Transcript Lumbar Arthroplasty Overview

Lumbar Arthroplasty
CHARITÉ® Artificial Disc
Physician Name
Physician Institution
Date
Agenda
• Data Review
•
•
•
•
Preclinical: Design and Durability
Investigational Device Exemption (IDE) Trial
Revision
Long-term Results
• Questions and Answers
Goals of Lumbar Total
Disc Replacement
• To maintain segmental spinal motion
• To provide pain relief and increased
patient activity
• To restore disc height and lordosis
• To eliminate postoperative fusion problems,
such as
• Bone graft donor site pain
• Pseudarthrosis
Design:
Total Disc Replacement
• Mobile-core design
• Preclinical testing indicates that the unique
mobile-core design of the CHARITÉ Artificial
Disc is intended to mimic the motion of the
operative spinal segment, maintain segmental
stability, restore proper disc height, and reestablish lordotic alignment
• Fixed-core design
• Fixed axis (nonfloating) center of rotation
• Translation is never independent from rotation
Dilip K. Sengupta, MD, PhD
Demonstrated in
preclinical testing.
Design:
Biomechanical Testing – Translation of the Mobile Core
• Cadaveric study by Cunningham et al demonstrates
that the CHARITÉ Artificial Disc preserves the
kinematics of the intact disc
• Mobile core reproduces natural segmental translation
• Translation is independent of rotation
• Mobile core reproduces natural floating center of rotation
Intact
spine
CHARITÉ
Artificial Disc
Avg 2.06 (.77) mm
Intact spine
Avg 1.9 (.98) mm
Cunningham BW et al. Biomechanical evaluation of total disc replacement arthroplasty: an in vitro human cadaveric model. Spine. 2003;28:S110-S117.
Biomechanical Evaluation of Total
Disc Replacement Arthroplasty:
An In Vitro Human Cadaveric Model
Cunningham BW et al. Biomechanical evaluation of total disc replacement
arthroplasty: an in vitro human cadaveric model. Spine. 2003;28:S110-S117.
BAK is a registered trademark of Zimmer, Inc.
110%
ROM Distribution (%)
• Cunningham et al
• The CHARITÉ Artificial Disc
mimicked the intact spine in
distribution of motion at both
the operative and adjacent
levels
• This study suggests that
natural motion may reduce
adjacent-level disease
100%
L3-L4
(Adjacent
level)
90%
80%
70%
L4-L5
(Operative
level)
60%
50%
40%
L5-S1
(Adjacent
Level)
30%
20%
10%
Intact
Spine
CHARITÉ BAK®
Artificial
Disc
BAK+
Screws
Incidence of Adjacent-level Disease:
Fusion Literature
•
Loss of motion in the operative levels can result in stress and increased
motion in the segments adjacent to the fused level1-3
•
•
•
This stress and increased motion at adjacent levels may lead to adjacentlevel disease with rates of incidence as high as 35%-41%4-9
In a series of 106 lumbar fusion patients with 2 to 15 years’
follow-up, Gillet reported a 20% reoperation rate for symptomatic
lumbar adjacent-level disease6
In a series of 215 lumbar fusion patients with a mean follow-up of
6.7 years, Ghiselli et al reported a reoperation rate of 27.4% with
a predicted rate of reoperation for adjacent-level disease of
36.1% at 10 years, following lumbar fusion surgery9
1 Cunningham BW et al. Biomechanical evaluation of total disc replacement arthroplasty: an in vitro human cadaveric model. Spine. 2003;28:S110-S117.
2 Huang RC et al. The implications of constraint in lumbar total disc replacement. J Spinal Disord Tech. 2003;16:412-417.
3 Chosa E et al. Analysis of the effect of lumbar spine fusion on the superior adjacent intervertebral disk in the presence of disk degeneration using the three-dimensional
finite element method. J Spinal Disord Tech. 2004;17:134-139.
4 Throckmorton TW et al. The impact of adjacent level disc degeneration on health status outcomes following lumbar fusion. Spine. 2003;28:2546-50.
5 Chen WJ et al. Surgical treatment of adjacent instability after lumbar spine fusion. Spine. 2001;26:E519-E524.
6 Gillet P. The fate of the adjacent motion segments after lumbar fusion. J Spinal Disord Tech. 2003;16:338-345.
7 Kumar MN et al. Correlation between sagittal plane changes and adjacent segment degeneration following lumbar spine fusion. Eur Spine J. 2001;10:314-319.
8 Rahm MD et al. Adjacent-segment degeneration after lumbar fusion with instrumentation: a retrospective study. J Spinal Disord Tech. 1996;9:392-400.
