SPINE Supplement April 2017 PDF

SPINE Volume 42, Number 7S
ß 2017 Wolters Kluwer Health, Inc. All rights reserved
SUPPLEMENT
Foreword and Executive Summary

The Third Annual Musculoskeletal Education and Research Center (MERC) Symposium was held on August 5–6,
2016, in Audubon, Pennsylvania. This event brought together a group of world-renowned spine surgeons and
researchers, who presented information on topics ranging from the latest techniques in spinal surgery to basic science
such as biomechanics and biologics. This special issue of Spine is dedicated to presenting abstract summaries of the topics
discussed at this meeting. The keynote speaker for the Symposium was Dr Paul A. Anderson, an internationally renowned
spine surgeon who serves as Professor of Orthopedic Surgery and Adjunct Professor of Neurological Surgery and
Biomedical Engineering at the University of Wisconsin, in Madison. Dr Anderson’s keynote address, ‘‘Introduction of
New Technologies in Orthopaedic Surgery,’’ is summarized in the fourth article of this issue. The lead article in this issue,
entitled ‘‘Surgical Anatomy of the Spine, Revisited,’’ summarizes a presentation by Professor Wolfgang Rauschning, the
world-renowned and incomparable master of spinal anatomy, based on his cryomicrotome and cryoplaning techniques.
Papers two through eight cover topics of biomechanics, as well as biologics and their role in spinal surgery. Papers nine
through thirteen discuss new concepts and treatment options for deformity surgery. Paper fourteen discusses the latest
developments in spinal cord injury treatment, and paper fifteen presents the topic of intradural spinal cord tumors. Paper
sixteen discusses the newest trends in spinal cord stimulation—a last resort when surgical treatment fails or is not an
option. Papers seventeen through twenty-one discuss treatment complications and new techniques in minimally invasive
surgery, including the use of robotics and navigation. Finally, the last two papers discuss the latest in implant
technologies, including bioactive surface coatings and the use of three-dimensional printing of implants for spine
surgery. I believe that spine specialists will find these articles, written by leaders in their field, both intellectually
stimulating and clinically relevant.
K. Daniel Riew, MD
On August 5–6, 2016, the Musculoskeletal Education and Research Center (MERC), the Research Division of Globus
Medical, Inc, hosted the Third Annual MERC Symposium, in Audubon, Pennsylvania. Prominent scientists, surgeons, and
researchers reviewed the basics of spinal biomechanics and anatomy, discussed clinical challenges, and highlighted the latest
advances in surgical treatment of spinal disorders.
The 2016 Symposium featured five sessions and several panel discussions covering topics including biologics; adult spinal
deformity; spinal cord injury and peripheral nerve disorders, robotics and navigation, and implant surface coating technologies.
A clinically relevant debate topic on the treatment of adult spinal deformity highlighted an innovative concept, proposed by Dr
Paul McAfee, which focused on surgical correction of spinal deformity through middle column gap balancing—a method for
measuring a key parameter (the middle column) to predict optimal anterior structural support height in spinal reconstructive
surgery.
Keynote Speaker, Dr Paul A. Anderson, from the University of Wisconsin, in Madison, described the advantages and
potential of new technology in the treatment of spinal disorders; the use of optimal study design in examining the quality and
efficacy of treatment approaches; and importance of surgeon education in improving and updating skills. Dr Anderson
presented examples of successful new technology including cervical disc arthroplasty FDA trials and discussed complications
associated with other implant technologies resulting from inappropriate indications, inadequate physician training, lack of
regulatory oversite, and unproven safety and effectiveness.
Professor Wolfgang Rauschning, from Uppsala University, in Sweden, presented highly detailed anatomical images
obtained through his innovative Uppsala Cryoplaning Technique—demonstrating normal anatomy compared with path-
ologies such as trauma, degenerative disease, tumor, and metastasis. Through this unique view, Professor Rauschning
reminded Symposium attendees of the importance of understanding the anatomical basis for biomechanical function of the
cervical and lumbar spinal regions. Faculty and attendees shared their expertise as they discussed their own experiences and
challenges during these highly relevant and informative sessions. Continued research in biologics and biomaterials,
navigation and robotics, and spinal cord and regenerative therapies suggests future challenges for surgeons and optimism
for patients.
On behalf of MERC and our prestigious faculty participants, we hope you enjoy the enclosed synopsis of our 2016
Annual Symposium.
Bryan W. Cunningham, PhD
Copyright © 2017 Wolters Kluwer Health, Inc. All rights reserved.

SPINE Volume 42, Number 7S, pp S1–S2
SUPPLEMENT
Surgical Anatomy of the Spine, Revisited

Wolfgang Rauschning, MD, PhD
Key words: anatomy, cryomicrotome, cryoplaning technique.

Spine 2017;42:S1-S2
T
his presentation focuses on anatomy and function of
the cervical spine, characteristics and appropriate
treatment of cervical spine trauma, and anatomy
and degeneration of the intervertebral disc, as well as
degenerative disc disease and its treatment.
For spine surgeons, an understanding of the ligaments
of the cervical spine and their purpose is essential.
Although delicate, the cervical spine is a well-crafted,
remarkably strong, and flexible structure that houses
the spinal cord and sends messages from the brain to
control all aspects of the body and allow movement in all
Figure 1. Illustration of ligaments, tendons, and muscles at the cra-
directions. The cervical spine is supported and stabilized niocervical junction. Copyright 2017 Professor Wolfgang Rauschn-
by a complex system of ligaments, tendons, and muscles ing, MD, PhD.
that serve as connective tissue for the spine. Ligaments of
the spine are strong, fibrous bands that prevent suspicious
activity but allow normal activity. At the craniocervical transverse ligaments, they can break in half and snap
junction, the two main ligaments that hold the bones back like a rubber band, leading to instability and exces-
together are the alar—strongest ligament between skull sive movement, irritation, further injury, and arthritis.
and spine—and transverse—center of axial rotation— Traumatic injuries may occur at multiple levels; thus,
ligaments (Figure 1). imaging of both the upper and lower cervical spine is
When trauma to the skull occurs, force is also trans- required (Figure 2). Traumatic lesions are not usually
mitted to the alar and transverse ligaments of the cervical apparent on radiographs, and computed tomography
spine. Reported cases have involved motor vehicle acci-
dents, a sudden jolt to the head, or something falling onto
the head. Ligaments can stretch and become partially
torn, or, as occurs more frequently with alar and
From the Department of Orthopaedic Surgery, Academic University Hos-

pital, Uppsala University, Uppsala, Sweden.
Acknowledgment date: December 6, 2016. Acceptance date: December 6,
2016.
The manuscript submitted does not contain information about medical
device(s)/drug(s).
No funds were received in support of this work.
No benefits in any form have been or will be received from a commercial
party related directly or indirectly to the subject of this manuscript.
Address correspondence and reprint requests to Wolfgang Rauschning, MD,
PhD, Department of Orthopaedic Surgery, Academic University Hospital,
Uppsala University, 751 85 Uppsala, Sweden;
E-mail: rauschning@quicknet.se
Figure 2. Depiction of traumatic injuries in the upper cervical spine.
DOI: 10.1097/BRS.0000000000002018 Copyright 2017 Professor Wolfgang Rauschning, MD, PhD.
Spine www.spinejournal.com S1
SUPPLEMENT Surgical Anatomy of the Spine, Revisited Rauschning
scanning and dynamic magnetic resonance imaging are

most efficient for detection. Dr. Henry Bohlman exten-
sively studied cervical spine injury and its treatment. In
1979, he reported on 300 cases of cervical spine injury
and concluded that lack of immobilization led to spinal
deterioration in some patients. Consequent to his work,
spinal immobilization became the standard of care for
patients with traumatic spinal cord injury, and physicians
are cautioned against recommending physiotherapy for
these patients. Dr. Bohlman went on to develop effective
surgical techniques to decompress the spinal cord of
patients with traumatic injury to achieve pain reduction
and improved motor function. Figure 3. Illustration of degenerative disc disease. Copyright 2017
Intervertebral discs account for one-fourth of the length Professor Wolfgang Rauschning, MD, PhD.
of the spinal column. These discs are fibrocartilaginous
cushions that protect the vertebrae, brain, and other and cervical regions (Figure 3). Initial treatment for
structures. Intervertebral discs are complicated structures degenerative disc disease ranges from ice or heat on the
that consist of annulus fibrosus (including lamellae that affected area to pain medication. For those who develop
buckle outward and fan in many directions), nucleus osteoarthritis, a herniated disc, or spinal stenosis, physical
pulposus (structure that resists compression), and therapy and exercise may be recommended. In some cases,
vertebral endplates (including apophyseal ring of special- surgery is advised. Surgery usually involves removing the
ized strong woven bone and an inner spongy, innervated, damaged disc and permanently fusing bone to protect the
elastic portion). Subarticular collecting veins underlying spinal cord; in other cases, an artificial disc may be used to
the cancellous bony portion of the endplates branch and replace the disc that is removed. However, it is my belief that
communicate and terminate in glomeruloid buds, which even a degenerated or unhealthy disc should be preserved as
are highly vasoactive. Contrast magnetic resonance imag- long as possible. The best treatment option consists of main-
ing shows transgression of nutrients and transport of taining immobilization to avoid progression while improving
metabolites and waste products through this system— the supply of nutrients and blood to the disc.
not through the annulus. At Uppsala University, my cryoplaning technique has
Disc degeneration refers to normal changes in spinal been used for more than 30 years to study normal spinal
discs that occur with aging. In some people (such as those anatomy and pathologies such as trauma, degeneration,
who smoke or do heavy physical work), age-related tumors, and metastases. A heavy-duty sledge cryomicro-
changes such as loss of fluid in the discs (making them tome creates authentic anatomical images of slices from the
less flexible) and tiny cracks or tears in the outer layer surface of in situ fresh-frozen specimens at submillimeter
(causing bulging, rupture, or breaking into fragments) lead intervals. Shown here are some of the images presented at
to degenerative disc disease, which can take place through- this symposium to improve understanding of spine surgeons
out the spine but most often occurs in discs in lumbar regarding spine anatomy.
S2 www.spinejournal.com April 2017

SPINE Volume 42, Number 7S, p S3
SUPPLEMENT
Clinical Biomechanics of the Spine

Dilip K. Sengupta, MD, Dr Med
Key words: spine biomechanics, spine fusion, spine stability. Subsequent designs for the disc prosthesis focused more
Spine 2017;42:S3 on restoration of physiological quality and quantity of
motion, but lack of attention to shock absorption comprom-
ised long-term success. Newer designs are focusing not only
on restoration of physiological motion but also on shock
A
clear understanding of biomechanical principles is absorption at the same time. The simple straight Harrington
essential in the treatment of orthopedic and spinal rod required a lot of biomechanical work behind the design.
disorders. Charnley designed a smaller than ana- Restoration of sagittal balance in spinal deformity surgery
tomical femoral head to attain low-friction arthroplasty, and unstable spondylolisthesis (Figure 1) are areas of current
with less wear and tear. White and Panjabi1 put forward a interest in spine biomechanics. The human body is not a
landmark definition of instability of thoracolumbar burst mathematical entity, that is, in treating patients with spine
fracture, combining clinical and biomechanical perspect- pain, 2 þ 2 does not always equal 4. However, continued
ives, as inability to maintain structural integrity under exploration and understanding of mathematical and bioen-
physiological load to prevent progression of neurological gineering principles will ensure the discovery of new
deficit and pain. Mechanical back pain due to disc degener- solutions and more effective ways of helping patients.
ation is worse with sitting, as opposed to claudication pain
from spinal stenosis, which is worse after standing. This was
explained by Nachemson in 1964, and was endorsed later by
Wilke, who measured intradiscal pressure greater in sitting
posture than standing. Screws, rods, and various interbody
cages have been designed and used to achieve successful
spinal fusion. Withdrawal of cylindrical interbody cages,
marking the end of ‘‘cage rage’’ in the late 1990s, resulted
from failure caused by the smaller footprint of the implant-
bone interface. Adjacent segment degeneration after suc-
cessful rigid fusion achieved by instrumented fusion with
screws and rods led to the development of several nonfusion
stabilization devices. Lack of a biomechanical basis in
design led to early clinical failure of many such devices.
An early design of a lumbar disc prosthesis, AcroFlex, which
Figure 1. Radiographic illustration of unstable spondylolisthesis.
was made of a rubber cushion between metal endplates, was
clinically effective in the short term but did not last long,
with chemical disintegration of the rubber material.
Reference
1. White AA III, Panjabi MM. Clinical Biomechanics of the Spine, 2nd
ed. Baltimore, MD: Lippincott Williams & Wilkins; 1990.
From the Center for Scoliosis & Advanced Spine Surgery, Mansfield, TX.
2016.
device(s)/drug(s).
Address correspondence and reprint requests to Dilip K. Sengupta, MD, Dr
Med, Center for Scoliosis & Advanced Spine Surgery, 2800 East Broad St,
Suite 512, Mansfield, TX 76063; E-mail: dksq@hotmail.com
DOI: 10.1097/BRS.0000000000002019
SUPPLEMENT
Biological Responses to Spinal Implant Debris

