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Table of contents
1. Controversies about Interspinous Process Devices in the Treatment of Degenerative Lumbar Spine
Diseases: Past, Present, and Future...............................................................................................................

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Document 1 of 1

Controversies about Interspinous Process Devices in the Treatment of Degenerative Lumbar Spine
Diseases: Past, Present, and Future
Author: Gazzeri, Roberto; Galarza, Marcelo; Alfieri, Alex
ProQuest document link
Abstract: A large number of interspinous process devices (IPD) have been recently introduced to the lumbar
spine market as an alternative to conventional decompressive surgery in managing symptomatic lumbar spinal
pathology, especially in the older population. Despite the fact that they are composed of a wide range of
different materials including titanium, polyetheretherketone, and elastomeric compounds, the aim of these
devices is to unload spine, restoring foraminal height, and stabilize the spine by distracting the spinous
processes. Although the initial reports represented the IPD as a safe, effective, and minimally invasive surgical
alternative for relief of neurological symptoms in patients with low back degenerative diseases, recent studies
have demonstrated less impressive clinical results and higher rate of failure than initially reported. The purpose
of this paper is to provide a comprehensive overview on interspinous implants, their mechanisms of action,
safety, cost, and effectiveness in the treatment of lumbar stenosis and degenerative disc diseases.
Full text: Roberto Gazzeri 1 and Marcelo Galarza 2 and Alex Alfieri 3
Academic Editor:Vijay K. Goel
1, Department of Neurosurgery, San Giovanni-Addolorata Hospital, Via Amba Aradam 9, 00184 Rome, Italy
2, Regional Service of Neurosurgery, "Virgen de la Arrixaca" University Hospital, Avenida Primero Mayo, El
Palmar, 30120 Murcia, Spain
3, Klinik fr Neurochirurgie und Wirbelsulenchirurgie, Fehrbelliner Strae 38, 16816 Neuruppin, Germany
Received 8 January 2014; Revised 16 February 2014; Accepted 23 February 2014; 13 April 2014
This is an open access article distributed under the Creative Commons Attribution License, which permits
unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
1. Introduction
The degenerative lumbar spine is associated with significant structural failure of the intervertebral disc, of the
ligaments, and/or of the bone structures [1]. The typical findings are radial fissures, prolapses, endplate
damage, annular protrusion, internal disc disruption, disc space narrowing, hypertrophic ligaments, hypertrophic
facet joints, and osteophytes [1-4]. These degenerative changes may cause instability in advanced stages of
the disease [5-19]. The clinical endpoint of these degenerations is the compression of neural structures at the
level of the neural foramina or of the spinal canal.
Typically, patients complain about low back pain with or without pseudoradicular pain or dysesthesia. The actual
operative "gold standard" to treat degenerative lumbar spinal disease is generally decompression with or
without fusion of the affected segment [20-27]. However, some investigators began to explore novel minimally
invasive approaches to stabilize the lumbar spine.
Although a growing number of different minimal invasive treatments have been introduced for the degenerative
lumbar spine disease, the interspinous process devices are becoming an acceptable alternative for lumbar
decompressive surgery [28-32]. However, interspinous devices are presented also as a viable option for treating
a vast number of lumbar pathologies ranging from facet syndrome and discogenic low back pain to
degenerative spinal stenosis, discopathy, and lumbar instability. The arising consequence is the need to
understand the pathological and mechanical causes of each degenerative problem and determine the right
treatment paradigm through a critical analysis of all available experimental and clinical biomechanical
information [33-38]. Various authors suggest that advantages of IPD compared with standard surgical
decompression techniques are the option of local anesthesia, preservation of bone and soft tissue, reduced risk
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of epidural scarring and cerebrospinal fluid leakage, with a shorter hospital stay and rehabilitation period, and
reversibility of the surgical procedure that does not limit future surgical treatment options [39-46]. Currently,
there are no long-term clinical trials for IPD: published clinical data are sparse and in the majority of cases
consist of small, nonrandomized studies with short-term follow-up. In this paper we provide an overview of the
current notions of the biomechanical principles of the interspinous process devices, as well as in experimental
and clinical studies. These considerations are applicable with different types of interspinous spinous devices
with only few differences between the distinct categories.
2. Pathophysiology and Mechanism of Action
The pathoanatomic feature of neurogenic intermittent claudication in lumbar degenerative diseases is the
venous stasis in lumbar spine extension, causing neurologic symptoms as motor weakness in the lower
extremities, pain, tingling, and sensory deficit, which make walking for a long distance impossible. The first
recommended indication for the implantation of an IPD was mild and moderate intermittent neurogenic
claudication from spinal stenosis [36]. The key selection criteria were (and are) that patients symptoms must be
relieved by flexion of the lumbar spine. This phenomenon is called "shopping cart sign" due to the improvement
in walking endurance in stenotic patients leaning forward on a shopping cart. Flexion of the stenotic lumbar
spine stretches the redundant ligamentum flavum and enlarges the neural foramina, thus relieving lower
extremity symptoms. Recently, most of the devices have been marketed as treatments for discogenic low back
pain: posterior elements distraction unloads posterior annulus modulating the mechanical stimuli to the
nociceptive nerve endings of the sinuvertebral nerve.
2.1. Enlargement of the Spinal Canal Area
A decisive index for the relief of the clinical signs and symptoms is the enlargement spinal canal area. The
mean expansion of the spinal canal after insertion of the interspinous process devices is reported between 18%
[37] and 22% [35], with significant differences between the standing, the seated neutral, and the seated
extended position [45] being, respectively, 8.3%, 8.6%, and 7.9%. Cross-sectional area of the dural sac studied
with a dynamic magnetic resonance imaging was reported to increase from 78 mm 2 preoperatively to 93 mm2
postoperatively in the standing position, from 93 to 108 mm2 in the seated neutral position, and from 85 to 107
mm2 in the seated extended position. In a magnetic resonance imaging cadaver study, Richards et al. reported
that the X-Stop increases the spinal canal area by 18% during extension [37] (Table 2).
2.2. Increase of the Neural Foramina Area
Neural foramina area is increased after insertion of an interspinous device. In a dynamic magnetic resonance
imaging study, neural foramina were increased between 23 and 26 mm2 in the extended position. Another study
shows that the foraminal area is increased by 25% [37] after insertion of interspinous process devices, but the
foraminal width can increase up to 40%.
Richards showed in a radiological cadaver study that IPD (in their case X-Stop) increased the neural foramen
area by 26% with a subarticular diameter that was increased by 50% in extension [37].
Lee et al. reported an increase of the foraminal area of 22 mm2 (37%) after X-Stop implantation [35].
2.3. Unload of the Posterior Annulus and Intradiscal Pressure
The interrelation between unloading of the discal structures and distraction of posterior lumbar elements is a
much debated issue. The rabbit models suggest that prolonged disc distraction might reverse some aspects of
the compression-induced degeneration with better results at the L3/L4 level [47-51]. Nevertheless, the
biomechanical mechanism is not clear, because both compression and distraction cause a significant decrease
in nucleus pressure; however, the compression results in a greater pressure decrease than distraction. It was
theorized that reduction in pressure with distraction results from a void between both endplates [44]. The
measurement of the height of the posterior disc as indirect sign of the intradiscal pressure showed an average
