Cervical Plasma disc decompression (Nucleoplasty): Indications Results and Limits
Alessandro Cesaroni
Is a minimally invasive technique
for disc decompression that
utilizes Coblation technology for
ablating soft tissue by means of a
low temperature (52
C) molecular
dissociation process to create
small channels within the disc. 1 2 3 4 5
0
5
10
15
20
Ch
an
ge in
Tem
pera
ture
(ºC
)
Distance from tip (mm)
Porcine Intradiscal Thermal Mapping
Temperature Gradient
By the tissue removal (from 10 to 20 %)
we obtain a disc reduction and the
decompression of the root
VOLUME REDUCTION
PR
ES
SU
RE
RE
Nucleoplasty
Decompression “Intradiscal pressure was
markedly reduced in non severe degenerate discs” “Nucleoplasty treatment for herniated discs immediately (within two channels) and dramatically reduced intradiscal pressure” “Nucleoplasty has the potential to be a viable, effective and safe treatment for lower back pain resulting from disc
disease”.
0 1 2 3 4 5 6
0
5
10
15
20
25
30
PSI
Number of Coblation Channels
Nucleoplasty Intradiscal Pressure
Non-Severe Degeneration
Nucleo PSI
Control PSI
Intradiscal pressure study of percutaneous disc decompression with Nucleoplasty in human cadavers. Y. Chen, S. Lee and D. Chen, SPINE, (2003) 28: 661-665
Decompression
0,1
1
10
100
Pre 1 2 3 4 5 6 P.O.
CHANNELS
PR
ES
SU
RE
RE
Intradiscal pressure study of Nucleoplasty in 60 live patients.
Dr A. Cesaroni, Rome, Italy, Unpublished results.
0
20
40
60
80
100
120
140
Nucleoplasty
Università degli studi di Roma “Tor Vergata”:
Facoltà di ingegneria
Radiofrequenza ablativa nel trattamento
mininvasivo del dolore discogenico:
Modellazione e simulazione
• Symptomatic patients with contained herniated disc
• Integrity of the annulus
• Failure of 6 weeks of conservative therapy
• MRI evidence of contained herniated disc protrusion
(degree 2 and 3 Pfirmann’s classification)
Contraindications
• Extruded hernia or with a free fragment
• Reduction more than 1/3 diameter of the spinal canal
• Spinal or foraminal stenosis, Osteophytosis
• Spinal instability and >50% loss of disc height
Indications
Pfirmann Classification of disc degeneration with MRI Pfirrmann CWA, Metzdorf A, Zanetti M, Hodler J, Boos N: Magnetic resonance classification of lumbar intervertebral disc degeneration. Spine 26:4873-4878. 2001
MRI Classification
I II III
IV V
Indications
Disc Pain
Herniated Disc Degenerative Disc Disease
Conservative Care (Medications,PT, Steroid injection)
Conservative Care (Medication, PT)
Contained Non contained
Nucleoplasty
Other Surgical Technique
Disc/Nucleus Replacement
Fusion
Patient in supine position with head slightly hyper extended, under fluoroscopic LL vision
The needle is inserted by an anterior lateral approach, medially to the SCM and vessels
Introduced the wand, the ablation starts for 3 cycles
in withdrawal, rotating the wand for 360
in each cycle
Surgical Technique
The percentage of secondary discitis detected is the same
for a normal discography (0.25% per patient or 0.14% per
disc). Usually a temporary local pain in the side of the skin
entry point is referred. At present no other complications
are reported.
Guyer et al. Lumbar discography. Position statement from the North American Spine
Society Diagnostic and Therapeutic Committee. Spine vol 20, N
18, pp 2048-2059, 1995.
Slipman et al. Early-term side effects and complications of lumbar nucleoplasty :
preliminary series. ISPRM – 2nd world congress.
Complications
The results in over 1 year follow up shows a significative
improvement in pain between 85 and 91% in cervical
Singh et al. Percutaneous disc decompression in the treatment of chronic discogenic
pain. Pain Physician Vol 5, N
3, pp 250-259, 2002.
Sharps et al. Percutaneous disc decompression using Nucleoplasty. Pain Physician Vol
5, N
2, pp 121-126, 2002.
Results
Prospective longitudinal cohort study Retrospective study of 67
patients with primary radicular pain due to contained disc
herniations.
Evaluation at 3 and 6 months using SF36, VAS, and EuroQol 5D
(EQ5D).
No infections, nerve root injuries or complications associated with
the procedure. Statistically significant improvement in all outcome
measures.
Quality of life assessment in patients undergoing Nucleoplasty-based percutaneous discectomy.
P. C. Gerszten, W. C. Welch and J. T. King Jr. J of Neurosurgery: Spine (2006) 4: 36-42.
0
0,1
0,2
0,3
0,4
0,5
Baseline 3-month
Mean EQ5D Scores
Results
Case study of 55 patients with cervical soft disc
protrusion and associated radicular pain.
Clinical outcomes were graded by using the Macnab
criteria, at 6 months, 44 (85%) patients (n = 52/55) had
good or excellent outcomes.
