Lumbar Spinal Stenosis – Lumbar Spinal Stenosis – Symptoms and TreatmentSymptoms and Treatment

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Lumbar Spinal Stenosis:Symptoms and Treatment

Francis J. Pizzi, M.D., FACS, MBA

Diplomate of the American Board Neurological Surgery

Lumbar Spinal Stenosis:Symptoms and Treatment

SpecialtySpecialtyDifferencesDifferences Orthopedic SurgeonOrthopedic Surgeon

– 15% Spine15% Spine– 85% Other Bones85% Other Bones– Focus: Bones, Muscles, Joints Focus: Bones, Muscles, Joints

Neurological SurgeonNeurological Surgeon– 85% Spine85% Spine– 15% Brain and Nerves15% Brain and Nerves– Focus: NervesFocus: Nerves

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

• What is Lumbar Stenosis?

• Do I have Lumbar Stenosis?

• What can I do about it?

– Non-Operative & Surgical Treatment

– A New Alternative

GOALS

• 8 - 11% Incidence of LSS in the U.S.8 - 11% Incidence of LSS in the U.S.30,000,000 People!!30,000,000 People!!

• LSS is the most common reason for spine LSS is the most common reason for spine surgery in older peoplesurgery in older people

• More than 125,000 laminectomy More than 125,000 laminectomy procedures are performed annually for LSS procedures are performed annually for LSS

• Financial impact and lost work hours Financial impact and lost work hours reaches billions of dollars each year in the reaches billions of dollars each year in the U.S.U.S.

Lumbar Spinal Stenosis Lumbar Spinal Stenosis (LSS)(LSS)

Anatomy of the Spine

Understanding your spine:Helpful Terms

Spinous Process

Interspinous space

Vertebra

DiscLumbar Spine(L1-L5)

Anatomy of the Spine

Lumbar Spine

Extension – occurs when standing

Flexion – Occurs when sitting or bending forward

Anatomy of the Spine

Understanding your spine: Helpful Terms

Stenotic

• 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

Nerve Root

Spinal Canal

Lumbar Vertebra

Bone (Facet Joint)

Healthy

Intervertebral Disc

Thickened Ligament Flavum

Pinched Nerve Root

Narrowed Spinal Canal

Spinal Pain

• Axial Pain – Back Pain– From bones, joints, muscles, discs

• Neurogenic Pain – Leg Pain +/- Tingles– From nerve irritation

• Sitting or bending forward relieves symptoms

• Standing provokes symptoms

• Pain/weakness in the legs

• Patients lean forward while walking to relieve symptoms

Symptoms of Lumbar Spinal Stenosis(Elevator Syndrome)

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

Symptoms of Lumbar Spinal Stenosis

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”?

Lumbar Spinal StenosisCarries a Burden!

Treatment Options

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

Lumbar Spinal Stenosis Treatment Standard of Care: Mild to Moderate Symptoms

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

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

.

Lumbar Spinal Stenosis Treatment Options

Surgical Care • Laminectomy• Laminectomy

with Fusion

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

Spinal Stenosis Symptoms: Continuum of CareMild SevereModerate

Atlas - Clin Orth Rel Res 2006.

Surgical Care • Laminectomy• Laminectomy

with Fusion

Non Operative Care

• Lifestyle modification

• NSAIDs & other drugs

• PT, Chiropractic

• Epidural injections

X-STOP® Spacer

Spinal Stenosis Symptoms: Continuum of CareMild SevereModerate

Lumbar Spinal Stenosis Treatment Options

.

The X-STOP® Spacer

• 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

Pre-Op Post-Op

“Kissing” Spinous Processes

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

The X-STOP® Spacer

Supraspinousligament

Spinousprocess

• 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”

Patients with Clinically Significant Improvement(Indicated Population, 24-month follow-up)

6%

54%56%

73%66%64%

6%24%

17%17%0%

25%

50%

75%

100%

SymptomSeverity

PhysicalFunction

PatientSatisfaction

ZCQSuccess

OverallTreatmentSuccess

X-STOP (n = 73)

Control (n = 66)

X-STOP® Superior to Non-operative Care

Differences between X-STOP and Control groups statistically significant (p < 0.001) at all follow-up intervals.

(all 3 criteria)

SOURCE: X-STOP® IPD® System Summary of Safety and Effectiveness (SSE); Includes all study sites.

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

The X-STOP Spacer

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)

X-STOP® IPD® System Instructions For Use (IFU)

ContraindicationsThe 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.

X-STOP® Interspinous Process Decompression

(IPD®) System

16000805 Rev 1

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