Disc Replacement vs. Fusion Surgery

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

State of the Art

Disc Replacement vs. Fusion Surgery

Sanjay Jatana, MD

Cervical fusion indications & examples Cervical fusion results and problems

Ongoing research Rationale for fusion vs. disc replacement Cervical disc replacement results Disc replacement positives/negatives Fusion positives/negatives Summary

Cervical Fusion Indications

SPINAL ISTABILITY due to Acute fracture with or without progressive neurological

progression, tumor, abscess, infection, deformity SPINAL STENOSIS with Spondylolisthesis or documented

instability POSTERIOR APPROACH PRIOR SPINAL SUGERY with

Adjacent segment degeneration Recurrent Disc Herniation Spondylolisthesis Pseudoarthrosis (12 months)

DISC HERNIATION SPINAL STENOSIS WITH TREATMENT

FROM ANTERIOR APPROACH

AR, 3 level Fusion

Pseudoarthrosis

Fusion Rates

One Level ACDF 93-95% Two Level ACDF 70-75% (100%) Three Level ACDF 50-60%

Two & Three Level Fusion Rates UNACCEPTABLE

Anterior 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

Patient TT – C5 Stabilized

C5-6 Rotation = 1.1º; C4-5 Rotation = 5.0º

Anterior 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, deformity

Surgery 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

Prodisc-C for ALD

OPTIONS

Anterior Cervical Fusion & Non-union

Pseudoarthrosis rates vary Patients may be asymptomatic for a long time No 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

AR – 3 - LEVEL PSF

“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

EJ – 6mo, 1year

Spinal Fusion

Positive Stops motion at a

vertebral motion segment

Affords Stability Long track record Maintains vertebral

alignment Maintains central &

foraminal decompression

Negative Irreversible Approach related

denervation and soft tissue scarring

Long term effects on adjacent levels

Non-union (pseudoarthrosis)

Hardware related problems

Rationale Differences

Cervical Disc Replacement

Treat the neurologic problem from anterior approach

Fill 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

Treatment of Low Back & Neck Pain

with Fusion or Disc Replacement

Replacing a painful disc rather than fusion is ATTRACTIVE

Ability to diagnose a painful disc is IMPRECISE History & Physical Exam, X-rays: Low

sensitivity & specificity MRI: 19-28% false positive findings in younger

patients Injections can help with facet joint pain Discogram is the only test to establish disc as

the cause

Provocation 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.

BRYAN Disc Replacement

Prodisc-C and ACDF FDA Study Results 5 year

Randomized controlled trial, 103 Prodisc-C, 106 ACDF

NDI, VAS, SF-36 SINGLE LEVEL PROBLEM 2 year, 5 year all clinically significant

IMPROVEMENT from baseline 5 year: Prodisc-C had less NECK PAIN

intensity and frequency Secondary surgery: Prodisc-C 2.9%, ACDF

11.3% NDI: 50 to 23 range, VAS Neck pain 7 to 2 rangeZigler, JE., Delamarter, RB., et al., SPINE in publication 2012

Prodisc-C C5-6 Primary

PCM 2005 PG

PCM 2005 CB

Prodisc-C 7 year Results

81.8% available for follow up NDI, VAS similar in both fusion and

CDR Secondary procedures showed

difference 5.8% CDR, 16% fusion 7.2% CDR developed bridging bone 3.8% Fusion developed Non-union

CDR 100% would have it again (91.7% fusion) One – level problem

Murrey, DB., Zigler, JE. et al., NASS Annual Mtg, 2012.

Bryan CDREight-Year Clinical and Radiological Follow-Upof 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

REOPERATION

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.

Adjacent 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

Artificial Disc Replacement

Positive Early mobilization Maintains motion at

painful disc level Less stress shifted to

adjacent levels Similar if not better

than a fusion More 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

Lumbar 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

Disc Replacement Technology

Unanswered questionsLong term wearRevision strategiesInsurance coverageMulti-level approval and success

Disc Replacement vs. Fusion Surgery

Sanjay Jatana, MD

Lumbar & Cervical fusion indications & examples

Cervical fusion results and problems Ongoing 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

Summary 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%/yearCervical 2-3%/year

Summary

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.

Summary 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.

Adjacent Segment DiseaseACDF vs. Arthroplasty

• Analysis of Prospective Studies (6), 2-5yr FU

• Sample size 1,586 (ACDF = 777, TDA = 809)

• 70% overall follow-up• 36 (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

Disc 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] Wikipedia