9 Ghiselli G et al. Adjacent segment degeneration in the lumbar spine. J Bone Joint Surg Am. 2004;86-A:1497-1503.
Incidence of Adjacent-level Disease:
Long-term CHARITÉ Artificial Disc Clinical Results
• J. P. Lemaire, MD, et al1
• 100 patients
• Minimum of 10-year follow-up
• 2% adjacent-level disease
• Thierry David, MD2
• 106 patients
• Minimum of 10-year follow-up
• 3% adjacent-level disease
Lemaire JP et al. Clinical and radiological outcomes with the Charité™ Artificial Disc: a 10-year minimum follow-up. J Spinal Disord Tech.
2005;18:353-359.
2 David T. Long-term results of one-level lumbar arthroplasty: minimum 10-year follow-up of the CHARITÉ Artificial Disc in 106 patients. Spine.
2007;32(6).
1
Effect of Artificial Disc Placement on
Facet Loading:
Unconstrained vs Semiconstrained
•
•
•
Moumene et al
Finite Element Analysis
demonstrates that the CHARITÉ
Artificial Disc unloads the facets
in all planes of motion
Compared with the CHARITÉ
Artificial
Disc, a fixed-core artificial disc
increases facet loads
•
•
•
•
•
•
161% in axial rotation
24% in flexion/extension
35% in lateral bending
(under displacement control
conditions at L4-L5)
Design may protect facet joints
Model validated to Panjabi’s
data
Moumene M et al. Effect of artificial disc placement on facet loading: unconstrained vs. semiconstrained. Presented at the 4th Annual Meeting of the Spine Arthroplasty Society, May 2004.
Comp. Stress
-24
CHARITÉ Artificial Disc
-21
-19
-16
-13
-11
-8
-5
-3
0
Fixed core
Durability:
The Effects of Design
•
•
Moumene et al
Finite Element Analysis
demonstrates mobile-core
design may exhibit low
stresses on the endplates
and sliding core
•
•
May significantly reduce
wear potential
Under equivalent strain, a
fixed-core artificial disc shows
significantly higher stress
•
May lead to greater
potential for wear
Moumene M et al. Effect of artificial disc placement on facet loading:
unconstrained vs. semi-constrained. Presented at the 4th Annual Meeting of the
Spine Arthroplasty Society, May 2004.
Comp. Stress
-24
3 Mpa
CHARITÉ Artificial Disc
-21
-19
-16
-13
-11
-8
-5
-3
0
24 Mpa
Fixed core
Durability:
Material Biocompatability
• Analysis of porous ingrowth in intervertebral disc
prostheses: a nonhuman primate model
• McAfee et al1
• 6-month survival study
• No local accumulation of particulate wear debris nor
cytokines
• Epidural application of spinal instrumentation
particulate wear debris: an in vitro animal model
• Cunningham et al2
• 6-month survival study
• Under extreme exposure to ultra-high molecular weight
polyethylene (UHMWPE) wear particulate, no evidence of
acute neural or systemic histopathologic response
1 McAfee PC et al. Analysis of porous ingrowth in intervertebral disc prostheses: a nonhuman primate model. Spine. 2003;28:332-340.
2 Cunningham BW. Basic scientific considerations in total disc arthroplasty. Spine J. 2004;4(6S):219S-230S.
Materials:
Changes in UHMWPE
•
UHMWPE joints show reduced
wear and better performance
when oxidation is reduced
(Collier 2003)
Material performance
•
•
2000 (wire change)
X-ray wire optimized to allow
flexibility to eliminate breaks
• No known failures of new wire
•
•
2004 (packaging change)
GVF (foil pkg) greatly reduces
shelf oxidation (Greer 1999)
• Proven track record in DePuy
hips and knees
• Provides better creep
resistance than highly x-linked
• Provides better toughness
more than highly x-linked
1.40
Reactivity to Oxidation
•
G-Air-1,16, & 40 mos.
1.20
GVF-1,16, 40, & 50 mos.
