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Article
- Table of Cotents:
Introduction
After extensive review of the two year U.S. clinical trial results the
FDA approved the CHARITÉ™ Artificial Disc, the first artificial disc
for treatment of low back
pain. This
makes the CHARITÉ™ Artificial Disc the first and most clinically tested
total disc replacement in the world. A breakthrough in non-fusion
technology, it offers an innovative surgical option to physicians for
treating some patients with degenerative disc disease and related
conditions.
Keep in mind that
replacement of painful joints is already extremely common. For example,
artificial hip and knee replacements are among the most successful and
reliable operations performed today. The significance of
bringing motion to spinal surgery may have the same dramatic impact, as
did the above introductions.
What is the CHARITÉ™ Artificial Disc?
The CHARITÉ™ Artificial Disc is a three-piece articulating medical
device consisting of a sliding core sandwiched between two metal
endplates. The sliding core is made from a medical grade plastic and
the endplates are made from medical grade cobalt chromium alloy.These
materials usually do not harm the human body and are used in many other
medical implants such as total knee replacement implants.
The endplates support the core and have small teeth which secure them
to the vertebrae above and below the disc space. The sliding core fits
in between.
Laboratory testing shows that
the CHARITÉ™ Artificial Disc design allows your spine to move. In the
clinical study, patients were observed to have motion between 0 and 21
degrees while bending forward and backward.
The CHARITÉ™ Artificial Disc has a clinical history spanning 17 years.
Its safety, efficacy, and remarkable durability have been proven
through thousands of implants worldwide.
What Are the Potential Benefits and Risks of Disc Replacement Surgery?
There are potential benefits and risks of disc replacement surgery with
the CHARITÉ™ Artificial Disc as an alternative to spinal fusion
surgery.
Potential Benefits
Most importantly, when fusion surgery is performed, although your pain
symptoms may go away, the vertebrae surrounding the disc space are
immobilized and therefore typically limit flexibility in that area of
the spine. Laboratory testing shows that the CHARITÉ™ Artificial Disc
design allows your spine to move. In the clinical study, patients were
observed to have motion between 0 and 21 degrees while bending forward
and backward.
Another benefit to disc
replacement surgery with the CHARITÉ™ Artificial Disc is that no bone
graft is required. Often times with spinal fusion surgery, the bone
graft used to pack the disc space is bone that the surgeon has to
remove from the patient's hip. This means that the patient ends up
having two incisions that must heal, as well as pain in the back and
hip during recovery from the surgery.
Potential Risks
As with any surgery, there are some possible complications that can
occur when you have disc replacement surgery with the CHARITÉ™
Artificial Disc. Complications can occur singly or in combination and
may include:
- allergic reaction to the implant materials
- bladder problems
- bleeding, which may require a blood transfusion
- death
- implants that bend, break, loosen or move
- infection
- pain or discomfort
- paralysis
- side effects from anesthesia
- slow movement of the intestines
- spinal cord or nerve damage
- spinal fluid leakage
- the need for additional surgery
- tears of the dura (a layer of tissue covering the spinal cord)
- problems with your blood vessels other than bleeding
- incision problems
When to Consider Disc Replacement
If you or someone you love suffers from Degenerative Disc Disease
in the lumbar spine, and have failed at least six months of
conservative treatment without adequate results, you may be a candidate
for Artificial Disc Replacement.
Who is a Candidate?
The CHARITÉ™ Artificial Disc is an alternative to spinal fusion for patients that have one diseased disc between L4 and L5 or between L5 and S1.
Degenerative Disc Disease (DDD) is defined as a disc that has worn out
or become injured and causes back pain. The disc deterioration is
confirmed by history and x-rays or other diagnostic imaging. Patients with DDD whose vertebrae (bones)
have moved less than 3mm (0.12in) may still receive the CHARITÉ™
Artificial Disc. Patients receiving the CHARITÉ™ Artificial Disc should
have failed at least six months of treatment such as pain medication, a
back brace, or physical therapy. Patients who have had some types of
minor lower back surgery may still receive the CHARITÉ™ Artificial
Disc.
Your doctor can help you determine if you are a candidate for the CHARITÉ™ Artificial Disc.
