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Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_6011_Библиотеки_им_академика_М_И_Перельмана.pdf
Biologic Treatment of Osteoporotic
Compression Fractures: OptiMesh
Karl D. Schultz, Jr.
43
k e y p o i n t s
Goals of treating osteoporotic vertebral compression fractures
Current treatment options with polymethyl methacrylate (complications:
extravasation, higher number of adjacent level vertebral fractures)
New biologic option (porous mesh filled with bone allograft)
Surgical procedure (cavity creation, mesh filling)
Fracture stabilization and graft incorporation
INTRODUCTION
The Centers for Disease Control and Prevention (CDC) reports that there
were 36.8 million U.S. residents older than 65 years in 2005. That number is predicted to grow to over 70 million by 2030.
mated that 25% of women older than 50 years, 40% of women older than
80 years, and 33% of men reaching 75 years of age will sustain an osteoporotic compression vertebral fracture (OCVF).
appear to go clinically undetected, up to 30% of symptomatic fractures
remain unresponsive to conservative management and are considered candidates for surgical intervention.
general effectiveness of vertebral augmentation in treating chronic pain from
OCVFs, it is easy to understand the expected steady increase in frequency
of procedures performed to treat this disease process.
Originally developed in France during the mid-1980s to treat vertebral
hemangiomas and later introduced in the United States in 1994 in the
treatment of symptomatic OCVFs, the percutaneous injection of bone
cement, polymethyl methacylate (PMMA), has gained widespread use by
physicians who treat OCVFs. Vertebroplasty and kyphoplasty have consistently demonstrated the ability to improve patient function and quality
of life through excellent pain control and rapid mobilization for this “at risk”
group of patients.
mic reactions and tissue damage, embolism, and the potential neurologically
devastating complication of cement extravasation outside the vertebral body
(spinal canal, neuroforamen) remain.
raised and debated about whether vertebral bodies augmented with PMMA
(with or without intradiscal extravasation) are associated with a higher
adjacent-level vertebral fracture (ALF) rate than would be expected because
of the natural risk of additional fractures. Investigators have challenged the
direct causal relationship between PMMA-augmented vertebral bodies and
ALF, arguing that ALFs may simply be the result of the natural history of
the underlying disease (osteoporosis). However, it is generally agreed that
when fractures occur following PMMA augmentation, it is more common
to see them occur within the first 3 months after the procedure, and they
are more likely to occur at an adjacent level than elsewhere in the spinal
7
column.
In contrast, people with osteoporotic bones with compression
fractures who have not had PMMA vertebral augmentation have subsequent vertebral fractures that are distributed more randomly throughout
5
However, risks pertaining to cement toxicity, exother-
3,4
Considering these statistics along with the
2,6
Furthermore, concerns have been
1
Presently, it is esti-
2
Although many OCVFs
the spine and will occur sporadically throughout the following year. Data
such as these do suggest that PMMA augmentation of vertebral bodies at
least predisposes adjacent vertebral levels to fracture.
It has been proposed that the ideal bone cement for vertebral augmentation should be biodegradable and nontoxic, have a low setting temperature,
and have a biomechanical profile close to that of human bone.
of the drawbacks of PMMA noted previously, and to provide an “ideal” biological cement for vertebral augmentation, a new option was developed that
involves the minimally invasive injection of morselized allograft bone into a
polyester expandable mesh container (OptiMesh, Spineology Inc., Minneapolis, Minn.). The bone injection procedure generates lifting force for potential
fracture reduction, and the resultant bone graft strut is immediately load sharing and has a modulus of elasticity closely approximating that of native bone.
8-12
13
To avoid some
INDICATIONS AND CONTRAINDICATIONS
The primary indications for use of this mesh–bone construct include painful osteoporotic, traumatic, or steroid-induced Vertebral compression fractures (VCFs) from T4 to L5, with or without secondary kyphosis, that has
not responded to a reasonable trial of conservative therapy. An additional
indication is for benign but symptomatic vertebral hemangiomas. Pain and
tenderness should be localized to the fracture level identified on x-ray, CT,
MRI, or technetium Tc 99m bone scan. Patients should be medically stable
to at least tolerate a percutaneous procedure and be able to assume a prone
position for the procedure.
