Nucleus Arthroplasty Volume III

Nucleus
Arthroplasty
Technology
in Spinal Care
Volume III: Surgical Techniques

& Technologies
Table of Contents
1
Introduction
Deputy Editorial Board
CHAPTER 14
CHAPTER 15
12
Examination, Radiologic and Diagnostic Evaluation, and Patient Indications
History of Motion Preservation Surgery of the Lumbar Spine
CHAPTER 16
18
The Basis for Nucleus Replacement Surgery: Current Techniques
CHAPTER 17
24
Intervertebral Disc Space Preparation for Nucleus Arthroplasty Technologies
CHAPTER 18
29
Nucleus Arthroplasty Technology: Approach-Related Considerations
CHAPTER 19
33
Clinical Outcomes Assessment of Nucleus Pulposus Replacement
CHAPTER 20
39
Nucleus Replacement Complications and Salvage Procedures
44
Conclusion
his monograph series is a groundbreaking project in the

rapidly emerging field of non-fusion spinal surgery. The
full range of nucleus replacement technologies is examined
with discussion on surgical techniques, detailed information
on each cutting-edge device technology, indications, and
patient selection criteria.
Nucleus Arthroplasty Technology in Spinal Care is
published for the medical profession by Raymedica, LLC,
Minneapolis, MN 55431.
The views expressed in this series are those of the authors
and do not necessarily represent those of Raymedica, LLC.
ACKNOWLEDGEMENT
We, Raymedica, LLC, and the authors of this volume, wish
to acknowledge our debt of gratitude for the important
contribution of John Grabowski, Developmental Editor.
His guidance has added a great deal to the teaching value
of this volume.
Copyright 2006 and 2007 Raymedica, LLC. All rights
reserved. Printed in the U.S.A.
www.nucleusarthroplasty.com
Introduction
Reginald J. Davis, MD, FACS
Federico P. Girardi, MD
Frank P. Cammisa, Jr., MD, FACS
CHIEF OF NEUROSURGERY
ASSISTANT PROFESSOR
ASSOCIATE PROFESSOR
Baltimore Neurosurgical Associates, PA

Baltimore, MD 21204
OF ORTHOPEDIC SURGERY
OF CLINICAL SURGERY
Hospital for Special Surgery

New York, NY 10021

New York, NY 10021
he first documented works describing the diagnosis and

treatment of the spine, spinal disorders, and spinal instability
date back to 1900-2500 B.C. Interestingly, the documents recommended against the treatment of spinal cord injury. The development of therapeutic treatments has a long history starting with
the cane, the first load-sharing device. Today, our efforts to
improve therapies to treat spine disease persist. We continue to
recognize problems, identify issues, and define variables in an
effort to better understand spinal degeneration and to develop
innovative solutions that utilize a wide array of materials and
technologies. Our field has had a rich history of advancements,
accomplishments, and inventiveness. We owe a great debt to the
pioneers who, armed with little more than a detailed knowledge
of anatomy, heralded in the era of spinal surgery. Their trials,
errors, innovations, and teachings have guided our efforts to
ultimately improve clinical outcomes.
Early on, it was recognized that the disc played a vital role in overall
spine health. With great effort and ingenuity, the unique anatomical,
biomechanical, and physiological properties of the disc were elucidated and incorporated into elegant treatment algorithms. We now
have access to an almost overwhelming flow of information about
lumbar disc arthroplasty from countless sources. Central to the evolution of therapies is a better appreciation of the complexities of the
lumbar disc. By combining knowledge gleaned from anatomical dissection, biochemical processes, and resultant physiology with a disciplined foundation in biomechanics, we have created a fabric of
understanding never before enjoyed. Spine arthroplasty is now an
important and evolving area within the treatment of spinal disorders. This sub-discipline represents the coalescence of many areas of
study focused on the development of new and exciting solutions to
address clinical problems.
These significant advances in our understanding of the spine represent a culmination of efforts occurring across many fronts. Our
increased understanding of the biological factors at work in disc
disease has been a driving force in the development and emergence of new materials and delivery methods. The critical role
that advanced biocompatible alloys, polymers, and viscoelastic
hydrogels play in the innovation of disc arthroplasty technologies
cannot be over emphasized.
Technological advancements have played a vital role in supporting
and expanding our knowledge of motion preserving disc technologies. The latest imaging technologies allow a much more detailed
appreciation of pathological processes, such as disc degeneration,
and provide the ability to monitor the results of an intervention.
Computerized finite element analysis offers a risk-free environment
in which to test hypotheses and predict clinical impact. Biochemical

advancements yield an intimate understanding of the chemical environment including chemical mediators and potential intervention
portals. This wealth of knowledge can be used to great advantage
when developing disc arthroplasty technologies.
Not to be overlooked, the socioeconomic challenges involved in the
development of new technologies, such as the Nucleus Arthroplasty
motion preservation system, have also become more apparent.
The all important variable of proper patient selection continues to
require constant reassessment and vigilance. Increasingly, third-party
payers control access to care and treatment choice to an alarming
degree. Such considerations can no longer be ignored in the quest
for ideal patient management methods.
This publication has been constructed to provide an overview
of the current Surgical Techniques & Technologies in Nucleus
Arthroplasty technology. Key elements include an overview of
the History of Motion Preservation Surgery in the Lumbar Spine,
Current Techniques in Nucleus Replacement Surgery, Clinical
Outcomes Assessment, and Complications and Salvage Procedures.
In addition, Volume III of this series will provide insight into the
potential market and the current players working in the forefront
of Nucleus Arthroplasty technology development activities. This is
an incredibly exciting field as technologies focused on the repair
and replacement of the diseased disc nucleus will catapult us far
beyond the treatment options we have available today.
In conclusion, we can say that the spine arthroplasty specialist
of today is well prepared to deliver the most advanced solutions
to the clinical puzzle of disc disease with technologies based on
a rich tradition of innovation and compassion coupled with a
tremendous wealth of physiological knowledge and assessment
tools. As spine surgery evolves from mechanical solutions to
therapeutic solutions both surgeons and patients will benefit.
We hope you will find this series on Nucleus Arthroplasty
technology to be a valuable asset.

1
Deputy Editorial Board
aymedica has selected Reginald J. Davis, MD, FACS, Federico P. Girardi, MD, and Frank P. Cammisa, Jr.,
MD, FACS to edit this series of monographs on Nucleus Arthroplasty technology, because of their special interest in this dynamic area of medicine. Drs. Davis, Girardi, and Cammisa are noted for their expertise
in spine surgery and advanced training in minimally invasive surgical techniques. They are well respected for
their clinical work and travel widely to speak and train other physicians.
Dr. Davis is founder of Baltimore Neurosurgical Associates, chief of Neurosurgery at the Greater Baltimore
Medical Center, and a faculty member at the Johns Hopkins School of Medicine and the University of Maryland.
He is a Fellow of the American College of Surgeons and a Diplomate of the American Board of Surgery.
Dr. Davis received his medical degree from Johns Hopkins University School of Medicine, Baltimore, Maryland.
He has broad experience in advanced procedures such as spinal stabilization, intradiscal electrothermal therapy, and microendoscopic discectomy and has conducted physician training programs on these procedures. His
professional affiliations include the AANS-CNS Section on Disorders of the Spine, the American Association of
Neurological Surgeons, the Congress of Neurological Surgeons, and the North American Spine Society.
Dr. Girardi is assistant professor of orthopedic surgery, Weill Medical College of Cornell University and is
attending orthopedic surgeon at the Hospital for Special Surgery, New York, New York. He specializes in
the treatment of spinal disorders including degenerative disc disease (DDD), spinal deformities, metabolic
fractures, and spinal tumors. Dr. Girardi received his medical degree from the Universidad Nacional de
Rosario, Rosario, Argentina.
He has performed extensive clinical research in the areas of minimally invasive surgery, clinical outcomes,
and spinal imaging. He is also interested in basic research on bone, disc, and nerve tissue regeneration and
in the investigation of alternatives to spinal fusion for the treatment of DDD. His professional affiliations
include the North American Spine Society, Scoliosis Research Society, the European Spine Society, the
International Society for the Study of the Lumbar Spine, and the Spine Arthroplasty Society.

Dr. Cammisa is associate professor of clinical surgery, Weill Medical College of Cornell University and is the
Chief of Spinal Surgical Service at The Hospital for Special Surgery in New York, New York, where he also
serves as an associate scientist in the research division. Dr. Cammisa received his medical degree from the
College of Physicians and Surgeons at Columbia University, New York, New York.
His clinical interests include non-fusion and motion preservation technologies, minimally invasive, laparoscopic, and computer assisted spinal surgery; microsurgery and athletic spinal injuries. He is an active member of many spine societies, academic committees and editorial review boards. He has lectured widely and
published in numerous peer-reviewed journals and books.
Chapter 14
History of Motion Preservation

Surgery of the Lumbar Spine
Thierry Marnay, MD
ORTHOPEDIC SURGEON
Department of Orthopaedic Surgery

Clinique du Parc
Castelnau-le-Lez, France 34171
INTRODUCTION
hroughout history, the field of orthopedics has been intimately

focused on treating joint pathologies by seeking to restore normal function. Over the last 50 years, a great deal of research has
been conducted to advance our understanding of spinal function
and develop technologies to preserve spinal motion.
This chapter will provide a review of the basic principles of motion
preservation. In addition, a brief history of the devices that have
been developed to maintain spinal motion is also provided.
OVER THE LAST 50 YEARS, A GREAT DEAL OF RESEARCH

HAS BEEN CONDUCTED TO ADVANCE OUR UNDERSTANDING
OF SPINAL FUNCTION AND DEVELOP TECHNOLOGIES TO
PRESERVE SPINAL MOTION.
PRINCIPLES OF MOTION PRESERVATION

Motion preservation requires maintenance or restoration of the
functional elements of the spine. Often the ability to preserve or
restore spinal motion requires a thorough analysis of the affected
spinal segment or region. This includes an analysis of the loss in
spinal disc height, integrity of the ligamentous structures, degree

of disc degeneration, and condition of the facet joints, using CT
and MR imaging modalities (Figure 1). The goal of such analyses is to identify the presence of abnormal features or conditions
that impact the ability to perform normal motions.
A careful analysis of the spinal elements is critical as it provides
the information necessary for evaluating treatment options or
developing a treatment plan to stabilize the spinal segment by
recreating the proper tension in the annulus and surrounding
ligaments. This, in effect, will rebalance the spine and restore the
appropriate lumbar curvature and corresponding sagittal balance. Re-establishing the sagittal balance, and corresponding
range of motion (flexion-extension, lateral bending, rotation)
is integral to this process as it represents the key to maintaining
long-term motion preservation, while reducing the potential
for adjacent level disease.
SPINAL NUCLEUS REPLACEMENTS SEEK TO REPLACE

THE NUCLEUS PORTION OF THE SPINAL DISC, WHILE
RETAINING THE ANNULUS AND VERTEBRAL ENDPLATES.
The spinal elements under consideration include the spinal disc,

vertebral bodies, posterior facets, and ligamentous structures.
These elements work in concert with the surrounding tissues to
maintain spinal lordosis and balance. The spinal disc is basically
a self-contained viscoelastic system with multiple degrees of
freedom in which translations and rotations are limited by the
annulus fibrosus. The facets and posterior ligamentous structures provide additional support in controlling spinal segment
rotation and translational motion that occur during flexion and
extension activities. In addition, the anterior (ALL) and posterior (PLL) longitudinal ligaments assist in stabilizing the disc.
Damage to these structures can alter the dynamic behavior of
the spinal segment resulting in a change in the center of rotation
and corresponding motion pattern.
Figure 1
Magnetic resonance imaging is one of the main improvements
in degenerative disc knowledge and pathology.
The key to motion preservation is to analyze and treat elemental deficiencies. In fact, many of the device designs have been
developed to act as substitutes to address specific spinal pathologies or degenerative processes. In general terms, the available
device technologies can be classified into three major groups
that include spinal nucleus replacements, total disc replacements
and posterior stabilization devices.
SPINAL NUCLEUS REPLACEMENTS

Spinal nucleus replacements seek to replace the nucleus portion
of the spinal disc, while retaining the annulus and vertebral endplates. In the late 1950s, Dr. Ulf Fernstrm1 implanted a SKF ball
bearing in the disc space to reproduce the tension band across the
adjacent vertebral segments, while attempting to maintain joint
motion. The results of his use of this metallic nucleus replacement core were published in 1964. This early design showed significant issues with vertebral endplate subsidence that resulted
in a progressive loss in disc height.
While the success rate with the Fernstrm approach was relatively low, this technique inspired the development of several
early nucleus replacement devices including technologies that
utilized materials such as PMMA,2 CoCr spheres,3 and silicone.4
This initial work also served as the foundation for the development of the PDN prosthetic disc nucleus device and Charit
total disc replacement.
PDN PROSTHETIC DISC NUCLEUS

The prosthetic disc nucleus or PDN device was designed by
Charles Dean Ray, MD, FACS in the 1980s and consisted of a
hydrogel core encased in a polyethylene jacket (Figure 2). The
device was specifically designed to reproduce the hydroelastic
characteristics of the native nucleus. The hydrogel implant was
inserted into the disc space in a dehydrated state. As the implant
hydrated, it would grow in size to restore disc height, re-tension
the annulus, and recreate the pressure/fluid exchange through
the cartilage and endplates.
MORE THAN 20 DIFFERENT NUCLEUS ARTHROPLASTY

DEVICES ARE CURRENTLY IN EITHER THE CONCEPTUAL
OR DEVELOPMENTAL STAGES.
OTHER NUCLEUS DEVICES

Over the past 10 years, disc nucleus replacements have been
constructed of plastics, ceramics, polymers, injectable fluids, and
hydrogels. More than 20 different Nucleus Arthroplasty devices
are currently in either the conceptual or developmental stages.
These devices include hydrogel, polymer/synthetic, and mechanical
technologies as shown below:
Hydrogels
PDN-SOLO and HydraFlex devicesRaymedica, LLC
NeuDiscReplication Medical
Gelifex family of hydrogelsSynthes, Inc.
AquarelleStryker Howmedica Osteonics
Figure 2
PDN prosthetic disc
nucleus designed by
Charles Dean Ray, MD, FACS
Early design generations were intended to be used in a paired

configuration, while later generations used a single implant configuration (PDN-SOLO) that was sized to better fit the nuclear
space. All of these PDN designs were implanted into the disc space
via a posterior or PLIF type approach. While a review of the clinical results confirms the concept can be effective, technical complications were noted including implant migration and secondary
subsidence5 (Schnmayr Spine Arthroplasty Society(SAS) 2001).
Bertagnoli et al6 developed the anterolateral transpsoatic surgical
approach (ALPA) to address the difficulties associated with nucleus
removal and device placement using a posterior access. This surgical approach also provided the opportunity to suture the annulus
closed after device placement to address migration issues.
Polymers/Synthetics
DASCORDisc Dynamics, Inc.
NuCore Injectable Nucleus DeviceSpine Wave, Inc.
SINUX ANRSinitec, AG / DePuy Spine, Inc.
BioDiscCryoLife, Inc.
Mechanical
EBI RegainBiomet, Inc.
NUBACPioneer Medical, Inc.
While the early use of nuclear replacement devices has shown
promise, potential pitfalls remain. Efforts to simulate the native
nucleus have led to the introduction of a number of new
implant materials for use as nucleus replacement devices. Of
particular concern is the potential for changes in mechanical
performance over the life of the implant, possibly due to physical
or chemical breakdown of the implant materials.
Additionally, many nucleus replacement devices seek to restore the
intradiscal pressure environment within the disc. However, there
may be a wide variation in the disc pressures from one individual
to another. Given this scenario, one would expect that the pressure-volume relationship within the disc space both before and
after implantation to be of critical importance. This relationship
may be directly influenced by the amount of disc material
TOTAL DISC REPLACEMENTS ARE DESIGNED TO REPRODUCE THE MOTION AND/OR

SHOCK ABSORBING CAPABILITIES OF THE NATIVE DISC. THESE DEVICES INVOLVE
REPLACEMENT OF THE DISC NUCLEUS, A PORTION OF THE ANNULUS, AND ALSO OFTEN
REQUIRE MODIFICATION OF THE VERTEBRAL ENDPLATES TO ACHIEVE LONG-TERM
IMPLANT FIXATION.
removed and the subsequent volume of the implant utilized to

replace the nucleus. A post-implantation intradiscal pressure that
is too low may not adequately restore the disc height, while an
intradiscal pressure that is too high may influence implant migration or subsidence. Thus, it may be challenging to strike a balance
that can adequately address the specific needs of each individual.
Currently, there are no FDA-approved nucleus arthroplasty
devices. Any device placed in the nucleus space where the intent
is not to fuse the spine is considered an off-label use. As of April
2007, four companies are in the process of conducting five U.S.
Investigational Device Exemption (IDE) pilot clinical trials using
Nucleus Arthroplasty technologies.
TOTAL DISC REPLACEMENT

