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Living
A patient’s
guide to
low back
pain
If you’ve been struggling with back pain                         The least invasive
                                                             solution to lumbar fusion
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
Table of                                  Healthy
Contents                                  Spine
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
6                                                               7


                    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
          (7)       your pain, it is important to understand the
        Cervical
       Vertebrae    structure of the healthy spine.

                    The spine consists of 33 bones
                    and is divided into 5 main areas:
           (12)
         Thoracic   - Cervical Spine (Neck) 7 - Vertebrae
        Vertebrae
                    - Thoracic Spine (Ribs) 12 - Vertebrae
                    - Lumbar Spine (Lower Back) 5 - Vertebrae
         (5)
       Lumbar       - Sacral Spine (Pelvis) 5 – Vertebrae
      Vertebrae
                      (naturally fused)
         Sacral
         Spine      - Coccyx (Pelvis) 4 – Vertebrae
                      (naturally fused)
    Coccyx
                    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.
8                                                                                            9




                           L1

                           L2                      Transverse
                                                    Process                    Pedicle
                                    5 Lumbar
                           L3       Vertebrae
                           L4

                           L5


                                                                          Lamina
                                                          Spinous
                                                          Process




The Bones in Lumbar Spine                       The Vertebrae
The lumbar spine consists of five numbered      The vertebrae bear the majority of weight
vertebrae: L1, L2, L3, L4, and L5. The “L”      for the spine. The outermost layer of each
represents the lumbar spine, and the            vertebra consists of hard bone called
number represents the order in which the        cortical bone while the inside of the
vertebrae appear. L5 is the closest vertebra    vertebra consists of cancellous bone, a
to your tailbone, farthest away from your       porous bone structure.
head. The numbers of the vertebrae
get smaller as you move away from the           The spinal cord passes through the vertebra
tailbone. Therefore L1 is the farthest lumbar   via a bony ring called the spinal canal. The
vertebra from the tailbone.                     posterior elements of the spinal cord break
                                                into the cauda equina, which is a series
                                                of nerves and nerve roots that continues
The Bones in Sacral Spine                       through the spinal canal.
The bones of the sacral spine are normally
fused together. The five fused vertebrae        The spinal canal is made up
however are still labeled S1 through S5 as if   of different parts:
they were separate. The S1 vertebra is the       • lamina
closest to the lumbar spine. The L5/S1 disc
                                                 • spinous process
space connects the lumbar and sacral spine
and is a common source of low back pain.         • transverse processes
                                                 • pedicle
10                                                                                        11


                                                                              Nucleus
                                                                              Pulposus
  Intervertebral Discs
                                                    Nerve
                                                    Roots

                                                                                Annulus




                                                                     Spinal
                                                                     Cord




Intervertebral Discs                         The Spinal Cord and Nerve Roots
Between each vertebrae in the spine is       The spinal cord passes through each
a disc that, when healthy, functions as      vertebra via the spinal canal. When healthy,
a natural shock absorber between the         the vertebral structure helps protect the
vertebra and helps maintain proper disc      spinal cord and the sensitive nerves that
height. The intervertebral disc is made up   extend from it. Most low back pain and
of two different parts:                      leg pain associated with spine conditions
• Annulus – a strong, outer ring of fibers   originates from pressure that is placed on
  that helps keep the vertebra intact        these nerve roots when the bones in the
                                             spine become misaligned or move too
• Nucleus – a soft, jelly-like center        closely together.
  consisting mostly of water that helps
  absorb pressure
12

                                              Conditions
                              Facet Joint
                                              Contributing
                                              T Low
                                               o
                                              Back Pain



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.
14                                                                  15



                          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
     Stenosis
                          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
     Spondylolisthesis    compression and pain.

