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A Clinical Review of Cervical and Lumbar Arthroplasty

A Clinical Review of Cervical and Lumbar Arthroplasty. Part i: Cervical arthroplasty. Course Objectives. Identify Causes of Cervical Pain Identify Treatment Options Highlight of Clinical Data for Cervical Arthroplasty. objective 1: . Identify Causes of CERVICAL Pain.

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A Clinical Review of Cervical and Lumbar Arthroplasty

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  1. A Clinical Review of Cervical and Lumbar Arthroplasty

  2. Part i: Cervical arthroplasty

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

  4. objective 1: Identify Causes of CERVICAL Pain

  5. Neck Pain and Radiculopathy • 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

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

  7. Degenerative Disc Disease (DDD) • 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

  8. objective 2: Identify Treatment Options

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

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

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

  12. Treatment Options: Surgery • 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)

  13. Treatment Options: Fusion (ACDF) • 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

  14. 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 Fusion Success May Not Always Equal Clinical Success

  15. Clinical Disadvantage of ACDF • 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

  16. Treatment Options: TDR • 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

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

  18. TDR vs ACDF

  19. FDA Approved TDR Devices 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)

  20. Cervical TDR Indications and Contraindications • 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

  21. objective 3: Highlight of Clinical Data for Cervical Arthroplasty

  22. TDR Clinical Evidence • Comparison of BRYAN Cervical Disc Arthroplasty with Anterior Cervical Decompression and Fusion • Heller, et al (Spine 2009, V34, No2, 101-107) 6 463 patients TDR had a higher rate of success TDR patients returned to work 13 days earlier

  23. TDR Clinical Evidence • Clinical and Radiographic Analysis of Cervical Disc Arthroplasty Compared with Allograft Fusion • Mummaneni, et al, (J Neurosurg Spine 2007, V6 198-209) 7 541 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. TDR Clinical Evidence • Long-term Clinical and Radiographic Outcomes of Cervical Disc Replacement with the Prestige Disc • Burkus, et al (J Neuosurg Spine 13, 301-318, 2010) 8 144 patients TDR patients had statistically significant differences in NDIscores TDR patients demonstrated higher neurologic success Revision rates were statistically significantly lower for TDR patients

  25. TDR Clinical Evidence • 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, 275-286) 9 209 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

  26. TDR Clinical Evidence • Five-year Reoperation Rates, Cervical Total Disc Replacement Versus Fusion • Delamarter, et al (SPINE Volume 38, Number 9, pp 711–717) 10 209 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)

  27. TDR Clinical Evidence • 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) 11 209 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

  28. QUESTIONS?

  29. PART II: LUMBAR ARTHROPLASTY

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

  31. objective 1: Identify Causes of Lumbar Pain

  32. Lumbar Pain • 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

  33. Causes of Lumbar Pain • 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)

  34. Causes of Lumbar Pain • 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

  35. Causes of Lumbar Pain • 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)

  36. Degenerative Cascade 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

  37. objective 2: Identify Treatment Options

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

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

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

  41. Treatment Options: Surgery • 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)

  42. TDR vs Lumbar Fusion

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

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

  45. Lumbar TDR Indications and Contraindications • 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

  46. objective 3: Highlight of Clinical Data for Lumbar Arthroplasty

  47. TDR Clinical Evidence • Results of PRODISC® L TDR Versus the Circumferential Fusion for the Treatment of 1-Level DDD • Zigler, et al (SPINE 2007, V32, NO11, 1155-1162) 13 286 patients 97% follow-up rate In properly chosen patients, PRODISC® L has been shown to be superior to circumferential fusion by multiple clinical criteria

  48. TDR Clinical Evidence • 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) 14 577 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

  49. TDR Clinical Evidence • Five-year Results PRODISC® L Versus Circumferential Arthrodesis for the treatment of single-level DDD • Zigler, et al (J Neurosurg: Spine.  October 19, 2012) 15 286 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

  50. TDR Clinical Evidence • Five-Year Adjacent-level Degenerative Changes in Patients Treated Using PRODISC® L Versus Fusion • Zigler, et al (J Neurosurg Spine. 2012 Dec; 17(6):504-11) 16 286 patients Fusion patients were 3times 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).

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