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Lumbar Arthroplasty CHARITÉ® Artificial Disc

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.

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Lumbar Arthroplasty CHARITÉ® Artificial Disc

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  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. 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 Dilip K. Sengupta, MD, PhD Demonstrated in preclinical testing.

  5. Avg 2.06 (.77) mm Intact spine Avg 1.9 (.98) mm 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 Cunningham BW et al. Biomechanical evaluation of total disc replacement arthroplasty: an in vitro human cadaveric model. Spine. 2003;28:S110-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. 2003;28:S110-S117. BAK is a registered trademark of Zimmer, Inc.

  7. 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.

  8. 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).

  9. Comp. Stress -24 -21 -19 -16 -13 -11 -8 -5 -3 0 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 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. 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 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. 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.

  12. 1.40 G-Air-1,16, & 40 mos. 1.20 GVF-1,16, 40, & 50 mos. GVF at RT (same lot) 1.00 0.80 Reactivity to Oxidation 0.60 0.40 0.20 0.00 0 200 400 600 800 1000 1200 1400 1600 Days in Package 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

  13. 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

  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 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.

  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. 2004;1:143-154.

  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 360°Fusion 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. 2004;1:143-154. 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. 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 VAS ODI 2 Years’ Follow-up 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.

  22. ODI CHARITÉ Artificial Disc vs Control 60 n=375 50 P=0.0015 P=0.0004 P=0.0218 P=0.0004 40 * P=0.0203 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 n=375 80 70 60 P=0.0030 P=0.0014 P=0.0089 50 P=0.0002 P=0.0147 Mean VAS (Pain) Score 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.

  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 • 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.

  25. Patient Selection: The Effects of Age on Clinical Outcomes Ages 18–45 vs 46–60

  26. ODI Outcomes Based on Age P=0.5717 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 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.

  27. VAS Outcomes Based on Age 80 70 P=0.8436 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 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.

  28. Outcomes Based on Age—Patient 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 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.

  29. Outcomes Based on Age—Range of Motion P=0.0704 9 7.7 8 6.9 7 6.3 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 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.

  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. 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.

  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. 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.

  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 • N=1938 CHARITÉ patients from 5 countries • N=56 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%) 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.

  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 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.

  41. 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.

  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 (P=0.003)

  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. 2005;18:353-359.

  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. 2007;32(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. 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.

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