GVF at RT (same lot)
1.00
0.80
0.60
0.40
0.20
0.00
0
200 400 600 800 1000 1200 1400 1600
Days in Package
Summary:
Biomechanics
• The CHARITÉ Artificial Disc mimics the
intact spine, enabling independent rotation
and translation
• Motion may reduce the potential of adjacent-level disease
• Mobile-core design may significantly reduce wear potential
• Biocompatibility (animal studies)
• No local or systemic accumulation of particulate wear debris,
nor cytokines, were detected
• No evidence of acute neural or systemic histopathological
response found under extreme exposure to UHMWPE
wear particulate
Agenda
• Data Review
•
•
•
•
Preclinical: Design and Durability
IDE Trial
Revision
Long-term Results
• Questions and Answers
IDE Trial:
CHARITÉ Artificial Disc
•
•
IDE study results published in July 2005
Multicenter, prospective, randomized, controlled study to compare 2
different surgical treatments for lumbar degenerative disc disease
(DDD)
A prospective, randomized, multicenter Food and Drug
Administration investigational device exemptions study of lumbar
total disc replacement with the CHARITÉ Artificial Disc versus
lumbar fusion: part I: evaluation of clinical outcomes
Scott Blumenthal MD, Paul C. McAfee MD, Richard D. Guyer MD, Stephen H. Hochschuler MD,
Fred H. Geisler MD, PhD, Richard T. Holt MD, Rolando Garcia Jr. MD, MPH, John J. Regan MD
and Donna Ohnmeiss PhD
A prospective, randomized, multicenter Food and Drug
Administration investigational device exemptions study of lumbar
total disc replacement with the CHARITÉ Artificial Disc versus
lumbar fusion: part II: evaluation of radiographic outcomes and
correlation of surgical technique accuracy with clinical outcomes
Paul C. McAfee MD, Bryan Cunningham Mmech Eng, Gwen Holsapple BS, Karen Adams BS,
Scott Blumenthal MD, Richard D. Guyer MD, Anton Dimitriev MS, James H Maxwell MD, John J.
Regan MD and Jorge Isaza MD
IDE Trial:
CHARITÉ Artificial Disc Level 1 Data—24 Months
• At 24 months, the CHARITÉ Artificial Disc was demonstrated to
be safe and effective for DDD at 1 level from L4-S1
• High patient satisfaction
• At 24 months, 74% of patients with the CHARITÉ Artificial Disc
were satisfied versus 53% of fusion patients
• At 24 months, the CHARITÉ Artificial Disc maintained motion
• Allowed segmental spinal motion at the operative level versus loss
of motion in the fusion patients
• Improvement in pain and function
• 71.0% achieved a 25% improvement in Oswetry Disability Index
(ODI) scores compared to baseline versus 62.0% in the control
group
• 78% had at least a 10-pt. change in ODI
• 0% psuedoarthrosis versus 9.1% in the control group
• 0% bone graft donor pain versus 18.2% in the control group
Blumenthal SL et al. A prospective randomized, multicenter food and drug administration investigational device exemptions study of lumbar total disc
replacement with the CHARITÉ Artificial Disc versus lumbar fusion: part I: evaluation of clinical outcomes. Spine. 2005;301:565-575.
McAfee PC et al. A prospective randomized, multicenter food and drug administration investigational device exemptions study of lumbar total disc replacement
with the CHARITÉ Artificial Disc versus lumbar fusion: part II: evaluation of radiographic outcomes and correlation of surgical technique accuracy with clinical
outcomes. Spine. 2005;30:1576-1583.
BAK as the Control
• FDA requires that IDE study-control groups incorporate only
FDA-approved devices
• A meta-analysis of the fusion literature included 25 papers and
29 separate data sets with 360º fusion involving anterior lumbar
interbody fusion (ALIF), posterior lumbar interbody fusion
(PLIF), or transforaminal lumbar interbody fusion (TLIF), and
stand-alone fusion with ALIF or PLIF
• CHARITÉ Artificial Disc compared favorably in mean change in ODI
and visual analog scores (VAS) to all other treatments
• Comparing the clinical results as measured by ODI, BAK
subjects in the CHARITÉ Artificial Disc trial performed similarly
to 360º fusion subjects from the ProDisc® trial
Geisler FH et al. Neurological complications of lumbar artificial disc replacement and comparison of clinical results with those related to lumbar arthrodesis in
the literature: results of a multicenter, prospective, randomized investigational device exemption study of Charité intervertebral disc. J Neurosurg Spine.
2004;1:143-154.
CHARITÉ Artificial Disc
vs Stand-alone Interbody Fusion
Results of meta-analysis involving studies in which ODI and VAS scores were reported:
stand-alone ALIF or PLIF
% Change in
Mean VAS
(799 patients)
No. of
Cases
Approach/
Instrumentation
Pfeiffer et al, 1996
Tiusanen et al, 1996
80
83
ALIF w/ auto
ALIF w/ auto
Kuslich et al, 1998*
299
BAK ALIF + BAK/PLIF
-41.2
Kuslich et al, 2000
Madan & Boeree et al, 2001
Burkus et al, 2002A
Burkus et al, 2002A
Burkus et al, 2002B
185
27
22
24
108
122
68
12
104
285
215
48
BAK ALIF + BAK/PLIF
ALIF w/ HH
Allo BD auto ALIF
Allo BD BMP-2 ALIF
LT auto ALIF
LT BMP-2 ALIF
ALIF w/ IntFix
ALIF w/ Br
BAK ALIF
LT auto ALIF
LT BMP-2 ALIF
FRALIF
-44.8
-31.4
-33.1
-54.6
-50.9
-53.8
Authors & Year
Pellise et al, 2002
Beutler & Peppelman, 2003
Burkus et al, 2003
Sasso et al, 2004
Weighted mean
CHARITÉ IDE Study n=276
*Pain scale scores were converted to VAS score equivalent.
