Cervical Radiculopathy Syllabus

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8/21/2014

1

The Case for Posterior Foraminotomy

Michael Y. Wang, MD

Professor

Departments of Neurological Surgery & Rehab Medicine

The Miller School of Medicine at the

University of Miami

Disclosure

Consultant: Depuy Spine

Royalties: Depuy Spine

Springer Publishing

Quality Medical Publishing

Stock: Innovative Surgical Devices

Spinicity

Grants: Department of Defense

C4/5

Today’s Case

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Thanks Sheeraz !

This is a perfect case for a

posterior foraminotomy:

1. Young patient

2. Unilateral symptoms

3. Single level

4. Minimal neck pain

5. No abnormal alignment

6. No abnormal motion

Pro Con

No approach problems

No need to stabilize

Decreased adjacent level

disease

Possibility of recurrence

No treatment of instability

Unilateral treatment

Interrupts neck musculature

Is it Effective?

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•44 patients followed for 6 or more years (mean 8.8 years)

•98% of patients experienced symptomatic relief

•No index level reoperations

•Two cases of adjacent level disease

Does it Work for Two

Levels?

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35 patients

1. 99 minutes

2. 55 g Blood loss

3. 88% had relief at 3 months

4. 97% had relief at final F/U

What About MIS?

What About the

Posterior Approach ?

Standard open techniques require extensive

disruption of dorsal musculoligamentous

resulting in :

Incision-related pain

Devitalization of neck musculature

Poor cosmesis

Interruption of the posterior “dynamic tension

band”

Minimal access approaches attempt to overcome

these drawbacks of conventional open surgery Finite element analysis

8/21/2014

5

Tubular Dilator Retractors

1. Utilizes serial expansion of

muscles over a guide wire

2. Spreads muscles instead of

cutting them

3. Final dilation to 16 mm to 24

mm in diameter

4. Serves essentially as an

access port

“Mom…look what I did

through the Tube !”

Minimally invasive techniques are being

used for:

1. Odontoid screw fixation

2. Transarticular screw placement

3. C1-2 Harms techniques

4. Tumor removal

5. Laminectomy

6. Trans-facet fixation

Cervical Foraminotomy

•100 consecutive patients

undergoing minimally invasive

cervical foraminotomy

• 97 patients reported as “good” or

“excellent” results

•Typical discharge home in 3 hours

•60 patients able to return to work

within one week.

•Two dural tears

•One wound infection

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•19 open and 22 tubular foraminotomies

•Groups were similar in all respects

What is the Rate of

Reoperation or

Adjacent Disease?

Thanks Sheeraz !

•178 patient followed a mean of 31.7 months

•9 (5%) of patients underwent reoperation at index level

•Associated factors: young, thin, anxious patients

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70 patients:

1. No secondary intervention

2. 5 patients had ACDF

3. ACDF was a mean of 44

months later

4. 1.1% per year same level

5. 0.9% per year adjacent

level surgery

Biomechanical Effects in vivo

Cost Utility Analysis

Alvin, et al (JSDT)

The Cleveland Clinic experience w/ foraminotomy:

•45 ACDF vs 25 foraminotomy patients

•Assessed with VAS, NDI, EQ-5D & PHQ-9

•Both groups showed improved outcomes and MCID

•At one year, foraminotomy was more cost effective

ACDF $131,951 / QALY

Foraminotomy $ 79,856 / QALY

8/21/2014

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Military Experience

ACDF Foraminotomy

Number of patients 19 19

Mean Age 39.3 41.5

OR Time 151.6 153.9

Blood Loss 32.6 39.7

Complications 2 0

Direct Costs 10,078 3,570

Return to work (weeks) 19.6 4.8

Foraminotomy has been around for over

50 years, so what does the future hold?

Use of smaller tubes

•Randomized trial of ACDF vs. Foraminotomy

•N=175 with f/u 2 years

•Dx: Radiculopathy

•6 complications, 3 revisions

•87.4% resolution of symptoms

•No difference between groups

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9

Central Canal Decompression

Minimally Invasive Fusion

! Thank You !