                           • Degenerative Disc Disease
                           • Spondylolisthesis
                           • Stenosis
           Degenerative
           Disc Disease
16                                                                                           17




 Bone Spurs




  Degenerative                                   Forward Slip
  Disc Disease                                      at L5-S1
                                                Vertebral Bodies



Degenerative Disc Disease (DDD)                   Spondylolisthesis
Degenerative disc disease is not truly a          Spondylolisthesis occurs when one vertebra
disease. It’s a term used to describe the         slips forward in relation to an adjacent
gradual deterioration of intervertebral discs     vertebra. The symptoms that accompany
that may occur naturally with the aging           spondylolisthesis include pain in the low
process or as result of injury.                   back, thighs and/or legs, muscle spasms,
 • Loss of hydration in the disc can shrink       weakness, and/or tight hamstring muscles.
   the disc and compromise its ability to           • Degree of slippage classified in grades,
   act as a shock absorber between each               Grade 1 being the least amount, Grade
   vertebra                                           IV the most
 • Loss of disc height can place pressure           • Many people affected experience
   on the nerve roots causing pain in the             no pain or symptoms
   buttocks and legs
                                                    • May result from improper lifting of
 • Ruptured discs can bulge and put                   heavy items, weightlifting, or high
   pressure on nerves causing leg and                 impact sports, such as football or
   back pain                                          gymnastics

Common Symptoms                                   Common Symptoms
 • Low back pain                                    • Low back pain
 • Pain in legs and/or buttocks                     • Lordosis (swayback)
 • Pain may increase while sitting or               • Pain and/or weakness in legs
   standing for extended time
                                                    • Tightness in the hamstrings
 • Pain may decrease while walking,                   (muscles at back of thigh)
   or laying down
                                                    • Symptoms grow worse with exercise
18

                                               Treatments
                                     Spinal
                                    Stenosis




           Bone Spurs




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
20                                              21


     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.
22                                                                                              23


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.
                                                  ALIF
Traditional Fusion
                                                  The ALIF procedure takes an anterior (from
     • ALIF                                       the front) approach to the spine through
       (Anterior Lumbar Interbody Fusion)
                                                  an incision in the abdomen. The procedure
     • PLIF                                       is often performed by two surgeons. One
       (Posterior Lumbar Interbody Fusion)        general/vascular surgeon may provide
     • TLIF                                       access to the spine through the abdomen
       (Transforaminal Lumbar Interbody Fusion)
                                                  and ensure all major vessels are successfully
                                                  retracted away from the surgical approach.
Minimally Invasive Techniques (MIS)               The spine surgeon will then proceed to
                                                  remove all, or a portion of the damaged
     • Lateral Interbody Fusion
                                                  disc and replace it with a surgical implant
     • MIS TLIF                                   and bone graft material. For additional
                                                  stability, a second posterior(from the back)
Least Invasive Techniques
                                                  procedure may be performed to insert
     • AxiaLIF®                                   support rods or screws.
     • AxiaLIF 2L®
                                                   • 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
24                                                                                          25




PLIF                                          TLIF
The PLIF procedure takes a posterior          Like the PLIF procedure, TLIF begins with a
(from the back) approach to the lumbar        posterior (from the back) incision, however
spine through an incision in the patient’s    the surgical angle approaches the vertebra
back. The surgeon must detach and move        more laterally, or diagonally toward the
muscles attached to the vertebrae, and in     patient’s side. The altered approach to the
some cases a portion of vertebral bone        spine, compared to PLIF, limits some of the
called the lamina, may be removed for         operative trauma to supporting muscle and
better visualization and access to the disc   soft-tissue.
space.
                                              To access the disc space, the surgeon may
 • Surgical times ranges from 3 to 8 hours    remove a portion of the lamina (a bone
 • Hospital stay ranges from 3 to 5 days      covering the spinal nerves) and all of the
                                              facet joint, which is a major stabilizer of
 • Typically a 6-inch incision                the spine. The access route, though less
 • Dissection of muscle and soft-tissue of    invasive than the PLIF procedure, still
   the spine can cause post-operative pain    involves disruption of muscle, soft-tissue
   and slow healing process                   and nerves and it may pose a risk of post-
 • Risks reported in literature of vascular   operative pain and complications.
   injury, nerve injury, incontinence,         • Surgical times range 2 to 4 hours
   impotence, muscle and tissue scarring       • 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
26                                                                   27
                                                AxiaLIF   ®