Geisler FH. Spine Arthroplasty Summit, Salt Lake City, February 2006.
HH = Harshill horseshoe cage; IntFix = internal fixation; LT = LT-Cage.
Change
in Mean ODI (1186
patients)
-35.7
-18.3
-45.5
-60.4
-26.4
-22.5
-33.5
-31.3
-33.4
-21.6
-69.2
-24.0
-26.3
-31.3
-21.2
-27.9
-26.3
INFUSE
IDE
CHARITÉ Artificial Disc
vs 360°Fusion
Results of meta-analysis involving studies in which ODI and VAS scores were
reported: 360° fusion via ALIF, PLIF, or TLIF8
Authors & Year
Soini, 1994
Gertzbein et al, 1996
Hinkley & Jaremko, 1997
Gertzbein et al, 1998
Whitecloud et al, 1998
Leufven & Nordwall, 1999
Tandon et al, 1999
Barrick et al, 2000
Brantigan et al, 2000
Thalgott et al, 2000
Lowe et al, 2002
Thalgott et al, 2002
Thalgott et al, 2002
Madan, 2003
Weighted mean
CHARITÉ IDE Study n=276
No. of
Cases
Approach/
Instrumentation
27
67
81
51
35
29
53
18
92
46
40
20
50
35
FRALIF ExtPed
FRALIF
AlloBDauto ALIF
FRALIF
Mesh ALIF
Auto PLIF
Br PLIF
Delayed FRALIF
Br PLIF
Mix ALIF
Mesh TLIF
200 ALIF
Mesh ALIF
Mix PLIF
% Change in
Mean
VAS (591
patients)
Change
in Mean
ODI (162
patients)
-47.9
-70.4
-14.1
-40.5
-23.6
-19.0
-61.6
-12.1
-40.5
-60.0
-56.0
-61.4
-61.8
-57.3
-52.4
-49.1
-60.4
-8.7
Table Adapted From: Geisler FH et al.
Neurological complications of lumbar
artificial disc replacement and
comparison of clinical results with
those related to lumbar arthrodesis in
the literature: results of a multicenter,
prospective, randomized
investigational device exemption
study of Charite intervertebral disc.
J Neurosurg Spine. 2004;1:143-154.
Geisler FH et al. Spine Arthroplasty
Summit, Salt Lake City, February
2006.
-29.0
-36.0
-20.6
-26.3
Allo = allograft; AlloBDauto = allograft bone dowels filled with autograft; auto = autograft; Br = Brantigan Cage;
ExtPed = external transpedicular fixation; FRALIF = femoral ring allograft ALIF; mesh = titanium mesh cage; mix = mixed grafts.
IDE Trial: Statistical Analysis
IDE Trial:
Alternative Statistical Analysis
• What is clinically significant improvement?
• ODI reduction of 10 points
• VAS reduction of 18-19 points
• Why is the Wilcoxon Rank Sum Test the appropriate statistical
test?
• Nonparametric test for non-normally distributed data
VAS
ODI
2 Years’
Follow-up
0
10 20
30 40 50 60 70 80 90 100
0
10 20
30 40 50 60 70 80
All CHARITÉ Artificial Disc and BAK Patients n=375
Non-Normal Distribution
Hägg et al. The clinical importance of changes in outcome scores after treatment for chronic low back pain.
Eur Spine J. 2003;12:12–21.
ODI
CHARITÉ Artificial Disc vs Control
Mean ODI
(Function) Score
n=375
60
50
P=0.0015
P=0.0004 P=0.0004
P=0.0218
*
P=0.0203
40
*
30
*
*
*
20
10
0
Preop
6 wk
3 mo
6 mo
12 mo
24 mo
Follow-up Time Point
CHARITÉ Artificial Disc Replacement
Fusion Control
Wilcoxon Rank Sum Test.
Geisler FH et al. Alternative statistical testing demonstrates superiority of lumbar arthroplasty clinical outcomes at
2 years vs. fusion for the treatment of one-level lumbar degenerative disc disease at L4-5 or L5-S1. Presented at SAS6, Montreal, May 2006.