Nadim J. Hallab, PhD
Key words: adaptive immune response, metal hypersensitivity, hypersensitivity include dermal patch testing and lympho-
spine implant. cyte transformation testing (LTT; Figure 1). Cohort studies
Spine 2017;42:S4-S5 over 30þ years have suggested a strong connection
between the amount of metal implant debris and the
development of metal sensitivity.1,3 DTH responses are
T
o identify the role of adaptive immune responses in
the long-term performance of spine implants (i.e., clinically important for spinal implants, but it remains
spinal implant debris), the contributions of both the unknown how prevalent or severe this problem is. Very
innate and the adaptive immune system to implant debris few case reports of spinal implant–related pain/poor
bioreactivity need to be evaluated. Clinical evidence points implant performance and osteolysis have shown any evi-
to implant wear debris as the main reason for implant dence of pathogenic adaptive immune responses such as
failure. However, most data pertain to polymeric wear histologically identifiable local lymphocyte accumu-
debris from articular surfaces, not to metal debris. Some lations.4 – 6 Cohort studies of quantitative diagnostic tech-
cases are the result of adaptive immune reactivity to metal niques such as metal-LTT are required to identify metal-
debris, also termed metal sensitivity, metal allergy, or induced DTH responses to spinal implants. Metal allergy
delayed-type hypersensitivity (DTH) responses.1,2 Most diagnostic testing (LTT) may be beneficial for optimizing
often, aseptic implant failure over time is due to slow, subtle biocompatibility and/or planning revision surgery with
innate macrophage reactivity to particulate debris. This patient-specific nonreactive implant materials.
innate immune response controlled by macrophages elicits
an immediate maximal response, is not antigen specific, and References
results in no (little) immunologic memory following 1. Hallab NJ, Caicedo M, McAllister K, et al. Asymptomatic prospec-
tive and retrospective cohorts with metal-on-metal hip arthroplasty
exposure. Innate immune macrophage-dominated granulo- indicate acquired lymphocyte reactivity varies with metal ion levels
mas over time typically invade the implant/bone interface, on a group basis. J Orthop Res 2013;31:173–82.
causing pain and implant loosening. In contrast, adaptive 2. Hallab NJ, Merritt K, Jacobs JJ. Metal sensitivity in patients with
orthopaedic implants. J Bone Joint Surg Am 2001;83-A:428–36.
immunity in orthopedics generally is controlled by lympho-
3. Hallab NJ. A review of the biologic effects of spine implant debris:
cytes, is antigen dependent, involves lag time (weeks to fact from fiction. SAS J 2009;3:143–60.
years) between immediate or accumulated exposure and 4. Dimar JR, Endriga DT, Carreon LY. Osteolysis and cervical cord
maximal response, is antigen specific, and results in immu- compression secondary to silicone granuloma formation around a
dorsal spinal cord stimulator: a case report. J Neurol Surg Rep
nologic memory following exposure. A total joint arthro- 2016;77:e67–72.
plasty implant may produce adaptive immune responses to 5. Guyer RD, Shellock J, MacLennan B, et al. Early failure of metal-on-
implant debris that can cause premature implant failure and metal artificial disc prostheses associated with lymphocytic reac-
generally are correlated with aseptic long-term failure tion: diagnosis and treatment experience in four cases. Spine (Phila
Pa 1976) 2011;36:E492–7.
(Figure 1).1,2 Through DTH responses, lymphocytes can 6. Cavanaugh DA, Nunley PD, Kerr EJ III, et al. Delayed hyper-
become activated to the metal-protein complexes formed reactivity to metal ions after cervical disc arthroplasty: a case report
from implant corrosion and wear. Diagnostic tests of and literature review. Spine (Phila Pa 1976) 2009;34:E262–5.
From the Rush University Medical Center, Chicago, IL. No benefits in any form have been or will be received from a commercial
Acknowledgment date: December 6, 2016. Acceptance date: December 6, party related directly or indirectly to the subject of this manuscript.
2016. Address correspondence and reprint requests to Nadim J. Hallab, PhD, Rush
The manuscript submitted does not contain information about medical University Medical Center, 1653 W. Congress Pkwy, Chicago, IL 60612;
device(s)/drug(s). E-mail: nhallab@bioengineeringsolutions.com
No funds were received in support of this work. DOI: 10.1097/BRS.0000000000002020
SUPPLEMENT Biological Responses to Spinal Implant Debris Hallab
Figure 1. Local tissue cell reactivity is determined by immune cell interactions with implant debris and an associated chart demonstrating the
increased incidence of hypersensitivity responses associated with aseptic implant failure. IL indicates Interleukin; PDGF, platelet-derived
growth factor; PGE2, prostaglandin E2; TGF, transforming growth factor; TNF, tumor necrosis factor.
SUPPLEMENT
Biologics and Spine: Cells, Signaling, and Surfaces

Ira L. Fedder, MD, PharmD
Key words: mesenchymal stem cells, tissue engineering, tissue Caplan, PhD, from ‘‘mesenchymal stem cells’’ to ‘‘medicinal
repair. signaling cells.’’ How do they talk to each other? When
Spine 2017;42:S8 injected into the vein, how do stem cells move from the
vasculature into the tissue? Much has been learned about
orthopedic treatment at organ and cellular levels, but the
F
or patients with spine pain, the future holds great next advances will occur at the molecular level—cell-to-cell
promise. Treatment methods of the past reflect lim- signaling and cell-to-cell control. Ongoing research is exam-
ited insight into the spine and include techniques used ining ways to manipulate biomaterial at the nano level to
to treat patients with spine disorders that now seem rudi- make the orthopedic implant biologically active and able to
mentary. Researchers are advancing our understanding of participate in and enhance tissue repair and tissue engin-
cellular biology and the ways in which cells communicate, eering. We have discovered inside the stem cell the entire
and more efficient and effective treatments are already orchestra that we need to create and repair tissue. We have
changing the treatment landscape. Surgeons relied on cor- modified surfaces to make them more bioreactive. Revolu-
tico-cancellous graft without instrumentation to stimulate tionary treatments for degenerative disease and spinal
fusion, although in retrospect, the properties and functions deformity and injury are at hand. We look forward to
were not fully understood. Bone grafting failures led to the the future!
use of stainless-steel devices that provided stability but did
not participate in a biological fashion to promote healing
and strength. A new frontier has emerged. Autogenous and
allogenic bone graft once thought to consist of dead tissue
actually may contain cells and proteins that signal events
that control formation of bone, cartilage, and/or soft tissue.
A new era of tissue engineering is under way, with surgeons
now injecting patients with proteins and other components
of cancellous bone, including bone marrow, mesenchymal
stem cells (MSCs), and hematopoietic cells, to promote
healing of tendons, cartilage, muscle, spinal cord, and
ligaments, for example. Continued studies have led to our
awareness that MSCs are pericytes that live on the capillary
and are activated by trauma to move off the capillary and
morph into stem cells that stimulate a healing response—
resulting in a change in the definition of ‘‘MSCs’’ by Arnold
From the University of Maryland St. Joseph Medical Center, Towson, MD.
2016.
device(s)/drug(s).
Address correspondence and reprint requests to Ira L. Fedder, MD, PharmD,
University of Maryland St. Joseph Medical Center, O’Dea Medical Arts
Building, 7505 Osler Dr #104, Towson, MD 21204;
E-mail: drfedder@gmail.com
DOI: 10.1097/BRS.0000000000002022
SUPPLEMENT
Introduction of New Technologies in Orthopedic

Surgery
Paul A. Anderson, MD, MS
Key words: investigational device, spine surgery, technology. nerve and neurotoxicity is examined. This type of testing can
Spine 2017;42:S6-S7 lead to unexpected failure in vivo after approval. Testing of
input parameters versus what actually happens in vivo is not
understood, and correlation between testing standards and
clinical results is often inadequate.
N
ew technology may be less invasive, may cause less Clinical trials are most important for confirming safety
collateral damage and faster recovery, and offers and efficacy. Study design is essential in choosing an appro-
promise for better diagnostic and treatment priate control, whether nonoperative therapy or a compet-
modalities. Most new technologies when first distributed ing device or technique. Time points appropriate for
do not translate to better outcomes. The choice of a new determining reasonable safety and efficacy must be selected.
technology should be based on a biological need and justi- A randomized controlled trial is most appropriate when
fied by an established physiological mechanism. Unfortu- control efficacy is unknown, outcomes are poorly measured,
nately, new technology is often developed for marketing cost of treatment is high, and acceptable alternatives are
advantage rather than to address a biological need. available. A randomized controlled trial yields evidence of
Food and Drug Administration is the main regulator for the highest quality and can prove efficacy but cannot show
both pharmaceutical and medical devices in the United efficiency of treatment. Efficiency involves broadened
States; its goal is to establish safety and efficacy. The agency indications, greater surgeon variability, and oftentimes less
permits marketing of devices but does not actually approve than optimal training and inconsistent management before
them, and assigns risk as low (class 1), moderate (class 2), or and after surgery. These problems can greatly influence the
high (class 3) (Table 1). distributive nature of new technology.
Preclinical mechanical testing is usually based on testing Examples of successful new technology for spine surgery
standards created by the American Society of Testing include cervical disc arthroplasty performed to address a
Materials and the International Standards Organization, biological need, at least theoretically, to prevent adjacent
which include static and dynamic testing to determine segment degeneration. An excellent alternative is fusion. A
strength and fatigue properties of all components. For less successful example is a minimally invasive shaver used
devices that allow motion, wear testing measures durability. in foraminotomy. This technique involves making a small
Cell culture is often performed on wear material, and laminotomy and passing a guidewire out the neuroforamen
biological testing for spinal devices can include use of a and back through the skin, allowing placement of a shaver
laminectomy model by which wear debris is placed on the that can be used to undercut the foramina and the subar-
ticular area of the lamina; this is done under special neuro-
From the Department of Orthopedic Surgery and Rehabilitation, University monitoring. This device was approved as an instrument
of Wisconsin, Madison, WI. rather than a medical device because it is removed at the
Acknowledgment date: December 6, 2016. Acceptance date: December 6, time of surgery. Systematic problems, including poor indica-
2016. tions, inadequate physician training, lack of regulatory
The manuscript submitted does not contain information about medical oversight, faulty surgeon understanding of neuromonitoring
device(s)/drug(s).
principles, and unproven safety and effectiveness, may lead
to complications.
party related directly or indirectly to the subject of this manuscript. The final aspect of new technology is surgeon education.
Address correspondence and reprint requests to Paul A. Anderson, MD, MS, Many experienced surgeons see new technology as not very
Department of Orthopedic Surgery and Rehabilitation, University of different from what they are already doing and may not
Wisconsin, 1685 Highland Ave, UWMFCB 6215, Madison, WI 53705; adequately prepare for its use. Courses typically involve
E-mail: anderson@ortho.wisc.edu
cadaveric or synthetic models and may not include critical
DOI: 10.1097/BRS.0000000000002021 components, such as use of neuromonitoring. Surgeons
SUPPLEMENT Introduction of New Technologies in Orthopedic Surgery Anderson
TABLE 1. Food and Drug Administration Classification for Medical Devices

