1 DJ5895D A CLINICAL REVIEW OF CERVICAL AND LUMBAR ARTHROPLASTY

DJ5895D PART I: CERVICAL ARTHROPLASTY

3 DJ5895D 1.Identify Causes of Cervical Pain 2.Identify Treatment Options 3.Highlight of Clinical Data for Cervical Arthroplasty Course Objectives

DJ5895D OBJECTIVE 1: IDENTIFY CAUSES OF CERVICAL PAIN

5 DJ5895D  Neck pain is a common reason for visiting a doctor Over 6 million patient visits per year in the US for neck pain Represents 1.5 % of all health care visits to hospitals and physician offices 1  Main causes of neck pain Soft Tissue Strain Fractures Facet Joints Cervical Disc Disorders Neck Pain and Radiculopathy

6 DJ5895D  Pain can be accompanied by numbness in the neck and or arms and can limit daily activities/ability to work Neck Pain and Radiculopathy

7 DJ5895D  Natural process that ultimately affects all of us as we age Nucleus Dehydrates Loss of Disc Height Annulus Cracks /Tears Daily activities or trauma can accelerate the degenerative process Degenerative Disc Disease (DDD)

DJ5895D OBJECTIVE 2: IDENTIFY TREATMENT OPTIONS

9 DJ5895D  In most cases, DDD responds to conservative care Physical Therapy Chiropractic Care Spinal Injections Bed Rest Bracing Analgesics / NSAIDS Treatment Options: Conservative Care

10 DJ5895D  If the disability or pain is non-responsive to conservative care, surgery may be considered Treatment Options: Conservative Care

11 DJ5895D  The primary goal of surgery is decompression of the neural structures Reduce pressure on spinal nerves or spinal cord Treatment Options: Surgery

12 DJ5895D  The surgeon must stabilize or reconstruct the spine after decompression Option 1: Anterior Discectomy with Fusion (ACDF) Option 2: Total Disc Replacement /Spinal Arthroplasty (TDR) Treatment Options: Surgery

13 DJ5895D  Traditionally, ACDF is the procedure of choice 50 years of clinical experience Widely accepted technique  The goal of ACDF is to fuse two vertebrae, stabilize the spine, and prevent motion  Fusion is very successful, with fusion rates typically above 90% 2 Treatment Options: Fusion (ACDF)

14 DJ5895D Fusion Success May Not Always Equal Clinical Success Clinical Disadvantage of ACDF  Adjacent level disease 25.9% of cervical fusion patients predicted to have second surgery within 10 years 3  Hardware (plate and screws) may impact adjacent levels 23.7% of ACDF patients developed moderate to severe ossification at adjacent level 4

15 DJ5895D  Adjacent level will compensate for loss of motion at fused level Fusion causes increased compensation at the adjacent segments, which is postulated to accelerate the degenerative process 5 Clinical Disadvantage of ACDF

16 DJ5895D  TDR is a Newer Procedure Compared to ACDF 20+ years of clinical experience with TDR in the cervical spine  Like total joint replacement procedures, TDR uses a mobile implant to restore stability and allow the potential for motion Treatment Options: TDR

17 DJ5895D  Rationale for TDR Restore Mechanical Stability Following Decompression Maintain Disc Height Decelerate Adjacent Level Degeneration Allow Potential For Motion Treatment Options: TDR

18 DJ5895D TDRACDF Anterior Cervical Approach Neural Decompression In or Out Patient Stabilize Operative Site Restore Disc Height Allow Potential for Motion Potential To Slow the Rate of Adjacent-Level Disease TDR vs ACDF

19 DJ5895D Prestige-ST ® (Medtronic, approved 2007) PRODISC® C (DePuy Synthes Spine, approved 2007) Bryan ® (Medtronic, approved 2009) PCM ® (NuVasive, approved 2012) Secure-C ® (Globus, approved 2012) Mobi-C ® (LDR, approved 2013) FDA Approved TDR Devices

20 DJ5895D  Indications Skeletally Mature One Symptomatic Disc (C3-C7) Neck or Arm Pain for at Least 6 Weeks that has Not Responded to Conservative Care  Contraindications Active Infection Osteoporosis or Osteopenia Allergies or Sensitivity to Implant Material Instability Clinically Compromised Vertebral Bodies at the Affected Level due to Current or Past Trauma Cervical TDR Indications and Contraindications

DJ5895D OBJECTIVE 3: HIGHLIGHT OF CLINICAL DATA FOR CERVICAL ARTHROPLASTY

22 DJ5895D 463 patients TDR had a higher rate of success TDR patients returned to work 13 days earlier TDR Clinical Evidence Comparison of BRYAN Cervical Disc Arthroplasty with Anterior Cervical Decompression and Fusion Heller, et al (Spine 2009, V34, No2, ) 6 Comparison of BRYAN Cervical Disc Arthroplasty with Anterior Cervical Decompression and Fusion Heller, et al (Spine 2009, V34, No2, ) 6

