New treatment approved in US for treatment of arthritis at the base of the big toe
Cartiva, Inc in US has announced that the first patient has received the Cartiva Synthetic Cartilage Implant (SCI) following its approval by the US Food and Drug Administration (FDA). The new SCI device is intended for the treatment of painful osteoarthritis of the first metatarsophalangeal (MTP) joint, the most common site for osteoarthritis in the forefoot. This is the first synthetic cartilage device approved by the FDA.
The Cartiva implant is a molded cylindrical device containing polyvinyl alcohol and saline that is implanted into the metatarsal head in the first MTP joint via press-fit implantation. The implant is also approved in Europe, Canada, and Brazil.
The FDA approval was based on the 236-patient, multicenter, prospective, randomized MOTION study comparing the Cartiva device with arthrodesis/fusion, the current standard of care.
The Cartiva SCI patient group had clinical success of 80% for the composite primary endpoint of pain, function, and safety at 24 months compared with 79% success for the fusion group
The Cartiva implant group also saw a 93% reduction in median pain, a 168% improvement in median function of sporting activities, and a 65% improvement in activities of daily living. The implant patients also experienced a 26% improvement in range of motion from baseline.
“The landmark MOTION study clearly shows Cartiva SCI to be a safe and effective alternative to fusion for patients wishing to maintain motion in their great toe,” says Dr Judith Baumhauer, MD, from the University of Rochester Medical Center, in New York, and principal investigator on the MOTION study.
The implant procedure takes about 35 minutes and is performed on an outpatient basis. Unlike fusion therapy, patients may begin weight-bearing immediately as tolerated.
“Today, one in 40 Americans over the age of 50 experience arthritis of the toe, and with the aging population, that number is likely to grow. This condition can be particularly life-impacting – limiting a person’s ability to conduct functional activities of daily living, producing pain and discomfort and restricting shoe wear options,” says Dr. Baumhauer. “The Cartiva implant was accomplished in a quick, simple surgical procedure and we look forward to offering this innovative option to more people in need.”
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