                                                The Least Invasive
                                                Solution to
                                                Lumbar Fusion




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
28                                                    29



     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.
30                                                                                        31


AxiaLIF Step-by-Step
               ®




Step 1                                       Step 4
Degenerative disc and improper disc height   Bone growth material is inserted in place
before the AxiaLIF ® procedure.              of the diseased disc




Step 2                                       Step 5
Access to the diseased disc is obtained      Lost disc height is restored and the spine
                                             is stabilized




Step 3
Center of the diseased disc is removed
32                                                                                      33

                                              AxiaLIF®
A soft-tissue sparring                        Patient Testimonials
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          “I feel very fortunate, that I got
   done through a small tube                     referred to this physician who was
                                                     using the TranS1 approach.”
 • 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                               “All around it’s just a better procedure.”
 • 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
                                              “It has changed my life . . . immediately.”
 • No disruption of spine supporting
   muscles or tissue which allows for
   faster recovery




                                               “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.”
34                                                                                           35


What to Expect from
the AxiaLIF Procedure* ®



To help you understand what to expect           What kind of follow-up can I expect?
from the AxiaLIF ® surgery, we have listed      Follow-up varies from surgeon to surgeon.
the more common questions that patients         However, your first follow-up visit will
ask. If you have further questions, please      probably be within a few weeks of surgery,
consult your doctor. Your doctor is the         then every few months for the first year.
best source of information regarding            After the first year, you should be checked
your healthcare.                                annually.

What is the goal of surgery                     How do I rehabilitate after surgery?
of the AxiaLIF ® surgery?                       Every surgeon follows a slightly different
The primary goal of surgery is to relieve       program. Your doctor will advise you
your pain. This will be acheived by             accordingly.
stabilizing and fusing the vertebra(e).
As with any back surgery, relief of pain will   When can I return to work?
vary from patient to patient.                   Typically, AxiaLIF ® patients can return
                                                to work in 2 weeks.
How long will my surgery last?
Surgery time will vary from surgeon to          What complications are
surgeon and patient to patient. On average,     associated with the procedure?
AxiaLIF® surgery will take 1.5 to 2.5 hours.    The most serious risk associated with
                                                procedure is the risk of bowel perforation.
When can I go home from the hospital?           Thankfully, this is treatable, non-permanent
Usually, a patient can leave the hospital       and the occurence has been reported in
in one or two days. Typically you can be        only 1/2 of 1% of all AxiaLIF ® procedures.
released once you have adjusted to oral         You may be asked to do a bowel preparation
pain medications and you and your doctor        prior to surgery to reduce the likelyhood of
are comfortable with your ability to get up     any injury.
and move about without problems.
                                                *Individual results may vary
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.
36                                                                                            37


Glossary of Terms

Allograft – obtained from a bone bank, this       Cauda Equina – a bundle of nerve roots
human bone graft material is placed between       from the lumbar and sacral spinal nerves
vertebrae to develop fusion
                                                  Cervical Spine – the uppermost portion
Annulus – the outer casing of a vertebral disc    of the spine; the neck