Risk Controls Reporting Criteria Examples
Class 1 Low General Registration, explanation of the Band aids
manufacturing process, labeling and Ace bandages
maintenance of the device
Class 2 Moderate General Proven equivalency to existing products, Pedicle screw
Special performance standards, special labeling, systems
premarket data requirements, postmarket Plates
surveillance, and development of patient Many joint
registries arthroplasties
510 (k) process
Class 3 High General Investigational device exemption clinical Disc arthroplasty
Special trial rBMP-2
More clinical Premarket approval application Dynamic
trials stabilization
rBMP-2 indicates recombinant bone morphogenic protein.
using new technology should gain experience by visiting complications occurred in the first 40 cases. Another con-
proficient users or by having their cases proctored. Assisting cept involves mass learning versus distributed learning.
at their own hospital or at another surgeon’s institution may Mass learning is achieved in a single session, such as a
provide the best training. By using the instruments in a sham half-day program, whereas distributed learning takes place
process, that is, by doing a familiar similar technique while in 1 hour spread over 4 days. Distributed learning leads to
using instruments needed to place the new device or apply significantly longer-term retention of technical skills.3
the new technique, the surgeon can improve skills. Through In summary, new technology offers the promise of
minimally invasive placement of pedicle screws by an open improved clinical outcomes but must be based on biological
procedure, the surgeon can use percutaneous instruments. plausibility and a biological need. The surgeon cannot
Early cases should be proctored and critically reviewed by assume that testing is rigorous, and should evaluate the
the surgeon; CT scans should confirm that desired results literature himself before adopting a new technology. The
were achieved. Learning must be contemporary with per- surgeon’s training must be completed by practicing with
formance of the surgical procedure; if time passes between high-fidelity models or by visiting surgeons experienced in
undergoing training and doing the procedure, the surgeon the technique.
should retrain to keep skills up-to-date.
To overcome the learning curve, the surgeon usually will References
need to perform complex tasks, such as completing an 1. Nandyala SV, Fineberg SJ, Pelton M, et al. Minimally invasive
transforaminal lumbar interbody fusion: one surgeon’s learning
entirely new procedure, in 30 to 35 cases, and will require
curve. Spine J 2014;14:1460–5.
as few as 10 cases to add a new step to a procedure. 2. Park Y, Lee SB, Seok SO, et al. Perioperative surgical complications
Nandyala et al1 reviewed minimally invasive transforaminal and learning curve associated with minimally invasive transforami-
lumbar interbody fusion and found a significant decrease in nal lumbar interbody fusion: a single-institute experience. Clin
Orthop Surg 2015;7:91–6.
time, estimated blood loss, and IV fluids after the first 30 3. Moulton CA, Dubrowski A, Macrae H, et al. Teaching surgical
cases but no differences in rates of complications. Park et al2 skills: what kind of practice makes perfect? A randomized, con-
noted a 9% complication rate and reported that most trolled trial. Ann Surg 2006;244:400–9.
SUPPLEMENT
Understanding the Potential of Mesenchymal

Stem Cells for Clinical Use
Archana Bhat, PhD
Key words: cell therapy, mesenchymal stem cells, regenerative knowledge of required dosage are some of the shortcomings
medicine. of this approach. Cell-secreted ECMs have been shown to
Spine 2017;42:S10 possess the underlying structure and trophic factors needed
to facilitate MSC attachment and differentiation.2 ECM-
coated microcarrier beads incorporated within alginate
hydrogels have been used to promote osteogenesis with
M
esenchymal stem cells (MSCs) have gained
MSCs.3 Additionally, it has been shown that the survival
remarkable interest in the field of regenerative
and osteogenic potential of MSCs can be improved by the
medicine because of their innate high prolifer-
formation of three-dimensional spheroids compared with
ation ability, paracrine effects, multipotent differentiation
monolayer culturing of MSCs.4 MSCs cultured by this
potential, and immunomodulatory properties. Autologous
method were shown to have significantly higher vascular
bone marrow aspirate has been the gold standard source for
endothelial growth factor secretion and to better resist
MSCs. However, the number of MSCs in BMA has been
apoptosis posttransplantation compared with dissociated
shown to decline with age, warranting cell expansion to
MSCs.
achieve therapeutic efficiency. Additionally, the efficacy of
MSCs have a promising role in cell therapy for the
MSCs is dependent on several factors such as source of
treatment of various disorders. However, many challenges
MSCs, viability of MSCs after implantation, potency of
remain in making this cell population safe and effective. It is
MSCs, and severity of the disease condition.1 One of the
important to select optimal cell sources, culture conditions,
major limitations of cell therapy is the loss of cell viability
scaffolding materials, and delivery methods to overcome the
that may occur shortly after implantation. This shortcoming
challenges associated with MSCs.
can potentially be resolved by (A) in vitro priming of MSCs
to make them potent enough that paracrine effects trigger
the tissue regenerative cascade, and (B) optimization of the References
delivery mechanism of MSCs to enhance cell viability. 1. Dimarino AM, Caplan AI, Bonfield TL. Mesenchymal stem cells in
In vitro priming of MSCs may be accomplished by tissue repair. Front Immunol 2013;4:201.
2. Hoch AI, Mittal V, Mitra D, et al. Cell-secreted matrices perpetuate
predisposing them to survive in hypoxic and ischemic con- the bone-forming phenotype of differentiated mesenchymal stem
ditions commonly seen with bone defects. Growth factors cells. Biomaterials 2016;74:178–87.
and cytokines have been shown to direct MSC fate. How- 3. Bhat A, Hoch AI, Decaris ML, et al. Alginate hydrogels contain-
ever, increased costs due to use of recombinant proteins, ing cell-interactive beads for bone formation. FASEB J 2013;27:
4844–52.
failure to capture the complex microenvironment of the 4. Murphy KC, Fang SY, Leach JK. Human mesenchymal stem cell
native extracellular matrices (ECM), and inadequate spheroids in fibrin hydrogels exhibit improved cell survival and
potential for bone healing. Cell Tissue Res 2014;357:91–9.
From the Globus Medical, Inc, Audubon, PA.

2016.
device(s)/drug(s).
Address correspondence and reprint requests to Archana Bhat, PhD, Globus
Medical, Inc, 2560 General Armistead Avenue, Audubon, PA 19403;
E-mail: abhat@globusmedical.com
DOI: 10.1097/BRS.0000000000002024
SUPPLEMENT
Biologics Development and Carrier Innovation

Kee D. Kim, MD, Plamena M. Koleva, BS,y James H. Keefer, BS,y Christine E. Han, BS,y
Stacy E. Ralston, MS,y and Charles C. Lee, PhD z
Key words: biologics carrier, bone fusion, bone graft substi- determined by CT (Figure 1, top) and histologic findings.
tutes. When implanted in the lateral femoral condyle of rabbits
Spine 2017;42:S9 with a critical-sized bone defect, HCCP supported efficient
bone formation similarly to autologous bone and the PLGA-
based predicate device (Figure 1, bottom). HCCP has been
shown to be biocompatible with no pyrogenicity, immuno-
M
ost bone graft substitutes currently used in
genicity, cellular toxicity, genotoxicity, or carcinogenicity in
surgery can be broadly categorized into calcium
in vivo and in vitro studies. We also investigated the ability
and demineralized bone matrix-based technol-
of HCCP to carry growth factors and cells. HCCP was
ogies that were developed several decades ago. We have
incubated with bone morphogenetic protein 2 (BMP-2) at
investigated the safety and efficacy of a novel hypercros-
1 mg/mL or with bone marrow mononuclear cells (BM
slinked carbohydrate polymer (HCCP) for the repair of a
MNCs) at 1 107 cells/mL. HCCP was washed and incu-
critical sized bone defect and lumbar interbody fusion. We
bated in fresh phosphate-buffered saline for 3 days. BMP-2
also explored the possibility of utilizing HCCP as a carrier
and BM MNC released from HCCP were measured by
for various biologics. For lumbar interbody fusion, we
ELISA or by cell counts. Approximately 97% of BMP-2
custom-designed HCCP to fit into an interbody cage,
and BM MNC was retained in HCCP over 3 days. Results
implanted into the disc space at L4–5 in sheep (N ¼ 18),
indicate that HCCP can (A) be used to promote lumbar
and compared it with autologous bone. Animals were
interbody fusion; (B) bridge and fill a critical-sized defect
monitored by computed tomography (CT), and the implant
similarly to autologous bone; and (C) carry BMP-2 and BM
site was harvested 5 months after implantation. For the
MNC effectively without significant loss of biologics due to
repair of a critical-sized bone defect, we implanted HCCP
leakage.
granules (N ¼ 5) into a defect (7 mm 10 mm) created in the
femoral condyle of rabbit and compared them with autol-
ogous bone (N ¼ 5) and poly (lactide-co-glycolide) (PLGA)-
based substitutes (N ¼ 5). We evaluated with CTs and, at
4 months, histology. At 5 months after implantation, com-
plete spinal fusion was observed in sheep implanted with
HCCP at a level comparable with autologous bone, as
From the Department of Neurological Surgery, UC Davis School of

Medicine, Sacramento, CA; yMolecular Matrix, Inc, Davis, CA; zCell
Biology and Human Anatomy, School of Medicine, University of California,
and Sacramento, CA.
2016.
device(s)/drug(s).
Address correspondence and reprint requests to Kee D. Kim, MD,
Department of Neurological Surgery, UC Davis School of Medicine,
Figure 1. HCCP showed complete spinal fusion (top) at 5 months
4860 Y Street, Ste 3740, Sacramento, CA 95817;
E-mail: kdkim@ucdavis.edu after implantation and safely and effectively bridged a critical-sized
defect (bottom) at 4 months after implantation. HCCP indicates
DOI: 10.1097/BRS.0000000000002023 hypercrosslinked carbohydrate polymer.
SUPPLEMENT
Current State of DBM

Christopher D. Chaput, MD
Key words: bone graft extenders, demineralized bone matrix,

osteoinductivity.
Spine 2017;42:S11
S
ince 2005, demineralized bone matrices (DBMs) are
subject to the 510(k) premarket approval process,
during which they must demonstrate the potential to
induce bone formation. However, differences between lots
of DBM from the same supplier can be significant, and the Figure 1. Average pH value of substrates buffered in human plasma
manner in which producers test each lot to ensure some over 48 hours, with pH after buffering in phosphate-buffered saline
shown in parentheses.
degree of osteoinductivity varies considerably. Some com-
panies rely on in vivo assays, and others use in vitro assays of
biomarkers as a surrogate. In addition, some producers of surgeons should be conscious of pH issues because placing
DBM might test it after acid removal and early processing, cells from autograft or bone marrow aspirate in contact with
but others might perform terminal product testing after the products that do not have a near physiologic pH on the
addition of a carrier and final aseptic processing or steri- ‘‘back table’’ for long periods might lead to cell death.
lization. How well in vitro assays correlate with established The rat muscle pouch continues to be the preferred
animal models is a topic of debate in the literature, and no method of documenting osteoinductivity, and standardized
generally accepted in vitro assay is currently available. methods have been described (ASTM 2529-13). It makes the
In hopes of eliminating the need for animal testing, our most sense to perform the test on the final product of each
research group demonstrated that mesenchymal stem cell lot of DBM, as it would be done clinically, as this is the only
(MSCs) can be used to determine which bone graft extenders way to account for all variables in the manufacturing
induced markers for bone formation.1 However, we found process. Although this does not guarantee clinical success,
this approach potentially problematic for two reasons: (A) it is the most pragmatic way to ensure that each lot has the
some products tend to dissolve so quickly in culture that potential to induce bone formation after final processing.
MSCs have little surface area to which to adhere, and (B)
some DBM formulations and nonorganic carriers are so Reference
basic or acidic that they are cytotoxic and kill the MSCs 1. Murphy MB, Suzuki RK, Sand TT, et al. Short term culture of
human mesenchymal stem cells with commercial osteoconductive
(Figure 1). Buffering has not proved helpful for the most carriers provides unique insights into biocompatibility. J Clin Med
basic products (bioactive glass). This work shows that 2013;2:49–66.
From the Baylor Scott and White Health, Roney Bone and Joint Institute,
Temple, TX.
2016.
device(s)/drug(s).
Address correspondence and reprint requests to Christopher D. Chaput,
MD, Baylor Scott and White Health, Roney Bone and Joint Institute, 2401 S.
31st Street, Temple, TX 76508; E-mail: Christopher.Chaput@BSWhealth.org
DOI: 10.1097/BRS.0000000000002025
SUPPLEMENT
Patient-Specific Spinal Alignment and Adult