Total disc replacements are designed to reproduce the motion
and/or shock absorbing capabilities of the native disc. These
devices involve replacement of the disc nucleus, a portion of the
annulus, and also often require modification of the vertebral endplates to achieve long-term implant fixation. Over time, there
have been a number of total disc design concepts incorporating
the use of different materials. While some of these designs utilize
polymer technologies, the majority of the current total disc
designs are mechanical in nature often incorporating a ball and
socket style design.
Acroflex
The Acroflex is a polymeric disc prosthesis originally designed by
Dr. Art Steffee in 1988 (Figure 3). This one-piece disc was composed of an elastomeric core bonded to titanium alloy baseplates.
Cone shaped posts were incorporated into the baseplates to provide short-term fixation. For long-term fixation, the baseplates
were coated with sintered titanium beads for bone ingrowth.
Figure 3
Acroflex implant created and implanted
by Dr. Art Steffee.
Despite extensive bench testing, early designs implanted in

humans had limited success due to failure of the rubber core. The
core failures of this fully constrained implant design were likely a
result of the complex motion of the functional spinal unit which
undergoes both translation and rotation during flexion-extension
activities. This creates a dynamic center of rotation that can
impose combined axial rotation and shear forces on the implant
core. The development of an appropriate elastomeric material that
can accommodate such forces and resulting motions has not yet
been resolved.
Additionally, a number of other polymeric disc designs have
also been studied. Urbaniak et al7 designed a device with a silicon core sandwiched between layers of Dacron mesh, while
Edeland8 proposed the use of a silicon core bounded by polyethylene end caps. Lee et al9 designed a disc with a softer center
core (polysiloxane) surrounded by a stiffer matrix material
(polyurethane). Early animal studies of such devices showed
issues with infection, resorption, and dislodgement.
Charit
The Charit disc prosthesis was designed by Drs. Kurt Schellnack
and Karin Bttner-Janz10 in 1982 and implanted at the Charit
Hospital in Berlin in 1984 (Figure 4). This three-piece semi-constrained disc design consists of a mobile biconcave polyethylene
core that is sandwiched between convex CoCr baseplates. The
mobility of the central core allows the device to accommodate both
translation and rotation. A number of design iterations occurred
over time to increase the size of the device footprint and improve
fixation to the vertebral bodies including modification of the spike
pattern/location and the addition of a plasma spray coating.
Promising clinical results were reported by Drs. David and
Lemaire,11 however, others noted complications with device dislocation and expulsion.12 The Charit was granted FDA approval
for use in the U.S. in 2005 following an excellent study report;
early use in the U.S. has shown similar device complications as
in the past.
Figure 4
Charit prosthesis from Dr. Kurt Schellnack
and Dr. Karin Bttner-Janz.
In general, motion of the spinal segment is limited by the ligamentous structures and surrounding musculature. As noted
above, the Charit disc has the ability to translate and protect
the facets, while reproducing the center of rotation of the normal space. However, surgical implantation requires the removal
of the ALL, and often resection of the PLL, resulting in a loss of
horizontal stability.
THE CHARIT DISC HAS THE ABILITY TO TRANSLATE

AND PROTECT THE FACETS, WHILE REPRODUCING
THE CENTER OF ROTATION OF THE NORMAL SPACE.
ProDisc
The ProDisc was designed by the author, Dr. Thierry Marnay, in
the mid 1980s with the first generation device produced in 1989
(Figure 5). This semi-constrained disc is a three-piece design
composed of a polyethylene core with CoCr baseplates. The baseplates incorporate a keeled design to assist in initial positioning
and provide short-term device stability. The polyethylene core is
snapped into the lower CoCr baseplate during the surgical procedure to form the inferior component. The superior surface of the
polyethylene component then forms a ball and socket type articulating joint with the upper CoCr baseplate. The radius and
position of the core combine to reproduce the translation and
rotation of the normal disc. Design iterations include modification of the baseplate keel configuration and the addition of a
porous coating to enhance bone ingrowth.
The first generation of the ProDisc was implanted in 64
patients.13 An analysis of the long-term data showed good clinical and radiological outcomes. This paved the way for the use of
the next-generation design with implant studies initiated in
1999. Implantation associated with the U.S. clinical study began
in 2001 with subsequent FDA approval granted in 2006.
To date, there is roughly 17 years of experience with the ProDisc
design showing good clinical outcomes and maintenance of
spinal segment motion. At this time, there is no evidence of
wear debris; however, the longer-term performance of the polyethylene/CoCr articulating surfaces has yet to be confirmed.
Additional load-bearing surface materials may be proposed in
the future device generations.
This phenomenon can make it difficult to appropriately size and

position the implant, while restoring the desired level of ligamentotaxis. Thus, undersizing may increase the potential for implant
migration and/or expulsion, while oversizing or improper positioning can lead to early facet degeneration. Regardless of these
issues, with proper surgeon training and appropriate patient
selection, this device can maintain mobility of the disc space
and provide good clinical outcomes.
7
Figure 5a
Prodisc implant
motion preservation in L5-S1.
Figure 5b
Maverick
Other Total Disc Replacements
The Maverick was designed by Drs. Kenneth Pettine and Richard

Salib in 1993. This is a two-piece metal-on-metal articulating
disc design that incorporates a more posterior center of rotation.
The device has a large central keel for alignment/guidance and
initial device stability. The metal-on-metal articulating surface
is constrained and asymmetrically located on the baseplate surfaces. As with other metal-on-metal designs in orthopedics,
long-term scientific data will be important to determine the
potential for metal ion release. A multicenter U.S. clinical study
using the Maverick disc was initiated in the spring of 2003; the
device is not currently FDA approved.
At this time, there are more than 20 different total disc designs
in the conceptual or development stage. These designs vary in
material choice, shape, surgical technique, and implantation philosophy. In addition, there are currently a number of lumbar
total disc replacements in clinical study (Activ-L, Kineflex,
Mobidisc). In general, the basic operating principles of these
devices are similar to the technologies presented above.
FlexiCore
The FlexiCore was designed by Dr. Thomas Errico in 2001. This
is a two-piece metal-on-metal articulating disc design that is
inserted as a single unit. The superior and inferior components
are linked by a captured ball-and-socket joint. This prosthesis is
implanted through an anterior approach and inserted en bloc.
The unique dome-shaped baseplate surfaces are designed to
approximate the concavities of the vertebral endplates for initial
stability. The surfaces are coated with a titanium plasma spray to
enhance bone ingrowth. Future issues with the metal-on-metal
articulation are similar to those discussed above. This technology is currently under U.S. clinical investigation; the device is
not currently FDA approved.
POSTERIOR TECHNOLOGIES
Dynamic stabilization is a term applied to devices that provide
non-fusion support to the spine, while still allowing motion at
the affected levels. Such implants were first developed in France
during the 1980s and were initially referred to as ligamentoplasty, as the early concepts all used various tethering methods
to stabilize posterior segments. Two different philosophies of posterior stabilization evolved based on different patient populations
and device biomechanics: 1) the use of adjunct support structures/ligaments used in combination with pedicle screw fixation14
and 2) the use of spinous process attachments.15 These concepts
are discussed in the following sections.
DYNAMIC STABILIZATION IS A TERM APPLIED TO DEVICES THAT PROVIDE

NON-FUSION SUPPORT TO THE SPINE, WHILE STILL ALLOWING MOTION
AT THE AFFECTED LEVELS.
Figure 6
Dynesys pedicle screws
and ligament system with
polyurethane spacers.
Pedicle Screw-Based Systems

The Graf Ligament was designed by Dr. Henri Graf. It was one
of the earliest pedicle screw-based devices developed in France
in the late 1980s. This system uses braided polyester ligaments
that are looped around the screws to provide stability while still
allowing motion. The device was used in over 10,000 patients
during the early 1990s. However, long-term results were not
promising as the ligament loosened, causing failure in the tension
band and/or the pedicle screw.
The Dynesys system was invented by Drs. Gilles Dubois and
Otmar Schwarzenbach. The device consists of pedicle screws,
cords/ligaments and polyurethane spacers (Figure 6). This system is implanted and tensioned to provide spinal support such
that the cord provides support and limits flexion, while the
spacer limits extension. Thus, the Dynesys is designed to restabilize spinal segments that show symptoms of stenosis or spondylolisthesis. When used without bone graft, it is designed to
preserve the natural function of the spine by allowing motion
and sharing in-load transmission.
At this time, there are more than 30 pedicle screw-based posterior dynamic systems in development or undergoing clinical trials. However, regardless of the system, it is difficult to determine
if posterior dynamic stabilization will be capable of maintaining
long-term segmental motion, while providing adequate spinal

stabilization to slow the progression of disc disease.
Interspinous Process Spacers

The Wallis System was invented in 1984 by Dr. Jacques Senegas.
This interspinous process spacer incorporates a tethering system
to stabilize discectomy patients and restore motion. The firstgeneration implant for non-rigid stabilization of lumbar segments was developed in 1986. The device consisted of a titanium
interspinous blocker and an artificial ligament made of Dacron;
the latest generation incorporates a PEEK blocker. Functionally,
the device restrains flexion and blocks extension; thus, increasing
the rigidity of destabilized segments. The overall implant has no
permanent fixation in the vertebral bone which is intended to
avoid the risk of device loosening.
The coflex Interspinous Implant, previously known as the
interspinous U, was developed by Dr. Jacques Samani in 1994
(Figure 7). The device is made of a single machined piece of titanium alloy with no articulating parts. It was designed to be used
for patients with moderate to severe lumbar spinal stenosis with
concomitant low back pain and neurogenic claudication. Unlike
the other interspinous spacers, the coflex Interspinous Implant is
functionally dynamic allowing both flexion and extension. The
device has been implanted in more than 20,000 patients worldwide

with up to 12 years of follow-up data demonstrating its safety. The
coflex is currently in a U.S. FDA-approved study.
The X-STOP implant was developed by Drs. James Zucherman
and Kenneth Hsu. The device is used in the treatment of patients
with mild lumbar spinal stenosis and neurogenic claudication.
The implant is designed as a two-piece system comprising a titanium alloy extender and a PEEK Optima oval spacer. It functions
by opening the lumbar space through permanent distraction of
the posterior spinous process. This unloads the facets, opens the
neuroforamen, and widens the spinal canal, removing the pressure
on the nerve roots. Functionally, the X-STOP allows flexion, but
blocks or restrains extension activities. The X-STOP has received
FDA approval for commercial use in the U.S.
The DIAM, or Device for Intervertebral Assisted Motion, was
developed by Dr. Jean Taylor in 1997. The implant acts as a
shock absorber that reduces loads on the surrounding vertebrae
and restores the natural function at the affect level. Functionally,
the DIAM system is designed to restrain flexion and allow extension. The core of the DIAM system is made of silicone, while the
outer mesh and tethers are made of medical-grade polyester. The
flexible properties of the DIAM system materials may also protect the integrity of the spinous process. More than
20,000 surgeries have been
successfully performed in
Europe, Asia and Latin
America using this device.
The DIAM is currently in an
investigational U.S. FDAapproved study.
In general, dynamic stabilization systems represent an attractive

option for patients that would otherwise undergo fusion procedures. As with any spinal care treatment, there are concerns associated with long-term performance. As a principle of their action,
the use of posterior stabilization implants may induce kyphosis at
the operative level. The major concern is that creating kyphosis at
the affected level will increase potential for hyperextension at the
adjacent levels. Another concern, particularly for devices that
block extension by bearing load on the spinous processes, is the
potential for progressive bony erosion resulting in a loss in effectiveness and an increased potential for bone fractures. This may be
problematic as the indications for use of such devices is generally
segmental stenosis that often occurs at the age when osteoporosis
is also a factor.
BIOTECHNOLOGIES
Currently, there is great deal of research being conducted to
develop biological or regeneration solutions to spinal care.
Techniques such as the transplantation of nucleus cells16 and cell
culturing with subsequent reimplantation are being evaluated
for use after disc herniation. Additional work is underway investigating our ability to block the factors associated with apoptosis
in nucleus cells. Such research will greatly influence future treatment options and redefine how we go about preserving motion
when addressing degenerative disc disease. While many of theses
technologies remain in their infancy, such solutions will ultimately displace the mechanical repair methods that represent
our current treatments and standard of care.
Figure 7
Coflex Interspinous
Dynamic System
UNLIKE THE OTHER INTERSPINOUS SPACERS, THE COFLEX INTERSPINOUS IMPLANT

IS FUNCTIONALLY DYNAMIC ALLOWING BOTH FLEXION AND EXTENSION.
10
THESE SOLUTIONS WILL NO DOUBT EXPAND OUR AVAILABLE TREATMENT OPTIONS

TO ADDRESS ALL STAGES OF DEGENERATIVE DISC DISEASE AND RELATED SPINAL
PATHOLOGIES; THUS, BROADENING OUR CONTINUUM OF CARE.
CONCLUSION
Our understanding and development of motion preservation
technologies in the spine is only just beginning with initial solutions dating back over 50 years. Indeed some of the technologies
that are now clearing the necessary regulatory hurdles and gaining
acceptance in clinical use have been in a continuum of development and refinement for more than 15 years. As in many fields, it
is likely that only a few of these current technologies will survive
the tests of time and rigors associated with long-term follow up.
Regardless of form, the developers of current and future motion
preserving concepts share the same attributes: an original concept, a strong knowledge of pathology, an in-depth understanding of disc physiology/anatomy, and an ability to share their
passion with structured development teams. In the future, rest
assured that we will continue to discover new and innovative
solutions to preserve spinal motion. These solutions will no
doubt expand our available treatment options to address all
stages of degenerative disc disease and related spinal pathologies;
thus, broadening our continuum of care.
REFERENCES
1. Fernstrm U : Arthroplasty with intercorporal endoprothesis in herniated disc
and in painful disc. Acta Chir Scand Suppl. 1966; 357:154-9.
2. Cleveland D: Interspace reconstruction and spinal stabilization after disk
removal. J Lancet. 1956 Oct; 76(10):327-31.
3. Harmon PH: Subtotal anterior lumbar disc excision and vertebral body fusion.
III. Application to complicated and recurrent multilevel degenerations. Am J
Surg. 1959 May; 97(5):649-59.
5. Shim CS, Lee SH, Park CW, Choi WC, Choi G, Choi WG, Lim SR, Lee HY:
Partial disc replacement with the PDN prosthetic disc nucleus device: early
clinical results. J Spinal Disord Tech. 2003 Aug;16(4):324-30.
6. Bertagnoli R, Vazquez RJ: The Anterolateral TransPsoatic Approach (ALPA): a
new technique for implanting prosthetic disc-nucleus devices. J Spinal Disord
Tech. 2003 Aug;16(4):398-404.
7. Urnbaniak JR, Bright DS, Hopkins JE: Replacement of intervertebral discs in
chimpanzees by silicone-dacron implants: a preliminary report. J Biomed
Mater Res. 1973;7(3):165-86.
8. Edeland HG: Suggestions for a total elasto-dynamic intervertebral disc prosthesis. Biomater Med Devices Artif Organs. 1981; 9(1):65-72.
9. Langrana NA, Parsons JR, Lee CK et al. Materials and design concepts for an
intervertebral disc spacer. I. Fiber reinforced composite design. J Appl
Biomater. 1994; 5:125-32.
10. Karin Bttner KJ, Schellnack K, Zippel H: Biomechanics of the SB Charit
lumbar intervertebral disc endoprosthesis. Int Orthop. 1989;13(3):173-6.
11. Lemaire JP, Skalli W, Lavaste F, Templier A, Mendes F, Diop A, Sauty V,
Laloux E: Intervertebral disc prosthesis. Results and prospects for the year
2000. Clin Orthop Relat Res. 1997 Apr;(337):64-76.
12. Kurtz SM, van Ooij A, Ross R, de Waal Malefijt J, Peloza J, Ciccarelli L,
Villarraga ML: Polyethylene wear and rim fracture in total disc arthroplasty.
Spine J. 2007 Jan-Feb; 7(1):12-2.
13. Tropiano P, Huang RC, Girardi FP, Cammisa FP Jr, Marnay T: Lumbar total
disc replacement. Seven to eleven-year follow-up. J Bone Joint Surg Am. 2005
Mar; 87(3):490-6.
14. Graf H: Lumbar instability. Surgical treatment without fusion. Rachis 1992;
412:123-37.
15. Senegas J, Etchevers P, Vital JM, Baulny D, Grenier F: Widening of the lumbar
vertebral canal as an alternative to laminectomy in the treatment of lumbar
stenosis. Rev chir orthop repar appar mot 74:15-22, 1988 (Fr).
16. Iwashina T, Mochida J, Sakai D, Yamamoto Y, Miyazaki T, Ando K, Hotta T:
Feasibility of using a human nucleus pulposus cell line as a cell source in cell
transplantation therapy for intervertebral disc degeneration. Spine. 2006
May 15; 31(11):1177-86.
4. Fassio B, Ginestie JF: Discal prosthesis made of silicone: experimental study

and 1st clinical cases. Nouv Presse Med. 1978 Jan 21; 7(3):207.
11
Chapter 15
Examination, Radiologic
and Diagnostic Evaluation,
and Patient Indications
Andrew A. Sama, MD
ASSISTANT PROFESSOR OF ORTHOPEDIC SURGERY
Weill Medical College of Cornell University

