Lumbar Spinal Stenosis

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Lumbar Spinal Stenosis Symptoms and
Treatment

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Lumbar Spinal StenosisSymptoms and Treatment
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Lumbar Spinal StenosisSymptoms and Treatment
Francis J. Pizzi, M.D., FACS, MBA Diplomate of
the American Board Neurological Surgery
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(No Transcript)
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SpecialtyDifferences

• Orthopedic Surgeon
• 15 Spine
• 85 Other Bones
• Focus Bones, Muscles, Joints
• Neurological Surgeon
• 85 Spine
• 15 Brain and Nerves
• Focus Nerves

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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

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GOALS

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

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Lumbar Spinal Stenosis (LSS)

• 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.

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Anatomy of the Spine
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Anatomy of the Spine

• Understanding your spine
• Helpful Terms

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Lumbar Spine
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Anatomy of the Spine

• Understanding your spine Helpful Terms

Extension occurs when standing
Flexion Occurs when sitting or bending forward
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Lumbar Vertebra
Healthy
Intervertebral Disc
Nerve Root
Spinal Canal
Bone (Facet Joint)

• 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

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Spinal Pain

• Axial Pain Back Pain
• From bones, joints, muscles, discs
• Neurogenic Pain Leg Pain /- Tingles
• From nerve irritation

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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

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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

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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?

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Treatment Options
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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

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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

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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

.
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Lumbar Spinal Stenosis Treatment Options
Spinal Stenosis Symptoms Continuum of Care
Mild
Severe
Moderate

• Surgical Care
• Laminectomy
• Laminectomy with Fusion

• Non Operative Care
• Lifestyle modification
• NSAIDs other drugs
• Exercise weight reduction
• PT, Chiropractic
• Epidural injections

Atlas - Clin Orth Rel Res 2006.
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Lumbar Spinal Stenosis Treatment Options
Spinal Stenosis Symptoms Continuum of Care
Mild
Severe
Moderate

• Surgical Care
• Laminectomy
• Laminectomy with Fusion

• Non Operative Care
• Lifestyle modification
• NSAIDs other drugs
• PT, Chiropractic
• Epidural injections

X-STOP Spacer
.
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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

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The X-STOP Spacer

• Minimally invasive procedure
• Rapidly alleviates pain
• Typically doesnt require the removal of bone or
  tissue
• Can be done under local anesthesia
• Low rate of complications
• Not attached to bone or ligaments

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

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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)

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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.

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