Nucleus

Arthroplasty
Technology

in Spinal Care

Volume IV: Emerging

Technologies

Table of Contents
1

Introduction

Deputy Editorial Board

CHAPTER 21

Nucleus Arthroplasty Technology: Patient Demographics and Selection

CHAPTER 22

Spinal Motion Preservation Technologies: Surgical Approach and Procedure

CHAPTER 23

15

Nucleus Arthroplasty Design and Evaluation Challenges

CHAPTER 24

25

Early Clinical Results of Nucleus Arthroplasty Technology

CHAPTER 25

30

Socioeconomic Impact of Nucleus Arthroplasty Procedures

CHAPTER 26

37

Biologics and Nucleus Arthroplasty Technology Applications

CHAPTER 27

42

The Future of Nucleus Arthroplasty Technology

44

Closing Remarks

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 emerging technology, 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 the developmental editors, John J. Grabowski,
Rebecca S. Gorman, O. James May, and Steven J. Seme.
Their collective 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

ASSOCIATE PROFESSOR

ASSOCIATE PROFESSOR

Baltimore Neurosurgical Associates, PA

Baltimore, MD 21204

OF ORTHOPEDIC SURGERY

OF CLINICAL SURGERY

Hospital for Special Surgery

New York, NY 10021

Hospital for Special Surgery

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
Nucleus Arthroplasty as an emerging technology. Key elements
include an overview of Patient Demographics and Selection, Surgical
Approach and Procedure, Challenges of Design and Evaluation,
Clinical Experience, Socioeconomic Impact, Biological Applications,
and Future Technology Applications. In addition, Volume IV 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.

Reginald J. Davis, MD, FACS

Federico P. Girardi, MD

Frank P. Cammisa, Jr., MD, FACS

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.
Reginald J. Davis, MD, FACS
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.

Federico P. Girardi, MD
Dr. Girardi is associate 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.

Frank P. Cammisa, Jr., MD, FACS

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 21

Nucleus Arthroplasty Technology:

Patient Demographics and Selection

Barn Zrate-Kalfpulos, MD
DEPARTMENT OF ORTHOPEDICS

Instituto Nacional de Rehabilitacin Mexico

Mexico City, Mexico 10700

Alejandro ReyesSnchez, MD
HEAD OF SPECIAL SURGERGY DIVISION

Instituto Nacional de Rehabilitacin Mexico

Mexico City, Mexico 10700

John S. Thalgott, MD
ORTHOPEDIC SPINE SURGEON

International Spine Development & Research Foundation

Las Vegas, NV 89106

Viscogliosi Brothers, LLC

New York, NY 10022

KEYPOINTS
Based on estimates, nucleus arthroplasty technology may
represent up to 28% of the spinal motion preservation market
by the year 2015.
Potential benefits of nucleus arthroplasty include maintaining
disc height and improving function, while preserving the annulus
fibrosus, cartilaginous endplate, and ligamentous structures.
Nucleus arthroplasty is an attractive treatment method for degenerative disc disease as it either follows or accompanies discectomy; it may serve to fill the treatment gap between conservative
therapies and more aggressive surgical measures.

INTRODUCTION

ver the last 15 years, the global spine industry has grown
from a market that was less than $100 million in annual
revenues to approximately $6.5 billion in 2007. Current estimates show the spine market is growing by 15%20% a year,
with certain niches in distinct geographical markets growing
by 40%100%.
While the spinal device market has grown dramatically, it is
still relatively small in comparison to the annual incidence of
back pain and the availability of approved treatments with
demonstrated clinical efficacy.
Recent trends in the surgical management are shifting toward
techniques that attempt to minimize soft tissue dissection and
preserve the spinal motion segment. The future market opportunity for such technologies is expected to be quite large
($8.25 billion by 2015), with many applications being years
away from commercialization.
2015 Motion Preservation Market
Facet Replacement

$.75
9%
Total Disc
Replacement

Nucleus Arthroplasty/
Replacement

$2.25
28%

$1.5
18%

$1.75
21%

$2.0
24%

Posterior Dynamic
Stabilization

Interspinous Process
Spacers

$8.25 Billion
Source: Viscogliosi Bros., LLC

Based on this projection, in 2015 the nucleus arthroplasty/

replacement market represents 28% of the total motion preservation market, or roughly $2.25 billion dollars. The goal of nucleus
arthroplasty is to address degenerative disc disease (DDD) by
replacing the diseased nucleus with a prosthetic implant that
mimics the behavior of the normal nucleus pulposus (NP).
Potential benefits include maintaining disc height and improving
function, while preserving the annulus fibrosus, cartilaginous
endplate, and ligamentous structures. Ideally, such technologies
can also be implemented to treat mechanical back pain, prevent
post-discectomy degeneration, and reduce the rate of recurrent
disc herniation.
4

PATIENTS SUFFERING FROM DDD NORMALLY

PRESENT WITH SIGNIFICANT PAIN. THIS MANIFESTS
MOST COMMONLY AS DEBILITATING LOW BACK PAIN,
WITH OR WITHOUT LEG PAIN, OR, IN MANY CASES,
DEBILITATING RADICULAR PAIN WITH A MILD BACK
PAIN COMPONENT.

CURRENT TREATMENTS FOR DDD

Patients suffering from DDD normally present with significant
pain. This manifests most commonly as debilitating low back
pain, with or without leg pain, or, in many cases, debilitating
radicular pain with a mild back pain component.
At this time, there are few treatment options to address DDD
at its various stages. The current treatment continuum has been
limited, consisting largely of conservative care, discectomy, and
fusion. In some instances, total disc replacement may also be
utilized; however, use of this application has been slower than
expected, principally due to reimbursement issues.
1. Conservative Treatment: Conservative therapy consists of
bed rest, pain medication, and physiotherapy. If this process
does not work, then surgery may be considered. The challenge
remains: when to pursue surgical intervention or when to stay
the course with conservative management. There is a lack of
options for a surgeon who has a patient that is not responding
well to pain medication and bed rest, but is not ready to go
into the operating room.
2. Discectomy Surgery: The most common surgery for herniated discs of the lumbar spine is a discectomy. This surgery is
an early-stage treatment, where the patient with a bulging disc
undergoes removal of the tissue which is causing nerve compression. This is the first surgical option because it is relatively
less invasive than others and it directly treats the cause of the
pain, namely the herniated disc. Unfortunately, there are many
patients for whom a discectomy alone does not work and who
require an additional treatment option, but are not degenerated
to the point of being the perfect patient for fusion. These
patients have to make the difficult decision of either having
continued pain and/or discomfort without undergoing an
additional surgical procedure, or possibly receiving a fusion,
which is excessive surgery and may not solve their problem.

3. Fusion: Fusion was originally developed to assist those

patients who were in unbearable clinical conditions, such as
those suffering from a spinal deformity. Soon enough, the
methods went outside of their intended patient population,
and were used in non-deformity patients to fuse painful segments in the spine. While fusion immobilizes the painful area
within the spine and can provide stability to the spinal column, it is in many cases not the ideal option. Although conservative therapy does not necessarily get to the root of the
problem, fusion tends to over-treat patients. Fusing the
affected levels may afford some temporary relief of pain, but
it can also have a negative effect on the adjacent levels.1 Some
opinion leaders believe, and it has been corroborated by clinical evidence, that the adjacent levels can suffer from facet
hypertrophy, facet arthropathy, spinal stenosis, osteophyte
formation, and posterior muscular debilitation.

NUCLEUS ARTHROPLASTY REPRESENTS ONE OF

MANY OPPORTUNITIES TO EXPAND UPON THE
CURRENT TREATMENT CONTINUUM.

NUCLEUS ARTHROPLASTY TECHNOLOGY

Nucleus arthroplasty represents one of many opportunities to
expand upon the current treatment continuum. The technology
is primarily intended for early to mid-stage degenerative disc
disease in a patient population that is non-responsive to
extended conservative care. Should surgical intervention be pursued, nucleus arthroplasty represents an attractive treatment
method as it either follows or accompanies discectomy and is
less invasive than total disc replacement (TDR).
Currently, there are two general types of nucleus replacement
implants: preformed implants that are inserted into the nucleus
space and in situ formed implants that are injected into the
nucleus space in a viscous state. Preformed implants have the
advantage of providing more uniform implant polymer 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 nucleus cavity to improve implant
conformity and stress distribution, while decreasing the risk of
dislodgement. While the general indications between the two
types are similar, they are likely to undergo further refinement
as more clinical experience is gained.2, 3
The accompanying table provides an outline of the current
nucleus replacements by device name, company, device type,
and clinical stage.

DEVICE

COMPANY

TYPE

CLINICAL STAGE

BioDisc

CryoLife

Injectable

CE Mark Trial

DASCOR

Disc Dynamics

Injectable

Pilot IDE Trial

DiscCell

Gentis

Injectable

European Pilot Study

Geliflex SP

Synthes

Injectable

Pre-Clinical Development

HydraFlex

Raymedica

Preformed

Pilot IDE Trial

NeoDisc

Nuvasive

Preformed

Pivotal IDE Trial

NeuDisc

Replication Medical

Preformed

European Trial

NUBAC

Pioneer Surgical

Preformed

Pilot IDE Trial

NuCore

Spine Wave

Injectable

Pilot IDE Trial

PNR

TranS1

Injectable

Filed for Pilot IDE Trial

Regain

Biomet

Preformed

Pilot IDE Trial

PATIENT SELECTION
As with any medical device, proper patient selection for the use
of nucleus replacement technologies is crucial to clinical success.
The underlying principle of nucleus arthroplasty is to replace
only the diseased nucleus portion of the patients intervertebral
disc. The objective of the procedure is to restore or maintain disc
height necessary to re-establish annular tension and ligamentous
stability. The nucleus replacement device may also assist in shock
absorption and load transmission, a critical component lacking
in the design of total disc replacements.4
Ultimately, nucleus arthroplasty procedures are intended to preserve the bone and ligamentous structures that are integral to the
patients spinal segment motion. To that end, it is of great importance that the patient has annular, endplate, and posterior elements that are still capable of functioning properly. Significant
compromise of these base components will directly affect the
ability of a nucleus replacement device to perform as intended,
potentially resulting in implant subsidence or migration.
A more detailed discussion of the indications/contraindications
specific to nucleus arthroplasty procedures is provided below.

Other
BMI >35
Malignant tumors
Systemic or localized infection

KEY FACTORS TO SUCCESS

For nucleus arthroplasty technologies to be successful, current concepts must show acceptable clinical outcomes in relation to alternative treatments. In addition, a shift in mindset will be required in
regard to the importance of early surgical intervention.
Given that nucleus replacement is a nascent technology, the market must adapt to its benefits and learn its downfalls. It is certainly
possible that the market for nucleus replacements can reach $2.25
billion because, not only can nucleus arthroplasty assist current
DDD patients, but it can also draw in those who were previously
left untreated, or are currently being over-treated.
With new technologies being developed and moved through the
commercialization pathways, surgeons will soon have a myriad of
options to choose from. It is then the responsibility of industry
to educate the surgeons and patients on the proper indications,
contraindications, surgical technique, etc., so that these new
minimally and less-invasive solutions can truly benefit patients.

Indications
Symptomatic degenerative disc disease (L2 to S1)
Discogenic low back pain, with or without leg pain

IT IS CERTAINLY POSSIBLE THAT THE MARKET FOR

Failed conservative (non-operative) management

NUCLEUS REPLACEMENTS CAN REACH $2.25 BILLION

No significant osteophyte formation

BECAUSE, NOT ONLY CAN NUCLEUS ARTHROPLASTY

Appropriate disc height at index level (device dependent)

ASSIST CURRENT DDD PATIENTS, BUT IT CAN ALSO DRAW

IN THOSE WHO WERE PREVIOUSLY LEFT UNTREATED,
OR ARE CURRENTLY BEING OVER-TREATED.

Contraindications
Severe symptomatic central spinal, foraminal,
or lateral recess stenosis
Spondylolisthesis (greater than Grade I)
Segmental instability
Fractured and/or degenerated facet joints (greater than Grade I)
Disc collapse of greater than 50% as compared to
a healthy adjacent level
Schmorls nodes or endplate irregularities
Significant disc herniation (extrusions)
Incompetent annulus (defect in annular contour)
Osteoporosis

REFERENCES
1. Fardon M, Milette P. Nomenclature and Classification of Lumbar Disc
Pathology. Spine 2001(26):E93-E113.
2. DiMartino A, Vaccaro A, Lee J, Denaro V, Lim M. Nucleus Pulposus
Replacement: Basic Science and Indication for Clinical Use. Spine 2005(30):
S16-S22.
3. Bao Q, Yuan H. New Technologies in Spine: Nucleus Replacement. Spine
2002(27):1245-1247.
4. Mulholland R. Arthroplasty of the Spine. J Bone Joint Surg Am 2005(87):591.

Chapter 22

Spinal Motion
Preservation Technologies:
Surgical Approach and Procedure
Dr. med. univ. Rudolf Bertagnoli
FOUNDER

Pro-Spine Medical Consulting

Straubing, Germany 94315

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 Medicine UCLA

Los Angeles, CA 90095

Rick Delamarter, MD
MEDIAL DIRECTOR

The Spine Institute

Santa Monica, CA 90404

INTRODUCTION

ver the last decade, the medical industry has invested significant resources in the development of new technologies for
patients suffering from spinal disorders. The result has been the
introduction of many new and promising concepts for the treatment of degenerative disc
disease. These concepts seek
to provide the surgeon with
DEGENERATIVE DISC DISEASE IS CHARACTERIZED BY
a vast array of motion preTHE LOSS OF THE DISCS CAPACITY TO BIND WATER
serving treatment alternaRESULTING IN A REDUCTION IN DISC VOLUME AND
tives that extend beyond
CORRESPONDING LOSS OF HEIGHT.
traditional fusion.

While this development process has been dynamic, it has also

proven to be systematic as the engineering of such implants is
more closely matched to the intended surgical approach and
corresponding implantation technique. This is particularly relevant in the lumbar region where factors such as individual
anatomical differences, previous surgeries or comorbidities may
favor a specific approach.
The goal of this chapter is to review the available motion preserving technologies that may be utilized to address degenerative disc
disease. The authors will then discuss the potential impact of each
technology in regard to the surgical approach and subsequent
challenges associated with the implantation technique.