from 0.09 to maximal 1.75 mm [11, 35, 40]. In a cadaveric disc pressure study, Swanson et al. reported that the
pressures in the posterior annulus and nucleus pulposus were reduced by 63% and 41%, respectively, during
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extension and by 38% and 20%, respectively, in the neutral, standing position [52]. The exhaustive mechanism
of the intradiscal pressure interaction with the neural structures is today not clarified. Axial loading MRI
examination is seldom used to show the dynamical modification of a degenerative disc in the lumbar spine. It is
performed with the patient supine and gravity is typically simulated using a compressive system comprised of a
vest worn by the patient over the shoulders and upper chest attached to a footplate against which the patient's
feet are braced. The platform pushes under computer control, maintaining a stable push during the examination:
the load applied is 65% of the patient's weight. The examination is performed in a neutral position and after
loading with axial and sagittal T2-weighted scans. The images are subsequently evaluated to identify loadinduced changes. A dynamically degenerative modification of the lumbar spine has been observed when
performing MRI under axial loading. Previously studies reported that disc bulging increases under loading
conditions with consequent restrictions of the spinal canal area, irregular slipping, and abnormal movements of
the articular facet joints, as well as increases in local scoliosis with asymmetric restrictions of the neuroforamen
area [53].
2.4. Distraction of Interspinous Distance
Another indirect measure published is the distance between the spinous processes. The reported data [38, 40]
show the persistence of the distraction over a period of two years and four years. Nevertheless, major criticism
against this index is the absence of a direct correlation between the interspinous distance and the clinical
symptoms. Consequently, the interspinous distance should be used only as auxiliary indicator.
2.5. Strength of the Spinous Processes
The lateral force required to fracture a human lumbar spinous process with varying bone densities ranges
between 95-786 N with a load of average 317 N [41]. The distraction force necessary to break the lumbar
spinous process ranged between 242-1 and 300 N with an average load of 339 N [54].
The lateral experimentally measured force to implant an interspinous device ranges from 11 to 150 N [41].
Based on these data, a severely osteoporotic patient may be contraindicated for interspinous device, because a
fracture of the spinous process might occur intraoperatively or postoperatively.
Surgeons should be aware that the insertion of an interspinous device requires personalized forces and caution,
but osteopenia is not an absolute contraindication for the operation.
2.6. Combining IPD Insertion and Microdiscectomy/Foraminal Decompression/Interbody Fusion
Recently various studies have been published combining the insertion of an interspinous device and
microdiscectomy/foraminotomy and interbody fusion. Fuchs was the first to suggest that interspinous device can
be implanted with unilateral medial or total facetectomy to stabilize the spine; however, there is no
biomechanical paper to show the level of stability provided by IPD after unilateral facetectomy specially that
biomechanical studies have documented the destabilizing effects of unilateral facetectomy [55, 56].
Ploumis et al. evaluated the combination of direct unilateral decompression and indirect decompression with an
X-Stop in twenty-two lumbar spinal stenosis and described an effective clinical improvement at two-year followup [57].
Gonzalez-Blohm et al. evaluated the biomechanical performance of an interspinous fusion device as a standalone device, after lumbar decompression surgery, and as supplemental fixation in a posterior lumbar interbody
fusion (PLIF) construct. They suggested that IPD may be a suitable device to provide immediate flexionextension balance after a unilateral laminotomy. PLIF constructs with IPD and pedicle screws performed
equivalently in flexion-extension and axial rotation, but the PLIF-bilateral pedicle screws construct was more
resistant to lateral bending motions. The authors requested further biomechanical and clinical evidence to
strongly support the recommendation of a stand-alone interspinous fusion device or as supplemental fixation to
expandable posterior interbody cages [58].
3. Historical Background of Interspinous Process Devices
The first interspinous implant for the lumbar spine was developed in the 1950s by Knowles. Owing to flaws in
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design, material, surgical technique, and applied indications, its use was abandoned. The first modern
interspinous device, the Wallis system, was developed by Abbot Spine in 1986 and it was used primarily in
patients with recurrent disc herniation [14]. It was a "floating system" that was comprised of a titanium spacer
placed between the spinous processes and secured with two Dacron ligaments wrapped around the spinous
processes. This system was not initially marketed commercially while waiting for long-term follow-up results. In
a reported prospective trial, the application of the first generation Wallis device improved outcome in patients
who underwent a second discectomy. Despite favorable results, Senegas thought that the device could be
improved. A second generation of the Wallis device, slightly different in shape, and composed of
polyetheretherketone (PEEK), was used with other surgical procedures, to reduce pain severity in cases of
moderate disc degeneration, central spinal stenosis, and significant lower back pain. The Minns device was the
first "soft" interspinous spacer indicated for sagittal plane instability [32]. The implant was fashioned out of
silicone into the shape of a dumbbell to off-load the facet joints and decrease the intradiscal pressure. But
despite the promising in vitro results, no further clinical application was published to date and it is unclear
whether the implant advanced much further than the laboratory settings. In the 1990s, several other IDP
devices displaying significant differences in design, materials, surgical techniques, and indications appeared in
Europe and South America, for which there are ongoing trials of evaluation for a host of clinical indications.
Kaech et al. first reported on the interspinous "U" (Coflex) suggesting that it was indicated for protection against
adjacent level disc disease and restabilization of a lumbar laminectomy [59]. Caserta et al. reported on the
DIAM implant, which was indicated for a number of conditions, including degenerative disc disease, herniated
nucleus pulposus, and lumbar instability [29]. The X-Stop device (Medtronic, Tolochenaz, Switzerland) was
approved by the US Food and Drug Administration in 2005 for the treatment of neurogenic intermittent
claudication secondary to lumbar stenosis [38].
4. Type of Implants
Contemporary models of fusion interspinous devices have evolved from spinous process wiring with bone
blocks and early device designs as the Wilson plate: the newer devices range from paired plates with teeth to
U-shaped devices with wings that are attached to the spinous processes. They are intended to be an alternative
to pedicle screw and rod constructs and also to aid in the stabilization of the spine with interbody fusion.
Recently with greater focus on motion-preservation alternatives, interest in nonfusion interspinous devices has
emerged. Interspinous fixation devices are placed under direct visualization or percutaneously using a C-arm
and they can be categorized by design as static, dynamic, or fusion devices. Despite the fact that they are
composed of a wide range of different materials including titanium, polyetheretherketone, bone allograft, and
elastomeric compounds, the intention of the implant is to maintain a constant degree of distraction between the
spinous processes. In the latest years, the spine market saw few of the world's leading medtech companies
abandon their position in the hotly contested sector, where they were, at best, a bit player. Deciding that they
did not want to invest any additional resources in attempting to grow its small share of the market, Abbott Spine
agreed to be acquired by Zimmer Holdings Inc. and St. Francis Medical Technologies was acquired by
Medtronic. We listed the most important devices that are still on the market (Table 1).
Table 1: List of the most important interspinous implants available on the market.
(a)
X-Stop Coflex