VAS
CHARITÉ Artificial Disc vs Control
n=375
Mean VAS (Pain) Score
80
70
60
50
P=0.0030 P=0.0014 P=0.0002
40
*
*
30
*
P=0.0147
*
P=0.0089
*
20
10
0
Preop
6 wk
3 mo
6 mo
12 mo
24 mo
Follow-up Time Point
CHARITÉ Artificial Disc Replacement
Fusion Control
Wilcoxon Rank Sum Test.
Geisler FH et al. Alternative statistical testing demonstrates superiority of lumbar arthroplasty clinical outcomes at
2 years vs. fusion for the treatment of one-level lumbar degenerative disc disease at L4-5 or L5-S1. Presented at SAS6, Montreal, May 2006.
Wilcoxon Rank Sum Test
• In this analysis, patients
treated with the CHARITÉ
Artificial Disc had statistically
better clinical outcomes, as
measured by ODI and VAS
at all time points, compared
to the BAK fusion control
group
• P<0.05 at all time points
including
2 years
• Highly significant
improvement in pain and
function at all time points
compared to baseline
Geisler FH et al. Alternative statistical testing demonstrates superiority of lumbar arthroplasty clinical
outcomes at 2 years vs. fusion for the treatment of one-level lumbar degenerative disc disease at L4-5
or L5-S1. Presented at SAS6, Montreal, May 2006.
Patient Selection:
The Effects of Age
on Clinical Outcomes
Ages 18–45 vs 46–60
ODI Outcomes Based on Age
P=0.5717
Mean ODI Scores
60
50
40
30
20
10
0
Preop
6 wk
3 mo
6 mo
12 mo
24 mo
Follow-up
Ages 18-45
Ages 46-60
Using Student’s t Test.
Guyer RG et al. One-level lumbar arthroplasty in patients 18-45 years of age vs. patients 46-60 years of age: is there a difference in clinical outcome? Presented at the
annual meeting of the North America Spine Society, Seattle, September 2006.
VAS Outcomes Based on Age
80
Mean VAS Scores
70
P=0.8436
60
50
40
30
20
10
0
Preop
6 wk
3 mo
6 mo
12 mo
Follow-up
Ages 18-45
Ages 46-60
24 mo
Using Student’s t Test.
Guyer RG et al. One-level lumbar arthroplasty in patients 18-45 years of age vs. patients 46-60 years of age: is there a difference in clinical outcome? Presented at the
annual meeting of the North America Spine Society, Seattle, September 2006.
Outcomes Based on Age—
Patient Satisfaction
80
87% Satisfied/somewhat satisfied
70
85% Satisfied/somewhat satisfied
Percent
60
50
40
30
20
10
0
Satisfied
Somewhat
Satisfied
Ages 18-45
Somewhat
Dissatisfied
Dissatisfied
Ages 46-60
Using Student’s t Test.
Guyer RG et al. One-level lumbar arthroplasty in patients 18-45 years of age vs. patients 46-60 years of age: is there a difference in clinical outcome? Presented at the
annual meeting of the North America Spine Society, Seattle, September 2006.
Outcomes Based on Age—
Range of Motion
Flex/Ext ROM (deg)
P=0.0704
9
8
7
6
5
4
3
2
1
0
7.7
6.9
6.3
5.5
Preop
3 mo
6 mo
12 mo
24 mo
Follow-up
Ages 18-45
Ages 46-60
Using Student’s t Test.
Guyer RG et al. One-level lumbar arthroplasty in patients 18-45 years of age vs. patients 46-60 years of age: is there a difference in clinical outcome? Presented at the
annual meeting of the North America Spine Society, Seattle, September 2006.
IDE Trial:
Clinical Outcomes Based on Age
• Comparator groups ages 18-45 versus 46-60
• No statistical difference in VAS, ODI, patient
satisfaction, and ROM at 24 months
• Higher incidence of osteoporosis and
osteopenia in older patients requires
preoperative screening
• If older patients are otherwise indicated for
total disc replacement, age alone up to age
60 should have no effect on their clinical
outcome
Summary: IDE Trial
• Level I data supporting safety and efficacy at 24 months in the
treatment of DDD at 1 level from L4 to S1
• In the IDE trial, 74% of the patients with the CHARITÉ Artificial
Disc exhibited high levels of satisfaction, maintained motion,
and showed improvement in pain and function, as measured by
the VAS at 24 months and compared to baseline
• Significantly better clinical outcomes in terms of VAS and ODI
scores compared to function at all time points through 24
months, using an alternative statistical method from that used in
the original analysis of the IDE study data (ie, Wilcoxon Rank
Sum Test)
Agenda
• Data Review
•
•
•
•
Preclinical: Design & Durability
IDE Trial
Revision
Long-term Results
• Questions & Answers
Published Worldwide Revision Rates
•
Worldwide third-generation CHARITÉ Artificial Disc
•
•
•
JP Lemaire, MD1 : reported rate of 5%
(in 100 patients with a maximum of 10-years’ follow-up)
M Scott-Young, MD2: reported rate of 2.7%
(in a series of 182 patients over 7 years)
United States clinical trial3,4
•
5.4% of CHARITÉ Artificial Disc implanted patients versus 9.1% of fusion
patients
• Similar complications were observed with the CHARITÉ Artificial Disc and BAK
procedures
•
No significant difference in complication rate between the CHARITÉ Artificial Disc and
the control group
1 Lemaire JP et al. Clinical and radiological outcomes with the Charité™ Artificial Disc: a 10-year minimum follow-up. J Spinal Disord Tech. 2005;18:353-359.
