The Journal of Bone and Joint Surgery (American) 86:1587-1596 (2004)
© 2004 The Journal of Bone and Joint Surgery, Inc.
What's New in Spine Surgery
Keith H. Bridwell, MD1,
Paul A. Anderson, MD2,
Scott D. Boden, MD3,
Alexander R. Vaccaro, MD4 and
Jack E. Zigler, MD5
1 Department of Orthopaedic Surgery, Washington University School of Medicine,
One Barnes-Jewish Hospital Plaza, Suite 11300 West Pavilion, St. Louis, MO
63110. E-mail address:
bridwellk{at}msnotes.wustl.edu
2 Department of Orthopedics and Rehabilitation, University of Wisconsin
Hospital, 600 Highland Avenue, Suite K4-738 CSC, Madison, WI 53792-0001.
E-mail address:
anderson{at}surgery.wisc.edu
3 The Emory Spine Center, 2165 North Decatur Road, Decatur, GA 30033. E-mail
address:
scott_boden{at}emoryhealthcare.org
4 Rothman Institute at Jefferson, 925 Chestnut Street, 5th Floor, Philadelphia,
PA. E-mail address:
alexvaccaro3{at}aol.com
5 Texas Back Institute, 6300 West Parker Road, Plano, TX 75093. E-mail address:
jackzigler{at}juno.com
Specialty Update has been developed in collaboration with the Council of
Musculoskeletal Specialty Societies (COMSS) of the American Academy of
Orthopaedic Surgeons.
The authors did not receive grants or outside funding in support of their
research or preparation of this manuscript. One or more of the authors
received payments or other benefits or a commitment or agreement to provide
such benefits from a commercial entity (Medtronic, Centerpulse, Osteotech
[S.D.B. and P.A.A.] and Synthes/Spine Solutions [J.E.Z.]). In addition, a
commercial entity (Medtronic [S.D.B.] and Synthes/Spine Solutions [J.E.Z.])
paid or directed, or agreed to pay or direct, benefits to a research fund,
foundation, educational institution, or other charitable or nonprofit
organization with which the authors are affiliated or associated.
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Spinal Deformity Surgery
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The Scoliosis Research Society (SRS) was founded in 1966 with a principal
interest in pediatric spinal deformity. Quite a bit has changed since then,
and the main interest is no longer simply teenage idiopathic scoliosis. Other
interests and concerns include adult deformity, tumors, fractures, and
spondylolisthesis, which are conditions that can affect patients throughout
life. The current mission statement of the Scoliosis Research Society is
"to foster optimal care of the patient with any disorder that may affect
the shape, alignment or function of the spine, throughout life. The SRS
accomplishes this, through education, research, advocacy and ethical
practice."
Idiopathic Scoliosis
It is debatable whether lumbar and thoracolumbar curves are best treated
surgically through an anterior or a posterior approach. Problems that have
been associated with anterior treatment in the past have included loss of
segmental lordosis and early failure of the implants. However, three studies
that were presented at the Scoliosis Research Society meeting in Quebec City
in September 2003 suggested that modern anterior instrumentation is associated
with better results. The use of solid-rod implants with structural interbody
anterior-column support and/or a two-screw two-rod technique reportedly leads
to better correction of the curvature, fewer levels being fused, and better
"spontaneous correction" of adjacent curves.
Posterior surgical methods for the treatment of thoracic and double-major
curves are tending toward the use of segmental pedicle-screw fixation. The use
of screws allows for improved segmental purchase and appears to offer
potentially greater coronal, sagittal, and apical correction. This greater
correction may allow surgeons to fuse fewer spinal segments in selected cases.
However, the surgical technique of thoracic pedicle screw placement has to be
precise. Although greater correction is possible, the potential for
catastrophe (e.g., placing the screws into the spinal cord or the great
vessels) remains a great concern.
We continue to be very interested in long-term studies on the natural
history of untreated idiopathic scoliosis. It is very difficult to find a
substantial cohort of patients. Previous studies have suggested that curves of
>50° have a high propensity for progression into adulthood. In a study
from the Twin Cities Spine Center in Minneapolis, Minnesota, a total of
forty-six patients with curves of 30° to 50° were followed for at
least ten years after skeletal maturity. The investigators found that these
curves progressed an average of 0.5° per year. However, only 4% of the
curves progressed >1° per year, and only two patients
"required" posterior spinal fusion. Therefore, it would appear
that the prognosis for curves of 30° to 50° is better than that for
larger curves.
Adult Spinal Deformity
Several studies have analyzed the validity of the SRS-22 questionnaire as
an outcome instrument for the assessment of adolescent idiopathic scoliosis.
Studies that are now emerging have suggested that this instrument is valid for
the evaluation of adult spinal deformity.
The treatment of adult spinal deformity is more complex than the treatment
of adolescent deformity and is associated with a higher rate of complications.
In both adolescents and adults, there is a certain prevalence of proximal
junctional kyphosis cephalad to the fusion. This is a topic about which we are
just starting to scratch the surface, and additional studies are needed to
analyze risk factors and the consequences of cephalad junctional
deformity.
In many adults in whom lumbar scoliosis is the principal abnormality, there
is rotatory subluxation at L3-L4 and fixed tilt at L4-L5. In these cases, a
decision has to be made about whether to stop the fusion at L5 or at the
sacrum. It would appear that stopping the fusion at L5 would be associated
with fewer short-term complications, but investigators have reported a
relatively high prevalence of later breakdown (kyphosis and accelerated disc
degeneration) at L5-S1 with a subsequent need to extend the fusion to the
sacrum. Therefore, controversy remains regarding the indications for stopping
the fusion at L5 as opposed to the sacrum. Additional multicenter work is
required in this area in order to achieve universal agreement.
It is also apparent that the risk of pseudarthrosis following a long fusion
is much greater in adults than it is in teenagers. Furthermore, teenagers
usually tolerate aggressive anterior surgery well whereas adults have a higher
prevalence of postoperative pulmonary complications following transthoracic
and thoracoabdominal approaches. One study from the Twin Cities Spine Center
assessed the relationship between the rate of complications and the age of the
patient. The investigators concluded that, although the number of
complications in the elderly population was high, comorbidities were a more
important factor for assessing risk than was patient age per se.
