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The spine consists of 33 bones & is divided into 5 main areas:
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.
Cervical
Vertebrae
Thoracic
Vertebrae
A fusion procedure called AxiaLIF + provides doctors with an additional approach to spine
fusion. The AxiaLIF+ procedure gives surgeons the ability to stabilize painful joints in the spine
through very small incisions. The procedure is designed to spare the muscles and supporting
soft-tissues of the spine, thus minimizing surgical trauma and post-operative pain.
®
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.
Lumbar
Vertebrae
Sacral
Spine
Coccyx
The Spine
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.
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.
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)
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The Vertebrae
The Lumbar Spine
Transverse
Process
Pedicle
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.
Lamina
The spinal cord passes through the vertebra via a bony ring
called the spinal canal. At the bottom of the spine the spinal
cord breaks into the cauda equina, which is a series of
nerves and nerve roots that continues through the spinal canal.
Spinous
Process
The spinal canal is made up of 4 different parts: the Lamina, Spinous Process, Transverse
Processes, and Pedicle.
L1
L2
L3
Intervertebral Discs
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.
5 Lumbar
Vertebrae
The intervertebral disc is made up
of two different parts:
L4
L5
• 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
Nerve
Roots
Nucleus
Pulposus
Annulus
Spinal
Cord
The Spinal Cord & 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.
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.
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Facet Joint
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.
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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:
Spinal
Stenosis
Bone Spurs
Spinal Stenosis is typically a degenerative condition
most common in older adults – years of wear-and-tear
contribute to the condition. It is also 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
Spondylolisthesis occurs when one vertebra slips
forward in relation to an adjacent vertebra. The
degree of slippage is classified in grades: Grade I being
the least amount of slippage, Grade IV the most.
Spondylolisthesis may be the result of improper lifting
of heavy items, weightlifting, or high impact sports,
such as football or gymnastics. Many people affected
experience no pain or symptoms.
Forward
Slip at L5-S1
Vertebral Bodies
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
Degenerative disc disease is a term used to describe the
gradual deterioration of intervertebral discs that may occur
naturally with the aging process or as result of injury.
•
Bone Spurs
•
•
Degenerative
Disc Disease
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
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Spinal 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.
Spondylolisthesis
Conditions Contributing to Low Back Pain
Degenerative Disc Disease
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.
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Minimally Invasive Techniques (MIS)
Treatment of Lower Back Pain
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 lowback 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 procedures, 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.
Fusion Techniques
Benefits of Minimally Invasive Surgery:
Minimally invasive surgery, or MIS, may offer the following possible benefits:
• Minimal blood loss
• Less post-operative pain
• Improved recovery times
• Potentially shorter hospital stay
• Potentially less pain medication required
All surgeries, open or minimally invasive, have some degree of risk and/or complications. Your
surgeon will work with you to discuss these risks and determine the best treatment for you.
Minimally Invasive Surgical Approaches:
AxiaLIF+ (Axial Lumbar Interbody Fusion)1,2
The surgeon accesses your lower back through an approximately 1-inch incision next to
your tailbone. The center of the degenerated disc is removed, and bone growth material is
inserted in its place. This material helps bone growth over time in order to “fuse” the spine.
The AxiaLIF+ implant is inserted to stabilize the vertebrae while fusion is occurring. During
insertion, your surgeon can restore disc height and alignment. Your physician will add
posterior implants for further stabilization of your spine after the AxiaLIF+ procedure has been
performed. The AxiaLIF+ approach was developed to allow the surgeon to access the lumbar
spine with minimal risk of damaging vital nerves, blood vessels, and muscles. The access
occurs via the presacral region near the tailbone. As with all surgical approaches, there are
risks. Some of the risks with AxiaLIF+ include bowel perforation, infection, and hematoma.
There are other risks as well; you should discuss these with your surgeon in detail.
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.
See page 14 for additional AxiaLIF+ patient safety information.
Traditional Fusion
LLIF (Lateral Lumbar Interbody Fusion)
The lateral technique 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.
