Sanjay Jatana MD Concepts Rationale and Results February 22 2013 Disclosures Conflict of Interest None Paid Consultant Zimmer FDA IDE Study site PCM disc replacement Hospital Agreement Rose Spine Institute ID: 916303
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Slide1
Disc Replacement vs. Fusion Surgery
Sanjay Jatana, MD
Concepts, Rationale, and ResultsFebruary 22, 2013
Slide2Disclosures
Conflict of Interest: None
Paid Consultant: ZimmerFDA IDE Study site : PCM disc replacementHospital Agreement: Rose Spine Institute
Slide3State of the Art
Slide4Disc Replacement vs. Fusion Surgery
Sanjay Jatana, MD
Cervical fusion indications & examplesCervical fusion results and problems
Ongoing research
Rationale for fusion vs. disc replacement
Cervical disc replacement results
Disc replacement positives/negatives
Fusion positives/negatives
Summary
Slide5Cervical Fusion Indications
SPINAL ISTABILITY due toAcute fracture with or without progressive neurological progression, tumor, abscess, infection, deformity
SPINAL STENOSIS with Spondylolisthesis or documented instability POSTERIOR APPROACHPRIOR SPINAL SUGERY withAdjacent segment degenerationRecurrent Disc Herniation
Spondylolisthesis
Pseudoarthrosis
(12 months)
DISC HERNIATION
SPINAL STENOSIS WITH TREATMENT FROM ANTERIOR APPROACH
Slide6AR, 3 level Fusion
Slide7Pseudoarthrosis
Fusion Rates
One Level ACDF 93-95%Two Level ACDF 70-75% (100%)
Three Level ACDF 50-60%
Two & Three Level Fusion Rates UNACCEPTABLE
Slide8Anterior Cervical
Pseudarthrosis
67% symptomatic
(28% asymptomatic for 2 years)
33% asymptomatic
Re-operation : fusion: 19 Excellent, 1 Good
Phillips, FM et al: Spine, 1997
Bohlman, HH., et. al: JBJS, 1993
Slide9Patient TT – C5 Stabilized
C5-6 Rotation = 1.1º; C4-5 Rotation = 5.0º
Slide10Anterior Cervical Fusion
Overall success range from 70-90%Historical standard of care
Surgery for disc herniation and one and two level problem do better than surgery for 3 or more levels, cord compression, deformitySurgery for neck pain is less successful
As more levels get involved, problems exist that have not been solved
Levels above and below breakdown over time
Slide11Prodisc-C for ALD
Slide12OPTIONS
Slide13Anterior Cervical Fusion & Non-union
Pseudoarthrosis
rates varyPatients may be asymptomatic for a long timeNo agreed upon radiographic criteria, probably underestimated
Treatment Options not perfect
Revision anterior fusion
Posterior spinal fusion
BMP use in the neck is OFF-LABEL
Not 100% successful
Higher complications
Stand alone laminectomy /
laminoplasty
/
foraminotomy
,
non fusion options have limitations
Slide14AR – 3 - LEVEL PSF
Slide15“
Improve the Environment”
Don’t Fuse
Laminectomy
Laminoplasty
Multilevel
arthroplasty
Anterior
Corpectomy
/Discectomy
Accept
pseudoarthrsis
rate and address as needed
Mechanical – Plate, Screw designs
Biological – Bone, Cells, BMP
’
s
Slide16EJ – 6mo, 1year
Slide17Spinal Fusion
PositiveStops motion at a vertebral motion segment
Affords StabilityLong track recordMaintains vertebral alignmentMaintains central & foraminal decompression
Negative
Irreversible
Approach related
denervation
and soft tissue scarring
Long term effects on adjacent levels
Non-union (
pseudoarthrosis
)
Hardware related problems
Slide18Rationale Differences
Cervical Disc Replacement
Treat the neurologic problem from anterior approachFill the VOID that is created by the decompression.Lumbar Disc Replacement
Treat low back pain
Neurologic problem not primary concern
Assuming DISC is the cause
Lumbar DR rationale not same as cervical DR rationale
Slide19Treatment of Low Back & Neck Painwith Fusion or Disc Replacement
Replacing a painful disc rather than fusion is ATTRACTIVE
Ability to diagnose a painful disc is IMPRECISEHistory & Physical Exam, X-rays: Low sensitivity & specificityMRI: 19-28% false positive findings in younger patientsInjections can help with facet joint pain
Discogram
is the only test to establish disc as the cause
Slide20Provocation Discography
Long-standing topic of debate.Strict operational criteria, ISIS
VAS, pressure difference at pain from opening pressure, anesthetic response, control levels, CT scan to evaluate grade of annular tear.False positive Rate is 10%Systematic analysis with strict operational criteria False positive rate is 6% and specificity of 94%.**Re-analysis 38 months after discography led to 1.3% new pathology#
**
Wolfer
LR, Derby R, Lee JE, Lee SH, Pain Physician, 11: 4, 513-38 2008
#Johnson RG, Spine, 14:4, 424-26, 1989.