The main contraindication, as with all vertebral augmentation procedures, is the presence of an unstable vertebral fracture with retropulsed fragments causing more than 20% canal compromise (i.e., true burst fracture
pattern) or any fracture pattern with neurologic deficit. The author has successfully and safely used this technique to treat compression fractures with
“bowing” of the posterior cortex (posterior longitudinal ligament intact)
along with fractures demonstrating minimal retropulsion of the superior
or inferior endplate into the canal causing less than 20% canal compromise.
Of interest, the use of this device as a minimally invasive option to treat true
burst fractures with the AO classification of A1 has even been shown effective when combined with short-segment pedicle screw fixation.
Because of issues of healing in the presence of adjuvant therapy as well as
the inherent biologic aggressiveness of metastatic tumor leading to compression fractures, this device should not be used, when used with allograft bone
as a filler material. Other absolute contraindications include comorbid conditions such as uncorrected coagulation or bleeding disorders, osteomyelitis, epidural abscess, and vertebra plana. Finally, the efficacy of prophylactic
treatment in patients at high risk for VCFs has not been proved.
14
DESCRIPTION OF THE DEVICE
The basic concept behind this technology is that a cavity within a fractured
vertebra is created percutaneously through a relatively small access portal
via a fluoroscopically guided unilateral, extrapedicular approach. A deflated
265
266
9
F I GU R E 4 3- 1 Distribution of fracture levels among
patients treated with OptiMesh.
P A R T V Ostteoporotic Surgical Treatment Modalities: Thoracic Spine
8
7
6
5
4
3
2
1
0
T6 T7 T8 T9 T10 T11 T12 L1 L2 L3 L4 L5
porous polyester mesh bag (OptiMesh) is inserted and subsequently filled
with allograft morsels, allowing a large load-sharing graft and strut to
be built within the vertebral body. OptiMesh is designed to contain and
reinforce morselized bone graft. The pore size of the mesh is nominally
1500 μm, allowing the mesh to effectively constrain the morselized allograft
while also allowing ingrowth of vessels and native bone elements for ultimate graft incorporation and remodeling.
Using the principles of granular mechanics, impaction of bone granules
into the mesh bag generates a distractive force, producing the capability for
reduction (i.e., height restoration) of the fractured vertebra. Because the
bone granules are tightly packed, force chains develop between the bone
chips, thus creating a strut capable of supporting the axial loads of the spine.
The bone allograft (Musculoskeletal Transplant Foundation [MTF],
assessment. Only two patients (5%) rated a poor score in the early postoperative period. All of the patients with longer than 6-month follow-up
expressed satisfaction with the procedure and were rated an excellent or
good Odom score.
Postoperative x-rays were evaluated for new vertebral body fractures and
maintenance of restored vertebral body height. Six patients (15%) suffered
new fractures, but only two patients (5%) had ALF. The postoperative CT
scan on one patient identified a fracture of the medial pedicle wall, without sequelae. One patient with a recurrent glioblastoma was treated for an
osteoporotic VCF, but at 3-month follow-up had significant loss of restored
vertebral body height on x-ray, although this was asymptomatic. All patients
who had a CT scan beyond 12 months postoperatively showed good evidence of graft incorporation within the mesh.
Edison, N.J.) is a mixture of lyophilized corticocancellous chips and demineralized bone matrix (DBM), providing both osteoconductive and osteoinductive properties for graft incorporation.
CLINICAL PRESENTATION AND EVALUATION
Patent MW: A 69-year-old woman with osteoporosis who suffered T7 and
BACKGROUND OF SCIENTIFIC TESTING AND CLINICAL OUTCOMES
The nonresorbable mesh is knitted from yarn made of polyethylene tere-
phthalate (PET) thread. Animal studies have shown that the mesh does
not produce an adverse tissue reaction or create a barrier to bone growth
from the host into the graft pack.
that the mesh filled with bone graft restores intact vertebral body strength
in compression. The final construct’s restored strength and stiffness is less
15
In vitro biomechanical testing has shown
T8 VCFs (T-score: −2.5) secondary to a fall. Fractures were demonstrated
by plain x-rays and MRI, and she had severe pain and disability unresponsive to conservative therapy. She underwent a T7 and T8 biologic vertebral
augmentation procedure with OptiMesh and morselized allograft during
a single session under IV conscious sedation. She reported complete pain
relief at 24 hours, and within 48 hours was able to ambulate and perform
activities of daily living without assistance. At the 3-year postoperative visit,
she continued to be pain free and her 3-year follow-up CT scan showed
osseous integration of the graft pack (Figure 43-2).
