The US Food and Drug Administration (FDA) has approved the Cartiva Synthetic Cartilage Implant (SCI) for treatment of painful osteoarthritis of the first metatarsophalangeal (MTP) joint, the most common site for osteoarthritis in the forefoot, according to a company new release.
This is the first synthetic cartilage device approved by the FDA, the company notes.
The FDA's Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee recommended approval of the implant back in April, as reported by Medscape Medical News.
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 company said in the news release.
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," Judith Baumhauer, MD, from the University of Rochester Medical Center, in New York, and principal investigator on the MOTION study, said in the release.
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.
"Before Cartiva SCI, the options we could provide to patients with osteoarthritis of the great toe were limited, as the fusion procedure often necessitates sacrificing range of motion to get pain relief," Mark Glazebrook, MD, from the Queen Elizabeth II Health Sciences Centre in Halifax, Nova Scotia, said in the release. "Due to the simplicity of the procedure, speed of recovery and range of motion benefits, I see that patients are relieved to have this option available to them and the majority are electing Cartiva over fusion."