element method, is an extremely valuable tool for determining how implants and osseous loading patterns change with varying param­eters of the device design. This type of modeling may also provide information about temporal changes in the bone quality due to the changing loading patterns as bone adapts to the implant (e.g., stress shielding-induced bone remodeling). After a certain level of confidence in the implant’s safety and effectiveness is established through all or some of the aforementioned tests, controlled clini­cal trials allow for the determination of an implant’s suit­ability for widespread clinical use. The following sec­tions discuss each of these testing modalities, with specific examples used to illustrate the type of infor ma­tion that different tests can provide.
Implant-Bone Interface
Device-Ver tebra Interface
Depending upon the spinal instrumentation, the device-vertebra interface may deal with laminae, pedi­cles, the vertebral body itself, or the end plates.
Interlaminar Hooks
Interlaminar hooks are used as a means for fixing the device to the spine. Hook dislodgment, slippage, and incorrect placement have led to loss of fixation, however, resulting in nonfusion and pseudoarthrosis. Purcell et al. (9) investigated construct stiffness as a function of hook placement with respect to affected level in a thoracolum­bar cadaver model. They created posterior ligamentous defects through sectioning and imposed bony fracture at T-12 and L-1 by flexion testing to failure. The unstable spines were instrumented with Harrington distraction instrumentation and interlaminar hooks placed initially on T-11 and L-2. The hooks w ere relocated to v arious lev­els about the affected area and the construct retested. The failure moment was found to be a function of the hook placement. The authors recommended hook placements three levels above and two levels below the affected area. This placement reduced vertebral tilting (analogous to intervertebral motion) across the stabilized area, where fusion is to be promoted.
Transpedicular Screws
Proper application of screw-based anterior or posterior spinal devices requires an understanding of screw biome­chanics, including screw characteristics and insertion techniques, as well as an understanding of bone quality, pedicle and vertebral body morphometries, and salvage options (10–12). This is best illustrated by the fact that the pedicle, rather than the vertebral body, contributes approximately 80% of the stiffness and about 60% of the pullout strength across the screw-bone interface (10).
Carlson et al. (13) evaluated the effects of screw orien­tation, instrumentation, and bone mineral density (BMD) on screw translation, rotation at maximal load, and com­pliance of the screw-bone interface in human cadaveric bones. An inferiorly directed load was applied to each screw, inserted either anteromedially or anterolaterally, until failure of the f ixation was perceived. Anteromedial screw placement with fully constrained loading linkages provided the stiffest f ixation at low loads and sustained the highest maximal load. Larger rotation of the screws, an indication of screw-out failure, was found with the semi-constrained screws at maximal load. BMD directly correlated with maximal load, indicating that bone qual­ity is a major predictor of bone-screw interfacial strength. Peif fer et al. and Ryken et al. also found a significant cor­relation between BMD and torque (p < .0001, r < 0.42), BMD and pullout force (p < .0001, r < 0.54), and torque and pullout force (14–16).
Since the specimens used for pullout strength studies pri­marily come from older adult subjects, Choi et al. used foams of varying densities to study the effect of BMD on the pullout strength of several screws (17). Pedicle screws (6.0 mm × 40 mm, 2 mm pitch, titanium alloy) of several geometric variations were used for the study. They included the buttress (B), square (S), and V-shape (V) screw tooth profiles. For each type of tooth prof ile, its core shape (i.e., minor diameter) also varied, either straight (i.e., cylindrical, core diameter < 4.0 mm) or tapered (i.e., conical, core diameter < 4.0 mm/2.0 mm). In addition, for the cylindrical screws the major diameter was kept straight or tapered. The conical screws had their major diameters tapered only. Therefore, screws with a total of nine different geometries were prepared and tested (Fig. 6-1A). Nomenclature used for identifying each screw type followed this sequence: tooth profile, the shape of the major diameter, and core type. For example, BST represents the screw with the but­tress tooth profile and straight major diameter on a tapered core. The screws were implanted in the rigid polyurethane foams (77 cm × 127 cm × 77 cm) (Sawbones, Pacific Research Laboratory , Vashon Island , WA) of three different grades (grades 10, 12, and 15). These grades “simulated”
3
the variations in BMD (10 lbm/ft
3
, respectively) of the cancellous bone of a vertebra.
