Experts in Resolving Painful Joints with Cartiva
WHAT IS THE CARTIVA® SCI?
The Cartiva® Synthetic Cartilage Implant (Cartiva SCI) is a man-made
(synthetic) implant that is made of a soft plastic-like substance (polyvinyl
alcohol) and salt water (saline). These materials are combined and
molded into a solid, slippery and durable implant. Figure 1 shows
a picture of the Cartiva SCI. The implant replaces the damaged
cartilage surface of the big toe.
WHAT IS THE CARTIVA® SCI USED TO TREAT?The Cartiva SCI is intended to treat painful arthritis in the joint of the big toe
(first metatarsophalangeal joint). This arthritis of the big toe, also known as
osteoarthritis or “OA”, involves the wearing down of the cartilage tissue located
in the big toe joint. The worn down cartilage can cause pain.
HOW DOES THE CARTIVA® SCI TREAT OA OF THE BIG TOE?
Your doctor thinks that the Cartiva SCI may help you. The Cartiva SCI (Figure 1)
is made to replace the damaged cartilage surface of the big toe. The implant is
placed into the bone in your big toe (See Figure 2 for an image of the bones of
the big toe). The
Cartiva SCI provides a new smooth, slippery surface in the joint.
As a result, the Cartiva SCI may help relieve the pain and stiffness in your big toe
caused by the worn cartilage.
WHAT YOU NEED TO KNOW
WHO SHOULD NOT RECEIVE THE CARTIVA® SCI
• Tell your doctor if you think you have an infection in your foot. An infection makes it risky to
have the Cartiva
SCI. You might need another surgery to remove it because infections near the implant are hard to treat. Your doctor should not implant this device in you if you have
an infection. (It is not allowed for use in patients with infections).
• Tell your doctor if you think you have ever had any allergy to or reacted to any plastic or
an implant. The Cartiva SCI is made from a plastic-like mixture (polyvinyl alcohol and
saline). You could be allergic to it. An allergic reaction to the Cartiva SCI might mean you
would need more surgery to remove it. Your doctor should not implant this device in you if
you might be allergic to it. (It is not allowed for use in patients who are allergic to polyvinyl
alcohol or saline.)
• Tell your doctor if you have a form of arthritis called gout that also causes small lumps (tophi)
to form under the skin around your joints. The Cartiva SCI might not work in your joint with this
kind of arthritis. Your doctor should not implant this device in you if you have gout with tophi.
• Tell your doctor if you have any of the following conditions that can hurt implant support.
– You had cancer
– You had a hip dislocation
– You have brittle bone or bone that breaks easily
– You have taken a steroid medication in the past
– You had an organ transplant
– You have taken a medication called an immunosuppressant in the past
– You have a history of any growths (tumors) in your bones
These conditions might lead to changes in your bone that might make the Cartiva SCI device
unable to work properly.
You should speak to your doctor to determine if the above conditions apply to you, or if other
conditions may make the Cartiva SCI not right for you.
WHAT ARE PRECAUTIONS RELATED TO THE USE OF THE CARTIVA® SCI?
Not all patients with first MTP osteoarthritis were studied. The following patients were not in the Cartiva study:
– Patients with hammer toe (hallux valgus) more than mild
– Patients needing a Cartiva device in more than one joint
– Patients needing a Cartiva device in a joint other than the MTP joint
WHAT WARNINGS SHOULD I KNOW ABOUT
WHEN THE CARTIVA SCI® IS USED?
• Tell your doctor if you are younger than 22 years old. The Cartiva SCI device was not studied
in people younger than 22 years old. The effect of the Cartiva SCI device for
these people is not known.
• Tell your doctor if you have very poor bone quality due to poor blood supply (osteonecrosis)
of the first MTP joint. The Cartiva SCI device was not studied in people
with poor blood supply of the first MTP joint. The effect of the Cartiva SCI device for
these people is not known.
• Tell your doctor if you have a low grade (Grade 1 or 0) of osteoarthritis in your big toe.
The Cartiva SCI device was not studied in people with low-grade osteoarthritis of the
big toe. The effect of the Cartiva SCI device for these people is not known.
HOW HAVE WE TESTED THE CARTIVA SCI® IN CLINICAL TRIALS?
• A controlled clinical study tested the Cartiva SCI. The study happened in hospitals in Canada
and the United Kingdom. Patients had OA of the first MTP joint, similar to you. Study patients
received the Cartiva SCI or a fusion of their first MTP joint. 202 patients were treated in this
study. 152 patients received the Cartiva SCI implant. 50 patients had fusion surgery. Patients
were seen over a two-year period from surgery including a visit two years after surgery. Of the
Cartiva patients, 151 patients of the 152 were available for the two year visit and 47 of the 50
fusion patients were available at two years. The study results
were reported to the U.S. Food and Drug Administration (FDA).