Deformity Surgery: Are All Patient Deformities
the Same?
Themistocles S. Protopsaltis, MD
Key words: adult spinal deformity, pelvic retroversion, sagittal Computed tomography (CT) and magnetic resonance
vertical axis. imaging (MRI) to assess for pseudarthrosis and neural
Spine 2017;42:S14-S15 compression are important standard components of the
preoperative radiographic workup for adult spinal deform-
ity. Baker et al1 demonstrated that lumbar MRI and CT
have further utility in determining lumbar flexibility. A
A
dult spinal deformity is a complex pathologic proc-
change in pelvic incidence (PI)-lumber lordosis (LL) mis-
ess with many etiologies and several mechanisms
match identified on supine imaging can obviate the need for
of compensation. A complete understanding of
a more invasive three-column osteotomy.
patient-specific spinopelvic alignment is required to differ-
The literature is replete with studies that demonstrate the
entiate the origin of the deformity from postural compen-
negative health impact of sagittal spinal deformity. The
satory mechanisms and, ultimately, to optimize surgical
sagittal vertical axis (SVA) has been widely used to quantify
correction. Specific spinopelvic parameters have been
spinal malalignment, but the complexities of standing align-
shown to be invaluable in the evaluation and surgical treat-
ment cannot be described with this parameter alone.2,3
ment of adult spinal deformity.
Researchers have demonstrated that the pelvis is a key
X-ray radiography is the principal tool used in the diag-
component of the spinopelvic axis and an important regu-
nosis of spinal deformity. Global and regional imaging with
lator of standing alignment.2,3 The SVA should always be
anteroposterior and lateral views in the standing and unsup-
considered in tandem with the pelvic tilt—a measure of
ported position can assess the true magnitude of the deform-
pelvic retroversion.
ity in the presence of axial loading. Spinal deformity and
Another key parameter is PI, which does not change after
recruitment of compensatory mechanisms are best evaluated
skeletal maturity.3 PI has been described as useful for
with full 36-inch cassettes or full-body imaging. For pur-
assessing pathologic changes to LL7 because PI is related
poses of standardization and for optimal visualization of
to pelvic tilt and sacral slope (PI ¼ PT þ SS), and sacral slope
critical landmarks, the ‘‘clavicle position’’ should be utilized
is highly correlated with LL in asymptomatic well-aligned
when the patient stands unsupported in a position of com-
patients. Sagittal malalignment results in changes in pelvic
fort, with elbows fully flexed and fingers placed at the
version, but because PI is a static parameter related to LL,
supraclavicular fossa.
surgeons can utilize the PI-LL relationship to determine
optimal sagittal correction.
Patients with sagittal spinal deformity utilize predictable
From the NYU Langone Hospital for Joint Diseases, New York, NY. compensatory responses to optimize their standing align-
Acknowledgment date: December 6, 2016. Acceptance date: December 7, ment depending on the magnitude of their deformities.2 A
2016. deformity localized to one or more spinal regions will lead to
The manuscript submitted does not contain information about medical compensatory changes in adjacent regions, followed by
device(s)/drug(s).
compensatory changes in the pelvis and, finally, in the
lower extremities.
party related directly or indirectly to the subject of this manuscript. Pelvic retroversion is a key compensatory mechanism in
Address correspondence and reprint requests to Themistocles Protopsaltis, the modulation of standing alignment. When attempting to
MD, NYU Langone Hospital for Joint Diseases, 301 East 17th Street, 4th reposition the center of gravity of the body over the feet, a
Floor, Suite 413C, New York, NY 10003; patient with spinal deformity will rotate the pelvis back-
E-mail: Themistocles.Protopsaltis@nyumc.org
ward through the femoral heads to maintain economic
DOI: 10.1097/BRS.0000000000002027 standing posture. Pelvic retroversion is one of the first
SUPPLEMENT Patient-Specific Spinal Alignment and Adult Deformity Surgery Protopsaltis
correction of sagittal malalignment.2 Failure to recognize

increased pelvic tilt in a well-compensated lumbar flatback
deformity or in a large sagittal deformity with increased
SVA can lead to under correction, residual sagittal malalign-
ment, and persistent pain and disability.2
A novel measure of sagittal spinal alignment is the T1
pelvic angle (TPA), which accounts for sagittal inclination
and pelvic tilt simultaneously. The TPA has been shown to
correlate with health-related quality-of-life measures and is
useful in perioperative planning because it is a direct
measure of the geometry of spinal deformity separate from
pelvic and lower extremity compensation (Figure 1). TPA
can be measured on a full-length intraoperative radiograph
to confirm appropriate deformity correction. Furthermore,
the alignment goal for TPA can be deduced intuitively. This
measure is the sum of T1 spinopelvic inclination and pelvic
tilt, and surgical correction requires restoration of spinal
inclination back to a neutral or slightly negative position
and correction of the pelvic tilt to a normal range (158–258).
Using TPA, surgeons may optimize postoperative correction
of the spine to fit the patient’s age. Recent work suggests that
a TPA target of 108 to 158 is optimal for middle-aged
patients (age 40–65), and a TPA target of 158 to 258 is
favorable for elderly patients (age >65).4
Adult spinal deformity is a complex pathologic process
with many etiologies and several mechanisms of compen-
sation. A complete understanding of spinopelvic alignment
is required to differentiate the origin of deformity from its
compensation and, ultimately, to optimize surgical correc-
tion. Compensatory mechanisms are activated in a predict-
able manner and progress to include pelvic and lower
extremity mechanisms such as pelvic tilt and knee flexion
Figure 1. The T1 pelvic angle (TPA) is the angle between the line as tolerated. Optimal correction can be determined on the
from the femoral head axis to the center of the T1 vertebral body basis of radiographic spinopelvic parameters such as PI, LL,
and the line from the femoral head axis to the middle of the S1 PT, and TPA.
endplate. TPA is the sum of T1 spinopelvic inclination and pelvic tilt.
References
mechanisms of compensation adopted by adult patients 1. Baker JF, Day LM, Oren J, et al. Assessment of lumbar flexibility
with spinal deformity.2 Furthermore, patients with poor with supine MRI and CT may reduce the need for more invasive
spinal osteotomy in adult spinal deformity surgery. Washington,
motor strength, including frail and sacropenic elderly patients DC: Presented at: International Meeting on Advanced Spine Tech-
and those with neurodegenerative disorders such as Parkin- niques (IMAST); 2016.
son disease, cannot effectively tilt the pelvis, even in the 2. Lafage V, Schwab F, Patel A, et al. Pelvic tilt and truncal inclination:
presence of severe sagittal malalignment. Patients with a two key radiographic parameters in the setting of adults with spinal
deformity. Spine (Phila Pa 1976) 2009;34:E599–606.
relatively small pelvic tilt often demonstrate greater levels 3. Legaye J, Duval-Beaupere G, Hecquet J, et al. Pelvic incidence: a
of disability.2 The most disabled class of patients consists of fundamental pelvic parameter for three-dimensional regulation of
those with a combination of severe sagittal deformity and spinal sagittal curves. Eur Spine J 1998;7:99–103.
4. Protopsaltis TS, Lafage R, Henry J, et al. Do optimal spinal
inability to compensate with pelvic retroversion.2
alignment targets result in less PJK for vulnerable elderly spinal
Pelvic retroversion is the most important compensatory deformity patients? Valencia, Spain: Presented at: International
mechanism to be considered in planning for surgical Meeting on Advanced Spine Techniques (IMAST); 2014.

SUPPLEMENT
Appropriate Use Criteria in Adult Scoliosis

Sigurd H. Berven, MD
Key words: adult spinal deformity, decompression, monolithic. were defined as ‘‘inappropriate’’ when the expected negative
Spine 2017;42:S12-S13 consequences exceed the expected health benefit; ‘‘reason-
able’’ when the balance of risk and benefit is unknown but a
reasonable chance of positive benefit exists; and ‘‘appropri-
ate’’ when the expected health benefit exceeds anticipated
T
he management of adult spinal deformity is charac- negative consequences by a wide margin. The study involved
terized by significant variability.1–3 Indications for three Web-based surveys and one physical meeting. Consen-
surgery, preoperative preparations, intraoperative sus on each question required 70% agreement.
strategies, and postoperative care are variable between pro- Appropriate goals of surgery include improvements in
viders and within the community of physicians who care for mobility, pain, and neural function. Important preoperative
patients with spinal disorders.4–6 The presence of variability considerations for which consensus was reached include
is clear evidence of the absence of an evidence-based approach history elements (symptoms, comorbidities, smoking, and
to care. A consensus on evaluation and management of adults prior surgery), physical examination, imaging with full-
with spinal deformity is challenging, and a monolithic length standing films, bone quality, and cardiovascular and
approach to adult deformity would not be responsive to pulmonary testing. Consensus is greater for identifying inap-
important considerations such as patient values and prefer- propriate rather than appropriate surgical approaches. Long
ences, physician preferences and skills, and cost and value fusion with deformity correction is considered appropriate
considerations.7,8 Appropriate use criteria are based upon for patients with severe sagittal and coronal plane deformity
assessment of care for specific scenarios, with appropriate and limited comorbidities. Decompression alone is viewed as
care defined as care in which the expected benefits of treat- inappropriate for patients with progressive deformity.
ment exceed the expected risks and costs of care. Appropriate Decompression alone and decompression with limited fusion
care for adults with spinal deformity may encompass a broad is inappropriate for patients with sagittal plane deformity.
range of approaches and strategies, and may be responsive to Anterior column support has been deemed appropriate for
specific considerations and priorities of the patient, the care patients with fusion above T12 to S1, pelvic fixation appro-
provider, and the health care system. The purpose of this priate for patients with sagittal deformity and osteoporosis,
presentation is to describe appropriate management of adult pedicle subtraction osteotomy appropriate for patients with
deformity across the spectrum of care, including preopera- rigid deformity and no comorbidities, and percutaneous
tive, intraoperative, and postoperative considerations. posterior fixation inappropriate for patients with more severe
The AOSpine Knowledge Forum Deformity performed a deformity in the coronal or sagittal plane. Local bone is the
modified Delphi survey of 53 experienced spine deformity only material on which consensus was reached for use in adult
surgeons representing 24 countries. Surgeons rated appropri- deformity. Forum participants agreed that use of neuromo-
ateness of procedures and management strategies. Procedures nitoring with MEP and SSEP is appropriate in adult deformity
reconstruction, postoperative mechanical prophylaxis is
From the Department of Orthopaedic Surgery, University of California San appropriate for patients with low risk of DVT, and chemical
Francisco, San Francisco, CA. prophylaxis is appropriate for patients at high risk. They
Acknowledgment date: December 6, 2016. Acceptance date: December 7, concur that return to sedentary work is appropriate within 3
2016.
months for patients with fusion in fewer than five segments
device(s)/drug(s). and return to contact sports is inappropriate for patients with
No funds were received in support of this work. fusion in more than seven segments.
No benefits in any form have been or will be received from a commercial Deformity of the spine is an important disorder affecting
party related directly or indirectly to the subject of this manuscript. the adult spine, and management of spinal deformity
Address correspondence and reprint requests to Sigurd Berven, MD, Depart- accounts for a significant and increasing portion of our
ment of Orthopaedic Surgery, University of California San Francisco, 400 health care economy. Operative and nonoperative manage-
Parnassus Ave, San Francisco, CA 94143; E-mail: Sigurd.Berven@ucsf.edu
ment of symptomatic adult spinal deformity is characterized
DOI: 10.1097/BRS.0000000000002026 by significant variability. The optimal strategy will lead to
SUPPLEMENT Appropriate Use Criteria in Adult Scoliosis Berven
the greatest possible improvement in patient-reported 2. Yadla S, Maltenfort MG, Ratliff JK, et al. Adult scoliosis
surgery outcomes: a systematic review. Neurosurg Focus 2010;
health-related quality of life with the least risk and cost. 28:E3.
An optimal choice of surgical approach requires consider- 3. Cho KJ, Kim YT, Shin SH, et al. Surgical treatment of adult
ation of patient preferences, values, comorbidities, and goals degenerative scoliosis. Asian Spine J 2014;8:371–81.
of care. Therefore, a monolithic or dogmatic approach to 4. Everett CR, Patel RK. A systematic literature review of nonsurgical
treatment in adult scoliosis. Spine (Phila Pa 1976) 2007;32(19
care is not appropriate, and each case requires informed suppl):S130–4.
choice in discussion between patient and physician. Appro- 5. Tribus CB. Degenerative lumbar scoliosis: evaluation and manage-
priate care for adults with spinal deformity must be respon- ment. J Am Acad Orthop Surg 2003;11:174–83.
sive to specific considerations of the patient, the care 6. Liang CZ, Li FC, Li H, et al. Surgery is an effective and reasonable
treatment for degenerative scoliosis: a systematic review. J Int Med
provider, and the health care system. Res 2012;40:399–405.
7. Garber AM, Tunis SR. Does comparative-effectiveness research
References threaten personalized medicine? N Engl J Med 2009; 360:1925–7.
1. Wang G, Hu J, Liu X, et al. Surgical treatments for degenerative 8. Paulus MC, Kalantar SB, Radcliff K. Cost and value of spinal
lumbar scoliosis: a meta-analysis. Eur Spine J 2015;24:1792–9. deformity surgery. Spine (Phila Pa 1976) 2014;39:388–93.