lbm/ft
, 12 lbm/ft3, and 15
Screws were implanted according to the American Society for Testing and Materials (ASTM: F1839-97) protocol. The
CHAPTER 6/SPINAL INSTRUMENTATION / 61
FIG. 6-1. A: Different types of screws used in the foam model to determine the pullout strengths of various designs. The nomenclature used is as follows: thread shape—square (S), buttress (B), V-shape (V); screw diameters—straight major diameter on straight core (SS), straight major diameter on
tapered core (ST), tapered major diameter on tapered core (TT). B: Regression analysis. The maximum and minimum val-
ues from pullout test for each foam gr ade were used regardless of tooth or core profiles. (From Choi W, Lee S, Woo KJ, et al. Assessment of pullout strengths of various pedicle screw designs in relation to the changes in the bone mineral density. Paper presented at: 48th Annual Meeting of the Orthopedic
A
Research Society; February 10–13, 2002; Dallas, TX.)
B
screws were pulled out at a loading rate of 5 mm per minute (ASTM: F1691-98) using MTS858 Bionix Machine (MTS Corp., Eden Prairie, MN). A one-way analysis of variance (ANOVA) test was done for the statistical analysis with SPSS 7.0 (SPSS, Inc., Chicago, IL). Comparison of the
TABLE 6-1. Axial strength (N) data for different types of screws pulled out in foam of different densities
Foam grade Body profile Square Buttress V-shape
SS 591 ± 22 497 ± 80 615 ± 36
10 ST 622 ± 43 598 ± 25 634 ± 19
TT 525 ± 36 547 ± 30 568 ± 74 SS 864 ± 50 769 ± 56 987 ± 55
12 ST 956 ± 30 825 ± 108 1,005 ± 92
TT 811 ± 41 808 ± 25 944 ± 32 SS 1,397 ± 93 1,303 ± 126 1,516 ± 78
15 ST 1,582 ± 82 1,438 ± 36 1,569 ± 79
TT 1,197 ± 43 1,352 ± 88 1,396 ± 68
SD, standard deviation; SS, straight major diameter on straight core; ST, straight major diameter on
tapered core; TT, tapered major diameter on tapered core.
Source: Choi W, Lee S, Woo KJ, et al. Assessment of pullout strengths of various pedicle screw designs in relation to the changes in the bone mineral density. Paper presented at: 48th Annual Meet­ing or the Orthopedic Research Society; February 10–13, 2002; Dallas, Texas.
pullout strength between the screw types was assessed with the Tukey test and Scheffe test. P values less than 0.05 were regarded as statistically significant.
The maximum pullout strengths for various screw
designs are shown in Table 6-1. The highest purchasing
Tooth profile (mean ±SD)
62 /SECTION I/BASIC SCIENCE
pow er in an y screw design w as observed in foams with the highest density (grade 15). Exponential increase in pullout strength was seen when the foam density increased from grade 10 through 15 (Fig. 6-1B). The VST screws exhib­ited the highest strength while the BSS the lowest with grades 10 and 12. The SST type screws were strongest against pullout with grade 15 foam while the STT the weakest. Statistical analysis showed that regardless of the foam grades or tooth profiles, the conical screws with straight major diameter (i.e., ST types) were stronger than the other two designs (i.e., SS or TT, p < .05). Within the ST types, the buttress (B) tooth screws showed the lowest pullout strength among the three tooth profiles (p < .05), while there was no statistical difference between the square and V-shape tooth with grades 12 and 15. Howe ver , with grade 10 foam, no significant difference was observed statistically among the three. In a case for the SS type screws, the buttress (B) tooth was the w eakest re gard­less of the foam grades. Between the square and V-shape tooth screws, no difference was found. As for the TT types, V-shape screws had higher pullout strength than the square with grades 12 and 15. No statistical differences were found between the V-shape and the buttress (B) screws with grades 12 and 15, nor were any found among the three tooth types with grade 10.