Surgical Complications
One of the most devastating complications of spinal deformity surgery is a
major neurological deficit. Studies presented at the recent Scoliosis Research
Society meeting in Quebec City indicated that the patients who are at highest
risk are those with congenital spinal deformities and spinal stenosis with
osseous dysplasia, those undergoing combined anterior and posterior
procedures, adults undergoing revision surgery for the treatment of kyphosis,
and those undergoing procedures in which multiple segmental vessels are
harvested on the left side of the spine. Following a major perioperative
neurological deficit, many patients demonstrate some return of function but
few have complete recovery.
Spondylolisthesis
The Morbidity and Mortality Committee of the SRS has analyzed trends within
the society with regard to the treatment of spondylolisthesis. For high-grade
spondylolisthesis, there has been a trend toward more reduction,
circumferential fusion, and instrumentation. For medium-grade
spondylolisthesis in adults, it is also now more common to perform posterior
instrumentation and circumferential fusion. It is believed that these
techniques lead to a higher rate of fusion and a better outcome, although the
more invasive the method used, the higher the neurological risks. The greatest
neurological risk associated with aggressive treatment of spondylolisthesis
continues to be foot drop.
Spinal Deformity Subspecialty Certification
On three occasions, the Board of Directors of the Scoliosis Research
Society has endorsed the concept of applying for subspecialty certification
through the American Board of Orthopaedic Surgery and the American Board of
Medical Specialties. The potential benefits include improving the education of
spine surgeons, as most spine fellowships currently do not focus on the full
spectrum of spinal surgery. Quite a bit of work has been done in this regard,
and an initial application has been made. This issue is highly contentious.
Although most spine surgeons agree that subspecialty certification would
improve surgeon education and patient care, this process is associated with
many practice concerns and inconveniences that will have to be resolved.
Whether it will become a reality for the field of spinal deformity remains to
be seen.
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The Cervical Spine
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A paradigm change from fusion to motion preservation is occurring in the
treatment of cervical spine disorders. In the United States, three cervical
disc prostheses are currently under investigation in approved studies. The
theoretical advantages of disc replacement are to prevent adjacent segment
degeneration, to maintain cervical motion, to avoid complications related to
fusion (such as pseudarthrosis, implant-related effects, and bone-graft
morbidity), and to allow earlier return to activities. There have been no
long-term follow-up studies thus far, and one should use caution when
interpreting short-term results.
Justification for Disc Arthroplasty
Effects of Fusion
Anterior cervical fusion is a well-accepted procedure that is associated
with a high rate of satisfactory results. However, long-term studies have
shown a 25% prevalence of adjacent-segment symptoms within ten years.
Researchers in Belgium recently presented additional evidence on the long-term
adverse effects of cervical fusion. At a minimum of five years after cervical
fusion, 92% of 120 patients had new-onset or progressive degenerative changes
at adjacent levels. There was no significant difference between patients with
traumatic and spondylotic etiologies with regard to the development of
degenerative changes. This finding suggests that the interbody fusion acts as
a triggering factor. Findings that were presented at the 2003 Annual Meeting
of the Cervical Spine Research Society confirmed these observations. Disc
pressures at adjacent segments were found to be significantly increased. With
use of a finite-element model, a 20% to 30% increase in flexion-extension and
rotation was noted adjacent to fused levels. This increase in motion more than
doubled after two-level fusions.
In Vivo and In Vitro Analysis of Disc Arthroplasty
Kinematic studies have confirmed that disc replacement normalizes motion
compared with fusion. In a biomechanical study, no differences in
flexion-extension or coupled motions were observed at adjacent segments before
or after disc replacement. Researchers from both Belgium and Denver, Colorado,
evaluated adjacent-segment motion with use of cinefluoroscopy in ten normal
individuals, ten patients with C5-C6 spondylosis, ten patients with a C5-C6
fusion, and ten patients with a C5-C6 disc replacement. The adjacentsegment
motion was normalized following disc replacement. Compared with the patients
with spondylosis and the patients with fusion, the patients with disc
replacement had normal, synchronous patterns during motion.
Early Clinical Results of Disc Arthroplasty
The short-term results of disc arthroplasty have been reported to be
equivalent to those of fusion. In one European study, eighty-three patients
who had been treated with the Bryan disc were evaluated after a minimum
duration of follow-up of two years. According to the criteria described by
Odom, fifty-five outcomes were rated as excellent, seven were rated as good,
thirteen were rated as fair, and eight were rated as poor. Functional
improvements as measured with the SF-36 instrument were similar to those
observed in fusion studies. Radiographically, the average range of
flexion-extension at the site of the arthroplasty was 8°, although 11% of
the patients had <2° of motion. Similar results were observed in a
separate study of patients who had been treated with disc arthroplasty at two
levels and in patients with myelopathy.
The two-year results associated with the Frenchay prosthesis (developed in
Bristol, England) have been reported. The average range of flexion-extension
was 6.5°, and the average anteroposterior translation was 2 mm. The
clinical improvement also was similar to that associated with fusion. One
patient had a revision to fusion because of loosening of the device.
Biological Effects of Disc Arthroplasty
Arthroplasty devices with bearing surfaces most commonly fail because of
wear with the production of particulate matter and the development of an
inflammatory reaction. A similar process is likely to occur in association
with spinal prostheses. Hallab et al. measured inflammatory markers related to
spinal fusion devices. The levels of tumor necrosis factor-alpha and the rates
of cell apoptosis were increased. Furthermore, metallic devices release ions
that can disseminate throughout the body and can be identified in the serum in
as many as one-third of patients. The consequences of these findings are
unknown.
Anderson et al. reported on the in vivo and in vitro wear response of the
Bryan cervical disc prosthesis. After ten million simulated cycles, an average
of 1.75% of the mass was lost. Elliptically shaped wear particles with a mean
size of 3.8 µm were produced. In a caprine model, the biologic effect of
wear was assessed. In four of eleven animals, small quantities of wear debris
were observed in the periprosthetic tissues; however, no inflammatory response
was noted. In another caprine model, a different device (the Porous Coated
Motion implant) showed excellent osseous ingrowth and no wear debris or
inflammatory reaction at six months postoperatively.