than PMMA-augmented vertebral bodies, which may have a desired protective effect to reduce the potential for adjacent level fractures. As the reduction of the fracture (i.e., height restoration) occurs while the device is being
deployed and filled, the author has found that this procedure more reliably
restored and maintained vertebral body height. This is in contrast to loss of
almost two thirds of potential restored height that occurs upon deflation
of the kyphoplasty balloon in treating similar “mobile” compression frac-
16
tures.
Finally, the MTF bone mixture has been shown to generate new
bone formation equivalent to autograft when placed in the vertebral bodies
17
of sheep.
To assess clinical efficacy, the author conducted an INVESTIGATIONAL
REVIEW BOARD (IRB)-approved retrospective study to review consecutive
patients treated with OptiMesh from March, 2004, to December, 2007. Forty
patients were enrolled under the protocol. There were 32 women and 8 men
with an average age of 73.4 years (range: 44 to 95 years). Of the 40 patients,
29 patients had osteoporotic compression fractures, 10 patients had trauma,
and 1 patient had breast cancer. A total of 48 levels were implanted. More than
50% of the fractures occurred at the thoracolumbar junction (Figure 43-1).
Average follow-up was 16 months. There were 27 patients (67.5%) who had
greater than 6-month follow-up, with an average of 23 months. Of the patients
treated for osteoporotic VCFs, 19 patients had preoperative DUAL X-RAY
ABSORPTIOMETRY(DEXA) scores with an average T-score of −2.4.
Pain and function were assessed using the four-point Odom score
(excellent, good, fair, poor). This scale allows the treating physician to combine clinical observations and physical examination with the patient’s global
OPERATIVE TECHNIQUE
These procedures are performed most commonly with monitored anesthe-
sia control on a radiolucent table. Because the procedure uses a unilateral,
parapedicular approach into the vertebral body, biplanar fluoroscopic imaging is required to guide instrument placement, reduce the risk of neural
injury, and size and fill the mesh.
Guide pin (i.e., Steinmann pin) placement determines instrument trajectory throughout the entire procedure and is thus the most critical portion of
the procedure to perform correctly. The guide pin is passed percutaneously
from a paramedian approach (approximately 7 cm from midline, depending
on the level being treated). It is ultimately docked and then allowed to penetrate the lateral base of the pedicle at the pedicle–vertebral body junction.
The pin is then advanced into the center of the vertebral body with a trajectory
that ultimately positions its tip halfway across the silhouette of the vertebral
body on both anteroposterior (AP) and lateral fluoroscopic images. Once
an appropriate trajectory is obtained, a dilator is introduced over the guide
pin and docked onto the pedicle vertebral body junction. The access portal
(i.e., working channel), in turn, is passed over the dilator tube and similarly
docked onto the vertebral body. The guide pin and dilator tube are then removed.
A cavity is then created within the vertebral body by first drilling obliquely
across the vertebral body to within 5 to 6 mm of the contralateral vertebral
body cortex with a 6-mm hand drill. An expandable shaper is then used to core
out a cavity that leaves 2 to 3 mm of bone between the cavity and the endplates.
C H A P T E R 4 3 Biologic Treatment of Osteoporotic Compression Fractures: OptiMesh
T7
F IG UR E 4 3 -2 CT scans at 36
months showing good osseous integration of
bone graft.
T8
267
A
F IG UR E 4 3- 3 A, A cavity is created. B, Mesh is inserted empty. C, Mesh is filled and released.
B
Based on the drill depth, shaper usage, neighboring normal vertebral
body height, and the stiffness of the fracture (i.e., acute vs subacute),
the appropriate size of mesh bag is determined. An acute fracture may
require a larger construct to restore vertebral body height, whereas in a
nonmobile fracture, the goal may only be to fill the cavity created without
height restoration. Each size mesh has a maximum fill volume, and this
should never be exceeded to avoid potential rupture and loss of containment of the allograft. Chronic fractures may allow little expansion of the
mesh if a cavity is inappropriately undersized. In this situation, the graft
pack may achieve load-bearing capabilities at fill volumes less than that
recommended.
