Lumbar Arthroplasty CHARIT Artificial Disc

1
Lumbar ArthroplastyCHARITÉ Artificial Disc

• Physician Name
• Physician Institution
• Date

2
Agenda

• Data Review
• Preclinical Design and Durability
• Investigational Device Exemption (IDE) Trial
• Revision
• Long-term Results
• Questions and Answers

3
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

4
DesignTotal 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 re-establish
  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.
5
DesignBiomechanical 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
Cunningham BW et al. Biomechanical evaluation of
total disc replacement arthroplasty an in vitro
human cadaveric model. Spine. 200328S110-S117.
6
Biomechanical Evaluation of Total Disc
Replacement Arthroplasty An In Vitro Human
Cadaveric Model

• 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

Cunningham BW et al. Biomechanical evaluation of
total disc replacement arthroplasty an in vitro
human cadaveric model. Spine. 200328S110-S117.
BAK is a registered trademark of Zimmer, Inc.
7
Incidence of Adjacent-level DiseaseFusion
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 adjacent-level disease with
  rates of incidence as high as 35-414-9
• 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.
200328S110-S117. 2 Huang RC et al. The
implications of constraint in lumbar total disc
replacement. J Spinal Disord Tech.
200316412-417. 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.
200417134-139. 4 Throckmorton TW et al. The
impact of adjacent level disc degeneration on
health status outcomes following lumbar fusion.
Spine. 2003282546-50. 5 Chen WJ et al.
Surgical treatment of adjacent instability after
lumbar spine fusion. Spine. 200126E519-E524. 6
Gillet P. The fate of the adjacent motion
segments after lumbar fusion. J Spinal Disord
Tech. 200316338-345. 7 Kumar MN et al.
Correlation between sagittal plane changes and
adjacent segment degeneration following lumbar
spine fusion. Eur Spine J. 200110314-319. 8
Rahm MD et al. Adjacent-segment degeneration
after lumbar fusion with instrumentation a
retrospective study. J Spinal Disord Tech.
19969392-400. 9 Ghiselli G et al. Adjacent
segment degeneration in the lumbar spine. J Bone
Joint Surg Am. 200486-A1497-1503.
8
Incidence of Adjacent-level DiseaseLong-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

1 Lemaire JP et al. Clinical and radiological
outcomes with the Charité Artificial Disc a
10-year minimum follow-up. J Spinal Disord Tech.
200518353-359. 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. 200732(6).
9
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 ArtificialDisc, 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 Panjabis data

CHARITÉ Artificial Disc
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.
Fixed core
10
DurabilityThe 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

3 Mpa
CHARITÉ Artificial Disc
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.
24 Mpa
Fixed core
11
DurabilityMaterial 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. 200328332-340. 2
Cunningham BW. Basic scientific considerations in
total disc arthroplasty. Spine J.
20044(6S)219S-230S.
12
MaterialsChanges 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

13
SummaryBiomechanics

• 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

14
Agenda

• Data Review
• Preclinical Design and Durability
• IDE Trial
• Revision
• Long-term Results
• Questions and Answers

15
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
16
IDE Trial CHARITÉ Artificial Disc Level 1
Data24 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.
2005301565-575. 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. 2005301576-1583.
17
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.
20041143-154.
18
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
INFUSE IDE
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.
19
CHARITÉ Artificial Disc vs 360Fusion
Results of meta-analysis involving studies in
which ODI and VAS scores were reported 360
fusion via ALIF, PLIF, or TLIF8
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. 20041143-154. Geisler FH
et al. Spine Arthroplasty Summit, Salt Lake City,
February 2006.
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.
20
IDE Trial Statistical Analysis
21
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
All CHARITÉ Artificial Disc and BAK Patients n375
Non-Normal Distribution
Hägg et al. The clinical importance of changes in
outcome scores after treatment for chronic low
back pain. Eur Spine J. 2003121221.
22
ODI CHARITÉ Artificial Disc vs Control
60
n375
50
P0.0015
P0.0004
P0.0218
P0.0004
40

P0.0203
Mean ODI (Function) Score

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.
23
VASCHARITÉ Artificial Disc vs Control
n375
80
70
60
P0.0030
P0.0014
P0.0089
50
P0.0002
P0.0147
40
Mean VAS (Pain) Score





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.
24
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
• Plt0.05 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.
25
Patient Selection The Effects of Age on
Clinical Outcomes Ages 1845 vs 4660
26
ODI Outcomes Based on Age
P0.5717
60
50
40
Mean ODI Scores
30
20
10
0
Preop
6 wk
3 mo
6 mo
12 mo
24 mo
Follow-up
Ages 18-45
Ages 46-60
Using Students 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.
27
VAS Outcomes Based on Age
80
70
P0.8436
60
50
Mean VAS Scores
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 Students 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.
28
Outcomes Based on AgePatient Satisfaction
87 Satisfied/somewhat satisfied
80
70
85 Satisfied/somewhat satisfied
60
50
Percent
40
30
20
10
0
Satisfied
Somewhat Satisfied
Somewhat
Dissatisfied
Dissatisfied
Ages 18-45
Ages 46-60
Using Students 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.
29
Outcomes Based on AgeRange of Motion
P0.0704
9
7.7
8
6.9
6.3
7
5.5
6
5
Flex/Ext ROM (deg)
4
3
2
1
0
Preop
3 mo
6 mo
12 mo
24 mo
Follow-up
Ages 18-45
Ages 46-60
Using Students 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.
30
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

31
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)

32
Agenda

• Data Review
• Preclinical Design Durability
• IDE Trial
• Revision
• Long-term Results
• Questions Answers

33
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.
200518353-359. 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. 200441155. 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.
2005301565-1575. 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.
2005301576-1583.
34
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.
35
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. 2005301576-1583. 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. 200518465-469.
36
5-Year Implant Survivorship Analysis
37
5-Year Implant Survivorship Analysis

• Kaplan-Meier regression analysis to predict rate
  of 5-year implant survivorship
• 8 high-enrolling sites
• N1938 CHARITÉ patients from 5 countries
• N56 BAK fusion patients from 4 IDE sites

Methods
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.
38
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) p0.0034
• 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
  (p0.0350)

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.
39
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.
40
5-Year Implant Survivorship Analysis
P0.0034
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.
41
5-Year Adjacent-Level Survivorship Analysis
P0.0350
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.
42
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 (P0.003)

43
Agenda

• Data Review
• Precinical Design and Durability
• IDE Trial
• Revision
• Long-term Results
• Questions and Answers

44
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.
45
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.
200518353-359.
46
16-Year Experience

• Thierry David, MD
• Single-level DDD
• Minimum 10-year follow-up in 106 pts
• 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

10-year postop F/E 19 (5,14) Lateral 11
(8,3)
David T. Long-term results of one-level lumbar
arthroplasty minimum 10-year follow-up of the
CHARITÉ Artificial Disc in 106 Patients. Spine.
200732(6)661-6.
47
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

48
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.

49
Questions and Answers
50
ReferencesIn Order of Appearance

• Cunningham BW et al. Biomechanical evaluation of
  total disc replacement arthroplasty an in vitro
  human cadaveric model. Spine. 200328S110-S117.
  
• Huang RC et al. The implications of constraint in
  lumbar total disc replacement. J Spinal Disord
  Tech. 200316412-417.
• 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.
  200417134-139.
• Throckmorton TW et al. The impact of adjacent
  level disc degeneration on health status outcomes
  following lumbar fusion. Spine.
  2003282546-2550.
• Chen WJ et al. Surgical treatment of adjacent
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