Patient Safety
Patient safety is increasingly being scrutinized by physicians, regulators,
insurers, and patients themselves. Recent attention has been directed to the
soft-tissue morbidities associated with the anterior approach to the cervical
spine, including dysphagia, voice disorders, and airway obstruction.
Prospective studies have shown that dysphagia is far more common than was
previously appreciated. Persistent symptoms are noted in 12% to 30% of
patients at one year. These rates are increased in patients who are managed
with cervical plates and in women. Similarly, symptomatic vocal cord paresis
is present in 1% to 2% of patients at one year. Reported efforts to protect
the recurrent laryngeal nerve from iatrogenic injury include intraoperative
electromyography and repositioning of the endotracheal tube by deflating and
reinflating the cuff after retractor placement.
The most devastating complication is airway obstruction. Approximately 2%
to 6% of patients require reintubation postoperatively. Occasionally, this is
an emergent or even fatal situation. Variables that have been associated with
an increased likelihood of reintubation include prolonged operative time (more
than three to five hours), the exposure of more cephalad levels (C2-C4), blood
loss of >300 mL, a history of smoking, and other comorbidities. It has been
recommended that high-risk patients remain intubated until the swelling
resolves. Steroids are used frequently but have not been shown to be effective
in a controlled, randomized study. Tracheostomy should be performed if needed.
A new tracheostomy technique involving the use of percutaneous dilation has
been shown to be more efficient than open surgical tracheostomy in patients
with a spinal cord injury.
In summary, disc replacement appears to diminish the adverse mechanical
effects of fusion. Short-term results have been satisfactory, but long-term
follow-up is needed to determine if the preservation of motion translates into
a lower prevalence of adjacent-segment disease. Wear studies have indicated
that particulate debris is produced without a substantial inflammatory effect;
however, the clinical importance of these models has not been established.
Finally, the effect of trauma following disc arthroplasty is unknown.
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Biologic Research
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One of the most active areas of study related to the spine continues to be
biologic research. There is a continued effort to enhance bone-healing
following spine fusion. With the United States Food and Drug Administration's
first postmarketing approval of a recombinant bone morphogenetic protein
(rhBMP-2) last year, there have been continued efforts to develop BMPs as well
as alternatives. In addition, a substantial amount of research continues to be
focused on understanding the biological characteristics of the intervertebral
disc and on developing biological strategies to retard or reverse
degeneration.
Bone-Graft Substitutes
Although preclinical and clinical trials on the use of rhBMP-7 for spine
fusion have yielded less-than-consistent results, efforts are underway to
utilize BMP-7 in other ways. In a study from the Hospital for Special Surgery,
the use of an adenovirus to deliver BMP-7 cDNA in bone-marrow cells was
successful in 70% of rats at eight weeks. One of the lingering questions
regarding BMP-7 is whether its inability to achieve 100% successful bone
induction in primates is due to suboptimal carrier and/or dosing or whether
BMP-7 is less osteoinductive than some other BMPs. A study from the University
of Chicago suggested that BMP-2, BMP-6, and BMP-9 are the most osteoinductive
BMPs, both in vitro and in vivo. BMP-7 appears to be less osteoinductive,
especially in uncommitted cells. Whether this finding will have any clinical
implications remains to be seen.
Despite a successful European pilot study, the extracted mixture of bovine
BMPs currently is not being further developed because of budgetary
constraints. The largest number of clinical trials on the spine that are
currently underway involve rhBMP-2. One of the major concerns associated with
rhBMP-2 is that the dose and carrier that are currently approved by the Food
and Drug Administration are geared for interbody spinal fusions inside cages
and are not geared for posterolateral spinal fusions. As a result, the
approved kit will not provide consistent results posterolaterally. A recent
study of nonhuman primates suggested that, with the addition of a bulking
agent (ceramic or allograft chips) to the absorbable collagen sponge carrier,
the currently approved dose could produce consistent posterolateral bone
formation. Similar studies of humans are currently underway.
With the approval of rhBMP-2 has come an increased interest in lower-cost
enhancers of bone-healing. Trials are underway to examine the selective
retention of bone-marrow progenitor cells on osteoconductive scaffolds. While
the preliminary results in lower animal models have been encouraging, the
results of human trials are still forthcoming. The key question is whether a
five to sevenfold concentration of the relatively scant numbers of mesenchymal
stem cells will be enough to achieve spine fusion consistently in
primates.
Platelet-concentration strategies have been in clinical use for several
years, despite the lack of stringent preclinical data to support their use.
The primary growth factors that are present in platelets are transforming
growth factor-beta and platelet-derived growth factor. Neither of these
cytokines are considered to be osteoinductive, and under certain circumstances
both can inhibit osteoblast differentiation. Three studies suggested that one
form of platelet concentrate with "autologous growth factors"
(AGF) does not enhance bone-healing in the spine and indeed may be inhibitory.
The first study, from the Pennsylvania State College of Medicine, involved
fifty-nine patients who underwent a single-level posterolateral lumbar spinal
arthrodesis. The rate of radiographic fusion decreased from 91% when
autogenous iliac crest bone graft was used alone to 62% when AGF was added to
the bone graft. The second study, from the University of Louisville,
demonstrated that the rate of fusion was 88.2% in the control group and 80.3%
in the AGF group (p = 0.18). The third study, from Tulane University, showed
similar results in patients managed with transforaminal lumbar interbody
fusion. The rate of radiographic fusion was 55% in the control group and 46%
in the AGF group (p = 0.12). None of those studies showed a beneficial healing
effect in association with the use of AGF, and all showed a trend toward a
lower rate of successful healing compared with that associated with the use of
autograft alone.
Biological Treatments for Disc Degeneration
The second area of increased interest involves an improved understanding of
intervertebral disc biology and the development of animal models that will
allow for the testing of strategies designed to retard disc injury or
degeneration. There is not yet a universally accepted animal model of
age-related disc degeneration. Most models involve an acute disc injury such
as a needle puncture with acute loss of nuclear material. In a rabbit study
from the University of Virginia in which disc degeneration was induced by the
injection of a 30-kDa fibronectin fragment, osteophytes were evident
radiographically by twelve weeks.