8/26/2014

1

Cervical Radiculopathy: Case Based Debate

CERVICAL TDR

Pierce D. Nunley MD

Director, Spine Institute of Louisiana

Assistant Professor, Louisiana State University

Disclosures

Research Funding

LDR Spine

Speaker’s Bureau

LDR Spine

K2M

Smith and Robinson introduced anterior cervical discectomy and

arthrodesis in 1958 as a surgical option for the management of

cervical disc disorders.

Smith GW, Robinson RA. The treatment of certain cervical spine disorders by anterior removal of

the intervertebral disc and interbody fusion. J Bone Joint Surg Am. 1958; 40: 607-24

ACDF has gained acceptance as standard of care for patients with

persistent radicular and/or myelopathic symptoms that have failed

to improve with conservative treatments.

Rao RD, Currier BL, Albert TJ et al. Degenerative cervical spondylosis: clinical syndromes,

pathogenesis and management. J Bone Joint Surg Am 2007; 89: 1360-78

History

8/26/2014

2

20-32% of patients undergoing ACDF would develop ASP

during the next 10 years

As longer term results became available, the outcome studies

increasingly focused on the adverse effects of this procedure.

ASP –Adjacent Segment Pathology

Similar stress profiles were recorded from intact

specimens and those with the artificial joint inserted.

The artificial joint resulted in reduced stresses in the

annulus compared with spines with a simulated

fusion.

The concern that spinal fusion may be a contributing

factor to accelerated ASP led to increased interest in

“motion preservation”

Rationale

This immediately led the scientists and surgeons

to focus their attention towards developing

alternative procedures to ACDF

The concept of “motion preservation

technology” was thus born and subsequently led

to the development of cervical total disc

replacement (c-TDR).

Since then several total disc arthroplasty implants

have been used for treating cervical degenerative

disc disease and the clinical outcomes have been

published in the literature.

8/26/2014

3

FDA Clearance of Cervical Discs in U.S.

1. Garrido BJ, Taha TA and Sasso R. Clinical outcomes of Bryan cervical disc arthroplasty: a

prospective, randomized, controlled, single site trial with 48-month follow-up. J Spinal

Disord Tech. 2010 Aug;23(6):367-71

2. Quan GM, Vital J, Hansen S. Eight –year clinical and radiological follow-up of the Bryan

cervical disc arthroplasty. Spine 2011; 36(8): 639-646

3. Sasso RC, Anderson PA, Riew KD and Heller JG. Results of cervical arthroplasty compared

with anterior discectomy and fusion: Four-year clinical outcomes in prospective randomized

controlled trial. J Bone Joint Surg Am 2011; 93: 1684-92

4. Coric D, Nunley PD, Guyer RD, Mustane D et al. Prospective randomized multicenter study

of cervical arthroplasty: 269 patients from the Kineflex/C artificial disc investigational

device exemption study with a minimum 2-year follow-up. J Neurosurg: Spine/ June 24,

2011; epub ahead of print

5. Huppert J, Beaurain J, Steib JP and Bernard P et al. Comparison between single and multi-

level patients: clinical and radiological outcomes 2 years after cervical disc replacement.

Eur Spine J. 2011; Sep 20(9): 1417-26

6. Zechmeister I, Winkler R, Mad P. Artificial total disc replacement versus fusion for the

cervical spine: a systematic review). Eur. Spine J. 2011; 20(2): 177-84

A review of the published literature raises the following

basic questions:

1. Are the short or long term clinical outcomes better in patients with disc

replacement as compared to ACDF?

2. Is there a significant difference in the incidence of Clinical adjacent segment

pathology (CASP) after the two procedures?

3. Is there a strong, evidence-based rationale to perform total disc replacement

instead of ACDF?

4. Are there specific patient subsets in which either of the procedures may

provide better longer term outcomes (index level or adjacent segment

disease)?