DIAM

BacJac

Viking

Ellipse

Aperius

Producer

Medtro Paradigm
nic
Spine

Medtroni Zimme
Pioneer
c
r

Sintea

Sintea

Medtroni
c

Category

Static

Dynamic Static

Dynam
Static
ic

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Dynamic

Wallis

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Static

Static

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Material

Titaniu
Titanium
m

Silicon

Peek

Peek

Paek

Titanium/
Paek

Approach

Bilater
al

Bilateral

Monolat
eral

Bilater
al

Monolat
eral

Bilater
al

Monolater Percutan
al
eous

Fixation

Wings

Wings

Ribbons

Ribbon
Clip
s

Ribbon
Clip
s

Wings

Preservation
supraspinous ligament

Yes

No

Yes

No

No

Yes

Yes

Yes

Titanium

(b)

BacFuse

Stabilink

Bridge Point

Posterior Fusion
System

Alphatec Spine Lanx

Pioneer

Southern
Spine

Alphatec Spine

Lanx

Static

Static/Fusion

Static/Fusion

Static/Fusion

Expandable/Fusio
Expandable/Fusion
n

Peek

Titanium

Titanium

Titanium

Titanium

Titanium

Percutaneous

Bilateral

Bilateral

Bilateral

Bilateral

Bilateral

Helical tip

Spikes

Spikes

Spikes

Spikes

Spikes

Yes

Yes

Yes

Yes

Yes

Yes

Helifix

Aspen

Table 2: Relevant Biomechanical studies on interspinous devices.

Author

Ca
Ye
Device
se Study
ar
s

Swanson et
al. [52]

X-Stop

20
03

XLee et
St
al. [35]
op

Increase of
22.3% spinal
canal and
36.5%
foraminal
area

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Evaluation

Results

Cadav
Intradiscal pressure
er

Unloading of the disc

20
04

10

Case series

Foraminal and spinal canal area

2005

191

Case series

Zu
ch
er
ma Xn
St
et op
al.
[38
]

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X-ray
assessment

No
differe
nces
betwe
en 12
and 24
month
s

Cadaver

Inc
rea
se
of
18
%
spi
nal
ca
nal
Forami
an
nal
d
and
25
spinal
%
canal
for
area
am
ina
l
are
a
in
ext
en
sio
n

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Ric
har
ds
et X-Stop 2005
al.
[37
]

Fuchs
et al.
[55]

X-Stop

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2005

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2005

As
se
ss
me
nt
Cadav
aft
er
er
fac
ete
cto
my

Bil
ate
ral
fac
ete
cto
my
inc
rea
se
s
ran
ge
of
mo
tio
n

Fa
Ca cet
da loa
ver din
g

Wiseman et al. [53]

Reduc
ed
mean
peak
pressu
re

Siddiqui et al. [45]

2006

26

Ca
Significant increase of
se Kinem
spinal canal and foraminal
ser atics
area
ies

Phillips et al.
Diam
[60]

20
06

X-Stop

Co
Tsai et
20
fle
al. [42]
06
x
Returns a
partially
destabilized
spine back
to intact
condition
Adjacent
segment
motion
compared
with PLIF

Kinematics after
Cadav
facetectomy and
er
discectomy

Reduces increased segmental motion

after discectomy

Cadaver

Kinematics

42

Case series

2007

62

Ko
ng
Co
et
fle 2007
al.
x
[61
]

Increa
sed in
PLIF

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X-Stop

Ki
m
et
Diam
al.
[62
]

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No
ch
an
ge
s
in
dis
c
hei
ght
at
12
mo
nth
s

Case series

Disc
height

Lo
we
r
str
Kin
es
Cadav em
s
er
ati
in
cs
dis
c
fib
ers

Lafage
et al.
Wallis
[63]

Wilke et al. [8]