DEGENERATIVE DISC DISEASE

Degenerative disc disease (DDD) is characterized by the loss of
the discs capacity to bind water resulting in a reduction in disc
volume and corresponding loss of height. This process has been
described and graded in three stages1 and can be one of many
causes for low back pain.
Proper diagnosis of DDD involves the use of diagnostic tools as
described in previous chapters. During evaluation, it is important to identify the pain generator (e.g. the disc, degenerated
facet joints, or a nerve compression phenomenon), as low back
pain is often a multi-faceted condition.

NUCLEUS REPLACEMENT
The prime indications for nucleus replacements are mild to moderate forms of DDD with a loss in disc height that is less than 50%
when compared to the adjacent healthy disc. The objective of
nucleus replacement is to replace only the diseased portion of the
disc with an implant that has similar biomechanical properties to
that of the native nucleus pulposus.
The ultimate goal is to maintain disc height and alleviate pain,
while preserving the segmental range of motion and bio-elastic
properties of the natural disc. Thus, for long-term viability, it is
paramount that the vertebral endplates, facets, and posterior ligamentous structures that provide the functional stability to the
spinal segment are in good condition.
One of the more challenging aspects of any nucleus replacement
technology is the ability to design a device that performs the functions of the native disc. This is largely due to the fact the nucleus
is an integral component in both load sharing and nutrient transport within the intervertebral space. Multiple design concepts
have been developed to simulate the current working knowledge
of the native nucleus including hydrogels, polymers/synthetics,
and mechanical devices (Figures 1 & 2). The following is a list of
current nucleus replacement technologies:

Hydrogels
PDN-SOLO and HydraFlexRaymedica, LLC

DDD TECHNOLOGIES

NeuDiscReplication Medical

The decision to pursue a surgical treatment option for DDD is

dependent on the degree of degeneration and the individual
patient circumstances. If surgery is deemed appropriate, several
motion preserving surgical options are available including partial disc or nucleus replacement, total disc replacement, and posterior dynamic stabilization. These technologies are based on the
lessons learned from the treatment of hips and knee in which
preserving motion provides the most desirable outcome.

Gelifex family of hydrogelsSynthes, Inc.

For the spine surgeon, motion preserving technologies offer the

opportunity to treat patients at an earlier stage in the degenerative
process than traditional fusion techniques. While fusion has
known disadvantages such as adjacent level degeneration (35% at
10 years), symptomatic pseudarthrosis, and graft site morbidity,2
arthrodesis procedures will always remain an option for severe
mechanical instabilities such as fracture, tumors, spondylolisthesis
or deformities such as scoliosis and kyphosis.

Polymers/Synthetics
DASCORDisc Dynamics, Inc.
NuCore Injectable Nucleus DeviceSpineWave, Inc.
SINUX ANRSinitec, AG/DePuy Spine, Inc.
BioDiscCryoLife, Inc.

Mechanical
EBI RegainBiomet, Inc.
NUBACPioneer Medical, Inc.

Figure 1
HydraFlex device

In general, there are three basic concepts that define the motion
characteristics of TDRs which include unconstrained, semiconstrained, and constrained implant designs. The range of
motion of unconstrained designs is normally limited by physiological and anatomical structures; such designs have a floating
center of rotation. In contrast, semi-constrained devices and
constrained devices have prescribed flexion-extension limits
that define the allowable range of motion at or near normal
physiologic limits with a fixed center of rotation that is a function of the specific design (Figures 3 & 4). The following is a
list of current TDR technologies:

Unconstrained
CharitDePuy Spine, Inc.

Figure 2
Nubac

As noted above, current nucleus replacement technologies are

designed specifically for the intervertebral space and supplement
the existing functional anatomy to maintain motion. As such,
use of these technologies leaves the door open for future
treatment options should the need arise.

Semi-Constrained
ProDisc LSynthes, Inc
MaverickMedtronic, Inc.

Constrained
FlexiCoreStryker Corp.

TOTAL DISC REPLACEMENT

Total disc replacement (TDR) is applicable primarily when the
degenerative disease state has progressed to the point that it has
a significant impact on disc height and/or disc morphology.
Unlike nucleus arthroplasty, which aims to maintain disc height,
the treatment objective for TDR is to re-establish disc height,
while removing the pain generator (disc) and preserving motion
at the affected level.

Figure 4a

ProDisc implant
motion preservation at L5-S1.

Figure 4b

Figure 3
Charit prosthesis

Similar to nucleus replacements, TDRs are also intended to be

used in conjunction with functional facets and posterior ligamentous structures. Thus, the kinematics of each design has clinical
relevance as each device concept may have a different long-term
impact on the posterior elements. In addition, the surgical procedure requires sacrifice of the intervertebral disc and its components and modification of the vertebral endplate; thus, future
treatment options may be somewhat limited.

The interspinous devices are mainly designed to prevent compression of the neural foramen during extension (Figures 5 & 6). A few
of the devices (Wallis, Diam) are designed to form a tension band
that provides increased segmental rigidity and limits flexion.

Figure 5
Coflex Interspinous
Dynamic System

POSTERIOR DYNAMIC STABILIZATION

Posterior dynamic stabilization systems are primarily utilized
to address stenosis; however, such systems can be utilized to
address DDD for specific indications. There are two basic
design concepts, interspinous spacers, and pedicle screw-based
systems. From a clinical perspective, the objective is to relieve
compressive neurological symptoms and restore stabilization.
Additionally, both systems provide a certain degree of disc space
distraction which acts to unload the disc, potentially alleviating
pain of discogenic origin.
Biomechancially, such systems are different than nucleus
replacements or TDRs as the posterior placement is relatively
far away from the center of rotation of the disc. In addition,
the design intent is to control segmental motion by using the
device to define and/or limit the range of motion in flexion,
extension or both. The following is a list of current posterior
stabilization technologies:

Interspinous
CoflexParadigm Spine

Figure 6
Wallis

Pedicle screw-based stabilization concepts are similar to standard

rigid pedicle screw systems; however, the interconnecting elements
between the screw anchors are composed of flexible elements
(Figures 7 & 8). While there may be differences in regard to how
each system redistributes loads across the disc space,3 such devices
are intended to stabilize the affected segments by re-establishing
the natural anatomic position and controlling segmental motion.

WallisAbbott Spine, Inc.

DiamMedtronic
X-StopKyphon, Inc.

Pedicle Screw-Based
DSSParadigm Spine
DynesysZimmer Spine, Inc.
Stabilimax NZApplied Spine Technologies Inc.

10

Figure 7
DSS

THE CHOICE OF TECHNIQUE IS LARGELY DEPENDENT

ON THE LEVEL OF SURGERY, AND OTHER FACTORS
SUCH AS OBESITY, HISTORY OF PREVIOUS ABDOMINAL
SURGERIES, AND IMPLANT CHOICE.

Figure 8
Dynesys pedicle screws
and ligament system with
polyurethane spacers.

DEVICE-RELATED SURGICAL APPROACH

The surgical approaches in current use are tailored to specific
device characteristics. The potential need for revision of the
index procedure, as well as performance of subsequent procedures, has been taken into consideration where possible. This
section will provide a brief overview of the advantages and
disadvantages associated with the surgical approaches currently
being utilized.

Anterior
The anterior surgical approach is a muscle sparing procedure in
which access to the disc space is achieved by one of three principal techniques (Paramedian, ALPA and ARPA). The choice of
technique is largely dependent on the level of surgery, and other
factors such as obesity, history of previous abdominal surgeries,
and implant choice.

grade ejaculation. From the standpoint of the functional

spinal unit, this procedure can be destabilizing, as the anterior
longitudinal ligament is sacrificed.7

AnteroLateral TransPsoatic Approach (ALPA): The ALPA

was developed specifically for implantation of the PDN-SOLO
nucleus replacement device, as an alternative to the traditional
posterior approach.8 In addition to providing improved exposure
and increased ease of disc denucleation and device implantation,
ALPA avoids the destabilization associated with disruption of the
posterior elements. For this approach, the patient is positioned
in a lateral decubitus position, allowing direct lateral access to
the disc through the mid-portion of the psoas muscle (Figure 9).
The use of ALPA poses the risk of neurapraxia to the exiting
nerve roots posteriorly and to the ventral ramus branches of L1
anteriorly, as a result of traction applied to the psoas muscle
during exposure of the disc space. The limitation of this
approach is that it cannot be used at L5-S1 due to obstruction
by the iliac crest, and the lateral position of the iliac vessels at
this level.

Anterior Paramedian: A direct anterior approach is necessary

for implantation of the current generation of TDR devices. The
patient is placed in the supine position with the legs abducted
(da Vinci position), affording the spine surgeon a direct orthogonal view of the target disc space and vertebral bodies. A paramedian, muscle-sparing, retroperitoneal approach is utilized.4
Significant mobilization of the aortic terminus and iliac vessels is
generally required to permit discectomy, vertebral body distraction, and device placement in the midline. Degree of vessel
mobilization is a function of the index level and the profile
of the particular device chosen for implantation.
Potential approach-related complications include injury to the
vascular structures5, 6 and genitourinary tract. Manipulation of
the hypogastric plexus at L5-S1 in a male may result in retro-

Figure 9
ALPA approach.

11

Anterolateral Retroperitoneal Approach (ARPA): The ARPA

technique was developed as a total system approach for access
and placement of the HydraFlex nucleus replacement device,
and is described in detail in Volume III of Nucleus Arthroplasty
Technology in Spinal Care.9 The patient is placed in a supine
position allowing an easier and direct retroperitoneal access to
all lumbar levels. As the name implies, ARPA utilizes an oblique
pathway that is lateral to midline of the spine, yet anterior to
the trajectory of ALPA. As with ALPA, this is a muscle-sparing
approach, with the oblique musculature of the flank being split
along the direction of the respective fibers. The peritoneal sac is
then mobilized medially in standard retroperitoneal fashion
(Figure 10). This defined pathway limits the degree of vascular
mobilization and provides access to the disc space without sacrifice of the anterior longitudinal ligament. There is essentially
no vascular mobilization required during the course of nucleus
arthroplasty at L2-L3 or L3-L4, and only minimally so at L4-L5
and L5-S1. As with ALPA, ARPA also provides good access to
the disc space, while allowing for closure of the annular flap.
Access to the upper lumbar levels is done from the left, while the
L5-S1 level is approached from the right. Previous pelvic and/or
abdominal surgery in the right lower quadrant can increase the
risk of adhesion formation, and may complicate access to the
L5-S1 disc space via this approach.10, 11

Posterior
The posterior approach avoids manipulation of the peritoneal
sac and large vessels. Access to the disc space is achieved by one
of two principal techniques (Midline, Paraspinal). The choice of
technique is mainly a function of the intended treatment and
device placement, but may also be influenced by the need to
address a disc herniation or perform decompression.
Posterior Midline: A direct posterior approach is used for
implantation of the current generation of interspinous devices
and can also be implemented for pedicle-based systems. The
patient is placed in a prone position and an incision is made
on midline. The muscular and ligamentous structures are then
dissected to reach the bony structures of the spine.
Paraspinal: A paraspinal or Wiltse-style technique can be performed to achieve placement of pedicle screw-based systems.7
The patient is placed in a prone position and a pair of incisions is
made lateral to the midline. The deep longitudinal musculature is
then separated along muscle planes to gain access to the pedicle
and/or disc space (Figure 11). When applicable, use of this
approach can avoid significant muscle dissection and damage
to the ligamentous structures.

Figure 11
Paraspinal approach.

Figure 10
ARPA exposure of the L4-L5 disc space.

12

In general, the risks associated with the use of posterior

approaches are low, as the surgery tends to be less complicated.
Risks include damage to the neural structures and potential
spinal instability resulting from dissection and/or additional
procedures, such as a laminotomy or a hemifacetectomy that
may be required to properly access the disc space.

DEVICE-RELATED SURGICAL PROCEDURE

Implant Sizing and Insertion

As noted previously, the challenges associated with the surgical

procedure can vary considerably, impacting both the short and
long-term clinical success. More than 90% of all device-related
complications revolve around patient selection, improper sizing,
and implantation technique. This section will touch on the
procedure-related elements and potential differences between
the spinal motion preservation technologies. While all of these
technologies are ultimately designed to stabilize the spine, the
manner in which this goal is achieved may provide or limit the
opportunities for additional surgical intervention.

At this time, the clinical outcomes for many non-fusion technologies are heavily influenced by the procedural elements associated with implant sizing and insertion techniques. Implant
sizing is the key to restoring the appropriate motion pattern
and/or stabilizing the spine segment. However, the corresponding
distraction necessary to establish correct spinal position, or provide a pathway for implant delivery and placement, has a direct
impact on sizing. Thus, the two variables are interrelated.

Anterior Technologies: Currently, the devices that can be

effectively delivered using an anterior surgical approach
(Paramedian, ALPA, ARPA) are nucleus replacement and TDR
technologies. The use of an anterior approach allows adequate
visualization of the disc space, permitting discectomy and vertebral body distraction as necessary to accommodate sizing and
implant placement.
From a procedural perspective, nucleus replacements attempt to
preserve the annulus and the cartilaginous endplates. In contrast,
the TDR procedure entails removal of the entire pain-generating
disc and anterior annulus, as well as intentional sacrifice of the
cartilaginous endplate to allow for fixation of the prosthesis.
Posterior Technologies: Currently, the devices that can be effectively delivered using a posterior surgical approach (Midline,
Paraspinal) include interspinous spacers, pedicle screw-based
systems, and some nucleus replacements. The use of a posterior
approach provides more direct access to the lamina and pedicle
region, and can be much more desirable if a disc herniation or
decompression must also be performed.
From a procedural perspective, interspinous spacers require
minimal tissue dissection. Visualization is good and there is relative ease of insertion, resulting in high confidence in implant
placement. In contrast, pedicle screw-based systems require
much deeper tissue dissection, with far lateral placement of the
pedicle screw anchors that can be challenging. Anatomically,
both systems require little, if any, modifications to the anatomy
leaving future surgical options open.
A posterior approach may also be applicable for certain nucleus
replacements. However, this approach can prove to be challenging for larger designs (mechanical or preformed), due to the limited anatomical space for nucleus cleanout, device insertion and
repair of the annulotomy upon exit.

Regardless of approach, during the sizing process, care must be

taken to ensure that an appropriate level of distraction is applied
for a corresponding implant size. Improper distraction can cause
undue strain or injury of the ligamentous structures and facets that
are integral to maintaining the range of motion and corresponding
segmental stability.