It has been several years since Hanley et al. studied the feasibility of
disc allograft transplantation in canines. A study from the University of Hong
Kong demonstrated successful transplantation of fresh-frozen intervertebral
disc allografts in seventeen rhesus monkeys. The investigators reported
survival of the allografts with some degree of cell metabolism and mobility,
but they also noted severe disc degeneration by twenty-four months. If
transplantation could be combined with a blocker of disc degeneration, this
could be an effective strategy for the treatment of severely degenerated
discs.
A biological strategy to retard disc degeneration would be very useful. In
a rabbit study from Rush Medical College, a single injection of osteogenic
protein-1 (OP-1) prevented the loss of disc height and hydration that is
normally associated with the injection of chondroitinase ABC enzyme. The
results of that study were similar to those of another study, by the same
authors, in which OP-1 prevented the loss of disc height that is normally seen
after an 18-gauge needle puncture. Other investigators are pursuing strategies
involving the implantation of cells that have been culture-expanded and
selected. Those results are less well developed, and the technique is less
convenient compared with the injection of a recombinant protein.
Another potentially promising area of research involves the use of gene
therapy to deliver cDNA encoding for certain growth factors. Various
researchers have utilized the adenovirus vector to deliver a variety of
anabolic and anticatabolic cytokines into the cells of the intervertebral
disc. The theoretical advantage of gene therapy is to allow for a more
sustained production of growth factors within the disc in order to upregulate
matrix production or inhibit matrix catabolism. For example, gene transfer
with use of the cDNA for rhBMP-2 and Sox 9 has been shown to enhance
proteoglycan and collagen synthesis, respectively. Furthermore, a study from
the University of Pittsburgh demonstrated that gene transfer of the catabolic
inhibitor TIMP-1 can increase proteoglycans in cells from degenerated human
intervertebral discs. That study, along with other studies from the Pittsburgh
group, suggests that a single cytokine may not be ideal and that a cocktail of
anabolic and anticatabolic factors may be required for optimal stimulation of
disc chondrocytes.
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Spinal Cord Injury
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Advances in the understanding and treatment of spinal cord injury continues
to evolve at a slow but steady pace. The major research, as illustrated in
abstracts submitted for the American Spinal Injury Association meeting that
was held in May 2004, centers on understanding and modulating the secondary
cascade of injury following a traumatic spinal cord injury, on rehabilitation
techniques and devices for the injured patient, and on biological strategies
for the regeneration of neural connections in the injured spinal cord.
Medical Complications of Spinal Cord Injury
Contemporary research efforts addressing the morbidities associated with
spinal cord injury are focused on the understanding and treatment of bedsores,
neuropathic pain, osteoporosis, and lipid-profile abnormalities. One
prospective, randomized trial suggested that COX-2 inhibitors could be
effective for the prevention of heterotopic ossification. Another study
documented a high rate of lipid-profile and vitamin-D abnormalities among
patients with spinal cord injury and suggested that close monitoring of these
parameters was warranted. Indium(111)-labeled leukocyte scintigraphy was found
to be more sensitive and specific than technetium bone-scanning for the
evaluation of severe pressure sores for the presence of osteomyelitis.
Neurological Recovery and Basic Science
Secondary injury occurs in the minutes and hours following a traumatic
spinal cord injury as a result of inflammation, apoptosis (programmed cell
death), and cytokine release, thereby widening the zone of injury. The
prevention of secondary injury is a major focus of basic spinal cord injury
research. Another hot topic is the use of biological strategies to regenerate
functional connections across the injured spinal cord. The p75 receptor has
been shown to cause apoptosis and thus may be a good target for
pharmacotherapy. Quercetin, a flavonoid, was shown to be neuroprotective by
reducing apoptosis in a rat model. Other neuroprotective drugs are being
studied, including Rolipram, an inhibitor of cAMP hydrolysis, and minocycline,
an antibiotic. A new drug, HP184, which blocks both Na+ and K+ channels, has
been tested in healthy volunteers and in patients with spinal cord injury. In
healthy patients, the drug was found to be safe and well tolerated. Early data
have suggested that this drug may improve ASIA motor scores following an
injury. These studies have paved the way for wider human clinical trials.
The healing of a spinal cord lesion may be promoted by activated
macrophages. One study evaluated human monocytes that were stimulated by
co-incubation with skin tissue. These cells were found to secrete
proinflammatory cytokines, adhesion molecules, and high levels of CD80 and
CD86, all of which are potentially beneficial to the injured spinal cord. When
injected at the site of injury in ASIA-A patients within fourteen days after
the injury, some patients demonstrated improvement in motor and sensory
function. In rehabilitation medicine, early electrical stimulation of the
common peroneal nerve was shown to improve the flexion-withdrawal response
necessary for gait.
Prevention
The issue of spinal cord injury prevention continues to be evaluated by
policy makers and automobile manufacturers. One study evaluated the relative
risk of a cervical spine injury to motor-vehicle occupants when using
seatbelts, airbags, a combination of seatbelts and airbags, or no restraint
system. The combination of seatbelts and airbags provided the greatest
protection against cervical spine injury relative to an unrestrained occupant,
with an odds ratio of 0.19. The use of a seatbelt alone also significantly
reduced the risk of cervical spine injury, while the use of an airbag alone
did not have any significant effect on the risk of a cervical spine
injury.
Spinal Cord Injury Outcomes
Both medical and surgical therapies continue to improve. Imaging studies
have documented a strong correlation between the severity of a spinal cord
injury and the degree of spinal canal compromise and spinal cord compression
as seen on magnetic resonance imaging. A randomized clinical trial to
determine the benefit of early surgical decompression of spinal cord injuries
has begun. Early surgical stabilization of the spine following a spinal cord
injury has been shown to reduce medical complications and to enhance early
rehabilitation, but the effects on neurologic recovery remain controversial.
The ASIA motor and sensory examination has been shown to have high interrater
reliability when used by trained examiners and should be viewed as the state
of the art for the neurological assessment of the patient who has a spinal
cord injury. Although elderly patients continue to have poorer outcomes than
younger patients, a strong multidisciplinary approach can produce
better-than-expected outcomes in this challenging group.
