|
The Joint Preservation Center (JPC) is a cooperative
effort of the Arlington Orthopedic Associates, the Surgery Center of
Arlington, and Medical Center of Arlington. One of only ten such centers
in the United States, it was created to provide options to patients
with knee injury or pathology. Injuries to the joint surface, instabilities
or angular problems are addressed. Options to repair the joint rather
than replace the joint are evaluated. One of the more unique operative
options is Autologous Chondrocyte Implantation (ACI). This operation
repairs localized injuries in the knee joint. The JPC has helped pioneer
clinical research in this area and is one of the leading centers in
the United States.
Back to top
ACI is a procedure that provides you and your doctor
an option to repair articular cartilage injuries by implanting your
own (Autologous) cultured cartilage cells (Chondrocytes) in damaged
areas of your knee. These autologous cultured chondrocytes are called
Carticel.
Carticel has demonstrated important benefits in patients with damaged
articular cartilage. Carticel is indicated for the repair of symptomatic,
cartilaginous defects of the joint surface, caused by acute or repetitive
trauma, in patients who have had an inadequate response to a prior arthroscopic
or other surgical repair procedure. Carticel is not indicated for the
treatment of cartilage damage associated with osteoarthritis.
Back to top
Carticel is a biologic product used to repair articular
cartilage damage. The procedure is called Autologous Chondrocyte Implantation
(ACI). First, an orthopedic surgeon takes a small biopsy of your healthy
articular cartilage, usually the size of two pencil erasers, and sends
it to Genzyme Biosurgery. This is a unique laboratory and the only one
of its kind in the United States. Genzyme then grows the cells until
there are enough to repair your defect (this takes about 5 weeks). The
cells are put into a transfer vial and shipped back to your surgeon.
It arrives by special courier the morning of surgery.
The second step is the surgery itself. Your surgeon will make an incision
in your knee, and prepare your injury site by cleaning away all the
damaged tissue. The surgeon will then cover the lesion with a patch
taken from tissue covering your shinbone (tibia). The surgeon injects
your newly grown cartilage cells (Carticel) under the patch into the
lesion. The cells attach to the bone, multiply and mature to form a
cartilage repair.
Third, you will need to go through the personalized rehabilitation program
recommended by your surgeon.
Back to top
No. Carticel is a biologic material. It is a growth
of cells from your own body and therefore it cannot be rejected. It
is implanted as a suspension of cells, then congeals like gelatin, and
then with time slowly hardens. If the rehabilitation process is not
done correctly or done too aggressively, it can damage or retard the
cell maturation process. Though very rare, programs too aggressive can
lead to graft failure. Because the graft is biologic, it must heal and
mature like other tissues. A consistent conservative program prescribed
by your surgeon may yield more successful results.
Back to top
If you’ve undergone other treatments to address
your cartilage injury but are still experiencing pain and swelling,
you may be a candidate for Carticel. Consult with an orthopedic surgeon
specifically trained in Autologous Chondrocyte Implantation (ACI) to
find out if Carticel is the right treatment for you. To locate a qualified
surgeon in your area call Genzyme Biosurgery at 1-800-453-6948 or visit
www.carticel.com.
In the Texas, New Mexico, Oklahoma, Arkansas, and Louisiana areas, you
may elect to call The Joint Preservation Center located in Arlington,
Texas. Physicians associated with The Arlington Orthopedic Associates
have extensive experience in ACI. They can help with your questions
and evaluate whether ACI is a good option for your problem. They can
be reached at phone 817-784-7062; fax 817-299-1756 or at our web site
at www.jointpreservationcenter.com.
Back to top
No. Carticel was created for injuries that are not
applicable to other treatment options. Many injuries are too large for
other options. Lesions greater than approximately 1.5 X 1.5 cm are too
large for many other treatments currently available and may best be
treated by Carticel. Further, there are certain areas of the knee such
as the notch (trochlea) or the kneecap (patella) of the knee where the
contours may prohibit other options.