Revision
Regardless of the procedure, it is important to ensure that reasonable opportunities exist for potential revision or additional
surgeries at adjacent levels. Revision surgery may be deemed
necessary due to clinical performance issues such as persistent
pain, neurological disorders, and trauma. Alternatively, revision
may be required secondary to device-related complications such
as malpositioning, migration, subsidence, component failure or
the presence of infection/rejection. While no surgeon selects a
device or surgical approach based on the likelihood of a revision,
consideration of this possibility will make any reoperation much
safer, should it be necessary.
From an anterior perspective, a strategic selection of the initial
approach, minimal mobilization of the vessels, and the use of an
anti-adhesion membrane between implant and vessels may reduce
surgical revision challenges.13 However, any anterior lumbar revision surgery should be performed in specialized centers that have
ready access to multidisciplinary services and experience in the
potential pitfalls involved.
The implant type, design, and index surgical approach of the initial and the corresponding revision implant technology can have a
significant impact on revision. For example, removal of a nucleus
replacement is expected to be low risk leaving reasonable options
open for the use of other technologies, including another nucleus
replacement, TDR, supplemental posterior fixation or fusion.

13

IN THE FUTURE, IT IS EXPECTED THAT SUCH RELATIONSHIPS WILL BECOME MORE

IMPORTANT WHEN EVALUATING SURGICAL OPTIONS FOR THE TREATMENT OF DDD.

In contrast, revision of a TDR can be far more complex and is

highly dependent on implant design and the corresponding reason for revision. TDR prostheses with a modular design may
provide the opportunity to replace a portion of the device, such
as the inner core, thus minimizing vascular mobilization and
contact with vertebral bone. However, if explantation is necessary, en bloc designs or modular designs with keels and/or
bone ingrowth surfaces are far more difficult to remove.13 In
such instances, extensive pre-operative imaging, and possible
pre-emptive intervention with regard to the vascular and genitourinary systems, is necessary in order to develop a safe and
coherent treatment strategy.6, 10
Posteriorly, the risks associated with revision are greatly reduced.
Removal of an interspinous spacer is expected to be low risk, leaving reasonable options open for the use of other motion-sparing
technologies via an anterior or posterior approach. Similarly, a low
degree of risk is expected for the revision of pedicle screw-based
systems, provided that screw breakage and/or pedicle damage is
not an issue.

CONCLUSION
This chapter provided a brief review of the current spinal motion
preservation technologies and the interrelationships that exist
between implant design, surgical approach, and surgical procedure. While the selection of a particular treatment modality has
important implications for the initial surgery, it may have significant impact on future surgeries associated with both treatment of
the adjacent levels and revision of the index level. In the future, it
is expected that such relationships will become more important
when evaluating surgical options for the treatment of DDD.

14

REFERENCES
1. Kirkaldy-Willis WH. Managing low back pain. N.Y. 1983 Churchill Livingston.
2. Ghiselli GWJ, Bhatia NN, Hsu WK, et al. Adjacent segment degeneration in
the lumbar spine. J Bone Joint Surg Am 2004; 86: 1497-503.
3. Segupta D. The mechanism of action of posterior dynamic stabilization
assessed by disc pressure profilometry. The Spine Journal Vol 6 (5) 2006:
148149.
4. 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.
5. Brau SA, Delamarter RB, Schiffman ML, Williams LA, Watkins RG. Vascular
injury during anterior lumbar surgery. The Spine Journal 4 (2004): 409-412.
6. Fantini GA, Pappou IP, Girardi FP, Sandhu HS, Cammisa Jr FP. Major
vascular injury during anterior lumbar spinal surgery: Incidence, risk factors
and management. Spine (in press).
7. Lehman RA, Vaccaro AR, Bertagnoli R, Kuklo TR. Standard and minimally
invasive approaches to the spine. Orthop Clin N Am 36 (2005) 281292.
8. Bertagnoli R, Vazquez RJ. The AnteroLateral transPsoatic Approach (ALPA).
J Spinal Disorders Tech 2003 Vol 16 (4) 398404.
9. Fantini GA, Brau SA. Nucleus Arthroplasty: Approach-Related Considerations.
In: Nucleus Arthroplasty in Spinal Care. Book III: Surgical Techniques and
Technologies Davis RJ, Girardi FP, Cammisa Jr FP (eds). Raymedica LLC,
Minneapolis, MN. 2007 (in press).
http://www.nucleusarthroplasty.com/surgical.html.
10. Kostiuk JP. Complications and surgical revision for failed disc arthroplasty.
The Spine Journal 4 (2004) 289S 291S.
11. Bertagnoli R, Zigler J, Karg A, Voigt S. Complications and strategies for revision
surgery in total disc replacement. Orthop Clin Am 36 (2005) 389395.
12. Ivanic GM, Pink PT, Schneider F, Stuecker M, Homann NC, Preidler KW.
Prevention of epidural scarring after microdiscectomy: A randomized clinical
trial comparing gel and expanded polytetrafluoroethylene. Eur Spine J (2006)
15: 13601366.
13. David T. Long-term results of one-level lumbar arthroplasty. Spine 32 (6)
(2007) 661-666.

Chapter 23

Nucleus Arthroplasty
Design and Evaluation Challenges

Prof. Dr. Hans-Joachim Wilke

PROFESSOR

Institute of Orthopaedic Research and Biomechanics

University of Ulm
Ulm, Germany 89801

KEYPOINTS
Successful nucleus arthroplasty devices have numerous clinical
design challenges including anatomy preservation and restoration
of segmental spinal motion.
There are a number of methods that can be utilized to characterize a nucleus arthroplasty device. It is important to select
and perform tests that are appropriate and representative of
the physiological conditions for a particular device type.
In addition to mechanical analyses, functional performance
under biological conditions should be studied using
in vivo experiments.

INTRODUCTION

he science of nucleus arthroplasty represents an exciting

multidisciplinary challenge. The successful development
of such technologies requires key input from individuals within
many disciplines including
biomechanical engineering,
design engineering, material
SUCCESSFUL NUCLEUS ARTHROPLASTY DEVICES
sciences, tissue engineering,
HAVE NUMEROUS CLINICAL DESIGN CHALLENGES
biology, microbiology, and
INCLUDING ANATOMY PRESERVATION AND
of course spine surgeons.
RESTORATION OF SEGMENTAL SPINAL MOTION

15

F R O M A C L I N I C A L P E R S P E C T I V E , T H E P R I M A RY G O A L O F N U C L E U S
A RT H R O P L A S T Y T E C H N O L O G I E S I S T O R E M O V E O R R E D U C E D I S C O G E N I C
PA I N , W H I L E S E E K I N G T O P R E S E R V E A S M A N Y E X I S T I N G A N AT O M I C A L
STRUCTURES AS POSSIBLE.

Integral to the process is a thorough understanding of the function

of the disc, the biomechanics of the spinal segment and the loading
of the entire spine. Furthermore, it requires additional knowledge in
regard to the corresponding biological responses, biomechanical
loads, and resulting deformations at the tissue level.

Part II of this chapter provides a review of potential experimental

tests and corresponding methods that may be utilized to characterize or benchmark nucleus replacement implants. The testing
schemes that are presented are only recommendations; specific
tests may not be appropriate for each device type or group.

From a clinical perspective, the primary goal of nucleus arthroplasty technologies is to remove or reduce discogenic pain, while
seeking to preserve as many existing anatomical structures as
possible. Secondarily, it is also desirable to provide segment
stabilization and slow the progression of the degenerative cascade.

CLINICAL DESIGN ASPECTS OF

NUCLEUS ARTHROPLASTY CONCEPTS

Thus, in theory, an optimal nucleus replacement should be capable of restoring the function of the spinal segment. This implies
that it should re-establish the intact disc height, motion, and the
load-sharing behavior between the different structures, thereby
restoring the nominal stresses and strains in the collagen fibers
of the annulus, remaining nucleus, and endplate.
Currently, there is a wide array of nucleus implants in clinical
application or under development.1 The major design concepts
include mechanical, preformed polymer, in situ formed polymer,
and tissue engineered implants (Volume II, Chapter 8).2 However,
while each design concept has certain advantages or disadvantages,
to date, it is the authors opinion that there is no single device that
can be referred to as an optimal nucleus replacement implant.
The following chapter is intended to be multipurpose with Part I
focusing on the design challenges associated with nucleus arthroplasty devices. Unfortunately, there is limited data published about
the biomechanical or clinical performance of such systems. Thus,
in most cases the information that is provided represents the personal opinion and judgment of the author. As such, certain items
may not apply to each device type or specific group.

16

Nucleus replacement implants seek to maintain the anatomical

integrity of the disc and restore spinal segment motion. To
achieve these goals in design, requires proper consideration of
the anatomical and motion preservation characteristics of the
native disc.

Anatomical Considerations
From an anatomical perspective, it is important to address and
attempt to preserve the structures that compose the healthy
spinal segment. Anteriorly, it is important to preserve the anterior longitudinal ligament and annulus, and protect the integrity
of the vertebral endplate when performing the nucleotomy.
Posteriorly, it is important to maintain the facet joint, capsule, and
posterior ligamentous structures. Implant systems that require significant anatomic disruption may place more biomechanical
demands on the device, impacting long-term function.

Annulus Preservation
One of the big advantages of nucleus arthroplasty devices is that
the annulus can be preserved to a greater extent than artificial disc
prostheses. The degree of annular preservation is largely dependent on the surgical technique, corresponding implant design
(preformed, in situ, other), and insertion technique. To assist in
healing and reduce the potential for implant mobility, it may be
of benefit to close the annular opening after implantation.

Endplate Integrity
The importance of maintaining endplate integrity was noted in
early studies with the Fernstrom3 ball. The relationship between
implant stiffness or compliance, implant shape, and contact area,
has a direct impact on the potential for implant subsidence that
cannot be overlooked.

Ligaments and Facets

Anatomically, the spinal ligaments and facets play a vital role
in nucleus arthroplasty in regard to segment stability. From a
design system perspective, damage to these structures during
surgical approach or device placement may significantly alter the
segment motion and impact both short and long-term effectiveness of the surgical treatment. For example, insertion of
implants using a postero-lateral approach may require a hemifacetectomy, potentially leading to instability. Such concerns will
be discussed in more detail in the next section.

Motion Preservation
One of the primary goals of nucleus replacement is to restore or
maintain disc height which can assist in improving function and
corresponding disc kinematics. The kinematic characteristics of
the spinal segment are very complex. The three-dimensional
motion is dictated by each of the spinal structures: the annulus,
nucleus, ligaments, and facet joints. It also differs from segment
to segment and is influenced by the spinal level, the disc height,
the degeneration state, and the facet joint orientation. These
characteristics determine the coupled and individual motion
patterns, based on an applied load or prescribed motion.
The motion patterns produce pathways of the center of rotation
when projected into the principle motion planes, or other orientations and axis configurations of interest. These so-called helical axes are very sensitive parameters, which are difficult to
precisely determine.4 While the exact kinematics of the spinal
segment are not completely understood, restoration after
implantation of a motion preservation device may be critical
for long-term clinical benefit.
Some motion preservation technologies represent a compromise
in kinematics as the motion pattern is not perfectly re-established.
Experiments have shown the coupled motions and thus, the helical
axes can be re-established in some cases almost ideally.5 In other
cases, the coupled motions are diminished and the implant acts
more like a hinge joint. The ability to re-establish the appropriate

motion patterns may be better achieved with compliant nucleus

arthroplasty devices which absorb energy, mimicking the function
of the nucleus.

Physiological Loading and ROM

The ability to re-establish the physiological load sharing between
the spinal structures is also important. Recreating the physiological condition requires that an implant solution is capable of
reproducing the physiological strains in the annulus and endplates that are present in a healthy segment.6, 7 Proper restoration
of the disc height after nucleotomy has been shown to restore
the range of motion to near that of the intact disc.8, 9 However,
further increasing the height, or over-distracting the segment,
decreases both the range of motion and neutral zone, while
stretching the annulus and stiffening the motion segment. In
addition, over-distraction can produce a lifting of the facet joints
resulting in an increased range of motion in axial rotation.

Damping Characteristics
Although the native disc exhibits a certain damping effect, little
is known about this parameter. Until recently, disc replacement
technologies were predominantly non-compliant mechanical
implants that paid little attention to this particular area. Most
nucleus arthroplasty devices have axial compliance and attempt
to address damping to some degree.
The elastic preformed, in situ formed polymer implants, and
tissue engineered implants may address damping as such
implants seek to control physiological strain distribution in the
remaining annulus, which is partially responsible for damping.
Non-polymer-based designs such as a knitted titanium filament
nucleus prosthesis may also work since they can undergo a
change in density due to the knitting technique used.10

Biological Considerations
Whether nucleus arthroplasty technology is able to support a
certain degree of biological regeneration is very speculative. As
mentioned above, nucleus implants may be an optimal method
to restore physiological conditions in the spine, hence potentially
slowing down the degeneration process. However, biological
regeneration requires a physiologic environment that allows the
endplates to provide adequate nutrition combined with viable
and healthy cells.11, 12 However, even if the conditions are perfect,
it is questionable whether the true origins of disc degeneration,
17

which are often genetically predetermined, can be corrected

using such an approach.
The future success of this challenging design space will be dependent on our ability to develop and evaluate implants that meet the
specific clinical design aspects and physiological conditions.

failure, whichever occurs first. At a minimum, static characterization should address the following: single cycle strength testing,
compression characterization testing, creep recovery testing,
subsidence testing and hydration/polymerization rate testing.

Test Rate, Temperature and Constraint Analysis

CHARACTERIZATION OF THE NUCLEUS
ARTHROPLASTY DESIGN CONCEPTS
As noted above, there are significant challenges associated with
the design of a nucleus arthroplasty implant. To improve the
odds for success, each proposed design concept must be properly
evaluated or characterized using preclinical experiments.
Initially, the implant can be tested using several different methods to ensure that it can withstand the expected physiological
load environment. In addition to isolated implant testing, cadaveric studies must be performed with the implant to determine
the impact of the surgical approach and procedure. Finally, functional performance under biological conditions should be studied
using in vivo experiments. The following paragraphs provide an
overview and describe a battery of tests that may be applicable in
evaluating an implant design.