Classification systems for spinal fractures continue to evolve. In one
study, the Denis classification was compared with the AO classification for
thoracolumbar fractures. Only a moderate degree of reliability and
repeatability was found in association with either classification system when
applied to a group of fractures by expert spine surgeons. Less motion of the
cervical spine was found while using a kinetic treatment table (RotoRest
Delta; Kinetic Concepts, San Antonio, Texas) as compared with the standard log
roll procedure in two separate studies. Another study compared the outcomes
and complication profiles for patients with thoracolumbar burst fractures who
were treated with either an anterior or posterior surgical approach. The group
treated through an anterior approach sustained fewer complications, had better
sagittal alignment, and had less pain than did the group treated through a
posterior approach. A prospective, randomized study comparing anterior and
posterior treatment of unilateral facet injuries of the cervical spine
demonstrated that the group that was treated through an anterior approach had
better lordosis and a higher rate of fusion, although the clinical outcomes
were not significantly different between the groups.
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Surgical Treatment of the Lumbar Spine
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Dynamic changes in the field of lumbar spine surgery continued throughout
2003.
Surgery Outcomes
Persistent pain and dysfunction following lumbar fusion led investigators
at State University of New York-Syracuse to question whether preoperative
mental health testing could be predictive of outcomes following anterior
lumbar fusion. Higher preoperative mental scores on the SF-36 were significant
predictors of visual analog scale back-pain ratings at twelve months in a
study of 168 subjects who had been enrolled in a multiple-site trial of two
fusion systems (InFix and BAK). Patients with a mental score of <50 had
significantly more pain and poorer function, suggesting that a lower mental
health score may serve as a potential flag.
Patients with an age of more than eighteen years who had had lumbar spine
fusion between 1991 and 1992 at the Twin Cities Spine Center were evaluated
with regard to function, satisfaction, and the need for any additional spine
surgery after a minimum duration of follow-up of ten years. Of the 178
patients who returned a questionnaire, thirty-one (17%) had had adjacent-level
surgery. Fusion extension was required for 21% of the patients in whom the
index operation had been a posterior procedure, compared with 16% of those in
whom the index operation had been a combined anterior-posterior procedure.
Adjacent surgery was performed for 18% of the patients in whom the index
procedure had been performed for the treatment of degenerative disc disease,
compared with 26% of those in whom it had been performed for the treatment of
spondylolisthesis. Adjacent-segment extension was more commonly required when
the index fusion had been to the sacrum (22% compared with 12%) and when
decompression also had been done (24% compared with 15%). The overall rate of
patient satisfaction at ten years was 70%.
One-year outcomes data from the Swedish national lumbar spine registry
included data on 85% of all patients who had lumbar spine surgery in that
country in 2001. The rate of patient satisfaction with surgery was 72% among
patients with a disc herniation, 67% among patients with central spinal
stenosis, 68% among patients with spondylolisthesis, and 61% among patients
with degenerative disc disease. Reoperation within twelve months was necessary
in 7% of the patients.
Trauma
Researchers at the University of Minnesota prospectively evaluated outcomes
in patients in whom thoracolumbar burst fractures without an associated
neurological deficit were treated with either anterior or posterior
instrumented fusion. For the patients who were managed through a posterior
approach, the average kyphosis was 12° at the time of admission, 5° at
the time of discharge, and 12° at the time of the twenty-four-month
follow-up. In this group, the average canal compromise was 39% at the time of
admission and 20% at the time of follow-up. In the anterior fusion group, the
average kyphosis was 13.7° at the time of admission, 2.6° at the time
of discharge, and 3.7° at the time of follow-up. The average canal
compromise was 40% at the time of admission and 18% at the time of follow-up.
There were nineteen complications in sixteen patients who had been treated
posteriorly but only three minor complications in three patients who had been
treated anteriorly. Although both anterior and posterior approaches yielded
acceptable rates of patient satisfaction and return to work, anterior surgery
alone had a lower rate of complications and trended toward outcomes with less
pain.
Magnetic resonance imaging scans that were acquired for 110 patients who
had back pain following an injury demonstrated normal findings in only 9% of
the patients and multiple-level abnormalities in 66%. Sixty-seven percent of
these 110 patients demonstrated a disc protrusion, and 5% had a disc
extrusion. That series included fewer patients with normal findings than had
been previously reported in baseline studies of asymptomatic patients. The
rates of disc protrusion and extrusion in the study group were significantly
higher than those found in baseline studies of asymptomatic patients,
suggesting that disc pathology was a possible etiology of the back pain.
Artificial Disc Replacement
Investigators at the Texas Back Institute evaluated the twelve to
twenty-four-month results for a consecutive series consisting of the first
fifty-seven patients to receive the SB Charite disc prosthesis at a single
center. The mean visual analog score improved from 69.4 preoperatively to 34.1
at six weeks and remained stable during the twenty-four months of follow-up.
The mean Oswestry disability score had improved by 40% at six weeks and by as
much as 50% at twenty-four months. There were no instances of device failure,
displacement, or migration.
In another study from the Texas Back Institute, seventy-eight patients with
disabling degenerative disc disease that had been unresponsive to a minimum of
six months of conservative treatment were randomized to surgical treatment
with either an artificial disc (ProDisc; Synthes/Spine Solutions, Paoli,
Pennsylvania) or a 360° fusion. Fifty-four of these patients had one-year
follow-up data. The mean visual analog and Oswestry scores decreased
significantly (p < 0.05) in both groups by six weeks postoperatively. Over
time, the scores in the artificial disc group tended to continue to decrease
whereas those in the fusion group remained stable. Patient satisfaction at
each of the testing intervals was better in the artificial disc group. At the
time of the one-year follow-up, 20% of the patients with a fusion stated that
they would not have the surgery again whereas >95% of the patients with the
artificial disc stated that they definitely would have the procedure again.
None of the patients who had had the arthroplasty stated that they would
refuse the operation. The clinically measured range of motion in terms of both
forward flexion and lateral bend was significantly improved in the patients
who had been managed with the ProDisc (p = 0.02).
The range of spinal motion as measured radiographically after artificial
disc replacement with use of the ProDisc was reported in a separate series of
forty patients (fifty-seven levels) who had been managed at the Spine
Institute at St. John's Health Center in Santa Monica, California. In patients
with a one-level artificial disc replacement, the postoperative range of
motion was increased compared with the preoperative range of motion. In
patients with a two-level disc replacement, the L4-L5 level showed increased
motion, the L5-S1 level showed a tendency for decreased motion, and the total
range of motion was maintained compared with the preoperative range.