8/26/2014

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Primary Outcome Comparisons

Problems

1. the longest published follow-up period for total disc

replacement is about 8 years

2. Most of the published data for total disc replacement consists

of patients with one or two level disease

3. The data for total disc replacement is usually gathered from

the patients who have participated in the randomized

controlled trials (RCT) for particular implants. (Such trials have

very stringent inclusion/exclusion criteria for selecting patients and are

often criticized as not representing the general patient population.)

1. Most published results of the ACDF procedure

are retrospective and/or anecdotal from

experience of a single surgeon or institution,

(class III studies at best.)

2. The outcome instruments used and success

criteria used for the ACDF studies have varied

according to the different authors’ judgment and

tools available at the time of data acquisition.

ACDF Outcomes

Problems

Comparable success rates for both procedures at the average

follow-up of 2-4 years

Clearly established the non-inferiority of the TDR procedure

to the ACDF,

Questionable rationale for utilizing TDR as an alternative to

the fusion procedure**.

** Bartels RHMA, Donk R and VerBeek ALM. No justification

for cervical disc prostheses in clinical practice: a meta-analysis

of randomized controlled trials. Neurosurgery, 66(6): 1153-

1160; 2010

Bottom Line

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Adjacent Segment Pathology (CASP)

Hilibrand’s follow-up study: Admitted that the scientific literature

was unclear whether the ASP is a result of the spinal fusion with

iatrogenic motion restriction or whether it represented a

progression of the natural history of degeneration

Hillibrand AS, Robbins M: Adjacent segment degeneration and adjacent segment disease: the

consequences of spinal fusion? Spine J 2004; 4: 190S-194S

The primary end points of TDR clinical trials are focused on

improvements in patient’s symptoms attributable to the index-level.

The published results are mostly focused on the outcomes at 24-

month follow-up, the period being too short to assess ASD.

Our Experience

Total disc arthroplasty is equivalent to ACDF for providing relief from

symptoms

The risk of developing adjacent segment degeneration is equivalent after

both procedures but is significantly higher in patients with concurrent

DDD in lumbar spine.

Our Experience

At a projected follow-up of up to 54 months, the risk of

developing symptomatic adjacent segment disease (CASP) does

not significantly vary between patients receiving total disc

arthroplasty or anterior fusion.

Other factors including bone mineral density and presence of

concurrent lumbar degeneration have a more significant effect in

the incidence of adjacent segment degeneration.

8/26/2014

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Comparison of artificial cervical arthroplasty versus

anterior cervical discectomy and fusion for one-level cervical degenerative

disc disease: a meta-analysis of randomized controlled trials.

Luo, et al - Eur J Orthop Surg Traumatol –Jul 2014

•13 RCT’s, 24 month f/u

•Statistical significant improvement TDR over

ACDF in

•Neurological Success

•Secondary Surgical Procedures

•VAS –Neck & Arm

•NDI –Statistically similar

Artificial cervical disc arthroplasty versus anterior

cervical discectomy and fusion: a systematic review

Mroz, et al SPINE 25:1 2014

“Level I evidence suggests that artificial

cervical disc arthroplasty has relatively low

complication, reoperation, and heterotopic

ossification rates and that quality of life

measures such as Neck Disability Index, visual

analogue scale, and Short Form 36 (SF36)

significantly improved ….”

Two-level Total Disc Replacement with Mobi-C® Cervical Artificial Disc

versus Anterior Discectomy and Fusion: A Prospective, Randomized,

Controlled Multicenter Clinical Trial with 4 Year Follow-up Results

N=389 f/u 4-7 years

Patients receiving treatment with TDR at

TWO LEVELS had statistically significantly

greater improvement than ACDF for:

NDI

SF-12 PCS

Patient Satisfaction

Overall Success

Revision Surgeries

Radiographic ASP

Davis RJ, Nunley PD, et al J. of Neurosurgery –Spine 2014

8/26/2014

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Cervical TDR vs Foraminotomy

Patient Symptoms

Radiculopathy vs Neck Pain

Myelopathy?