Anterior Lumbar Interbody Fusion (ALIF)           Coccyx – the tailbone
– an operation where the lumbar spine is
approached from the front through an incision     Contraindication – a factor that renders
in the abdomen                                    the administration of a drug or device or
                                                  the carrying out of a medical procedure
Arthritis – inflammation of a joint, usually      inadvisable
accompanied by pain, swelling, and changes
in structure                                      Cortical Bone – the dense, hard outer
                                                  layer of bone material
Autograft – a bone graft taken from the
patient’s body that is placed between             Degenerative Disc Disease – a slow
vertebrae to develop fusion                       deterioration of discs located between
                                                  vertebrae
Axial Lumbar Interbody Fusion (AxiaLIF ®)
the least invasive lumbar fusion technique        Disc Degeneration – the deterioration of
where the spine is approached through a small     a disc and possible loss of disc height
incision near the tailbone
                                                  Discectomy – removal of a portion of a
Bone Graft – bone taken from the patient          herniated or degenerative intervertebral disc
during surgery or a bone substitute that is
used to take the place of removed bone or         Dura Mater – a protective membrane
to fill a bony defect                             covering the spinal cord and brain

Bone Spurs – bony projections formed along        Facet Joint – There is one facet joint on
joints that can limit motion and can cause pain   each side of a vertebra, together these
(also called osteophytes)                         joints allow movement between two
                                                  vertebrae and provide stability
Cancellous Bone – open, latticed, or porous
inner bone structure
38                                                                                           39




Fluoroscope – a portable x-ray machine          Minimally Invasive – a surgical procedure
used in surgery                                 where a small incision is made and
                                                instrumentation is used through this incision
Foramen – the small openings in the spine
which nerve roots pass through                  Nucleus Pulposus – center of the
                                                intervertebral disc
Fusion - the joining together of two or
more vertebra                                   Oswestry Disability Index (ODI) – a low back
                                                pain disability questionnaire used to measure
Herniated Disc – a bulge in a disc that         a patient’s permanent functional disability
can press on nerves and cause pain
                                                Pedicle – strong portion of the spinal
Intervertebral Disc – a flat, round “cushion”   vertebral bone that connects the front
that acts as a shock absorber between           of the spine to the back of the spine
vertebrae
                                                Pelvis – the bony structure formed by
Kyphosis – abnormal rearward curvature of       the hip bones, sacrum, and coccyx
the spine, resulting in protuberance of the
upper back (hunchback)                          Posterior Lumbar Interbody Fusion -
                                                (PLIF) – a spine fusion operation where
Lamina – a part of the vertebra located         the patient’s lumbar spine is approached
in the back of the vertebral body               through an incision in the lower back

Laminectomy – when part or all of the           Radiculopathy – pain originating from a
lamina is removed                               pinched, compressed or irritated nerve root
                                                that may extend into the extremities
Lordosis – abnormal forward curvature
of the spine in the lumbar region               Sacroiliac Joints – joints that connect
                                                the sacrum to the pelvis
Lumbar Spine – lower portion of the spine
between the thoracic spine and the sacrum.      Sacrum – The sacrum consists of five
The lumbar spine consists of five bones         vertebrae labeled S1-S5. The vertebrae are
(vertebrae) labeled L1-L5.                      normally fused, but in some patients may
                                                not all be fused due to natural anatomic
                                                variance.
40                                                                                                                            41




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
                                                           Learn more about AxiaLIF ® online

Spondylolysis – A crack in one or both sides
                                                          Our informative patient website includes
of the facet joint
                                                           patient testimonial videos, procedure
                                                           animations and additional resources
Spinal Stenosis – the narrowing of the spinal
                                                               to help answer your questions.
canal. Often results in compression putting
pressure on the nerve resulting in pain.
                                                     Please visit www.smallincisionsbigresults.com

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
                                                    Related Journal Articles
                                                  • Perez-Cruet MJ, Khoo LT, Fessler RG: An Anatomic Approach to Minimally
Vertebra - (plural: vertebrae) – any one of the     Invasive Spine Surgery: “Percutaneous Axial Lumbar Spine Surgery,
                                                    Surgical Techniques, St Louis: Quality Medical Publishing, Inc., 2006.
33 bony segments of the spinal column               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.
Visual Analog Scale - A tool used to help a         Copyright © 2006 The American Association of Neurological Surgeons.
person rate the intensity of certain sensations   • 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
and feelings, such as pain.                         Spinal Disorders & Techniques, 2006 June; 19 (4):237-241.
USA
              411 Landmark Drive, Wilmington, NC 28412
         Customer Service Tel: 866.256.1206 Fax: 910.332.1701
                   customerservice@TranS1inc.com