23 DJ5895D Clinical and Radiographic Analysis of Cervical Disc Arthroplasty Compared with Allograft Fusion Mummaneni, et al, (J Neurosurg Spine 2007, V ) 7 Clinical and Radiographic Analysis of Cervical Disc Arthroplasty Compared with Allograft Fusion Mummaneni, et al, (J Neurosurg Spine 2007, V ) 7 TDR Clinical Evidence 541 patients TDR was found to be equivalent or superior to ACDF ACDF group had 4.5 times more reoperations than the TDR group TDR patients returned to work 16 days earlier TDR patients return to work at a statistically significantly higher rate compared to the ACDF patients

24 DJ5895D Long-term Clinical and Radiographic Outcomes of Cervical Disc Replacement with the Prestige Disc Burkus, et al (J Neuosurg Spine 13, , 2010) 8 Long-term Clinical and Radiographic Outcomes of Cervical Disc Replacement with the Prestige Disc Burkus, et al (J Neuosurg Spine 13, , 2010) patients TDR patients had statistically significant differences in NDI scores TDR patients demonstrated higher neurologic success Revision rates were statistically significantly lower for TDR patients TDR Clinical Evidence

25 DJ5895D Results of the PRODISC® C TDR Versus ACDF for the Treatment of 1-Level Symptomatic Cervical Disc Disease Murrey, et al (Spine Journal 2009, V9, ) 9 Results of the PRODISC® C TDR Versus ACDF for the Treatment of 1-Level Symptomatic Cervical Disc Disease Murrey, et al (Spine Journal 2009, V9, ) patients TDR patients had a statistically significant reduction in the use of strong medications (narcotics or muscle relaxants) PRODISC® C is a safe and effective surgical treatment for patients with disabling cervical radiculopathy By all primary and secondary measures evaluated, TDR was found to be equivalent or superior to ACDF TDR Clinical Evidence

26 DJ5895D Five-year Reoperation Rates, Cervical Total Disc Replacement Versus Fusion Delamarter, et al (SPINE Volume 38, Number 9, pp 711–717) 10 Five-year Reoperation Rates, Cervical Total Disc Replacement Versus Fusion Delamarter, et al (SPINE Volume 38, Number 9, pp 711–717) patients 5 times more re-operations in the ACDF group (2.9% vs. 14.5%) 56% of the ACDF reoperations were for adjacent level disease (ALD) TDR Clinical Evidence

27 DJ5895D PRODISC® C and ACDF as Surgical Treatment for Single Level SDDD Five-year Results Zigler, et al (SPINE Volume 38, Number 3, pp 203–209) 11 PRODISC® C and ACDF as Surgical Treatment for Single Level SDDD Five-year Results Zigler, et al (SPINE Volume 38, Number 3, pp 203–209) patients Mean ROM at index level was maintained at 8.14  compared to 8.49  pre-op Patient satisfaction was maintained as indicated on VAS Statistically significant improvement of neck pain intensity and frequency TDR Clinical Evidence

DJ5895D QUESTIONS?

DJ5895D PART II: LUMBAR ARTHROPLASTY

30 DJ5895D 1.Identify Causes of Lumbar Pain 2.Identify Treatment Options 3.Highlight of Clinical Data for Lumbar Arthroplasty Course Objectives

DJ5895D OBJECTIVE 1: IDENTIFY CAUSES OF LUMBAR PAIN

32 DJ5895D  Affects about 80% of the US population 12  Only outnumbered by the common cold in absenteeism from work  Only a small percentage of cases ultimately require surgery Lumbar Pain

33 DJ5895D  Most commonly, back pain is caused by muscle strain  Back pain can also be caused by degenerative conditions or trauma Spinal Stenosis Osteoarthritis Bone Fractures Osteomyelitis Spondylolisthesis Degenerative Disc Disease (DDD) Causes of Lumbar Pain

34 DJ5895D  Disc degeneration or traumatic injury can damage the outer layers of the disc (annulus)  Annulus may weaken or tear, allowing the inner disc material (nucleus) to herniate Causes of Lumbar Pain

35 DJ5895D  Disc degeneration and or herniation can cause: Spinal Cord or Nerve Root Compression Neurologic Impairment Axial Back Pain Radicular Pain Injury of the Disc Can Impact Spine Function and Lead to Further Degeneration (Degenerative Cascade) Causes of Lumbar Pain

36 DJ5895D Loss of Disc Height Loss of Motion Change in Spinal Balance Formation of Osteophytes Increased Load on the Facets/Ligaments Impingement on Spinal Cord or Nerves Degenerative Cascade