2007

X-Stop/Diam

4.1. Static and Dynamic Interspinous Devices

X-Stop (Medtronic, Tolochenaz, Switzerland, Formerly St. Francis Medical Technologies, Alameda, CA). The XStop interspinous process decompression system is an interspinous spacer developed to treat patients with
neurogenic intermittent claudication. It is an all-titanium (peek surrounded since end of 2004) device composed
by an oval spacer, one fixed wing, one adjustable wing, and one tissue expander (Figures 1 and 2). X-Stop is
the only IDP device with class I data and a prospective randomized control trial supporting its safety and
efficacy compared to the nonoperative treatment. It is indicated for treatment of patients aged 50 or older
suffering from pain or cramping in the legs (neurogenic intermittent claudication) secondary to a confirmed
diagnosis of lumbar spinal stenosis. The X-Stop is indicated for those patients with moderately impaired
physical function who experienced relief in flexion from their symptoms of leg/buttock/groin pain, with or without
back pain and have undergone a regimen of at least 6 months of nonoperative treatment. The X-Stop may be
implanted at one or two lumbar levels. The U.S. Food and Drug Administration approval of X-Stop interspinous
decompression system was based on laboratory, mechanical, and cadaver studies and also a multicenter,
prospective randomized controlled clinical study [38].
Figure 1: Anterior-posterior X-ray image showing an X-Stop device implanted at L4-L5 interspinous level.
[figure omitted; refer to PDF]
Figure 2: Intraoperative image shows the X-Stop interspinous device implanted cranially to a posterior fixation
with pedicle screws, to avoid the topping off phenomenon.
[figure omitted; refer to PDF]
Surgical technique used was as follows: patients are placed on an operative table in a prone or right lateral

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decubitus position. The intervertebral level to be treated is identified by fluoroscopy. Because the implant was
designed to be placed without removing any bony or soft tissues, the technique may be performed under local
anesthesia. A midsagittal incision of approximately 4 cm is made over the spinous processes of the stenotic
levels. The fascia is split longitudinally 2 cm to the right and to the left of the midline. It is of paramount
importance to keep the supraspinous ligament intact. Paraspinal muscles are elevated off the spinous
processes and medial lamina bilaterally using electrocautery. Occasionally, hypertrophied facets that block
entry into the anterior interspinous space are trimmed partially to enable anterior placement of the implant. A
small curve dilator is inserted across the interspinous ligament; after the correct level is verified by fluoroscopy,
the small dilator is removed and the larger curve dilator is inserted. After removing the latter dilator, the sizing
distractor is inserted and the interspinous space is distracted until the supraspinous ligament becomes taught.
The correct implant size is indicated on the sizing instrument and the appropriately sized X-Stop implant is
inserted between the spinous process.
The oval spacer separates the spinous processes and limits extension at the implanted level. The oval spacer
distributes the load along the concave shape of the spinous processes. The screw hole for the universal wing
on the left side is visualized and the screw is engaged. The two wings are approximated towards the midline
and the screw is secured. The two lateral wings prevent migration anteriorly or laterally, and the supraspinous
ligament prevents the implant from migrating posteriorly.

Coflex (Paradigm Spine, LLC, New York). This device was originally developed in France by Dr. Jacques
Samani in 1994, also called "interspinous U." It is designed to be placed between two adjacent processes. It is a
titanium device with a U-shaped body and two wings on each side (Figure 3). This implant is designed to permit
flexion of the spine, thus restricting mobility in extension and rotation. The Coflex is FDA approved as an
adjunct to fusion but is not approved as a stand-alone spacer. Although it was initially developed as a motionpreserving alternative used to treat various lumbar degenerative disorders, long-term studies from Europe
suggested that the subset of patients with spinal stenosis and Grade I spondylolisthesis experienced the most
significant improvement.
Figure 3: Lateral X-ray image of a Coflex implant.
[figure omitted; refer to PDF]
Surgical technique used was as follows: the patient is placed in prone position with slightly lumbar flexion. After
a midline skin incision of 4-6 cm, the paraspinal muscles are stripped off the laminae. The interspinous ligament
is removed and its bony attachments are resected. To define the appropriate implant size, trials are utilized.
Some bony resection of the spinous process may be needed. The interspinous implant (8, 10, 12, 14, or 16
mm) is introduced tightly with gentle hammering using a mallet.
Thereafter, the wing clamps of the interspinous U are tightened against both edges of the upper and lower
spinal process. In the first generation of the device, the wing clamps could be attached to the spinous processes
by a suture passed through the central hole. Fixation at the spinous processes with the new generation of
Coflex is possible with crimping of the wings. Coflex F has a secure anchorage to the spinous processes
through rivet fixation. The depth of insertion of the Coflex can be verified under lateral fluoroscopy. The proper
depth is determined if a nerve hook can be passed freely leaving 3 to 4 mm between the bottom of the Coflex
and the thecal sac.

DIAM (Medtronic/Sofamor Danek). The DIAM (Device for Intervertebral Assisted Motion) is an "H" shaped
silicone bumper wrapped into a polyester sheath connected to artificial ligaments of the same material that is
designed to support dynamically the vertebrae, restoring posterior column height and maintaining distraction of
the foramina; the device acts as shock absorber, relieving stresses on both anterior and posterior elements of
the spine. This device was clinically used for multiple pathologies including degenerative disc disease, canal
and/or foraminal stenosis, disc herniation, black disc and facet syndrome, and topping-off.
Surgical technique used was as follows: with the patient placed in a prone position, a simple midline approach
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with dissection of muscles from the spinous process is performed. After opening the interspinous ligament, the
DIAM device is positioned on the open inserter. The wings of the device are folded as the inserter flanges are
compressed, thus the DIAM is driven as far anterior as possible using the impactor. Finally, the device is
secured to the adjacent spinous processes by means of the implant's tethers. Longitudinal tension is applied
and a crimper is used to secure the rivets and the excess length of the bands is cut.