             Authorized European Representative
    Medpass International Limited, Windsor House, Barnett Way
               Barnwood, Gloucester GL4 3RT, UK
                 Tel/Fax: +44 (0)1 452 619 2227


                                www.TranS1.com



                © Copyright TranS1® 2004-2008. All Rights Reserved.
This product and its implantation are covered by one or more of the following U.S. and EP

                                            Patents:
U.S. 6,575,979; U.S. 7,087,058; U.S. 6,558,386; U.S. 6,740,090; U.S. 6,790,210; U.S. 6,558,390;
  U.S. 7,014,633; U.S. 6,899,716; U.S. 6,921,403; U.S. 7,309,338; EP 1257217 and EP 1578315
        Additional U.S. and International Patents applied for. 45-0038 Rev. E 9-10-08

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Axia lif patient brochure english

  • 2. If you’ve been struggling with back pain The least invasive solution to lumbar fusion 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.
  • 3. The Table of Healthy Contents Spine 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
  • 4. 6 7 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 (7) your pain, it is important to understand the Cervical Vertebrae structure of the healthy spine. The spine consists of 33 bones and is divided into 5 main areas: (12) Thoracic - Cervical Spine (Neck) 7 - Vertebrae Vertebrae - Thoracic Spine (Ribs) 12 - Vertebrae - Lumbar Spine (Lower Back) 5 - Vertebrae (5) Lumbar - Sacral Spine (Pelvis) 5 – Vertebrae Vertebrae (naturally fused) Sacral Spine - Coccyx (Pelvis) 4 – Vertebrae (naturally fused) Coccyx 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.
  • 5. 8 9 L1 L2 Transverse Process Pedicle 5 Lumbar L3 Vertebrae L4 L5 Lamina Spinous Process The Bones in Lumbar Spine The Vertebrae The lumbar spine consists of five numbered The vertebrae bear the majority of weight vertebrae: L1, L2, L3, L4, and L5. The “L” for the spine. The outermost layer of each represents the lumbar spine, and the vertebra consists of hard bone called number represents the order in which the cortical bone while the inside of the vertebrae appear. L5 is the closest vertebra vertebra consists of cancellous bone, a to your tailbone, farthest away from your porous bone structure. head. The numbers of the vertebrae get smaller as you move away from the The spinal cord passes through the vertebra tailbone. Therefore L1 is the farthest lumbar via a bony ring called the spinal canal. The vertebra from the tailbone. posterior elements of the spinal cord break into the cauda equina, which is a series of nerves and nerve roots that continues The Bones in Sacral Spine through the spinal canal. The bones of the sacral spine are normally fused together. The five fused vertebrae The spinal canal is made up however are still labeled S1 through S5 as if of different parts: they were separate. The S1 vertebra is the • lamina closest to the lumbar spine. The L5/S1 disc • spinous process space connects the lumbar and sacral spine and is a common source of low back pain. • transverse processes • pedicle
  • 6. 10 11 Nucleus Pulposus Intervertebral Discs Nerve Roots Annulus Spinal Cord Intervertebral Discs The Spinal Cord and Nerve Roots Between each vertebrae in the spine is The spinal cord passes through each a disc that, when healthy, functions as vertebra via the spinal canal. When healthy, a natural shock absorber between the the vertebral structure helps protect the vertebra and helps maintain proper disc spinal cord and the sensitive nerves that height. The intervertebral disc is made up extend from it. Most low back pain and of two different parts: leg pain associated with spine conditions • Annulus – a strong, outer ring of fibers originates from pressure that is placed on that helps keep the vertebra intact these nerve roots when the bones in the spine become misaligned or move too • Nucleus – a soft, jelly-like center closely together. consisting mostly of water that helps absorb pressure
  • 7. 12 Conditions Facet Joint Contributing T Low o Back Pain 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.
  • 8. 14 15 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 Stenosis 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 Spondylolisthesis compression and pain. • Degenerative Disc Disease • Spondylolisthesis • Stenosis Degenerative Disc Disease
