Lumbar Arthroplasty CHARITÉ® Artificial Disc Physician Name Physician Institution Date

Lumbar ArthroplastyCHARITÉ® 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 re-establish lordotic alignment

• Fixed-core design • Fixed axis (nonfloating) center of rotation• Translation is never independent from rotation

Demonstrated in preclinical testing.

Dilip K. Sengupta, MD, PhD

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

Avg 1.9 (.98) mm

Intact spine

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 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. 2003;28:S110-S117. BAK is a registered trademark of Zimmer, Inc.

CHARITÉArtificial

Disc

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

110%

IntactSpine

BAK® BAK+Screws

L3-L4(Adjacent level)

L4-L5(Operative level)

L5-S1(Adjacent Level)R

OM

Dis

trib

uti

on (

%)

CHARITÉArtificial

Disc

10%

20%

30%

40%

50%

60%

70%

80%

90%

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110%

IntactSpine

BAK® BAK+Screws




OM

Dis

trib

uti

on (

%)

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

110%

IntactSpine

BAK® BAK+Screws




OM

Dis

trib

uti

on (

%)

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 adjacent-

level 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

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 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).

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 Panjabi’s

data

CHARITÉ Artificial Disc

Fixed core

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

-21

-19

-16

-13

-11

-8

-5

-3

0

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

3 Mpa

24 Mpa


CHARITÉ Artificial Disc

Fixed core

Comp. Stress-24

-21

-19

-16

-13

-11

-8

-5

-3

0

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

Days in Package0 200 400 600 800 1000 1200 1400 1600

Rea

ctiv

ity

to O

xid

atio

n

0.00

0.20

0.40

0.60

0.80

1.00

1.20

1.40

GVF at RT (same lot)

G-Air-1,16, & 40 mos.

GVF-1,16, 40, & 50 mos.

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


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 outcomesScott 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 outcomesPaul 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.

*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.

CHARITÉ Artificial Disc vs Stand-alone Interbody Fusion

Authors & YearNo. ofCases

Approach/Instrumentation

% Change in Mean VAS

(799 patients)

Change in Mean ODI (1186

patients)Pfeiffer et al, 1996 80 ALIF w/ auto -35.7

Tiusanen et al, 1996 83 ALIF w/ auto -18.3

Kuslich et al, 1998* 299 BAK ALIF + BAK/PLIF -41.2

Kuslich et al, 2000 185 BAK ALIF + BAK/PLIF -44.8Madan & Boeree et al, 2001 27 ALIF w/ HH -31.4 -26.4Burkus et al, 2002A 22 Allo BD auto ALIF -33.1 -22.5Burkus et al, 2002A 24 Allo BD BMP-2 ALIF -54.6 -33.5Burkus et al, 2002B 108 LT auto ALIF -50.9 -31.3

122 LT BMP-2 ALIF -53.8 -33.4

68 ALIF w/ IntFix -21.6

Pellise et al, 2002 12 ALIF w/ Br -69.2

Beutler & Peppelman, 2003 104 BAK ALIF -24.0

Burkus et al, 2003 285 LT auto ALIF -26.3

215 LT BMP-2 ALIF -31.3

Sasso et al, 2004 48 FRALIF -21.2

Weighted mean -45.5 -27.9CHARITÉ IDE Study n=276 -60.4 -26.3

Results of meta-analysis involving studies in which ODI and VAS scores were reported: stand-alone ALIF or PLIF

INFUSEIDE

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 & YearNo. ofCases

Approach/Instrumentation

% Change in Mean

VAS (591 patients)

Change in Mean ODI (162 patients)

Soini, 1994 27 FRALIF ExtPed -47.9 -19.0

Gertzbein et al, 1996 67 FRALIF -70.4

Hinkley & Jaremko, 1997 81 AlloBDauto ALIF -14.1

Gertzbein et al, 1998 51 FRALIF -40.5

Whitecloud et al, 1998 35 Mesh ALIF -23.6

Leufven & Nordwall, 1999 29 Auto PLIF -61.6

Tandon et al, 1999 53 Br PLIF -12.1

Barrick et al, 2000 18 Delayed FRALIF -40.5 -8.7

Brantigan et al, 2000 92 Br PLIF -60.0

Thalgott et al, 2000 46 Mix ALIF -56.0

Lowe et al, 2002 40 Mesh TLIF -61.4

Thalgott et al, 2002 20 200 ALIF -61.8 -29.0

Thalgott et al, 2002 50 Mesh ALIF -57.3

Madan, 2003 35 Mix PLIF -52.4 -36.0

Weighted mean -49.1 -20.6

CHARITÉ IDE Study n=276 -60.4 -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.

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.

IDE Trial: Statistical Analysis

0 10 20 30 40 50 60 70 80 90 100 0 10 20 30 40 50 60 70 80

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

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.

VAS ODI

2 Years’ Follow-up

Non-Normal DistributionAll CHARITÉ Artificial Disc and BAK Patients n=375

ODI CHARITÉ Artificial Disc vs 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.

Preop 6 wk 3 mo 6 mo 12 mo 24 mo

Follow-up Time Point

Mean

OD

I (F

un

cti

on

) S

core

CHARITÉ Artificial Disc Replacement Fusion Control

P=0.0015

P=0.0004

P=0.0004 P=0.020

3

P=0.0218

**

* * *

0

10

20

30

40

50

60n=375

VASCHARITÉ Artificial Disc vs Control

P=0.0030P=0.0014P=0.0002P=0.014

7

P=0.0089

* * * * *

0

10

20

30

40

50

60

70

80


Mean

VA

S (

Pain

) S

core

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.

n=375

Follow-up Time Point

CHARITÉ Artificial Disc Replacement Fusion Control

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

0

10

20

30

40

50

60


Follow-up

Ages 18-45 Ages 46-60

Mean

OD

I S

core

s

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


0

10

20

30

40

50

60

70

80

Mean

VA

S S

core

sP=0.8436


Follow-upAges 18-45 Ages 46-60

Outcomes Based on Age—Patient Satisfaction


Ages 18-45 Ages 46-60

0

10

20

30

40

50

60

70

80

Satisfied Somewhat Satisfied

SomewhatDissatisfied

Dissatisfied

Perc

en

t87% Satisfied/somewhat

satisfied 85% Satisfied/somewhat

satisfied

Outcomes Based on Age—Range of Motion

P=0.0704

6.97.7

5.56.3

0

12

345

6

789

Preop 3 mo 6 mo 12 mo 24 mo

Fle

x/E

xt

RO

M (

deg

)


Follow-up

Ages 18-45 Ages 46-60

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 insertion21. 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


• 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 sitesMethods

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.


• 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)






P=0.0034

5-Year Adjacent-Level Survivorship Analysis


P=0.0350

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


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;18:353-359.

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. 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

ReferencesIn 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).


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.

ReferencesIn 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.

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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.

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Documents

Lumbar Arthroplasty CHARITÉ® Artificial Disc Physician Name Physician Institution Date