The mesh bag is attached to a mesh holder and passed into the cavity. The mesh is then filled using prefilled tubes prepared and provided by
Muscu loskeletal Transplant Foundation. The mesh bag is filled circumferentially utilizing initially the diverted (i.e., angled tip) tubes to fill the bag
peripherally followed by a straight (i.e non-angled tip) tube which fills the
mesh bag centrally ensuring an even packing of allograft throughout the
construct. Upon completion of filling, the mesh is detached from its crimp
tip, and then all instruments are removed from the patient (Figure 43-3).
POSTOPERATIVE CARE
These procedures are often done on an outpatient basis with the patients
allowed to ambulate following clearance by the anesthesia team. No bracing
is necessary and patients can return to light to moderate levels of activity
immediately. In patients with osteoporosis, treatment of the underlying disease with best medical management is essential.
COMPLICATIONS AND AVOIDANCE
This procedure involves placement of an actual implant in the vertebral body,
so prophylactic antibiotics should always be used to avoid the development of spondylitis. As with all percutaneous spinal procedures, adequate
C
visualization with biplanar fluoroscopy and surgeon experience with interpreting these images are mandatory. Though the extrapedicular approach
reduces the likelihood of canal violation, nerve root injury, pedicle fracture,
spinal cord injury, and misplacement of the device outside the confines of
the fractured vertebral body can occur if the landmarks for guide pin placement and trajectory are not well visualized or interpreted.
The potential for retroperitoneal bleeding (for lumbar fracture repair)
and for hemothorax or pneumothorax (with thoracic fracture repair) are
valid concerns but in the author’s experience rarely occur. To avoid violating the pleural space in treating thoracic fractures, the guide pin should be
walked along the dorsal side of the rib cage as it is guided from lateral to
medial to the costovertebral junction, and then more ventrally along the lateral aspect of pedicle. Ipsilateral exiting nerve root injury at any level can be
avoided by always keeping the guide pin (which defines the subsequent trajectory of all additional instrumentation) within the shadow of the pedicle
on lateral fluoroscopic imaging.
ADVANTAGES AND DISADVANTAGES
e primary advantage of using a biologic material for VCF treatment is avoidance of complications associated with cement, which include containment, toxicity, and stiffness of final construct. With the biologic vertebral augmentation
with OptiMesh and bone graft, the chances for extravasation and embolism of
PMMA can be all but eliminated. e porous construct designed is entirely
biocompatible and yet is strong enough to bear weight and provide equivalent
pain relief. e final result may be that with biologic vertebral augmentation, a
less stiff construct is less likely to cause or predispose to adjacent level fractures.
Our early experience has demonstrated only a 5% rate of ALFs compared with
the quoted literature average for new adjacent level fractures after treatment
with vertebroplasty and kyphoplasty of 15% to 20%.18 Confirmation of these
rates by other investigators will need to be performed to confirm these results.
268
P A R T V Ostteoporotic Surgical Treatment Modalities: Thoracic Spine
CONCLUSIONS AND DISCUSSION
The clinical study indicates that placement of a load-sharing mesh and bone
graft strut into the anterior column creates structural stability and is effective in reducing pain and increasing function in patients with VCFs. Longterm radiographic follow-up shows a low incidence of ALFs, and osseous
integration of the graft occurs even in osteoporotic patients. New advancements of this technology currently being developed include new biologic
graft materials and a smaller (5.5-mm outside diameter) access portal with
fewer steps to the implant procedure.
References
1. Health, United States, 2007, Table 1. Retrieved 11/3/08 from http://www.cdc.gov/nchs/
fastats/older_americans.htm.
2. M. Eicholz, J.E. O’Toole, S.D. Christie, et al., Vertebroplasty and kyphoplasty, Neurosurg
Clin. N. Am. 17 (2006) 507–518.
3. D.M. Kado, T. Duong, K.L. Stone, et al., Vertebral fractures and mortality in older women,
Arch. Intern. Med. 159 (1999) 1215–1220.
4. T. Jalava, S. Sarna, L. Pylkkanen, et al., Association between vertebral fracture and increased
mortality in osteoporotic patients, J. Bone Miner. Res. 18 (2003) 1254–1276.