Entire procedure took no longer than 10-12 minutes to
complete from administration of local anesthetic to
withdrawl of SpineWand device.
Plasma radio-frequency based discectomy for treatment of cervical herniated nucleus pulposis;
Feasibility, safety and preliminary clinical results.
G. Bonaldi, F. Baruzzi, A. Facchinetti, P. Fachinetti and S. Lunghi
Am J. Neuroradiol., (2006) 27: 2104-2111
Results
Comparitive study of cervical nucleoplasty (n=50) vs conservative care
(n=20) with three month follow up.
Nucleoplasty group - 80% complete resolution of symptoms (VAS) at 3
months. CC group – 25% resolution of symptoms, 75% persistent
symptoms.
Average return to work for Nucleoplasty = 21 days, Conservative care =
46 days (with no amelioration of symptoms)
0
20
40
60
80
Pe
rce
nt
24 Hours 7 Days Later 60 Days Later
Nucleoplasty Group
Good Results Poor Results No amelioration
0
20
40
60
80
Pe
rce
nt
24 Hours 60 Days Later
Conservative Care Group
Good Results Poor Results No amelioration
Percutaneous cervical Nucleoplasty using Coblation technology. Clinical results in fifty consecutive cases.
P.V. Nardi, D. Cabezas, and A. Cesaroni Acta Neurochir (2005) [Suppl] 92: 73-78
Results
1910
37
20
73
27 31
39
55
72
0
10
20
30
40
50
60
70
80
Baseline 6 Weeks 3 Months 6 Months 1 Year
NPL CCC
Mea
n P
ain
VA
S
Pain VAS Score Reduction from
Baseline
NPL
(n=43)
CCC
(n=32)
p-value
6 Weeks post-op 46 ± 21
(39, 52)
17 ± 13
(11, 22)
<0.001
3 Months 53 ± 21
(47, 60)
33 ± 18
(27, 39)
<0.001
6 Months 54 ± 22
(48, 61)
41 ± 19
(34, 48)
0.004
1 Year 63 ± 3
(57, 69)
35 ± 22
(28, 43)
<0.001
Quality Of Life – NPL Group
20
30
40
50
60
70
PF RP BP GH VT SF RE MH
Pre-treatment 6 weeks 3 months 6 months 1 year
Best
Health
Poorest
Health
Norm
PF: Physical Functioning, RP: Role Physical, BP: Bodily Pain, GH: General Health, VT:
Vitality, SF: Social Functioning, RE: Role Emotional, MH: Mental Health
20
30
40
50
60
70
PF RP BP GH VT SF RE MH
Pre-treatment 6 weeks 3 months 6 months 1Year
Quality Of Life – CCC Group
Best
Health
Norm
Poorest
Health
PF: Physical Functioning, RP: Role Physical, BP: Bodily Pain, GH: General Health, VT:
Vitality, SF: Social Functioning, RE: Role Emotional, MH: Mental Health
1 year 2 year 3 years 4 years 5 years
Good (mean VAS <2.5)
59.9% 56.9% 56.7% 62.1% 60.8%
Satisfactory (mean VAS
>2.5<4.5)
35.5% 38.4% 38.6% 31.4% 30.6%
No results 4.6% 4.7% 4.7% 6.5% 8.6%
Biological Effects
Disc BioChemistry
0
2
4
6
8
10
12
14
16
Baseline 6 Weeks 12 Weeks
Time
Co
nc
en
tra
tio
n
IL-1 Degenerative Trend
IL-1 Nucleoplasty Impact
IL-8 Degenerative Trend
IL-8 Nucleoplasty Impact
“Our results suggest that Nucleoplasty may be capable of initiating a repair response in the disc”.
•Significant decrease in Interleukin-1
IL-1 associated with tissue degeneration
•Significant increase in Interleukin-8
IL-8 associated with tissue angiogenesis
Conor O’Neill, Jeff Lotz, Percutaneous plasma decompression alters cytokine expression in injured porcine intervetebral discs. The Spine Journal 4 (2004)
Biological Effects Difference in inflammitory mediator levels in normal nucleus pulposis
cells (normalized to sham)
-50
0
50
100
150
200
250
300
Il-8 Hsp70 NO PGE2
% c
ha
ng
e in
le
ve
l
3 Day
6 DayGraph illustrating percentage change in inflamatory mediators for normal nucleus cells at 3 and 6 days post ablation (Corrected against sham)
“These results support the hypothesis that Nucleoplasty can relieve pain by direct biologic effects”
The short-term effects of electrosurgical ablation on proinflammitory mediator production by intervertebral disc cells in tissue culture. K-W. Rhyu, A. Walsh, C. O’Neill, J. Lotz, and D. Bradford.
Conclusions
Nucleoplasty is a minimally invasive technique for disc
decompression in contained hernia with radicular
pain. The integrity of the annulus is the basis for
success
Nucleoplasty does not substitute conventional open
procedures required for extruded disc
The limits of this technique are related to the level of
the disc degeneration.
Thank You For Your Attention
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