Mechanical Characterization

Most of the nucleus arthroplasty devices on the market are manufactured from materials that have viscoelastic, or rate dependent,
properties. Therefore, the test rate utilized in a characterization
test is critical. Based on the various designs, one rate may not
be appropriate. Testing needs to be performed on the individual
device to identify the appropriate test rate as this could bias the
test results.
The effect of temperature needs to be addressed when conducting tests on polymeric devices or tissue-based implants as
device properties may vary at body temperature compared
to room temperature.
For devices with unconstrained deformation that depend or expect
contact with the annulus during in vivo use, the various tests identified below should be performed in unconfined constraints and
confined constraints using special test setups (Figures 1 & 2). Based
on implant design and intended function, the bulk properties of
the implant may be greatly impacted by test constraints.

Mechanical test standards (i.e. ISO, ASTM) for evaluating

nucleus replacement devices do not exist. Using FDA guidance
documents, test methods may be developed to adequately characterize the device performance. Mechanical characterization
involves both static and dynamic tests. The test methods and the
justifications of the test parameters (i.e. loading mode, frequency
of testing, failure loads, test environment) need to be defined
prior to initiation.

Load cell

Piston
Collagen implant

Static Characterization
Static testing needs to be carried out to sufficiently characterize
the performance properties of the individual components and
the finished device in simulated physiologic conditions. Strength
testing should evaluate the robustness of the device construct
and/or device under extreme loads. Testing should be conducted
on both the device components (if applicable) and finished
device to a representative worst-case physiologic load or to

18

Figure 1: Unconfined testing of a tissue

engineered nucleus implant in a material
testing machine.

Figure 2: Confined testing of a tissue engineered nucleus implant using a porous stainless
steel chamber (a, b) in a material testing machine (c).

Single Cycle Device Burst Testing

A nucleus replacement device may be subjected to extreme in
vivo compressive loads. In vivo studies performed in our lab
showed that the maximum load when bending over to lift a load
of 20 kg with straight legs was about 4000 N.13 Published literature reports peak compressive loads during lifting of heavy
objects to be as large as 7000 N through a vertebral segment,
with approximately 15% of the load carried through the facet
joints in an upright position.14, 15 Therefore, peak loads through
the anterior column are estimated at 6000 N maximum; similar
vertebral fracture loads are defined in the literature.16
In the anterior column, load is distributed nearly equally
between the nucleus and the annulus.17, 18 However, based on
implant design, a portion of, or all of the anterior column load
may pass through the device. Therefore, depending on the loadsharing characteristics of the implant, a maximum device load
between 3000 N and 6000 N is representative of a single cycle
worst-case physiologic load. Upon completion of testing, the
data should identify where and how device failure initiated.

Load Deflection Testing

Loads passing through the spinal column are cyclic in nature.
Therefore, a nucleus arthroplasty device should ideally be able to
absorb loads representative of daily living and recover upon load
removal. In order to estimate how the device will function clinically, compressive load deflection testing should be performed to
characterize the acute performance of the device. Relevant loads
may be determined based on a review of the literature. In vivo
research estimates a load of 200 N to represent supine disc loads,
800 N to represent relaxed standing, 2000 N to replicate standing

with flexion and up to 4000 N representing standing with flexion

while lifting 20 kg.13 Based on implant design and accounting for
load sharing between the facet joints and annulus, load-deflection
implant characterization should be conducted to maximum load
between 1700 N-4000 N to be representative of physiologic loading.

Contact Footprint and Pressure Testing

Loads applied to the vertebral bodies are transferred through a
nucleus replacement device. This load transfer also occurs through
the endplate-implant interface. To understand the conformability
and endplate stress associated with a nucleus arthroplasty device,
contact stresses should be analyzed. For characterization purposes,
concave steel load platens are recommended to isolate device performance and minimize variation in cadaveric tissue. Calibrated
Tekscan pressure film, or equivalent, provides a good measure of
contact footprint, contact stress and conformity for characterization testing. As above, to represent a physiologic condition, testing
should be conducted to 1700 N-4000 N.

Subsidence Testing
In addition to the contact footprint and pressure testing, subsidence testing in accordance with ASTM F2267-04 should be
performed to determine the relative resistance of the device to
subsidence in simulated cancelleous bone foam. To better
establish clinical relevance of the values calculated from the
ASTM test, it is recommended to utilize a control device with
documented clinical experience.

19

TO EVALUATE THE DEVICE RESPONSE AND ABILITY TO WITHSTAND PHYSIOLOGIC

LOADS REPRESENTATIVE OF HEAVY LIFTING, THE DEVICE SHOULD BE SUBJECTED TO
CYCLIC COMPRESSION TESTING IN REPRESENTATIVE TEST PLATENS.

Creep Recovery

Compression Shear Fatigue

Nucleus arthroplasty devices may be subjected to sustained loads;

therefore, characterizing the creep recovery response is important.
This test may be designed to generally comply with ASTM D2990-01
Standard Test Methods for Tensile, Compressive, and Flexural
Creep and Creep-Rupture of Plastics. The devices should be
subjected to various load ranges, load rates, and recovery times.

Due to the small amount of torsion in the lumbar spine, it is

believed that the potential failure modes in dynamic compressionshear testing exemplify the worst-case loading condition seen by a
nucleus arthroplasty device.

Dynamic Characterization
As with single cycle test rate analysis, for dynamic testing, test
rate analysis should be performed prior to dynamic characterization. The dynamic testing may include load deflection hysteresis
testing, compression-shear fatigue testing, and cyclic wear testing. The test methods and rationale will be somewhat dictated
by device design.

Load Deflection Hysteresis

To evaluate the device response and ability to withstand physiologic loads representative of heavy lifting, the device should
be subjected to cyclic compression testing in representative
test platens.
Load sharing through a vertebral segment varies during activities
involving flexion, extension, and lateral bending. Compressive
loads during relaxed standing are reported to be 800 N and, during
lifting of 20 kg objects, can be as large as 4000 N through the vertebral segment.13 A worst-case scenario can be established by assuming that the majority of the loads may pass directly through the
device. Excluding the reported 15% compressive load sharing of
the facet joints and accounting for annulus load sharing, the
physiologic spinal segment compressive cyclic testing scheme representative of standing and heavy lifting is 400 N to 2000 N.13
Estimating that heavy lifting is performed twice a week for 20
years, each device should be subjected to 2000 peak load cycles
during the course of evaluation.

20

Testing conducted at our laboratory, recorded compressive loads

experienced by the disc during typical daily activities (i.e. resting,
standing, sitting, walking, stair climbing) ranges from 200 N to
1250 N.13 During walking, we measured a compressive load of
approximately 1150 N. Others have reported lumbar compression
and shear loads during walking to be as high as 1850 N and 560 N,
respectively.19 Shear loads in the literature are reported to be up to
1200 N at L5/S1 with more strenuous activities.20 Therefore, selecting loads measured during walking as representative of physiologic cyclic loads and accounting for load distribution across the
segment, a simultaneous axial compression of 925 N and 280 N
shear is recommended. It is generally recommended to evaluate
a minimum of six devices to a minimum of 10 million cycles.

Cyclic Wear Testing

Cyclic wear properties can vary with implant design and material choice. Limited data is currently available for such tests as
they are often performed in-house during development with the
results used for regulatory purposes and not publication. Local
and systemic reaction from wear particulate is a risk with any
implantable device. Particle size, morphology, and quantity have
been demonstrated to be key factors in the bodys response to
wear debris. Therefore, testing should be conducted to determine
the wear debris generated over a representative device lifetime.
The compression shear fatigue loading described above may be
utilized to assess the durability and potential wear debris generation of nucleus arthroplasty devices. All devices should be
tested in Ringers solution to simulate the in vivo environment. The Ringers solution should be analyzed after 5 million
and 10 million cycles to characterize any wear particulate.

Cadaveric Studies
The nucleus arthroplasty device interactions with soft tissue
structures (i.e. annulus, ligamentous structures, facet joints) are
difficult to predict and replicate in bench tests. Therefore, upon
completion of the characterization bench tests, various cadaveric
studies should be performed to help bridge the characterization
test results to expected clinical performance.
Details and recommendations for a standardized in vitro stability
test, as well as information about handling of specimens, can be
found in another publication.21

Functional In Vitro Flexibility Tests

In contrast to the pure mechanical tests, flexibility tests are designed
with the goal of evaluating the in situ performance. Ideally, such
evaluations incorporate the use of cadaveric specimens mounted
on mechanical testing machines that produce loads that simulate
the expected physiological motion (Figure 3).22

Testing should be carried out in flexion/extension, lateral bending, and axial rotation. After completing the basic tests, additional studies using shear loading, compression, muscle forces,
and other representative in vivo loads may also be considered.
To assess device performance and account for potential variation
in cadaveric specimens, it is recommended that such in vitro
studies be performed for the intact, nucleotomized/degenerated,
and implanted states. It is also recommended for standardization
purposes that evaluations be performed under pure moments
without preload.21
The parameters of interest are the range of motion, the neutral
zone in the different motion planes, the shear translations, and
the corresponding changes in height. Additionally, information
such as the centers of rotation, helical axes, and load-sharing
capabilities of the different spinal structures, help to provide a
complete kinematic picture (Figure 4).
Test methods and corresponding results are included in Volume II
of the publication series. Details and recommendations for a
standardized in vitro stability test, as well as information about
handling of specimens, can be found in another publication.21

Expulsion Testing

Figure 3: Custom-built spine

loading apparatus to determine
the functional flexibility of a
cadaveric spinal segment
the simulator consists of three
axes with integrated motors,
gears, and clutches, which allow
application of pure moments.

Depending on the type of device, expulsion or subsidence of the

implant may be a serious problem. In order to evaluate this type
of biomechanical failure, the specimens should be subjected to
complex cyclic loading regime, as during daily activities, the spine
is not only loaded axially, but rather eccentrically.

Figure 4: Disc bulging can

be measured with a threedimensional laser scanning
device fixed in the spine
loading apparatus.

21

TO SIMULATE THIS COMPLEX LOADING, OUR LAB HAS

DEVELOPED A TEST SETUP SUCH THAT DURING CYCLIC
LOADING THE SPECIMEN REVOLVES CLOCKWISE
AROUND AN AXIS LOCATED IN THE CENTER OF THE
VERTEBRAL BODY AT A RATE OF 360/MIN.

To simulate this complex loading, our lab has developed a test

setup such that during cyclic loading the specimen revolves
clockwise around an axis located in the center of the vertebral
body at a rate of 360/min (Figure 5).23 This setup provides
complex motion as during testing the specimen experiences
loading in flexion, left lateral bending, extension, and right
lateral bending in a continual manner.
A total of 100,000 cycles at 5 Hz with an eccentric load (lever
arm of 40 mm) and an amplitude between 100 N-600 N should
be applied.23 Depending on the type of implant, testing should
be performed in a Ringers solution; however, degradation of
the cadaveric tissue may influence the ability to perform longterm tests (Figure 6).
Cyclic loading may also provoke subsidence or a loss in implant
height which can be quantified by measuring the overall height.
Measurements should be taken pre and post-loading and after
every 20,000 cycles in the material testing machine (Figure 7).
In order to obtain reproducible measurements, the upper plane
of the PMMA block should be leveled horizontally with the specimen loaded using a standardized preload, for example 100 N
axial preload. Following the cyclic test, secondary flexibility and
height measurement evaluations should also be performed.
Please note that the results obtained with the suggested test
setup may not correlate directly to clinical rates of device extrusion, but should serve as a basis for comparison of the relative
risk profile.

Figure 5: Setup in a dynamic material testing machine to load the

cadaveric specimens cyclically with an eccentric preload (100 N-600 N,
x 40 mm lever arm with 5 Hz) while the specimen is rotated around
its own axis at 360/minute.

Collagen implant
with annulus
sutured
Figure 6: Examples for
the process of nucleus
implant extrusion
(<300 cycles).
Textile implant
without annulus
sutured

22

associated local and systemic histological response to any such

wear debris. Other species like the sheep may also be considered,
but the limitations of these models have always to be discussed.26

Biocompatibility Testing

Figure 7: Height measurements should be performed

under reproducible conditions, the upper vertebra
should be leveled horizontally with the specimen loaded
using a standardized preload.

Functional In Vivo Studies

The baboon model is considered a relevant model for the
human spine based on the baboons anatomy, physiology, in
vitro mechanics, pseudo-bipedal gait and extremely active daily
activities.24, 25 In addition, the results from Ledet et al.25 suggest
the mechanical loads in baboons are equivalent to the human
spine. However, the disc space is smaller than the human spine
and requires miniaturized devices for implantation. Based on the
materials utilized in most nucleus arthroplasty devices, miniature devices may not have equivalent performance characteristics
as those utilized for human implants. Thus, the baboon model
represents a worst-case in vivo evaluation and has been used for
numerous nucleus replacement technologies primarily to assess
the safety of the device material when exposed to daily movements.24 One of the primary purposes in performing such in vivo
baboon model testing is to assess device wear generation and the

Manufacturers should consider performing all relevant tests recommended by ISO 10993-1, FDAs Blue Book Memorandum
#G95-1, and possibly a carcinogenicity assay. Tests performed
included cytotoxicity; sensitization; irritation/intracutaneous
reactivity; acute systemic toxicity; subacute, subchronic, and
chronic systemic toxicity (for general systemic and local effects);
material-mediated pyrogenicity; and genotoxicity (bacterial,
and in vivo and in vitro mammalian) and hemolysis.

CONCLUSION
Nucleus arthroplasty is an exciting and challenging technology
and may be a promising alternative to other non-fusion concepts. While current patient demographics continue to support
the need for such innovative ideas, creating a nucleus arthroplasty device requires a multi-discipline approach with respect
to the design, development, and testing.
This chapter outlined the design challenges, methods of characterization, and importance of biomechanical testing. Based on
the specific biomechanical demands, each type of nucleus
arthroplasty device may have a target population in which it
works well clinically. The challenge is to balance the biomechanics with the other surgical and pathology factors that are often
difficult to identify and control.
Although the described test methods may have limitations,
they provide important and useful information during development and may provide relevant findings prior to clinical
application. Nevertheless, even if a particular implant performs
well in the lab, the ultimate test of the biomechanical data will
be the clinical outcomes.

NUCLEUS ARTHROPLASTY IS AN EXCITING AND CHALLENGING TECHNOLOGY

AND MAY BE A PROMISING ALTERNATIVE TO OTHER NON-FUSION CONCEPTS.

23

BASED ON THE SPECIFIC BIOMECHANICAL DEMANDS, EACH TYPE OF NUCLEUS ARTHROPLASTY DEVICE MAY HAVE A TARGET POPULATION IN WHICH IT WORKS WELL CLINICALLY.
THE CHALLENGE IS TO BALANCE THE BIOMECHANICS WITH THE OTHER SURGICAL AND
PATHOLOGY FACTORS THAT ARE OFTEN DIFFICULT TO IDENTIFY AND CONTROL.