Who is a Not a Candidate?
While the use of an artificial disc is considered to be an extremely
effective option for patients with degenerative disc disease, this
technology is not appropriate for everyone. The CHARITÉ™ Artificial Disc should not be used if:
- you have either an infection throughout your body or localized to your spine; or,
- you have disc deterioration or instability at more than one spinal level; or,
- if you have poor bone quality (osteoporosis or osteopenia).
Your
occupation or activity levels, your weight, the condition of other
levels of your spine, whether or not you are pregnant, and any
allergies you have may influence whether you should have surgery with
the CHARITÉ™ Artificial Disc. If any of these factors apply to you,
please discuss them with your doctor.
Diagnostic Tests for Degenerative Disc Disease
The most common diagnostic tests used to diagnose degenerative disc disease are ordinary X rays and MRI scans.
If your doctor suspects disc degeneration, X rays can be used to verify
a decrease in the height of space between vertebrae. A decrease often
indicates the the disc is damaged, may be bulging outward, and may have
lost water content.
An MRI shows the spine
in very clear detail. Through the use of an MRI, your doctor can verify
if there is loss of water in a disc.
Treatments
Conservative Treatment
Back
specialists often use the term "conservative treatment" to describe any
treatment option that does not involve surgery. Treatment will depend
on the seriousness of your condition. In many low back pain cases,
simple therapies can help alleviate low back pain, including:
- Mild pain medications to relieve immediate pain
- Rest to take the pressure off your spine and the muscles around it
- Physical Therapy and Exercise to assist in calming pain and inflammation, and improve mobility and strength
Epidural steroid injections (ESI) are also sometimes used to relieve
the pain of stenosis and irritated nerve roots, as well as to decrease
inflammation. These injections can also help reduce swelling from a
bulging or herniated disc. The steroid injections are a combination of
cortisone (a powerful anti-inflammatory steroid) and a local anesthetic
that are given through the back into the epidural space. ESIs are not
always successful in relieving symptoms of inflammation. They are
typically used only when conservative treatments such as those listed
above have failed.
The goal of treatment
is to make you feel comfortable, reduce further degeneration, and get
you back to normal activity as quickly as possible. As a last resort,
and only if all other conservative treatments fail, surgery might be
considered.
Spinal Fusion
One of the main goals of any surgical procedure on the skeletal system
is to stop the pain caused by joints that have worn out over time, also
called degenerative joints. One of the most reliable ways to reduce
pain from degeneration is to fuse the joints together. A fusion is an
operation where two bones, usually separated by a joint, are allowed to
grow together into one bone. The medical term for this type of fusion
procedure is arthrodesis.
Spinal fusion has been used successfully for over forty years to
address a variety of conditions of the lumbar spine, including
degenerative disc disease. Over the past decade, there have been
dramatic improvements in the way that spinal fusion operations are
performed. One major improvement has been the development of new and
innovative fixation devices to promote successful fusion of the
vertabrae in the affected area and maximum stability for the patient
post surgery.
During a
spinal fusion, a bone graft is used to join two or more vertebrae. The
vertebrae grow together during the healing process, creating a solid
piece of bone. The bone graft helps the vertebrae heal together, or
fuse. The bone graft may be taken from the hip at the time of surgery.
Many bone grafting technologies are comprised of allograft or donor
tissue from licensed tissue banks. Other technologies are manufactured
of synthetic materials that mirror the characteristics found in human
bone. The use of allograft or synthetic materials in spine fusion
surgery has been shown to promote bone formation, effective fusion of
the vertabrae, cell proliferation and faster healing times without the
need for a second procedure to harvest bone from the hip area.
Ask your doctor for more information on Bone Grafting Technologies and
Lumbar Spinal Fusion for the treatment of Degenerative Disc Disease.
Artificial Disc Replacement
Early research in the development of artificial disc replacement began
in the 1960's. Because of the complications sometimes associated with
lumbar spinal fusion, a renewed interest in artificial disc replacement
resurfaced in the 1990's. Since then, the number of studies and overall
level of research and design efforts relative to disc replacement has
increased significantly.