5. R.S. Taylor, P. Fritzell, R.J. Taylor, Balloon kyphoplasty in the management of vertebral compression fractures: an updated systematic review and meta-analysis, Eur. Spine J. 16 (2007)
1085–1100.
6. A.A. Patel, A.R. Vaccaro, G.G. Martyak, et al., Neurologic deficit following percutaneous
vertebral stabilization, Spine 32 (16) (2007) 1728–1734.
7. D. Fribourg, C. Tang, P. Sra, R. Delamarter, H. Bae, Incidence of subsequent vertebral fracture after kyphoplasty. Clinical Case Series, Spine 29 (20) (October 15, 2004) 2270–2276.
8. T. Faciszewski, F. Kiernan, R. Rao, Treatment of osteoporotic vertebral compression
fractures, in: J.M. Spivak, P.J. Connolly (Eds.), Orthopedic Knowledge Update, Spine 3,
American Academy of Orthopedic Surgeons, Rosemont, IL, 2006.
9. F. Grados, N. Hardy, Treatment of vertebral compression fractures by vertebroplasty
[abstract], Rev. Rheum. 64 (1997) 38.
10. Carlson SD, Smith JS, Gordon CD. Is there an increased risk of adjacent segment compression fracture after kyphoplasty. Poster presentation, Annual Meeting of the American
Academy of Orthopaedic Surgeons, Feb 13-17, 2002, Dallas, TX.
11. Anselmetti GC. Long-term data confirm benefit of vertebroplasty for back pain relief
after osteoporotic vertebral collapse. Presented at Society of Interventional Radiology
33rd Annual Scientific Meeting: Abstract 182, March 18, 2008, Washington, DC.
12. E.P. Lin, S. Ekholm, A. Hiwatashi, P.L. Westesson, Vertebroplasty:cement leakage into the
disc increases the risk of new fracture of adjacent vertebral body, AJNR Am. J. Neuroradiol.
25 (2004) 175–180.
13. U. Berlemann, S.J. Ferguson, L.P. Nolte, P.F. Heini, Adjacent vertebral failure after vertebroplasty. A biomechanical investigation, J. Bone Joint Surg. Br. 84 (2002) 748–752.
14. J. Inamasu, B.H. Guiot, J.S. Uribe, Flexion-distraction injury of the L1 vertebra treated with
short-segment posterior fixation and OptiMesh, J. Clin. Neurosci. 15 (2008) 214–218.
15. B.W. Cunningham, S.D. Kuslich, J.C. Sefter, et al., Interbody arthrodesis using a polyester
surgical mesh (the BAG™ surgical mesh): an in-vivo and in-vitro assessment. Presented at the
3rd Annual Meeting of the Spine Society of Europe, Gotenburg, Sweden, Sept. 4-8, 2001.
16. L. Beckman, D. Giannitsios, T. Steffen, An evaluation of the height restoration performance
of three vertebral body fracture repair procedures, ex-vivo. Presented at the 8th Annual Meeting of the Spine Society of Europe, Istanbul, Turkey, Oct. 25-28, 2006.
17. T. Fujishiro, T.W. Bauer, N. Kobayashi, et al., Histological evaluation of an impacted bone
graft substitute composed of a combination of mineralized and demineralized allograft in a
sheep vertebral bone defect. J Biomed Mat Res, published online 16 February 2007 in Wiley
InterScience (www.interscience.wiley.com). DOI: 10.1002/jbm.a.31056.
18. R . Lindsay, S. Silverman, C. Cooper, et al., Risk of new vertebral fracture in the year following
a fracture, JAMA 285 (3) 320–323, 2001.
Vessel-X
Darwono A. Bambang
44
k e y p o i n t s
e Vessel-X is designed to restore the height of symptomatic vertebral
compression fractures and to prevent the leakage of the injected bone filler
material (BFM).
e device is made of double-layer nonstretchable polyethylene terephthalate
with 100 μm pores, the anterior titanium marker, and titanium nozzle.
When the BFM is injected inside, the Vessel-X acts as an implant body
expander, combining the advantages of both balloon and vertebroplasty yet
preventing the leakage.
