11/8/2013

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Cervical Total Disc Replacement

Bobby KB Tay MD

HS Clinical Professor

Department of Orthopaedic Surgery

University of California at San Francisco

Director UCSF Spine Fellowship

UCSF Spine Techniques Symposium

Las Vegas, NV

November 8, 2013

Disclosures

Stryker Spine consultant, honoraria

Synthes Spine honoraria

Biomet Spine honoraria

Fellowship support: OREF, AOA, AOSpine, Globus,

Nuvasive

Acknowledgements

Jack Zigler MD

Globus Spine

LDR Spine

11/8/2013

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Courtesy of Gary Ghiselli MD

Materials and Fixation CTDR

Prestige ST(Medtronic)

Prodisc-C (Synthes)

Bryan (Medtronic)

PCM (Cervitech )

Secure-C (Globus)

Mobi-C (LDR)

Metal-on Metal

316 stainless steel

Cobalt-Chrome

UHMWPE

Polyurethane Center

titanium endplates

Flexible membrane

Cobalt-Chrome

UHMWPE

Cobalt-Chrome

UHMWPE

Screw fixation

Grit blast ingrowth

Keel Fixation.

Titanium Plasma Spray

Convex endplates

Titanium porous

coating

Serrated surface.

Titanium/calcium

phosphate coating

Mobile bearing

3 spikes

Titanium plasma spray

Semi-constrained

Semi-constrained

Semi-constrained

Semi-constrained

Semi-constrained

Unconstrained

Cobalt-Chrome

UHMWPE

Published IDE Clinical Trials

Prosthesis Company US Approval Last FU Data

Published from

RCTs

Prestige Medtronic July 17, 2007 JNSpine, Sep 2010

Prodisc-C Depuy-Synthes December 17,

2007

Spine J. 2009

Apr;9(4):275-86

Secure-C Globus September 18,

2012

Vaccaro et. Al, in

press

Bryan Medtronic Approved May12,

2009

J Spinal Disord

Tech. 2010

Aug;23(6):367-71

Mobi-C LDR August 7, 2013 In press

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Patient Selection Inclusion Criteria

Has cervical degenerative disc disease as defined as:

– intractable radiculopathy and/or myelopathy with at least one of the following items

producing symptomatic nerve root and/or spinal cord compression that is documented

by patient history:

• a) herniated disc;

• b) osteophyte formation

One level requiring surgical treatment

C3-C4 disc to C6-C7 disc level involvement

Unresponsive to non-operative treatment for six weeks or presence of progressive

symptoms or signs of cord compression

No previous surgical procedures at the involved level or any planned surgical procedure at

the involved or adjacent level.

Preop Neck Disability index score ≥ 30

Preop Neck Pain score of ≥ 20 based on the Preop Neck & Arm Pain Questionnaire

Not pregnant at time of surgery

Willing and able to comply with study plan and able to understand and sign patient informed

consent

Contraindications to cTDR

Cervical instability (translation >3 mm and/or

>11° rotational difference to that or either

adjacent level)

Known allergy to implant materials (titanium,

polyethylene, cobalt, chromium, and

molybdenum)

Posttraumatic vertebral body

deficiency/deformity

Facet joint degeneration

Neck or arm pain of unknown etiology

Axial neck pain as the solitary presenting

symptom

Severe spondylosis (bridging osteophytes, disc

height loss >50%, and absence of motion

<2°)

Osteoporosis/osteopenia

Prior surgery at the level to be treated

Active malignancy; any patient with history of

invasive malignancy, unless treated and

asymptomatic for at least 5 years

Presently on medications that can interfere with

bone/soft tissue healing (ie, steroids)

Autoimmune spondyloarthropathies

(rheumatoid arthritis

Active local/systemic infection

Autoimmune spondyloarthropathies

(rheumatoid)

Pregnant

Other metabolic bone disease (ie, Paget's and

osteomalacia)

Morbid obesity (BMI>40 or weight>100 lb over

ideal body weight)

Adapted from Auerbach, Balderston , Spine Journal 2008

CTDR RCT Enrollment

ACDF

265

221

103

164

148(88)