DJ5895D OBJECTIVE 2: IDENTIFY TREATMENT OPTIONS

38 DJ5895D  In most cases, back pain responds to conservative care Physical Therapy Chiropractic Care Spinal Injections Bed Rest Bracing Analgesics / NSAIDS Treatment Options: Conservative Care

39 DJ5895D  If the disability or pain is non-responsive to conservative care, surgery may be considered Treatment Options: Conservative Care

40 DJ5895D  The primary goal of surgery is to remove pain generators and restore disc height Treatment Options: Surgery

41 DJ5895D  The surgeon must stabilize or reconstruct the spine after decompression Option 1: Lumbar Fusion (posterior, lateral or anterior) Option 2: Total Disc Replacement /Spinal Arthroplasty (TDR) Treatment Options: Surgery

42 DJ5895D TDRFUSION Neural Decompression Remove Pain Generators Restore Disc Height Stabilize Operative Site Restore Spinal Balance Allow Potential for Motion Potential To Slow the Rate of Adjacent-Level Disease TDR vs Lumbar Fusion

43 DJ5895D  Approach Options TDR is performed through an anterior approach only Fusion can be performed through a posterior, posterolateral, lateral and/or anterior approach TDR vs Lumbar Fusion

44 DJ5895D PRODISC® L (DePuy Synthes Spine, approved 2006) FDA Approved TDR Devices

45 DJ5895D  Indications Skeletally Mature DDD at One Level from L3 to S1 No More than Grade 1 Spondylolisthesis at the Involved Level Failed at Least 6 Months of Conservative Treatment  Contraindications Active Systemic Infection Osteoporosis or Osteopenia Boney Lumbar Spinal Stenosis Allergies or Sensitivity to Implant Material Isolated Radicular Compression Syndromes Pars Defect Lytic Spondylolisthesis or Degenerative Spondylolisthesis of Grade > 1 Clinically Compromised Vertebral Bodies at the Affected Level due to Current or Past Trauma Lumbar TDR Indications and Contraindications

DJ5895D OBJECTIVE 3: HIGHLIGHT OF CLINICAL DATA FOR LUMBAR ARTHROPLASTY

47 DJ5895D Results of PRODISC® L TDR Versus the Circumferential Fusion for the Treatment of 1-Level DDD Zigler, et al (SPINE 2007, V32, NO11, ) 13 Results of PRODISC® L TDR Versus the Circumferential Fusion for the Treatment of 1-Level DDD Zigler, et al (SPINE 2007, V32, NO11, ) patients 97% follow-up rate In properly chosen patients, PRODISC® L has been shown to be superior to circumferential fusion by multiple clinical criteria TDR Clinical Evidence

48 DJ5895D Maverick TDR Versus Anterior Lumbar Interbody Fusion with the INFUSE Bone Graft / LT-CAGE Device Gornet, et al (The Spine Journal Volume 7, Issue 5, Supplement, Page 1S, September 2007) 14 Maverick TDR Versus Anterior Lumbar Interbody Fusion with the INFUSE Bone Graft / LT-CAGE Device Gornet, et al (The Spine Journal Volume 7, Issue 5, Supplement, Page 1S, September 2007) patients TDR had statistical superiority over fusion at all follow-up intervals for ODI, SF-36 PCS, back pain scores, and patient satisfaction with surgery TDR patients tend to return to work sooner than fusion patients TDR Clinical Evidence

49 DJ5895D Five-year Results PRODISC® L Versus Circumferential Arthrodesis for the treatment of single-level DDD Zigler, et al (J Neurosurg: Spine. October 19, 2012) 15 Five-year Results PRODISC® L Versus Circumferential Arthrodesis for the treatment of single-level DDD Zigler, et al (J Neurosurg: Spine. October 19, 2012) patients TDR demonstrated equivalent clinical outcomes and non-inferiority compared to spinal fusion at both 2 & 5 years Improvement in ODI, VAS Pain, SF-36, neurologic function, and decrease in narcotic use were maintained at 5 years in TDR patients TDR had a lower overall reoperation rate at 5 years compared with fusion Average range of motion of 7.2 degrees was maintained at 5 years TDR Clinical Evidence

50 DJ5895D Five-Year Adjacent-level Degenerative Changes in Patients Treated Using PRODISC® L Versus Fusion Zigler, et al (J Neurosurg Spine Dec; 17(6):504-11) 16 Five-Year Adjacent-level Degenerative Changes in Patients Treated Using PRODISC® L Versus Fusion Zigler, et al (J Neurosurg Spine Dec; 17(6):504-11) patients Fusion patients were 3 times more likely to experience ALD than were the TDR patients. Changes in ALD at 5 years were observed in 9.2% of TDR patients and 28.6% of fusion patients (p = 0.004). TDR Clinical Evidence

51 DJ5895D  Neck and Back Pain affects 80-90% of the US population 17  Most patients improve with conservative care  Surgery may be considered if pain and disability are non-responsive to conservative treatment Summary

52 DJ5895D  The Primary goal of surgery for these patients is to decompress neural structures, restore neurologic function and eliminate pain  Fusion and Total Disc Replacement have been discussed here as safe and affective surgical options Summary

53 DJ5895D The studies sited here have shown that TDR patients Were more satisfied Returned to work more quickly Required fewer reoperations Had lower incidence of Adjacent Level Disease Maintained greater range of motion When Compared to Fusion patients Summary

DJ5895D QUESTIONS?