ACKNOWLEDGMENTS
A portion of the studies mentioned above have been supported
by the German Research Foundation (Deutsche
Forschungsgemeinschaft (WI 1352/8-1).

REFERENCES

12. Wuertz K, Urban JP, Klasen J, et al. Influence of extracellular osmolarity

and mechanical stimulation on gene expression of intervertebral disc cells.
J Orthop Res 2007.
13. Wilke HJ, Neef P, Caimi M, et al. New in vivo measurements of pressures in
the intervertebral disc in daily life. Spine 1999;24:755-62.
14. Han JS, Goel VK, Ahn JY, et al. Loads in the spinal structures during lifting:
development of a three-dimensional comprehensive biomechanical model.
Eur Spine J 1995;4:153-68.

1. Bao QB, Yuan HA. New technologies in spine: nucleus replacement. Spine
2002;27:1245-7.

15. Adams MA, Hutton WC. The effect of posture on the role of the apophysial
joints in resisting intervertebral compressive forces. J Bone Joint Surg Br
1980;62:358-62.

2. Wilke HJ. Principles and Mechanical Requirements of Nucleus Implants. In

Davis RJD, Girardi FP, Cammisa FP, et al. eds. Nucleus Arthroplasty
Technology in Spinal Care. Minneapolis, MN: Raymedica, LCC, 2007:11-6.

16. Brinckmann P, Biggemann M, Hilweg D. Prediction of the Compressive

Strength of Human Lumbar Vertebrae. Clin Biomech 1989;4:S1-S27.

3. Fernstrom U. Arthroplasty with intercorporal endoprothesis in herniated disc

and in painful disc. Acta Chir Scand Suppl 1966;357:154-9.

17. Adams MA, McNally DS, Dolan P. Stress distributions inside intervertebral
discs. The effects of age and degeneration. J Bone Joint Surg Br
1996;78:965-72.

4. Schmidt H, Claes L, Wilke HJ. Instantaneous Axis of Rotation of a L4-5

Segment under Simple and Complex Load Situations. A Three Dimensional
Finite Element Analysis. Global Symposium on Motion Preservation
Technology 7th Annual Meeting. Berlin: Spine Arthroplasty Society, 2007:17.
5. Wilke HJ, Kettler A, Claes L. Range of motion or finite helical axis?
Comparison of different methods to describe spinal segmental motion in
vitro. Roundtables in Spine Surgery Spine Biomechanics 2005;1:13-21.
6. Neidlinger-Wilke C, Wurtz K, Liedert A, et al. A three-dimensional collagen
matrix as a suitable culture system for the comparison of cyclic strain and
hydrostatic pressure effects on intervertebral disc cells. J Neurosurg Spine
2005;2:457-65.
7. Neidlinger-Wilke C, Wrtz K, Urban JP, et al. Regulation of gene expression
in intervertebral disc cells by low and high hydrostatic pressure. Eur Spine J
2006;15:S372-S8.
8. Wilke HJ, Kavanagh S, Neller S, et al. Effect of a prosthetic disc nucleus on
the mobility and disc height of the L4-5 intervertebral disc postnucleotomy.
J Neurosurg 2001;95:208-14.
9. Wilke HJ, Heuer F, Neidlinger-Wilke C, et al. Is a collagen scaffold for a tissue
engineered nucleus replacement capable of restoring disc height and stability
in an animal model? Eur Spine J 2006;15 Suppl 3:S433-8.
10. Kaps HP, Kettler A, Haegele B, et al. Nearly Natural Biomechanical Properties
of a Nucleus Prosthesis Made of Knitted Titanium Filaments. Global
Symposium on Motion Preservation Technology 7th Annual Meeting. Berlin:
Spine Arthroplasty Society, 2007:66.
11. Urban JP, Smith S, Fairbank JC. Nutrition of the intervertebral disc. Spine
2004;29:2700-9.

24

18. McNally DS, Adams MA. Internal intervertebral disc mechanics as revealed
by stress profilometry. Spine 1992;17:66-73.
19. Khoo B, Goh J, Bose K. A biomechanical model to determine lumbosacral
loads during single stance phase in normal gait. Medical Engineering and
Physics, 1995. 17:p. 27-35.
20. Bazrgari B, Shirazi-Adl A, Arjmand N. Analysis of squat and stoop dynamic
liftings: muscle forces and internal spinal loads. Eur Spine J 2007;16:687-99.
21. Wilke H-J, Wenger K, Claes L. Testing Criteria for Spinal Implants:
Recommendations for the Standardization of In Vitro Stability Testing of
Spinal Implants. European Spine Journal 1998;7:148-54.
22. Wilke HJ, Claes L, Schmitt H, et al. A universal spine tester for in vitro experiments with muscle force simulation. Eur Spine J 1994;3:91-7.
23. Wilke HJ, Mehnert U, Claes LE, et al. Biomechanical evaluation of vertebroplasty and kyphoplasty with polymethyl methacrylate or calcium phosphate
cement under cyclic loading. Spine 2006;31:2934-41.
24. Allen MJ, Schoonmaker JE, Bauer TW, et al. Preclinical evaluation of a poly
(vinyl alcohol) hydrogel implant as a replacement for the nucleus pulposus.
Spine 2004;29:515-23.
25. Ledet EH, et al. Direct real time measurements of the in vivo forces in the
lubmar spine. The Spine Journal 2005;5:8-94.
26. Alini M, Eisenstein SM, Ito K, et al. Are animal models useful for studying
human disc disorders/degeneration? Eur Spine J 2007.

Chapter 24

Early Clinical Results of Nucleus

Arthroplasty Technology

Robert Tatsumi, MD
CLINICAL FELLOW

The Spine Institute, Santa Monica

Los Angeles, CA 90404

Jason Gallina, MD
CLINICAL FELLOW

The Spine Institute, Santa Monica

Los Angeles, CA 90404

Hyun Bae, MD
DIRECTOR OF RESEARCH

The Spine Institute, Santa Monica

Los Angeles, CA 90404

KEY POINTS
A vast array of nucleus arthroplasty implants is currently
available including hydrogels, polymer/synthetics,
and mechanical devices.
Early pilot data with these devices has been promising
in clinical studies outside of the United States.
Pilot studies are underway in the United States and pivotal
studies will need to be designed and implemented to determine
the efficacy of nucleus replacement devices.

25

INTRODUCTION

UNITED STATES CLINICAL TRIALS

Currently, the United States has four nucleus replacement Pilot

Investigation Device Exemption (IDE) trials from three companies that have been actively enrolling patients. These pilot studies
have small sample numbers (10-40 patients) and are geared to
prove device safety. Data accumulated from each of these studies
will then be used to establish pivotal FDA IDE trials to determine
device efficacy. The pivotal FDA IDE trial will ultimately require
250 to 500 patients and have to prove efficacy against a randomized control. The proposed control arms at this point have not
been finalized. The possible groups that have been proposed are
non-operative treatment, lumbar interbody fusion, and total disc
replacement. The current pilot IDE trials are as follows:

s people age, the lumbar discs undergo a progressive

alteration of chemical composition and biomechanical
properties.1-11 Such chemical and biomechanical changes can
lead to back pain.12 There are various surgical procedures for
the treatment of low back pain caused by degenerative disc
disease.13-19 Nucleus replacement is a newer option and this
chapter will discuss the early clinical results of this procedure.
At the present time, the Food and Drug Administration (FDA)
considers the term nucleus arthroplasty as broadly applicable
to any device that replaces the nucleus pulposus, while preserving the surrounding annulus. Nucleus arthroplasty has been
indicated for the treatment of early-stage degenerative disc disease with an intact annulus or status post-microdiscectomy
procedure where nucleus material has been removed. The goals
of nucleus arthroplasty surgery are to preserve the motion and
geometry of the index intervertebral disc, while preventing
adjacent segment degeneration.

NUCLEUS ARTHROPLASTY TECHNOLOGY

Spine Wave, created in 2001, developed NuCore as an adjunct

following a standard microdiscectomy procedure. NuCore is an
injectable protein that cures rapidly in situ forming a hydrogel
that adheres to the annulus. After a partial nuclectomy (<33%
of the nucleus is removed), NuCore is injected to fill the void
created during removal of the herniated nucleus material. Spine
Wave currently has two clinical trials with ten patients in each
trial (Figure 1).

Early nucleus arthroplasty devices were focused on replacing

the nucleus with stainless steel ball bearings, silicone rubber, or
polymethylmethacrylate (PMMA) cement.16-19 Some of these
devices had inferior results due to hardware failure and our
misunderstanding of disc biomechanics. Currently, there are
more than 20 different nucleus arthroplasty devices in the concept or development stages. These devices vary greatly in design
and function utilizing hydrogel, polymer/synthetic, or mechanical technologies to preserve the motion and geometry of the
intervertebral disc.

Figure 1
NuCore

AT THE PRESENT TIME, THE FOOD AND DRUG ADMINISTRATION (FDA) CONSIDERS THE
TERM NUCLEUS ARTHROPLASTY AS BROADLY APPLICABLE TO ANY DEVICE THAT REPLACES
THE NUCLEUS PULPOSUS, WHILE PRESERVING THE SURROUNDING ANNULUS.

26

NUCLEUS ARTHROPLASTY HAS BEEN INDICATED FOR THE TREATMENT OF EARLY

STAGE DEGENERATIVE DISC DISEASE WITH AN INTACT ANNULUS OR A STATUS POSTMICRODISCECTOMY PROCEDURE WHERE NUCLEUS MATERIAL HAS BEEN REMOVED.

Figure 2a
Dehydrated PDN-SOLO

Figure 2b
HydraFlex device

Raymedica, founded in 1990, has been a pioneer in the field of

disc nucleus arthroplasty with the invention of the paired pillowshaped hydrogel device in 1996 (PDN prosthetic disc nucleus).
Raymedica has since introduced single-device implants utilizing
the same hydrogel components and high molecular weight polyethylene jacketed designsthe PDN-SOLO and HydraFlex
devices (Figures 2 a & b). The hydrogel core is a shaped pellet
that absorbs fluid after implantation and expands within the
disc space. A subtotal nuclectomy (34-66% of the nucleus
removed) is required to insert this device via a posterior or
Anterolateral RetroPeritoneal Approach (ARPA). Currently,
Raymedica is conducting a trial evaluating patients with the
HydraFlex device.

Figure 3
DASCOR

Disc Dynamics, founded in 2000, applies an implant delivery

system similar to that used for interventional cardiology. The
DASCOR device is two-part curable polyurethane substrate
that is delivered via a catheter and balloon under controlled
pressure (Figure 3). A complete nuclectomy (67-100% of the
nucleus removed) needs to be performed for proper graft placement usually through the AnteroLateral transPsoatic Approach
(ALPA). The polyurethane polymer is presumed to be an ideal
substrate due to its biocompatibility profile, mechanical
strength, and elastic properties. In the United States, a trial is in
process to evaluate 20 patients with the DASCOR device.

27

Figure 4: In vivo sectioning with NuCore device.

CLINICAL EXPERIENCE OUTSIDE THE UNITED STATES

RAYMEDICA: PDN-SOLO

The U.S. clinical experience with nucleus arthroplasty is still in

its infancy. The majority of the clinical data available in regard
to nucleus replacement devices originates from outside the
United States. A review of the available short and mid-term
follow-up data is provided below.

Currently there are six sites in five different countries (Germany,

Sweden, Greece, Turkey, and Korea) evaluating the PDN-SOLO.
From March 2003 to November 2005, 75 patients were enrolled
in the trial. Sixty-six patients had a diagnosis of DDD with herniation and nine patients had DDD without herniation; patient
demographics are shown in Table 2.

SPINE WAVE: NUCORE

Early pilot data shows that 16 patients have undergone this procedure for mono-segmental radicular pain (Table 1). NuCore
was implanted in 11 patients at L5/S1 and in five patients at
L4/L5. The average injection volume was 1.2 cc with an average
of 71% of the tissue being replaced with the NuCore material.
Average ODI scores decreased from 44 pre-operatively, to 8.1 at
12 months post-operatively. The manufacturer also reported significant improvement in SF-36 and VAS scores. No devicerelated complications occurred and disc height decreased 9% at
the latest follow-up (Figure 4).20

Table 1
Age range
Sex:

In this study, 91% of the implants were located at L4/L5 and L5/S1.
Visual Analog Scores (VAS) demonstrated a decrease from 73 at
the pre-operative assessment, to 22 at 24 months post-operatively.
Mean Oswestry Disability Index (ODI) demonstrated a decrease
from 53 to 14 over the same time period. Seven adverse events
occurred (9.3%). One patient had device protrusion and has been
managed with observation. Two patients had posterior and/or
anterior device migration. The former patient had a device explant
and fusion, whereas the latter patient had an anterior lumbar interbody and posterior instrumented fusion. Four patients had continued back pain despite any device-related complications. Three
patients underwent posterior dynamic stabilization and one had
an explant with a 360 fusion.21

Table 2
23-51

Mean age

39

Mean age

39

Males

Mean height

171 cm

Mean BMI

25

Females

Mean weight

72 kg

Sex:

Males

41

Mean BMI

24

Females

39

Sex:

Males

37

Smoking

Females

38

Work related

Mean disc height

28

Table 3

7.4 mm

46%
0%

DISC DYNAMICS: DASCOR

2. Battie MC, Videman T. Lumbar disc degeneration: epidemiology and genetics.

J Bone Joint Surg Am. 2006 Apr;88 Suppl 2:3-9.

A total of 80 patients have been implanted with the DASCOR

device at 12 clinical sites in six countries (Belgium, Germany,
France, Hungary, Venezuela, and Switzerland) from 2/2004
through 7/2007; patient demographics are illustrated in Table 3.

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.

