Oregon Health & Science University is the state's only medical center implanting a new artificial disc just approved by the Food and Drug Administration for treating degenerative cervical disc disease.
Johnny Delashaw, M.D., professor of neurological surgery, and otolaryngology/head and neck surgery, OHSU School of Medicine, was among the first physicians in the country, and the first in Oregon, to implant the Prestige Cervical Disc during an early study. He is the only Oregon surgeon now implanting the disc and will train other surgeons on the procedure.
The Prestige disc, the first and only artificial disc approved by the FDA for the cervical spine, became available for treatment beginning yesterday.
The surgically implanted, stainless steel disc, manufactured by Minneapolis-based Medtronic Inc., is intended to relieve neck pain and stiffness, and the occasional weakness or numbness in the arms, due to a pinched nerve. This can be caused by a herniated disc between cervical vertebrae or a bone spur on a vertebra, both of which can push on the nerve root.
The Prestige disc mimics the natural motion of the neck through a "ball-and-trough" design that allows for a variable center of rotation. It is inserted through a 1½-inch incision in the front of the neck.
"It's really simple," Delashaw, who specializes in skull base surgery, said of the hour-long procedure. "You just slide it in and put the screws in. People go home the same day. It's a mild modification of a procedure that's done routinely."
That routine procedure - spinal fusion - has, until now, been one of only two options available for the estimated 200,000 Americans per year who seek surgical treatment for degenerative cervical disc disease. Fusion involves removing a troubled disc and bolting the vertebrae together with steel plates to restrict motion.
"The problem is when you fuse a segment, (vertebrae) above and below have to work harder when you bend your neck, and that increases the chance for other segments having stress," said Delashaw, who underwent cervical spinal fusion eight years ago. "That's why people prone to spine surgery are prone to have more spine surgery."
The other available procedure, foramenotomy, involves enlarging the passageway where the nerve root exits the spinal canal so the nerve can more easily get around the spur.
In foramenotomy, "we don't alter movement in the neck, but theoretically it may not be the best thing," Delashaw said. And surgery "hurts a lot because you go through a lot of muscle. But it doesn't alter motion like fusion."
In a two-year clinical trial ending in August 2004, patients receiving the Prestige disc experienced "statistically significant outcomes" 24 months after surgery in an index that measures how much a patient's neck pain affects the ability to manage everyday activities, according to Medtronic. Prestige patients also returned to work an average of 26 percent faster than those receiving spinal fusion. The trial involved 541 patients enrolled at 32 sites across the country.
"This study compared Prestige to the gold standard, and it's better than the gold standard," Delashaw said. The Prestige disc also costs the same as spinal fusion, "so it's kind of a win-win."
And if the disc ever fails, it can be easily removed, Delashaw noted. "If you have to take it out, it's really easy because the access point is easy. If it doesn't work five, 10 years later, you can always do fusion."
Todd Welch, district sales manager at Medtronic, said OHSU has always been progressive in its efforts to use new technologies like the Prestige disc to treat spinal disorders, as well as back and neck pain.
"In addition to providing the latest technologies available, the surgeons at OHSU have invested the time necessary to learn new techniques like the Prestige Artificial Disc," he said.
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