55 DJ5895D DJ 5895-C Norton References ReferenceAuthorSourceTitle 1NA The Burden of Musculoskeletal Diseases in the United States 2011 Spine: Low Back and Neck Pain - Chapter 2 2Fraser et alJ Neurosurg Spine 6: , 2007 Anterior approaches to fusion of the cervical spine: a meta-analysis of fusion rates 2Mummaneni et alJ Neurosurg Spine 2007, V6, Clinical and Radiographic Analysis of Cervical Disc Arthroplasty Compared with Allograft Fusion: A Randomized Controlled Clinical Trial 2Murrey et alSpine Journal 2009, V9, Results of the Prospective, Randomized, Controlled, Multicenter Food and Drug Administration Investigational Device Exemption Study of the PRODISC® C Total Disc Replacement Versus Anterior Discectomy and Fusion for the Treatment of 1-Level Symptomatic Cervical Disc Disease 3Hilibrand et alJ Bone Joint Surg Am Apr;81(4): Radiculopathy and Myelopathy at Segments Adjacent to the Site of a Previous Cervical Arthrodesis 4Park et elJ Bone Joint Surg Am Mar;87(3): Development of adjacent-level ossification in patients with an anterior cervical plate 5Schwab et alSPINE Volume 31, Number 21, pp 2439– Motion Compensation Associated With Single-Level Cervical Fusion: Where Does the Lost Motion Go? 6Heller et al SPINE Volume 34, Number 2, pp 101–107 ©2009, Lippincott Williams & Wilkins Comparison of BRYAN Cervical Disc Arthroplasty with Anterior Cervical Decompression and Fusion 7Mummaneni et alJ Neurosurg Spine 2007, V6, Clinical and Radiographic Analysis of Cervical Disc Arthroplasty Compared with Allograft Fusion: A Randomized Controlled Clinical Trial 8Burkus et alJ Neurosurg Spine 13:308–318, 2010 Long-term clinical and radiographic outcomes of cervical disc replacement with the Prestige disc: Results from a prospective randomized controlled clinical trial 9Murrey et alSpine Journal 2009, V9, Results of the Prospective, Randomized, Controlled, Multicenter Food and Drug Administration Investigational Device Exemption Study of the PRODISC® C Total Disc Replacement Versus Anterior Discectomy and Fusion for the Treatment of 1-Level Symptomatic Cervical Disc Disease

56 DJ5895D DJ 5895-C Norton References ReferenceAuthorSourceTitle 10Delamarter et alSPINE Volume 38, Number 9, pp 711– Five-year Reoperation Rates, Cervical Total Disc Replacement versus Fusion: Results of a Prospective Randomized Clinical Trial 11Zigler et al SPINE Volume 38, Number 3, pp 203–209 PRODISC® C and ACDF as Surgical Treatment for Single Level Cervical Symptomatic Degenerative Disc Disease: Five-Year Results of an FDA Study. Spine 12Viscogliosi BrosSpine Industry Analysis Series Future of Spine Surgery “Beyond Total Disc” 13Zigler et alSPINE 2007, V32, No11, Results of the Prospective, Randomized, Multicenter Food and Drug Administration Investigational Device Exemption Study of the PRODISC® L Total Disc Replacement Versus the Circumferential Fusion for the Treatment of 1-Level Degenerative Disc Disease 14Gornet et alNASS 2007 / The Spine Journal 7 (2007) 1S–163S Maverick Total Disc Replacement versus Anterior Lumbar Interbody Fusion with the INFUSE Bone Graft /LT- CAGE Device: A Prospective, Randomized, Controlled, Multicenter IDE Trial 15Zigler et alJ Neurosurg: Spine. October 19, Five-year results of the prospective, randomized, multicenter, Food and Drug Administration investigational device exemption study of the PRODISC® L total disc replacement versus circumferential arthrodesis for the treatment of single-level degenerative disc disease 16Zigler et al J Neurosurg Spine Dec;17(6): Five-year adjacent-level degenerative changes in patients with single-level disease treated using lumbar total disc replacement with PRODISC® L versus circumferential fusion 17Viscogliosi BrosSpine Industry Analysis Series Future of Spine Surgery “Beyond Total Disc”