In this study, 92.5% of the implants were implanted at L4/L5 and

L5/S1 with 7.5% of the implants located at L3-L4. The mean
operative time was 88.6 minutes with a mean blood loss of 42 cc.
Average VAS values decreased from 7.6 pre-operatively, to 3.1 at
24-month follow-up. Average ODI values decreased from 57.8
to 18.8 over the same time period. SF-12 scores increased from
30.4 to 41.9 over the same time period. Radiographic measurements demonstrated that the disc height was completely maintained at 24 months with no evidence of fusion or device
degradation. The investigators reported three patients with procedure-related complications and four patients with device AND
procedure-related complications. Five patients had device
explants for increasing pain,3 infection, and disc herniation.22

CONCLUSION
Nucleus arthroplasty has the potential to be an excellent treatment alternative for patients in the mild to moderate stages of
degenerative disc disease. Today, this represents a relatively large
unmet opportunity for advancement in patient care. Ideal candidates are patients with discogenic back pain that present without
significant annular tears, endplate irregularities, reasonable
preservation of disc height, good bone quality, and normal body
mass index (BMI).
While there are still many unanswered questions regarding the
safety and efficacy of nucleus arthroplasty, this chapter demonstrates that early clinical results are promising. Patients implanted
with these devices will need to be followed to evaluate the longterm efficacy and freedom from complications. Larger pivotal
trials (200-500 patients) will need to be developed to establish
sufficient statistical power and comparison to a randomized
controlled treatment arm.

REFERENCES
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 Science Biology and biomechanics for the musculoskeletal system. 2nd ed. Rosemont: American
Academy of Orthopaedic Surgeons, 2002:548-55.

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.
10. Melrose J, Roberts S, Smith S, Menage J, Ghosh P. Increased nerve and blood
vessel ingrowth associated with proteoglycan depletion in an ovine annular
lesion model of experimental disc degeneration. Spine. 2002 Jun 15;
27(12):1278-85.
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.
15. Gillet P. The fate of the adjacent motion segments after lumbar fusion.
J Spinal Disord Tech. 2003 Aug;16(4):338-45.
16. Sieber AN, Kostuik JP. Concepts in nucleus replacement. Spine J. 2004 NovDec;4(6 Suppl):322S-324S.
17. Mckenzie AH, Fernstrom 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.
20. Berlemann U, Schwarzenbach O. Clinical evaluation of an injectable, in situ
curing nucleus replacement. Presented at Spine Arthroplasty Society Meeting,
Berlin, Germany, 5/3/07.
21. Ray C. PDN-SOLO results. Poster presentation at Spine Arthroplasty Society
Meeting, Berlin, Germany, 5/3/07.
22. Ahrens, M. Nucleus replacement with the DASCOR disc arthroplasty system.
Presented at Spine Arthroplasty Society Meeting, Berlin, Germany, 5/3/07.

29

Chapter 25

Socioeconomic Impact of
Nucleus Arthroplasty Procedures

Michael A. Finn, MD

Daniel R. Fassett, MD

RESIDENT NEUROSURGERY

SPINE FELLOW

Department of Neurosurgery
University of Utah
Salt Lake City, UT 84132

Thomas Jefferson University

Philadelphia, PA 19107

Alexander R. Vaccaro, MD

Musculoskeletal Clinical
Regulatory Advisers, LLC

PROFESSOR

New York, NY 10022

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

Key Points
The role of economics in health care is becoming an increasingly
prominent issue and has implications for the development of
new technologies.
Low back pain is a leading cause of health care expenditure in
the United States, spurring 10 million physician visits annually.
Although there has been a remarkable proliferation in the
spinal device market over the past 10 years, there remains a significant population of patients with mild to moderate degenerative disc disease who suffer from disabling pain for whom no
good treatment options exist.
By restoring normal spinal biomechanics after discectomy and
offering an alternative to fusion in the treatment of discogenic
back pain, nucleus arthroplasty technology may offer an
improved means of treating back pain with less long-term
morbidity, less initial and long-term cost, and quicker return
to pre-morbid functional level.
30

 With accumulating experience, sales of nucleus arthroplasty

devices are expected to increase to $2.25 billion by 2015.
Economic challenges to be addressed include payer coding
mechanisms and adoption and payment by insurance carries.

INTRODUCTION

onsideration of health economics has now become a prerequisite in the practice of medicine. In our current environment, it is becoming increasingly important for care providers
and industry to have an in-depth understanding of the socioeconomic and net health impact of their intended treatment population and available options. This phenomenon is driven by many
factors including the growing needs of our aging population and
an increased level of scrutiny of the financial information
reviewed by insurance carriers.
This chapter will describe trends in patient demographics and
historical costs associated with fusion. In addition, it will describe
a promising intervention being developed to delay, or avoid, more
costly surgical procedures associated with degenerative disc disease.
First and foremost, it is important to note how prevalent lower
back pain is within the United States. Although the below statistics do not necessarily address degenerative disc disease only, it
is still imperative to understand how many people within the
United States actually suffer from back conditions.
Back pain is a leading cause for health care expenditures
in the United States.
Back pain is the principal reason for doctor visits in the
United States, and back pain affects more than 10.0 million
people annually.
Back pain is the principal ailment cited in workers
compensation claims in the United States.
Back pain is the principal cause of employee absenteeism in
the United States.
More than 220 spinal conditions, indications, and pathologies
afflict patients throughout the world.1
An estimated 30% of people aged 30-50 years old will have some
degree of disc space degeneration, although not all will have pain
or ever receive a formal diagnosis.2 Most of the patients within the
above statistics will recover on their own or receive conservative
treatment that will alleviate their symptoms. Surgery is utilized
only when non-surgical options have failed and when the pain has
become uncontrollable and debilitating. It should be noted that

more than one-half of those patients who recover from a back pain
experience will have a recurring episode at some point in their life.3
Only 1 to 3% of back pain is related to a herniated disc within the
spine, and these may or may not need surgical intervention.4 For
those where conservative treatment is not effective, and surgical
procedures are not yet an option, the patient and treating physicians are left with limited choices. It is these refractory patients that
nucleus arthroplasty technology seeks to address.
It is therefore the focus of this chapter to address the limits of
current surgical options that were discussed in Chapter 21 and
highlight the importance of proper reimbursement for new
additions to the degenerative disc disease treatment algorithm.

DEMOGRAPHIC OVERVIEW
Degenerative disc disease (DDD) is defined as an aberrant cellmediated response to progressive spinal structural failure that is
irreversible, always affected by physical and biological mechanisms,
and can be associated with mechanical dysfunction and pain.
Chapter 21 describes the demographics that pertain to this disease
state, amongst which are the progressive aging of the population
and early onset of obesity. Both of these conditions contribute to
degeneration of the spine. With an 18% increase in the world life
expectancy, 7% within more developed countries and 22% in Latin
America, the amount of orthopedic procedures is likely to increase.

TREATMENT CONTINUUM
There has been a remarkable proliferation of spinal devices over
the past 15 years with a corresponding increase in market size. The
spinal market worldwide has grown from $100 million dollars in
1990 to $6.5 billion dollars in 2007. This market segment is projected to grow at a rate of 15-20% annually.6 A large portion of this
growth is attributed to a change in philosophy in the treatment of
spinal disorders which has resulted from a greater understanding
of spinal biomechanics, mechanisms of spinal degeneration, and
the origins of low back pain. An emphasis is now being placed on
motion preservation and tissue sparing approaches, two factors
which putatively affect short and long-term morbidity in lumbar
surgery. Treatment algorithms continue to evolve through the
introduction of emerging technologies and procedures. A few
examples include: vertebroplasty/kyphoplasty, minimally invasive
instrumentation, posterior dynamic stabilization devices, and total
disc replacements (TDR).

31

Potential Treatment Population

n=0%

sin
rea
Inc

re
gt

e
atm

,
ize
ts

risk

o
dc
an

e
ag
am
d
l
era
llat

Fusion
surgeries

Open
Disc surgeries
Percutaneous
Disc surgeries

n=100%

Conservative
treatment

Dis

urg
S
c

/
ery

3C

s
tep
S
cal
rgi
u
S
cal
i
s
l as

Figure 1
Bertagnoli10

For those unfortunate enough to experience a spinal injury in the

lumbar region, there have historically been few surgical options.
Two major gaps in the care continuum become apparent in
Figure 1:
1. Gap between conservative care and discectomy.
2. Gap between discectomy and fusion

Consequently, historical treatment options may have resulted in

under-treatment when conservative care has been ineffective or
over treatment when DDD has not progressed to a level requiring more extensive surgical intervention such as with fusion.
Stakeholders (physician, patient, payer, community and others)
welcome the innovation of promising technologies designed to
address treatment opportunities which better serve the patient,
avoid unnecessary services and are proven safe, effective and
with a durable response.
Conservative treatment modalities include physical therapy,
medication therapy, heat and cold therapy, use of anti-inflammatory and opioid medications. Patients diagnosed with moderate to severe degenerative disc disease may require surgical
interventions ranging from total disc arthroplasty to fusion.
Discectomies, laminectomies, and fusions have demonstrated
32

efficacy in the treatment of moderate to severe symptomatic

DDD in the absence of improvement after a trial of conservative
care. Although these treatments have demonstrated efficacy in
selected patients, they are expensive, not right for all patients
and do not necessarily correct the underlying problem.
The clinical performance of lumbar fusion for back pain has
increased dramatically since the 1980s with the advent of better
instrumentation, implants, and bone morphogenic proteins
(BMPs). The procedure, although associated with significant
short-term costs, may be economically beneficial as surgical
patients have been shown to return to work in greater proportion than those managed conservatively.7, 8 Patients undergoing
fusion procedures, however, may be at a higher long-term risk
for developing adjacent-level degeneration which may cause
future disability, necessitate further surgical intervention and
contribute to greater overall cost.
Total disc replacement devices are now available which promise
to restore motion and regional biomechanics. Although often
thought of as an expensive option, costs to payers and hospitals
may be significantly less overall when compared with common
fusion constructs.9 Longer-term health economic and utilization
outcome study is required to evaluate long-term durability and
net health impact upon patient care, quality of life, functional
improvement, and cumulative cost.

Potential Treatment Population

n=0%

In

ng
as i
e
r
c

a
tre

e
tm

sk
, ri
ize
s
t

an

g
ma
da
l
a
t er
lla
o
c

Interspinous
Implants
Wallis, Diam,
Flexicore
Anthroplasy
surgeries:
Nucleus
replacements

Open
Disc surgeries

n=100%

Percutaneous
Disc surgeries

II

e
Fusion
surgeries

Anthroplasy
surgeries:
Total Disc
replacements

IV

III

r
de
o
M

isc
D
n

e ry
g
r
Su

Post.
Dynamic
stabilization:
Dynesys

VII

VI

s
te p
S
l
ca
rgi
u
7S

Figure 2
Bertagnoli10

Nucleus arthroplasty technologies were developed to provide a

minimally or less-invasive surgical option to treat low back pain
associated with mild-moderate DDD, while preserving natural
motion and anatomic structures (i.e. annulus, endplate).
Although no nucleus arthroplasty technology is on the U.S.
market yet, the first is expected to receive FDA approval by 2011.
Nucleus arthroplasty procedures may also be used prophylactically after discectomy to restore normal segmental biomechanics
and prevent or forestall the development of degenerative changes
at the same or adjacent levels. In this manner, nucleus arthroplasty may prove to be an extremely valuable tool in the reduction of direct and indirect costs associated with back pain. As
with other interventions, it will be prudent to measure the longterm durability of nucleus arthroplasty procedures, evaluating the
impact upon total cost of care and the ability to delay (or avoid)
the need for more invasive and complex procedures associated
with this patient segment diagnosed with DDD.

COMMON SPINE PROCEDURES

In 2005, there were approximately 278,000 thoracolumbar fusions
performed in the United States. Additionally, 129,000 independently
performed laminectomies and 92,000 discectomies were performed
this same year. Increases in procedure rates are expected as the
overall population continues to age. Using major data resources,
Orthopedic Network News estimates that by 2006, these procedures
will increase by 5.8%, 1.9%, and 5.3%, respectively (Figure 3).
In the aggregate, these numbers will increase by 4.6%.

US In-patient Spinal Procedures 2005-2006

300
250
Thousands

Despite these advances, current surgical options are not universally

beneficial and there remains a large group of patients who are
poorly served. This group includes patients with mild to moderate
DDD who fail conservative management but whose pathology
does not warrant total disc replacement or fusion (Figure 2).

200
150
100
50
0
2005
Lumbar Fusions

Years

2006

Laminectomies

Discectomies

Orthopedic Network News, Volume 17, Number 4, October 2006

Figure 3

33

Key Diagnoses Relating To In-patient Spinal Repair Procedures - 2001

ICD Procedure

ICD

3.02 Reopen laminectomy site

3.09 Spinal canal exploration, nec

80.51 Intervertebral disc excision

81.06 Lumbar fusion

81.08

722.10
724.02
722.83
721.30
729.20
724.02
721.30
722.10
723.00
721.10
722.10
722.00
724.02
722.73
722.52
722.10
722.52
724.02
738.40
721.30

Source: Konwledge Enterprise, Inc. 2002

MedPAR national in-patient hospital data for the year 2005

reveals $3.7 billion in charges for thoracolumbar
fusion.
K
Remaining fusion procedures totaled over $1.7 billion. Other
spine-related procedures
totaled $3.4 billion.11
I
On average, reimbursement for a single level fusion procedure is
approximately $13,558, an increase from an average reimbursement rate of $5,688 six years ago.+ While data continues to be
compiled, projected fusion procedure costs within the United
States in 2006 are estimated to be $732,900,000.12 Variability in
this estimate is predicated upon the complexity of each case and
implants used during each procedure.13
Although the elderly population in the world is increasing and
orthopedic healthcare costs will certainly rise, it is imperative to
note that those over 65 years of age are not the ones who are getting most of the procedures. According to Orthopedic Network
News, only 29% of all laminectomies and excisions were performed on patients over age 65, while 23% of all fusion cases
were performed on patients in this same population. Younger
patients therefore present the greater burden of illness and will
require costly care over a longer period of time.