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 the L4/L5 disc space, which
are often the source of a patient’s back pain and levels that are frequently operated on.
ALIF (Anterior Lumbar Interbody Fusion) *Traditionally an open procedure
ALIF is a procedure that has been used traditionally for lumbar spinal fusions. The surgeon
enters through the abdomen to access the lower portion of the spine. The risks associated
with this approach are significant if the patient has had multiple abdominal procedures in the
past which could have caused scarring and damage. As commonly referenced in medical
literature, this approach carries risk of damaging blood vessels, nerves, and vital organs.
MIS TLIF (Transforminal Lumbar Interbody Fusion)
MIS TLIF procedures are performed in a similar manner to open TLIF procedures, except
the surgeon accesses the spine through a small incision slightly to the left or right of the
center of the patient’s back. After reaching the spine, the surgeon removes a portion of the
facet joint and navigates through the foramen to gain access to the disc space.
PLIF (Posterior Lumbar Interbody Fusion)
PLIF is traditionally an “open” surgery, in which back muscles are moved out of the
way in order to perform the procedure. Because these muscles are being pulled from
their attachments to the spine, the surgery can cause pain and scarring. As commonly
referenced in medical literature, this approach also carries risks.
TLIF (Transforminal Lumbar Interbody Fusion)
TLIF procedures are performed in a similar manner to PLIF procedures, but more from the
side of the spinal canal through a midline incision in the patient’s back. After reaching the
spine, the surgeon removes a portion of the facet joint and navigates through the foramen
to gain access to the disc space. This approach reduces the amount of surgical muscle
dissection and minimizes the nerve manipulation required to access the vertebrae, discs
and nerves. Complications and risks associated with TLIF procedures are similar to those
found in PLIF procedures.
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AxiaLIF+ Illustrated Guide
Step 1
Step 2
Step 3
Center of the
diseased disc is
removed
Step 4
Bone growth material
is inserted in place of
the diseased disc
Degenerative disc
and improper disc
height before the
AxiaLIF procedure
Access to the
diseased disc is
obtained
Lost disc height is
restored and the
spine is stabilized
Step 5
10
Further stabilized
with posterior fixation
of pedicle or facet
screws
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AxiaLIF+ Frequently Asked Questions
I read what people are saying about
AxiaLIF+. Do all AxiaLIF+ Patients do
so well?
How long will it take to return to my daily activities?
Only your doctor can determine when you should resume your regular daily activities.
In two separate AxiaLIF studies, patients
experienced a reduction in pain.1,2
However, results do vary from patient to
patient.
AxiaLIF+, like any minimally invasive
surgery, involves small incisions and
minimal muscle damage. As a result,
some patients may experience less
post-operative pain associated with the
approach compared to traditional open
procedures. Each patient’s results are
unique and will be discussed through
your surgeon.
References
1.
“Minimally-invasive Axial Pre-sacral L5-S1 Interbody Fusion: Two Year Clinical and
Radiographic Outcomes”
Tobler, et al.
SPINE, Sept 2011
2.
“Axial Presacral Lumbar Interbody Fusion and Percutaneous Posterior Fixation for Stabilization
of Lumbosacral Isthmic Spondylolisthesis”
Gerszten, et al.
Journal of Spinal Disorders & Techniques, Accepted, not yet published. Epub ahead of print
September 29, 2011
3.
“Complications with Axial Presacral Lumbar Interbody Fusion: A 5-year Postmarketing
Surveillance Experience.”
Gundanna, et al.
SAS Journal, Sept 2011
How many scars will I have from this procedure? How big will they be?
The AxiaLIF+ portion of the procedure carries only one scar which is typically about oneinch long and located next to your tailbone. You will have further stabilization in your spine
that would require one or more small vertical scars down each side of your back. Ask
your doctor about posterior instrumentation such as facet screws or pedicle screws which
further stabilize your spine after the AxiaLIF+ procedure is performed.
What are the risks of this procedure?