• The patients with the Cartiva SCI implant saw similar outcomes to the patients with the fusion
treatment. In the clinical study, 89 out of every 100 Cartiva SCI patients had significant pain relief
at two years after treatment. 98 out of every 100 Cartiva SCI patients maintained or improved
their function at two years after treatment.
• 74 of every 100 Cartiva SCI patients maintained or improved their amount of motion at two
years after treatment. People with a fusion surgery were unable to keep their motion. This
motion in the Cartiva SCI patients did not cause better function in day-to-day activities.
The Cartiva SCI and fusion groups had similar improvements in function at two years.
HOW LONG CAN I EXPECT THE CARTIVA SCI® TO LAST?
The Cartiva SCI device is a long-term treatment for your big toe joint. There have been limited
cases where the Cartiva SCI was removed because a patient still had pain in their big toe joint.
In the study, 9 out of every 100 Cartiva SCI subjects had the device removed within 2 years after
surgery. In these cases, the patient’s joint was fused with plates or screws (arthrodesis). The use
of the Cartiva SCI device did not limit the patient’s options for a successful fusion.
WHAT WILL HAPPEN BEFORE SURGERY?
Your doctor will give you instructions prior to your surgery. You should follow these instructions
the day before the operation. This surgery usually occurs without an overnight stay in the
hospital. The procedure usually lasts about 25 minutes.
WHAT WILL HAPPEN DURING SURGERY?
The Cartiva SCI goes through a small cut in the top of your toe. You will be given drugs.
The drugs will make you sleep during surgery. You will not feel the surgery.
|1: First, your doctor will make a small
(about 2 inch) cut in the skin over the
top of your big toe joint.
|2: This will open the joint of your big toe. Then,
the doctor will use special tools to remove
bone to make a hole for the implant.
|3: Your doctor will then place the Cartiva SCI into
the hole. The Cartiva SCI implant provides a
smooth, slippery, load-bearing surface.
|4: The Cartiva SCI stays in place without the
use of cement or glue. Then, your doctor
will close the cut in your toe with stitches.
WHEN SHOULD I CALL MY DOCTOR?
Ask your doctor to describe how you will feel after surgery. Some pain and discomfort is normal.
The problems you had before surgery may not lessen right away. Talk to your doctor about when
to call with problems after surgery.
You should call your doctor immediately if you have too much pain, are sick to your stomach and
vomit, or have a fever, redness or rash, itching, tenderness, or swelling of the foot.
ARE THERE ALTERNATIVES TO USING THE CARTIVA® SCI?
Surgery will likely be recommended by your doctor if other non-operative methods have not been
successful at reducing your big toe arthritis pain. You may wish to ask your doctor about any
other possible treatments for your big toe arthritis pain.
Other surgical treatment options may include:
• Cheilectomy: A surgery that involves shaving bone from both the joint surfaces of your big toe
and removal of the diseased portion of the metatarsal head.
• Hemi-arthroplasty: A surgery that replaces part of your joint with metal or plastic parts to
serve as the new surface of the first metatarsophalangeal head.
• Total Joint Replacement: A surgery that replaces your joint with metal and plastic parts to
replace both sides of the MTP joint.
• Fusion (arthrodesis): A surgery where the two sides of the MTP joint are cleared of cartilage.
The two bones are held together with plates and/or screws so that the bones grow together.
Fusion was studied and compared to the results for patients implanted with the Cartiva device,
as discussed above.
Your doctor will have more information on each of these options and other possible treatments,
as well as the benefits and risks for each of the treatment options.
TALK TO YOUR DOCTOR
This site is meant to give you useful information and knowledge about the Cartiva SCI
implant. It is not intended to replace medical advice or instruction from your doctor.
Your doctor or physician is the only person responsible and qualified to appropriately diagnose
and treat your health condition. Should you have any questions about the Cartiva SCI implant
or its relevance to your course of treatment, please call us today 248-258-0001!.
- What is Cartiva made of?
The implant is composed of a biocompatible, durable, slippery
organic polymer that functions similarly to natural cartilage.
- What is Cartiva used to treat?
Cartiva treats painful arthritis in the joint of the big toe. This arthritis involves
the wearing down of the cartilage tissue in the big toe joint.
- How does recovery compare to fusion?
With Cartiva, your foot will be weight bearing immediately following surgery. You
should begin exercises that move your joint immediately. Your doctor may instruct
you in the exercises to undertake in order to regain movement of your toe. Fusion
normally takes 6 weeks before your foot will be weight bearing.
Our podiatrists provide Cartiva Synthetic Joint Replacement to patients in all areas including but not limited to Livonia, Northville, Farmington, Farmington Hills, West Bloomfield, Redford, Westland, Garden City, Dearborn Heights, Canton, Plymouth, Wayne, Novi, Southfield, and all other surrounding areas.