Diagnosis

Occurrence

Lumbar disc displacement

Spinal stenosis, lumbar
Post-laminectomy syndrome, lumbar
Lumboscacral spondylosis
Neuralgia/neuritis, nos

Percent

Total

331
314
79
52
42
818

40%
38%
10%
6%
5%
100%

Total

50,656
7,436
6,173
4,297
3,534
72,096

70%
10%
9%
6%
5%
100%

Total

141,853
14,397
7,092
4,086
2,870
170,298

83%
8%
4%
2%
2%
100%

Total

22,362
20,132
16,228
14,553
8,973
82,248

27%
24%
20%
18%
11%
100%

Spinal stenosis, lumbar

Lumboscacral spondylosis
Lumbar disc displacement
Spinal stenosis, cervical
Cervical spondylosis w/myelopathy
Lumbar disc displacement
Cervical disc displacement
Spinal stenosis, lumbar
Lumbar disc disease w/myelopathy
Lumbar/lumbosacral disc degeneration
Lumbar disc displacement
Lumbar/lumbosacral disc degeneration
Spinal stenosis, lumbar
Acquired spondylolisthesis
Lumbosacral spondylosis

Figure 4

Given that the onset of DDD generally occurs when a person is

between 30 and 50 years of age, it is quite important to commence treatment early so that the pain does not recur or become
more problematic. While most patients will not need surgical
treatment, those who do warrant surgical intervention may not
necessarily need a fusion, as discectomies and laminectomies
may not correct the problem. Nucleus arthroplasty technology
will then act as an earlier stage treatment for those who require
surgical intervention.
As can be seen from the chart above, 70% of all laminectomies
had spinal stenosis associated with the procedure, and 83% of all
discectomies had lumbar disc displacement as the top diagnosis.
This chart demonstrates which diagnoses are most commonly
associated with various spinal procedures. This will be important to monitor as more surgical technologies and procedures
come on the market. A question remaining to be answered is:
Will the advent of nucleus arthroplasty technologies increase or
decrease the use of laminectomies or discectomies? (Figure 4)

* DRG codes used in this analysis are: DRG 9, DRG 497, DRG 498, DRG 499,
34

DRG 500, DRG 519, DRG 520, DRG 531, and DRG 532
+Fusion implants include metals, bone graft, autograft, interbody fusion devices
and BMP

Key Procedures Relating To In-patient Back Problems - 2001

ICD Diagnosis
722.10 Lumbar disc displacement

722.52 Lumbar/lumbosacral disc degeneration

722.73 Lumbar disc disorder with myelopathy

722.83 Post-laminectomy syndrome, lumbar

724.00- Spinal stenosis

724.09

ICD
80.51
81.08
3.09
3.92
81.06
81.08
81.06
3.09
80.51
3.92
80.51
81.08
3.09
3.92
81.07
81.08
3.90
3.93
86.06
3.09
3.09
81.08
80.51
81.07
3.92

Source: Konwledge Enterprise, Inc. 2002

Another important aspect to the above chart is that lumbar fusion

is most commonly associated with disc displacement, disc degeneration, and spinal stenosis. This implies that other surgical procedures and technologies are currently being evaluated within the
worldwide spinal community that may tend to lower the frequency in which fusion is utilized for degenerative disc disease.
Although such technologies are currently not approved in the
United States, should they be successful in Europe and Asia, the
number of fusion procedures will likely decrease. The anticipated
decrease in the use of fusion creates a win-win situation
for both patient and surgeon. In addition, it will ultimately lower
the cost borne by the public sector as these new technologies are
expected to carry a lower price tag.

Procedure

Occurrence

Intervertebral disc excision

Posterior lumbar fusion
Spinal canal exploration, nec
Injection into spinal canal, nec
Anterior lumbar fusion

Percent

Total

141,853
16,167
6,173
5,868
3,597
173,658

82%
9%
4%
3%
2%
100%

Total

13,088
5,463
3,202
2,870
1,883
26,506

49%
21%
12%
11%
7%
100%

Total

4,086
814
483
257
172
5,812

70%
14%
8%
4%
3%
100%

Total

1,338
863
583
485
404
3,673

36%
23%
16%
13%
11%
100%

Total

50,656
12,797
7,092
2,773
2,426
75,744

67%
17%
9%
4%
3%
100%

Posterior lumbar fusion

Anterior lumbar fusion
Spinal canal exploration, nec
Intervertebral disc excision
Injection into spinal canal, nec
Intervertebral disc excision
Posterior lumbar fusion
Spinal canal exploration, nec
Injection into spinal canal, nec
Lateral transverse lumbar fusion
Posterior lumbar fusion
Insertion, catheter, spinal canal
Insertion, spinal neurostimulator
Insertion, infusion pump
Spinal canal exploration, nec
Spinal canal exploration, nec
Posterior lumbar fusion
Intervertebral disc excision
Lateral transverse lumbar fusion
Injection into spinal canal, nec

Figure 5

The chart above compares the diagnosis to the procedure that is

most commonly associated with it. As can be seen, to treat lumbar disc displacement, i.e., herniation, discectomy is used 82%
of the time. To treat disc degeneration, fusion is used 70%. For
these diagnoses, over 50% of the patients are between 40 and 64
years of age. Given the problems associated with fusion procedures, for young patients, it should not be the first resource for
a surgical treatment. It can be extrapolated that perhaps if surgeons had a different and validated surgical proceduresomething outside of fusionthey would choose it over such invasive
surgeries (Figure 5).

35

NUCLEUS ARTHROPLASTY TECHNOLOGY IS A PROMISING TECHNOLOGY

WHICH, WHEN PROVEN SAFE AND EFFECTIVE, MAY ADDRESS A TREATMENT
VOID FOR PATIENTS WITH MILD TO MODERATE DDD.

Another interesting point on this graph is that to treat postlaminectomy syndrome, surgeons choose fusion 36% of the
time. Although the following point may not be confirmed until
we monitor surgeon behavior, surgeons might tend to lean to a
less invasive procedure, such as nucleus arthroplasty, or another
form of treatment that is not yet on the U.S. market.

LESS INVASIVE PROCEDURES:

NUCLEUS ARTHROPLASTY
Refinement of current treatment algorithms for DDD will
require continuing revision as development of new technologies
are proven to be safe and effective. For example, inclusion of less
invasive interventions such as nucleus arthroplasty will eventually require consideration. Avoiding unnecessary fusions, while
providing medically necessary interventions for patients with
mild to moderate stenosis, will address the current void in treatment algorithms. Given the nature of the implant and use in
patients who are refractory to conservative care, nucleus arthroplasty will likely result in lower overall costs due to avoidance or
deferral of more invasive procedures. Unlike fusion procedures
described above, an average nucleus arthroplasty procedure is
expected to cost in the range of $5,000 to $6,000.14
International sales of nucleus arthroplasty devices are expected to
increase over the next five to seven years with industry revenues
expected to be approximately $2.25 billion by 2015.15 While there
are currently no United States FDA-approved nucleus arthroplasty devices, several have been approved for implantation under
an IDE clinical trial. Payer coding mechanisms must be established, as well as education, adoption (coverage), and payment by
insurance carriers which support access to nucleus arthroplasty
devices for appropriate patient populations.

CONCLUSION
Nucleus arthroplasty technology is a promising technology
which, when proven safe and effective, may address a treatment
void for patients with mild to moderate DDD. Longer-term clinical and economic outcomes studies, comparative effectiveness
trials and refinement of surgical technique, surgical training, and
appropriate patient selection will be required. Throughout this
process, stakeholder engagement, including major payers, health
care providers, employer coalitions, and the manufacturing
industry must work in concert to ensure patient access to emerging technologies, while addressing community need for quality,
cost-effective care.

REFERENCES
1. Dynawell Back Pain Statistics. http://www.dynawell.biz/clin_spin_back.asp.
2. http://www.spine-health.com/topics/cd/overview/lumbar/young/degen01.html.
3. http://www.neurology.health-cares.net/lower-back-pain.php.
4. http://www.spineuniverse.com/displayarticle.php/article1932.html.
5. UN World Population Prospects.
6. Viscogliosi Brothers, LLC company estimates.
7. Moller H, Hedlund R. Surgery versus conservative management in adult
isthmic spondylolisthesisa prospective randomized study: part 1. Spine,
2000. 25(13): p. 1711-5.
8. Fritzell P, et al. 2001 Volvo Award Winner in Clinical Studies: Lumbar fusion
versus nonsurgical treatment for chronic low back pain: a multicenter randomized controlled trial from the Swedish Lumbar Spine Study Group.
Spine, 2001. 26(23): p. 2521-32; discussion 2532-4.
9. Guyer, RD, Tromanhauser, SG, Regan, JJ. An economic model of one-level
lumbar arthroplasty versus fusion. Spine J, 2006.
10. Orthopedic Network News, Volume 17, Number 4, October 2006.
11. Center for Medicare and Medicaid Services. MEDPAR Data 2005.
12. Ibid.
13. Ibid.
14. Viscogliosi Brothers, LLC company estimates.
15. Viscogliosi Brothers, LLC company estimates.

36

Chapter 26

Biologics and Nucleus Arthroplasty

Technology Applications

Corey J. Wallach, MD
SPINE SURGEON

The Anderson Orthopaedic Clinic

Arlington, VA 22206

Jeffrey Wang, MD
ASSOCIATE PROFESSOR OF NEUROSURGERY,
ORTHOPAEDIC SURGERY AND BIOMECHANICAL ENGINEERING

UCLA School of Medicine

Co-Director of the UCLA Comprehensive Spine Center
Los Angeles, CA 90404

THE INTERVERTEBRAL DISC IS A COMPLEX BIOLOGICAL STRUCTURE CONFERRING MANY OF THE DYNAMIC AND BIOMECHANICAL CHARACTERISTICS
TO THE HUMAN SPINE.

KEY POINTS
Alterations in the biochemical composition and properties of
the intervertebral disc result in changes in the discs biomechanical properties and subsequent clinical manifestations.
Animal models of intervertebral disc degeneration have been
validated and provide the opportunity to assess the potential
of novel biologic treatment strategies, such as growth factor
delivery, gene therapy, and cell transplantation.
At this time, evaluations of biological strategies in human
clinical trials are pending.
The use of biological strategies in conjunction with nucleus
replacement technologies may provide a stepping stone until a
suitable stand-alone biological solution is available.

37

THE INTERVERTEBRAL DISC IS A COMPLEX BIOLOGICAL STRUCTURE CONFERRING MANY

OF THE DYNAMIC AND BIOMECHANICAL CHARACTERISTICS TO THE HUMAN SPINE.

INTRODUCTION

he intervertebral disc is a complex biological structure conferring many of the dynamic and biomechanical characteristics to the human spine. The discs broad range of function is a
result of the interrelation and variation in the properties of each
of its anatomic components.
The outer annulus fibrosus imparts significant tensile strength to
the intervertebral disc, due to the highly organized structure of its
collagen fibers. The orientation of the lamellae provides resistance to the axial and torsion loads experienced between adjacent
vertebral bodies during physiologic range of motion. The inner
nucleus pulposus is less organized and composed primarily of a
few notochordal cells dispersed within a heterogeneous extracellular matrix. This matrix consists largely of proteoglycans that are
highly hydrophilic and enable the nucleus pulposus to retain
large quantities of water.
In a healthy disc, the nucleus pulposus is a gelatinous core that
serves as a hydrostatic load-bearing structure functioning in conjunction with the annulus fibrosus to effectively distribute loads
in the spine. The differing properties of these two components
contribute substantially to spinal stability.
Intervertebral disc degeneration disrupts the balance of these
properties and, subsequently, their biomechanical capacities. As
the nucleus pulposus degenerates, it gradually loses proteoglycans
and corresponding aqueous content such that it can no longer
effectively sustain physiologic loads. Experimental models have
shown that the removal of the nucleus pulposus dramatically
increases spinal mobility, as the discs ability to resist compression
is lost.1-3

Studies have also demonstrated that removal of the nucleus pulposus can initiate disc collapse, causing the fibers of the annulus
fibrosus to respond or deform differently based on their
anatomic location. During loading of a collapsed disc, the

38

peripheral fibers of the annulus protrude outwardly, while the

inner fibers protrude into the vacant center.4-6 This response
places additional stress on the remaining annular fibers resulting
in an increase in annular disruption, tears and disc prolapse.
Such injury to the annulus negatively impacts its structural
integrity and function, altering stresses within the intervertebral
disc.4, 7, 8 As the components of the intervertebral disc begin to
fail, radiographic and clinical manifestations develop, such as
loss of disc height, compression of the neural structures, and
disruption of spinal stability.
Unfortunately, the lack of direct arterial supply or proximity to
nutrient rich synovial fluid mandates that the biologically active
components within the intervertebral disc receive their nutrition
via diffusion from the adjacent vessels in the vertebral endplate.
This avascular nature of the intervertebral disc provides little
capacity to slow disc degeneration, undergo significant repair, or
potentially regenerate.
To date, traditional conservative and surgical treatment options
have targeted the clinical manifestations of intervertebral disc
degeneration such as pain and instability, as opposed to treating
its underlying cause. While lumbar fusion has shown success in
treating intervertebral disc degeneration, it is not without significant potential morbidity and cost. Similarly, though the initial
enthusiasm for lumbar intervertebral disc arthroplasty has
waned, clinical improvement in an appropriately selected patient
group may be expected as well.
Presently, a number of novel treatment strategies are being pursued that seek to target the actual etiology of disc degeneration in
the hope of slowing the degenerative process and potentially
inducing regeneration. Several promising in vitro studies have
attempted to maintain the aqueous composition of the nucleus
pulposus by increasing production of the highly hydrophilic proteoglycans, or by decreasing the rate of their degradation.9, 10
Additionally, in vivo studies in non-degenerated intervertebral

Figure 2: In vivo injection of the factor OP-1 to a degenerative intervertebral disc results in increased signal intensity on T2 weighted images, consistent with increased
aqueous content.

Figure 1: Animal model of disc degeneration showing reproducible changes in magnetic resonance imaging, radiographs, and
histology, consistent with intervertebral disc degeneration.

INJECTION OF OSTEOGENIC PROTEIN-1 (OP-1)

INTO DEGENERATIVE INTERVERTEBRAL DISCS
HAS BEEN SHOWN TO INCREASE SIGNAL
INTENSITY OF THE INTERVERTEBRAL DISC ON

discs have demonstrated that the delivery of growth factors, either

directly or with the assistance of gene therapy, can favorably modulate biological activity with improved production of proteoglycans and radiological evidence of increased water retention.11, 12

T2-WEIGHTED IMAGES.

While promising, these studies were performed in relatively

healthy intervertebral discs. Additional studies are required to
determine if cells within a degenerated intervertebral disc demonstrated the same capacities. As such, the development of a valid
and reproducible animal model for intervertebral disc degeneration is of critical importance to accurately assess whether these
novel treatment strategies can favorably alter the biologic activity
within degenerated discs.

Several different methods to deliver biologic factors have been

suggested including direct injection and stimulation of local
production via gene or cell-based therapies. Proponents of gene
therapy have argued that direct delivery of growth factors would
likely have minimal effect on the biological composition of the
intervertebral disc due to their relatively short half-life; however,
recent studies suggest that this in fact may not be true.