Wallis (Zimmer Spine, Formerly Abbot Spine, Inc., Austin, TX). The device consists of an interspinous spacer
made of polyetheretherketone (PEEK), which limits extension, and two woven dacron bands that secure the
implant and limit flexion (Figure 4). The spacer has a distal and proximal 10 degrees inclined groove to better
house the spinous processes and adapt to the anatomy of the spinous processes. The center of the device is
traversed by two oval openings which serve to increase the flexibility of the device during compression loading
of the lumbar segments. The flat polyester bands have an increased surface contact with the spinous
processes, minimizing local concentration of contact stresses on the bone during flexion movements. The
spacers have all the same width but the heights increases from 8, 10, 12, and 14 to 16. The Wallis device is
indicated for the treatment of low back pain associated with degenerative disc diseases as well as lateral recess
and central spinal stenosis.
Figure 4: Model of a second generation Wallis implant with the polyester bands passed around the overlying
and underlying interspinous ligaments and tightened.
[figure omitted; refer to PDF]
Surgical technique used was as follows: surgery is performed with the patient under general anesthesia.
Depending on the indication, the Wallis implant is placed either subsequent to a conventional posterior
decompressive surgical procedure or in isolated fashion through a midline incision. The patient is placed in a
prone neutral position of physiological lumbar lordosis. After skin incision, the supraspinous ligament is
detached from the two spinous processes of the degenerative lumbar level with a scalpel and retracted intact
with the underlying paravertebral muscles. If necessary, a decompressive procedure is performed. The
interspinous ligament is removed with a gouge and, if bone trimming is necessary to improve seating of the
implant, the inferior aspect of the upper spinous process at the junction with the lamina is trimmed to seat the
spacer deeply as much as possible with the laminae.
After determining the size with a trial implant, the selected implant is placed in the interspinous space. With a
sharp, curved instrument, the polyester bands are passed around the overlying and underlying interspinous
ligaments, as close as possible to the instrumented spinous process. The bands are secured to the spacer and
tightened: a small titanium ring is crimped onto each band to avoid fraying at the severed end. The
supraspinous ligament is reinserted onto each spinous process with suture.

Viking (Sintea, Italy). It is a dynamic interspinous system that allows for compression movements, lateral
bending, and load transfer along the spine preserving the kinematic movements in the vertebral segment where
it is implanted. It works at the same time as a shock adsorber. The device is made of PAEK, a biocompatible
polymer, with stiffness similar to human cortical bone. It is anatomical shape consists of two concave shaped
ends, and it is core is an elastic spring which can be deformed. The system is used to treat lumbar minor
instabilities and to reduce the incidence of disc herniation recurrence after microdiscectomy of the affected
level.
Surgical technique used was as follows: the patient is placed in prone position on a surgical frame avoiding
hyperlordosis of the spinal segment to be operated on.
The inferior aspect of the spinous processes must be trimmed, if necessary, to facilitate insertion of the
interspinous spacer. The bony junction between the spinous processes and the laminae may be trimmed to
position the implant as anterior as possible to ensure a stable fit against the laminae.
Two bands are secured to the spacer and tightened: a small titanium ring is crimped onto each band to avoid
fraying after cutting off the excess band (Figure 5).
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Figure 5: The BacJac interspinous device implanted in a lumbar spinal model.

[figure omitted; refer to PDF]

Ellipse (Sintea, Italy). The Ellipse ISD is made of 2 elliptic components made of titanium and PAEK (plastic
polymer) assembled by a click closure. The device has been developed to anatomically embrace both spinal
processes in the PAEK surface in order to reduce the pull-out and respect the bone elasticity module. It must be
applied between the spinous processes of the involved levels with monolateral MIS access (right or left,
depending on the affected side) (Figures 6 and 7). This device is mainly used to expand the intervertebral space
in mild and moderate lumbar stenosis.
Figure 6: The lateral X-ray image reveals the radiographic marker of the BacJac implanted at L4-L5 interspinous
area.
[figure omitted; refer to PDF]
Figure 7: Intraoperative image of a double Viking implanted at higher lumbar levels. The bands are passed at
the cranial and caudal interspinous level and tightened. When possible, the supraspinous ligament must be
sutured.
[figure omitted; refer to PDF]

BacJac (Pioneer). The BacJac is a minimally invasive device manufactured from PEEK, implanted through a
unilateral surgical approach that reduces operating room and patient recovery time, while preserving future
surgical options. The BacJac is a self-deploying, nonfusion device which is tissue sparing and ligament
preserving. This device achieves spinal decompression by limiting the symptomatic extension while maintaining
physiologic motion. Due to its large contact area with the spinous processes and its near-physiologic modulus, it
ensures a minimal risk of subsidence (Figures 8 and 9). The best indication for this device seems to be
radiculopathy and neurogenic claudication secondary to lumbar spine degenerated disc diseases.
Figure 8: Intraoperative image of the first generation (prototype) all titanium Ellipse device. In this case the
supraspinous ligament was removed to check the appropriate distraction of the interspinous area.
[figure omitted; refer to PDF]
Figure 9: Anterior-posterior image of the second generation of Ellipse (half titanium/half PAEK) implanted at L4L5.
[figure omitted; refer to PDF]
Multiple companies have offered in recent years various devices, such as NuVasive (San Diego, CA) with
ExtendSure and Biomech (Teipi, Taiwan) with the Promise and/or Rocker designs made of PEEK and mobile
core and articulated design, respectively; Cousin Biotech (France) with the Biolig silicon encapsulated in woven
synthetics device, Vertiflex (San Clemente, CA) with the Superion implant with deployable wings aiming at less
invasive insertion that has started IDE study since 2008, Synthes (West Chester, PA) with the In-Space system
with minimal insertion-that also started IDE in 2008 that was terminated at later date, or Orthofix (Bussolengo,
Italy) with InSWing, Maxx Spine (Bad Schwalbach) with I-MAXX, Globus Medical (Audubon, PA) with Flexus,
Privelop (Neunkirchen-Seelscheidm Germany) with Spinos.
4.2. Percutaneous Interspinous Devices

Aperius (Medtronic). The Aperius PercLID System is a percutaneous interspinous bullet-shaped implant. The
system is composed of a set of color-coded distraction trocars of increasing sizes (8, 10, 12, and 14 mm) and of
the preassembled inserter devices with implants. The 8-mm distraction trocar has a sharp pointed tip to facilitate
piercing of the interspinous ligament for the subsequent trocars and for the implant. Each trocar and each
inserter have a curved shape, which facilitates convenient access to the target level and positioning of the
implant. Each implant is preassembled on the inserter so it can be inserted without intermediate steps once the
desired distraction is achieved. The implant core is made of titanium (TiAl6V4) alloy, whereas the external shell
is composed of commercially pure titanium. By turning the actuating handle of the inserter, a compressive force
is created, retracting the outer shell and deploying the wings, which expand on each side of the spinous
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process, stabilizing the interspinous implant on the midline (Figures 10, 11, 12, and 13).
Figure 10: Anteroposterior radiographs of the lumbar spine during introperative radioscopy showing the
insertion of an Aperius PercLID System at the L3-L4 level. The implant is preassembled on the inserter so it can
be inserted without intermediate steps once the desired distraction is achieved. The implant core is
manufactured of Titanium alloy (TiAl6V4 alloy) while the external shell is composed of pure Titanium.
[figure omitted; refer to PDF]
Figure 11: Axial CT image of the Aperius inserted at L4-L5 level showing the wings expanded on each side of
the spinous process.
[figure omitted; refer to PDF]
Figure 12: Sagittal CT image of the Aperius inserted at L4-L5 level.
[figure omitted; refer to PDF]
Figure 13: Coronal CT image of the Aperius inserted at L4-L5 level.
[figure omitted; refer to PDF]

