Vertebral augmentation

• Assistant Professor, Department of Orthopaedics,

Patras University, GREECE
• Olympion Hospital and Rehabilitation Center, Patras
• Elected President, Spine Division, Greek Orthopaedic
Society for year 2011
• Interest:
MIS, Aging spine
Rehabilitation
Medical education, training and evaluating MIS
techniques
• Enjoys Basketball, Gym, Travel, Social Networking
Panayotis E. Zouboulis, • Contact: pzoub@otenet.gr
MD, PhD
Vertebral augmentation

Panayotis E. Zouboulis
Assistant Professor Orthopaedics
University of Patras Disclosure:
GREECE consultant, stockholder
Alphatec Spine
 Literature review

• PMMA – hypotension
• embolic disease – death (> 3 levels)
• cement leakage (neurologic complications – greater vessels?)

“A review of complications associated with vertebroplasty

and kyphoplasty as reported to the Food and Drug Administration
medical device related web site.”
Nussbaum DA et al, J Vasc Interv Radiol 2004
Literature review (c’ ed)
2002 – 2008 balloon kyphoplasty
101 pts – 200 levels

60

50

40

30

20

10

0
primary osteoporosis secondary osteoporosis trauma tumor

overall risk
0.7% per level
1.2% per patient
Garfin SA et al, Spine 2001
 Literature review (c’ ed)

3m p.op.

Adjacent level fracture

“...subsequent adjacent fractures, especially during

the first 2 months after the index procedure.”
Fribourg D et al, Spine 2004

“may be related to the underlying etiology (weakening of the bone)

rather than the surgical intervention.”
Villarraga ML et al, J Spinal Disord Tech 2005
 Literature review (c’ ed)

• Zaccheo MV et al, Am J Emerg Med 2008

• Monticelli F et al, Forensic Sci Int 2005
• Kao FC et al, Spine 2008 Pulmonary embolism
• Lim KJ et al, Anesth Analg 2007

Mortality rate 0.4%

“CT-guided vertebroplasty: analysis of technical results,
extraosseous cement leakages and complications in 500 cases.”
Pitton MB et al, Eur Radiol 2008

“Balloon kyphoplasty and vertebroplasty for VCF:

a comparative systematic review of efficacy and safety.”
Taylor RS et al, Spine 2006
 “internal brace”

Implant expandable device

Star shaped Bone “captured” within
interdigitation implant

Observations

Cement
extruding from
implant and
“grabbing”
bone

Tip of implant
 Biomechanical data
Collapse of Repaired Vertebral Bodies Following Testing

0,00
Initial Repaired
-0,05
Height
-0,10

-0,15
Height Loss (cm)

-0,20 Kyphoplasty
Implant
-0,25
D = 1.0mm
-0,30
p<0.025
-0,35

-0,40

-0,45

Implant provided significantly greater height maintenance during

compressive loading following repair compared to standard
kyphoplasty
 Biomechanical data
Cement Injection Volume

Implant
3,5
Kyphoplasty
p<0.006
3

2,5
Volume (mL)

1,5

0,5

Implant required approximately 40% less cement than standard

kyphoplasty for equivalent biomechanical stability
Clinical experience since 1.2009
35

30

25

20

15 65 patients
10

0
primary osteoporosis secondary osteoporosis acute trauma tumor

35
30
25
20
15 147 levels
10
5
0
Th 4Th 5Th 6Th 7Th 8Th 9 Th Th Th L 1 L 2 L 3 L 4 L 5
10 11 12
Osteoporosis

4m p.op.

P.G. female, 72y

Secondary osteoporosis
Stenosis - kyphotic deformity

1y p.op.

G.L. female, 75y

 Acute trauma

p.op.

S.N. male, 38y

 Acute trauma

6m p.op.

Z.D. male, 52y

 Ca uterus

p.op.

L.M. female, 58y

Ca prostate
CML

1,5y p.op.

P.A. male, 71y

Ca colon

H.G. female, 84y

 Results
46 patients, 111 levels
mean age 66,4 y
1y p.op.

• VAS 51mm
• ODI 25.1
• height restoration 9% (7% last follow up)
• kyphotic angle 3.7’’ (2.9’’ last follow up)

• 6 adjacent level fractures

• No pulmonary embolism
• No severe cement leakage
 Conclusions
• Improved clinical results
• Well tolerated by respiratory restricted patients
• Expanded indications
acute trauma (stand-alone device?)
osteolytic lesions
combined open/MIS procedures
• Adjacent level fractures?