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A patient’s guide to low back pain

If you’ve been struggling with back pain then you know firsthand the impact that the pain can have on your life. Fortunately there are advancements in treating back pain that, after conservative treatments have failed, can help ease your pain and help get you back to living.

A new fusion procedure called AxiaLIF® is changing the way many doctors approach spine fusion — and is making the road to recovery for patients much easier.

Unlike the open spine surgeries of the past, the AxiaLIF® procedure gives surgeons the ability to stabilize painful joints in the spine through very small incisions. The procedure spares the muscles and supporting soft-tissues of the spine which means less surgical trauma and an overall less painful post-operative experience — many patients are released from the hospital the day after surgery.

This guide to low-back pain has been developed to help patients better understand how the spine works, and the conditions that may be causing their pain. Along with highlighting the various procedures used to treat pain in the lumbar spine, this guide will introduce you to the AxiaLIF® procedure that is changing the way people think about back surgery — and helping them get back to living.

The information in this guide is provided for general education and is not intended to replace professional medical care or advice. Only your physician and/or surgeon is qualified to diagnose or recommend treatment for your pain or related conditions.

The least invasive solution to lumbar fusion

The Healthy Spine 5

Understanding the Low Back 7

How We Talk About the Spine 7

The Bones in the Lumbar Spine 8

The Bones in the Sacral Spine 8

The Vertebrae 9

Intervertebral Discs 10

The Spinal Cord and Nerve Roots 11

Facet Joints 12

Conditions Causing Low Back Pain 13

Degenerative Disc Disease 16

Spondylolisthesis 17

Spinal Stenosis 18

Treatments 19

Surgical Treatments 21

Fusion Techniques 22

ALIF 23

PLIF 24

TLIF 25

Lateral Approach 26

AxiaLIF® 27

A Different Approach to Fusion 32

AxiaLIF® Step-by-Step 30

AxiaLIF® Patient Testimonials 33

What to Expect from the Procedure 34

Glossary of Terms 36

Table of Contents

The Healthy Spine

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The human spine is a well-protected structure of bones and joints surrounded by muscles and supporting soft-tissues. We often only come to learn about its unique structure at the time we may be experiencing a problem, such as leg or back pain. In order to understand the source of your pain, it is important to understand the structure of the healthy spine.

The spine consists of 33 bones and is divided into 5 main areas:

- Cervical Spine (Neck) 7 - Vertebrae

- Thoracic Spine (Ribs) 12 - Vertebrae

- Lumbar Spine (Lower Back) 5 - Vertebrae

- Sacral Spine (Pelvis) 5 – Vertebrae (naturally fused)

- Coccyx (Pelvis) 4 – Vertebrae (naturally fused)

Understanding Your Low Back

Your low back, or lumbar spine, bears the majority of the load for the spine. It holds the weight and supports almost every type of movement that your body performs. Because the lumbar spine is under almost constant physical stress its structure may begin to fail over time. This is why the lumbar spine is so commonly the source of back pain.

How We Talk About the Spine

When doctors talk about the spine they refer to each bone in the spine by a letter and a number. As a patient, this initially may be confusing. To simplify the terms, we will focus on how we identify each vertebra in your lower back.

(7) Cervical

Vertebrae

(12) Thoracic

Vertebrae

(5) Lumbar

Vertebrae

Sacral Spine

Coccyx

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The Vertebrae

The vertebrae bear the majority of weight for the spine. The outermost layer of each vertebra consists of hard bone called cortical bone while the inside of the vertebra consists of cancellous bone, a porous bone structure.

The spinal cord passes through the vertebra via a bony ring called the spinal canal. The posterior elements of the spinal cord break into the cauda equina, which is a series of nerves and nerve roots that continues through the spinal canal.

The spinal canal is made up of different parts:

• lamina

• spinous process

• transverse processes

• pedicle

The Bones in Lumbar Spine

The lumbar spine consists of five numbered vertebrae: L1, L2, L3, L4, and L5. The “L” represents the lumbar spine, and the number represents the order in which the vertebrae appear. L5 is the closest vertebra to your tailbone, farthest away from your head. The numbers of the vertebrae get smaller as you move away from the tailbone. Therefore L1 is the farthest lumbar vertebra from the tailbone.

The Bones in Sacral Spine

The bones of the sacral spine are normally fused together. The five fused vertebrae however are still labeled S1 through S5 as if they were separate. The S1 vertebra is the closest to the lumbar spine. The L5/S1 disc space connects the lumbar and sacral spine and is a common source of low back pain.