Injection of the BFMs inside a container creates a pressure that will
be distributed equally to all directions, and it is followed in the same
distribution when the interdigitation of BFMs through the pores occurred,
thus preventing the leakage.
1
INTRODUCTION
Since vertebroplasty was introduced by Herve and Deramond in 1984,
many methods of percutaneous osteoplasty (molding the bone) evolved to
treat symptomatic vertebral compression fractures (VCFs), by injection of
bone filler material (BFM): polymethylmethacrylate (PMMA), other kinds
of bone cement, and bone grafts (autografts and allografts), or different
kinds of osteoinductive or osteoconductive materials. The same risk in performing the previously mentioned techniques is the leakage of BFM, because
the injected pressure will go to the fracture’s weakest area and lead to a leakage. Vesselplasty is an osteoplasty technique using the Vessel-X, which acts
as an implant body expander to restore vertebral height in VCFs but prevents the potential risk of leakage.
1,2
INDICATIONS AND CONTRAINDICATIONS
Indications
The procedure is indicated for symptomatic VCFs in the thoracic or lumbar
vertebrae stemming from
Primary osteoporosis
Secondary osteoporosis
High energy trauma
Lesion from multiple myeloma or bone metastasis
Painful vertebral hemangioma
2
:
Contraindications
Contraindications include the following2:
Pregnancy
Uncorrected coagulopathy
Pain unrelated to vertebral compression fractures
Technically not possible (e.g., vertebra plana)
Osteolytic tumor
Allergy to components used
Fractures with posterior wall interrupted
DESCRIPTION OF THE DEVICE
The idea behind the prototype originated in Taiwan, in February 2002 (Fig-
ure 44-1). The cadaveric study using the prototype was done by the author
in Jakarta, Indonesia, in July 2003. The first generation used in the clinic was
named threadplasty, because the connection used was thread (Figure 44-2).
A clinical trial was done in Jakarta, Indonesia, by the author from July
2004 until July 2005. As a preliminary report the first three cases were presented at the Asia Pacific Orthopaedic Association (APOA) Triennial
Meeting in Kuala Lumpur on September 5-10, 2004. After the ten firstgeneration vesselplasty devices (Threadplasty) were made and during the
clinical trial, major improvements and developments were made to formulate
the last-generation instruments available for clinical use (Figure44-3).
1-6
Vessel-X is a bone filler container made of polyethylene terephthalate
(PET), a nonstretchable material. In deflated condition its shape is long,
and when it is inflated the shape becomes short and bigger until a certain
size is reached. When the pressure inside the container is equal to the surrounding resistance, the final size is achieved and the size will remain constant. This mechanical device is used to lift the vertebral endplate, acting like
an implant body expander (Figure 44-4).
The Vessel-X container is a PET mesh and has 100-μm porosity.
When the pressure inside the container is greater than the surrounding
resistance, the BFM starts to interdigitate through the pores; some pressure
is then relieved and the endplate is lifted further (Figures 44-5 and 44-6).
The Variations in technical concepts in percutaneous osteoplasty
have led to the differences in techniques and results for the numerous
methods: vesselplasty (KYPHON INC. CA), vertebroplasty, kyphoplasty, VEX-3000 (Taeyeon Medical CO., LTD, South Korea), Sky
Expander (DISC-O-TECH MEDICAL TECHNOLOGIES, LTD.,
IS), arcuplasty (Warsaw Orthopedic, Inc, IN), and the Optimesh system
(Spineology, Inc., MN) (Figure 44-7). Vertebroplasty is not used to
restore the vertebral body height (VBH), whereas the other techniques
are accomplishing the same goal by first creating a void. The other concepts do restore VBH and create a void by mechanical or hydrostatic
pressure. The difference between the restoring VBH group is based on
the technical methods and instruments to lift the vertebral endplate. To
restore VBH, all techniques except vesselplasty need to first create a void
by mechanical or hydrostatic pressure, followed by filling the void with
PMMA or other BFM. All the previously mentioned techniques carry
different risks of leakage, because if the BFM is injected directly into the
bone or void, it will go to the weakest fracture area. The vesselplasty technique requires only that a hole be drilled into the vertebral body as a place
to be occupied by the deflated PET container (almost like screw insertion into the bone). Then the container is inflated by injecting viscous
PMMA or other BFM, and the hydrostatic pressure lifts the vertebral
endplate, acting as an implanted vertebral body expander.
