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ByWilliam F Young, M.D. NeuroSpine and Pain Center / Fort Wayne, Neurological Center

Lumbar Spinal Stenosis:Symptoms and Treatment

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Disclosures

I have received nothing of value as it relates to the X-stop device or Medtronic inc.

This includes but is not limited to money, stock , gifts etc.

Nor has any of my family

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William F Young, M.D. Medical School - Cornell Univ. Medical College Residency Neurosurgery Temple University Hospital

Philadelphia, Pa. Fellowship in Spine Surgery N.Y.U. Practiced in Philadelphia , Pa. for 10 years at Temple

University Hospital ( Director of the NeuroSpine program ) 10 years practicing in Fort Wayne in association with the

Fort Wayne Neurological Center /NeuroSpine and Pain Center

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Medical Philosophy

Primum Non Nocere

“First do no harm”

Hippocrates (460-370 B.C.)

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Introduction

Anatomy of the Spine – Helpful Terms

Clinical Presentation

Symptoms of Lumbar Spinal Stenosis

Treatment Options

Non-Operative & Surgical Treatment

A New Alternative

Agenda

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8 - 11% Incidence of LSS in the U.S.1

LSS is the most common reason for spine surgery in older people2

More than 125,000 laminectomy procedures were performed for LSS in 20033

Financial impact and lost work hours reaches billions of dollars each year in the U.S.4

1. Murphy et al, BMC Musculoskeletal disorders, 2006, Jenis et al, Spine 2000.2. Murphy et al, BMC Musculoskeletal disorders, Sepals, European Spine Journal, 20033. The Ortho FactBook™; U.S. 5th Edition; Solucient, LLC and Verispan, LLC4. Knowledge Enterprises, Inc.

Lumbar Spinal Stenosis (LSS)

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Anatomy of the Spine

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Understanding your spine:Helpful Terms

Spinous Process

Interspinous space

Vertebra

DiscLumbar Spine(L1-L5)


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Stenotic

Vertebrae provide support for your head and body

Discs act as “shock absorbers” Vertebra protects spinal cord Nerves have space and are not

pinched

As we age, ligaments and bone can thicken

Narrowing is called “stenosis” Narrowing impinges on nerves

in spinal canal and nerve roots exiting to the 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

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Extension – occurs when standing

Flexion – Occurs when sitting or bending forward


Understanding your spine: Helpful Terms

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• Sitting or bending forward relieves symptoms

• Standing provokes symptoms

• Pain/weakness in the legs

• Patients lean forward while walking to relieve symptoms


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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


X-STOP Patient Brochure – FDA Patient Labeling

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Lack of activity may lead to: Obesity General physical deterioration Depression/other psychological problems Worsening of co-morbidities

Treatment of Degenerative Lumbar Spinal Stenosis, Agency for Health and Quality 2004

Burden of Lumbar Spinal Stenosis

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Treatment Options

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Lumbar Spinal Stenosis Treatment Options

Surgical Care Laminectomy Laminectomy with

Fusion Micro Endoscopic

Decompressive Laminectomy

Laminotomy- facetectomy

Non Operative Care Epidural injections Physical therapy NSAIDs & other drugs Lifestyle modification Exercise & weight reduction

Spinal Stenosis Symptoms: Continuum of Care

Mild SevereModerate

Atlas - Clin Orth Rel Res 2006.

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Non-operative care Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

Reduce swelling and pain, and analgesics to relieve pain Epidural Steroid Injection

Reduce swelling and treat acute pain that radiates to hips or down the legs

May be temporary Typically limited to 3 injections every six months

Physical Therapy, Exercise & Weight Reduction To help stabilize the spine Build endurance Self-limiting activities of daily living

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


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Lumbar Spinal Stenosis Treatment Options Standard of Care: More Severe Symptoms

1. Turner – Spine 19922. Atlas - Clin Orth Rel Res 2006.

Laminectomy Referred to as “unroofing” the spine Removal of parts of the vertebra, including:

Lamina (bone) Attached ligaments Facets (bone)

Goal: relieve pressure on spinal cord and nerves by increasing area around spinal canal and neural foramen

Most common surgery for stenosis, may require a fusion1,2

General anesthesia1,2

In-patient procedure1,2

OR time: 1.5 – 4.5 hours1,2

Average length of hospital stay: 4 days1,2

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Lumbar Spinal Stenosis Treatment Options Standard of Care: More Severe Symptoms