2 Scott-Young, M. Revision strategies for lumbar disc replacement. Presented at the annual meeting of the North American Spine Society, September 2004. Spine J.
2004;4:1155.
3 Blumenthal SL et al. A prospective, randomized, multicenter Food and Drug Administration investigational device exemptions study of lumbar total disc replacement with
the CHARITÉ Artificial Disc versus lumbar fusion: part I - evaluation of clinical outcomes. Spine. 2005;30:1565-1575.
4 McAfee PC et al. A prospective, randomized, multicenter Food and Drug Administration investigational device exemptions study of lumbar total disc replacement with the
CHARITÉ Artificial Disc versus lumbar fusion: part II: evaluation of radiographic outcomes and correlation of surgical technique accuracy with clinical outcomes. Spine.
2005;30:1576-1583.
Revision Strategies and Fixation
• Primary revision strategy is
instrumented posterolateral
lumbar fusion
• Prosthesis acts as an
anterior column spacer
• Posterior pedicle screw
fixation combined with
CHARITÉ Artificial Disc was
shown to be not statistically
different from pedicle
screws combined with
femoral ring allograft
Cunningham BW et al. Multidirectional flexibility properties of single versus multi-level CHARITÉ total
disc arthroplasty – an emphasis on revision strategies. Presented at SAS5, New York, May 2005.
Revision Strategies and Fixation
• Endplate fixation teeth
• Vertebral body sparing
• The teeth, as compared to a keel, allow intraoperative
adjustment and removal for proper positioning
• Preserves the possibility of revision with (TDR)
• Keel design
• No ability to revise with TDR “burns the bridge”
• Difficult to revise, may require a corpectomy
• No ability to adjust positioning
• Proper positioning has been correlated with improved clinical
outcomes in the Charite Artificial Disc trial1
• Possibility of fracturing endplate during insertion2
1. McAfee PC et al. A prospective randomized, multicenter food and drug administration investigational device exemption study of lumbar total disc replacement with the
CHARITÉ Artificial Disc versus lumbar fusion: part II - evaluation of radiographic outcomes and correlation of surgical technique accuracy with clinical outcomes.
Spine. 2005;30:1576-1583.
2. Shim CS et al. Vertical split fracture of the vertebral body following total disc replacement using ProDisc: report of two cases. J Spinal Disord Tech. 2005;18:465-469.
5-Year Implant
Survivorship Analysis
5-Year Implant Survivorship Analysis
Methods
• Kaplan-Meier regression
analysis to predict rate of
5-year implant survivorship
• 8 high-enrolling sites
• N=1938 CHARITÉ patients
from 5 countries
• N=56 BAK fusion patients
from 4 IDE sites
McAfee et al. Implant and Adjacent-Level Survivorship of the CHARITÉ Artificial Disc – 1938 Cases from Eight Leading Spine Centers Worldwide: A Kaplan-Meier
Analysis. Presented at the 2007 Joint Section on Disorders of the Spine meeting, Phoenix, AZ, March 2007.
5-Year Implant Survivorship Analysis
• CHARITÉ Artificial Disc implant predicted to have a
longer implant survival profile
• Significant difference in implant survivorship in the CHARITÉ
Artificial Disc group (93.1%), as compared to the fusion
group (80.1%) p=0.0034
• Implant survivorship = no reoperation of any kind at the
index level
• The rate of adjacent-level disease requiring
reoperation was significantly less in the CHARITÉ
Artificial Disc group
• 4.4% compared to the BAK cage fusion group 11.0%
(p=0.0350)
McAfee et al. Implant and Adjacent-Level Survivorship of the CHARITÉ Artificial Disc – 1938 Cases from Eight Leading Spine Centers Worldwide: A Kaplan-Meier
Analysis. Presented at the 2007 Joint Section on Disorders of the Spine meeting, Phoenix, AZ, March 2007.