Anterior Lumbar Surgery
One surgeon reported on 1315 anterior approaches to the lumbar spine that
had been performed over a sixty-six-month period. Six patients had development
of left iliac artery thrombosis, and four required thrombectomy. There were
nineteen venous injuries to the left common iliac vein (prevalence, 1.4%); all
were successfully repaired, with a mean blood loss of 650 mL. Fifteen of the
venous injuries were exposures at the L4-L5 level.
Thirty patients who had had an anterolateral interbody fusion were
retrospectively compared with twenty-four matched patients who had had a
360° fusion for the treatment of discogenic lumbar pain. No significant
difference was found between the groups in terms of clinical outcome, although
patients who had undergone a single-level anterolateral interbody fusion had
improved Oswestry scores compared with patients who had undergone a 360°
fusion (p = 0.007). However, six patients in the anterolateral interbody
fusion group required revision posterior fusion because of symptomatic
anterior nonunion. One patient in the 360° fusion group required revision
fusion, and two additional patients required implant removal.
Schuler et al. attempted to determine the effect of preoperative disc
height on clinical outcomes after a single-level anterolateral interbody
fusion. Patients in the "collapsed disc" group, who had a mean
preoperative disc height of 0.5 mm, showed better improvement in Oswestry
scores both in the early postoperative period and at all follow-up visits,
with the differences in outcome becoming more pronounced over time. Thus,
patients with the most pronounced disc-space narrowing showed the earliest and
greatest clinical improvement.
Intradiscal Electrothermal Therapy
Investigators in Tyler, Texas, reported the results of a randomized
placebo-controlled trial of intradiscal electrothermal therapy for the
treatment of discogenic low-back pain. Thirty-seven patients were allocated to
intradiscal electrothermal therapy, and twenty-seven received sham treatment
(needle placement to the anulus but no anular puncture and no thermal energy
applied). Although patients in both groups demonstrated improvement, the mean
improvement in terms of pain, disability, and depression was better in the
intradiscal electrothermal therapy group. More patients in the sham group
demonstrated deterioration over time. While approximately 40% of the patients
who had been treated with intradiscal electrothermal therapy achieved >50%
relief of pain, approximately 50% of the patients experienced no appreciable
benefit.
 |
Upcoming Meetings and Events Related to Spine Surgery
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The next annual meeting of the Scoliosis Research Society (SRS) will be
held on September 6 through 9, 2004, in Buenos Aires, Argentina. It will be
preceded by a one-day course on Innovative Treatment Options in Spine Surgery,
to be held on September 6, 2004. Web site:
www.srs.org.
The Federation of Spine Associations will present the spine program at
Specialty Day at the Annual Meeting of the American Academy of Orthopaedic
Surgeons, to be held on Saturday, February 27, 2005, in Washington, DC. Web
site:
www.aaos.org.
The next annual meeting of the North American Spine Society (NASS) will be
held on October 26 through 30, 2004, at the McCormick Place Convention Center,
Lakeside Center, in Chicago, Illinois. Web site:
www.spine.org.
The Twenty-second Annual Meeting of the Cervical Spine Research Society
(CSRS) will be held on December 9 through 12, 2004, at the Marriott Copley
Place Hotel in Boston, Massachusetts. In addition, an Instructional Course
will be held on December 11 and 12, 2004. Web site:
www.csrs.org.
The meeting of the American Spinal Injury Association (ASIA) is the major
event related to spinal cord injury medicine. The next meeting will be held on
May 12 through 14, 2005, at the Fairmont Hotel in Dallas, Texas. Web site:
www.asia-spinalinjury.org.
 |
Evidence-Based Orthopaedics
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|---|
During 2002, the editorial staff of The Journal reviewed a large
number of research studies related to spine surgery that received a Level of
Evidence grade of I. Over forty medical journals were reviewed to identify
these articles, which all have high-quality study design. In addition to
articles published previously in this journal or cited already in this Update,
fourteen level-I articles were identified that were relevant to spine surgery.
A list of those titles is appended to this review after the standard
bibliography. We have provided a brief commentary about each of the articles
to help to guide your further reading, in an evidence-based fashion, in this
subspecialty area.
 |
Evidence-Based Articles Related to Spine Surgery
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|---|
Fouyas IP, Statham PF, Sandercock PA. Cochrane review on the role of
surgery in cervical spondylotic radiculomyelopathy. Spine.
2002;27:736-47.
The authors performed a meta-analysis in which operative and nonoperative
treatment of cervical myeloradiculopathy were compared with use of Cochrane
methodology. They identified only two randomized, controlled studies that met
their criteria. Both studies concluded that there were no differences in
outcome variables between operatively and nonoperatively treated patients. The
conclusion that there was no evidence to support surgical treatment must be
tempered. The two studies had several shortcomings, and the findings cannot
necessarily be generalized to patients who fail to respond to conservative
therapy and then present for surgical consideration. Also, Carl Sagan has
stated that the absence of evidence is not evidence of absence.
Touger M, Gennis P, Nathanson N, Lowery DW, Pollack CV Jr, Hoffman JR,
Mower WR. Validity of a decision rule to reduce cervical spine radiography
in elderly patients with blunt trauma. Ann Emerg Med.
2002;40:287-93.
The authors retrospectively examined the efficacy of the National Emergency
X-radiography Utilization Study (NEXUS) decision instrument to identify
cervical spine injuries in patients more than sixty-five years of age.
According to the NEXUS instrument, patients who are at low risk for spinal
injury as determined on the basis of five criteria do not require radiographic
investigation. In this study, cervical spine injuries (especially odontoid
fractures) were twice as frequent in elderly patients. No difference was
observed between older and younger age-groups with regard to the performance
of the NEXUS criteria. The NEXUS instrument had a 100% sensitivity for
identifying clinically important injuries in elderly patients. Although this
study included a large number of patients, inadequate descriptions of injuries
and lack of follow-up after emergency room or hospital discharge limit the
conclusions that can be drawn.
Kadanka Z, Mares M, Bednanik J, Smrcka V, Krbec M, Stejskal L, Chaloupka
R, Surelova D, Novotny O, Urbanek I, Dusek L. Approaches to spondylotic
cervical myelopathy: conservative versus surgical results in a 3-year
follow-up study. Spine. 2002;27:2205-11.