CTDR

276

242

106

81

144

Total

541

463

209

245

380

Mummaneni et. al

Sasso et. al

Murrey et. al

Hisey et. al

Vacarro et. al

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Patient Accountability RCT’s

Combined TDR 2y f/u 584 pts (94%)

Combined ACDF 2y f/u 515 pts (86.9%)

RCT VAS Arm Pain

RCT VAS Arm Pain CTDR RCT VAS Neck Pain

* * * *

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Cervical TDR RCT NDI

*

* * * *

ROM PDC, Prestige, Bryan

7.26 +/- 4.13

degrees

7.67

degrees

95% Fusion

Summary of Combined Results

(Upadhyaya, Haid, Traynelis, Coric, Tay, Trost, Mummaneni,)

NDI

SF-36 MCS

SF-36 PCS

VAS Neck Frequency

VAS Neck Intensity

VAS Arm Frequency

VAS Arm Intensity

Neurologic Success

All Secondary Surgery

Surgery for ASD

Favor Arthroplasty Favor ACDF Outcome Measure

Not significant

Not significant

Not significant

Not significant

Not significant

Not significant

Not significant

Arthroplasty

Arthroplasty

Arthroplasty with fixed effect model

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0

10

20

30

40

50

60

70

THA TKA ACDF cTDR

preop follow-up

SF-36 PCS SF-36 MCS

Secondary Procedures @ Index Level Prodisc C

(Delamarter et. al SASJ 2010, *Zigler et al)

24 months 48 months 84 months*

ACDF 8.5%

(9 patients

total)

11.3%

(12 patients

total)

16%

(18 patients

total)

ProDisc®-C 1.9%

(2 patients

total)

2.9%

(3 patients total)

5.0%

(6 patients total)

PDC 6 patients had secondary procedures

(1) Index level- implant removal and fusion

ACDF Index level: 8 patients index level revisions (7.5 %)

(3) pseudoarthrosis, posterior supplemental fixation

(3) pseudoarthrosis, anterior revision

(1) plate removed after lift off with dysphagia

(1) laminotomy and foraminotomy

Adjacent level: 12 patients (11.3 %)

(2) adjacent level TDR

(10) adjacent level ACDF

(1) Adjacent level ADR (4) adjacent + index level fusion (w/ ADR

removal at index)

Adjacent level: 5 patients

Secondary Procedures @ Index Level Prestige at 5 years

(Mummaneni and Burkus JNS Spine 2010) Adjacent Level Surgery Significantly Lower at 2 Yrs for PRESTIGE

But at 5 Yrs -

Lower in PRESTIGE Group but NOT Statistically Significant

(Mummaneni and Burkus JNS Spine 2010)

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6.2%

14.3%

1.5%

7.2% 8.8%

24.2%

12.7%

21.7%

0%

5%

10%

15%

20%

25%

30%

12 Months 24 Months 12 Months 24 Months

TDR

ACDF

Inferior Adjacent Segment Superior Adjacent Segment

*

*

*- statistically significant difference in rates between groups (p<0.05)

Adjacent Level Degeneration Mobi-C

Mobi-C

Prodisc-C- reop 7 years

ACDF C-ADR

Total

Reoperations

17.0% 5.8%

Index Level % 7.5% 4.9% (5/103)

Adjacent Level 11.3% 4.9% (5/103)

Slide Courtesy of Jack Zigler MD

Heterotopic Ossification

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Bridging Bone/Nonunion Prodisc-c

• 8/103 C-ADR patients (7.2%) developed bridging bone at 7 years (3 at 2 years)

– 6 patients from same 2 centers

– clinical outcomes were good

• 4/106 ACDF’s (3.8%) had nonunions that did not require reoperation

Slide Courtesy of Jack Zigler MD

Difference in Occurrence of Heterotopic Ossification

According to Prosthesis Type in the Cervical Artificial

Disc Replacement SPINE 2010

Seong Yi, MD, PhD,* Keung Nyun Kim, MD, PhD,* Moon Sul Yang, MD,*

Joong Won Yang, MD,* Hoon Kim, MD,* Yoon Ha, MD, PhD,* Do Heum Yoon, MD, PhD,*

and Hyun Chul Shin, MD, PhD†

(10) (15) (9)