Radiological Considerations

Central vs Peripheral

Soft vs Hard

Adjacent Segements

Long Term Consequences

Bridge Burning?

Long-term patient outcomes after posterior

cervical foraminotomy: an analysis of 151 cases

Bydon, et al –J Neursurgery Spine 15:1-5 2014

n=151, f/u 4 to 15 years

Reoperation Rates:

18.3% f/u > 2 years

24.3% f/u > 10 years

“Patients with no preoperative neck pain

had the lowest rates of revision surgery

after PCF.”

Reoperation Rates After Anterior Cervical Discectomy and Fusion vs

Posterior Cervical Foraminotomy: A Propensity Matched Analysis.

Mroz, et al Neurosurgery 2014

N=790, f/u 2 –6 years

Reoperation rate at the index level was:

4.8% for the ACDF

6.4% for the PCF group (p = 0.7),

8/26/2014

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Cervical arthroplasty after previous surgery: results of treating

24 discs in 15 patients.

Sekhon et al - J Neurosurg Spine. 2005 Nov;3(5):335-41.

“provided encouraging early clinical

results, although patients with preoperative

hypermobility should be treated with

caution. Issues such as accelerated

device-related wear and the use of

arthroplasty after aggressive facetectomy

resection will need further study”

The Effect of Posterior Decompressive Procedures on Segmental

Range of Motion Following Cervical Total Disc Arthroplasty.

Patwardhan AG, et al –SPINE June 2014

Human Cadaver Biomechanical Study

Unilateral Hemilaminotomy MAY be safe, but

warned against cyclic loading in In-Vivo state

Bilateral Hemi and Laminectomy UNSTABLE

By performing Hemilaminotomy, what FUTURE

are we relegating our patients to?

Debate Case

C4/5

More Pathology

Hypermobile

8/26/2014

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Conclusions

c-TDR is a safe and efficacious procedure for

the indications of cervical myeloradiculapathy

in appropriately selected patients

c-TDR at two levels has shown superiorty

over 2 level ACDF (Class I Evidence)

PCF may lead to as many or more revision

surgeries as well as prevent conversion to

c-TDR

THEREFORE: c-TDR is the best choice

Thank You!

8/24/2014

1

For Single Level Disease With

Radiculopathy, ACDF is the Best Option

Todd J. Albert, MD

Surgeon-in-Chief and Medical Director

Korein-Wilson Professor

Hospital for Special Surgery

Chairman, Department of Orthopaedic Surgery

Weill Cornell Medical College

NY , NY

Todd J Albert, MD

DISCLOSURES

INDUSTRY

(c,e) DePuy, Biomet; (d) Vertech, In Vivo Therapeutics, Paradigm Spine, Biomerix,

Breakaway Imaging, Crosstree, Invuity, Pioneer, Gentis, ASIP, PMIG; (e) Facetlink

•a)Research or institutional support received; b) Miscellaneous non-income support (e.g., equipment or services),

commercially derived honoraria, or other non-research related funding (e.g., paid travel); c) Royalties; d) Stock or

stock options held; e) Employee or Consultant; n) Nothing of value received

EXTERNAL ADVISORY ROLE

SIC HSS

MAB –United Healthcare

CSRS –Past President

SRS-BOD

IMAST Past Chair

AOA –Chair Development Committee

Agenda

•ACDF Has a Long Track

Record of Outstanding

Outcome

•CDA Data Cannot Be Trusted

•Laminoforaminotomy Not Ideal

8/24/2014

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ACDF

•Disc dehydration

•Altered biomechanics

•Annular disruption

•Herniated disc

•Spondylotic compression

Pathophysiology of Cervical Spondylosis

ACDF for Radiculopathy

•Direct nerve root compression

–soft disc herniation

–spondylosis (osteophyte formation)

•Foraminal stenosis (disc degeneration)

•Dynamic nerve root compression

Good Solution For All

Possible Causes of Radiculopathy

ACDF for Radiculopathy

•Direct

decompression

•Excellent

visualization

•No manipulation of

neural elements

Logic of Anterior Surgery

“Where the pathology is!”