SUPPLEMENT
How to Create Sagittal Balance in MIS Correction

of Adult Spinal Deformity
Neel Anand, MD
Key words: minimally invasive, sagittal balance, spinal

deformity.
Spine 2017;42:S17-S18
S
agittal balance, an important radiological criterion,
directly affects functional outcomes in patients with
adult spinal deformity (ASD). Recent data on pelvic
parameters and spinal alignment objectives indicate that
spinal alignment objectives should be age-specific. Norma-
tive values for elderly patients show increasing sagittal
vertical alignment and decreasing lumbar lordosis.
Sagittal balance has been achieved intraoperatively
through positioning, facetectomy, interbody lordotic
implant, and osteotomy. Specific deformity factors such
as flexibility, degree and type, extent of imbalance, instru-
mentation level, and prior spinal surgery must be considered
when techniques are chosen to achieve sagittal balance.
Morbidity and complications of open correction of ASD
are especially significant in the elderly. Hence, surgical goals
in the elderly should advocate the least risky path, should be
age-specific, and probably should avoid the use of three-
column osteotomy.
Selection among minimally invasive surgery (MIS) tech-
niques should be predicated on judicious patient selection
and basic principles of sagittal balance. Figure 1 shows our
staged protocol for creating sagittal balance in ASD. Evalu- Figure 1. Staged surgical MIS protocol for achieving sagittal balance
ation with 36’’ standing radiographs, magnetic resonance with CMIS techniques for ASD. ASD indicates adult spinal deform-
imaging, computed tomography, and bone density scans ity; CMIS, circumferential MIS; MIS, minimally invasive surgery.
is followed by an MIS ante-psoas lateral approach,
discectomy, and sequential placement of segmental 128

From the Cedars Sinai Spine Center, Los Angeles, CA. lordotic cages anteriorly from L4–5 and rostrally to L1–
Acknowledgment date: December 6, 2016. Acceptance date: December 7, 2 or T12–L1. On the same day, an L5–S1 anterior lumbar
2016.
interbody fusion is carried out through an MIS oblique
device(s)/drug(s). lateral approach. Patients are recovered postop, transferred
No funds were received in support of this work. to the floor, and encouraged to ambulate on the same day.
No benefits in any form have been or will be received from a commercial This allows for documentation of relief of neurogenic clau-
party related directly or indirectly to the subject of this manuscript. dication and radiculopathy due to indirect reduction of
Address correspondence and reprint requests to Neel Anand, MD, Cedars spinal stenosis. On the second day, a standing 36’’ radio-
Sinai Spine Center, 444 S San Vincente Blvd, Suite 901, Los Angeles, CA graph is obtained and coronal and sagittal balance reas-
90048; E-mail: neelanand@mac.com
sessed, allowing planning and fine-tuning at the posterior
DOI: 10.1097/BRS.0000000000002029 second stage 3 days later.
SUPPLEMENT How to Create Sagittal Balance in MIS Correction of ASD Anand
During the posterior stage, paraspinal 1’’ incisions allow Our 10-year experience with a staged surgical protocol
placement of pedicle screws with extenders under fluoro- consisting of MIS lateral intradiscal release, segmental 128
scopy or navigation. The rod is contoured according to the lordotic cages, MIS anterior lumbar interbody fusion, staged
lordosis required and is passed through the extenders. reassessment of coronal and sagittal balance followed by
Sequential reduction allows for translation and derotation second-stage percutaneous instrumentation, and rod con-
of the spine. Posterior fusion is carried out, usually at T12– touring and reduction allows circumferential MIS correc-
L1, T11–12, and T10–11, without interbody fusion. tion of sagittal balance in ASD.

SUPPLEMENT
Adult Degenerative Spinal Deformity

Overview and Open Approaches for Treatment
Ryan M. Kretzer, MD
Key words: osteotomy, sagittal balance, scoliosis. posterior facet-based osteotomies (Ponte, Smith-Peterson)
Spine 2017;42:S16 and/or interbody fusion. A fixed anterior column, however,
typically requires a three-column osteotomy (pedicle sub-
traction, vertebral column resection) for adequate treat-
A
dult degenerative spinal deformity is a complex ment. The main goals of surgery in patients with
disorder that affects the thoracolumbar spine. degenerative spinal deformity are (A) to correct the sagittal
The spine must be balanced in both sagittal and plane deformity, (B) to decompress the neural elements, and
coronal planes to allow pain-free movement and function. (C) to stabilize the scoliotic curve, with curve correction as a
As the spine ages, disc degeneration and facet arthrosis can secondary goal. Effective treatment should yield a balanced
cause disc height collapse, spondylolisthesis, and loss of spine in both sagittal and coronal planes.
lumbar lordosis. Scoliosis, a coronal plane deformity, can
lead to back pain and leg pain in a radicular distribution due
to lateral recess and/or foraminal stenosis. Kyphosis, a
sagittal plane deformity, can also cause back pain, as well
as leg muscle fatigue due to compensatory mechanisms
required to bring the spine back into alignment. The clinical
diagnosis and treatment of degenerative thoracolumbar
kyphoscoliosis require a detailed understanding of both
spinal alignment and pelvic parameters. The sagittal vertical
axis is determined by dropping a vertical plumb line from
the C7 vertebral body. Horizontal displacement of this
plumb line to the posterior superior corner of S1 defines
the patient’s sagittal balance, which ideally should be cor-
rected to less than 5 cm. Other key measurements in the
assessment of sagittal imbalance include pelvic incidence
and lumbar lordosis, which should be matched to within 98.
Correction of sagittal plane deformity correlates with
improvement in quality-of-life measures, including Short
Form-36 and the Oswestry Disability Index. Surgical treat-
ment of thoracolumbar kyphoscoliosis is selected according
to whether the deformity is mobile or fixed. A mobile
anterior column can be treated with a combination of
From the Western Neurosurgery, Ltd, Tucson, AZ.

2016.
device(s)/drug(s).
Address correspondence and reprint requests to Ryan M. Kretzer, MD,
Carondelet Neurological Institute, St. Joseph’s Hospital, Tucson, AZ 85710;
E-mail: ryankretzer@me.com
DOI: 10.1097/BRS.0000000000002028
SUPPLEMENT
Middle Column Gap Balancing to Predict Optimal

Anterior Structural Support and Spinal Height in
Spinal Reconstructive Surgery
Paul C. McAfee, MD, MBA, Lukas Eiserman, PhD, Bryan W. Cunningham, PhD,y Kenneth A. Mullinix, BS,z
and Daina M. Brooks, BS z
Key words: middle column gap balancing, posterior longitudi- If the thickness of the posterior spacer is too thin, a flexion
nal ligament, vertical instability. gap is present and the knee joint is unstable in 908 of flexion
Spine 2017;42:S19-S20 (positive anterior and posterior joint laxity). This is analo-
gous to our objective, which was to optimize anterior and
posterior spacer thickness within intervertebral disk height
by making use of spinal ligaments and annular tension.
A
total of 24 patients with normal flexion-extension
Therefore, MCMG is a method of ‘‘gap balancing’’ the
cervical radiographs and a second group of 22
ligaments of the spine, specifically, balancing posterior
consecutive patients with multilevel deformities
longitudinal ligament tension with the bony height of the
had middle column gap balancing (MCGB) height preop-
middle column. This method can be effective in one or
eratively and postoperatively as measured by three observers
multiple vertebral segments (Figures 1 and 2).
blinded to treatment. The aim was to determine a reliable
method to obtain optimal spinal height in spinal deformity
PHASE 1 METHODS
reconstruction without causing flat back syndrome and
A total of 24 consecutive patients underwent reliable flex-
keeping the reconstruction angular correction within
ion, extension, and neutral lateral radiographic studies with
optimal sagittal and frontal plane alignment. Measurement
a calibrated marker. Anterior, middle, and posterior col-
and assessment of vertical instability as the ‘‘third’’ Eulerian
umns were measured by using a proprietary software pro-
axis in spinal deformity are validated. MCGB is a reference
gram capable of measuring the length of curved lines and
measurement of the path of the posterior longitudinal liga-
specifically written for this purpose. Lengths of anterior,
ment that is reconstructed under tension and balanced by the
middle, and posterior spinal columns were measured
combined height of the posterior one-third of vertebral
throughout the range of motion to determine which column
bodies and the posterior one-third of disks and/or load-
would be most constant and would have the least variation
sharing spacers. Gap balancing in knee surgery is used to
with posture.
determine optimal anterior and posterior implant thickness,
while simultaneously maintaining smooth ligament tension.
From the University of Maryland St Joseph Medical Center, Towson, MD;

y
Department of Orthopaedic Surgery, University of Maryland Medical
System, Baltimore, MD; and zMusculoskeletal Education and Research
Center, Research Division of Globus Medical, Inc., Audubon, PA.
2016.
The device(s)/drug(s) is/are FDA-approved or approved by corresponding
national agency for this indication.
Address correspondence and reprint requests to Paul C. McAfee, MD, MBA,
University of Maryland St Joseph Medical Center, 7601 Osler Drive,
Towson, MD 21204; E-mail: mack8132@gmail.com
Figure 1. Radiographic illustration of restoring the middle column
DOI: 10.1097/BRS.0000000000002030 height in a complex cervical spine deformity case.
SUPPLEMENT MCGB to Predict Optimal Anterior Structural Support and Spinal Height McAfee et al
Figure 2. Depiction of exact same middle column length between