Helifix (Alphatec Spine). The Helifix Interspinous Spacer System is a percutaneous self-distracting implant
manufactured from PEEK (polyetheretherketone) material and tantalum radiographic markers. It is composed of
a self-distracting helical tip (Figure 14). Surgical technique is done through a posterior lateral approach, after a
2-3 cm incision; a guidewire is inserted under lateral fluoroscopy to find the interspinous space; a ligament
splitter dilates through the interspinous ligament; then a dilator trial is positioned between the superior and
inferior spinous processes. The insertion of increasing size trocars allows for a gradual distraction of the
interspinous area to measure the optimal decompression and prevent overdistraction. Once proper fit is
established, the Helifix implant is inserted with a rotating movement of the self-distracting helical tip in the
interspinous area. This device stretches the ligamenta flava and the posterior fibers of the annulus fibrosus,
thus enlarging the spinal canal in mild and moderate lumbar stenosis.
Figure 14: The self-distracting helical tip of the Helifix Interspinous Distraction System.
[figure omitted; refer to PDF]
4.3. Interspinous Fusion Devices
Interspinous fusion devices contrast with interspinous distraction devices (also called spacers); the latter are
used alone for decompression and may not be fixed to the spinous processes.

Aspen (Lanx). The Aspen Device is an alternative to pedicle screws in achieving fusion; it delivers simplified
posterior stabilization and renewed anatomical alignment through a minimally invasive implant and can be used
in single- or multilevel constructs (Figure 15). Aspen is used alone or as an adjunct to interbody fusion and/or
posterior fusion with decompression in treatment from T1-S1. It provides an alternative to more conventional
means of fixation such as pedicle screws or anterior plates. This device is an alternative to dynamic
interspinous spacers for the treatment of spinal stenosis and to conventional means of fixation to achieve
fusion. Proprietary spiked-plate design provides reliable bone fixation. The interspinous implant serves to
support the formation of fusion and decompression by fixation, load sharing, and interspinous process spacing,
while decompressing spinal canal. It has an offset shape to accommodate multilevel placement with a wide
range of sizes for patient variations.
Figure 15: Postoperative anteroposterior X-ray image of Aspen shows the spikes in the lateral plates of the
device for bone fixation.
[figure omitted; refer to PDF]

BacFuse (Pioneer). This device is used alone or as an adjunct to interbody fusion and/or posterior fusion with
decompression in treatment from T1-S1. It has a spiked-plate design that provide spinous process fixation. The
BacFuse decompresses the spinal canal while supporting the formation of interspinous fusion (Figure 16).
Figure 16: Intraoperative X-ray image of a BacFuse implanted at L4-L5 interspinous level.
[figure omitted; refer to PDF]
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Stabilink (Southern Spine). The implant has a small diameter wide-spike design with 16 spikes per implant over
a broad area. There are three different implant designs and a wide range of sizes for an optimum anatomical fit.
The anterior design maximizes containment area for bone graft material to optimize bony fixation (Figure 17).
Figure 17: Intraoperative X-ray image of a Stabilink implanted at L3-L4 interspinous level.
[figure omitted; refer to PDF]
4.3.1. Expandable Interspinous Fusion Devices

BridgePoint (Alphatec Spine). The BridgePoint is an advanced spinous process fixation system that was
developed to address some of the disadvantages of traditional stabilization devices. The implant has unique
telescoping plates that allow surgeons to fixate and compress spinous processes to restore sagittal alignment
and facilitate a reliable interbody fusion (Figure 18). The device's large contact area provides a strong anchor
point from which is possible to apply compression between the adjacent spinous processes during the surgical
procedure and it offers optimal stability during the fusion process. The system is easy to use and the quick
procedure offers minimal exposure, dissection, muscle trauma, and blood loss as well as protection of neural
structures. The device has a large bone graft window and is intended for use with bone graft material and is not
intended for stand-alone use. Surgical technique was as follows: after a midline exposure of the spinous
processes, the supraspinous and interspinous ligaments are removed entirely. Bilateral hemilaminectomies and
partial medial facetectomies are done preserving the laminae, facets, and spinous processes. The facing
surfaces of the spinous processes are decorticated. The interspinous space distance is determined using a
measuring guide. The appropriate sized interspinous device is chosen and placed between the spinous
processes and squeezed together, and the device is compressed or distract with an appropriate device. The
space between the spinous processes and within the space between the BridgePoint plates is filled with
allograft bone product.
Figure 18: Intraoperative lateral X-ray of the BridgePoint System with the telescoping plates that fixate and
compress spinous processes restoring sagittal alignment.
[figure omitted; refer to PDF]