8/24/2014

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ACDF for Radiculopathy

•Directly remove pathology

•Distraction indirect decompression

•Eliminates motion = root irritation (ACDF only)

Benefits of Procedure

ACDF for Radiculopathy

•Eliminates motion

•Removes arthritic

stimulus

•Regression of

osteophytes

Arrests Progression of Cervical Spondylosis

CRITICAL DISTINCTION

Adjacent Segment Disease

Reoperation Rate Lowest In

Patients With Most Fusion

Levels

-Contradicts Theory That Fusion

ASD

Length of fusion

single level = 18%

multilevel = 12%

Hilibrand et al., (Am), 1999JBJS

8/24/2014

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ACDF Effective, Safe, Procedure

Proven Outcome

Comparable to Hip/Knee

Replacement

Anderson Spine 2009

ACDF Improves Sagittal Balance

–ACDF Corrects Kyphosis

•Uchida JNS 2009

•Song JBJS Br 2010

•Shamji Spine 2013

•Important Factor Anterior Reconstruction

•Kyphosis Poor Outcome

•Kyphosis Increased Incidence of ASD

•Sagittal Balance Associated with Myelopathy

Ferch JNS Spine 2004

Kawakami JSDT 1999

Villavicencio Neurosurgery 2011

Gum AJO 2012

Faldini CORR 2011

Hansen Spine 2012

Park MS Spine 2014

Smith Spine 2013

Agenda

•ACDF Has a Long Track Record of

Outstanding Outcome

•CDA Data Cannot Be Trusted

•Laminoforaminotomy Not Ideal

8/24/2014

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My Opponent Will Cite Data Supporting CDA

•Try To Create Mass Confusion With Charts, Tables, and

Meta Analyses

–ProDisc C 5 Year Results

•Zigler JE Spine 2013

–Prestige 7 Year Results

•Burkus JNS 2014

DON’T BELIEVE IT

REOPERATION RATES SUSPECT

UNDERREPORTING COMPLICATIONS

NOT ALL CDAs Do Well

Reoperation Data Is Unreliable

•Reoperation Rates at the same institution

different for ACDF patients in the control

arm of an IDE study (9%) versus outside

of IDE study (2.1%)

CDA Patients Highly Selected

•Only 43% percentage of patients are

candidates for CDA

–Auerbach Spine 2008

•Cannot extrapolate CDA results to general

population

8/24/2014

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Reports of CDA Complications

Increasing

•Early

–Dislocation

•Late

–Osteolysis

–Subsidence

Hacker Spine 2013

Where Are These

Complications In

IDE Study Data?

Tsermoulas Br J Neurosurg 2013

Other Late Complications

•Wear Osteolysis

•Ossification

Tumilian Spine 2011

Where Are These

Complications In

IDE Study Data?

ASD Occurs After CDA

9/72 Adjacent

Segment

Degeneration

(12.5%)

Bryan

No Industry Funding

Yi Surg Neurol 2009

8/24/2014

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Same Segment Disease After CDA

Yi Surg

Neurol 2009

Where Are These

Complications In

IDE Study Data?

Not All CDAs Do Well

•Review of Discover Data

•Decreased Disk Height Poor Outcome

•Excessive Lordosis Poor Outcome

Rihn JSDT 2014

Laminoforaminotomy

•High Neurological Injury

•High Reoperation Rate

•Kyphosing

8/24/2014

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Laminoforaminotomy

•Neurological Injury

–2.3% Palsy

•Choi World Neurosurgery 2013

–2.1% Palsy

–But if you are part of that 2% it’s a big deal

Jagannathan JNS 2009

High Reoperation After

Laminoforaminotomy

•N=790, Cleveland Clinic, n=627 ACDF, 163 PCF

•2 year reop rate (p=0.7)