  • 9. 16 17 Bone Spurs Degenerative Forward Slip Disc Disease at L5-S1 Vertebral Bodies Degenerative Disc Disease (DDD) Spondylolisthesis Degenerative disc disease is not truly a Spondylolisthesis occurs when one vertebra disease. It’s a term used to describe the slips forward in relation to an adjacent gradual deterioration of intervertebral discs vertebra. The symptoms that accompany that may occur naturally with the aging spondylolisthesis include pain in the low process or as result of injury. back, thighs and/or legs, muscle spasms, • Loss of hydration in the disc can shrink weakness, and/or tight hamstring muscles. the disc and compromise its ability to • Degree of slippage classified in grades, act as a shock absorber between each Grade 1 being the least amount, Grade vertebra IV the most • Loss of disc height can place pressure • Many people affected experience on the nerve roots causing pain in the no pain or symptoms buttocks and legs • May result from improper lifting of • Ruptured discs can bulge and put heavy items, weightlifting, or high pressure on nerves causing leg and impact sports, such as football or back pain gymnastics Common Symptoms Common Symptoms • Low back pain • Low back pain • Pain in legs and/or buttocks • Lordosis (swayback) • Pain may increase while sitting or • Pain and/or weakness in legs standing for extended time • Tightness in the hamstrings • Pain may decrease while walking, (muscles at back of thigh) or laying down • Symptoms grow worse with exercise
  • 10. 18 Treatments Spinal Stenosis Bone Spurs 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
  • 11. 20 21 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.
  • 12. 22 23 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. ALIF Traditional Fusion The ALIF procedure takes an anterior (from • ALIF the front) approach to the spine through (Anterior Lumbar Interbody Fusion) an incision in the abdomen. The procedure • PLIF is often performed by two surgeons. One (Posterior Lumbar Interbody Fusion) general/vascular surgeon may provide • TLIF access to the spine through the abdomen (Transforaminal Lumbar Interbody Fusion) and ensure all major vessels are successfully retracted away from the surgical approach. Minimally Invasive Techniques (MIS) The spine surgeon will then proceed to remove all, or a portion of the damaged • Lateral Interbody Fusion disc and replace it with a surgical implant • MIS TLIF and bone graft material. For additional stability, a second posterior(from the back) Least Invasive Techniques procedure may be performed to insert • AxiaLIF® support rods or screws. • AxiaLIF 2L® • 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
  • 13. 24 25 PLIF TLIF The PLIF procedure takes a posterior Like the PLIF procedure, TLIF begins with a (from the back) approach to the lumbar posterior (from the back) incision, however spine through an incision in the patient’s the surgical angle approaches the vertebra back. The surgeon must detach and move more laterally, or diagonally toward the muscles attached to the vertebrae, and in patient’s side. The altered approach to the some cases a portion of vertebral bone spine, compared to PLIF, limits some of the called the lamina, may be removed for operative trauma to supporting muscle and better visualization and access to the disc soft-tissue. space. To access the disc space, the surgeon may • Surgical times ranges from 3 to 8 hours remove a portion of the lamina (a bone • Hospital stay ranges from 3 to 5 days covering the spinal nerves) and all of the facet joint, which is a major stabilizer of • Typically a 6-inch incision the spine. The access route, though less • Dissection of muscle and soft-tissue of invasive than the PLIF procedure, still the spine can cause post-operative pain involves disruption of muscle, soft-tissue and slow healing process and nerves and it may pose a risk of post- • Risks reported in literature of vascular operative pain and complications. injury, nerve injury, incontinence, • Surgical times range 2 to 4 hours impotence, muscle and tissue scarring • 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
  • 14. 26 27 AxiaLIF ® The Least Invasive Solution to Lumbar Fusion 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