1,6-16
Sequential injection of BFM into a nonstretchable container will prevent leakage, because inside the container the pressure will be distributed
equally to all direction. Under a continuous sequential injection the pressure is released outside the Vessel-X through the pores sequentially,
because the container size is constant, and starting the interdigitation
works like vertebroplasty. The sequential pressure release and the interdigitation will further lift the endplate yet still preventing leakage,
because the pressure is equally distributed in all directions. The most
269
270
P A R T V Ostteoporotic Surgical Treatment Modalities: Thoracic Spine
F IG UR E 4 4- 1 The prototype.
F IG UR E 4 4- 4 Vessel-X, the PET container.
F IG UR E 4 4- 2 The threadplasty.
F IG UR E 4 4- 3 The instruments for vesselplasty.
important point is the experienced surgeon’s judgment of when to end
the procedure, which is related to the individual patient’s condition
(Figures 44-8 and 44-9).
BACKGROUND OF SCIENTIFIC TESTING AND CLINICAL OUTCOMES
A nonrandomized 3-year prospective follow-up study on 103 patients who
had single- or multiple-level stable VCFs from T5 to L5, involving a total of
117 vertebrae (Figure 44-10). In 86 cases, fractures were in osteoporotic
F IG UR E 4 4- 5 Mesh container.
F IG UR E 4 4- 6 Interdigitation of BFMs.
vertebrae, compared to 17 cases where the fractures were due to high energy
trauma. The number of females, 69 cases, was twice the number of males, at
34 cases. The average patient age was 70.3 years, with the youngest 34 years
old and the oldest 98 years old. Fracture age ranged from 1 day to 70 days
after the trauma.
All cases were treated with 20-mm Vessel-X through transpedicular or
extrapedicular routes, using either unilateral or bilateral containers. The
minimum follow-up was 3 months, and the outcomes were measured with
Visual Analoq Scale (VAS), SF-36, and Oswestry Disability Index (ODI).
One day after treatment, all patients gained significant pain relief, as
determined from the VAS, which dropped from 9.9 to 1.7 (p < .001), and
Percutaneous
30
C H A P T E R 4 4 Vessel-X
271
Not restore
vertebral body height
Not create
a void
Vertebroplasty
Optimesh Arcuplasty
F IG UR E 4 4- 7 The osteoplasty: different concepts and different techniques.
Create
a void
Not create
a void
Hydrostatic
pressure
Vesselplasty
Restore
vertebral body height
Mechanical
pressure
VEX 3000 Sky
expander
Create
a void
Hydrostatic
pressure
Kyphoplasty
F IG UR E 4 4- 8 Vesselplasty’s x-ray shows 100% correction.
F IG UR E 4 4- 9 Vesselplasty’s CT scan shows container size is constant.
25
20
15
10
patients (N = 117)
Number of operated
5
0
T5
T6 T7 T8 T9 T10 T11 T12 L1 L2 L3 L4 L5
FIGURE 44-10 Distribution of level of the affected vertebrae relief (T5-L5;) .
272
10
P A R T V Ostteoporotic Surgical Treatment Modalities: Thoracic Spine
OPERATIVE TECHNIQUE
8
6
4
Days in hospital
2
0
Pre-operation
F IG UR E 4 4- 11 VAS pain (p < .001).
Post-operation
Anesthesia
During the procedure both local anesthesia and conscious sedation to make
the patient comfortable and relaxed are recommended rather than general
anesthesia. The combination of conscious sedation and local anesthesia
could reduce the risk of injuring the nerve root because the patient can feel
the radiating pain caused by the procedure, which is not possible with general anesthesia. The local anesthetic preparation should involve the skin and
subcutaneous tissues along the expected needle tract, and the periosteum of
the bone at the bone entry site must be thoroughly infiltrated. Once this is
accomplished, the patient will experience only mild discomfort while the
bone needle is being placed, and the patient will become more relaxed if
conscious sedation is used. The local anesthesia being used is a mixture of
0.5% lidocaine and 1:200,000 epinephrine, because it allows the use of a
more generous volume locally with less risk of toxicity.