Slide21Slide22BRYAN Disc Replacement
Slide23Prodisc-C and ACDF FDA Study Results 5 year
Randomized controlled trial, 103 Prodisc
-C, 106 ACDFNDI, VAS, SF-36 SINGLE LEVEL PROBLEM2 year, 5 year all clinically significant IMPROVEMENT from baseline5 year: Prodisc-C had less NECK PAIN intensity and frequencySecondary surgery:
Prodisc
-C 2.9%, ACDF 11.3%
NDI: 50 to 23 range, VAS Neck pain 7 to 2 range
Zigler, JE., Delamarter, RB., et al., SPINE in publication 2012
Slide24Prodisc-C C5-6 Primary
Slide25PCM 2005 PG
Slide26PCM 2005 CB
Slide27Prodisc-C 7 year Results
81.8% available for follow upNDI, VAS similar in both fusion and CDR
Secondary procedures showed difference5.8% CDR, 16% fusion7.2% CDR developed bridging bone3.8% Fusion developed Non-unionCDR 100% would have it again (91.7% fusion) One – level problem
Murrey, DB., Zigler, JE. et al., NASS Annual Mtg, 2012.
Slide28Bryan CDR
Eight-Year Clinical and Radiological Follow-Up
of the Bryan Cervical Disc Arthroplasty, Gerald M. Y. Quan, MBBS, FRACS, PhD, Jean-Marc Vital, MD, PhD, Steve Hansen, MD,
and Vincent
Pointillart
, MD,
PhD, SPINE
Volume 36, Number 8,
pp
639–646,2011.
FRANCE
Randomized, Controlled, Multicenter,
Clinical Trial
Comparing BRYAN Cervical Disc
Arthroplasty
With
Anterior Cervical
Decompression and
Fusion in
CHINA
Xuesong
Zhang , MD ,
Xuelian
Zhang , PhD ,
Chao Chen , PhD ,
Yonggang
Zhang , MD ,
Zheng
Wang , MD ,
Bin
Wang , MD , *
Wangjun
Yan , MD
,
Ming Li , MD ,
Wen
Yuan , MD ,
and
Yan Wang , MD
SPINE
Volume 37, Number 6,
pp
433–438 2012.
Comparison of BRYAN Cervical Disc
Arthroplasty
With
Anterior Cervical Decompression and
Fusion Clinical
and Radiographic Results of a Randomized,
Controlled, Clinical Trial
John
G. Heller,
MD,Rick
C.
Sasso
,
MD,Stephen
M. Papadopoulos,
MD,Paul
A. Anderson,
MD, Richard
G.
Fessler
, MD,
PhD, Robert
J. Hacker,
MD,
Domagoj
Coric
, MD
,
Joseph C.
Cauthen
, MD
,
and Daniel K.
Riew
,
MD SPINE
Volume 34, Number 2,
pp
101–107 2009.
USA
Slide29REOPERATION
CDR
5/84 (6%)Mean follow-up 49.7 mo.(1) Decompression same level(1) Decompression same level and adjacent level(2) Adjacent level (HNP)(1) SCS for pain mgmt
Longer time to re-op (55.9 mo)
FUSION
9/51 (17.6%)
Mean follow-up 49.7 mo.