Posterior Fusion System (Lanx). The posterior Fusion device consists of spinous process plates made of
Titanium Alloy and commercially pure titanium (Figure 19). It is intended to provide stabilization in the lumbar
and thoracic spine as an adjunct to interbody and/or posterior fusion, or as stand-alone device. The device is
designed to support the formation of fusion and decompression by fixation and interspinous process spacing,
while renewing anatomic alignment. The implant has an adjustable, fenestrated core and adjustable-length
plates which allow for expansion and compression. The in situ compressibility allows surgeons to control the
lordosis at the treated level, while the adjustable sizing allows for an optimized anatomical fit. Bone graft
material is then packed within the hollow post of the implant.
Figure 19: The Posterior Fusion System is a titanium implant that has an adjustable, fenestrated core and
adjustable-length plates which allows for expansion and compression.
[figure omitted; refer to PDF]
5. Pathologies Treated
Interspinous fixation systems are less invasive and present fewer risks than pedicle or facet screws in
combination with fusion for the treatment of degenerative lumbar diseases. Biomechanical studies suggest that
interspinous fusion implants may be similar to pedicle screw-rod constructs in limiting the range of flexionextension, but they may be less effective than bilateral pedicle screw-rod fixation for limiting axial rotation and
lateral bending.
6. IPD Compared with Other Treatments
6.1. IPD Compared with Nonoperative Treatment
FDA approval of X-Stop was based on a multicenter, prospective randomized controlled clinical study: patients
were randomized to X-Stop (n=100 ) or to a control group (n=91 ) which received continued nonoperative
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therapy, including bed rest, a lumbar corset, and epidural injections [38]. At two years, the Symptom Severity
score for the X-Stop and the control group was 45.4% above baseline scores and 7.4%, respectively; the mean
physical function score changes were 44.3% and -0.4%, respectively. In another report, published by the same
authors, the X-Stop group showed improvements in physical and mental component scores (Quality of life SF36) compared to both baseline and control patients. But in this paper, the beneficial outcomes reported were
misleading inflated and, in addition, there was a conflict of interest for the two primary authors. Anderson
reported two years outcome in patients whose symptoms were due to degenerative spondylolisthesis at one or
two levels; using ZCQ and SF-36 questionnaire, 63.4% of patients in the X-Stop group met success criteria
while 12.9% of the control group were satisfied. In all these studies, while the short-term results are
encouraging, it is not possible to reach scientific conclusions related to long-term health outcomes.
6.2. IPD Compared with Decompressive Surgery
The IDE (investigational device exemption) trial for the Coflex was a randomized multicenter noninferiority study
that compared Coflex implantation with decompression and posterolateral fusion with pedicle screw fixation
[64]. Patients were randomized in a 2 : 1 ratio: noninferiority between Coflex and pedicle screws was reported,
with 66.2% success with Coflex and 57.7% success with fusion. ZCQ success was achieved in 78.3% of Coflex
patients compared with 67.4% of control group. The percentage of adverse events was 5.6% for both groups
with a reoperation rate of 10.7% in the Coflex group and 7.5% in the fusion group. In another randomized trial of
100 cases with lumbar stenosis, patients were randomized in a 1 : 1 ratio to undergo either X-Stop implantation
or surgical decompression. Although at 24 months follow-up there was no significant difference in scores for
symptoms and function, reoperation rates were higher in the X-Stop group (26%) than in the decompression
group (6%) [65].
6.3. IPD versus IPD
Wilke compared four different interspinous implants (Wallis, Diam, Coflex, and X-Stop) in terms of their flexibility
and intradiscal pressure [8]. They found that they all had similar effect on the flexibility, reducing the intradiscal
pressure in extension, but having no effect in flexion, lateral bending, and axial rotation. Sobottke et al.
compared retrospectively the clinical and radiological results of three different IPD (Diam, X-Stop, and Wallis)
[31]. The foraminal height, foraminal width, and foraminal cross-sectional area were significantly increased after
surgery with all the three devices, but progressively decreased during follow-up. They reported that the X-Stop
group showed a significantly larger foraminal cross-sectional area and height than the other two devices. The
best pain relief, but not statistically significant, was noted for patients who received the Diam, followed by the XStop and the Wallis devices.
7. Cost-Effectiveness of ISP
First study published examining the cost of laminectomy versus ISP surgery was in 2007 [40]. Kondrashov
reported that X-Stop was significantly more cost-effective than laminectomy. But in their study, they used the
cost perspective of the hospital rather than that of the society; in addition, the senior author of the study was
one of the inventors of the X-Stop device and had financial ties to the manufacturer. It has been reported
recently [66] in a health economical analysis that considerable healthcare cost savings can be obtained using
an IPD on an outpatient basis. Following standard cost-effectiveness principles, Burnett published a literature
review comparing the costs of conservative treatment, decompressive laminectomy, and X-Stop implantation in
patients with lumbar spinal stenosis. They suggested that laminectomy was the most effective treatment
strategy, followed by X-Stop and then conservative treatment at a 2-year time horizon [67]. For single level
surgery, laminectomy was more effective, but X-Stop was less costly. The cost difference was secondary to the
fact that laminectomy was performed as an inpatient surgery, whereas X-Stop was performed as an ambulatory
setting. But for double-level procedure, laminectomy was less costly and more effective than X-Stop. Relative
effectiveness and cost treatment strategies for lumbar stenosis revealed for 1-level procedure a mean cost of
$9.291 for laminectomy, $7.900 for X-Stop, and $3.478 for conservative treatment; for 2-level procedures, the
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mean cost was $9.329 for laminectomy, 13.429 for X-Stop, and $3.435 for conservative treatment. In Epstein's
series, the average charge for X-Stop devices ranged from $17.600 for one-level procedures to $57.201 for
three-levels procedures; additionally, the average operating room charge/patient was $3908 (average time 2.1
hours) and the average recovery room charge was $1151/patient (average 4.6 hours) [68].
8. Complications
Interspinous process spacers have been introduced as a possible alternative to spinal decompression and
fusion for the treatment of lumbar spinal stenosis and discogenic lower back pain. Although lumbar canal
decompression with laminectomy and fusion have shown to offer a good outcome, it is a rather invasive
procedure and some long-term clinical studies report a high rate of complications. In 1992, an extensive metaanalysis of the literature of spinal stenosis surgery reported by Turner et al. showed the following complication
rate for lumbar decompressive surgery: dural tears 5,9%, superficial infection 2,3%, deep infection 1,1%,
perioperative mortality 0,3%, and deep vein thrombosis 2,7% for an overall complication rate of 12,6% [78]. The
overall complication rate in X-Stop surgery amounts in some series for 3,3%, including fracture of the spinous
processes, dislocation of the prosthesis, and skin infections whereas such rate is 9,7% for decompressive
laminectomies [79]. More recently, Bowers et al. showed a long-term complication rate of 38%, with 11 (85%) of
13 patients requiring additional spine surgery after X-Stop placement [80]. They observed a higher rate of
spinous process fracture (23%) than previously reported.
In a retrospective study done by Tuschel et al., a fairly high revision rate (30.4%) was observed [81]. Verhoof et
al. described the outcome of X-Stop placement in a group of patients with Grade I spondylolisthesis,
documenting a high rate (58%) of failure [71] (Table 3). We found an increasing number of recent studies
suggesting that IPD may not be as free of complications and reoperations as previously reported in the first
studies. Three main causes of failure are reported in the literature: errors of indications, technical errors, and
structural failure of the implant.
Table 3: Relevant clinical studies on interspinous devices.