As with any surgical procedure, there are risks. With AxiaLIF+, there is minimal dissection
of vital nerves, arteries or muscle.
There is a low risk of bowel injury (0.6%)3. There are other risks associated with AxiaLIF+,
which should be discussed with your surgeon in reference to this procedure and surgery
in general.
See page 14 for additional AxiaLIF+ patient safety information.
How much pain should I expect after the procedure is performed?
The amount of pain that a patient will experience immediately following the procedure can
vary. As with most spine surgeries, this discomfort will tend to diminish over time. In two
separate patient studies, patients experienced a reduction in pain over time.1,2
How long will I have to stay in the hospital after surgery?
AxiaLIF+ length of stay may be as short as one to two days2, but is dependent on your
individual surgical outcome and your surgeon’s medical opinion.
How long will it take to get back to work?
Only your doctor can determine when you should resume your regular work activities.
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Additional Patient AxiaLIF+ Safety Information
AxiaLIF (all configurations)
Intraoperative: All steps of the procedure should be followed as per the “Surgical Technique”. All steps
in this technique require the use of active or real time fluoroscopy. Refer to “Surgical Technique” for
proper implant sizing. Risk of fluctuation in blood pressure exists in any surgery where instruments
are introduced through tubes. Rapid introduction of instruments should be avoided in order to
minimize introduction of excessive pressure or air into the disc space. As with any surgical procedure,
careful patient monitoring is required to minimize risk. As with any surgical procedure, there is some
risk that instrumentation will fail to perform as expected or may result in an unretrievable device
fragments.
INTENDED USE and INDICATIONS for the United States:
TranS1 AxiaLIF System is intended to provide anterior stabilization of the L5-S1 or L4-S1 spinal
segment (s) as an adjunct to spinal fusion. The AxiaLIFSystem is indicated for patients requiring
fusion to treat pseudoarthrosis (unsuccessful previous fusion), spinal stenosis, spondylolisthesis
(Grade 1 or 2 if single-level; Grade 1 if two-level), or degenerative disc disease as defined as
back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic
studies. Its usage is limited to anterior supplemental fixation of the lumbar spine at L5-S1 or L4-S1
in conjunction with use of legally marketed posterior fixation such as facet screw or pedicle screw
systems at the same levels that are treated with AxiaLIF.
Postoperative: Risk of occult bleeding exists during and after the procedure. As with all surgical
procedures, careful patient monitoring is required to minimize this risk. Following the procedure the
patient should be monitored until released for any effects of the procedure. Specifically, patients
should be monitored for any sign of potential bowel perforation that include but may not be limited
to: severe abdominal pain, blood in stool, fever, and/or elevated white cell counts. In the event that
a bowel injury is present, a colorectal surgeon should be consulted. Treatment may range from
antibiotics alone (if the injury is small and detected early) to laparoscopic repair of the injury or in
instances where a bowel injury is more significant or detected later, the patient may require general
antibiotics, gram negative specific antibiotics and possibly a temporary diverting colostomy.
CONTRAINDICATIONS:
Coagulopathy; bowel disease including any condition that may make the likelihood of adhesions of the
bowel to the sacrum more likely (e.g. Crohn’s, ulcerative colitis); pregnancy; scoliosis that extends to
the treated level(s); sacral agenesis; severe spondylolisthesis (L5-S1: >grade 2 or L4-L5: >grade 1);
tumor; prior radiation treatment to the sacral or pre-sacral anatomy; trauma. Do not use with facet
screws when correction of spinal stenosis requires removal of significant portions of the lamina or any
portion of the facets.
The patient should adhere to post-operative instructions as provided by physician. • Revision of the
AxiaLIF 2L+ system should not include the use of anterior plates. • AxiaLIF has not been evaluated
for safety and compatibility in the MR environment. AxiaLIF has not been tested for heating or
migration in the MR environment.
