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TransDiscal TM System
For intervertebral disc biacuplasty in the management of axial low back pain
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Mechanisms of Discogenic Pain
• Irritation of nerve endings in outer third of the annulus (Bogduk J Anat 1981)
• Mechanoreceptors are present in outer posterolateral portion of the lumbar disc
• Sensitization of nociceptors in chronic discogenic pain. (Burke JBJS 2002)
• In-growth of granulation tissue and small unmyelinated nerve fibers are present in degenerative disc. (Freemont AJ Lancet 1997)
• Nerve root irritation in full thickness tears• Increased shear stress across annular wall
Coppes MH et al. Spine 22:2342-50,1997, Roberts S et al. Spine 20:2645-51,1995
Kitano T et al. Clin Orthop 293, 372-377,1993, Bogduk N et al. J Anat 132:39-56,1981
Groen et al. Am J Anat 188:282-296,1990
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Potential Mechanisms of Pain Relief by Heating
• Heating nerve tissue at 45 degrees Centigrade causes irreversible neural blockade
• Change the structure of the collagen fibers in the annulus, causing an increase in annular stability
Smith H.P., McWhorter J.M., Challa V.R., "Radiofrequency Neurolysis in a Clinical Model,“ Journal of Neurosurgery, Aug 1981, Vol. 55 pp.248-253
Shah RV, Lutz GE, Lee J, Doty SB, Rodeo S. Intradiskal electrothermal therapy: a preliminary histologic study. Arch.Phys.Med.Rehabil. 2001; ; 82:1230-1237.82:1230-1237.
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History of Treating the Disc With Heat
Intradiscal RF Sluijter, 1994
IDET Smith and Nephew, 1998
DiscTRODE Tyco / Radionics, 2000
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Patient Selection
Indications• Internal disc disruption• Chronic pain (>6 mo)• Failed conservative
treatment• Axial low back pain greater
than referred leg pain• Positive discography in 1
or 2 discs.• Abnormal disc morphology
Contraindications• Large decrease in disc height >50%• Extruded or sequestered herniation• Severe degeneration• Segmental instability• Neurological deficit• Pregnancy• Endplate damage or Schmorl’s nodes• Systemic infection or at site of
treatement• > 2 discs degenerated on MRI*
Kapural L, Mekhail N, Korunda Z, Basali A. Intradiscal thermal annuloplasty for the treatment of lumbar discogenic pain in patients with multilevel degenerative disc disease. Anesth Analg. 99(2):472-6,2004.
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Transdiscal Bipolar RF Disc Treatment
• Radiofrequency current is concentrated between electrodes on two straight probes.
• The electrodes are internally cooled allowing deep, even heating and eliminating tissue adherence.
• Temperature sensors allow monitoring at the electrode tips and disc periphery.
• Heating parameters can be adjusted to achieve a specific thermal dose.
cooled
Tip Temperature
Peripheral Temperature
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Transdiscal Bipolar RF Disc Treatment
Heating Profile
• The ideal temperature profile is 55°C in the inner posterior disc decreasing to 45°C in the peripheral edge of the posterior disc.
Temperature vs Distance
Therapeutic Zone
Probe Probe
35
40
45
50
55
30
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Initial Introducer Placement
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Lateral View- Electrode Position
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Anterior-Posterior View
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Cleveland Clinic Cadaver Study
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Cleveland Clinic Cadaver Study
Disc ArrayDisc 1Disc 2Disc 3
NF ArrayNF 1NF 2NF 3
Epidural ArrayEpidural 1Epidural 2Epidural 3Epidural 4
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In vivo porcine safety study
Temperatures monitoring at designated safety zones outside the disc demonstrated maintenance of near-physiologic conditions while
temperature across the posterior annuls reached 65°C1
1 Petersohn J et al. Pain Medicine; 2007: (In Press)
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Cleveland Clinic Pilot Study
• Primary Investigator: Dr. Leo Kapural• Consent and approval by IRB-15 patients• Previously denied IDET• MRI and discography within 12 months
• Two patients out of the study, 13 followed
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Results
• Notice the rapid decline in pain scores and improvement in function
• In most cases almost a week later!