Laminectomy and Fusion with or without Instrumentation 3-6 hours surgery Long general anesthetic Significant risk of blood loss and post operative infection 3-5 days in hospital Post operative pain 6-12 weeks of recovery (sometimes longer)

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Lumbar Spinal Stenosis Treatment Options Standard of Care: More Severe Symptoms (pedicle screws and bone graft)

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Complex Spinal Procedures in Elderly (4/10/2010- New York Times)

The percentage of older adults undergoing a complicated fusion procedure for the painful lower-back condition called spinal stenosis has increased steeply, rising fifteen f old from 2002 to 2007, a new study reports.

Researchers said the increase was leading to higher Medicare costs and more life-threatening complications. They noted that although the overall rate of all types of surgery for spinal stenosis fell slightly during the five-year period, the proportion undergoing complex fusion increased to 19.9 per 100,000 Medicare beneficiaries, up from 1.3.

In the complex surgery, more than three vertebrae are fused and both the back and the front of the vertebrae are involved. Alternative procedures are decompression — removal of part of the bone pressing on the nerve — and simple fusion, in which two or three vertebrae are fused and only the front or the back of the vertebrae is involved.

The complex procedure costs almost four times as much as decompression and is associated with three times the rate of life-threatening complications, according to the study.

Earlier studies have not found that the complex surgery leads to better results or greater pain relief, said Dr. Richard A. Deyo, a professor of family and internal medicine at Oregon Health and Science University in Portland and the lead author of the study, published April 7 in The Journal of the American Medical Association.

“It’s hard to argue that the most severe pathology has increased fifteenfold over the same period of time,” Dr. Deyo said, adding: “Surgeons do prefer the more complex procedures. There are financial reasons to prefer them.”

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Surgical Care Laminectomy Laminectomy with

Fusion Micro Endoscopic

Decompressive Laminectomy

Laminotomy- facetectomy

Non Operative Care Epidural injections Physical therapy NSAIDs & other drugs Lifestyle modification

X-STOP® Spacer

Spinal Stenosis Symptoms: Continuum of Care

Mild SevereModerate

Lumbar Spinal Stenosis Treatment Options


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X-STOP® Spacer for Lumbar Spinal Stenosis

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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

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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 or short general anesthetic

Low rate of complications1,2

Not attached to bone or ligaments

1. Zucherman – Spine 20052. X-STOP® IPD® System Instructions For Use (IFU)

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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”

Siddiqui – Spine 2006

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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.

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Percent Patients with Significant Improvement at 2 years

60%57%

73%

48%

63% 59%

72%

47%

0%

25%

50%

75%

100%

SymptomSeverity

PhysicalFunction

PatientSatisfaction

ZCQ Success

X-STOP *Laminectomy **

Comparing X-STOP to Laminectomy

SOURCE: Zucherman – Spine 2005

* Data from Zucherman – Spine 2005 cohort (n = 93)

** Data from Katz – Spine 1999 & Katz – Spinal Stenosis Data. Boston: Harvard Medical School, 2003:1-33 (n=197); These patients were worse at baseline than the X-STOP patients.

(all 3 criteria)

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Compared to traditional LSS surgery, X-STOP benefits include:

Can be done under local anesthesia (short general anesthetic)

Can be done as an outpatient procedure or overnight stay in the hospital

No removal of the lamina (vertebral bone) or ligaments that protect and stabilize the spine

Potential of a shorter recovery

The X-STOP Spacer

X-STOP Patient Brochure – FDA Patient Labeling

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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);

significant scoliosis (Cobb angle greater than 25 degrees);

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;

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

Potential Adverse Events Implant dislodgement /malposition

Infection

Bleeding

Complications of general anesthesia

Failure to relieve symptoms

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See X-STOP® IPD® System Instructions For Use (IFU) for complete product labeling

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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Conclusions

X-Stop is a safe ,effective, minimally invasive alternative for the surgical treatment of lumbar spinal stenosis

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Thanks!

Doris E. Troy – Young R.N., B.S.N. Clinical and Media Coordinator of the X-Stop Clinic

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For More Information

Face Book - type in “X-Stop Clinic”

[email protected]

(260) 460-3122

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Questions & Answers

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