Lumbar Spinal Stenosis – Symptoms and Treatment

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2. Lumbar Spinal Stenosis:Symptoms and Treatment

3. Lumbar Spinal Stenosis:Symptoms and Treatment Francis J. Pizzi, M.D., FACS, MBA Diplomate of the American Board Neurological Surgery

5. SpecialtyDifferences • Orthopedic Surgeon • 15% Spine • 85% Other Bones • Focus: Bones, Muscles, Joints • Neurological Surgeon • 85% Spine • 15% Brain and Nerves • Focus: Nerves

6. Lumbar Spinal Stenosis Not too much Magic! Too much pain after working all day to enjoy leisure time Pay the price for what you do Limited “Golden Year” activities

7. What is Lumbar Stenosis? Do I have Lumbar Stenosis? What can I do about it? Non-Operative & Surgical Treatment A New Alternative GOALS

8. 8 - 11% Incidence of LSS in the U.S. 30,000,000 People!! LSS is the most common reason for spine surgery in older people More than 125,000 laminectomy procedures are performed annually for LSS Financial impact and lost work hours reaches billions of dollars each year in the U.S. Lumbar Spinal Stenosis (LSS)

9. Anatomy of the Spine

10. Spinous Process Vertebra Disc Lumbar Spine (L1-L5) Interspinous space Anatomy of the Spine Understanding your spine: Helpful Terms

11. Lumbar Spine

12. Anatomy of the Spine Understanding your spine: Helpful Terms Extension – occurs when standing Flexion – Occurs when sitting or bending forward

13. Vertebrae provide body support Discs act as “shock absorbers” Vertebra protects spinal cord and nerves Nerves have space and are not pinched As we age, ligaments and bone can thicken Narrowing is called “stenosis” Narrowing squeezes nerves in spinal canal and nerve roots exiting spine to legs Result - pain & numbness in back and legs Stenotic Pinched Nerve Root Narrowed Spinal Canal Thickened Ligament Flavum Lumbar Vertebra Healthy Intervertebral Disc Nerve Root Spinal Canal Bone (Facet Joint)

14. Spinal Pain • Axial Pain – Back Pain • From bones, joints, muscles, discs • Neurogenic Pain – Leg Pain +/- Tingles • From nerve irritation

15. Symptoms of Lumbar Spinal Stenosis(Elevator Syndrome) • Standing provokes symptoms • Pain/weakness in the legs • Patients lean forward while walking to relieve symptoms • Sitting or bending forward relieves symptoms

16. Symptoms of Lumbar Spinal Stenosis Classic Presentation: • Dull or aching back pain spreading to your legs • Numbness and “pins and needles” in your legs, calves or buttocks • Weakness, or a loss of balance • A decreased endurance for physical activities

17. Lumbar Spinal StenosisCarries a Burden! Pay the price for physical activity – 24 Hours Lack of activity may lead to: • Obesity • Hermitism • Depression What is so golden about the “Golden Years”?

18. Treatment Options

19. Lumbar Spinal Stenosis Treatment Standard of Care: Mild to Moderate Symptoms Non-operative care • Avoid activities that bring on pain (24 Hour Thermostat) • Impact aerobics • Frequent bending, twisting, lifting • Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), Herbals • Physical Therapy, Chiropractic, Exercise & Weight Reduction • To help stabilize the spine • Lessen the burden on the spine • Reduce irritation of pain sensitive structures

20. Lumbar Spinal Stenosis Treatment Standard of Care: Mild to Moderate Symptoms • Epidural Steroid Injection • Reduce swelling and inflammation of nerves • May or may not be effective (24-48 Hours) • Can break a pain cycle but will not correct underlying problem • Typically limited to 3-4 injections every 12 months

21. Lumbar Spinal Stenosis Treatment Standard of Care: More Severe Symptoms Laminectomy • Un-roofing the spine, Opening the “pipe” • Removal of parts of the vertebra, including: • Lamina (bone) • Attached ligaments • Facets (bone) • Goal: relieve pressure on nerves by increasing size of spinal canal and nerve exit openings • Most common surgery for stenosis, may require a fusion • General anesthesia • In-patient procedure • 6-12 week recovery .

22. Lumbar Spinal Stenosis Treatment Options Spinal Stenosis Symptoms: Continuum of Care Surgical Care • Laminectomy • Laminectomy with Fusion Mild Moderate Severe Non Operative Care • Lifestyle modification • NSAIDs & other drugs • Exercise & weight reduction • PT, Chiropractic • Epidural injections Atlas - Clin Orth Rel Res 2006.

23. Lumbar Spinal Stenosis Treatment Options Spinal Stenosis Symptoms: Continuum of Care Surgical Care • Laminectomy • Laminectomy with Fusion Mild Moderate Severe Non Operative Care • Lifestyle modification • NSAIDs & other drugs • PT, Chiropractic • Epidural injections X-STOP® Spacer .

24. The X-STOP® Spacer Pre-Op Post-Op “Kissing” Spinous Processes • X-STOP Spacer is implanted, separating the spinous processes and relieving pinched nerves • Designed to remain safely and permanently in place • The first Interspinous Spacer approved by FDA to treat the symptoms of LSS

25. The X-STOP® Spacer • Minimally invasive procedure • Rapidly alleviates pain • Typically doesn’t require the removal of bone or tissue • Can be done under local anesthesia • Low rate of complications • Not attached to bone or ligaments

26. The X-STOP® Spacer • Spacer only limits extension • Wings prevent side-to-side and upward migration • Preserves your supraspinous ligament, which prevents backward migration • Preserves anatomy • Treats LSS symptoms, not “anatomy” Supraspinous ligament Spinous process

27. X-STOP® Superior to Non-operative Care (all 3 criteria) Differences between X-STOP and Control groups statistically significant (p < 0.001) at all follow-up intervals. SOURCE: X-STOP® IPD® System Summary of Safety and Effectiveness (SSE); Includes all study sites.

28. The X-STOP Spacer Compared to traditional LSS surgery, X-STOP benefits include: • Can be done under local anesthesia • Can be done as an outpatient procedure • No removal of the lamina (vertebral bone) or ligaments that protect and stabilize the spine • Potential of a shorter recovery

29. Are you a candidate? The X-STOP Spacer is indicated for: • People aged 50 or older • Pain or weakness in the legs • Confirmed diagnosis of lumbar spinal stenosis • Moderately impaired physical function • Experience symptom relief in flexion (sitting) • Completed 6 months of non-operative treatment • Operative treatment indicated at one or two lumbar levels (but no more than 2 levels)

30. X-STOP® IPD® System Instructions For Use (IFU) Contraindications The X STOP is contraindicated in patients with: • an allergy to titanium or titanium alloy; • spinal anatomy or disease that would prevent implantation of the device or cause the device to be unstable in situ, such as: • significant instability of the lumbar spine, e.g., isthmic spondylolisthesis or degenerative spondylolisthesis greater than grade 1.0 (on a scale of 1 to 4); • an ankylosed segment at the affected level(s); • acute fracture of the spinous process or pars interarticularis • significant scoliosis (Cobb angle greater than 25 degrees); • cauda equina syndrome defined as neural compression causing neurogenic bowel or bladder dysfunction; • diagnosis of severe osteoporosis, defined as bone mineral density (from DEXA scan or some comparable study) in the spine or hip that is more than 2.5 SD below the mean of adult normals in the presence of one or more fragility fractures; • active systemic infection or infection localized to the site of implantation.

31. X-STOP® Interspinous Process Decompression (IPD®) System 16000805 Rev 1

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