•ACDF 4.8%

•PCF 6.4%

Lubelski Neurosurgery 2014

Laminoforaminotomy Kyphosing Procedure

•N=162, UVA, Postop Kyphosis 20% of Patients at 5

Years

–Jagannathan JNS 2009

Laminoforaminotomy

Flat Neck Deformity

8/24/2014

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Progressive Kyphosis After

Laminoforaminotomy

•Described Even In Paper Favorable to Laminoforaminotomy

•Had to Be Rescued with ACDF Jagannathan JNS 2009

Summary

•ACDF Great, Safe, Effective Durable Procedure

•Need More Independent Verification of CDA Data

•Laminoforaminotomy Potential To Be Cost Effective

Conclusion

•Need Better Understanding of the Drivers of Outcome of

Cervical Surgery

–Sagittal Balance?

–Fusion Rate?

–Motion?

–Reoperation Rate?

8/24/2014

10

Thank You

8/24/2014

1

Current Surgical

Strategies for Cervical

Radiculopathy

Sheeraz Qureshi, MD,MBA

Associate Professor,

Orthopaedic Surgery

Spinal Surgery, Mount Sinai

Hospital

Icahn School of Medicine at

Mount Sinai

Co-Director, Spinal Surgery

Fellowship

Disclosures

1. Committee Appointments

1. AAOS Evaluations Committee

2. CSRS Research Committee

3. NASS Evidence-Based Guidelines Committee

4. CSRS Survey Committee

5. NASS Value Committee

2. Journals

1. Spine Journal (Reviewer)

2. Spine (Reviewer)

3. CORR (Reviewer)

4. Global Spine Journal Reviewer

3. Royalties

1. Zimmer

4. Consulting

1. Medtronic

2. Stryker

3. Zimmer

4. Orthofix

5. Teaching

1. Medtronic

2. Stryker

3. Globus

6. Advisory Boards

1. Zimmer Scientific Advisory Board

2. Orthofix Scientific Advisory Board

3. MTF Medical Board of Directors

4. Axiomed Data Safety Monitoring Board

Increasingly Common Problem

8/24/2014

2

Economic Crisis

What is Value?

▶“Goalposts around which we define outcomes”

The Past …

▶Spine surgery outcomes

–Technical concepts

•Fusion Rates

•Complications

8/24/2014

3

The Past …

▶Goal of surgery

–Technically successful procedure

Outcomes Measures

McCormick et al, 2013, JAAOS

The Surgeon’s Task

▶Choose the procedure that results in the best

possible outcome for the patient

8/24/2014

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Emphasis

▶Cost

▶Cost Effectiveness

▶Value

How is Value Defined

▶Value

–Quality of an intervention divided by the cost

measured over time

▶Key factors

–Quality

–Cost

–Time

Obligation

▶Goal of healthcare is NOT simply to achieve

lowest cost treatment for given pathology

8/24/2014

5

What’s the CHEAPEST

treatment?

▶NSAIDs

▶Tylenol

▶PT

▶Home exercise program

▶Injections

Case

1. 37 year old right hand dominant attorney with 4 week

history of right upper extremity pain, numbness, and mild

weakness

2. Attempted oral steroid with minimal relief only and

currently doing PT

3. Physical exam confirms positive Spurling’s on the right,

with 4+/5 weakness of deltoid and biceps

4. No physical exam findings of spinal cord irritation

8/24/2014

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8/24/2014

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C4 C4/5

C4/5 C5

8/24/2014

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Esteemed Faculty

Mike Wang Pierce Nunley Todd Albert

22

Mount Sinai / Presentation Slide / December 5, 2012 23

Case

1. 37 year old right hand dominant attorney with 4 week

history of right upper extremity pain, numbness, and mild

weakness

2. Attempted oral steroid with minimal relief only and

currently doing PT

3. Physical exam confirms positive Spurling’s on the right,

with 4+/5 weakness of deltoid and biceps

4. No physical exam findings of spinal cord irritation

8/24/2014

9

What Would You Do?

1. ACDF

2. CDR

3. PCF

26