TOE TO TOE One study found that patients given the implant had shorter surgeries and higher success rates than those who had fusion.

A synthetic cartilage implant that can be used to treat degenerative and post-traumatic arthritis in the big toe (metatarsophalangeal joint) warrants premarket approval, says the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee of the FDA.

The panel based its recommendation primarily on a study that showed that patients who were given the implant had shorter surgeries and a high success rate, maintained motion in the metatarsophalangeal (MTP) joint and had lower risks of nonunion and hardware fracture than patients who underwent fusion.

But not everyone on the panel was sold on the Cartiva device. The panel voted 10-2 that it's safe, 9-3 that it's effective and 8-2 with 2 abstentions its benefits outweigh its risks.

John D. Kelly IV, MD, a temporary voting member of the panel and an orthopedic surgeon and sports-shoulder specialist at the University of Pennsylvania in Philadelphia, has some "profound" concerns about the study design, he says, particularly in relation to "people who had fusions which were not indicated." But, he says, the device should be given a chance. "I am a big fan of minimally invasive treatment," says Dr. Kelly, "and this may serve as a useful adjunct in the treatment of MTP arthritis."

If the FDA accepts the recommendation, post-approval studies should be performed for 5 years to determine survival rate and evaluate safety issues, says the panel. There should also be strict limitations on indications for use, it says, and patients with hallux valgus (unstable joint) should be excluded.

Jim Burger