(Left) preoperative, (Right) postoperative, radiographs using the ‘‘Gap
Balancing’’ method.
PHASE 2 METHODS Figure 3. Comparison of preoperative and postoperative measure-

In all, 22 consecutive patients with multilevel deformities ments by linear regression analysis.
undergoing cervical, thoracic, and lumbar surgical pro-
cedures had MCGB height measured preoperatively and
postoperatively by three blinded observers. Preoperative
column measurements. A strong, positive correlation
and postoperative measurements were compared by a linear
between preoperative and postoperative measurements
regression analysis and Pearson product-moment corre-
was statistically significant (r ¼ 0.983, n ¼ 21, P <0.01)
lation (Figure 3). The technical error of measurement and
(Figure 3). Intraobserver and interobserver coefficients
the coefficient of reliability (R) for intraobserver and inter-
of reliability for measurements were R ¼ 0.987 and
observer errors were calculated by three measurers, each
R ¼ 0.970, respectively, indicating very high precision and
measuring 44 radiographs (preoperative and postoperative)
reliability with regard to intraobserver and interobserver
at two different time intervals.
measurement results (P <0.01). The average percent error
across all observations for three observers was 2.09 2.62%,
PHASE 1 RESULTS with no statistical differences detected between observers
Flexion, extension, and neutral bending radiographs of (P >0.05).
spinal segments not containing deformities showed that This consecutive series of 24 normal patients and
the middle column (C3–C7) had the most reliable measure- 22 patients with deformity demonstrated the utility of
ments of spinal axial height both in actual measurements of measuring preoperative middle column length to predict
change from flexion to extension (mm) and in percent the optimal height of spacers and intervertebral disks and
change (%). The actual change from flexion to extension posterior vertebral body height while simultaneously
of axial height for each longitudinal spinal column was as restoring sagittal and coronal plane alignment. This
follows: anterior column, 7.16 mm; middle column, method of measuring spinal height proved to be more
4.56 mm; and posterior column, 21.5 mm. The percent accurate, reproducible, and useful than the cage tool
change in axial height from C3 to C7 throughout the program or the sagittal spinal length techniques advocated
flexion-extension cycle showed the same relationship: by the International Spine Study Groups—cervical and
anterior column, 8.74% change; middle column, 6.36% thoracolumbar.1
difference; and posterior column, 31.8% change.
PHASE 2 RESULTS Reference

1. Spurway AJ, Chukwunyerenwa CK, Kista WE, et al. Sagittal spinal
A Pearson product-moment correlation was run between height measurement: a novel technique to assess the growth of the
each individual’s preop and postop middle osteoligamentous spine. J Spin Deform 2016;4:331–7.

SUPPLEMENT
Spinal Cord Injury Treatment

What’s on the Horizon?
Kee D. Kim, MD and Jared D. Ament, MD, MPH
Key words: advances in spinal cord injury, spinal cord injury

clinical trials, updates in spinal cord injury.
Spine 2017;42:S21
A
pproximately 250,000 people in the United States
live with spinal cord injury (SCI), and more than
12,000 new cases occur each year. Injury is associ-
ated with significant morbidity, quality of life issues, and
long-term costs. The average lifetime cost of caring for a
patient with quadriplegia is estimated at $US1.35 million.
The most common causes of SCI include motor vehicle
crashes, falls, assaults, and sports. SCI is three to four times
more likely to occur in men than in women and has a
bimodal age distribution. A myriad of novel studies and Figure 1. Different aspects of the pathophysiology of spinal cord
injury.
therapies are targeting different aspects of the pathophysi-
ology of SCI (Figure 1). An extensive review of the literature,
including clinicaltrials.gov, was conducted. The review was
limited to 2010 to 2016 data. A summary of findings was to ASIA C or D in a phase 1/2a study. Advances have also
organized by treatment type: (A) intervention at the injury been made in neuromodulation. Functional electrical stimu-
(pharmacologic, neuroprotectant therapies); and (B) stimulation led to improvements in muscle strength and bone
lation to bypass the site of injury (neuromodulation). mineral density. Stimulation of the central pattern generator
Multiple uncontrolled and unregulated studies were initially of the lumbar spine is also being actively evaluated. Direct
identified; therefore, focus was on phase 2/3 registered trials epidural stimulation was shown to augment recovery in a
only. Some novel therapies, such as SUN13837 (a basic 23-year-old man with C7–T1 ASIA B SCI. With active
fibroblast growth factor), had exciting results in animals, stimulation and physical therapy came improvement in
but this finding did not translate to humans. Others, such as the ability to stand and in bladder/sexual function. Progress
minocycline, riluzole, Rho-antagonists, stem cells, and has been made with brain machine interfaces. Participants
intramedullary scaffolds (INSPIRE), have shown promise. have learned to control computer cursors, virtual reality
For example, two of three patients with cervical SCI receiv- environments, hand orthotics, and wheelchairs. In a patient
ing a specific dose of Rho-antagonist converted from ASIA A with C5–6 ASIA A, direct cortical arrays that bypass the
spinal cord led to functional improvement to C7–T1. Spinal
From the Department of Neurological Surgery, UC Davis School of cord injury is devastating, and ideal treatments are currently
Medicine, Sacramento, CA. lacking. However, it is an exciting time for those who work
Acknowledgment date: December 6, 2016. Acceptance date: December 7, in the SCI field, with numerous clinical trials exploring the
2016. topics of neuroprotection, neuroregeneration, and neuro-
The manuscript submitted does not contain information about medical modulation. A multimodal approach will soon lead to
device(s)/drug(s).
significant advances in SCI treatment.
Address correspondence and reprint requests to Kee D. Kim, MD, Depart-
ment of Neurological Surgery, UC Davis School of Medicine, 4860 Y Street,
Ste 3740, Sacramento, CA 95817; E-mail: kdkim@ucdavis.edu
DOI: 10.1097/BRS.0000000000002031
SUPPLEMENT
New Developments in Spinal Cord Stimulation

Seth M. Zeidman, MD
Key words: complex regional pain syndrome, neuromodu- many patients. For patients who find the traditional
lation, spinal cord stimulation. paresthesias associated with tonic SCS to be very painful,
Spine 2017;42:S23 even intolerable, and for those who have developed tol-
erance to SCS, revolutionary new treatments are proving
tremendously successful in providing pain relief. Burst
stimulation offers SCS placement at higher levels of the
T
echnological advances in spinal cord stimulation spine and use of alternative waveforms, in which neurons
(SCS) represent some of the most exciting develop- fire in bursts, followed by periods of dormancy, leading to
ments in pain management. The gate-control theory, pain reduction without painful paresthesias. In combi-
which proposes that activation of non-nociceptive fibers nation with conventional tonic stimulation, burst stimu-
prevents painful stimuli from reaching the thalamus, lation represents a comprehensive approach to effective
serves as the basis for SCS. Devices that deliver SCS have pain management. Additional exciting developments in
evolved over the years from large instruments with bat- this field include (A) high-frequency SCS, a novel SCS
teries lasting 3, 5, or 10 years—later with rechargeable system that allows a pulse rate up to 10 kHz with more
batteries—to miniaturized devices with multiple smaller efficient anatomic positioning, providing paresthesia-free
leads and configurations. This technique has proved pain relief; (B) percutaneous leads and paddles, which
particularly useful for patients with complex regional pain permit tailored stimulation patterns for patients with
syndrome, who present some of the greatest challenges for chronic pain; (C) magnetic resonance imaging-compatible
physicians who seek to relieve patient pain. Symptoms of SCS systems, which allow magnetic resonance imaging
this disorder, including swelling, loss of motion, and scans on hips, shoulders, back, and elsewhere, without
extreme sensitivity to light touch, are tremendously concern about lead heating, device damage, unintentional
relieved by SCS, and the Neuromodulation Therapy stimulation, and magnetic pull; and (D) battery-free SCS,
Access Coalition has assigned a Grade A recommendation which transmits energy wirelessly from an external unit.
supporting use of SCS for patients with complex regional Recent developments in the field of SCS and devices and
pain syndrome. A new technique, dorsal root ganglion approaches of the future, although not curative, are
(DRG) stimulation, involves placement of the stimulator expected to continue to significantly relieve pain and
directly on the DRG through an epidural (inside out) promote activity postoperatively, and among those whose
approach and selective stimulation of different parts of cause of pain cannot be identified, for better outcomes and
the DRG, providing superior treatment outcomes for improved quality of life.
From the Rochester Brain and Spine Neurosurgery and Pain Management,
University of Rochester Medical Center, Rochester, NY.
2016.
device(s)/drug(s).
Address correspondence and reprint requests to Seth M. Zeidman, MD,
Rochester Brain and Spine Neurosurgery and Pain Management, University
of Rochester Medical Center, 400 Red Creek Drive, #120, Rochester, NY
14623; E-mail: drseth@frontiernet.net
DOI: 10.1097/BRS.0000000000002033
SUPPLEMENT
Nerve Injury in Lateral Lumbar Interbody Fusion

Joseph R. O’Brien, MD, MPH
Key words: llif, lumbar plexus, nerve injury, xlif. magnification will assist the surgeon in avoiding these nerves.
Spine 2017;42:S24 Tracing out the given pain pattern on the patient’s leg will
assist the surgeon in understanding the pain pattern, and will
likely reveal that the neural injury is not a root level problem
(i.e., L4 or L5). In addition to direct injury, excessive retractor
T
high pain is common after lateral lumbar interbody time (>20 to 40 min per level) and table flexion without
fusion (LLIF), but it is important to distinguish psoas ipsilateral hip flexion may injure the nerves of the lumbar
pain from pain associated with neural injury, which plexus. Shallow docking may help reduce thigh symptoms by
may result from traction, positioning, or excessive retractor avoiding direct damage to involved nerves.
time and is common at L4–5. As with upper extremity nerve Direct visualization, appropriate positioning, and differ-
injury, it is important to realize that the spinal root is not entiation of psoas pain as compared with neural injury will
injured, but peripheral nerves may be injured. Documen- aid surgeons in understanding the approach-related morbid-
tation of a careful postoperative examination and under- ity of LLIF. Realistic comparisons of morbidity as compared
standing of these details will help surgeons avoid with open surgical methods will substantiate the role of
complications. LLIF in the modern spine surgeon’s armamentarium.
After transpsoas LLIF, approximately 20% to 40% of
patients have thigh pain, and 10% to 20% report numbness
or dysesthetic pain.1,2 Psoas pain as a distinct entity has been References
described by physical therapists and total joint surgeons as 1. Cummock MD, Vanni S, Levi AD, et al. An analysis of postoper-
ative thigh symptoms after minimally invasive transpsoas lumbar
activity-related pain that worsens with exertion. It radiates interbody fusion. J Neurosurg Spine 2011;15:11–8.
to the ipsilateral groin and anterior thigh and is exacerbated 2. Moller DJ, Slimack NP, Acosta FL Jr, et al. Minimally invasive
by active flexion of the hip while sitting and while navigat- lateral lumbar interbody fusion and transpsoas approach-related
morbidity. Neurosurg Focus 2011;31:E4.
ing stairs. Psoas pain is expected after transpsoas surgery
3. Hart R, Perry E, Hiratzka S, et al. Post-traumatic stress symptoms
and must be differentiated from neural injury. A 22% after elective lumbar arthrodesis are associated with reduced clinical
incidence of posttraumatic stress disorder and associated benefit. Spine 2013;38:1508–15.
inferior outcomes have been associated with open spinal
fusion.3 It is clear that no matter the approach, one must
consider the given morbidity and goals before obtaining
informed consent.
Neural injury may be seen in discectomy, open spinal
fusion, and LLIF. Subcostal, iliohypogastric, and ilioinguinal
nerves may be injured during skin incision, resulting in thigh
pain after LLIF. Direct visualization and intraoperative
From the Orthopaedic Center, Rockville, MD.