4
the average hospital stay was 2.2 days (Figure 44-11). The average vertebral
height restoration was 96.4% (range, 100% to 50%) related to the variable
bone density from old to young patients, fracture type, and fracture age. A
variable amount of BFM was injected into the small 20-mm Vessel-X, from
2.5 ml to 10.25 ml, without any leakage, bleeding, or neurologic deficits, and
only two adjacent level fractures were detected 1 year after treatment on the
eldest patients, who were older than 90 years.
Case Studies
CASE 1 (2005) (Figures 44-12 and 44-13)
e patient was a 77-year-old woman with VCFs at T11 and T12 that
occurred during a fall 2 days earlier. Vesselplasty was done on two levels
on day 3 using a 20-mm container, unilaterally through the extrapedicular
route. Bone cement of 3.5 ml was injected, without leakage, and 100% restoration was achieved. One day after treatment the patient was able to sit and
walk, and was discharged on day 4. Follow-up was done for 3 years, and the
patient remained in good condition.
Position
Patient positioning should be prone on a beanbag or just supported by pillows located under the chest and the hip. If hyperextension is needed to
promote some reduction of the fractured vertebra, additional pillows can be
added under the hip and the legs of the patient. This position allows a clear
visualization during fluoroscopy using the C-arm in both the anteroposterior and lateral views because there is no metal in between.
CASE 2 (2006) (Figures 44-14 and 44-15)
e patient was a 67-year-old woman with a VCF at L3 that occurred during a fall 1 week earlier. Vesselplasty was performed with a 20-mm container,
6.75 ml cement was injected through a unilateral extrapedicular route, with
no leakage. Height restoration of 100% was achieved, and the patient was
discharged the day after in good condition. After 2 years of follow-up, the
patient remained in good condition.
2
F IG UR E . 4 4– 1 2 Case 1: Before vesselplasty. F IG UR E 4 4 -1 3 Case 1: After vesselplasty.
C H A P T E R 4 4 Vessel-X
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CASE 3 (2007) (Figures 44-16 and 44-17)
e patient was a 77-year-old woman with VCFs at T12 and L1 that
occurred 2 weeks earlier. Two levels of vesselplasty using 20-mm containers were performed using a unilateral extrapedicular route. Complete height
restoration (100%) was achieved in both vertebrae. Different amounts of
cement were injected in each vertebra, with 9 ml in one and 7.25 ml in the
other without any leakage. e patient was discharged the day after in good
condition.
CASE 4 (2005) (Figures 44-18 and 44-19)
e patient was a 98-year-old woman with a VCF of T12 that occurred
2 weeks previous. Single level and bilateral vesselplasty using 20-mm containers was performed through a transpedicular route; 3.5 ml cement was
injected into each Vessel-X for a total of 7 ml, and 100% restoration was
achieved. e patient was discharged 1 day after. She still had good quality
of life 4 years later at the age of 102 years.
F IG UR E 4 4- 14 Case 2: Before vesselplasty.
F IG UR E 4 4- 15 Case 2: After vesselplasty.
F IG UR E 4 4- 16 Case 3: Before vesselplasty. F I GU RE 4 4- 17 Case 3: After vesselplasty.
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P A R T V Ostteoporotic Surgical Treatment Modalities: Thoracic Spine
F IG UR E 4 4- 18 Case 4: Before vesselplasty.
F IG UR E 4 4- 19 Case 4: After vesselplasty.
CASE 5 (2006) (Figure 44-20)
e patient was an 81-year-old woman with a VCF at L1 that occurred 1
month earlier. Vesselplasty was performed with a 20-mm container. A unilateral extrapedicular approach was used. A total of 10.25 ml cement was
injected, but because of the fracture’s age (1 month), the maximum height
restoration was only 90%. e advantage was that no leakage occurred, and
the patient was discharged the day after with good quality of daily living.
F IG UR E 4 4- 20 Case 5: Neglected fracture at 1 month, 90% height restoration, no leakage.
CASE 6 (2005) (Figure 44-21)
e patient was a 70-year-old woman with a 2-month-old VCF (vertebra
plana) at T9. Vesselplasty was performed using a 20-mm container. A unilateral, extrapedicular route was used and 4 ml cement was injected. e
height restoration was 90% yet no leakage occurred, and the patient was
discharged the day after.