(4)
Pseudoarthrosis
(5) Adjacent level (DD, HNP)
Shorter time to re-op (27.5 mo)
Reoperation rate less and survival longer for CDR group
Blumenthal, SL., et al., NASS Annual Mtg, 2012.
Slide30Adjacent Level Radiographic Degeneration CDR / Fusion Prodisc – C
48% CDR, 78% Fusion
(p<0.0001)Increase ROM superior level Fusion (p<0.0233)Increase ROM inferior level Fusion (p<0.0876)
Adjacent level degeneration
lower
in the CDR group.
Higher rate of ALD in the fusion group related to higher ROM at adjacent levels.
Spivak, JM., Delamarter, RB., et al., NASS Annual Mtg, 2012
Slide31Artificial Disc Replacement
PositiveEarly mobilization
Maintains motion at painful disc levelLess stress shifted to adjacent levelsSimilar if not better than a fusionMore cost effective with less time off from work
Negative
No long term data in USA
Requires more attention to decompression of neural structures
Long term wear effects of bearing surface unknown
Aging of spine and implant survival unknown
May ultimately require fusion of the motion segment
Revision more complicated
Slide32Lumbar Total Disc Replacement
Overall beneficial (Charite
, XLTDR, Phisio-L, Maverick, Prodisc, Mibidisc, Active-L)
Long term complications
Persistent LBP 9.1%
Facet Degeneration 25%
Misplacements 8.5%
Subsidence 7%
Partial
explantations
2%
Fracture 2%
Retrievals 6.21%
Model dependent, facet pain, core fracture, pedicle fracture, scoliosis, HO formation,
CrCo
allergy, subsidence, mal-positioning
.
Pimanta, LH., Marchi, L., Oliveira, L., NASS Annual Mtg., 2012
Slide33Disc Replacement Technology
Unanswered questionsLong term wear
Revision strategiesInsurance coverageMulti-level approval and success
Slide34Disc Replacement vs. Fusion Surgery
Sanjay Jatana, MD
Lumbar & Cervical fusion indications & examplesCervical fusion results and problemsOngoing research
Lumbar
fusion concepts
and results
re: low back pain
Rationale for fusion vs. disc replacement
Lumbar & Cervical disc replacement results
Disc replacement positives/negatives
Fusion positives/negatives
Summary
Slide35Summary
Fusion surgery for LBP caused by a symptomatic degenerative disc in properly selected patients has an acceptable success rate.Fusion surgery on the cervical spine for one and two level problem still offers good to excellent results
Both lead to adjacent level degeneration Lumbar 3%/year Cervical 2-3%/year
Slide36Summary
Disc Replacement technology is safe and effective. (FDA/IDE )Disc replacement in the low back is also acceptable treatment but long term revision and conversion to a fusion is a likely reality.Cervical disc replacement
offers a better solution than fusion for one and two level disease in properly selected patients.
Slide37Summary
Revision strategies are easier with less potential complications for cervical disc replacement.Overall lumbar disc replacement at 7 years is equal to lumbar fusion
Overall cervical disc replacement is better than fusion for single level patient with a disc herniation re: result, neck pain, revision rates.Patients need to understand that additional surgery is likely in the future with either option.
Slide38Adjacent Segment DiseaseACDF vs. Arthroplasty
Analysis of Prospective Studies (6), 2-5yr FU
Sample size 1,586 (ACDF = 777, TDA = 809)70% overall follow-up36 (6.9%) ACDF repeat surgery (50 patients*)30 (5.1%) TDA repeat surgery (58 patients*)
NO Detectable difference in rate of ASD
More time
Verma
, K., et al. Rothman Institute, CSRS, 2012
*
2.9% yearly
incedence
of symptomatic adjacent level
Slide39Disc Replacement vs. Fusion Surgery
Sanjay Jatana, MD
Confusion (from Latin confusĭo, -ōnis, noun of action from confundere "to pour together", or "to mingle together"[1] also "to confuse") is the state of being bewildered or unclear in one’s mind about something:
[2
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Wikipedia