Life After Disc Replacement
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.