New York, NY 10021
Dr. med. univ. Rudolf Bertagnoli

FOUNDER
Pro-Spine Medical Consulting

Straubing, Germany 94315
ASSISTANT PROFESSOR OF ORTHOPEDIC SURGERY

New York, NY 10021
KEYPOINTS
The continued introduction of new treatment alternatives
emphasizes the need for better methods to examine and
evaluate patients.
A well-documented patient history is the foundation to understanding the etiology of the patients pain.
Advanced imaging modalities (CT, MRI) are of significant value
in visualizing the spine and associated soft tissue structures.
The combination of examination and diagnostic tools is critical
to the definition of potential treatment options.
12
INTRODUCTION
ow back pain (LBP) is a condition with a large multifaceted

socioeconomic impact that affects both the individual and
supporting healthcare system consuming significant therapeutic
and financial resources. The condition has been reported
throughout history1 and remains one of the primary reasons for
consulting a general practioner at all stages of a patients life.
The common causes of low back pain include muscle strain,
nerve irritation, radiculopathy, bony encroachment, and other
conditions of the bone and joints. Common pain generators
include the bone, disc, tendon, muscle, ligament and nerve.
Taken individually, identification of the underlying cause of
LBP is complex, however, when the potential causes present in
combination, the diagnostic evaluation becomes even more
challenging for the examiner.
One of the more difficult aspects of spine surgery in the lower
back has always been the ability to understand and identify the
proper patient indications for a given surgical procedure. The
evolution of new technologies that promise a more minimally
invasive approach without the permanence of fusion, make this
an even more challenging task.2
The continued introduction of new treatment alternatives highlights the importance of developing better methods to effectively
examine and evaluate patients. While the major elements of a
history and physical exam have not changed over the course
of time, the interpretation of results in the context of patientdriven-outcomes-measures has resulted in the more critical
assessment of current diagnostic techniques and potential
patient treatment procedures.
Patients that present with LBP are commonly seeking treatment for a physical ailment. As such, one of the primary tasks
in the diagnosis of LBP is the ability to classify it as acute, subacute, or chronic. Acute back pain usually lasts for up to six
weeks and subacute pain for six to twelve weeks, while chronic
back pain lasts for more than twelve weeks and is recalcitrant
to treatment. When assessing pain history, both the type of
pain (sharp, shooting, dull, burning, aching, radiating) and
corresponding location should be recorded to help the clinician
understand the possible etiology.
The positional character of the patients symptoms can often be
of significant value in diagnosis. For example, LBP that is exacerbated as a result of sitting or bending forward is more likely to be
discogenic in nature. Discogenic pain is typically located in the
lower back and upper buttock and should not radiate below the
level of the patients knee. This type of pain may also increase
when the patient attempts to carry load. LBP that worsens with
extension is typically facet mediated.
If the patient complains of sciatic pain, the nerve root is most likely
compressed. Nerve root compression most commonly results from
disc herniation, but can also arise from foraminal stenosis, secondary to the severe disc space collapse associated with degenerative
disc disease (DDD). Proper identification of such etiologies is
extremely important when considering surgical intervention.3
THE COMMON CAUSES OF LOW BACK PAIN INCLUDE

MUSCLE STRAIN, NERVE IRRITATION, RADICULOPATHY,
BONY ENCROACHMENT, AND OTHER CONDITIONS OF
THE BONE AND JOINTS.
PATIENT HISTORY
The cornerstone to any diagnosis is a good working knowledge
of the patients background and medical history. Thus, in addition to the patients physical presentation, the social background,
cultural differences, psychological state, and secondary gain scenarios (workers compensation or job dissatisfaction) must also
be considered in the evaluation of discogenic back pain.
A well-documented history will also include careful consideration
of the patients chief complaint, pain duration, precipitating
events, and activities that exacerbate or ameliorate the painful
condition, as these items form the foundation for developing an
understanding of the underlying cause of the patients symptoms.
PHYSICAL EXAMINATION
The physical examination of the spine should be standardized to
ensure complete evaluation of the patients posture, station, gait,
and ability to move around in the examination room without
pain. A thorough examination involves the evaluation of the
patients motor strength by individual muscle group, sensory
function by dermatome, and reflex examination including the
presence of long tract signs. Lumbar flexion, extension, lateral
bending, and axial rotation should be performed with the ability
to reproduce the pain symptoms duly noted.
13
In addition, pain and function associated with range of motion

studies of the hips and knees, and the condition of the sacroiliac
joints should be assessed. Assessment of the sacroiliac joints is
achieved by applying manual pressure over the joints and performing the Patricks flexion, abduction, external rotation maneuver. Finally, a vascular examination including an assessment of
pulses, edema, and trophic changes should be performed.
DIAGNOSTIC EVALUATION
The most common spine imaging modalities include plain x-rays,
computed tomography (CT) and magnetic resonance imaging
(MRI). Additional imaging studies, such as discography or myelography, may also be requested by spine specialists. Many of these
imaging modalities have established grading systems that can be
used to describe the stage of disc degeneration.8
INTERVERTEBRAL DISC ASSESSMENT

The intervertebral discs constitute roughly one third of the vertebral column length. Thus, changes that occur in the disc, such
as a loss in height or herniation, can have a profound effect on
other spinal structures including the facet joints, paraspinous
muscles, and exiting nerves resulting in pain. Degeneration of
the disc itself, can also be a pain generator due to innervation of
the annulus.4
Degenerative disc disease has been classified in stages.5 The radiographic onset of the disease usually occurs in patients between
20 and 60 years of age, but the clinical manifestation of this
condition to the actual onset of pain is difficult to predict.6 Some
authors have also reported that disc degeneration in certain
individuals may be a result of genetic predisposition.7
Figure 1
Figure 2
RADIOGRAPHY
THE RADIOGRAPHIC ONSET OF DEGENERATIVE DISC
DISEASE USUALLY OCCURS IN PATIENTS BETWEEN
20 AND 60 YEARS OF AGE, BUT THE CLINICAL
MANIFESTATION OF THIS CONDITION TO THE ACTUAL
ONSET OF PAIN IS DIFFICULT TO PREDICT.
In a normal disc, the properly hydrated nucleus pulposus accepts

compressive load and distributes it, via hydrostatic pressure, to the
annulus fibrosus. As the disc degenerates, the nucleus loses water
content resulting in a reduced intradiscal pressure and corresponding loss in height, altering the biomechanics of the spine.
Consequently, the annulus assumes the role of distributing the
excess compressive load resulting in stress induced morphological changes. Such morphological changes can be evaluated using
several diagnostic methods to assist in the identification of the
pain source and aid in developing a suitable therapeutic strategy.
14
X-ray is the most commonly performed spinal imaging study

as it is readily available in primary care settings. AP and lateral
plain films provide key information in regard to spinal alignment, scoliosis, spondylolisthesis, bone quality/density, and
potential fractures. Films taken in flexion and extension positions may also help identify normal spinal motion or potential
instabilities. In addition, properly scaled films allow for the
measurement of vertebral body and disc dimensions that may
be used in surgical planning (Figures 1 & 2).
A more detailed review of plain films can be used to identify
variations in endplate morphology, such as Schmorls nodules,
which represent protrusions of the nucleus pulposus into the
vertebral body. The presence of Schmorls nodes, may indicate
that degenerative processes are underway and may be advanced
in the affected spinal segments.9
While x-ray has many apparent advantages, there are a few wellrecognized disadvantages that include the two dimensional
nature of the information, exposure to radiation, and an inability to directly assess the condition of the cartilaginous endplate
and surrounding soft tissue structures.
MRI
AS THE DISC DEGENERATES, THE NUCLEUS LOSES
WATER CONTENT RESULTING IN A REDUCED
INTRADISCAL PRESSURE AND CORRESPONDING
LOSS IN HEIGHT, ALTERING THE BIOMECHANICS
OF THE SPINE.
COMPUTED TOMOGRAPHY
Computed tomography (CT) represents an advanced radiographic
technique that provides three dimensional imaging for analysis.
This imaging method offers improved resolution and provides
better visualization of the bony structures of the spine in comparison to plain radiography.
CT provides a more detailed view that can be utilized to assess
facet integrity and health, disc space height, endplate sclerosis,
and the presence of vacuum phenomena. When imaging is being
performed to evaluate bone-related issues, CT is preferable to
other methods as it
allows direct visualization of the cortical
bone. Thus, abnormalities such as pars
defects, bony foraminal
stenosis, and calcification of disc herniations
can readily be assessed
(Figures 3 a, b & c).
Figure 3a
Figure 3b
Figure 3c
Magnetic resonance imaging (MRI) is a powerful imaging modality

that can provide extraordinary detail. By using different relaxation
techniques (T1, T2, T1), MRI can be utilized to obtain high contrast images of the bone and soft tissue structures. In fact, this imaging method is sensitive enough to differentiate between different
soft tissue structures such as the annulus fibrosus and the nucleus
pulposus. For diagnostic purposes, the use of MRI can assist in
identifying the presence of high intensity zones, annular fissures,
and disc herniations allowing resultant neurologic compression to
be quantified. MRI has also been used to characterize signal changes
in the bone marrow adjacent to the vertebral endplates; a threestage classification has been described by Modic.10
Figure 4
When imaging the intervertebral disc, the major advantages of

MRI are best recognized by the use of T2 weighted, sagittal imaging. With the T2 technique, the hydration of the disc nucleus can
be easily visualized and compared from one level to the next
allowing classification into degenerative stages (Figure 4).
Additional diagnostic information can be obtained using T1
spin lock relaxation. This processing technique aids in assessing
the proteoglycan content of the nucleus which directly correlates
with the water binding capacity. The T1 technique also has the
potential to detect degeneration of the disc at a significantly earlier point in comparison to the more commonly used MRI techniques.11 This becomes relevant for the application of treatment
strategies such as biological repair enhancement12 or nucleus
pulposus replacement.
While MRI is well-recognized as an excellent tool for visualization of
the vertebral bodies, spinal discs, nerves and surrounding structures,
the diagnostic value of MRI to predict or identify potential pain
generators in the spine remains controversial.13, 14, 15, 16, 17
15
DISCOGRAPHY IS OFTEN REQUIRED TO IDENTIFY AN INDIVIDUAL DISC

A S T H E PA I N S O U R C E , PA R T I C U L A R LY W H E N S E V E R A L D I S C S H AV E B E E N
I D E N T I F I E D A S P O T E N T I A L C A N D I D AT E S V I A M R I .
DISCOGRAPHY (DISCOGRAM)
Discography is the injection of contrast media directly into the
nucleus pulposus to assess the extent of disc damage and characterize the pain response. This invasive diagnostic method is rarely
used in acute low back pain and should only be performed if
adequate attempts with non-invasive diagnostic tests have failed
to identify the pain source.
Discography is often required to identify an individual disc as
the pain source, particularly when several discs have been identified as potential candidates via MRI. The application of this
technology is technique dependent and should be performed
with the patient awake enough to communicate the character,
intensity, and location of their pain during the test.
During injection, the opening pressure, infused fluid volume,
and concordance of pain are all recorded. After all discs under
evaluation have been injected, a CT scan can be obtained to
assess the disc integrity. This combined approach allows
anatomical and functional assessment of a problematic disc.
A positive discogram produces a concordant pain response upon
injection into the symptomatic disc. Conversely, injection into
unaffected or control discs is not painful or produces pain different from that under evaluation.18 Some authors advocate the
use of anesthetic discograms following the provocative portion
of the study. If symptoms are relieved or improved with the
injection of anesthetic into the disc, this further supports the
role of that disc as the pain generator (Figure 5).
16
Figure 5
PATIENT INDICATIONS
The use of examination and diagnostic tools is critical to developing and understanding a patients pain etiology and, subsequently, defining potential treatment options. To properly
evaluate the use of nucleus arthroplasty, a review of the patient
indications is appropriate.
In Nucleus Arthroplasty procedures, the goal is to restore,
maintain or improve physiologic function of the degenerating
disc, while preserving motion. Current nucleus arthroplasty
technologies are designed to replace the diseased portion of the
nucleus with a substitute material. The ability to preserve
motion by replacing only the nuclear core requires that patients
are identified in an early disease state in which the degenerative
processes are mainly focused in the spinal disc without involvement of the facets. Thus, patients that have pathologies that
result in abnormal motion deterioration or significant alteration
of the posterior elements would not be appropriate candidates.
By using this information in combination with the anticipated physiological and biomechanical demands, a general outline of patient
selection criteria can be developed to improve the potential for
achieving good long-term clinical outcomes. Below is a general list
of inclusion and exclusion criteria for the use of nucleus arthroplasty
technologies that is based on available literature.2, 3, 19, 20, 21
REFERENCES
1. Latchaw Jr JP. A historical note on sciatiaChp 1. In: Hardy RW editors:
Lumbar disc disease. NY. 1982. Raven Press.
2. Bertagnoli R. Review of modern treatment options for degenerative disc disease. In: Kaech DL and Jinkins JR, editors: Spinal restabilization procedures
Diagnostic and therapeutic aspects of intervertebral fusion cages, artificial
discs and mobile implants. 2002. Elsevier BV.
3. Goins ML, Wimberley DW, Yuan PS, Fitzhenry LN, Vaccaro AR. Nucleus pulposus replacement: an emerging technology. The Spine J. 2005; 5:317S324S.
Inclusion
Mild to moderate DDD
Back pain and/or leg pain (L2-S1)
Skeletally mature
Failed conservative care (6+ months)
Loss in disc height less than 50%, based on
adjacent normal disc
Reasonable physical condition and weight (BMI < 30)
Documented pain/impact on quality of life
(VAS, ODI, SF-12/36)
Exclusion
Allergies to device materials
Congenital bony or spinal abnormalities
Spondylolisthesis
Spinal stenosis (severe)
Spinal segment instability
Facet degeneration
Schmorls nodules or endplate irregularities
Osteoporosis
Infection or malignancy
Significant emotional or psychological issues
As noted previously, this represents a general list of criteria suggested for the application of current nucleus arthroplasty technologies. As the medical community continues to gain more
clinical experience with these technologies, the criteria will certainly change. However, in the early stages, the ability to strictly
adhere to the inclusion and exclusion criteria defined for a particular technology will be of the utmost importance in obtaining
encouraging clinical results.
4. Coppes MH, Marani E, Thomeer RT, Groen G. Innervation of painful lumbar discs. Spine. 1997; 22 (20):23422349.
5. Kirkaldy-Willis WH. Managing low back pain. NY. 1983. Churchill Livingstone.
6. Urban JPG, Roberts S and Ralphs JR. The nucleus of the intervertebral disc
from development to degeneraion, Amer.Zool. 2000; 40:53-61.
7. Chan D, Song Y, Sham P, Cheung K. Genetics of disc generation. Eur Spine J.
2006; 15:S317-325 (2006).
8. Kettler A, Wilke H-J. Review of existing grading systems for cervical or lumbar
disc and facet joint degeneration. Eur Spine J. 2006; 15:705718.
9. Moore RJ. The vertebral endplate: disc degeneration, disc regeneration. Eur
Spine J. 2006; 15(S3):S333S337.
10. Modic MT, Steinberg PM, Ross JS, Masaryk TJ, Carter JR. Degenerative disc
disease assessment of changes in vertebrae with MR imaging. Radiology.
1988; 166:193199.
11. Auerbach JD, Johannessen W, Borthakur A, Wheaton AJ, Dolinskas CA,
Balderston RA, Ravinder R, Elliot DM. In vivo quantification of human lumbar disc degeneration using T1-weighted magnetic resonance imaging. Eur.
Spine J. 2006: 15(S3):S338344.
12. Yoon ST, Patel NM. Molecular therapy of the intervertebral disc. Eur Spine J.
2006; 15(S3):379388.
13. Aprill C, Bogduk N. Highintensity zone: A diagnostic sign of painful lumbar disc on magnetic resonance imaging. Br J Radiol. 1992; 65:361369.
14. Peng B, Hou S, Wu W, Zhang C, Yang Y. The pathogenesis and clinical significance of a high-intensity zone (HIZ) of lumbar intervertebral disc on MR
imaging in the patient with discogenic low back pain. Eur Spine J. 2006;
15:583587.
15. Schellhas KP, Pollei SR, Gundry CR, Heithoff KB. Lumbar disc high-intensity
zone: Correlation of magnetic resonance imaging and discography. Spine.
1996; 21:7986.
16. Carragee EJ, Paragiou SJ, Khurana S. 2000 Volvo award winner in clinical
studies: lumbar high-intensity zone and discography in subjects without low
back problems. Spine. 2000; 25(23):298792.
17. Rankine JJ, Gill KP, Hutchinson CE, Ross ER, Williamson JB. The clinical significance of the high-intensity zone on lumbar spine magnetic resonance
imaging, Spine. 1999; 24(18):1913-20.
18. Peh WGC. Provocative discography: current status. Biomed Imaging Interv J.
1(1): e2.
19. Ray CD. The PDN prosthetic disc nucleus device. Eur Spine J. 2002;
11(S2):S137S142.
20. Shim CS, Lee SH, Park CW, Choi WC, Choi G, Choi WG, Lim SR, Lee HY.
clinical results. J Spinal Disord Tech. Aug 2003; 16(4):324-330.
21. Bertagnoli R, Karg A, Voigt A. Lumbar partial disc replacement. Orthop Clin
N. Am. 2005; 36:341347.
17
Chapter 16
The Basis for Nucleus

Replacement Surgery:
Current Techniques
Eddie H. Chung, MD
CLINICAL FELLOW
The Spine Institute, Santa Monica

