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?
