Brochures

The Cartiva® Synthetic Cartilage Implant (Cartiva SCI) is a man-made implant that is made of a soft plastic-like substance and salt water. These materials are combined and moulded into a solid, slippery, and durable implant.

The Cartiva SCI is intended to treat painful arthritis in the joint of the big toe.

WHO SHOULD NOT RECEIVE THE CARTIVA® SCI (CONTRAINDICATIONS)?

Tell your doctor if you think you have an infection in your foot. An infection makes it risky to have the Cartiva SCI.

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.

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.

Tell your doctor if you have any of the following conditions that can hurt implant support. 

• Cancer
• Hip dislocation
• Brittle bones or bones that break easily
• You have taken a steroid medication in the past
• You had an organ transplant
• You have taken an immunosuppressant mediation 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. 

A controlled clinical study tested the Cartiva SCI. The study happened in hospitals in Canada and the United Kingdom. Patients had osteoarthritis in the joint of their big toe. Study patients received the Cartiva SCI or a fusion of their first 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. 

In the clinical study, 89% of Cartiva SCI patients had significant pain relief two years after treatment, while 98% maintained or improved their function at two years after treatment.

74% of patients maintained or improved their amount of motion at two years after treatment. 

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.

Surgery will likely be recommended by your doctor if other non-operative methods have not been successful at reducing 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.

The Cartiva SCI device study followed 152 patients for 2 years after surgery.

The most common adverse events were:

• Pain due to surgical procedure
• Wound swelling, draining or delayed healing or scarring
• Joint stiffness or hardening of your joint (induration)
• Tendon swelling (inflammation)
• Damage to nearby nerves, arteries, or veins
• Infection
• Numbness in toes
• Changes in the way you walk (gait disturbance)
• Blood clot formation in one or more of the deep veins in your body (deep vein thrombosis), collection of fluid in the lungs (pulmonary embolism), or blood clot (thrombosis) formation in other vessels
• Reactions to the drugs or anaesthesia (the medicine they used to put you to sleep) used during and after surgery
• Heart attack
• Blood loss, blood vessel damage, swelling of the blood vessel in your leg (phlebitis) or a localized collection of blood outside the blood vessels (hematoma)
• Additional surgery to remove or replace the implant due to more pain
• Other operative procedures
• Pain and discomfort associated with the operative site or presence of implants
• Joint with excess motion (instability) or at an abnormal angle (malalignment)
• Swelling or escape of fluid in body cavity (effusion)
• Fracture of part of your sesamoid or metatarsal bone
• Progressive osteoarthritis or disease of the joint (arthropathy)
• Changes to the foot bone
• Implant may loosen, wear out, or break which may need another operation to remove the implant and may need another method of treatment
• Sensitivity or allergy to the implant material 
• Bone loss
• Poor positioning of the implant
• Joint or bone irritation
• Damage to surrounding tissues
• Other unexpected reactions