Pimenta

Spine 2007 3 y PCM 2.18% reop rate 71 53 12 4

Schluessmann

(SWISS Spine)

Spine 2010

min 2y 2 complications and 6

revisions in 2lvl grp 691 117

Discover

Medtronic

Discocerv

Baguera C

PDC

Goffin

Spine 2003 6 y Bryan

5 comps

0 Device rel comps 103 43

1-2 y Bryan 4 comps in 2lvl grp 89 9 Goffin

JNS Spine 2010

Jawahar

Spine J 2010 4y

ASD rate equivalent bet ACDF

and TDR 28 43 6 16

Kineflex-c,

Mobi-c,

Advent

Cheng

Int’l Orthop 2009 Bryan 2y No device related comps 31 34

Kim

J Kor Nsg Soc 2009 29.2 m Bryan Excellent 61.5%

15 good 28.8%

5 fair 9.6%

36 13 3

Kim ESJ 2009 Bryan 12 28

1lvl 2 lvl 1 lvl 2lvl 3 lvl 4 lvl Brand F/U Study Observations

cTDA ACDF

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VAS 2lvl Bryan

Kim ESJ 2009

VAS 2-level cTDA

Jawahar The Spine Journal 2010

SWISSspine Registry Group SPINE 2010

NDI Multilevel cTDA

Jawahar The Spine Journal 2010

Cheng International Orthop 2009

SF-36 PCS multilevel cTDA

Cheng International Orthop 2009

Goffin JNS Spine 2010

Goffin Spine 2003

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Mobi-C Patient Groups

105 patients were randomized to the control

group and treated with ACDF

– Anterior cervical plate and allograft bone

225 patients were randomized to the

investigational group and treated with Mobi-C

VAS Arm Pain 2-level Mobi-C

VA

S P

ain

Sco

re

VAS Neck Pain 2-level Mobi-C

0

10

20

30

40

50

60

70

80

90

100

baseline 6 weeks 3 months 6 months 12 months 18 months 24 months

VA

S P

ain

Sco

re

TDR

ACDF* *

*- statistically significant mean difference from baseline in favor of Mobi-C (p<0.05)

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Mean NDI Scores 2 Level Mobi-C

0

10

20

30

40

50

60

70

80

90

100

baseline 6 weeks 3 months 6 months 12 months 18 months 24 months

Mobi-C

ACDF

* *

* * * *

* - significant improvement from baseline in favor of Mobi-C (p<0.05)

ND

I Sco

re

Mobi-C 2-Level Study: Re-operations within

24 months

3.1%

11.4%

0%

2%

4%

6%

8%

10%

12%

Mobi-C ACDF

Reo

pera

tions

Adjacent Level Degeneration

0%

5%

10%

15%

20%

25%

30%

35%

12mo 24mo . 12mo 24mo

Mobi-C

ACDF

Superior Segment Inferior Segment

*

*

*

*

Per

cen

tag

e o

f p

atie

nts

wit

h in

crea

sed

deg

ener

atio

n o

f se

gm

ent

fro

m b

asel

ine

* Significantly different rates between groups (p<0.05)

Comparison of 1 and 2 Level Study

Arms – Study Success

0%

10%

20%

30%

40%

50%

60%

70%

80%

6 Months 12 Months 18 Months 24 Months

1- Level Mobi-C

1- Level ACDF

2-Level Mobi-C

2-Level ACDF

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Multilevel cTDR

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229 patients

71 patients had single level PCM

69 patients had multilevel PCM

2 level 3 level 4 level

53 pts 12 pts 4 pts

Superiority of Multilevel Cervical Arthoplasty Outcomes Versus

Single-Level Outcomes Luiz Pimenta MD, Paul C. McAfee MD, Andy Cappuccino MD, Bryan

Cunningham MSc., Roberto Diaz MD, Etevaldo Coutinho MD

SPINE 2007

3rd Generation Cervical Discs

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Conclusions

Single level cTDR is safe and effective in short and

intermediate term follow-up 7 years

2 lvl cTDR (Mobi-C) outcomes are good and are

comparable to single level cTDR outcomes

Little data exist for > 2lvl cTDR

Data is mixed on the ability of cTDR to slow down ASD

Newer technologies have a potential to be better but may

create a new set of complications