1. Donald R. Johnson, II, MD Medical Director Southeastern Spine Institute MUSC Board of Trustees Past Chairman

2. Advancements in Spinal Surgery What’s New ? What Works? What Can Get An Injured Worker Back To Work What Saves Money?

3. Spinal Anatomy

4. Spinal Stenosis (Narrowing) Spinal stenosis is the narrowing of the bony ring that surrounds the spinal cord. Causes include: –Bone spurs –Disc degeneration –Arthritis –Congenital This condition is most common in elderly people, who have had years of wear-and- tear on their spines

5. Spinal Stenosis Stenosis of the spine can cause pain in the back as well as in other parts of the body. Primary symptom is decreasing ablilty to walk- better with cart in store and better after sitting and bending over Can lead to paralysis and bladder/bowel control

6. Traditional Surgery Laminectomy Usually Multiple Levels

7. Interspinons Distraction for Spinal Stenosis

8. FLEXUS Interspinous Spacer

9. Competitive Products Medtronic X-STOP Paradigm Spine Coflex Abbott Spine Wallis Medtronic DIAM

10. Surgical Technique

11. FLEXUS Surgical Technique Patient PositionPatient Position Prone and in flexionProne and in flexion IncisionIncision 2-3 cm length2-3 cm length MidlineMidline Separate paraspinal muscleSeparate paraspinal muscle on right side

12. FLEXUS Surgical Technique Interspinous PerforatorInterspinous Perforator Create starting hole through interspinous ligamentCreate starting hole through interspinous ligament

13. FLEXUS Surgical Technique Dilator – KEY PREPARATION STEPDilator – KEY PREPARATION STEP Separate the bones(spinous processes)

14. 3 Step Insertion Technique – Trialing 1. Insert horn of trial through interspinous ligament

15. 2.Push trial past midline 3.Rotate trial 90° 3 Step Insertion Technique – Trialing

16. Final Position

18. Discogenic Issues Discogenic Pain –Caused by a damaged disc. While this pain can be felt directly in the lower back, it may also be felt outside of the area of the damaged disc, such as in the buttocks or upper thighs. –Specific movements that put stress on this damaged disc can worsen the pain.

19. Discogenic Issues Pinched Nerve –Also know as radiculopathy, or sciatica, occurs when there is pressure on a nerve to cause irritation and inflammation.

20. Discogenic Issues Bulging or Herniated Disc –Herniated Disc occurs when the jelly-like center (nucleus) of the disc ruptures –Causes material to be pushed outside of the outer ring of the disc –Pressure on the spinal cord and nerve roots cause pain, weakness, and/or numbness to certain areas of the body

21. Degenerative Disc Disease (DDD) DDD is a slow deterioration of the cushions located between vertebrae. Since these discs act as a shock absorber between each vertebra, the reduction or loss of disc height can cause pain. The so-called “degenerative disc” is not getting enough nutrients and will not be able to repair itself once injured.

22. Degenerative Disc Disease (DDD) starts as an annular tear If the outer ring, or annulus fibrosis, tears it can cause back pain. The inner core of a disc, or the nucleus pulpous, is very soft and can cause severe leg pain if it comes into contact with the surrounding nerves.

23. Spondylolisthesis (Spinal Bone Slippage) Occurs when one vertebra slips forward in relation to an adjacent vertebra, usually in the lumbar spine. Symptoms include pain in the low back, thighs and/or legs, muscle spasms, weakness, and/or tight hamstring muscles.

24. Spondylolisthesis (Spinal Bone Slippage) May result from the physical stress placed on the spine - lifting of heavy items, weightlifting, football, gymnastics, trauma, and general wear and tear. As the vertebral components degenerate, the spine’s integrity is compromised.

25. Spondylolisthesis Depending on how far the vertebra has slipped, doctors label spondylolisthesis in four grades, I (one) being the least amount of slippage, all the way up to IV (four), which is the most slippage. Not all cases of spondylolisthesis require surgery.

26. Spinal Fusion Spinal fusion is a surgical procedure in which two or more of the vertebrae in the spine are united together so that motion no longer occurs between them. Between the vertebra- termed INTERBODY! Usually a box(cage) filled with a bone “glue” May be supported by screws(pedicle) to allow glue in boxes to heal by keeping the bone and boxes still. Spinal fusion can restore stability, correct alignment & reduce pain.

27. Interbody Fusion Approaches

28. Posterior Lumbar Interbody (PLIF) Fusion Direct decompression Exposes spinal cord elements Retraction risks to nerves

29. Transforaminal Lumbar Interbody (TLIF) Fusion Avoids spinal sac Direct decompression possible Potential nerve irritation

30. Anterior Lumbar Interbody (ALIF) Fusion Excellent visualization of disc space Avoids spinal cord Approach risks to organs and vascular structures

31. Extreme Lateral Interbody (XLIF)Fusion Approach for L4-L5 and above Reduces muscle trauma L5-S1 not accessible because of pelvis

32. Traditional Surgical Approaches BackFrontBack

33. XLIF ® Surgical Approach eXtreme Lateral Interbody Fusion (XLIF) Advantages: Does not require entry through back muscles, bones, or the retraction of major blood vessels Side