5 Lumbar Vertebrae

L1

L2

L3

L4

L5

Transverse Process

Spinous Process

Lamina

Pedicle

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The Spinal Cord and Nerve Roots

The spinal cord passes through each vertebra via the spinal canal. When healthy, the vertebral structure helps protect the spinal cord and the sensitive nerves that extend from it. Most low back pain and leg pain associated with spine conditions originates from pressure that is placed on these nerve roots when the bones in the spine become misaligned or move too closely together.

Intervertebral Discs

Between each vertebrae in the spine is a disc that, when healthy, functions as a natural shock absorber between the vertebra and helps maintain proper disc height. The intervertebral disc is made up of two different parts:

• Annulus – a strong, outer ring of fibers that helps keep the vertebra intact

• Nucleus – a soft, jelly-like center consisting mostly of water that helps absorb pressure

Annulus

Nucleus Pulposus

Nerve Roots

Spinal Cord

Intervertebral Discs

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Facet Joints

Facet joints act as connectors for the vertebrae in your spine and are involved in the overall motion of the spine.

There is one facet joint on each side of a vertebra. Known as synovial joints, these joints allow the movement between two bones. Ligaments and soft tissue surround the facet joints and hold synovial fluid which “grease” the joints to decrease friction as they rub together.

Conditions Contributing To Low Back Pain

Facet Joint

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Degenerative Disc Disease

Spondylolisthesis

Stenosis

Painful conditions of the spine may be difficult to understand because often the pain is felt elsewhere, such as in your legs or buttocks. This pain is caused by pressure placed upon the nerves that pass through your spine and extend through the rest of your body.

We’ve seen how the healthy spine works to protect its own structure, including the spinal cord and the nerves that pass through it. We’ll now focus on some conditions that can compromise the normal structure of the spine resulting in nerve compression and pain.

• Degenerative Disc Disease

• Spondylolisthesis

• Stenosis

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Degenerative Disc Disease (DDD)

Degenerative disc disease is not truly a disease. It’s a term used to describe the gradual deterioration of intervertebral discs that may occur naturally with the aging process or as result of injury.

Loss of hydration in the disc can shrink • the disc and compromise its ability to act as a shock absorber between each vertebra

Loss of disc height can place pressure • on the nerve roots causing pain in the buttocks and legs

Ruptured discs can bulge and put • pressure on nerves causing leg and back pain

Common Symptoms

Low back pain•

Pain in legs and/or buttocks•

Pain may increase while sitting or • standing for extended time

Pain may decrease while walking, • or laying down

Spondylolisthesis

Spondylolisthesis occurs when one vertebra slips forward in relation to an adjacent vertebra. The symptoms that accompany spondylolisthesis include pain in the low back, thighs and/or legs, muscle spasms, weakness, and/or tight hamstring muscles.

Degree of slippage classified in grades, • Grade 1 being the least amount, Grade IV the most

Many people affected experience • no pain or symptoms

May result from improper lifting of • heavy items, weightlifting, or high impact sports, such as football or gymnastics

Common Symptoms

Low back pain•

Lordosis (swayback)•

Pain and/or weakness in legs•

Tightness in the hamstrings • (muscles at back of thigh)

Symptoms grow worse with exercise•

Bone Spurs

Degenerative Disc Disease

Forward Slip at L5-S1

Vertebral Bodies

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Treatments

Spinal Stenosis

Spinal stenosis is the narrowing of the canal that surrounds the spinal cord. The narrowing can be caused by the enlargement of joints, arthritis, bone spurs or the calcification of ligaments in the spine. As the canal narrows, pressure may be placed on nerves causing pain and/or numbness felt in the back and legs.

A degenerative condition that is • most common in older adults

Years of wear-and-tear contribute • to the condition

It is possible to be born with • spinal stenosis

Common Symptoms

Low back pain•

Weakness, tingling, numbness • or pain in legs

Standing or walking brings on • symptoms

Rest may reduce symptoms•

Leaning forward often relieves • symptoms

Spinal Stenosis

Bone Spurs

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There are various methods of treating low-back pain including both non-surgical, and surgical techniques. Your doctor will work closely with you to isolate the source of your low-back pain and recommend the course of treatment that is most appropriate for you.

In most cases, a non-surgical treatment will be recommended. Treatments can range from exercise and behavior modification, to medications that reduce pain or swelling, or epidural injections. While some patients may improve with non-surgical treatments, others may try several treatments without success. In such cases, doctors may recommend a surgical treatment.