2016.
device(s)/drug(s).
Address correspondence and reprint requests to Joseph O’Brien, MD, MPH,
The Orthopaedic Center, 6000 Executive Blvd #510, Rockville, MD 20852;
E-mail: obrienjr@gmail.com
DOI: 10.1097/BRS.0000000000002034
SUPPLEMENT
Overview of Imaging, Robotics, and Navigation

Technologies
Neel Anand, MD, and Aniruddh Agrawal, HSC y
Key words: imaging, navigation, robotics. patients and surgeons by increasing accuracy, decreasing
Spine 2017;42:S25 the number of revisions, and allowing minimally invasive
techniques. Such systems benefit the surgeon by eliminating
the need to wear lead. Image-guided spinal surgeries min-
T
he computerization of traditional practices is a real- imize operating room radiation, offer precise orientation to
ity in all aspects of daily life. Spine surgery is no unexposed anatomy, and reduce surgical time and morbid-
exception. Careful evaluation of traditional tech- ity. They inform the surgeon regarding the screw entry
niques has exposed their drawbacks, and new technologies point, the sagittal and axial trajectory of the screw, and
are constantly being developed to offer relief to patients and the length and direction of the screw. Increasing evidence of
surgeons. It is important to be aware of the up-and-coming improved screw placement accuracy with navigation may
imaging, navigation, and robotics technologies in the field of allow it to become a widely accepted procedure (Figure 1).
spinal deformity surgery. The latest technology that integrates the benefits of
New imaging systems, including the O-arm (Medtronic, updated imaging and navigational capabilities is robotics.
Louisville, CO) and the Mobius Airo (Mobius Imaging, LLC, Data for the Renaissance Robotic Guidance system (Mazor
Shirley, MA), provide higher-quality intraoperative imaging Robotics, Orlando, FL) show pedicle screw placement
and have proved effective in their seamless integration with accuracy ranging from 98% to 99%. However, a failure
navigation technologies. Documented evidence of improved rate of 6% to 7% reflects the times opted for manual
screw accuracy has allowed the O-arm to become a widely placement of screws over robotic guidance.
accepted advancement. The debate that arises regarding the It is important to remember that all of the technologies
radiation dose received with the use of the O-arm and the C- discussed here have been developed to assist the surgeon—
arm can be challenged by the literature suggesting use of a not to replace him/her—and no amount of technology can
pediatric protocol for the O-arm, which decreases the radi- account for ignorance of spinal anatomy or basic knowl-
ation dose by more than seven times when compared with the edge. These technologies cannot make an incompetent sur-
standard protocol. These innovative systems improve oper- geon good but will help a good surgeon become better.
ating room efficiency by allowing fluoroscopy memory pre-
sets, three-dimensional reconstructions, lateral patient
access, and a quick scanning speed of 13 seconds for high
and standard definition images.
Complementary use of navigation systems such as the
StealthStation (Medtronic) boasts advantages for both
From the Cedars Sinai Spine Center, Los Angeles, CA; and yAnand Spine
Group, Los Angeles, CA.
2016.
device(s)/drug(s).
Address correspondence and reprint requests to Neel Anand, MD, Cedars
Sinai Spine Center, 444 S San Vincente Blvd, Los Angeles, CA 90048;
E-mail: neelanand@mac.com Figure 1. New and advanced spine navigation systems allow the
surgeon to be better prepared for surgery and increase the accuracy
DOI: 10.1097/BRS.0000000000002035 of pedicle screw placement.
SUPPLEMENT
How to Ensure Navigation Integrity Using Robotics

in Spine Surgery
Norbert Johnson, MSME
Key words: navigation, robotics, surgery. other instruments in the field. One issue common to robotic
Spine 2017;42:S26 guidance for pedicle screw placement is skiving. Even when
a rigid robot arm is used, the patient can move when
trajectories have a steep entry point. In this situation, care
T
he adoption of navigation in spine surgery has been must be taken when the entry hole is created to allow the
slow. One of the reasons for this is the steep learning drill to do the work. With an accurate entry hole, the rigid
curve associated with surgical navigation; another robotic arm will hold instruments at the correct trajectory. A
reason is the fear of navigation inaccuracies. The first step in final suggestion for ensuring navigation integrity is to lever-
using surgical navigation is to register the image data of the age surgeon experience. Ensure that the trajectory of the
patient to the physical patient during surgery. After a robot looks correct with respect to the patient’s anatomy,
successful registration has been performed, it is important and make sure the tactile feel is consistent with the
to check accuracy by touching known landmarks on the navigation feedback.
patient and verifying corresponding locations shown on the Use of navigation in spine surgery offers many benefits,
navigation display. At this point, navigation will be accu- but adoption has been very limited. Robotic guidance
rate, but it can become inaccurate if care is not taken. is reducing the steep learning curve associated with
During many cadaver labs under robotic guidance, surgical navigation, and by following a few key steps, the
researchers have discovered a few steps to help ensure surgeon can maintain confidence throughout the surgical
navigation integrity throughout the procedure. The surgeon procedure.
must securely attach the patient reference to the patient. An
easy way to become inaccurate is to disturb the patient
reference. This can happen without awareness and could be
critical if it occurs after the initial landmark check. Con-
tinued accuracy of the system throughout the procedure is
not guaranteed. For this reason, the navigation system
should continuously monitor the patient reference to ensure
that it has not been disturbed. Good navigation techniques
are also important, including new reflective spheres for
every case and verification that the spheres are pressed fully
onto the posts. One should position all arrays to face the
camera while avoiding steep angles and interference from
From the Globus Medical Inc., Audubon, PA.

2016.
device(s)/drug(s).
Address correspondence and reprint requests to Norbert Johnson, MSME,
Globus Medical Inc., 2560 General Armistead Ave, Audubon, PA 19403;
E-mail: njohnson@globusmedical.com
DOI: 10.1097/BRS.0000000000002036
SUPPLEMENT
Clinical Applications of 3D Printing

Paul A. Anderson, MD, MS
Key words: 3D printing, patient-specific, stereolithography. achieve high resolution with materials including ceramics,
Spine 2017;42:S30-S31 polymers, and metals. Fused deposition modeling uses wires
or filaments of material extruded through a polyjet and
melted, then polymerized or fused on the plate build, layer
by layer, similar to cake decorating. Metal devices can be 3D
T
hree-dimensional (3D) printing is a recent advance printed via direct laser deposition, shaped metal deposition,
that offers unique opportunities for biomedical and electron beam melting. The first two processes leave
applications. As opposed to traditional ‘‘manufac- internal stresses and currently are not suitable for medical
turing by subtraction,’’ whereby stock undergoes machining applications. However, electron beam melting, an FDA-
to remove material and attain a desired shape, additive approved process, is used to make orthopedic devices, such
manufacturing creates new objects by bonding layer upon as hip acetabular cups and interbody devices. Advantages
layer until the desired shape has been achieved. In 1987, include optimization of porous surfaces that can be fused to
stereolithography apparatus was created with liquid photo- the entire device, rather than sintered on, as is typically
polymers cured with ultraviolet (UV) laser; the UV laser done.
draws a desired section, and the photopolymer hardens. For a typical medical device, an object must be created
This process is repeated by constant lowering of the build through 3D printing, most commonly with computed tom-
platform until the 3D object is created. Choice of polymers is ography or magnetic resonance imaging through segmenta-
limited, but this process is widely used, particularly for rapid tion and isolation of a 3D object such as bone. For a biologic
prototype design. implant, a 3D drawing is made, and the region of interest is
Two more traditional methods of 3D printing were segmented, often requiring optimization and conversion to
developed through laser printing technology. The first STL (stereolithography) file format. The STL is then printed
method uses extrusion, whereby layer upon layer of sub- on the 3D printer and the object created.
strate is placed on the build platform, usually with added Advantages of 3D printing include customizable results,
energy that can cause melting, fusion, or polymerization. speedy design, low cost, availability in a variety of materials,
The second method is powder-based and consists of layering optimized mechanical properties, and low barriers facilitat-
of a substrate in powder form, followed by addition of ing performance in Third World countries. Disadvantages
energy to cause polymerization or other chemical processes include altered mechanical properties compared with
such as melting, sintering, or crystallization to the desired general manufacturing techniques, unknown performance
shape. This process is repeated layer by layer. in vivo, concerns regarding dimensional accuracy, and
Several techniques of 3D printing are used for biomate- unknown sterility of metallic devices, as pores created
rials. Selective laser sintering, a powder-based method, can may not be accessible with a gas autoclave. Long-term data
on this process are not yet available.
From the Department of Orthopedic Surgery and Rehabilitation, University Potential applications for 3D printing include education
of Wisconsin, Madison, WI. and simulation training, prosthetics or orthotics, preopera-
Acknowledgment date: December 6, 2016. Acceptance date: December 7, tive planning, design and rapid prototyping, manufacture of
2016. instruments customized to patients, custom implants, routine
The manuscript submitted does not contain information about medical manufacture of medical devices, and tissue-engineering
device(s)/drug(s).
applications.
Medical school curricula are de-emphasizing anatomic dis-
party related directly or indirectly to the subject of this manuscript. section, making models increasingly important. McMenamin
Address correspondence and reprint requests to Paul A. Anderson, MD, MS, et al1 created 3D complex anatomy models that act as
Department of Orthopedic Surgery and Rehabilitation, University of Wis- prosected dissection, are relatively low in cost, and can be
consin, 1685 Highland Avenue, UWMFCB – 6215, Madison, WI 53705; based on abnormal or normal patient anatomy. Madrazo et al2
E-mail: anderson@ortho.wisc.edu
used 3D models to enhance patients’ understanding of their
DOI: 10.1097/BRS.0000000000002039 medical condition to guide decision making.
SUPPLEMENT Clinical Applications of 3D Printing Anderson
Orthotic devices, such as a scoliosis brace, can be cus- whole implant system uses only a single set of instruments
tomized. Patients’ dimensions are digitized and a brace is and is customizable.
created through a process that allows patients to participate 3D printing is an intriguing idea for standard manufac-
in the design of the brace, leading to greater patient satis- turing processes. The initial cost for electron beam melting is
faction and improved compliance. Application of 3D high, but marginal costs for production of implants may be
models to prosthetics is even more important. Amputations lower. Advantages include stronger material properties in
are a worldwide problem, particularly in Third World plates manufactured with the titanium alloy and important
countries savaged by war or earthquakes. With 3D printing, surfaces fused to the implant rather than centered and
customizable prosthetic devices such as Willie Raptor, placed.
Cyborg Beast, and eNable prosthetic limbs can be assembled A variety of matrices used in tissue engineering can be
in less than 30 minutes and produced locally in a nonsterile created via 3D printing, including hydrogels, ceramics such
environment, at costs less than $50. as hydroxyapatite, and bioactive glasses of many materials.
For surgical planning in patients with complex deform- Cells and proteins can be added to create an implantable
ities, 3D-printed models have been used to prebend plates tissue-engineered device. Advantages of these methods
for clavicle fixation, to act as drill guides for placement of include production of customizable shapes and material
pedicle screws, and to prepare sterilizable models in com- properties that promote the desires of biological processes.
plex deformities such as congenital scoliosis to improve the In conclusion, 3D printing is transforming technology
accuracy of pedicle screw insertion. Custom metal and that can be used in many aspects of surgical care, including
ceramic implants can be created for complex reconstruction education, surgical planning, design, customization, and
of bone defects. In one case, a custom prosthesis was 3D manufacturing, and as a distributive technology for world-
printed from titanium alloy to reconstruct C2 after resection wide use with very few barriers.
of Ewing sarcoma.3
Patient-specific implants are gaining in popularity, References
1. McMenamin PG, Quayle MR, McHenry CR, et al. The production
although long-term outcomes have not been improved. In of anatomical teaching resources using three-dimensional (3D)
the current paradigm for total knee arthroplasty, the printing technology. Anat Sci Educ 2014;7:479–86.
implant of closest appropriate size is selected and manufac- 2. Madrazo I, Zamorano C, Magallon E, et al. Stereolithography in
spine pathology: a 2-case report. Surg Neurol 2009;72:272–5.
tured by traditional techniques, but custom patient-specific 3. Xu N, Wei F, Liu X, et al. Reconstruction of the upper cervical spine
instruments are created from CT through 3D printing tech- using a personalized 3D-printed vertebral body in an adolescent
nology, which requires lower storage costs because the with Ewing sarcoma. Spine (Phila Pa 1976) 2016;41:E50–4.