0 1 3 6
510
1520
2530
Oswestry
Time (Months)
Osw
estr
y S
core
0 1 3 6
2030
4050
6070
8090
SF-36 Physical Functionality
Time (Months)
SF
-36
PF
Sco
re
0 1 3 6
2040
6080
SF-36 Bodily Pain
Time (Months)
SF
-36
BP
Sco
re
0 1 3 6
02
46
810
VAS Pain
Time (Months)
VA
S P
ain
Sco
re
0 1 3 6
050
100
150
Opioid Use
Time (Months)
Opi
oid
Use
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Significant declines in functional and VAS but not did not reach statistical decline in opioid use
25th Median 75thBaseline 23.3 7.0 17 25 29
1 16.5 6.8 11 15 203 16.9 7.1 13 16 226 17.1 8.1 13 18 24
Baseline 50.8 17.5 40 55 601 59.4 13.0 50 55 673 65.7 14.4 50 70 756 69.9 16.2 55 70 80
Baseline 37.5 15.0 33 35 451 49.7 19.3 33 45 653 51.2 16.8 45 45 586 53.8 22.7 45 58 68
Baseline 7.2 1.9 6 7 81 3.3 2.1 2 4 53 3.8 1.9 3 4 56 3.4 1.9 2 3 5
Baseline 73.5 59.7 40 40 1201 56.5 62.6 0 40 803 45.0 59.2 0 40 406 38.8 61.6 0 5 40
VAS Pain Score
Opioid Use
Quantiles
Oswestry Score
SF-36 PF Score
SF-36 BP Score
Response Variable
Time (months)
MeanStandard Deviation
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Pain Management SInergy TM System
For effective denervation in the treatment of SIJ Syndrome
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SI Joint Innervation
Yin W, Willard F, Carreiro J, Dreyfuss P (2003) Spine 28:2419-2425. Images reprinted with permission of Lippincott Williams, 2007.
S1 S3S2
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• Joint is predominantly, innervated by posterior primary rami1,3,4
• Nerve location is variable: 2,5
– Person to Person– Side to Side– Level to Level
• Nerves may run along bone, or up to 8 mm superficial from the sacrum 5
SI Joint Innervation
Yin W, Willard F, Carreiro J, Dreyfuss P (2003) Spine 28:2419-2425. Images reprinted with permission of Lippincott Williams, 2007.
1Cohen S. Anesth Analg. 2005: 101: 1440-1453; 2Yin W. et al. Spine. 2003; 28(20):2419-24253Grob K. et al. Z Rheumatol. 1995;27:117-122; 4Fortin J. et al. Spine. 1994;19(13):1475-14825Willard F. et al. World Congress on Low Back and Pelvic Pain. Vienna, Austria, 1998
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Diagnosis
• Referral Zones• Screening Exam:
– Best PPV (60%)10, 11 Maximum pain below L5 coupled with pointing to the PSIS or local tenderness just medial to the PSIS has the
– Distraction Tests limited utility
• Imaging: Little value• Intra articular blocks gold
standard?• There is a 37-66% occurrence of
False positive responses from the first injection (22% FP rate)6,12
Fortin. Spine 1994; 19:1475-1482
Sacral Sulcus Tenderness
Buttocks 94%Lower lumbar 72%LE 50%Groin 14%Slipman C 1998
10 Dreyfuss P, Spine 1996; 21:2594-2602, 11 Slipman C, Arch Phys Med Rehabil, 1998; 79:288-92 6 Maigne, Spine 1996, 21:1889-1892, 12 Manchikanti. Pain Physician 4:308-316, 2001
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Sacroiliac RF Lesion Requirements
• Level L5– Lesion the primary
dorsal ramus at sacral ala
• Level S1, S2, S3– Lesion all lateral
branches as they exit foramen
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Cooled RF Lesions
SACRAL SURFACE
Isotherm MapWhite meat tests comparing SInergy
probe and Standard RF
10 mm
3.5 mm
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Physics of Cooled RF Lesions
Non-cooledCooled
Temperature
Distance
80° C
45° C r
• Without cooling, the size of lesion is limited by the heat generated in the tissue adjacent to the electrode
• Cooling the tissue adjacent to the electrode allows effective heating at a greater distance
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Perpendicular & Oblique Placement
Spherical lesion shape allows for perpendicular or oblique probe placement near the treatment site.
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Electrode Placement
• Spinal needles are used to mark the PSFA
• Introducer and electrode are directed “down the beam” towards the target anatomy
• Electrode is positioned 7-10mm from the PSFA for safety
Image provided courtesy of Dr. Robert E. Wright, Denver Pain Management
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Effective Lateral Branch Ablation
• Anatomical studies provide guidance on lateral branch location
• Cooled RF technology allows for controlled and repeatable large volume lesions
• This allows for the effective ablation of lateral branch nerves in the treatment of sacroiliac joint syndrome
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SInergyTM System Clinical Outcomes
Prospective Cohort Study by Dr. Robert Wright
• (n = 15, baseline VAS = 7)• >50 % reduction in VAS considered success
PRE OP 3 MONTHS 6 MONTHS
% Responders N/A 73%(11/15)
66%(10/15)
Avg. VAS 7.0 2.4(66% less)
2.9(59% less)
Opioid Use 8 x LA5 x SA2 x none
5 x LA4 x SA6 x none
3 x LA5 x SA7 x none
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SInergyTM System Clinical Outcomes
Placebo Controlled Study by Dr. Steven Cohen• 28 patients randomized to RF or sham denervation of L4-S3 • Strict success criteria:
– >50% VAS reduction AND – Positive GPE (Global Perceived Effect) AND
– >10 point ODI improvement
• 6 month follow-up complete with strong results. • Data Release Pending publication in 2007