34. Disc Degeneration before XLIF Restoration of Height after XLIF Symptoms –Pain in the back, buttocks, or leg XLIF Correction –Reduces motion between the vertebrae –Corrects alignment –Restores proper disc height –Alleviates pain XLIF ® Indication – Degenerative Disc Disease (DDD)

35. XLIF ® Indication – Spondylolisthesis Symptoms –Impingement of nerves and fatigue of back muscles XLIF Correction –Reduces motion between vertebrae, corrects alignment, and restores disc height Spondylolisthesis (Malalignment) before XLIF Restoration of Alignment and Disc Height after XLIF

36. Degenerative Scoliosis before XLIF Restoration of Alignment after XLIF XLIF ® Indication – Degenerative Scoliosis (Curvature) Symptoms –Back and/or leg pain due to muscle fatigue and nerve impingement XLIF Correction –Restores proper alignment and disc height

39. Axial Lumbar Interbody (AxiaLIF) Fusion Has ability to spare 100% of Annulus Preservation of Tissues & Muscles Dynamic Decompression via Distraction

40. AxiaLIF Pre-Sacral Fusion Unique Features Only interbody graft option where: –No muscle is dissected –No ligaments are cut –The disc annulus is preserved

42. Distraction AxiaLIF Immediate Results Pre OpPost Op

44. Patient Ms. C. F. Dx: Adult Lumbar Scoliosis 1. Lateral diskectomy L1-5 2. Xlif fusion L1-L5 3. Placement of plastic cage with bone glue

45. Pre-op Xrays Right Bending Left Bending

46. Pre-op LMRI Frontal

47. Pre-op Side View

48. Percutaneous (thru the skin) Pedicle Screw Fixation

50. Pre-Op Cross Section

51. 2 Week Post-Op

52. Patient Ms. C. G. Dx: Adult Degenerative Scoliosis 1.Xlif at multiple levels 2.Percutaneous screws and rods

53. Pre-op Xrays

54. Pre-Op MRI Frontal

55. Pre-Op MRI Side View

56. Pre-Op MRI Cross Section

57. 1mo Post-Op

58. 7mo Post-Op

59. Patient Mr. T.A. Dx: Degenerative Disc Disease L5-S1 1. Axialift

60. Pre-Op Xrays

61. Pre-Op MRI Side View

62. Pre-Op MRI Cross Scetion

63. 2 week Post-Op

64. 6mo Post-op

65. Patient Mr. M.B. Dx: Degenerative disc disease with disc space collapse L3-4, L4-5, L5-1. Dx: Annular tear with provocative discogram. 1.Xlif L3-L4, L4-L5 2. Percutaneous pedicle fixation L3, L4, L5, S1 3. Axilift L5-S1

66. Pre-Op Xrays

67. 2wk Post-Op

68. Intraoperative Neuro-Monitoring

69. Cell Mediated Disc Therapy

70. FDA Study Starting March 1 st - first FDA approved study of injection of cells to regrow and heal an injured disc

71. Isotech Davis Adkisson, Ph.D. Founder & Chief Scientific Officer from Summerville, SC

72. Outpatient Spine Surgery- Procedures currently being done at SSI Interspinous distraction Laminectomy/discectomy- single and multiple levels Anterior cervical fusion- 1and 2 levels

73. Anterior Cervical Fusion 32 Cases 3.5 Postop stay in RR before DC- no readmissions

74. Planning: as OUTPT Procedures at SSI Interbody Fusions Anterior lumbar fusion (ALIF) Posterior lumbar fusion (PLIF) XLIF Axialif Percutaneous pedicle screws Average operative time 1 hr at SSI

75. Cost Savings Vs Hospital Based on EOBs obtained from pts is 50-66% cheaper to commercial payers

76. 2010 Workers Comp Fee Schedule (not ▲’d since 2003)-medical provider cost index up 28%

77. Using Medicare Relative Valve Units (RVU’s) Good way to measure many different accounting metrics- but is system appropriate for the young injured worker?

78. Medicare Spine Surgery- most common spine surgeries Spinal Stenosis  X-stop or multiple level laminectomies Compression fx  Kyphoplasty Degenerative Scoliosis  Long Fusions with Screws

79. Workers Compensation- most common spine surgeries Herniated disc  lam/disc or anterior cervical fusion or cervical ADR Annular tear  lumbar disc replacement or interbody fusion or cell mediated therapy Degenerative disc with foraminal stenosis  interbody fusion ± screws Spondylolisthesis  laminectomy and fusion ± screws

80. Medicare not appropriate template for injured worker- especially for spinal care 1. Whats valued in Medicare may not be valued for injured worker 2.Diseases/Medical conditions of spine are different

81. Impact of New WC Fee Schedule on SSI (8-10% of pts) Office visits  12.9% EMG/Nerve  28.8% Injections  6.7% Spine Surgery decreased 10.0% !

82. Thoughts & Considerations Incentive to prolonged nonop care for injured spinal pts Disincentive for surgeons to see Time equals money in WC system May cause delays of definitive treatment and  cost to entire system Issue of surgery for injury worker needs to be addressed by all parties in system Spine cases are the most common and expensive cases in WC