The authors performed a prospective, randomized, controlled study of
patients with mild cervical spondylotic myelopathy to compare the results of
operative and nonoperative treatment. Sixty-eight patients were randomized to
operative or nonoperative treatment and were analyzed with use of the Benzel
myelopathy score, gait analysis, and self-evaluation. Only patients with mild
myelopathy (as indicated by a Benzel score of 14) were included. No
difference in outcome between the groups was observed at three years. The
conclusions of the study are justified but are limited to a very narrow group
of patients (those with mild spondylotic myelopathy). The long-term effect on
spinal cord function if the canal is allowed to remain stenotic is unknown as
the patients in this study had only three years of follow-up.
Hurwitz EL, Morgenstern H, Harber P, Kominski GF, Belin TR, Yu F, Adams
AH; University of California-Los Angeles. A randomized trial of medical
care with and without physical therapy and chiropractic care with and without
physical modalities for patients with low back pain: 6-month follow-up
outcomes from the UCLA low back pain study. Spine.
2002;27:2193-204.
The authors reported the results of a randomized, controlled study of
patients with more than a three-month history of low-back pain who were
treated with chiropractic manipulation with or without physical therapy
modalities. These modalities included ultrasound, heat or cold therapy, and
electrical stimulation. Patients were assessed at two, six, and twenty-six
weeks with regard to pain, functional disability, and satisfaction.
Significant improvements were seen in both treatment groups. Patients who were
managed with physical therapy modalities performed slightly better at two and
six weeks. However, no differences between the groups were noted at six
months, leading to the conclusion that adjunctive physical therapy modalities
do not improve results in patients treated with chiropractic manipulation.
Hagen KB, Hilde G, Jamtvedt G, Winnem MF. The Cochrane Review of
advice to stay active as a single treatment for low back pain and sciatica.
Spine. 2002;27:1736-41.
Four trials, involving a total of 491 patients with low-back pain and
sciatica, were selected from a database of randomized studies. In all four
trials, patients who had been advised to stay active were compared with
patients who had been advised to rest in bed. Only one study demonstrated
significantly better results in association with activity, but that study was
thought to have a moderate to high risk of bias and included only male
military trainees. Although there was no significant difference in terms of
improvement in either group, no harmful effects in terms of back pain or
sciatica were identified in association with increased activity.
This was a generally weak study that predominantly involved subjects in
Europe, where different customs and disability standards make comparison with
American patient care difficult. No strong conclusions can be drawn.
Hurwitz EL, Morgenstern H, Harber P, Kominski GF, Belin TR, Yu F, Adams
A; University of California-Los Angeles. A randomized trial of medical
care with and without physical therapy and chiropractic care with and without
physical modalities for patients with low back pain: 6-month follow-up
outcomes from the UCLA low back pain study. Spine.
2002;27:2193-204.
In this study, patients who were members of health maintenance
organizations and who presented with back pain agreed to be randomized to one
of four treatment groups. Of 1469 eligible patients, 681 were enrolled. After
six months of follow-up, chiropractic care and medical care for low-back pain
were deemed to be comparable in terms of the changes in pain intensity and
disability. There were no significant differences in disability time, days in
bed, or medication usage between the groups.
The weaknesses of this study included the patients' ability to selfenroll,
the failure to recruit >50% of eligible patients, and the
"captive" nature of patients in a health maintenance organization
system, which may limit extrapolation of these results to a more general
population of patients who have the ability to change services if they are
unhappy with their progress.
Petersen T, Kryger P, Ekdahl C, Olsen S, Jacobsen S. The effect of
McKenzie therapy as compared with that of intensive strengthening training for
the treatment of patients with subacute or chronic low back pain: a randomized
controlled trial. Spine. 2002;27:1702-9.
In this study from Denmark, 260 patients with chronic back pain (defined as
back pain of at least eight weeks' duration) were randomized to treatment with
McKenzie exercises performed under the supervision of a physical therapist or
group exercises that included supervised dynamic strengthening. In both
groups, patients received a maximum of fifteen treatments over eight weeks and
then participated in a self-administered program for an additional two months
before assessment. No significant differences were found between the two
groups in terms of disability. Pain tended to be lower in the McKenzie group
at two months, but the difference was not significant.
As 30% of the patients in both groups withdrew from the study, and as there
was no untreated control group, it is difficult to draw any meaningful
conclusion from this report.
Cardenas DD, Warms CA, Turner JA, Marshall H, Brooke MM, Loeser JD.
Efficacy of amitriptyline for relief of pain in spinal cord injury: results of
a randomized controlled trial. Pain. 2002;96:365-73.
The authors describe the results of the first placebo-controlled,
double-blind, prospective, randomized study evaluating the efficacy of a
tricyclic antidepressant, amitriptyline, for the treatment of chronic pain
following a spinal cord injury. The mechanism of action of amitriptyline is
through the selective reuptake inhibition of serotonin and norepinephrine. It
has been hypothesized that pain relief occurs as a result of central and
peripheral pain-inhibition mechanisms. Tricyclic antidepressants have been
found to be effective for relieving discomfort in patients with migraine
headaches, fibromyalgia, atypical facial pain, and diabetic neuropathy. Their
benefit in the treatment of dysesthetic pain in patients with spinal cord
injury has never been demonstrated, although they frequently are used for this
purpose. In this study, intent-to-treat analysis did not support the use of
amitriptyline when it was compared with an active placebo, benztropine
mesylate, for the relief of pain. This finding is important because spine
surgeons often choose this medication for the treatment of chronic neuropathic
pain and pain associated with degenerative disc disease although its efficacy
has never truly been confirmed in a prospective, randomized study. In fact,
only one previous study has evaluated the effect of this medication in the
treatment of pain associated with spinal cord injury, and that study also did
not support its efficacy. The investigation by Cardenas et al. is a
well-designed study and represents the largest clinical trial to date
evaluating the use of a medication for the treatment of chronic pain in the
setting of spinal cord injury.
Bracken MB. Methylprednisolone and acute spinal cord injury: an
update of the randomized evidence. Spine. 2001;26(24
Suppl):547-54.