Back to top
This of course depends on the injury. But, if we
presume that your knee is stable and you have an isolated injury to
your joint surface, then you can anticipate several things. If the lesion
is very small, less the one centimeter in diameter, you may go for several
years without any symptoms. If, however, your injury is larger or in
one of the more important weight bearing areas, then, without appropriate
treatment, you will have a greater than normal chance of arthritis.
In that case, you can anticipate pain, swelling, occasional locking
and giving way. These symptoms may well progress in severity with time.
Back to top
Once the biopsy is taken it is sent to a special
laboratory in Boston, Massachusetts. It is processed and then frozen.
It can then be stored. For safety reasons, most decisions for implant
need to be made with one year (12 Months). Although in rare circumstances,
patients can wait for their surgery, if your symptoms continue, you
should consider having your implantation as soon as is convenient to
your schedule to prevent possible further injury or progression of your
current injury.
Back to top
Many other treatment options try to repair the knee
by forming a type of repair tissue called fibrocartilage. Fibrocartilage
may hold up in smaller lesions that are protected from heavy weight
loading. However, in larger lesions, fibrocartilage is not durable enough
to withstand the forces within the knee and breaks down over time. Fibrocartilage
usually lasts about 3-5 years after which patients with active life
styles may be subject to further surgery or a possible increase incidence
of arthritis.
Back to top
Articular Cartilage also known as Hyaline cartilage
is a durable tissue that covers the ends of the thigh, shinbones and
the knee cap. Articular Cartilage can last a lifetime if undamaged.
Unfortunately, it can be injured by sports, traumatic injuries, work
injuries, repetitive trauma secondary to incorrect training techniques
or in some cases daily wear and tear. Articular Cartilage damage can
occur in conjunction with damage to another area of the knee, for example,
with injury to the Anterior Cruciate Ligament or the Meniscus. Articular
Cartilage does not have a natural ability to heal itself. Carticel has
the ability to repair defects or injury in the knee with hyaline cartilage,
a key difference from many other repair techniques.
Back to top
Yes. All patients undergoing Carticel (Autologous
Chondrocyte Implantation) will need to follow a prescribed rehabilitation
program. Although specific exercises and length of the rehabilitation
period may differ from patient to patient, your surgeon and physical
therapist will recommend a program for you based on the size, location,
severity of your cartilage injury and the extent of your operative repair.
Back to top
Within 6-24 hours of your surgery you will begin
using a CPM (continuous passive motion) machine. You will use the CPM
machine 6-8 hours per day non-sequentially. That means you may use it
in two-hour time intervals rather than the six to eight hours all at
once. You will also begin home exercises the next day. This will include
isometrics, straight leg raises, and contracting your quadriceps muscle
several times per day. (Please review the post-operative exercises program
on this web site.) Physical therapy starts one week following surgery.
Therapy runs approximately 2-3 times per week for 8 to 12 weeks. You
will not be allowed to put weight on your leg for the first 3 weeks.
By week 4 or 5 you will be allowed to gradually increase weight on your
leg. By week 6 or 8, you will be progressed to full weight bearing/walking.
Specific therapy programs may vary from patient to patient. Your surgeon
will be able to discuss your particular program with you.
Back to top
Crutches are used for the first 6 to 8 weeks. Too
much pressure initially on the cultured cells can damage them or inhibit
their growth. After that you may switch to a cane on an as needed basis,
though many patients do not need any further assistance. Consult with
your surgeon or physical therapist for specific recommendations regarding
the use of crutches or a cane.
Back to top
This can vary. Immediately after surgery, you will
begin decreasing your swelling, increasing motion and strength. Single
injuries improve faster, while multiple injuries and the Patella-Femoral
joint implants tend to be protected longer. If you require concurrent
operative procedures such as a knee reconstruction or an osteotomy (bone
cut for realignment), the length of time is influenced. However, in
general, the cells mature over many months. Regardless of how much better
you may feel after the operation, it takes time just for the cells to
grow. Most surgeons will not let you run until at least 9 months from
date of surgery.