WARNINGS:
The safety and effectiveness of this device has not been established in patients with osteoporosis. The
3D Axial Rod is used for anterior stabilization but may not remain stable in patients with osteoporosis
(defined as a bone density z-score of < - 1.5). The safety and effectiveness of this device has not
been evaluated in patients with spondylolysis. Pedicle screw systems, not facet screws, should be
considered when there is degenerative disease of the facets with instability.
PRECAUTIONS:
Single use risk is limited to the utilization of all instrumentation labeled and marked single use, but
used multiple times. Single use sterile instrumentation is clearly labeled as such and should be
used in the manner consistent to its labeling. Re-cleaning and reuse of single use instrumentation
is not recommended. The re-use of single use devices has not been evaluated and therefore the
manufacturer does not recommend reuse of items labeled for single use. Some single use devices
contain areas that will be difficult to clean after use, which may inhibit re-sterilization. In addition,
the function and integrity of single use devices may degrade after multiple uses and cannot be
guaranteed to perform as intended.
POSSIBLE ADVERSE EVENTS:
The most frequently stated risks are: bowel injury and associated presacral or disc infection, or
intraoperative hypotension. Other risks based upon rarely reported incidents include: general infection,
vascular injury, and superficial wound infection, and presacral hematoma, device subsidence
requiring treatment, implant migration, graft protrusion, sacral fracture, and ureter injury. Finally
there may be risks from surgery including: bleeding (including occult during and after surgery),
neurological damage, damage to soft tissue, spinal cord impingement or damage, loss of bowel or
bladder function, loss of erectile or ejaculatory function, meningitis, pain, or anesthesia complications.
The risks associated with the implant include: breakage of the implants, loosening or expulsion of the
implants possibly causing delayed nerve root impingement or damage, fracture of osseous structures,
and bursitis. There may be pain, discomfort or abnormal sensations due to the presence of the
device. There may be risks associated with harvesting autologous grafts such as pain at the donor
site, infection, herniation, and fracture. There may be nonunion or delayed union of fusion with the
autologous graft.
Preoperative: Portions of this system are supplied non-sterile and need to be cleaned and sterilized
according to the CLEANING AND STERILIZATION section of the package insert. Care should be taken
during the pre-operative preparation to evaluate the ability to achieve a desirable implant trajectory
that allows the device to be fully contained within the vertebral bodies without protrusion anterior
or posterior. The provided templates should be used. Severe angulation of the vertebral bodies
may make achievement of an effective trajectory difficult. Preoperative planning should include
identification of any pre-existing adhesions of the bowel to the sacrum or aberrant anatomy such
as vessels crossing the Sacrum (MRI view to tip of coccyx is recommended per established surgical
technique). A bowel perforation could occur during creation of the presacral channel if there is an
adhesion of the bowel to the sacrum. Unusual bleeding could occur if a vessel crossing the Sacrum
is injured. Radiolucencies have been observed around the implant in patients where posterior pedicle
screw fixation was secured and spanned only from L4 to S1. Segmental posterior screw fixation at
L4, L5 and S1 is recommended. Physicians using the TranS1® AxiaLIF® System should have
significant experience in spinal surgery, including spinal fusion procedures.
Physicians should not independently use the AxiaLIF System prior to participation in specific training
on its use.
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For More information please visit:
www.TranS1.com/patients
301 Government Center Drive
Wilmington, NC 28403
Phone: 1-866-256-1206 (US Only)
Fax: 1-910-332-1701
Customer Service: 1-910-332-1700
www.TranS1.com
“TRANS1,” “AXIALIF,” and “Back to Living” are registered trademarks of TRANS1, Inc.
Certain TRANS1 products or their use as described in this material are disclosed in one or
more issued United States or foreign Patents, or patents applied for.
Authorized European Representative
MedPass International Limited
Windsor House, Barnett Way
Barnwood, Gloucester GL4 3RT, UK
©TranS1® 2008 All Rights Reserved
U.S. Patents 6,558,386 6,558,390 6,575,979 6,740,090 6,790,210
Additional U.S. and International Patents pending
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