Los Angeles, CA 90404
Ben P. Pradhan, MD, MS

DIRECTOR OF CLINICAL RESEARCH

Hyun W. Bae, MD
DIRECTOR OF RESEARCH

KEYPOINTS
Degeneration of the spine may be due to familial inheritance,
age-related changes, or traumatic physical loading.
The use of Nucleus Arthroplasty technology has been indicated for early stage degenerative disc disease and prevention
of disc degeneration progression status post discectomy.
The degree of nuclectomy is an important consideration when
determining the optimal nucleus arthroplasty treatment system.
The amount of nucleus removal places differing mechanical
constraints on a nucleus arthroplasty device.
A vast array of nucleus arthroplasty implants are currently
available including hydrogels, polymer/synthetics, and
mechanical devices.
18
INTRODUCTION
he goal of this chapter is to discuss the basis for nucleus

replacement surgery. Key elements of this discussion are the
intervertebral disc construct and degenerative process. As such, a
brief review of the intervertebral disc structure and pathophysiology of disc degeneration is provided to establish a basis for
understanding the current nucleus arthroplasty concepts and
corresponding strategies.
DISC STRUCTURE
The intervertebral disc is composed of three concentrically
arranged sets of tissue. The outermost layer is a thick fibrous
ring of dense, highly organized Type I collagen called the annulus fibrosus. The cells found in the annulus have an ellipsoidal
morphology, similar to fibroblasts that produce Type I collagen
in response to deformation. The second layer is a fibrocartilaginous layer that is larger in size, however, less organized than the
annulus fibrosus, consisting predominantly of Type II collagen.
Cells found in this middle layer are a mixture of annular and
nuclear cells. The innermost layer, the nucleus pulposus, is also
dominated by Type II collagen arranged in a more random fashion. The cells found in the nucleus are initially notochordal in
origin, but are replaced by chondrocyte-like rounded cells during
early adulthood. These cells produce fine Type II collagen fibrils
and proteoglycans in response to large hydrostatic and osmotic
pressures. The high concentration of proteoglycans within the
nucleus provides for great strength in axial compression due to
their high water binding properties.1
Other changes that occur during degeneration include cell senescence, tissue dehydration, modification of the matrix proteins,
loss of aggregating proteoglycans, accumulation of degraded
macromolecules and apoptotic debris, increases in the degradative enzyme activity, decreases in the viable cell concentration,
and fatigue failure of the matrix.5
Currently, the most widely accepted theory of intervertebral disc
degeneration pathophysiology is a three-stage approach described
by Kirkaldy-Willis. Stage I describes the acute pain of an initial
insult occurring in the early 20 to 30 years of life. This is the beginning of what Kirkaldy-Willis described as the degenerative cascade.6 Repetitive microtrauma to the vertebral endplates and
motion segment result in ischemic events that compromise the
nutritional and metabolite transport to the disc. Microtrauma may
also be a possible cause for proteoglycan fragmentation that has
been shown to begin as early as childhood. This decrease in the
amount of nuclear aggregating proteoglycans in turn, decreases disc
hydration and resiliency. Type II collagen fibrils are replaced by
Type I collagen in the inner annulus, as the annulus encroaches on
the nucleus.7 This gradual advancement of the annulus, in addition
to its increase in load bearing, may be responsible for the annular
tears known to begin during this first stage.8 Clinically, pain in this
stage is usually intermittent and self-limiting.
CURRENTLY, THERE ARE MULTIPLE HYPOTHESES TO

EXPLAIN THE PROCESS OF DISC DEGENERATION. A
GROWING BODY OF EVIDENCE THROUGH TWIN STUDIES
SUPPORTS GENETICS AS THE PREDOMINANT FACTOR
IN DISC DEGENERATION.
DISC DEGENERATION
Currently, there are multiple hypotheses to explain the process of
disc degeneration. A growing body of evidence through twin studies
supports genetics as the predominant factor in disc degeneration.2
Degeneration through the simple wear and tear of aging has been
identified as a cause less frequently, and a very small percentage of
discs degenerate through physical loading or trauma.3
The pathophysiology of disc degeneration may be independent
of the epidemiological cause, but has also been shown to be
multifactorial in nature. A decline in nutritional and waste
transport seem to be the most critical events that occur within
the disc. This may be associated with the age-related increase in
disc size as well as the decreasing number of peripheral arteries.4
Stage II, or the instability stage, is a progression from Stage I with

continued disc degeneration, dehydration, and loss of disc height.
The disc space collapse occurs from trabecular microdamage of
the vertebral endplate and subsequent structural collapse. This
allows the nucleus to migrate or decompress into the endplate,
increasing the compressive load borne by the annulus.9 This loss
of hydrostatic nuclear pressure causes the annulus to bulge radially both outward and inward, therefore decreasing annular and
overall disc height.7 The loss of height and continued annular
tearing act as contributing factors that promote instability of the
motion segment. This stage of degeneration may carry on into the
fifth decade of life. Clinically, it presents as more severe episodes
of low back pain with longer periods of duration.
19
NUCLEUS ARTHROPLASTY HAS BEEN INDICATED FOR THE TREATMENT OF

EARLY STAGE DEGENERATIVE DISC DISEASE WITH AN INTACT ANNULUS OR
STATUS POST MICRODISCECTOMY PROCEDURES WHERE NUCLEAR MATERIAL
HAS BEEN REMOVED.
Stage III, known as the stabilization stage, usually occurs in the

60 and older population. Destruction of the vertebral endplates
and gross fissuring of the annulus have now reversed the previous ischemic insult and caused the blood and nerve supply to
the disc to increase.10 This increase in nutritional and metabolite
transport increases the presence of catabolic cells, metalloproteinases, and cytokines resulting in resorption of the nucleus.11
The damage to the annular and nuclear cells, in addition to the
tremendously increased compressive mechanical environment,
makes any attempt at repair impossible.12 Disc resorption continues on to its final phases leading to endstage disc collapse,
endplate destruction, disc fibrosis, and osteophyte formation.
Clinically, during this stage back pain typically decreases, while
leg pain increases due to the narrowing and collapse of the
neural foramen and lateral recesses.
This degenerative cascade occurs in a continuum with all three
stages blending into one another and possibly occurring simultaneously. Depending on the causative nature of the degenerative
process, there may also be a much earlier or delayed shift in the
timeframe at which these stages present.6
TREATMENT FOR DEGENERATIVE

DISC DISEASE (DDD)
The search continues for an optimal treatment option for degenerative disc disease (DDD), particularly in younger patients and
patients status post discectomy procedures. The ideal treatment
would be some form of biologic therapy that can stimulate tissue
regeneration or repair. Protein (BMPs, TGF-B, IL-1), intradiscal
gene, and cell therapies (autologous or allograft stem cells) are all
currently under investigation and appear to be future possibilities.13
Traditionally, treatment of degenerative disc disease has been
limited to some form of fusion procedure. However, the success
rates of fusion techniques to address discogenic pain have been
highly variable in the literature.14 The increase in stiffness of the
fused segment also increases stress transfer to adjacent levels,
20
often times resulting in the need for further surgical interverntion.15 The term motion preservation has been the catch-all
phrase to describe different non-fusion treatment options that
could potentially avoid the risk of adjacent segment degeneration and subsequent surgery. Total disc arthroplasty, facet
arthroplasty, motion stabilization, and nucleus arthroplasty are
all technologies that fall within this motion preservation category. The remainder of this chapter will focus on the basis for
nuclear replacement technologies.
NUCLEUS REPLACEMENT
Nucleus arthroplasty has been indicated for the treatment of
early stage degenerative disc disease with an intact annulus or
status post microdiscectomy procedures where nuclear material
has been removed. Currently, the available and developing
devices are either implantable or injectable materials that replace
a portion of the nucleus pulposus. Their purpose is to help preserve the geometry of the intervertebral disc and maintain the
motion of the disc space.16
Early nucleus arthroplasty device concepts, dating back to the
1950s, were focused on replacement of the nucleus with stainless steel ball bearings, silicone rubber, and polymethylmethacrylate (PMMA) cement.17, 18, 19 These devices failed mainly due to
our poor understanding of disc biomechanics, subsidence issues,
and implant/bone material properties. Significant advances in
our understanding of past issues and observation of device failure modes have brought us to a recent growth of new investigational nuclear implants and therapies. Todays new generation
of product offerings include hydrogels, polymers/synthetics, and
mechanical forms. These arthroplasty systems vary in their
application depending on whether treatment is for degenerative
disease or as an adjunct to discectomy. In addition, there are also
surgical approach-related and nucleus removal or degree of
nuclectomy considerations that must be evaluated to determine
an optimal treatment system.
The degree of nuclectomy is an important concept as it provides

insight as to which implants physical properties and mode of
function will be best suited for a particular treatment. The amount
of nucleus removal places differing mechanical constraints on the
arthroplasty device. Some devices may not be well suited to the
mechanical demands after a total nuclectomy. Conversely, other
devices may not be able to be properly placed after a small or partial nuclectomy. To obtain a clear functional understanding of terminology for our discussion, the degree of nuclectomy has been
classified below based on the percentage of nucleus removed:
Partial
Subtotal
Total
0-33%
34-66%
67-100%
Currently, the two main indications for nucleus arthroplasty

technologies are as an adjunct to discectomy and for treatment
of DDD. In the case of discectomy for a patient with little evidence of disc degeneration, the nuclear material has already been
disclocated and typically causes leg pain. Removal of the offending fragment provides reliable pain relief regardless of whether a
nucleus arthroplasty procedure is performed. The basis for using
arthroplasty in this indication lies in the belief that if the herniated nucleus is replaced, further symptomatic disc degeneration
can be delayed or prevented. For this scenario, it is hard to justify a complete or subtotal nuclectomy as the majority of the
native nucleus remains viable. Subsequently, the mechanical
demands placed on an arthroplasty device would be less vigorous than that of a total nuclectomy. Thus, nucleus arthroplasty
devices that require little or no nucleus removal may be best
suited for this type of patient.
In the case of DDD, the patient often presents with more advanced
stages of nucleus degeneration, disc collapse, and mechanical low
back pain. This patient may have little, if any, viable nucleus left and
may require a robust implant that can withstand the biomechanical
demands of the intervertebral disc after complete nuclectomy. In such
instances, a nucleus arthroplasty device designed to support or share
load after a more complete nuclectomy may be best suited for this
type of patient.
is uncertain. Devices that require subtotal nuclectomies may be

suited for this patient. However, an argument can be made that a
total nucleus arthroplasty is a more reliable procedure. In actuality,
once approved, all nuclear replacement technologies (partial,
subtotal, or total nuclectomy) will be competing for this group of
patients to varying degrees.
The classification system described above is by no means a recommendation linking use of a specific device type to a certain
indication. It is meant to serve as guide for the reader to organize, differentiate, and understand the basis for the numerous
nucleus arthroplasty technologies coming to market; below is a
short synopsis of the technologies.
Hydrogels
Hydrogels are preformed materials that have water absorbing
properties that allow the device to expand and maintain disc
height. Hydrogels also release water gradually in order to provide resistance against compression, similar to a natural
nucleus. There are three major competitors with hydrogels on
the market, each with a different design, but all with similar
water absorbing/releasing properties.
HYDROGELS ALSO RELEASE WATER GRADUALLY

IN ORDER TO PROVIDE RESISTANCE AGAINST
COMPRESSION, SIMILAR TO A NATURAL NUCLEUS.
PDN-SOLO and HydraFlex are two different generations of a

nuclear replacement from Raymedica. The PDN-SOLO is a
third-generation device in which a rectangular-shaped hydrogel
core is encased in a woven high molecular weight polyethylene
covering. The recommended surgical approach for implantation
is either posterior or direct lateral (trans-psoas), and it may be
used in conjunction with microdiscectomy.
These cases are for classification purposes only. Many of our

patients will present with varying degrees of disc prolapse, nucleus
degeneration, and both back and leg pain in the continuum of
DDD. A common example is the patient with a recurrent disc herniation who also has signs of disc degeneration with back and leg
pain. This patient still has some remaining nucleus, but its viability
21
TABLE 1: CURRENT REVIEW OF DEVICES, INDICATIONS, APPROACHES AND NUCLECTOMY REQUIRED FOR INSERTION.
Device
Indication
Clinical Trial
Approach
Nuclectomy
PDN-SOLO
DDD/Discectomy
No
AL, Lat, Post
Subtotal/Total
HydraFlex
DDD
Yes
AL, Lat
Subtotal/Total
Neudisc
DDD
No
EPL, Post
Subtotal
Geliflex
Discectomy
No
Post
Partial
DASCOR
DDD
Yes
AL, Lat
Total
NuCore
Discectomy/DDD
Yes
Post, Perc
Partial
SINUX ANR
Discectomy
No
Post
Partial
EBI Regain
DDD
Yes
AL
Total
NUBAC
DDD
Yes
AL, Lat, Post
Subtotal
AL=Anterior Lateral, Lat=Lateral or Direct Lateral, Post=Posterior, EPL=Endoscopic Posterior Lateral, Perc=Percutaneous
Design improvements upon the PDN-SOLO implant have led to

the fourth generation HydraFlex device which offers distinct
new features. A larger and softer hydrogel core have increased
the size of the footprint and improved upon any problems with
implant subsidence. The material properties have also changed
to allow the HydraFlex device to absorb water and hydrate
quicker. The surgical approach for placement of the device has
changed to an anterolateral retroperitoneal (ARPA) entry. This
approach provides better access to the disc space to facilitate
nucleus removal and allows the annulus to be repaired on the way
out. Both of these devices require a subtotal/total nucleus removal.
Neudisc (Replication Medical, Inc) is a subtotal nuclear
replacement that is a partially hydrolyzed multiblock acrylic
copolymer. During hydration, the device material can absorb up
to 90% of its own weight in water. It does, however, release water
when compressed to provide resistance against axial loading.
Insertion of the Neudisc is best performed through an anterolateral
retroperitoneal approach to allow access to the disc space.
Geliflex SP/IP (Synthes, Inc.) devices are room temperature liquids that harden inside the disc at body temperature. Once
hardened, the material is able to absorb water and expand, similar to the above mentioned hydrogels. The greatest difference
with this technology is that the material can be injected in liquid form which provides for a more minimally invasive procedure. Only partial or subtotal nuclear replacement is required
for injection/placement.
22
Polymer/Synthetics
The polymer/synthetics group is largely composed of injectable
liquid materials that solidify once reaching body temperature.
The concept is very similar to the Geliflex, however, these polymers do not have water binding capacity. Within this group,
there are again three major competing products.
DASCOR (Disc Dynamics, Inc.) is a two-part curable
polyurethane used with an expandable polyurethane balloon.
After a total nucleus removal, the balloon is placed in the disc
space and then injected with the flowable polymer that conforms
to the evacuated nuclear cavity. The polymer can be delivered
through a small annulotomy. This minimally invasive approach
helps to prevent implant extrusion.
NuCore (Spine Wave, Inc.) is an injectable material that is a
combination of a chemical cross-linking agent and a silk elastin
polymer that are mixed just prior to injection. NuCore is indicated for use right after performing a microdiscectomy. The partial discectomy cavity is filled with the injectable liquid which
has tremendous adhesive properties once solidified. The adhesion to the annulus coupled with the small entry hole and larger
solidified implant size help to resist device extrusion.
SINUX ANR (Sinitec, AG/DePuy Spine, Inc.) is a liquid polymethylsiloxane polymer that may be used to treat degenerated discs or as
an adjunct to microdiscectomy when addressing disc herniation.
Device insertion is achieved using a standard posterior approach for
microdiscectomy. However, this technique recommends suturing
of the annulus to prevent posterior extrusion.
Mechanical Implants
REFERENCES
Mechanical implants consist of single or multi-component

devices made of hard materials or metals.
1. Buckwalter JA, Mow VC, Boden SD, Eyre DR, Weidenbaum M. Intervertebral
disc structure, composition, and mechanical function. In: Buckwalter JA,
Einhorn TA, Simon SR, editors. Orthopaedic Basic ScienceBiology and biomechancis for the musculoskeletal system. 2nd ed. Rosemont: American
Academy of Orthopaedic Surgeons, 2002:548-55.
EBI Regain (Biomet, Inc.) is a one-piece, anatomically conforming device composed of pyrolytic carbon. The modulus of elasticity of the implant material is equivalent to bone. In addition, the
implant surface is highly polished to prevent damage to the cartilaginous endplate during motion. Total nucleus removal is required
to accommodate placement of the device via an anterolateral
retroperitoneal or direct lateral approach.
NUBAC (Pioneer Surgical Technology) is a two-piece implant
construct made from PEEK-OPTIMA LT1. The concave superior
endplate and convex inferior endplate form a ball and socket
joint. The device is designed to allow uniform stress distribution
under different loading conditions, while minimizing potential
subsidence and extrusion risks. Placement of the device requires
subtotal nuclear removal and can be accomplished using an anterior, anterolateral or even posterior approach. Retention of as
much annular tissue as possible is recommended.
CONCLUSION
2. Battie MC, Videman T. Lumbar disc degeneration: epidemiology and genetics.