The use of foam for pullout tests afforded a control on the variability in the quality of bone that is prevalent in other studies. Thus, the foam allowed for characterization of the effects of screw variables on the pullout strength. Overall, results demonstrate that the conical screws are consistently more effective against the pullout than the cylindrical designs. This is especially evident when the major diameter of the screw is kept straight. In this case, the contact area between the screw thread and surround­ing foam is large. Although no consistent statistical supe­riority was found with the tooth profiles, results did sug­gest that the V-shape tooth screws ranked highest in many statistical comparisons and the buttress types showed comparativel y lo wer pullout strength than the other types. This finding may be somewhat different from the litera­ture. This can be due to the absence of the cortical pur­chase in foam model used in this study. On the other hand, the square tooth screws faired well in terms of pull­out strength when the major diameter was kept straight but did not do so when tapered. Results also suggest that as the density of the host site is decreased no clear choice of tooth profile could be found.
Likewise, McKinley et al. de v eloped a synthetic model to study the role of variations in pedicle morphology on the loads in pedicle screws (18). Synthetic vertebral analogs were fabricated, varying in pedicle height, length, or width independently. Pedicle screws internally instru­mented with strain gauges were used as load transducers to determine screw-bending moments within the pedicle and body of the analog. Analogs were loaded in compres­sion to simulate loading of an unstable burst fracture.
Screw bending moments within the pedicle increased incrementally with increasing pedicle length, rising 30% as length increased from 8 mm to 12 mm. Screw moment increased 20% when pedicle height dropped below 15 mm, consistent with a threshold effect. Changes in pedi­cle width did not affect screw loads within the pedicle. Thus, in situ pedicle screw loads increased significantly as pedicle length increased and as pedicle height decreased.
Lim et al. investigated the relationship between the BMD of the vertebral body and the number of loading cycles to induce loosening of an anterior vertebral screw (19). (Screw loosening was defined as 1 mm displace­ment of the screw relative to bone.) There was a positive correlation between the number of loading cycles to induce screw loosening and BMD (r < 0.8, p < .01). The average number of loading cycles to induce screw loos­ening was significantly less for specimens with BMD
2
less than 0.45 g/cm greater than or equal to 0.45g/cm
compared to those with BMD
2
. These findings sug­gest that BMD may be a good predictor of anterior verte­bral screw loosening as well, just like the pedicle screws.
These findings of increase in pullout strength, number of cycles to failure, and tightening torque with BMD, however, are not fully corroborated with the cor respond­ing in vivo work. For example, moments and forces dur­ing pedicle screw insertion were measured in vivo and in vitro and correlated to BMD, pedicle size, and other screw parameters (material, diameter) (20). The mean in vivo insertion torque (1.29 Nm) was significantly greater than the in vitro value (0.67 Nm). The linear correlation between insertion torque and BMD was significant for the in vitro data but not for the in vivo data. No correla- tion was observed between insertion torque and pedicle diameter. However, another investigation that clinically evaluated 52 patients who underwent pedicle screw f ixa­tion augmenting posterior lumbar interbody fusion (PLIF) supports the in vitro findings. BMD was mea­sured using dual energy X-ray absorptiometry (DEXA) and radiographs were assessed for detecting loosening and at the pedicle screw bone interface. BMD was found to have a close relationship with the stability of pedicle screw in vivo, and BMD values below 0.674 ± 0.104
2
suggested a potential increased risk of “nonunion”.
g/cm Similar studies pertaining to screw vertebral body inter­face for the anterior instrumentation have yet to be under­taken.
The current literature is based on studies of cylindrical pedicle screw designs. Conical screws have been intro­duced that may provide better “f it and f ill” of the dorsal pedicle as well as improved resistance to screw bending failure. However, there is concern about loss of fixation if conical screws must be backed out after insertion (21). Abshire et al. evaluated these issues by pulling out cylin­drical and conical screws inserted in pedicles of porcine vertebrae (21). Pullout results were comparable to data