During disc replacement
surgery, the surgeon will remove the damaged disc and replace it with
an artificial disc. The goal of this and most all spine surgeries is to
help to reduce your pain and restore activity.
One of the artificial discs with the longest clinical history is the
CHARITÉ™ Artificial Disc. It is the first and only FDA approved
artificial disc on the market today. It has been approved for use in
patients that have one diseased disc in the lumbar area of the spine.
Preclinical testing indicates that the CHARITÉ™ Artificial Disc system is designed to:
- Maintain motion in the area of the spine where the disc is implanted
- Maintain stability in your spine
- Restore proper disc height between the vertebrae above and below the disc
- Re-establish proper spinal alignment / curvature of your spine in the lumbar area
- Reduce discogenic pain
Talk with your doctor to find out if artificial disc replacement is an option for you.
What Happens During the Surgery?
When undergoing surgery with the CHARITÉ™ Artificial Disc, you will be
lying on your back and the surgeon will operate on your spine through
an incision near your belly button. During the disc replacement
surgery, the surgeon will remove the diseased disc and replace it with
the CHARITÉ™ Artificial Disc.
Disc Implant in Spine
There are alternative treatments to this surgery. You should discuss
these other possibilities with your surgeon before you make your
decision.
What Possible Complications Could Occur?
As
with any surgery, there are some possible complications that can occur
when you have disc replacement surgery with the CHARITÉ™ Artificial
Disc. Complications can occur singly or in combination and may include:
- allergic reaction to the implant materials
- bladder problems
- bleeding, which may require a blood transfusion
- death
- implants that bend, break, loosen or move
- infection
- pain or discomfort
- paralysis
- side effects from anesthesia
- slow movement of the intestines
- spinal cord or nerve damage
- spinal fluid leakage
- the need for additional surgery
- tears of the dura (a layer of tissue covering the spinal cord)
- problems with your blood vessels other than bleeding
- incision problems
What Should I Expect After Surgery?
After your surgery with the CHARITÉ™ Artificial Disc, it is important
that you follow your surgeon's instructions for recovery. Make sure you
get and keep your surgeon's name and telephone number.
In most cases, immediately after surgery, your heart and lung function
will continue to be monitored, and your doctor will prescribe medicines
to control pain and nausea.The average hospital stay for disc
replacement surgery patients in the study used to evaluate the CHARITÉ™
Artificial Disc was about four days. A nurse will show you how to care
for your wound before you are sent home, and your doctor will discuss a
program to gradually increase your activity. It is possible that you
will be asked to wear a back brace or elastic bandage to support your
abdominal muscles after surgery.
Contact your doctor immediately after surgery if:
- you get a fever
- the wound starts leaking fluids
- you have trouble swallowing or breathing
- you have trouble urinating
- you have new or increased back or leg pain or numbness
Life After Disc Replacement
Pain relief, the reduction of further degeneration and resumption of
daily activities are typical goals of spine surgery. While both fusion
surgery and artificial disc replacement can provide pain relief and
stability, with spinal fusion the vertebrae surrounding the disc space
are immobilized, and therefore limit flexibility in that area of the
spine.
Laboratory testing shows that the
CHARITÉ™ Artificial Disc design allows the spine to move. In the U.S.
clinical study of the CHARITÉ™ Artificial Disc from DePuy Spine,
patients who had CHARITÉ™ Disc replacement surgery were observed to
have motion between 0 and 21 degrees while bending forward and
backward.
The clinical study also
demonstrated that patients who received the CHARITÉ™ Artificial Disc
had pain relief and restored function no worse than patients who had
fusion surgery two years after the surgery.The rates of complications
were about the same between the two groups.
Reports from Europe of patients who have had the CHARITÉ™ Artificial
Disc implanted for 10 years or more show similar results.
Nobody can guarantee that after disc replacement surgery you will never
feel pain again or that your spine will fully regain its flexibility.
If you're like the majority of spinal surgery patients, you'll
experience a decrease in pain and you'll gradually be able to increase
your level of activity. With your pain minimized or no longer an issue,
your concentration level on task will be noticeably better.
Ask your surgeon for more details about the results of the clinical study and life after disc replacement. |