Recently, such an animal model was successfully established by

creating an annular defect of defined depth with a hypodermic
needle.13, 14 This injury model reliably demonstrated radiographic
evidence of disc degeneration on conventional x-rays and serial
magnetic resonance imaging. In addition, the resulting histological changes were consistent with degeneration (Figure 1). With
this tool, researchers can now assess a wide array of potential
treatments to evaluate their capacity to alter both the biological
and radiographic indicators of disc degeneration.

Injection of Osteogenic protein-1 (OP-1) into degenerative

intervertebral discs has been shown to increase signal intensity
of the intervertebral disc on T2-weighted images, consistent with
an increase in water composition.15 Biochemical analysis of the
treated cells also showed a significant increase in proteoglycan
concentrations suggesting that, despite the relatively short halflife of this factor, sustained radiographic and biochemical
changes can be induced with a single direct delivery approach
(Figure 2). Based on these findings, clinical trials are now underway to evaluate the potential for such treatments to alleviate the
symptoms of intervertebral disc degeneration.

39

THE CONCEPT BEHIND CELL-BASED THERAPY IS

THAT STEM CELLS COULD THEORETICALLY BE
DIRECTED TO DEVELOP INTO CELLS SIMILAR TO
THE NUCLEUS PULPOSUS, AND THEREFORE BE
USED TO REPOPULATE THE DISC ITSELF.

The application of gene therapy techniques in the established

degenerative animal model is also ongoing, with similar results.16
Though sustained production of growth factors within the
degenerative disc has obvious benefits, one of the major criticisms associated with using gene therapy is the inability to adequately control or stop the production of the gene of interest, as
excess production may have deleterious effects. To address this
issue, regulatory systems have now been developed that enable
the investigator to turn the expression of the transduced gene
on or off. Recent studies have demonstrated the ability to adequately regulate protein expression in transduced nucleus pulposus cells using an in vitro model;17 however, similar findings have
yet to be adequately documented in vivo.
Another option for the biologic treatment of degenerative disc
disorders is the use of cell-based therapies. The concept behind
cell-based therapy is that stem cells could theoretically be
directed to develop into cells similar to the nucleus pulposus,
and therefore be used to repopulate the disc itself. This is important as the success of any biological therapy requires that an adequate number of healthy cells are available to populate the
degenerative intervertebral disc.
Studies have shown that the in vitro development of phenotypically similar cells is feasible, with gene expression similar to that
of the native nucleus pulposus cells.18 In theory, the ability to
repopulate the nucleus pulposus would re-establish the native
biochemical composition and corresponding biomechanical
properties, potentially restoring disc height, retensioning the
annulus fibrosus, and slowing disc degeneration. Experimental
degenerative models using allograft replacement of the nucleus
pulposus have reinforced this concept showing success in their

40

ability to slow subsequent disc degeneration.19 While these early

studies are promising, much work remains before this technology
can be applied in a clinical setting.
Finally, one concept that may hold promise is the ability to couple technologies to address disc degeneration. Specifically, the use
of a biological therapy in conjunction with nucleus arthroplasty
or other replacement technologies may be an ideal solution until
a suitable stand-alone biological approach is available.
The use of a coupled approach offers the distinct advantage of
providing additional mechanical support to assist in load distribution during early regeneration. In addition, depending on the
device design, the implant may also serve as a carrier to ensure
proper delivery and/or placement of the biological treatment,
while providing a suitable environment or scaffold during initial
regenerative activities.

THE APPLICATION OF BIOLOGICAL SOLUTIONS SUCH

AS GENE THERAPY AND STEM CELL REPLACEMENT TO
THE TREATMENT OF DISC DEGENERATION REPRESENTS
AN EXCITING NEW FRONTIER.

The application of biological solutions such as gene therapy

and stem cell replacement to the treatment of disc degeneration represents an exciting new frontier. While clinical application of such treatments as stand-alone technologies is not yet
within reach, the studies discussed in this chapter have demonstrated that the concept is certainly feasible. As an interim
approach, the use of a hybrid treatment that seeks to address
both the etiology and clinical aspects of disc degeneration may
bear further investigation.

REFERENCES
1. Goel VK, et al. Kinematics of the whole lumbar spine. Effect of discectomy.
Spine, 1985. 10(6): p. 543-54.
2. Eysel P, Rompe J SR. Biomechanical behaviour of a prosthetic lumbar
nucleus. Acta Neurochir, 1999(141): p. 1083-7.

12. Nishida K, et al. Modulation of the biologic activity of the rabbit intervertebral disc by gene therapy: an in vivo study of adenovirus-mediated transfer
of the human transforming growth factor beta 1 encoding gene. Spine, 1999.
24(23): p. 2419-25.

3. Goel VK, et al. Mechanical properties of lumbar spinal motion segments as

affected by partial disc removal. Spine, 1986. 11(10): p. 1008-12.

13. Masuda K, et al. A novel rabbit model of mild, reproducible disc degeneration by an annulus needle puncture: correlation between the degree of disc
injury and radiological and histological appearances of disc degeneration.
Spine, 2005. 30(1): p. 5-14.

4. 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. 16(6): p. 641-6.

14. Sobajima S, et al. A slowly progressive and reproducible animal model of

intervertebral disc degeneration characterized by MRI, X-ray, and histology.
Spine, 2005. 30(1): p. 15-24.

5. Meakin JR, Hukins DW. Effect of removing the nucleus pulposus on the
deformation of the annulus fibrosus during compression of the intervertebral
disc. J Biomech, 2000. 33(5): p. 575-80.

15. Masuda K, et al. Osteogenic protein-1 injection into a degenerated disc

induces the restoration of disc height and structural changes in the rabbit
annular puncture model. Spine, 2006. 31(7): p. 742-54.

6. Hanley EN Jr, Shapiro DE. The development of low-back pain after excision
of a lumbar disc. J Bone Joint Surg Am, 1989. 71(5): p. 719-21.

16. Shimer A, Sobajima S, Chadderdon R. BMP-2 gene transfer favorably alters

course of disc degeneration in rabbit model. in Orthopaedic Research
Society. 2005. Washington, D.C.

7. Frei H, et al. The effect of nucleotomy on lumbar spine mechanics in

compression and shear loading. Spine, 2001. 26(19): p. 2080-9.
8. Natarajan RN, et al. Effect of annular incision type on the change in biomechanical properties in a herniated lumbar intervertebral disc. J Biomech Eng,
2002. 124(2): p. 229-36.
9. Nishida K, et al. Spine update: potential applications of gene therapy to the
treatment of spinal disorders. Spine, 2000. 25(10): p. 1308-14.
10. Wallach CJ, et al. Gene transfer of the catabolic inhibitor TIMP-1 increases
measured proteoglycans in cells from degenerated human intervertebral
discs. Spine, 2003. 28(20): p. 2331-7.

17. Vadala G, et al. Regulation of transgene expression using an inducible system

for improved safety of intervertebral disc gene therapy. Spine, 2007. 32(13):
p. 1381-7.
18. Risbud MV, et al. Differentiation of mesenchymal stem cells towards
a nucleus pulposus-like phenotype in vitro: implications for cell-based
transplantation therapy. Spine, 2004. 29(23): p. 2627-32.
19. Nomura T, et al. Nucleus pulposus allograft retards intervertebral disc
degeneration. Clin Orthop Relat Res, 2001(389): p. 94-101.
20. Fernstrom U. Arthroplasty with intercorporal endoprothesis in herniated disc
and in painful disc. Acta Chir Scand Suppl, 1966. 357: p. 154-9.

11. An HS, et al. Intradiscal administration of osteogenic protein-1 increases

intervertebral disc height and proteoglycan content in the nucleus pulposus
in normal adolescent rabbits. Spine, 2005. 30(1): p. 25-31; discussion 31-2.

DEPE N D I N G O N T H E D E V I C E D E S I G N , T H E I M P L A N T M AY A L S O S E R V E A S A C A R R I E R
T O E N S U R E P R O P E R D E L I V E RY A N D / O R P L A C E M E N T O F T H E B I O L O G I C A L T R E AT MEN T, W H I L E P R O V I D I N G A S U I TA B L E E N V I R O N M E N T O R S C A F F O L D D U R I N G I N I T I A L
REGE N E R AT I V E A C T I V I T I E S .

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Chapter 27

The Future of Nucleus

Arthroplasty Technology

Federico P. Girardi, MD
ASSOCIATE PROFESSOR OF ORTHOPEDIC SURGERY

Hospital for Special Surgery

New York, NY 10021

Reginald J. Davis, MD, FACS

CHIEF OF NEUROSURGERY

Baltimore Neurosurgical Associates, PA

Baltimore, MD 21204

Frank P. Cammisa, Jr., MD, FACS

ASSOCIATE PROFESSOR
OF CLINICAL SURGERY

Hospital for Special Surgery

New York, NY 10021

ver the last few years, a significant amount of knowledge has

been gained in regard to the stages of degenerative disc disease or degenerative cascade. Although our understanding of the
process has improved, there is still a great deal of variability in
terms of the patients response to treatment. In some patients, the
degeneration will continue to progress, while others will return to
an asymptomatic state and remain so for long periods of time.
There is a significant clinical difference between the terms early
degenerative disc disease and mild degenerative disc disease as it
relates to deciding what is best for the patient. One term involves
radiographic parameters, the other, clinical parameters and
duration of symptomatology. It is quite possible to have disabling back pain for many months or years without significant
disc collapse that is visible on imaging studies. Conversely, it is
possible to have a two-week acute low back pain attack with
imaging studies showing advanced disc deterioration with no
prior history of back pain.

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BASED ON OUR CURRENT EXPERIENCES, WE BELIEVE THAT NUCLEUS ARTHROPLASTY

HAS THE POTENTIAL TO CREATE A MAJOR SHIFT IN OUR PRACTICE GUIDELINES
FOR PATIENT INDICATIONS AND THE TIMING OF SURGICAL INTERVENTION.

Thus, historically, the surgical treatment of degenerative disc disease has only been pursued after the failure of established nonsurgical alternatives. While some of these non-surgical options
have shown reasonable evidence of success, most have not.
Regardless, some patients have embarked on virtually unending,
expensive, and unpredictable treatments. Many of these individuals
declined into what is called "chronic pain syndrome."
We do know that patients that fall within this subset tend to
respond poorly to surgical treatment and often have central disc
protrusions that do not improve from decompressive surgeries
alone. In fact, some surgeons claim that outcomes for this treatment
group can be directly impacted by the fragile psycho-emotional
status of the patient by the time surgery becomes an option.
At this time, the remaining surgical options include fusion or
total disc replacement. Evidence-based medicine has shown in
multiple, randomized, controlled clinical studies that such technologies can be effective for the treatment of disabling chronic
low back pain secondary to degenerative disc disease in a select
group of patients.1, 2 However, due to the aggressive nature of
these approaches, to treat patients with such devices could be
considered a drastic over-treatment.
One of the more promising developments regarding the treatment of DDD is that early diagnosis can allow earlier treatment,
recovery, and return to normal function. The intent then would
be to hopefully avoid many late-stage surgeries and allow patients
to return to their normal life without enduring many long years
of suffering and prolonged recovery.
As this phenomenon has come to light, we have seen a definite
increase in both the use and awareness of nucleus replacement
devices to fill the treatment gap. Nucleus replacements represent a
very attractive alternative to the more invasive surgical options
noted above. Current concepts seek to address an existing disease
state with the intention of slowing or stabilizing disease progression without sacrificing the disc or other surrounding tissues. As a
next stage, we will most likely see nucleus replacements used in
hybrid configurations that provide the opportunity to combine

the mechanical load-sharing aspects of a device with physiologic

tissue engineering solutions (growth factors, gene therapies). The
use of hybrid treatments is an important concept as it represents
one in a series of steps to restore function of the nucleus pulposus.
Based on our current experiences, we believe that nucleus
arthroplasty has the potential to create a major shift in our
practice guidelines for patient indications and the timing of
surgical intervention.
As we look toward the future, we would expect this technology
to advance towards earlier intervention that is more focused on
repair and regeneration of the native nucleus. In fact, such transformations are already underway. Although in its infancy today,
advancements in gene expression analysis techniques and markers will hopefully identify patients that are unlikely to benefit
from conservative measures. This rapid recognition will provide
surgeons with the opportunity to pursue an appropriate surgical
treatment at an earlier stage when surgery may be a relatively
minor procedure.
Obviously, to reach this endpoint a great deal of additional
research will be required. However, one thing is clear: As our
knowledge of the degenerative cascade and its treatment continues to grow, we will constantly be re-evaluating our definition of
the perfect candidate within this emerging sector in spinal surgery
termed Nucleus Arthroplasty.

REFERENCES
1. Zigler, et al. Results of the prospective, randomized, multicenter Food and
Drug Administration investigational device exemption study of the ProDisc-L
total disc replacement versus circumferential fusion for the treatment of
1-level degenerative disc disease. Spine 2007 May 15;32(11):1155-62.
2. McAfee P. A prospective, randomized, multicenter Food and Drug
Administration investigational device exemption study of lumbar total disc
replacement with the CHARITE artificial disc versus lumbar fusion: part II:
evaluation of radiographic outcomes and correlation of surgical technique
accuracy with clinical outcomes. Spine 2005 Jul 15;30(14):1576-83.

43

Closing Remarks

he Board of Managers of Raymedica wishes to express its

appreciation and gratitude to the Deputy Editorial Board and
participating Authors. Without their dedication and perseverance,
the creation of this landmark series on Nucleus Arthroplasty
Technology in Spinal Care would not have been possible.
The objective of this publication was to provide the surgeon
community with a baseline knowledge and awareness of this
emerging technology. While our authors have provided the community with a great deal of their time, innovation, and insight,
we may have just barely scratched the surface.
It was an incredible challenge to produce a 4-Volume series on
this new and less invasive treatment option for early-stage
Degenerative Disc Disease (DDD). Of paramount importance to
this development effort was a strong emphasis on education and
its direct influence on clinical outcomes.
As we look toward the future, we can rest assured that the surgeon community will continue to provide the leadership and
vision necessary to foster continued growth within the field of
Nucleus Arthroplasty.

Sincerely,

Jon R. Luedke
VICE PRESIDENT, SALES & MARKETING

Raymedica, LLC
Minneapolis, MN 55431

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www.nucleusarthroplasty.com

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This series has been made possible through the financial support of Raymedica, LLC.
www.raymedica.com
Part No. 55169-001 Rev. A