Surgical Treatments

To alleviate low-back pain there are surgical processes, called spine fusion, that help restore disc height, and immobilize vertebrae to stop motion at painful joints and reduce any unnatural pressure on the neighboring nerve roots. These treatments utilize surgical implants and natural bone graft material that is placed between two vertebrae after the surgical removal of the damaged intervertebral disc material. In healing, the graft material grows in the disc space, joining the two vertebrae together effectively eliminating the painful motion.

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Fusion Techniques

There are several surgical techniques available for spine fusion. Traditional techniques approach the spine directly through open incisions, while newer, minimally invasive techniques approach the spine through small incisions. If you require spine fusion, the fusion techniques selected may depend on the treatment required for your particular case, individual anatomy, or on the preferences of your surgeon.

Traditional Fusion

ALIF • (Anterior Lumbar Interbody Fusion)

PLIF • (Posterior Lumbar Interbody Fusion)

TLIF • (Transforaminal Lumbar Interbody Fusion)

Minimally Invasive Techniques (MIS)

Lateral Interbody Fusion•

MIS TLIF •

Least Invasive Techniques

AxiaLIF• ®

AxiaLIF 2L• ®

ALIF

The ALIF procedure takes an anterior (from the front) approach to the spine through an incision in the abdomen. The procedure is often performed by two surgeons. One general/vascular surgeon may provide access to the spine through the abdomen and ensure all major vessels are successfully retracted away from the surgical approach. The spine surgeon will then proceed to remove all, or a portion of the damaged disc and replace it with a surgical implant and bone graft material. For additional stability, a second posterior(from the back) procedure may be performed to insert support rods or screws.

Surgical time ranges from 3 to 8 hours•

Hospital stay ranges from 3 to 5 days•

Typically a 5-inch incision in abdomen•

Some risk of muscle and tissue scarring •

The procedure does not preserve ligaments • and tissues directly supporting the spine

Risks reported in literature of vascular • injury, nerve injury, incontinence, impotence, muscle and tissue scarring

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PLIF

The PLIF procedure takes a posterior (from the back) approach to the lumbar spine through an incision in the patient’s back. The surgeon must detach and move muscles attached to the vertebrae, and in some cases a portion of vertebral bone called the lamina, may be removed for better visualization and access to the disc space.

Surgical times ranges from 3 to 8 hours•

Hospital stay ranges from 3 to 5 days•

Typically a 6-inch incision•

Dissection of muscle and soft-tissue of • the spine can cause post-operative pain and slow healing process

Risks reported in literature of vascular • injury, nerve injury, incontinence, impotence, muscle and tissue scarring

TLIF

Like the PLIF procedure, TLIF begins with a posterior (from the back) incision, however the surgical angle approaches the vertebra more laterally, or diagonally toward the patient’s side. The altered approach to the spine, compared to PLIF, limits some of the operative trauma to supporting muscle and soft-tissue.

To access the disc space, the surgeon may remove a portion of the lamina (a bone covering the spinal nerves) and all of the facet joint, which is a major stabilizer of the spine. The access route, though less invasive than the PLIF procedure, still involves disruption of muscle, soft-tissue and nerves and it may pose a risk of post-operative pain and complications.

Surgical times range 2 to 4 hours•

Hospital stay ranges from 3 to 5 days•

Typically a 4-inch incision•

Risks reported in literature of vascular • injury, nerve injury, incontinence, impotence, muscle and tissue scarring

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LATERAL APPROACH

The lateral approach is a newer technique that approaches the spine through a small incision in the patient’s side. It avoids the need to cut or remove muscles in the patient’s back to approach the disc space.

The procedure is less traumatic, and can offer better recovery time than open spine procedures; however, the procedure is effective only in treating vertebrae that are easily accessed from the side. This excludes the L5/S1 disc space and frequently L4/L5 in some patients. These are two disc spaces which are often the source of a patient’s back pain and levels that are frequently operated on.

Less invasive than open spine • procedures

Can offer faster patient recovery•

Lateral approach unable to access • the L5/S1 disc space

Access to L4/L5 disc space may be • limited in some patients

Risk of transient numbness and • prolonged thigh pain due to nerve retraction during surgery

AxiaLIF®

The Least Invasive Solution to Lumbar Fusion

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AxiaLIF 360® and AxiaLIF®2L™

The AxiaLIF® procedure is the least invasive approach to lumbar fusion. Rather than accessing the spine from the back, through muscle and supporting soft-tissue, or from the front, through the abdominal cavity — AxiaLIF® approaches the spine from below, through a small 1-inch incision next to the tailbone.