5-Year Implant Survivorship Analysis
McAfee et al. Implant and Adjacent-Level Survivorship of the CHARITÉ Artificial Disc – 1938 Cases from Eight Leading Spine Centers Worldwide: A Kaplan-Meier
Analysis. Presented at the 2007 Joint Section on Disorders of the Spine meeting, Phoenix, AZ, March 2007.
5-Year Implant Survivorship Analysis
P=0.0034
McAfee et al. Implant and Adjacent-Level Survivorship of the CHARITÉ Artificial Disc – 1938 Cases from Eight Leading Spine Centers Worldwide: A Kaplan-Meier
Analysis. Presented at the 2007 Joint Section on Disorders of the Spine meeting, Phoenix, AZ, March 2007.
5-Year Adjacent-Level
Survivorship Analysis
P=0.0350
McAfee et al. Implant and Adjacent-Level Survivorship of the CHARITÉ Artificial Disc – 1938 Cases from Eight Leading Spine Centers Worldwide: A Kaplan-Meier
Analysis. Presented at the 2007 Joint Section on Disorders of the Spine meeting, Phoenix, AZ, March 2007.
Summary: Revision
• Primary revision strategy is instrumented
posterolateral lumbar fusion
• 5-year implant survivorship analysis
• Significant difference in survivorship in CHARITÉ
Artificial Disc group (93.41), as compared to the
fusion group (80.1%) at 5 years (P=0.003)
Agenda
• Data Review
•
•
•
•
Precinical: Design and Durability
IDE Trial
Revision
Long-term Results
• Questions and Answers
Lumbar Disc Prosthesis:
Minimum 5-Year Follow-up Study on 96 Patients
(With Current Design)
• T. David, MD
• Patient satisfaction
• 75% good/excellent results
• Disc height maintenance
• No loss of height
• No device-related complications
• No loosening of the UHMWPE
sliding core
David T. Lumbar disc prosthesis: five years follow-up study on 96 patients. Presented at the annual meeting of the North American Spine Society, New
Orleans, Louisiana, October 2000.
Clinical and Radiological Outcomes
With the CHARITÉ Artificial Disc:
A 10-Year Minimum Follow-up (With Current Design)
• J. P. Lemaire MD, et al
• 100 patients with a minimum of 10-year follow-up
• Excellent patient satisfaction
• 90% good/excellent results
• Motion preservation
• 10.3º mean ROM flexion/extension
• 5.4º mean ROM lateral bending
• Quality of life
• 92% return to work
• Minimal adjacent-level disease
• 2% adjacent-level disease
Lemaire JP et al. Clinical and radiological outcomes with the Charité™ Artificial Disc: a 10-year minimum follow-up. J Spinal Disord Tech. 2005;18:353359.
16-Year Experience
• Thierry David, MD
• Single-level DDD
• Minimum 10-year follow-up
in 106 pts
10-year postop
F/E: 19° (+5,+14)
Lateral: 11°
(+8,+3)
• 82% excellent/good clinical
outcomes
• 90% return to work
• 7% secondary fusion
• 3% adjacent-level disease
• Mean F/E ROM 10.1°
• 90% of the prostheses
were still mobile
David T. Long-term results of one-level lumbar arthroplasty: minimum 10-year follow-up of the CHARITÉ Artificial Disc in 106 Patients. Spine.
2007;32(6):661-6.
Summary: Long-term Results (With
Current Design)
• T. David, MD, 5-year follow-up study on
96 patients
• 75% good/excellent results
• J. P. Lemaire, MD, 10-year follow-up study with 100
patients
• 90% good/excellent results
• 2% adjacent-level disease
• T. David, MD, minimum 10-year follow-up in
106 patients
• 82% excellent/good clinical outcomes
• 3% adjacent-level disease
CHARITÉ® ARTIFICIAL DISC
• The CHARITÉ Artificial Disc is indicated for spinal arthroplasty in
skeletally mature patients with degenerative disc disease (DDD)
at one level from L4-S1.
• DDD is defined as discogenic back pain with degeneration of
the disc confirmed by patient history and radiographic studies.
• These DDD patients should have no more than 3mm of
spondylolisthesis at the involved level.
• Patients receiving the CHARITÉ Artificial Disc should have failed
at least six months of conservative treatment prior to
implantation of the CHARITÉ Artificial Disc.
Questions and Answers
References
In Order of Appearance
Cunningham BW et al. Biomechanical evaluation of total disc replacement arthroplasty: an in vitro human cadaveric model. Spine.
2003;28:S110-S117.
Huang RC et al. The implications of constraint in lumbar total disc replacement. J Spinal Disord Tech. 2003;16:412-417.