J Bone Joint Surg Am. 2006 Apr;88 Suppl 2:3-9.
3. Battie MC, Videman T, Gibbons LE, Fisher LD, Manninen H, Gill K. 1995
Volvo Award in clinical sciences. Determinants of lumbar disc degeneration. A
study relating lifetime exposures and magnetic resonance imaging findings in
identical twins. Spine. 1995 Dec 15;20(24):2601-12.
4. Urban JP, Smith S, Fairbank JC. Nutrition of the intervertebral disc. Spine.
2004 Dec 1;29(23):2700-9.
5. Setton LA, Chen J. Cell mechanics and mechanobiology in the intervertebral
disc. Spine. 2004 Dec 1;29(23):2710-23.
6. Yong-Hing K, Kirkaldy-Willis WH. The pathophysiology of degenerative disease of the lumbar spine. Orthop Clin North Am. 1983 Jul;14(3):491-504.
7. Brinckmann P, Grootenboer H. Change of disc height, radial disc bulge, and
intradiscal pressure from discectomy. An in vitro investigation on human
lumbar discs. Spine. 1991 Jun;16(6):641-6.
8. Boos N, Weissbach S, Rohrbach H, Weiler C, Spratt KF, Nerlich AG.
Classification of age-related changes in lumbar intervertebral discs: 2002 Volvo
Award in basic science. Spine. 2002 Dec 1;27(23):2631-44.
9. Adams MA, McNally DS, Dolan P. Stress distributions inside intervertebral
discs. The effects of age and degeneration. J Bone Joint Surg Br. 1996
Nov;78(6):965-72.
Degeneration of the spine may be due to familial inheritance,

age-related changes, or traumatic physical loading. Independent
of the cause, the pathophysiology of degenerative disc disease
has been shown to be irreversible if left untreated. Recently,
motion preservation technologies have begun to emerge in an
attempt to advance the continuum of care and offer alternatives
to treatment using fusion. Of these emerging technologies,
nucleus arthroplasty has been indicated for early-stage degenerative disc disease and prevention of disc degeneration progression
status post discectomy.
10. Melrose J, Roberts S, Smith S, Menage J, Ghosh P. Increased nerve and blood
vessel ingrowth associated with proteoglycan depletion in an ovine anular lesion
model of experimental disc degeneration. Spine. 2002 Jun 15;27(12):1278-85.
While initial attempts to replace the nucleus failed, significant

advances in our understanding of spinal biomechanics, implant
material, and implant failure modes have led to the development
of a multitude of new nucleus arthroplasty technologies. The
ability to understand and classify the degree of nuclectomy
required for the optimal use of such devices will be an important
factor. Currently, a number of FDA clinical trials are underway to
investigate the safety and efficacy of these potentially preventive
and adjunctive treatment devices.
15. Gillet P. The fate of the adjacent motion segments after lumbar fusion. J Spinal
Disord Tech. 2003 Aug;16(4):338-45.
11. Nerlich AG, Schleicher ED, Boos N. 1997 Volvo Award winner in basic science
studies. Immunohistologic markers for age-related changes of human lumbar
intervertebral discs. Spine. 1997 Dec 15;22(24):2781-95.
12. Setton LA, Chen J. Mechanobiology of the intervertebral disc and relevance
to disc degeneration. J Bone Joint Surg Am. 2006 Apr;88 Suppl 2:52-7.
13. Evans C. Potential biologic therapies for the intervertebral disc. J Bone Joint
Surg Am. 2006 Apr;88 Suppl 2:95-8.
14. Hanley EN Jr, David SM. Lumbar arthrodesis for the treatment of back pain.
J Bone Joint Surg Am. 1999 May;81(5):716-30.
16. Sieber AN, Kostuik JP. Concepts in nuclear replacement. Spine J. 2004
Nov-Dec;4(6 Suppl):322S-324S.
17. Mckenzie AH, Fernstrm V. Intervertebral disc arthroplasty: a long-term
evaluation. Orthop Int 1995;3:313-24.
18. Hamby WB, Glaser HT. Replacement of spinal intervertebral discs with locally
polymerizing methylmethacrylate: experimental study of effects upon tissues
and report of a small clinical series. J Neurosurg. 1959 May;16(3):311-3.
19. Hou TS, Tu KY, Xu YK, Li ZB, Cai AH, Wang HC. Lumbar intervertebral disc
prosthesis. An experimental study. Chin Med J (Engl). 1991 May;104(5):381-6.
23
Chapter 17
Intervertebral Disc Space

Preparation for Nucleus
Arthroplasty Technologies
Alejandro Reyes-Snchez, MD
HEAD OF SPECIAL SURGERY DIVISION
National Rehabilitation Institute

Mexico City, Mexico 10700


Baltimore, MD 21204
Rick Delamarter, MD
MEDICAL DIRECTOR
The Spine Institute

Santa Monica, CA 90404
KEY POINTS
Nucleus Arthroplasty technology is relatively new with very
little information on proper disc preparation.
Nucleus arthroplasty requires the surgeon to focus special
attention on sparing the annulus, maintaining endplate
integrity, and nucleus pulposus removal.
The annulotomy associated with nucleus arthroplasty surgery
may be performed anteriorly or posteriorly; each method has
its own advantages and disadvantages.
Damage to the endplates during nucleus removal may induce
Modic changes that impact endplate mechanical properties
potentially leading to endplate subsidence.
Atraumatic nucleus removal can be performed using a variety
of techniques; a number of new technologies have emerged to
address this need.
24
INTRODUCTION
Posterior Approach:
When approaching the annulus posteriorly, direct repair is difficult, if not impossible. Annular repair devices for use in such
instances are being developed. But in the interim, it is desirable
to make a small incision that can then be carefully dilated to
allow for nucleus removal and subsequent device placement.
There is evidence indicating that this technique may allow the
annular tissue to fibrose forming organized scar tissue that acts
like a plug to aid in preventing device extrusion through the
annulotomy site. Device extrusion can also be minimized by
ensuring that the final location is not directly in line with the
axis of implantation.
isc space preparation has historically been guided by placement of interbody fusion devices and more recently, total
disc replacements (TDR). The hallmark disc preparation for
these devices is destruction of the cartilaginous endplate to
stimulate bony integration with little attention paid to annular
integrity. In the case of interbody fusion, the intended result
is bony ingrowth with subsequent elimination of motion.1
Conversely, while bony ingrowth is promoted to fix the endplate
components of the TDR, the intent is for motion to be maintained. With the introduction of nucleus arthroplasty, careful
attention to annulus sparing techniques and maintenance of the
cartilaginous endplate are paramount to a successful outcome.
Accordingly, surgical techniques have been tested and developed
to accomplish these goals. This chapter is intended to inform
the reader on the latest developments in disc space preparation
for nucleus arthroplasty.
The process of preparing the disc space for the introduction
of a nucleus replacement device can be simply divided into the
following five steps:
It is also very important to minimize the removal and/or disruption of posterior ligamentous and bony structures. Thus, the
amount of laminar bone removal, facet removal, and muscular
dissection should be kept to a minimum to reduce posterior
instability. Preservation of the posterior spinous and interspinous ligaments also helps to achieve this goal. A total
laminectomy can cause significant segmental instability when
compared to a carefully performed laminotomy.3
1) Annulotomy
2) Nucleus Pulposus Evacuation
Anterior Approach:
3) Cartilaginous Endplate Protection
The anterior approach offers several advantages with regard to

annular integrity when compared to the posterior approach. The
annulus tends to be thicker, more robust and free of herniations,
tears or defects. The tissue quality in this region allows the creation of an annular flap that can be later sutured closed versus
the tissue removal associated with a box style annulotomy.
Ideally, the flap is created by making a through cut laterally at
the border of the psoas muscle and then projecting the outer six
to ten layers of the annulus medially such that the attached or
hinged portion is located at the border of the anterior longitudinal ligament (ALL). This produces a flap that is roughly 5-7mm
in thickness with a length of 17-18mm laterally. Creating the flap
in this manner maintains the structural integrity of the ALL and
allows for subsequent suture reinforcement to form a physical
barrier to device expulsion. An I shaped incision is then made
through the remaining layers to access the disc space. Care must
be taken to protect the nerve when making the through cut at
the psoas due to the close proximity of the nerve root (~5mm).
4) Verification of Nucleus Evacuation

5) Assessment of the Evacuated Disc Space
1) ANNULOTOMY
It is well known that producing a transverse annulotomy incision can result in a propagation of a radial tear with resultant
instability, while the use of a vertical incision has a significantly
reduced impact on overall annular stability and disc function.2
Some surgical techniques for nucleus arthroplasty require the
creation of an annular flap. The annular incision should be carefully planned and positioned to maximize later repair and maintain overall integrity of the annulus. Ideally, the incision should
be created to allow adequate access to the disc space to ensure
removal of the greatest volume of degenerated tissue, while
maintaining a reasonable volume of viable annular tissue for
suture closure to enable more rapid healing and restore normal
segmental stability.
25
2) NUCLEUS PULPOSUS EVACUATION

Nucleus arthroplasty, unlike a simple discectomy, requires that
varying amounts of nucleus pulposus be removed based on the
device being considered. Further, unlike preparation for interbody fusion or total disc arthroplasty, this nuclectomy must be
accomplished without disrupting the cartilaginous endplates or
further damaging the fibrous annulus. Historically, nucleus evacuation has been achieved by a variety of means. Automated percutaneous lumbar discectomy (APLD) is one such technique.
When performing APLD, the patient is placed under IV sedation. Fluoroscopic guidance is then used to guide a 2mm tubular
dissector into the center of the nucleus pulposus. The instrumentation removes the disc material by combining suction with
an enclosed guillotine cutting blade that is positioned at the tip.
Once an initial passage has been created, more aggressive dissectors of larger diameter can be used; however, the degree of
nucleus removal with this technique is currently not satisfactory
for nucleus arthroplasty procedures.
Similarly, minimally invasive and percutaneous removal techniques have been employed using laser ablation and bi-portal
mechanical removal. Enzymatic dissolution with chymopapain
has also been employed in certain instances, but is not currently
available in the United States. While all these techniques require
only minor disruption of the annulus, these approaches are also
quite limited in ability to provide adequate nucleus removal.
Currently, the application of mechanical resection modalities
remains the standard. The use of 5mm pituitary rongeurs with
a straight, upbite and downbite orientation provides the most
consistent nucleus cleanout. Removal is initiated in a straight
longitudinal fashion and subsequently towards each quadrant
within the nuclear space. Special attention must be given to the
area immediately adjacent to the annulotomy which is the most
difficult to reach. The most common finding in the degenerated
disc is desiccated nucleus material that can be difficult to distinguish from annulus fibrosus when using the rongeur. As it is
critically important to avoid damaging the annulus to preserve
the nuclear container, caution must be exercised. Of significant
benefit is the injection of saline into the disc space. The saline is
rapidly absorbed by the remaining nucleus which then swells,
becoming easier to grasp and remove. When using a posterior
approach, advanced imaging should be used to identify the location of any potential herniations or extruded fragments so the
surgery can be performed while maintaining as much annular
integrity as possible. If a lateral approach (ALPA) is used,
26
UNLIKE PREPARATION FOR INTERBODY FUSION OR

TOTAL DISC ARTHROPLASTY, THIS NUCLECTOMY
MUST BE ACCOMPLISHED WITHOUT DISRUPTING THE
CARTILAGINOUS ENDPLATES OR FURTHER DAMAGING
THE FIBROUS ANNULUS.
Figure 1
Figure 2
care must be taken to ensure that there are no breaches in the

posterior annulus or extruded fragments in the canal.
Other technologies for more automated tissue resection are evolving
and may eventually be appropriate for intradiscal use. These include
the Spine-Jet (HydroCisionBillerica, MA, USA) and the MDS
FlexTip tissue shaver (EndiusPlainville, MA, USA).
HydroCision: When used for nucleus arthroplasty, the proprietary fluidjet technology of the SpineJet MicroResectors will
selectively hold, cut and remove the nucleus pulposus quickly
and safely without damaging the surrounding annulus. It
incorporates a retrograde-flowing fluidjet directed into an
evacuation tube forming a precise 1.5mm tissue-cutting window that will only consume tissue entering it. The high velocity
fluidjet (600 mph) creates a Venturi effect that simultaneously
pulverizes and removes the tissue away from the surgical site
(Figures 1 & 2).
Endius: The Endius FlexTip, consisting of a flexible shaver

blade and flexible hand held rongeurs, provides surgeons with
efficient and effective disc removal, while improving the levels
of control and maneuverability within the intervertebral disc
space. The FlexTip shaver blade allows tissue to be efficienctly
removed when performing a full or partial nuclectomy.
Simultaneous suction and irrigation, combined with an automated steerable distal tip that articulates up to 90o in one direction, allows the surgeon to perform a complete discectomy
efficiently using only one instrument (Figures 3 & 4).
Such systems can potentially be enhanced by pre-administration
of an enzymatic agent facilitating nucleus digestion and removal.
Automated and effective removal of nucleus pulposus will greatly
enhance efficiency and, ultimately, the clinical outcomes of
nucleus arthroplasty procedures.
Figure 3
Figure 4
3) CARTILAGINOUS ENDPLATE PROTECTION

Maintaining the integrity of the cartilaginous endplate is of the
utmost importance when considering nucleus arthroplasty.
Extreme care must be taken to avoid damage to the cartilaginous surfaces during nucleus pulposus evacuation as damage
may induce postoperative Modic changes. Modic endplate
changes, generally associated with painful pathology in the
minds of most spine specialists, are well recognized yet poorly
understood. There is limited clinical data regarding the correlation of postoperative Modic changes and long-term outcomes.
However, such changes will be viewed as undesirable, rightfully
or wrongfully so, until full clinical and physiological understanding of this phenomenon emerges. It is therefore imperative
to minimize endplate trauma to enhance outcomes.
Treatment of the endplate for the use of a nuclear arthroplasty
device must be completely different from the procedures used
to prepare the endplate for contact with ingrowth surfaces or
fusion devices. The issue of implant subsidence noted in total
disc or nucleus replacement procedures may in a large part be
due to injury of the vertebral endplate during the surgical
preparation. As such, the use of bone rasps or curettes should
be avoided. In addition, any distraction necessary to gain access
to the intervertebral space should be limited to the apophyseal
ring region where the bone is much stronger, as opposed to the
center portion, where fracture or subsidence are more likely to
occur. Improper placement of the distractor can cause
microfractures in the subchondral bone significantly increasing
the risk of implant subsidence. It should also be noted, that
care must be taken during the subsequent disc space sizing and
implant insertion procedures as these activities may also result
in endplate microfractures.
4) VERIFICATION OF NUCLEUS EVACUATION

THE ISSUE OF IMPLANT SUBSIDENCE NOTED IN TOTAL
DISC OR NUCLEUS REPLACEMENT PROCEDURES MAY
IN A LARGE PART BE DUE TO INJURY OF THE VERTEBRAL ENDPLATE DURING THE SURGICAL PREPARATION.
As noted previously, removal of the degenerated nucleus represents a crucial step when considering the use of a nucleus
replacement device. Prior to device insertion, the space must be
evaluated to ensure adequate nucleus removal. This can be
accomplished using various methods that incorporate the use
of fluoroscopy. The most effective method is the use of contrast
medium in combination with anterior-posterior and lateral fluoroscopic imaging.4 However, the ability to effectively use contrast may be limited by factors such as the surgical approach,
27
IN ORDER TO OBTAIN A TRUE ASSESSMENT OF THE DISC SPACE AFTER

NUCLEUS EVACUATION, IT IS BEST TO MEASURE THE SPACE INTRAOPERATIVELY, WITH ATTENTION GIVEN TO ASSESSING THE DISC SPACE
IN ITS NATURAL LORDOTIC STATE.
patient positioning that may not allow retention of the medium

within the disc space, or other issues such as the potential for
allergic reaction. As an alternative, a ball end probe can be used
in conjunction with fluoroscopic imaging to define the borders of
the evacuated space. The use of the probe has the advantage of
providing the surgeon with the tactile feel necessary to detect differences in tissue quality along the borders of the disc space.
While the probe is easy to visualize in anterior-posterior and lateral views, the limited size of the probe tip and its relatively
small contact area make it difficult to positively confirm complete evacuation of the volumetric space. An ideal method
would be to visualize the disc space directly using endoscopic
methods to ensure nucleus evacuation while assessing the
integrity of the annulus fibrosus. However, the use of an open
technique may be more complicated and overly burdensome
compared to the simple and practical methods described above.
5) ASSESSMENT OF THE EVACUATED DISC SPACE

Ideally, the patients spinal condition and disc space could be
fully characterized by the use of imaging prior to surgery.
While the use of magnetic resonance imaging (MRI) is integral
to this process, the resolution of such systems can be limiting;
slice thicknesses are commonly on the order of 4mm. The use
of plain film radiographs (anterior-posterior and lateral) can
be useful in such analyses, but radiographic images are also
prone to a certain margin of error (2.3 to 4.5%). In order to
obtain a true assessment of the disc space after nucleus evacuation, it is best to measure the space intra-operatively, with
attention given to assessing the disc space in its natural lordotic
state. Thus, the introduction of a distractor or other mechanical means to gain access to the disc space must be avoided to
eliminate measurement inaccuracies. An appropriate device
28
should be capable of being inserted through the established

annulotomy and provide accurate intradiscal measurements of
the central and lateral portions of the disc space. The resulting
disc space measurements should be repeatable among different
users to ensure accurate sizing and selection of an appropriate
nucleus replacement device. The ability to measure the disc
space intra-operatively would eliminate the need for the insertion/removal of trial components, thereby reducing potential
damage to the endplates that may result in future subsidence
of the prosthesis.
REFERENCES
1. Patwardhan AG, Carandang G, Ghanayem AJ, Havey RM, Cunningham B,
Voronov LI, Phillips FM. Compressive preload improves the stability of anterior lumbar interbody fusion cage constructs, J Bone Joint Surg Am. 2003 Sep;
85-A (9):1749-56.
2. Lu WW, Luk KD, Ruan DK, Fei ZQ, Leong JC. Stability of the whole lumbar
spine after multilevel fenestration and discectomy. Spine. 1999 Jul 1;
24(13):1277-82.
3. Natarajan RN, Andersson GB, Patwardhan AG, Verma S. Effect of annular incision type on the change in biomechanical properties in a herniated lumbar
intervertebral disc. J Biomech Eng. 2002 Apr; 124(2):229-36.
4. Smith LJ, Fazzalari NL. Regional variations in the density and arrangement of
elastic fibers in the annulus fibrosus of the human lumbar disc. J Anat. 2006
Sep; 209(3):359-67.
5. Rao RD, Wang M, Singhal P, McGrady LM, Rao S. Intradiscal pressure and
kinematic behavior of the lumbar spine after bilateral laminotomy and
laminectomy. Spine J. 2002 Sep-Oct; 2(5):320-6.
6. Frobin W, Brinckmann P, Biggemann M, Tillotson M, Burton K. Precision
measurement of disc height, vertebral height and sagittal plane displacement
from lateral radiographic views of the lumbar spine. Clin Biomech (Bristol,
Avon). 1997; 12 Supp 1:S1-S63.
Chapter 18
Nucleus Arthroplasty Technology:

Approach-Related Considerations
Gary A. Fantini, MD, FACS

CLINICAL ASSOCIATE PROFESSOR OF SURGERY (VASCULAR)
Weill Medical College of Cornell University

New York, NY 10021
Salvador A. Brau, MD, FACS

CLINICAL INSTRUCTOR OF SURGERY
Geffen School of MedicineUCLA

KEY POINTS
Anterolateral retroperitoneal approach (ARPA) with the patient in
the supine position permits access for nucleus arthroplasty procedures from L2 to S1, through a limited, muscle-splitting incision.
Annular exposure of only 20mm, from one oclock to three
oclock, is all that is required to permit an annulotomy of
approximately 17-18mm.
In contrast to total disc arthroplasty and anterior spinal fusion,
vascular mobilization is necessary only on a de minimus basis at
L5-S1 and L4-L5; no mobilization is required at L3-L4 or L2-L3.
In terms of revision surgery, the risk profile of nucleus arthroplasty procedures will be more favorable than those associated
with total disc arthroplasty and anterior spinal fusion, due to
minimal vascular mobilization.
Exposure for nucleus arthroplasty procedures preserves options
for subsequent anterior spinal surgical procedures by avoiding
anterior exposure of the spine from eleven oclock to one oclock.
29
INTRODUCTION
The 21st century has witnessed the mainstream introduction of
non-fusion technologies for the treatment of low back pain.1,2
Many of these new technologies use surgical approach alternatives
that avoid disruption of the posterior muscles and ligamentous
structures that stabilize the spine.
Procedures such as total disc arthroplasty utilize a direct anterior
approach orthogonal to the midline of the vertebral body and
demand unfettered anterior spinal exposure, as precise midline
placement is necessary for optimal device function and long-term
motion preservation. Extensive mobilization of major vascular
structures is necessary in order to achieve this, thus complicating
any scenario in which anterior revision surgery is required.3,4
Additionally, there is significant disruption of the anterior and
posterior annular elements.
In contrast, nucleus arthroplasty takes a de minimus approach to
mobilization of the major vascular structures and requires only a
limited annulotomy. An anterolateral retroperitoneal approach
(ARPA) for nucleus arthroplasty has been developed.
ANTERIOR RETROPERITONEAL APPROACH (ARPA)

FOR NUCLEUS ARTHROPLASTY
ertagnoli has described an anterolateral transpsoatic approach

(ALPA) for implantation of PDN prosthetic disc nucleus
devices.5 While ARPA incorporates many of the techniques set forth
in ALPA5, there are important differences, principally in regard to
positioning of the patient and in the ability to access the L5-S1 disc
space. The patient is positioned in the supine position on the operating table, with the arms in abduction. The operating table must
accommodate the use of C-arm fluoroscopy in the antero-posterior
Figure 1
The position of incisions used during
anterolateral retroperitoneal approach
(ARPA) for nucleus arthroplasty.
30
IN CONTRAST TO TOTAL DISC ARTHROPLASTY AND

ANTERIOR SPINAL FUSION, VASCULAR MOBILIZATION
IS NECESSARY ONLY ON A DE MINIMUS BASIS
AT L5-S1 AND L4-L5; NO MOBILIZATION IS REQUIRED
AT L3-L4 OR L2-L3.
and lateral planes. The target disc level is localized through bi-planar fluoroscopy. An inflatable bladder may be placed beneath the
level of interest, to permit addition of lordosis as necessary. A small
transverse incision (4-6cm) is utilized, the location of which is
based upon the target level (Figure 1). Incisions for access to L2-L3,
L3-L4 and L4-L5 are located on the left, while the incision for access
to L5-S1 is located on the right. In all instances, the medial boundary of the incision is the lateral aspect of the rectus sheath, and the
lateral border approximates the anterior axillary line. Once through
the skin and subcutaneous tissue, the fascia of the external oblique
muscle is opened along the direction of its fibers, and the muscle is
split. The internal oblique and transversus abdominis muscles are
split along the direction of their fibers as well. Complete muscle
relaxation by the anesthesiologist greatly facilitates the process of
anterior spinal exposure.
The presence of retroperitoneal fat typically signals entrance into
the retroperitoneal space. This potential space is developed by
gently mobilizing the peritoneal sac away from the overlying
transversalis fascia through blunt dissection with a peanut
sponge or spongestick, and proceeding initially in a posterior
direction, then medial and finally anterior, in a plane along the
anterior aspect of the psoas muscle (Figure 2). Failure to move
anteriorly along the psoas muscle, and instead continuing in a
posterior and medial direction, will result in unwanted dissection posterior to the psoas muscle into the area of the
quadratus lumborum muscle.
The psoas tendon is a useful
landmark in this regard, indicating the proper tissue plane. The
ureter is swept medially, along
with the visceral sac.
Figure 2
Retroperitoneal
dissection plane.
Figure 4
Anterolateral retroperitoneal exposure
of the L4-L5 disc space. The left iliac
vessels are not disturbed, or are mobilized on a de minimus basis only, as necessary. Brau reverse-lip retractor blades
are used to maintain exposure.
Figure 3a
Orientation of annulotomy
from one oclock to three
oclock in oblique (a) and
transaxial (b) planes.
Figure 3b
Continuing medially across the anterior surface of the psoas muscle, the anterolateral aspect of the lumbar spine is encountered.
The sympathetic chain can be preserved in most instances, and
may be gently retracted anteriorly or posteriorly in order to facilitate exposure of the annulus. On occasion, the sympathetic chain
will need to be sacrificed in order to obtain the proper exposure
of the annulus, and may result in leg warmth and/or anhidrosis.
Fluoroscopic confirmation of the target disc level is obtained by
placement of a fine needle into the disc space. Fibers of the psoas
muscle are then stripped away from the lateral aspect of the disc
using a Cobb elevator. Meticulous care must be taken not to proceed too posteriorly with the dissection, as the nerve root exiting
the foramen will be in proximity and susceptible to injury
through dissection or traction. This is especially true at the L4-L5
level, as the exiting nerve root takes a more ventral course than at
L3-L4 and L2-L3. The length of annulotomy required for creation
of an annular flap and performance of nucleus arthroplasty is
approximately 17-18mm. Therefore, no more than 20mm of
annulus need be exposed. The target zone for annulotomy corresponds to an area from one oclock to three oclock, leaving the
anterior longitudinal ligament intact (Figures 3a & b).
Figure 5
Anterolateral retroperitoneal exposure
of the L5-S1 disc space. The right iliac
vessels are mobilized on a de minimus
basis. The median sacral vessels are not
disturbed. Brau reverse-lip retractor
blades are used to maintain exposure.
Once the desired annular exposure of the target disc has been
obtained, a table-mounted self-retaining retractor system
(Thompson Surgical Instruments, Inc.Traverse City, MI)
is employed to maintain exposure (Figure 4). The use of Brau
reverse-lip retractor blades6 facilitates maintenance of exposure
and allows adequate space for completion of nucleus arthroplasty
procedures (Figures 4 & 5).
In general, there should be no need for mobilization of the left
iliac vessels for exposure of the disc space at L4-L5 and above.
On occasion, access to a low-lying L4-L5 disc space may require
elevation of the left iliac vessels, on a de minimus basis. When
using ARPA, every effort should be made to avoid and/or limit
mobilization of the iliac vessels in order to preserve peri-vascular
tissue planes, should the need for surgical re-intervention arise.
SPECIAL CONSIDERATIONS
CONCERNING L5-S1 EXPOSURE
In contrast to the L2-L3, L3-L4 and L4-L5 discs, the L5-S1 disc is
approached from the right side (Figure 1). The rationale for use of
a right-sided approach in this setting is that the relatively lateral
course of the iliac vessels at the level of the L5-S1 disc demands
mobilization of the iliac vessels toward the midline (Figure 5), if
only on a de minimus basis. The median sacral vessels should
31
remain undisturbed. In the event that subsequent surgical reintervention is required, such as for total disc arthroplasty or
anterior interbody fusion, a left-sided retroperitoneal approach
through virginal tissue planes will have been preserved. Similar to
the circumstance at the L4-L5 level, the exiting nerve root at the
L5-S1 level takes a more ventral course than at L3-L4 and L2-L3.
Therefore, care must be taken not to proceed too dorsally with
stripping of the psoas muscle away from the spine. The one
oclock to three oclock orientation should be maintained.
In approximately 50% of individuals, there will be a branch
emanating from the posterolateral aspect of the right common
iliac vein. This branch is similar to, but smaller than, the ileolumbar vein on the left side. Leaving the right common iliac vein
at a right angle, this branch courses posteriorly, and must be
clipped and divided in order to rotate the vessels medially and
obtain the proper exposure.
APPROACH RELATED COMPLICATIONS

The reported incidence of major venous injury during anterior
spinal surgery is in the two to four percent range. The vast
majority of venous injuries involve the left common iliac vein,
and occur during attempts to expose the L4-L5 and L5-S1 disc
spaces when performing anterior lumbar interbody fusion or
total disc arthroplasty procedures.7
The course of the left common iliac vessels runs obliquely across
the anterior aspect of the L5 vertebral body, traversing the L4-L5
and L5-S1 disc spaces. Retraction over distances of several centimeters is routinely necessary to permit anterior lumbar interbody
fusion or total disc arthroplasty.8
In contrast, the exposure required for nucleus arthroplasty takes
a decidedly more de minimus approach to mobilization of the
major vascular structures. There is essentially no vascular mobilization required to gain access at L2-L3 or L3-L4, and only minimal mobilization required at L4-L5 and L5-S1. Therefore, the
incidence of vascular injury should be correspondingly lower
when establishing a surgical window for a nucleus arthroplasty
procedure. Management of iliac venous injury includes extension
of the incision to improve exposure, use of Trendelenburgs position, and establishing proximal and distal control through manual pressure with spongesticks or Kitner peanut dissectors. Many
venous injuries can be successfully managed in sutureless fashion,
solely by application of topical hemostatic agents.9 Failing this,
vascular repair by lateral venorrhaphy9 or endoluminal stent
grafting10 will be necessary.
32
Nerve root injury can nearly always be avoided by maintaining a

plane of dissection ventral to the three oclock axis. The ilioinguinal and iliohypogastric nerves, arising from the ventral ramus
of L1, should remain lateral to the plane of dissection, as they
course along or through the psoas muscle. Incidence of injury to
the hypogastric plexus, resulting in retrograde ejaculation, can
be minimized by allowing these sympathetic nerve fibers, which
are adherent to the peritoneal sac, to elevate and rotate en bloc
with the peritoneal sac away from the sacrum and the L5-S1 disc
space. Similarly, the ureter should also be allowed to elevate and
rotate en bloc with the peritoneal sac, thus avoiding disruption of
segmental blood supply. Traction or section of the lumbar sympathetic chain may result in leg warmth and/or anhidrosis,
which is typically benign. Abdominal asymmetry, due to denervation and subsequent weakness of the oblique muscles, should
not occur with this muscle-splitting approach.
REFERENCES
1. Guyer RD, McAfee PC, Hochshuler SH, et al. Prospective randomized study of
the Charit artificial disc: Data from two investigational centers. Spine J. 2004;
4(6 suppl):252-59.
2. Delamarter RB, Bae HW, Pradhan BB. Clinical results of ProDisc-II lumbar
total disc replacement: Report from the United States clinical trial. Orthop
Clin North Am. 2005; 36(3):301-13.
3. Bertagnoli R, Zigler J, Karg A, et al. Complications and strategies for revision
surgery in total disc replacement. Orthop Clin North Am. 2005; 36(3):389-95.
4. Wagner WH, Regan JJ, Leary SP, et al. Access strategies for revision or explantation of the Charit lumbar artificial disc replacement. J Vasc Surg. 2006;
44:1266-72.
5. Bertagnoli R, Vazquez RJ. The anterolateral transpsoatic approach (ALPA): A
Tech. 2003; 16(4):398-404.
6. Brau SA. Mini-open approach to the spine for anterior lumbar interbody fusion:
description of the procedure, results and complications. Spine J. 2002; 2:216-23.
7. Brau SA, Delamarter RB, Schiffman ML, et al. Vascular injury during anterior
lumbar surgery. Spine J. 2004; 4:409-12.
8. Cammisa Jr FP, Girardi FP, Fantini GA, Huang RC, Marnay T. Lumbar total
disc replacement. Video J Orthopaed. Dec 2005; Video # 8018.
9. Fantini GA, Pappou IP, Girardi FP, Sandhu HS, Cammisa Jr FP. Iliac venous
injury complicating anterior spinal surgery: Incidence, predisposing factors and
management. Oral Presentation. SRS Annual Meeting, Monterey, CA, 2006.
10. Schneider JR, Alonzo MJ, Hahn D. Successful endovascular management of
an acute iliac venous injury during lumbar discectomy and anterior spinal
fusion. J Vasc Surg. 2006; 44:1353-6.
Chapter 19
Clinical Outcomes Assessment of

Nucleus Pulposus Replacement
Mike Finn, MD
Alexander R. Vaccaro, MD
RESIDENT NEUROSURGERY
PROFESSOR
Department of Neurosurgery
University of Utah
Salt Lake City, UT 84132
Department of Orthopaedics
and Neurosurgery
Co-Chief, Division of Spine Surgery
Co-Spine Fellowship Director
Co-Director Delaware Valley Regional
Spinal Cord Injury Center and
The Rothman Institute
Department of Orthopaedic Surgery
Philadelphia, PA 19107
Daniel R. Fassett, MD
SPINE FELLOW
Thomas Jefferson University

Philadelphia, PA 19107
KEY POINTS
Nucleus pulposus replacement is a new technology of which
there is a paucity of clinical data currently available.
Both preformed and in situ curing polymers have been proposed
as nucleus pulposus devices and tested to varying degrees.
Clinical success, with improved indices on several functional
scales, and radiographic success, with maintenance of disc space
height and motion, has been reported at follow-up intervals of up
to 10 years for the most widely used device, the PDN prosthetic
disc nucleus.
Some authors have reported an increase in endplate sclerosis
and Modic changes associated with nucleus pulposus implants,
the significance of which is unknown.
Longer-term follow-up and randomized controlled trials are
needed to fully determine the role of nucleus replacement in
the treatment of lumbar degenerative disease.
33
INTRODUCTION
umbar disc degeneration is a natural occurrence of the normal aging process resulting in low back pain and radiculopathy. On occasion, the degenerative process can be a contributing
factor associated with symptomatic lumbar stenosis and neurogenic claudication. The annulus fibrosus and the nucleus pulposus of the intervertebral disc work in concert to provide
biomechanical stability at each spinal segment, with the nucleus
supporting compressive loads and the annulus, together with the
facet joints, resisting shear forces.
The nucleus pulposus comprises a sparse cell population that produces an extracellular matrix (ECM) rich in proteoglycans that
bind water molecules to provide compressible properties to the
nucleus. The ECM of the intervertebral disc naturally undergoes
continuous remodeling, but generally maintains a fine homeostasis between ECM production and degradation. A number of factors, including those of genetic, metabolic, and mechanical origin,
can alter the homeostatic balance of the ECM, resulting in
destruction of proteoglycans and changes in collagen production.
As the ECM degrades, loss of water content within the disc results
in loss of disc height, altered biomechanics, and eventually
advanced degeneration with endplate changes. Disc degeneration
can alter the regional biomechanics in the spine placing additional
stress on the facet joints or accelerating circumferential degenerative changes. Back pain can result from isolated disc degeneration,
secondary to inflammation and irritation of the nerves within the
outer annulus, or from circumferential degeneration involving the
disc space and posterior facets.1
SURGICAL TREATMENT
Surgical treatment of degenerative disc disease (DDD) has traditionally relied on two techniques, discectomy or fusion, but new technologies like total disc replacement (TDR), nucleus arthroplasty,
and posterior motion sparing dynamization are gaining popularity.
Discectomy is performed when a portion of the nucleus has herniated into, or through, the annulus and is causing nerve root
compression and chemical irritation resulting in radicular pain,
numbness, and weakness. In patients that fail to improve with
conservative therapies, discectomy is a highly effective procedure
for alleviating radicular symptoms but is largely ineffective in
treating back pain. Furthermore, discectomy may lead to additional loss of disc height, contributing to hypermobility and biomechanical derangement of the segment. This has the potential
to hasten arthritic degeneration and increase low back pain.2
34
THE ELIMINATION OF A MOTION SEGMENT WITH FUSION