  • 15. 28 29 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.
  • 16. 30 31 AxiaLIF Step-by-Step ® Step 1 Step 4 Degenerative disc and improper disc height Bone growth material is inserted in place before the AxiaLIF ® procedure. of the diseased disc Step 2 Step 5 Access to the diseased disc is obtained Lost disc height is restored and the spine is stabilized Step 3 Center of the diseased disc is removed
  • 17. 32 33 AxiaLIF® A soft-tissue sparring Patient Testimonials 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 “I feel very fortunate, that I got done through a small tube referred to this physician who was using the TranS1 approach.” • 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 “All around it’s just a better procedure.” • 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 “It has changed my life . . . immediately.” • No disruption of spine supporting muscles or tissue which allows for faster recovery “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.”
  • 18. 34 35 What to Expect from the AxiaLIF Procedure* ® To help you understand what to expect What kind of follow-up can I expect? from the AxiaLIF ® surgery, we have listed Follow-up varies from surgeon to surgeon. the more common questions that patients However, your first follow-up visit will ask. If you have further questions, please probably be within a few weeks of surgery, consult your doctor. Your doctor is the then every few months for the first year. best source of information regarding After the first year, you should be checked your healthcare. annually. What is the goal of surgery How do I rehabilitate after surgery? of the AxiaLIF ® surgery? Every surgeon follows a slightly different The primary goal of surgery is to relieve program. Your doctor will advise you your pain. This will be acheived by accordingly. stabilizing and fusing the vertebra(e). As with any back surgery, relief of pain will When can I return to work? vary from patient to patient. Typically, AxiaLIF ® patients can return to work in 2 weeks. How long will my surgery last? Surgery time will vary from surgeon to What complications are surgeon and patient to patient. On average, associated with the procedure? AxiaLIF® surgery will take 1.5 to 2.5 hours. The most serious risk associated with procedure is the risk of bowel perforation. When can I go home from the hospital? Thankfully, this is treatable, non-permanent Usually, a patient can leave the hospital and the occurence has been reported in in one or two days. Typically you can be only 1/2 of 1% of all AxiaLIF ® procedures. released once you have adjusted to oral You may be asked to do a bowel preparation pain medications and you and your doctor prior to surgery to reduce the likelyhood of are comfortable with your ability to get up any injury. and move about without problems. *Individual results may vary 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.
  • 19. 36 37 Glossary of Terms Allograft – obtained from a bone bank, this Cauda Equina – a bundle of nerve roots human bone graft material is placed between from the lumbar and sacral spinal nerves vertebrae to develop fusion Cervical Spine – the uppermost portion Annulus – the outer casing of a vertebral disc of the spine; the neck Anterior Lumbar Interbody Fusion (ALIF) Coccyx – the tailbone – an operation where the lumbar spine is approached from the front through an incision Contraindication – a factor that renders in the abdomen the administration of a drug or device or the carrying out of a medical procedure Arthritis – inflammation of a joint, usually inadvisable accompanied by pain, swelling, and changes in structure Cortical Bone – the dense, hard outer layer of bone material Autograft – a bone graft taken from the patient’s body that is placed between Degenerative Disc Disease – a slow vertebrae to develop fusion deterioration of discs located between vertebrae Axial Lumbar Interbody Fusion (AxiaLIF ®) the least invasive lumbar fusion technique Disc Degeneration – the deterioration of where the spine is approached through a small a disc and possible loss of disc height incision near the tailbone Discectomy – removal of a portion of a Bone Graft – bone taken from the patient herniated or degenerative intervertebral disc during surgery or a bone substitute that is used to take the place of removed bone or Dura Mater – a protective membrane to fill a bony defect covering the spinal cord and brain Bone Spurs – bony projections formed along Facet Joint – There is one facet joint on joints that can limit motion and can cause pain each side of a vertebra, together these (also called osteophytes) joints allow movement between two vertebrae and provide stability Cancellous Bone – open, latticed, or porous inner bone structure