SUPPLEMENT
The Use of Intraoperative CT and Navigation for

the Treatment of Spinal Deformity in Open and
Minimally Invasive Surgery
Joseph R. O’Brien, MD, MPH
Key words: intraoperative CT scan, navigation, radiation. health care system $23,762.3 In the aggregate, such costs are
Spine 2017;42:S28-S29 undesirable, as are potential complications such as dural
tear or neurologic injury. Busy spine centers may consider
the utility of intraoperative CT scanning for screw checking
or three-dimensional navigation to improve the accuracy of
R
ecent advances in the use of in-operating room spinal instrumentation.
computed tomography (CT) scanning have Intraoperative CT scanning and associated navigation
enhanced the usability of navigation in spinal tools have evolved over the past 10 years with improved
surgery. Presurgical advanced imaging studies had limited accuracy. In part, acceptance of navigation has lagged as the
accuracy because of changes in spinal position from supine to result of work flow in the operating room and time con-
prone, making early efforts at spinal navigation cumbersome straints. Additionally, intraoperative CT scanning in the
and inaccurate. In-room scanning with patient-based markers prone position has enhanced the accuracy of navigation
has enhanced the accuracy of navigated spinal instrumenta- over preoperative scans, which are obtained supine. Modern
tion and of robot-guided spinal instrumentation. Both may be intraoperative navigation and robot-assisted navigation can
used in open and minimally invasive complex spinal deform- enhance surgical accuracy and improve the safety profile of
ity and revision surgeries to enhance the accuracy of spinal complex spinal surgery (Figure 1).
instrumentation and to decrease reoperation due to screw
malposition. Intraoperative navigation can result in net cost
savings to a hospital system and increased radiation safety for
hospital personnel.
The accuracy of pedicle screw placement depends on the
experience of the surgeon and the method used. Published
rates of accuracy hold thoracolumbar freehand screw place-
ment at 72% to 94%.1 Use of fluoroscopy may increase
accuracy to 84% to 94%.2 It is important to note that not all
malpositioned pedicle screws require revision surgery, and
published rates of revision range from 2% to 8%.3 Even
with such low rates, such revisions, on average, cost the
From the The Orthopaedic Center, Rockville, MD.

2016.
device(s)/drug(s).
Address correspondence and reprint requests to Joseph O’Brien, MD, MPH,
The Orthopaedic Center, 6000 Executive Blvd #510, Rockville, MD 20852;
E-mail: obrienjr@gmail.com
Figure 1. Navigation in minimally invasive spine surgery. Marker
DOI: 10.1097/BRS.0000000000002038 placement at T10 for percutaneous L1-pelvis surgery.
SUPPLEMENT Use of Intraoperative CT and Navigation O’Brien
References 2. Shin MH, Ryu KS, Park CK. Accuracy and safety in pedicle screw
placement in the thoracic and lumbar spines: comparison study
1. Silbermann J, Riese F, Allam Y, et al. Computer tomography between conventional C-arm fluoroscopy and navigation coupled with
assessment of pedicle screw placement in lumbar and sacral spine: O-Arm1 guided methods. J Korean Neurosurg Soc 2012;52:204–9.
comparison between free-hand and O-arm based navigation tech- 3. Watkins RG, Gupta A, Watkins RG. Cost-effectiveness of image-
niques. Eur Spine J 2011;20:875–81. guided spine surgery. Open Orthop J 2010;4:228–33.

SUPPLEMENT
Opportune Situations for Spine Surgical

Navigation
Vikas V. Patel, MD, MA, BSME
Key words: minimally invasive surgery, navigation, safety. safety while training other surgeons or working with an
Spine 2017;42:S27 assistant.2 Finally, spine surgical navigation improves safety
and understanding of complex anatomy, opening the pos-
sibilities of new and innovative surgical procedures with
increased safety. Sacroiliac joint fusion is a prime example of
S
pine navigation continues to evolve as a powerful tool complex anatomy that can be treated safely with navigation
not only for the treatment of complex spine surgery used to guide grafting of the joint and implant placement. In
but also for improved efficiency, accuracy, and safety conclusion, spine surgical navigation has advanced
of common procedures and for greater ease in performing dramatically from a simple tool for screw placement to
minimally invasive surgery (MIS). Once the basic principles an advanced tool, enabling more and more complex surgery
of navigation are clearly understood, the entire team of with less invasiveness and added safety.
nurses, surgical techs, radiology techs, and company reps,
along with the surgeon, must be involved in the process of
successful navigation. With this team and the navigation References
1. Bourgeois AC, Faulkner AR, Bradley YC, et al. Improved accuracy
tools, the surgeon gains the ability to ‘‘see’’ inside the of minimally invasive transpedicular screw placement in the lumbar
patient—where the tool is and where it might be spine with 3-dimensional stereotactic image guidance: a compara-
directed—and can even save ‘‘plans’’ of where the tool tive meta-analysis. J Spinal Disord Tech 2015;28:324–9.
2. Shin BJ, James AR, Njoku IU, et al. Pedicle screw navigation: a
was. The surgeon can use these tools with unlimited degrees systematic review and meta-analysis of perforation risk for com-
of freedom of his own hands. This can be especially useful puter-navigated versus freehand insertion. J Neurosurg Spine
during MIS, which is typically limited by very restricted 2012;17:113–22.
visualization of the anatomy and oblique approaches.
Regarding screw placement alone, three-dimensional surgi-
cal navigation improves accuracy in MIS spine surgery by
99%.1 Thus, navigation allows for improved accuracy in
MIS posterior lumbar interbody fusion, MIS lateral surgery,
MIS cervical fusion and foraminotomy, screw length and
diameter measurement, skull base surgery, and spinal
osteotomy, among other procedures. Additionally, the abil-
ity to ‘‘see’’ the location of instrumentation on a screen
allows the primary surgeon to maintain the highest level of
From the Spine Center at University of Colorado Hospital, Aurora, CO.

2016.
device(s)/drug(s).
Address correspondence and reprint requests to Vikas V. Patel, MD, MA,
BSME, The Spine Center at University of Colorado Hospital, Anschutz
Inpatient Pavilion—1st Floor, 12605 E. 16th Avenue, Aurora, CO 80045;
E-mail: vikas.patel@ucdenver.edu
DOI: 10.1097/BRS.0000000000002037
SUPPLEMENT
Bioactive Surface Coatings for Orthopaedic

Implants
Christopher D. Chaput, MD
Key words: autologous bone, bone healing, osteoblasts. optimized surfaces with micro and upper nanoscale pits
Spine 2017;42:S32 with specific architecture all have been shown to improve
the production of biomarkers for bone formation. Early
clinical data are promising. However, questions remain
regarding how much autologous bone is needed for these
T
he percentage of cases in which minimally invasive devices, and whether the preclinical data will translate to
surgical (MIS) techniques are used has increased and better bone healing in human patients, particularly in chal-
is expected to continue to climb. However, it is lenging environments such as MIS.
generally recognized that many MIS techniques can present
a challenging environment for arthrodesis.1 Additionally, References
most biologics are more effectively used as graft extenders 1. Kurd M, Cohick S, Park A, et al. Fusion in degenerative spondylolis-
thesis: comparison of osteoconductive and osteoinductive bone
with local autologous bone. However, in MIS, often no bone
graft substitutes. Eur Spine J 2015;24:1066–73.
needs to be ‘‘extended,’’ and no source of cells is known 2. McNamara LE, McMurray RJ, Biggs MJ, et al. Nanotopographical
other than the limited amount of decorticated surface. All of control of stem cell differenation. J Tissue Eng 2010;2010:120623.
these factors might play a role in the increased use of
rhBMP-2 in these settings. In contrast, awareness of related
complications is growing, and researchers are seeking safer
options that will improve bone healing over inert implants
such as traditional polyetheretherketone spacers. Total joint
surgeons have known for decades what spine surgeons are
rediscovering: that implant material and surface and struc-
tural characteristics can influence osseointegration and bone
formation. Recent in vitro and in vivo basic science research
is beginning to elucidate the cellular mechanisms involved in
macro, micro, and even nanoscale architectural changes that
can promote adhesion, osteoprogenitor differentiation, and
osteoblast activity.2 Implants that allow physiologic degrees
of tensile strain to be transferred to osteoblasts, those that
have macroscale roughened surfaces that promote a stable
bone/implant interface acutely, and those that have
From the Baylor Scott and White Health, Roney Bone and Joint Institute,
Temple, TX.
2016.
device(s)/drug(s).
Address correspondence and reprint requests to Christopher D. Chaput,
MD, Baylor Scott and White Health, Roney Bone and Joint Institute, 2401 S.
31st Street, Temple, TX 76508; E-mail: Christopher.chaput@bswhealth.org
DOI: 10.1097/BRS.0000000000002040

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SPINE Volume 42, Number 7S

ß 2017 Wolters Kluwer Health, Inc. All rights reserved

Foreword and Executive Summary

Copyright © 2017 Wolters Kluwer Health, Inc. All rights reserved.

Surgical Anatomy of the Spine, Revisited

Key words: anatomy, cryomicrotome, cryoplaning technique.

From the Department of Orthopaedic Surgery, Academic University Hos-

scanning and dynamic magnetic resonance imaging are

S2 www.spinejournal.com April 2017

Clinical Biomechanics of the Spine

Biological Responses to Spinal Implant Debris

Biologics and Spine: Cells, Signaling, and Surfaces

Introduction of New Technologies in Orthopedic

TABLE 1. Food and Drug Administration Classification for Medical Devices

Understanding the Potential of Mesenchymal

From the Globus Medical, Inc, Audubon, PA.

Biologics Development and Carrier Innovation

From the Department of Neurological Surgery, UC Davis School of

Current State of DBM

Key words: bone graft extenders, demineralized bone matrix,

Patient-Specific Spinal Alignment and Adult

correction of sagittal malalignment.2 Failure to recognize

Spine www.spinejournal.com S15

Appropriate Use Criteria in Adult Scoliosis

Spine www.spinejournal.com S13

How to Create Sagittal Balance in MIS Correction

Key words: minimally invasive, sagittal balance, spinal

discectomy, and sequential placement of segmental 128

S18 www.spinejournal.com April 2017

Adult Degenerative Spinal Deformity

From the Western Neurosurgery, Ltd, Tucson, AZ.

Middle Column Gap Balancing to Predict Optimal

From the University of Maryland St Joseph Medical Center, Towson, MD;

Figure 2. Depiction of exact same middle column length between

PHASE 2 METHODS Figure 3. Comparison of preoperative and postoperative measure-

PHASE 2 RESULTS Reference

S20 www.spinejournal.com April 2017

Spinal Cord Injury Treatment

Kee D. Kim, MD and Jared D. Ament, MD, MPH

Key words: advances in spinal cord injury, spinal cord injury

New Developments in Spinal Cord Stimulation

Nerve Injury in Lateral Lumbar Interbody Fusion

From the Orthopaedic Center, Rockville, MD.

Overview of Imaging, Robotics, and Navigation

How to Ensure Navigation Integrity Using Robotics

From the Globus Medical Inc., Audubon, PA.

Clinical Applications of 3D Printing

Spine www.spinejournal.com S31

The Use of Intraoperative CT and Navigation for

From the The Orthopaedic Center, Rockville, MD.

Spine www.spinejournal.com S29

Opportune Situations for Spine Surgical

From the Spine Center at University of Colorado Hospital, Aurora, CO.

Bioactive Surface Coatings for Orthopaedic

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