ALSO MAY PREDISPOSE THE PATIENT TO THE DEGENERATION
OF ADJACENT SEGMENTS.
The use of surgical fusion has been advocated for the treatment of
discogenic back pain, but the clinical success of this procedure is
highly variable and often dependent on complex psychosocial factors. In addition to involving a much more difficult patient selection, fusion entails a greater surgical risk because of complications
related to the more complex surgical approach, hardware failure,
autograft donor-site morbidity, and potential for nonunion. The
elimination of a motion segment with fusion also may predispose
the patient to the degeneration of adjacent segments.
Total disc replacement, in which a mechanical artificial joint
device is placed within the intervertebral disc space after total
removal of the nucleus and some of the annulus, is being studied
extensively. The hope is that TDR will remove the pain generator, while maintaining motion, to reduce the risk of adjacentsegment degeneration. TDR has been used in Europe for more
than a decade, but use within the United States has been limited
to clinical studies and a low usership during the last few years.
Early clinical studies have shown that TDR has at least equivalent outcomes to fusion procedures, but its use is still controversial and further study is needed to establish long-term safety and
efficacy. Other concerns about TDR include the cost and
longevity of the artificial joint devices and the complexity of
revision procedures due to the proximity of the greater vessels.
Nucleus Arthroplasty technology is receiving interest in the
treatment of lumbar disc disease as a means of restoring normal
biomechanical function to the degenerative spine. The goal of
such technologies is to preserve motion at the index level by simulating the biomechanical properties of the native nucleus and, in
theory, maintaining or restoring disc height. By replacing only the
nucleus, these devices largely preserve the annulus and cartilaginous endplates, while re-establishing annular and ligamentous
tension, and subsequent biomechanical function.3 Additionally, by
restoring disc height and near normal motion, nucleus replacement may delay or prevent facet degeneration after discectomy,
and adjacent segment degeneration after fusion. Advantages of
nucleus replacement in comparison with TDR include the possibility for less and/or minimally invasive placement, less complex
revision, and more natural biomechanics with preservation of
most of the annulus.
A broad array of nucleus replacement devices have been created

and tested biomechanically and in vivo using animal models.
There are basically two main types of devices: preformed implants,
which are implanted into the nucleus space, and in situ formed
implants, which are injected into the nucleus space. Preformed
implants have the advantage of providing more uniform implant
material characteristics and superior biocompatibility. In situ
polymers, on the other hand, are designed to be injected through
a smaller annular window and cured within the nuclear cavity
to improve implant conformity and stress distribution, while
decreasing the incidence of dislodgement. Only a few implants in
either group, however, have been tested in humans. This chapter
will review the currently available clinical results regarding nucleus
pulposus implantation.
CLINICAL EVALUATION OF NUCLEUS REPLACEMENT

As the new generation of nucleus replacement devices is developed, the rigorous assessment of clinical outcomes will be paramount in proving superiority to existing technology. Widely
accepted standards, including the Oswestry Disability Index
(ODI), Prolo Scale, Visual Analog Scale (VAS), and SF-12 or SF-36
(Table 1), have been used to assess outcomes and provide a basis
from which to compare the results of these procedures to the
results of other treatment strategies. The real clinical utility of
these devices will be answered in long-term studies evaluating
motion preservation and the prevalence of adjacent and samesegment disc disease. In the near term, however, surrogates of
these endpoints can be assessed with imaging, specifically by the
examination of the maintenance of disc space height, range of
motion, and facet and endplate integrity.
EXISTING CLINICAL DATA

PDNProsthetic Disc Nucleus
(Raymedica, LLC, Minneapolis, MN)
The PDN prosthetic disc nucleus has the most clinical data
reported to date. The PDN implant consists of a hydrogel core
encased in a polyethylene jacket. The hydrogel core can absorb up
to 80% of its weight in water, which allows the device to expand
and maintain or restore disc space height. The implant jacket prevents overexpansion and subsequent overdistraction of the disc
space that could cause endplate fracture.
The PDN device has traditionally been placed
through a posterior
approach following an
annulotomy. Early versions of the design were
used in a paired configuration, while later versions used a single PDN
(PDN-SOLO), with the
long axis of the implant
oriented in the coronal
plane (Figure 1).
Figure 1
Dehydrated PDN-SOLO
A Phase I clinical feasibility trial using the PDN paired design was
initiated in 1996. Two-year results were reported by Schnmayr,
et al,4 in 1999. In this study, 11 patients were treated with an early,
rectangular-shaped implant. Improvement was noted in mean
Prolo and Oswestry scores, and eight of ten patients were considered to have an excellent result. One patient required reoperation
TABLE 1: OUTCOME MEASURES USED IN THE TREATMENT OF LUMBAR SPINAL DISORDERS.
Outcome Measure
Description
Scale
Oswestry Disability Questionnaire
Widely used back-specific questionnaire considered the

gold standard, the questionnaire assesses functional
ability in ten categories including pain, sitting, standing,
and walking tolerance, and social and sex life
Ability rated on a 100 point scale,

with 100 being the best
Prolo Scale
Ten-point scale consisting of only two questions evaluating

the functional and economic status of the patient
Scores of 9 and 10 are excellent while

score of <4 is poor
Visual Analog Scale
Simple ten-point rating scale for pain
0=no pain; 10=worst imaginable pain
SF-12/SF-36
Validated survey assessing eight components of general

health including psychological, physical, and social function
Each category rated on a 100-point

scale with higher scores being better
35
for a migrated implant and another had early reoperation with

fusion for recurrent pain associated with marked facet degeneration. Two other patients whose outcomes were nonetheless
excellent were noted to have some migration of the implant
on imaging that did not require reoperation.
and 82.2%, respectively) on follow-up imaging. While the clinical relevance of Modic changes is unknown at this time, such
radiographic findings certainly warrant further investigation as
they may be associated with back pain and ongoing degeneration in some patients.7
Ten-year follow-up on this initial patient group was reported at

the 6th Annual Spine Arthroplasty Society Meeting, Montral,
QC, Canada in May 2006. All ten patients were able to work, three
had sporadic minor low back pain, and only one was taking occasional analgesics. Radiographic evaluation demonstrated a mean
range of motion of 5.2o at the operated level, but there was a slight
decrease in disc space height from 10.4mm postoperatively to
8.3mm at the latest follow-up. Nine of the patients expressed
satisfaction with their results stating that they definitely would
undergo the procedure again.
Shim and Lee presented interim data on their 20 patient cohort of

a 75 patient multi-center international clinical evaluation of the
PDN-SOLO at the 6th Annual Spine Arthroplasty Society
Meeting, Montral, QC, Canada in May 2006. The primary indication was discogenic back pain, with or without leg pain. Nine of
the 20 patients had reached the 24 month time point. Mean ODI
improved from 51.7 to 12 at 24 months, VAS decreased from 8.2
to 3. Mean ODI and VAS showed continued improvement as the
follow-up interval lengthened and segmental motion was maintained. Two patients had persistent postoperative pain, one for a
concomitant condition not discovered preoperatively. There were
no reoperations reported; the surgical success rate was 90%.
Additional studies performed with the PDN paired design had

rather mixed results. In a Phase II trial (1997), 17 patients were
treated with a reported success rate of 62%; failures were largely
due to device migration. Modifications to the implant shape,
instrumentation, surgical technique and post operative care
showed continued improvements. A Phase III trial (1998) performed with 26 patients showed an improved success rate of 79%.
In a subsequent Phase IV trial (1999), 51 patients were implanted
with a success rate of 91%. Again, failures in this group were
largely due to device migration with patients requiring additional
surgery within three months.5
Klara, et al,5 reviewed the outcomes of 423 patients in whom a
PDN paired design was implanted between 1996 and 2002 and
reported an explant rate of 10%. Analysis of the explant data
indicated that patients that were overweight or had smaller disc
spaces were more likely to have problems with device migration.
These findings prompted modifications to the clinical treatment
protocol to lessen the incidence of failure. In addition, the PDN
device design was revamped to utilize a single implant approach,
the PDN-SOLO.
Clinical studies with the PDN-SOLO, such as that by Shim, et al,6
have demonstrated encouraging results. This group reported on
46 patients with follow-up greater than six months. Mean VAS
scores improved from 8.5 to 3.1, mean ODI scores decreased
from 58.9% to 18%, and mean Prolo scores increased from 5.2
to 7.2 at one year. However, roughly 11% of patients experienced
a major complication, including device migration, requiring reoperation (4 patients). Additionally, there was a high incidence
of endplate sclerosis and vertebral body Modic changes (68.9%
36
IN COMPARISON WITH THE EARLIER PDN DESIGNS, THE

HYDRAFLEX TECHNOLOGY HAS A MORE ANATOMICALLY CONTOURED SHAPE, A SOFTER CORE, A LARGER
FOOTPRINT, AND FASTER HYDRATION CHARACTERISTICS.
Raymedica has recently

made further revisions to
the PDN technology with
the development of the
HydraFlex Nucleus
Arthroplasty System
(NAS). In comparison
with the earlier PDN
designs, this device has a
more anatomically contoured shape, a softer core,
Figure 2
a larger footprint, and
HydraFlex device
faster hydration characteristics (Figure 2). The system also incorporates a new instrumention system that
is designed to place the implant through an anterolateral
retroperitoneal approach (ARPA). An Investigational Device
Exemption clinical trial approved by the U.S. Food and Drug
Administration is currently underway in the United States.
NuCore (Spine Wave, Inc., Shelton, CT)
AS THE NEW GENERATION OF NUCLEUS REPLACEMENT

DEVICES IS DEVELOPED, THE RIGOROUS ASSESSMENT
OF CLINICAL OUTCOMES WILL BE PARAMOUNT IN
PROVING SUPERIORITY TO EXISTING TECHNOLOGY.
The NuCore injectable nucleus is an in situ curing polymer composed of a recombinant protein hydrogel (Figure 4). Early results
on 12 patients have recently been reported. Four of these have
been followed for a year and five have achieved 6-month
follow-up. Thus far, all have experienced good pain relief and
maintenance of disc height. There have been no device extrusion
or device-related complications.10
Figure 3
NewCleus
Newcleus (Zimmer, Inc., Warsaw, IN)

The Newcleus implant is composed of polycarbonate urethane
(PCU) and has a unique spiral shape derived from memory coiling (Figure 3), which enables it to be implanted through a very
small annular incision and recoil into its original shape. The
unique shape also eliminates any fixed axis of the device, which
allows for easy positioning, as rotation or movement within the
disc space is not an issue. Clinical results on five patients with
an average follow-up of 23.6 months (range 664 months) have
been reported.9 Results of this very limited study were promising, with all patients experiencing an improvement in Oswestry
score and all being satisfied with their outcome. There were no
device dislodgements, neurologic deficit creations, or reoperations reported. Disc height was maintained during follow-up
examinations and flexion/extension radiographs demonstrated
retained motion over the operated segments. Rotational CT
scanning demonstrated normal function of the facets without
arthropathy. All patients demonstrated vertebral body signal
changes (Modic changes) on magnetic resonance imaging, a
finding of questionable significance. An international multicenter study is currently underway to assess the long-term efficacy
of this implant.
Figure 4
NuCore
BioDisc (CryoLife, Inc., Kennesaw, GA)

BioDisc is a protein hydrogel composed of a mix of bovine albumin and glutaraldehyde (Figure 5). Nine patients with radiculopathy have been enrolled in a clinical trial of this device and early
results are encouraging, with patients demonstrating significant
improvements in Oswestry
score (mean 50.6 to 9.1),
VAS score (mean 5.9 to
1.6), and SF-36 physical
component (mean 28.5 to
48.1) after three months of
follow-up.11 No surgical
complications were noted
and magnetic resonance
imaging at follow-up examFigure 5
inations demonstrated no
BioDisc
migration of implants.
Although these early results are encouraging, it is unclear from
the data reported how many of these patients were treated for
only radicular symptoms and thus might have enjoyed similar
improvement for the discectomy portion of the procedure alone.
37
DASCOR (Disc Dynamics, Inc., Eden Prairie, MN)

The DASCOR device consists of an injectable
polyurethane that polymerizes minutes after
being injected into a balloon inserted into the disc
space (Figure 6). European
and U.S. trials are currently underway. Data
from the first 16 patients
enrolled has been
presented as promising.1
Figure 6
DASCOR
CONCLUSION
Nucleus arthroplasty in the lumbar spine is a promising technology that may prove to be effective in treating back pain and
preventing same and adjacent-level degeneration. Clinical experience with these devices is limited, and a large experience has
only been reported with one, the PDN device. Thus far, results
have been promising, with improvements in numerous functional indices and maintenance of segmental motion and disc
space height being reported in most studies. Of concern is the
frequency of device migration and the increases in vertebral
Modic changes and endplate sclerosis. Longer-term follow-up
and randomized controlled trials will be needed to conclusively
determine whether this technology is more beneficial than
simple discectomy or fusion procedures.
Nubac (Pioneer Surgical Technology, Marquette, MI)

REFERENCES
The Nubac device is an articulating PEEK-on-PEEK nucleus
replacement implant (Figure 7). Nubac received the CE mark
approval in 2005 and a U.S. FDA conditional approval for clinical
trials was granted in 2006.
1. Di Martino A, Vaccaro AR, Lee JY, Denaro V, Lim MR. Nucleus pulposus
replacement: basic science and indications for clinical use. Spine. Aug 15
2005;30(16 Suppl):S16-22.
2. Hoffman RM, Wheeler KJ, Deyo RA. Surgery for herniated lumbar discs: a
literature synthesis. J Gen Intern Med. Sep 1993;8(9):487-496.
3. Bao QB, McCullen GM, Higham PA, Dumbleton JH, Yuan HA. The artificial
disc: theory, design and materials. Biomaterials. Jun 1996;17(12):1157-1167.
4. Schonmayr R, Busch C, Lotz C, Lotz-Metz G. Prosthetic disc nucleus
implants: the Wiesbaden feasibility study. 2 years follow-up in ten patients.
Rive Neuroradiol. 1999;12 (Suppl 1):163-170.
5. Klara PM, Ray CD. Artificial nucleus replacement: clinical experience. Spine.
Jun 15 2002;27(12):1374-1377.
Figure 7
NuBac
Regain (EBI Biomet, Warsaw, IN)

The Regain nucleus replacement is a one-piece pyrocarbon
device (Figure 8). Pyrolytic carbon has a significant use history in
long-term implantable devices thus biocompatibility is not considered and issue. The Regain is in clinical trials in Europe; it is
not commercially available in the United States.
6. Shim CS, Lee SH, Park CW, et al. Partial disc replacement with the PDN prosthetic disc nucleus device: early clinical results. J Spinal Disord Tech. Aug
2003;16(4):324-330.
7. Kuisma M, Karppinen J, Niinimaki J, et al. A three-year follow-up of lumbar
spine endplate (Modic) changes. Spine. Jul 1 2006;31(15):1714-1718.
8. Bertagnoli R, Vazquez RJ. The Anterolateral TransPsoatic Approach (ALPA): a
Tech. Aug 2003;16(4):398-404.
9. Husson JL, Korge A, Polard JL, Nydegger T, Kneubuhler S, Mayer HM. A
memory coiling spiral as nucleus pulposus prosthesis: concept, specifications,
bench testing, and first clinical results. J Spinal Disord Tech. Aug
2003;16(4):405-411.
10. Berlemann U, Schwarzenbach O, Etter C, Kitchell S. Clinical evaluation of an
injectable, in situ curing nucleus replacement. Europ Cells Mater. 2006;11
(1 Suppl):24.
11. Singhal V, MacEachern C, Craig N, Wardlaw D. Early Clinical results of an
in situ polymerizing protein hydrogel nuclear repair system. Available at:
http://www.cryolife.com/pdf/Britspine_poster.pdf.
Figure 8
Regain
38
Chapter 20
Nucleus Replacement
Complications and
Salvage Procedures
Dr. med. univ. Rudolf Bertagnoli
FOUNDER
Pro-Spine Medical Consulting

Straubing, Germany 94315
ASSISTANT PROFESSOR

New York, NY 10021


Baltimore, MD 21204
KEYPOINTS
The surgical approach selected for implantation of nucleus
replacement technologies can influence initial placement
and performance.
Important aspects of the surgical technique include disc space
preparation and subsequent sizing of the selected implant to
the available space.
An additional complication associated with the use of nucleus
replacement technologies is the potential for allergic reaction.
Nucleus replacement is less invasive than fusion or TDR technologies that tend to be more destructive to the surrounding
tissues and bone.
Revision surgery for nucleus replacement devices offers many
advantages over other non-fusion alternatives that are utilized
later in the continuum of care.
39
Potential Treatment Population
n=0%
ng
asi
e
r
Inc
an
risk
,
ize
ts
en
m
at
tre
e
ag
am
d
l
era
lat
l
o
dc
Fusion
surgeries
Open
Disc surgeries
Percutaneous
Disc surgeries
n=100%
Conservative
treatment
ry
rge
u
cS
/3
l
ica
s
s
Cla
c
rgi
u
S
s
tep
S
al
Dis
Figure 1
Bertagnoli10
INTRODUCTION
egenerative disc disease (DDD) is one of the most common

etiologies associated with low back pain (LBP). Currently,
low back pain is addressed using treatment modalities that incorporate the use of non-operative or operative care. In general, surgical treatment for low back pain occurring as a result of DDD is
considered only after prolonged failure of non-surgical treatment
options. Often in such instances, the patients quality of life is so
profoundly affected, that surgery is the only viable treatment.
The main goals in treating lumbar DDD are to identify the pain
generator(s) and restore function. For many years, this goal has
been accomplished using spinal fusion with interbody devices
and/or rigid posterior instrumentation. More recently, the use of
motion preserving alternatives, such as total disc replacement
(TDR), are now being employed. In addition, the use of Nucleus
Arthroplasty or nucleus replacement therapies has moved to
the forefront. These technologies are very promising as the intent
is to replace only the damaged or diseased nucleus, while seeking
to restore function, maintain disc height, and preserve motion.
Thus, nucleus replacement is less invasive than fusion or TDR
technologies that tend to be more destructive to the surrounding
tissues and bone.
40
Currently, there are a number of different design concepts in

development and evaluation.1,2 In general, nucleus replacement can
be simply classified as preformed devices, which include hydrogels
or mechanical solutions, and in situ devices, which involve component mixing and in situ cure. The ability to successfully implement
nuclear replacement technologies is exciting as such solutions seek
to expand the available surgical treatment options and potentially
redefine the current continuum of care.
Paramount to the success of any surgical procedure is the proper
identification of the treatment indications and selection of the
corresponding patient population. Obviously, each surgical procedure has its own associated risks, complications, and potential
benefits that must be assessed prior to treatment. One of the
most common problems with nucleus replacement technologies
is their use in patients with advanced degenerative disc disease,
where the window of opportunity for this type of treatment is
far gone. Thus, prerequisites for positive and predictable surgical
outcomes involve adequate surgeon training in combination
with the application of strict inclusion and exclusion criteria.3
For the purposes of this chapter, the discussion associated with
complications will be divided into specific areas including biomechanical, surgical approach, surgical technique, patient
selection, and other concerns. This will be followed by a brief
discussion of salvage procedures related specifically to nucleus
replacement technologies.
Potential Treatment Population
n=0%
re
Inc
ng
asi
t
en
tm
a
tre
k
ris
e,
siz
lla
co
d
an
Interspinous
Implants
Wallis, Diam,
Flexicore
Anthroplasy
surgeries:
Nucleus
replacements
Open
Disc surgeries
n=100%
Percutaneous
Disc surgeries
a
ter
e
ag
am
d
l
II
Fusion
surgeries
Anthroplasy
surgeries:
Total Disc
replacements
rn
de
o
M
/7
ry
e
rg
Su
c
s
Di
VII
VI
IV
III
Post.
Dynamic
stabilization:
Dynesys
Su
s
tep
S
cal
rgi
Figure 2
Bertagnoli10
BIOMECHANICAL ISSUES
Biomechanical performance issues associated with nucleus
replacement devices are similar to those of other non-fusion,
motion preserving devices and include wear, fracture/failure, dislocation, migration, subsidence, and loss of motion. Based on
the existing clinical information, the majority of these complications are rare with the exception of device migration and subsidence. While migration tends to be related to the surgical
approach and device configuration, subsidence, and resulting
endplate damage, is more directly related to device design. The
ability to determine the appropriate device stiffness has proved
to be a challenging endeavor as it represents a balance between
the load carrying capacity of the device and the structural
integrity of the vertebral endplates. If the device load carrying
capacity is too low, disc height may not be maintained, while a
load carrying capacity that is too high may result in endplate
remodeling and/or fracture. Extensive testing has been performed
to further investigate the effects of implant stiffness, sizing and
conformity in an effort to strike an appropriate balance.
APPROACH RELATED ISSUES