Back to top
The second stage of Carticel is done through an open
procedure that requires an incision and will leave a scar. The scar
will vary depending on the exposure needed to perform the operation.
Single lesions require relatively small incisions. If you require an
osteotomy (bone cutting procedure), especially a patellar elevation
osteotomy, your incision will be larger. It is very important that your
surgeon have enough exposure to perform an adequate implantation.
Back to top
Carticel was first commercially available in 1995
in the United States. Prior to that it had undergone extensive evaluations
and trials in Europe. It is currently FDA approved. There are new studies
being done examining the results of over 17 years of experience. As
of September 2001, over 6000 patients had been treated with Carticel.
Back to top
The surgeon takes a biopsy of your healthy cartilage
and sends it to Genzyme Biosurgery. Once Genzyme begins to grow the
cells, it takes 4-5 weeks to accumulate enough cells. The biopsy usually
contains approximately 150,000 - 200,000 cells. These are then grown
to a volume of 10,000,000 for the second stage implantation.
Back to top
Once the biopsy is taken, it only takes 4-5 weeks
to grow the cells. However, most surgeons will ask you to get over your
first arthroscopic surgery before proceeding with the implant. This
can take about 4-6 weeks.
Back to top
Most insurance plans cover the cost of Carticel.
Check with your particular plan administrator or contact a Genzyme Biosurgery
specialist who will work with you to get approval for your surgery.
Call 1-800-453-6948.
Back to top
No. Only surgeons specifically trained in the implantation technique
may perform the procedure. To locate a surgeon who can perform the procedure
in your area, call Customer Care at 1-800-453-6948 or visit the Genzyme
web site at www.carticel.com.
Surgeons at the Joint Preservation Center (JPC) have been specifically
trained in the complicated procedure of ACI. The JPC in conjunction
with Arlington Orthopedic Associates has done extensive lecturing on
the topic and has hosted several seminars to teach the techniques to
physicians from around the United States.
Back to top
As with most surgeries, there will be some pain following
surgery. However, physicians at the Joint Preservation Center use special
nerve blocks and local injections to make the pain very manageable.
Speak to your physician about the appropriate ways to manage your pain.
Back to top
This is determined on a patient per patient basis.
Most procedures are done as an outpatient. The anesthesia, nerve blocks
and local injection anesthetics all are designed to keep you relatively
comfortable so that you may leave the same day of surgery. Your physician
can address your particular procedure.
Back to top
This depends upon the size and location of your lesion,
numbers of lesions, and the specific sport you are playing. Generally,
low-level activity such as swimming, biking, walking, or skiing, may
be resumed as early as 6 months following treatment. More strenuous
activity involving pivoting or twisting, such as basketball, soccer,
or tennis may compromise the durability of the new cultured cells and
generally should be attempted until 12-16 months post treatment. Individual
results may vary. Not all patients return to full activity.
Back to top
As with any surgery done with anesthesia, complications
can occur. Autologous Chondrocyte Implantation has no more but no less
complications than any other orthopedic surgical procedure. In patient
data included in the biologic license application, the following were
reported as possible adverse events: “overgrown” tissue at
the site of the cartilage repair, adhesions, wound infection, inflammation
of the tissues in or around the joint, and postoperative bruising.
Back to top
Carticel has been shown to be about 90% successful with single lesions.
With multiple lesions and patellar lesions success ranges from 80% to
90%. Success is significantly influenced with correction of instabilities,
malalignments, presence of the meniscus, and patellar elevation decompression
procedures.
Back to top
The product is not recommended for use in patients
with a known history of allergy to the antibiotic Gentamicin, in patients
with sensitivity to materials of bovine origin, who have an unstable
knee, or who have abnormal weight distribution within the joint. Patients
who have previously had cancer of the bones, cartilage, fat or muscle
of the treated limb should also not be treated with Carticel. Any instability
of the knee or malalignment of the joint should be corrected before
or concurrent with Carticel implantation. Use in children, or in joints
other than the knee has not yet been assessed.
Back to top
|