With this approach, no muscles or blood vessels are retracted or dissected, and the nerve roots at the back of the spine are avoided, thus reducing the potential for complications.

Access to the disc space is achieved without compromising the outer supporting structures of this disc, including the annulus and major supporting ligaments. This allows the surgeon to remove the damaged disc from within, without sacrificing the overall disc structure.

A strong, titanium rod is used to engage the vertebral bodies above and below the disc space. This allows the surgeon to restore the height of the disc space which can remove pressure from the nerves.

The AxiaLIF® procedure is the least invasive approach to L5/S1 fusion and AxiaLIF® 2L™ offers a 2-level fusion with a single one-inch incision.

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AxiaLIF® Step-by-Step

Step 1

Degenerative disc and improper disc height before the AxiaLIF® procedure.

Step 2

Access to the diseased disc is obtained

Step 3

Center of the diseased disc is removed

Step 4 Bone growth material is inserted in place of the diseased disc

Step 5

Lost disc height is restored and the spine is stabilized

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A soft-tissue sparring approach to fusion

Return to work in as little as 2 weeks • unlike open procedures which may require as many as 30 or more days

Not an open procedure - percutaneous • approach means the entire procedure is done through a small tube

Visually guided under flourscopy – a • live x-ray guides the surgeon during the procedure, rather than using a large incision for a direct view

Small 1 inch incisions•

Surgical time typically less • than 2 hours

Hospital stay typically ranges from • 1 to 2 days

Posterior fixation can be completed • in a single surgical setting

Less likelihood of post-operative • complications

No disruption of spine supporting • muscles or tissue which allows for faster recovery

AxiaLIF® Patient Testimonials

“I feel very fortunate, that I got referred to this physician who was

using the TranS1 approach.”

“After the surgery, I’m driving around in my big truck and I’m crying. I’m

crying because I’ve got my life back.”

“All around it’s just a better procedure.”

“It has changed my life . . . immediately.”

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To help you understand what to expect from the AxiaLIF® surgery, we have listed the more common questions that patients ask. If you have further questions, please consult your doctor. Your doctor is the best source of information regarding your healthcare.

What is the goal of surgery of the AxiaLIF® surgery? The primary goal of surgery is to relieve your pain. This will be acheived by stabilizing and fusing the vertebra(e). As with any back surgery, relief of pain will vary from patient to patient.

How long will my surgery last? Surgery time will vary from surgeon to surgeon and patient to patient. On average, AxiaLIF® surgery will take 1.5 to 2.5 hours.

When can I go home from the hospital? Usually, a patient can leave the hospital in one or two days. Typically you can be released once you have adjusted to oral pain medications and you and your doctor are comfortable with your ability to get up and move about without problems.

When should I start feeling relief from my back and/or leg pain? Apart from the pain of surgery, which may take days to recover from, you may feel relief of back and leg pain symptoms almost immediately post-operatively.

What kind of follow-up can I expect? Follow-up varies from surgeon to surgeon. However, your first follow-up visit will probably be within a few weeks of surgery, then every few months for the first year. After the first year, you should be checked annually.

How do I rehabilitate after surgery? Every surgeon follows a slightly different program. Your doctor will advise you accordingly.

When can I return to work? Typically, AxiaLIF® patients can return to work in 2 weeks.

What complications are associated with the procedure? The most serious risk associated with procedure is the risk of bowel perforation. Thankfully, this is treatable, non-permanent and the occurence has been reported in only 1/2 of 1% of all AxiaLIF® procedures. You may be asked to do a bowel preparation prior to surgery to reduce the likelyhood of any injury.

*Individual results may vary

What to Expect from the AxiaLIF® Procedure*

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Allograft – obtained from a bone bank, this human bone graft material is placed between vertebrae to develop fusion

Annulus – the outer casing of a vertebral disc

Anterior Lumbar Interbody Fusion (ALIF) – an operation where the lumbar spine is approached from the front through an incision in the abdomen

Arthritis – inflammation of a joint, usually accompanied by pain, swelling, and changes in structure

Autograft – a bone graft taken from the patient’s body that is placed between vertebrae to develop fusion

Axial Lumbar Interbody Fusion (AxiaLIF®) the least invasive lumbar fusion technique where the spine is approached through a small incision near the tailbone

Bone Graft – bone taken from the patient during surgery or a bone substitute that is used to take the place of removed bone or to fill a bony defect

Bone Spurs – bony projections formed along joints that can limit motion and can cause pain (also called osteophytes)