Until recently, the most common surgical approach used in conjunction with the placement of spinal devices has been an open
posterior hemilaminotomy. This approach has the advantage of
allowing the surgeon to address posterior pathologies, such as

herniations. However, depending on the extent of the pathology,
access to the disc space requires significant dissection of the posterior musculature and associated osteoligamentous structures,
and may require a partial facetectomy, leading to spinal instability. Spinal instability is more problematic with nucleus replacements devices, primarily due to the lack of attachment to bony
structures, making device migration an issue.
The use of a posterior approach also poses challenges to the
nucleus removal process. The limited surgical window coupled
with the anatomy of the spine make it difficult to adequately
remove nucleus from the contralateral regions within the disc.
Inadequate nucleus removal can inhibit proper device placement
and subsequently influence implant motion. Intraoperatively, the
use of contrast medium can be helpful to assess the extent of the
nucleus evacuation prior to device placement.
Bertagnoli, et al,4 have described the use of an anterior lateral
transpsoatic approach (ALPA) for nucleus replacement. In this
procedure, the disc space is accessed laterally by way of the
retroperitoneum, and involves longitudinal splitting of the psoas
muscle. The approach utilizes a safe anatomical zone that allows
for sparing of the posterior osteoligamentous structures. With
ALPA, a larger section of the annulus can be exposed, simplifying
the nucleus evacuation and implant insertion processes.
41
The most commonly reported complications with the ALPA

approach were transient (< 3 months) psoas neurapraxia that
presented as numbness of the left anterior thigh5, particularly at
L4-L5, due to the location of the nerve root. Experience in combination with the use of neural surveillance monitoring can help
to minimize this risk. In addition to neurapraxia, minor asymptomatic issues with anterior device migration (within the disc
space) were also noted. Obviously, the major limitation to ALPA
is that, due to iliac crest location in most patients, the procedure
can not be used for implantation at L5-S1.4
The use of an anterolateral or anterolateral retroperitoneal
approach (ARPA) allows complete access to the lumbar region
including L5-S1, via an oblique pathway to the spine. Ideally, it is
intended that the disc space be accessed without disruption of
the anterior longitudinal ligament and minimal mobilization of
the greater vessels. Proper training and the assistance of a vascular surgeon can be of great benefit in performing this procedure.
Complications related to this approach are similar to other anterior surgeries and include potential injuries to the muscles,
nerves and major vessels, but to a lesser degree when compared
to a direct anterior approach.
Lastly, the transcoccygeal axial approach is a novel concept that
can be used to access the lower lumbar spine through the sacrum.6
This approach can be performed without damaging the annulus,
but requires penetration of the endplate in order to obtain access
to the disc space and remove the nucleus. Clinical complications
associated with this procedure are not yet known.
use of sharp instruments is discouraged due to the possibility of

damaging the cartilaginous endplates as damage may impact the
biomechanical strength and characteristics.
Coupled with the importance of nucleus removal is the ability to
appropriately size the implant to the evacuated space as improper
implant sizing can have an significant impact on long-term
implant performance. If the implant is too small for the disc
space, the likelihood of migration is increased. In contrast, if the
implant is too large for the disc space, the intradiscal forces will be
much higher than the normal loading state resulting in endplate
remodeling, subsidence and, to a lesser degree, potential migration
of the implant. Additionally, the use an ALPA or ARPA surgical
approach offers the ability to suture or reapproximate the annulus
after implant insertion helping to prevent implant migration.
DEVICE-RELATED COMPLICATIONS
In general, device-related complications with nuclear replacement
technologies are less serious than others, such as total disc
replacement.8 One of the more challenging complications with
nucleus replacement technologies is vertebral endplate remodeling. The general consensus is that endplate remodeling indicates
an altered load environment in which the nuclear replacement
device is much stiffer than the native disc material. Based on a
review of the literature, it is not uncommon to have some changes
in the endplate morphology that resolve over time. In addition,
despite the somewhat ominous radiographic appearance of endplate remodeling, in many cases it is not associated with a bad
clinical outcome.9
SURGICAL TECHNIQUE/
PROCEDURE RELATED COMPLICATIONS
As mentioned earlier, device migration and subsidence have
been noted in the literature.5,7 Shim, et al, reported on extrusions
with the PDN prosthetic disc nucleus device. In this study, the
authors noted that extrusion issues were closely related to surgical technique and patient selection. All extrusions in this series
occurred in the early surgical cases. The authors indicated that
there is a learning curve associated with disc space preparation
and implant sizing techniques for nucleus replacement devices
that is different from other spinal procedures.
Disc space preparation is a key element as inadequate removal of
the nucleus material can influence the ability to properly position
the implant. Any remaining nucleus can also produce increased
intradiscal forces that act to move the device out of the nuclear
cavity. In addition, during the preparation of the disc cavity, the
42
PATIENT SELECTION AND CONTRAINDICATIONS

Appropriate patient selection is integral to obtaining good clinical outcomes. Nuclear replacement technologies are currently
targeted for use in mild to moderate DDD. The intent of the
procedure is to replace the diseased nucleus and maintain disc
height, while preserving segmental motion. Thus, patients with
significant facet arthropathy, spinal deformity or instability
would not be appropriate for this technology.
Ideal patients would have a reasonable preservation of disc height
(< 50% loss in height as compared to a healthy adjacent segment),
with vertebral endplates that are slightly concave and free of irregularities. In addition, good bone quality and competent annular
tissue are also desirable. In contrast, patients that are significantly
overweight (expressed by body mass index (BMI)), osteoporotic or
present with significant disc herniations would be undesirable

candidates. Currently, the ability to extend or broaden the use of
this technology for such applications is still not clear.
REVISION SURGERY FOR NUCLEUS REPLACEMENT

DEVICES HAS MANY ADVANTAGES OVER REVISION SURGERIES FOR OTHER NON-FUSION ALTERNATIVES, SUCH
OTHER MISCELLANEOUS COMPLICATIONS

The goal of a nucleus replacement device is to replace the native
nucleus material. Technologies developed to achieve this goal are
utilizing a host of new materials in comparison to those used in
standard orthopedic implants. Thus, additional complications
include the potential for allergic reaction to the implant materials
or contrast media used during the implant sizing process. In addition, depending on the implant technology, the ability to adequately view the implant or surrounding tissues post-operatively
may be problematic using standard imaging modalities, (X-ray,
MRI, CT).
Based on existing clinical data, the risk of heterotopic ossification
has not been shown to be a significant problem with nucleus
replacements. This can be a problem in more invasive procedures
that require more involved dissections and/or preparation of the
endplates, such as in total disc replacement procedures.
AS TOTAL DISC REPLACEMENT, THAT ARE PERFORMED

LATER IN THE CONTINUUM OF CARE.
vertebral bodies and surrounding tissue. This preservation of the

annulus and posterior anatomy, enables the use of surgical revision
strategies that utilize additional motion preservation technologies
(interspinous spacers, TDR, dynamic stabilization).
In essence, the successful introduction of nucleus replacements
and other motion sparing technologies will significantly expand
the treatment options currently utilized today10 (Figures 1 & 2).
This potential shift in the continuum of spinal care will provide
the surgeon flexibility in selecting an appropriate initial or salvage procedure that is focused on maintaining spinal motion
and slowing the progression of the degenerative cascade.
REFERENCES
SALVAGE
The removal of failed nucleus replacement devices will largely be
accomplished via mechanical means. Consequently, the difficulties associated with removal will be closely related to the device
type. Preformed and mechanical devices may be easier to revise
as their inherent design facilitates removal en bloc. In addition,
such technologies possess a known shape quality allowing visual
inspection to be utilized to ensure complete device removal.
Revision of in situ curable designs may pose more of a challenge
as the implant size and shape will vary for each application. In
addition, some implants of this type are not contained within a
barrier, and may potentially integrate with the surrounding disc
tissue. In such instances, the ability to ensure complete removal
may be challenging as the devices may not be viewable using
imaging modalities. Regardless of the device type, the tissue
destruction required to complete the removal process may limit
the surgeons revision options.
In general, revision surgery for nucleus replacement devices has
many advantages over revision surgeries for other non-fusion alternatives, such as total disc replacement, that are performed later in
the continuum of care. This is largely due to the fact that the initial
surgery to place a nuclear implant is much less destructive to the
1. Goins ML, Wimberley DW, Yuan PS, Fitzhenry LN, Vaccaro AR. Nucleus pulposus replacement: an emerging technology. The Spine J. Nov-Dec Suppl 2005;
5:317S324S.
2. Ray CD. The Raymedica prosthetic disc nucleus (PDN): stabilizing the degenerated lumbar vertebral segment without fusion or total disc replacement. In.
Eds. Kim DH, Camissa FP, Fessler RG. Dynamic reconstruction of the spine,
2006; Chp 14:105114.
3. Triano JJ, Bougie J, Rogers C, Scaringe J, Sorrels K, Skogsbergh D, Mior S.
Procedural skills in spinal manipulation: do prerequisites matter? The Spine
J. Sep-Oct 2004; 4:557563.
4. Bertagnoli R, Vazquez RJ. The anterolateral transpsoatic approach (ALPA):
a new technique for implanting prosthetic discnucleus devices. J Spinal
Disord Tech. Aug 2003; 16(4):398-404.
5. Shim CS, Lee SH, Park CW, Choi WC, Choi G, Choi WG, Lim SR, Lee HY.
clinical results. J Spinal Disord Tech. Aug 2003; 16(4):324-330.
6. Cragg A, Carl A, Castaneda F, Dickman C, Guterman L, Oliveira C. New percutaneous access method for minimally anterior lumbosacral surgery. J Spinal
Disord Tech. 2004; 17(1):2128.
7. Jin D, Qu D, Zhao L, Chen J, Jiang J. Prosthetic disc nucleus (PDN) replacement
for lumbar disc herniation. J Spinal Disord Tech. Aug 2003; 16(4):331337.
8. Bhattacharyya T, Blyler C, Shenaq D. The natural history of new orthopeadic
devices. Clin Orthop Relat Res. Oct 2006; 451:263266.
9. Bertagnoli R, Schnmayr R. Surgical and clinical results with the PDN
prosthetic disc-nucleus device. Eur Spine J. 2002; 11(S2):S143S148.
10. Bertagnoli R. Disc surgery in motion. Spine Line. 2004; 11/12:2328.
43


Baltimore, MD 21204
ASSISTANT PROFESSOR
Conclusion

New York, NY 10021

ASSOCIATE PROFESSOR OF CLINICAL SURGERY

New York, NY 10021
lthough much remains to be learned about degenerative

disc disease (DDD), we are on the precipice of a new treatment stratagem for this problem effecting a wide-ranging patient
population which has been inadequately treated with available
treatment options. Nucleus Arthroplasty is poised to address
mild to moderate DDD and may be a successful treatment option
for later stage disease as well.
Pioneering spine surgeons have successfully used nucleus
replacement to treat DDD. However, nucleus arthroplasty takes
this promising therapy one step further. Nucleus arthroplasty is
a total system approach that encompasses patient selection, indications, device sizing, surgical technique and approach, and
post-operative patient care. By adopting this system approach,
nucleus arthroplasty is expected to offer an effective treatment
option for patients who are currently left untreated.
FUTURE PUBLICATIONS ON
NUCLEUS ARTHROPLASTY TECHNOLOGY
We hope this monograph, Volume IIISurgical Techniques &
Technologies, provides valuable guidance to spine surgeons as
they seek to provide more effective and less invasive options for
the treatment of DDD. This volume is part of a continuing series
on nucleus arthroplasty that can be used individually or collectively. A number of well-known authors will be represented in
future monographs on nucleus arthroplasty.
WE ARE ON THE PRECIPICE OF A NEW TREATMENT
STRATAGEM FOR THIS PROBLEM EFFECTING A
WIDE-RANGING PATIENT POPULATION WHICH HAS
BEEN INADEQUATELY TREATED WITH AVAILABLE
TREATMENT OPTIONS.
Upcoming scheduled publication dates are as follows:

Emerging Technology is scheduled to be released at the
North American Spine Society (NASS) meeting in Austin,
Texas, October 2007.
Please note that each one of these volumes will be available at:
44
This series has been made possible through the financial support of Raymedica, LLC.
www.raymedica.com
Part No. 55125-001 Rev. A

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Nucleus

Volume III: Surgical Techniques

Deputy Editorial Board

Examination, Radiologic and Diagnostic Evaluation, and Patient Indications

History of Motion Preservation Surgery of the Lumbar Spine

The Basis for Nucleus Replacement Surgery: Current Techniques

Intervertebral Disc Space Preparation for Nucleus Arthroplasty Technologies

Nucleus Arthroplasty Technology: Approach-Related Considerations

Clinical Outcomes Assessment of Nucleus Pulposus Replacement

Nucleus Replacement Complications and Salvage Procedures

his monograph series is a groundbreaking project in the

Frank P. Cammisa, Jr., MD, FACS

Baltimore Neurosurgical Associates, PA

Hospital for Special Surgery

Hospital for Special Surgery

he first documented works describing the diagnosis and

in which to test hypotheses and predict clinical impact. Biochemical

Reginald J. Davis, MD, FACS

Frank P. Cammisa, Jr., MD, FACS

Deputy Editorial Board

Frank P. Cammisa, Jr., MD, FACS

History of Motion Preservation

Department of Orthopaedic Surgery

hroughout history, the field of orthopedics has been intimately

OVER THE LAST 50 YEARS, A GREAT DEAL OF RESEARCH

PRINCIPLES OF MOTION PRESERVATION

spinal disc height, integrity of the ligamentous structures, degree

SPINAL NUCLEUS REPLACEMENTS SEEK TO REPLACE

The spinal elements under consideration include the spinal disc,

SPINAL NUCLEUS REPLACEMENTS

PDN PROSTHETIC DISC NUCLEUS

MORE THAN 20 DIFFERENT NUCLEUS ARTHROPLASTY

OTHER NUCLEUS DEVICES

Early design generations were intended to be used in a paired

TOTAL DISC REPLACEMENTS ARE DESIGNED TO REPRODUCE THE MOTION AND/OR

removed and the subsequent volume of the implant utilized to

TOTAL DISC REPLACEMENT

Despite extensive bench testing, early designs implanted in

THE CHARIT DISC HAS THE ABILITY TO TRANSLATE

This phenomenon can make it difficult to appropriately size and

Other Total Disc Replacements

The Maverick was designed by Drs. Kenneth Pettine and Richard

DYNAMIC STABILIZATION IS A TERM APPLIED TO DEVICES THAT PROVIDE

Pedicle Screw-Based Systems

long-term segmental motion, while providing adequate spinal

Interspinous Process Spacers

device has been implanted in more than 20,000 patients worldwide

In general, dynamic stabilization systems represent an attractive

UNLIKE THE OTHER INTERSPINOUS SPACERS, THE COFLEX INTERSPINOUS IMPLANT

THESE SOLUTIONS WILL NO DOUBT EXPAND OUR AVAILABLE TREATMENT OPTIONS

4. Fassio B, Ginestie JF: Discal prosthesis made of silicone: experimental study

Weill Medical College of Cornell University

Dr. med. univ. Rudolf Bertagnoli

Pro-Spine Medical Consulting

Hospital for Special Surgery

ow back pain (LBP) is a condition with a large multifaceted

THE COMMON CAUSES OF LOW BACK PAIN INCLUDE

In addition, pain and function associated with range of motion

INTERVERTEBRAL DISC ASSESSMENT

In a normal disc, the properly hydrated nucleus pulposus accepts

X-ray is the most commonly performed spinal imaging study

Magnetic resonance imaging (MRI) is a powerful imaging modality

When imaging the intervertebral disc, the major advantages of

DISCOGRAPHY IS OFTEN REQUIRED TO IDENTIFY AN INDIVIDUAL DISC