  • 20. 38 39 Fluoroscope – a portable x-ray machine Minimally Invasive – a surgical procedure used in surgery where a small incision is made and instrumentation is used through this incision Foramen – the small openings in the spine which nerve roots pass through Nucleus Pulposus – center of the intervertebral disc Fusion - the joining together of two or more vertebra Oswestry Disability Index (ODI) – a low back pain disability questionnaire used to measure Herniated Disc – a bulge in a disc that a patient’s permanent functional disability can press on nerves and cause pain Pedicle – strong portion of the spinal Intervertebral Disc – a flat, round “cushion” vertebral bone that connects the front that acts as a shock absorber between of the spine to the back of the spine vertebrae Pelvis – the bony structure formed by Kyphosis – abnormal rearward curvature of the hip bones, sacrum, and coccyx the spine, resulting in protuberance of the upper back (hunchback) Posterior Lumbar Interbody Fusion - (PLIF) – a spine fusion operation where Lamina – a part of the vertebra located the patient’s lumbar spine is approached in the back of the vertebral body through an incision in the lower back Laminectomy – when part or all of the Radiculopathy – pain originating from a lamina is removed pinched, compressed or irritated nerve root that may extend into the extremities Lordosis – abnormal forward curvature of the spine in the lumbar region Sacroiliac Joints – joints that connect the sacrum to the pelvis Lumbar Spine – lower portion of the spine between the thoracic spine and the sacrum. Sacrum – The sacrum consists of five The lumbar spine consists of five bones vertebrae labeled S1-S5. The vertebrae are (vertebrae) labeled L1-L5. normally fused, but in some patients may not all be fused due to natural anatomic variance.
  • 21. 40 41 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 Learn more about AxiaLIF ® online Spondylolysis – A crack in one or both sides Our informative patient website includes of the facet joint patient testimonial videos, procedure animations and additional resources Spinal Stenosis – the narrowing of the spinal to help answer your questions. canal. Often results in compression putting pressure on the nerve resulting in pain. Please visit www.smallincisionsbigresults.com 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 Related Journal Articles • Perez-Cruet MJ, Khoo LT, Fessler RG: An Anatomic Approach to Minimally Vertebra - (plural: vertebrae) – any one of the Invasive Spine Surgery: “Percutaneous Axial Lumbar Spine Surgery, Surgical Techniques, St Louis: Quality Medical Publishing, Inc., 2006. 33 bony segments of the spinal column 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. Visual Analog Scale - A tool used to help a Copyright © 2006 The American Association of Neurological Surgeons. person rate the intensity of certain sensations • 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 and feelings, such as pain. Spinal Disorders & Techniques, 2006 June; 19 (4):237-241.
  • 22. USA 411 Landmark Drive, Wilmington, NC 28412 Customer Service Tel: 866.256.1206 Fax: 910.332.1701 customerservice@TranS1inc.com Authorized European Representative Medpass International Limited, Windsor House, Barnett Way Barnwood, Gloucester GL4 3RT, UK Tel/Fax: +44 (0)1 452 619 2227 www.TranS1.com © Copyright TranS1® 2004-2008. All Rights Reserved. This product and its implantation are covered by one or more of the following U.S. and EP Patents: U.S. 6,575,979; U.S. 7,087,058; U.S. 6,558,386; U.S. 6,740,090; U.S. 6,790,210; U.S. 6,558,390; U.S. 7,014,633; U.S. 6,899,716; U.S. 6,921,403; U.S. 7,309,338; EP 1257217 and EP 1578315 Additional U.S. and International Patents applied for. 45-0038 Rev. E 9-10-08