Author

Devi
ce

Ye
ar

Ca
Study
ses

Follow
Results
up

Zucherman et al.
[36]

XStop

200
191 Prospective comparative
4

Prosp
ective
nonco 11 months
mpara
tive

Lee X200
et al. Sto
10
4
[35] p

Satisfaction 70%

10 January 2015

12
Good outcome (implant group
month
59%/control 12%)
s

Zuc
her
Xma
Sto 2005
n et
p
al.
[38]

191

Page 15 of 25

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24 months

Goo
d
outc
ome
in
impla
nt
grou
p

Prospective
comparative

Go
od
out
co
me
(im
pla
24
nt
mont
gro
hs
up
63
%/c
ontr
ol
13
%)

18

Pros
pecti
ve
nonc
omp
arati
ve

51
mo
nth
s

Go
od
out
co
me
78
%

191

Pro
spe
ctiv
e
co
mp
arat
ive

24
mo
nth
s

2006

10 January 2015

An
der
son
X-Stop
et
al.
[69]

Kondrashov et al. [40]

2006

75

XStop

2006

Hsu et
X-Stop
al. [39]

Better outcome in implant

group

Page 16 of 25

Taylor et al. [70]

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Diam

Ret
ros
pec
tive
2007 104 non 18 months
co
mp
arat
ive

Analg
esic
reduc
ed in
63.1%

Kim et al. [62]

200
Diam
62
7

12
month Improvement in pain scores
s

Retrospective
noncomparative

Prosp
ective
nonco 12 months
mpara
tive

Siddi
Xqui
200
Sto
40
et al.
7
p
[45]
Ko
ng
Cof
et
2007
lex
al.
[61]

Reoperation 8%;
satisfied 71%

12 months

Clini
cal
impr
ove
ment
in
both
grou
ps

Retrospective
noncomparative

Re
ope
30
rati
mont
on
hs
58
%

10 January 2015

Ver
hoo
f et X-Stop
al.
[71]

Sngas et al. [72]

Page 17 of 25

42

Retrospective-prospective
comparative

2008

12

Wallis

2009

ProQuest

107

Go
od
out
Retr
co
ospe
me
ctive 13 80
nonc yea %;
omp rs
reo
arati
per
ve
atio
n
20
%
Pro
spe
ctiv
e
non
co
mp
arat
ive

24
mo
nth
s

Kucht
a et al. X-Stop
[73]

VAS and ODI decreased

39% and 20.3%

2009

175

X-Stop

Ret
ros
pec
tive
2009 129 non 10 months
co
mp
arat
ive

Good
sympt
om
control

Barbagallo et al.
[74]

XStop

23
month Reoperation of 7 cases
s

200
69
9

Retrospective
noncomparative

Richt
er et Cof 201
60
al.
lex 0
[75]

No differences

10 January 2015

Sobottke et al. [31]

Prosp
ective
12 months
compa
rative

Gal
arz Ap
a et eriu 2010
al. s
[30]

40

Page 18 of 25

Prospective noncomparative

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12 months

Satis
factio
n
90%

Prospective
noncomparative

Hig
h
clini
cal
imp
rov
em
12
ent
mont
in
hs
58
%;
reo
per
atio
n
9%

van
Mei
rha
egh Aperius
e et
al.
[76]

2013

Surace et al. [77]

156

Aperiu
2013
s

9. Conclusions
The increasing use of interspinous implants, combined with a growing older population, has raised questions
from the scientific community. While the rationale of their use in the treatment of spinal stenosis is clear, the role
in the treatment of degenerative disc disease remains to be defined. One proposed mechanism of action is
unloading of the posterior annulus by distraction. Interspinous devices with shock absorption and postoperative
adjustability may present the future of these devices. However, coupling surgical decompression techniques
with the use of interspinous devices has added confusion to the contribution of interspinous devices in
pain/symptom relief. The 2011 clinical guidelines from the NASS (North American Spine Society) suggested
that there is insufficient evidence at this time to make a recommendation for or against the placement of an
interspinous process spacing device in patients with lumbar spinal stenosis. The American pain Society
guidelines indicated that interspinous spacer device have a B recommendation: the net benefit is considered
moderate through two years, with insufficient evidence to estimate the net benefit for long-term outcomes [82,
83]. Current evidence is not sufficient to permit conclusions whether any beneficial effect from interspinous
process decompression provides significant advantages over laminectomy, which is the current standard of
care for surgical decompression of lumbar spinal stenosis. Interspinous process decompression is still
considered investigational and poor clinical results in the medical literature will continue to limit the appeal of
these devices to many surgeons in the future. But, because of the low invasiveness of the surgical implantation
of the interspinous devices, this technique seems to have robust pathophysiological grounding and promises to
play an important role in the future degenerative lumbar microsurgery, especially in the older population.
Conflict of Interests
The authors report no conflict of interests concerning the materials and methods used in this study or the
findings specified in this paper.
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Publication title: BioMed Research International
Publication year: 2014

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Publication date: 2014

Year: 2014
Publisher: Hindawi Publishing Corporation
Place of publication: New York
Country of publication: United States
Publication subject: Biology--Biotechnology, Medical Sciences
ISSN: 23146133
Source type: Scholarly Journals
Language of publication: English
Document type: Journal Article
DOI: http://dx.doi.org/10.1155/2014/975052
ProQuest document ID: 1609377235
Document URL: http://search.proquest.com/docview/1609377235?accountid=50673
Copyright: Copyright 2014 Roberto Gazzeri et al. Roberto Gazzeri et al. This is an open access article
distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and
reproduction in any medium, provided the original work is properly cited.
Last updated: 2014-10-11
Database: ProQuest Medical Library

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