Cancellous Bone – open, latticed, or porous inner bone structure

Cauda Equina – a bundle of nerve roots from the lumbar and sacral spinal nerves

Cervical Spine – the uppermost portion of the spine; the neck

Coccyx – the tailbone

Contraindication – a factor that renders the administration of a drug or device or the carrying out of a medical procedure inadvisable

Cortical Bone – the dense, hard outer layer of bone material

Degenerative Disc Disease – a slow deterioration of discs located between vertebrae

Disc Degeneration – the deterioration of a disc and possible loss of disc height

Discectomy – removal of a portion of a herniated or degenerative intervertebral disc

Dura Mater – a protective membrane covering the spinal cord and brain

Facet Joint – There is one facet joint on each side of a vertebra, together these joints allow movement between two vertebrae and provide stability

Glossary of Terms

38 39

Fluoroscope – a portable x-ray machine used in surgery

Foramen – the small openings in the spine which nerve roots pass through

Fusion - the joining together of two or more vertebra

Herniated Disc – a bulge in a disc that can press on nerves and cause pain

Intervertebral Disc – a flat, round “cushion” that acts as a shock absorber between vertebrae

Kyphosis – abnormal rearward curvature of the spine, resulting in protuberance of the upper back (hunchback)

Lamina – a part of the vertebra located in the back of the vertebral body

Laminectomy – when part or all of the lamina is removed

Lordosis – abnormal forward curvature of the spine in the lumbar region

Lumbar Spine – lower portion of the spine between the thoracic spine and the sacrum. The lumbar spine consists of five bones (vertebrae) labeled L1-L5.

Minimally Invasive – a surgical procedure where a small incision is made and instrumentation is used through this incision

Nucleus Pulposus – center of the intervertebral disc

Oswestry Disability Index (ODI) – a low back pain disability questionnaire used to measure a patient’s permanent functional disability

Pedicle – strong portion of the spinal vertebral bone that connects the front of the spine to the back of the spine

Pelvis – the bony structure formed by the hip bones, sacrum, and coccyx

Posterior Lumbar Interbody Fusion - (PLIF) – a spine fusion operation where the patient’s lumbar spine is approached through an incision in the lower back

Radiculopathy – pain originating from a pinched, compressed or irritated nerve root that may extend into the extremities

Sacroiliac Joints – joints that connect the sacrum to the pelvis

Sacrum – The sacrum consists of five vertebrae labeled S1-S5. The vertebrae are normally fused, but in some patients may not all be fused due to natural anatomic variance.

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Sciatica – pressure on the sciatic nerve, causing pain which radiates from the back to the lower extremities

Spinous Process – bony portion opposite the body of the vertebra

Spondylolisthesis – forward displacement of one of the lumbar vertebrae over the vertebrae below it

Spondylolysis – A crack in one or both sides of the facet joint

Spinal Stenosis – the narrowing of the spinal canal. Often results in compression putting pressure on the nerve resulting in pain.

Thoracic Spine – middle portion of the spine below the cervical spine (neck) and above the lumbar spine. This area consists of your upper body and ribs.

Transforaminal Lumbar Interbody Fusion - (TLIF) – an operation where the lumbar spine is approached from the side

Transverse Processes – small, bony bumps where back muscles attach to vertebrae

Vertebra - (plural: vertebrae) – any one of the 33 bony segments of the spinal column

Visual Analog Scale - A tool used to help a person rate the intensity of certain sensations and feelings, such as pain.

Learn more about AxiaLIF® online

Our informative patient website includes

patient testimonial videos, procedure

animations and additional resources

to help answer your questions.

Please visit www.smallincisionsbigresults.com

Related Journal Articles• Perez-Cruet MJ, Khoo LT, Fessler RG: An Anatomic Approach to Minimally

Invasive Spine Surgery: “Percutaneous Axial Lumbar Spine Surgery, Surgical Techniques, St Louis: Quality Medical Publishing, Inc., 2006. Copyright © 2006 Quality Medical Publishing, Inc.

• Marotta N, Cosar M, Pimenta L, Khoo LT: A Novel Minimally Invasive Presacral Approach and Instrumentation Technique for Anterior L5-S1 Intervertebral Discectomy and Fusion, Neurosurgical Focus, January 2006. Copyright © 2006 The American Association of Neurological Surgeons.

• Yuan P, Day T, Albert T, Morrison W, Pimenta L, Cragg A, Weinstein M: Anatomy of the Percutaneous Presacral Space for a Novel Fusion Technique, Journal of Spinal Disorders & Techniques, 2006 June; 19 (4):237-241.

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