The authors of this study performed a systematic review with use of
Medline, CINAHL, and the Cochrane Library to determine the effectiveness of
methylprednisolone in the treatment of acute spinal cord injury. The lead
author has been the lead investigator in three National Acute Spinal Cord
Injury studies (NASCIS). These studies have demonstrated that the
administration of high-dose methylprednisolone within eight hours after an
acute spinal cord injury is safe and is modestly effective for improving
functional outcome following a spinal cord injury. These data have come under
criticism over the last several years because the intent-to-treat groups in
the NASCIS II and III studies showed no significant neurological improvement
with methylprednisolone and only after a post ad-hoc analysis did a subgroup
of patients show improvement in motor scores. To date, the United States Food
and Drug Administration has not approved the use of high-dose
methylprednisolone for the treatment of spinal cord injury. In the spinal
community, this medication is generally recommended because a better
alternative is not available, because it involves minimal cost, and because it
may be effective in certain patient subgroups if given early. The search
continues for an optimum pharmacological intervention that may ultimately
modify or alter the secondary injury cascade following a spinal cord
injury.
Ishida Y, Tominaga T. Predictors of neurologic recovery in acute
central cervical cord injury with only upper extremity impairment.
Spine. 2002;27:1652-8.
The authors of this study observed that patients who had a central cord
syndrome that involved impairment of motor and sensory function of only the
upper extremities but who had no evidence of abnormal changes to the cervical
spinal cord on magnetic resonance imaging often responded well to nonoperative
treatment, with substantial neurological recovery after six weeks of
follow-up. The authors did not study patients with a dense central cord
syndrome that involved impairment of both upper and lower extremity function.
It is clear that patients who show substantial recovery and have mild deficits
without instability following a spinal cord injury respond favorably to
nonoperative intervention. The pressing issue is the degree of aggressiveness
(i.e., surgical intervention) that should be afforded to a patient with both
upper and lower extremity dysfunction in the setting of a dense central cord
syndrome. Should certain parameters be defined in which surgical intervention
is not in the patient's best interest, as in the case of an elderly patient
with multiple comorbidities or a patient with severe motor impairment? Such
questions can only be answered through controlled, prospective, randomized
studies, which are necessary to provide a better understanding of the natural
history of all degrees of central cord syndromes.
Fritzell P, Hägg O, Wessberg P, Nordwall A; Swedish Lumbar Spine
Study Group. Chronic low back pain and fusion: a comparison of three
surgical techniques: a prospective multicenter randomized study from the
Swedish lumbar spine study group. Spine. 2002;27:1131-41.
This was a multicenter, randomized study with a two-year follow-up. Over a
six-year time-period, 294 patients who had been referred to nineteen spinal
centers were blindly randomized into four treatment groups. Three groups were
treated operatively, and one was treated nonoperatively. The operative
procedures were (1) posterolateral fusion, (2) posterolateral fusion with
pedicle screws, and (3) posterolateral fusion with pedicle screws and
interbody fusion. All surgical techniques were found to reduce pain and to
decrease disability substantially, but there were no significant differences
among the groups with respect to clinical outcome. The overall fusion rate was
72% in group 1, 87% in group 2, and 91% in group 3.
Gibson S, McLeod I, Wardlaw D, Urbaniak S. Allograft versus
autograft in instrumented posterolateral lumbar spinal fusion: a randomized
control trial. Spine. 2002;27:1599-603.
This study from Scotland evaluated the clinical outcomes for sixty-nine
patients who had been managed with instrumented lumbar fusion. The patients
were randomized to receive either their own bone (harvested from the iliac
crest) or allograft bone (fresh-frozen bone obtained from the femoral head at
the time of total hip arthroplasty). The same surgeon performed all
procedures, and Steffee plates were used for all patients. Thirty-seven
patients received allograft bone, and thirty-two received their own bone. The
allograft bone was thawed at the time of surgery and was morselized with use
of a manually operated bone mill in the operating room. On the basis of Roland
and Morris scores at the time of the one-year evaluation, the two groups were
identical when the patients with donor-site pain were excluded. The fusion
rates in both groups were somewhat unclear, and the authors did state that the
results deteriorated over time. Furthermore, at the time of "long-term
followup," they stated that 33% of the patients in the allograft group
and 40% of those in the autograft group had no improvement in their scores or
had a poor result. This article points out the morbidity that is associated
with harvesting bone from the iliac crest. However, without a better
assessment of fusion status, it is hard to truly compare the two groups. We
know that implants often will maintain immobilization without failure for two
to five years postoperatively.
Furlan AD, Brosseau L, Imamura M, Irvin E. Massage for low-back
pain: a systematic review within the framework of the Cochrane Collaboration
Back Review Group. Spine. 2002;27:1896-910.
In an effort to assess the effects of massage therapy for nonspecific
low-back pain, the authors assessed nine publications describing eight
randomized trials. The authors concluded that massage might be beneficial for
patients with subacute and chronic non-specific low-back pain, especially when
combined with exercises and education. However, the results of the eight
trials were not strongly conclusive. A large-volume, multicenter, prospective,
randomized study probably would be needed to truly answer the question
regarding the effectiveness of massage therapy compared with other
nonoperative modalities in the treatment of lumbar back pain.
Hofstee DJ, Gijtenbeek JM, Hoogland PH, van Houwelingen HC, Kloet A,
Lötters F, Tans JT. Westeinde sciatica trial: randomized controlled
study of bed rest and physiotherapy for acute sciatica. J Neurosurg.
2002;96(1 Suppl):45-9.
In this study from The Netherlands, the investigators attempted to compare
the efficacies of three nonoperative treatment strategies for patients with
sciatica. The three methods were bed rest, physiotherapy, and continuation of
activities of daily living. The analysis of the primary and secondary outcome
measures showed no significant differences among the three treatment groups.
Neither bed rest nor physiotherapy had a more favorable effect on recovery
from sciatica than did continuation of activities of daily living. This
article from the neurosurgery literature seems to confirm what has been
published in orthopaedic literature.
 |
Acknowledgments
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|---|
NOTE: The authors thank Drs. Richard Guyer, James Kang, Steven
Mardjetko, Glen Rechtine, and K. Daniel Riew for peer reviewing the sections
of this manuscript.
 |
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