cervical total disc replacement disclosures. tay- cervical disc...cervical total disc replacement...
TRANSCRIPT
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
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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