Chosa E et al. Analysis of the effect of lumbar spine fusion on the superior adjacent intervertebral disk in the presence of disk degeneration
using the three-dimensional finite element method. J Spinal Disord Tech. 2004;17:134-139.
Throckmorton TW et al. The impact of adjacent level disc degeneration on health status outcomes following lumbar fusion. Spine.
2003;28:2546-2550.
Chen WJ et al. Surgical treatment of adjacent instability after lumbar spine fusion. Spine. 2001;26:E519-E524.
Gillet P. The fate of the adjacent motion segments after lumbar fusion. J Spinal Disord Tech. 2003;16:338-345.
Kumar MN et al. Correlation between sagittal plane changes and adjacent segment degeneration following lumbar spine fusion. Eur Spine J.
2001;10:314-319.
Rahm MD et al. Adjacent-segment degeneration after lumbar fusion with instrumentation: a retrospective study. J Spinal Disord Tech.
1996;9:392-400.
Ghiselli G et al. Adjacent segment degeneration in the lumbar spine. J Bone Joint Surg Am. 2004;86-A:1497-1503.
Lemaire JP et al. Clinical and radiological outcomes with the Charité™ Artificial Disc: a 10-year minimum follow-up. J Spinal Disord Tech.
2005;18:353-359.
David T. Long-term results of one-level lumbar arthroplasty: minimum 10-year follow-up of the CHARITÉ Artificial Disc in 106 patients. Spine.
2007;32(6).
Moumene M et al. Effect of artificial disc placement on facet loading: unconstrained vs. semi-constrained. Presented at the 4th Annual
Meeting of the Spine Arthroplasty Society, May 2004.
McAfee PC et al. Analysis of porous ingrowth in intervertebral disc prostheses: a nonhuman primate model. Spine.
2003;28:332-340.
Cunningham BW. Basic scientific considerations in total disc arthroplasty. Spine J. 2004;4(6S):219S-230S.
Blumenthal SL et al. A prospective randomized, multicenter food and drug administration investigational device exemptions study of lumbar
total disc replacement with the CHARITÉ Artificial Disc versus lumbar fusion: part I: evaluation of clinical outcomes. Spine.
2005;30:1565-1575.
References
In Order of Appearance
McAfee PC et al. A prospective randomized, multicenter food and drug administration investigational device exemptions study of lumbar total
disc replacement with the CHARITÉ Artificial Disc versus lumbar fusion: part II: evaluation of radiographic outcomes and correlation of
surgical technique accuracy with clinical outcomes. Spine. 2005;30:1576-1583.
Geisler FH et al. Neurological complications of lumbar artificial disc replacement and comparison of clinical results with those related to
lumbar arthrodesis in the literature: results of a multicenter, prospective, randomized investigational device exemption study of Charité
intervertebral disc. J Neurosurg Spine. 2004;1:143-154.
Geisler FH. Spine Arthroplasty Summit, Salt Lake City, February 2006.
Hägg et al. The clinical importance of changes in outcome scores after treatment for chronic low back pain. Eur Spine J. 2003;12:12–21.
Geisler FH et al. Alternative statistical testing demonstrates superiority of lumbar arthroplasty clinical outcomes at 2 years vs. fusion for the
treatment of one-level lumbar degenerative disc disease at L4-5 or L5-S1. Presented at SAS6, Montreal, May 2006.
Guyer RG et al. One-level lumbar arthroplasty in patients 18-45 years of age vs. patients 46-60 years of age: is there a difference in clinical
outcome? Presented at the annual meeting of the North America Spine Society, Seattle, September 2006.
Van Ooij A et al. Complications of artificial disc replacement: a report of 27 patients with the SB Charite disc. J Spinal Disord Tech.
2003;16:369-383.
Scott-Young, M. Revision strategies for lumbar disc replacement. Presented at the annual meeting of the North American Spine Society,
September 2004. Spine. 2004;4:1155.
Cunningham BW et al. Multidirectional flexibility properties of single versus multi-level CHARITÉ total disc arthroplasty – an emphasis on
revision strategies. Presented at SAS5, New York, May 2005.
Shim CS et al. Vertical split fracture of the vertebral body following total disc replacement using ProDisc: report of two cases.
J Spinal Disord Tech. 2005;18:465-9.
McAfee et al. Predicted 5-year implant survivorship of the CHARITÉ Artificial Disc vs. anterior lumbar interbody fusion: a Kaplan-Meier
analysis. Presented at IMAST, Rome, July 2006.
David T. Lumbar disc prosthesis: five years follow-up study on 96 patients. Presented at the annual meeting of the North American Spine
Society, New Orleans, Louisiana, October 2000.