FDA-Approved Disc is Alternative to Spinal Fusion
MAYWOOD, Ill. - The neck and arm pain caused by degenerative cervical (neck) disc disease may be eliminated by replacing the problem disc with a metal-on-metal artificial disc, said Loyola University Health System neurological surgeon Dr. Russ P. Nockels.
Loyola was the first and only medical center in the Chicago area five years ago to begin evaluating the Medtronic PRESTIGE(tm) Artificial Cervical Disc that the FDA approved July 16, 2007. This is the only cervical disc approved by the FDA. Nockels was principal investigator for the Loyola site.
It is estimated that more than half of people ages 40 and older have cervical disc disease, characterized by degenerative changes in the upper spine. Cervical discs are located between the seven vertebrae of the neck.
"The prosthesis simulates the function of a natural cervical disc and provides patients with the ability to move their necks compared to the traditional practice of spinal fusion," said Nockels, associate professor and vice chair, department of neurological surgery, Loyola University Chicago Stritch School of Medicine, Maywood, Ill. "As a result, patients recover more quickly and get back to work faster.
"The results of the clinical trial show that the disc is strong enough to withstand sudden movement and to support the head," said Nockels. "Patients are able to move their head up and down, and from side to side." When Wheaton, Ill., resident Tom N's neck pain was diagnosed as degenerative disc disease, the then-41-year-old businessman could barely lift a cup of coffee. He didn't know if he could ever play golf again.
But after surgery at Loyola, Tom plays golf, wrestles with his children and lifts his coffee cup and other objects with ease.
"Since the surgery, Tom no longer has neck and arm pain; no longer experiences numbness at night; and no longer has trouble sleeping," said Nockels.
Natural discs are gel-like cushions that act as shock absorbers between each vertebrae in the spine. Herniation, resulting from disc degeneration, injury or heavy lifting, can occur when a portion of the disc is pushed out of place and presses on adjacent nerve endings.
Symptoms include pain radiating down the arm and numbness, in addition to neck pain. As a result, many people have difficulty sleeping. Discs dehydrate and shrink over time, producing areas where bone touches bone. Cervical disc disease typically increases as baby boomers age.
The new artificial disc, placed through an incision at the front of the neck, is designed to alleviate neck pain and other ailments associated with disc herniations, spinal arthritis and other spine degenerative conditions. The disc consists of a stainless-steel ball and trough that functions as a joint. It is attached to the vertebrae with screws. The components are designed to act as a pivot point, which may allow the spine to move more naturally.
Loyola was one of 20 centers nationwide evaluating the device in a study monitored by the U.S. Food and Drug Administration.
"The new device eliminates the need for transplanted human bone, which is required with spinal fusion," said Nockels. "In addition, it permits more motion of the neck. This reduces the likelihood of stress on the surrounding vertebrae, which could lead to further degeneration in adjacent discs.
"Previously, the only approved method to help patients was to clear away the problem disc material and then fuse adjacent cervical vertebrae together with screws and a metal plate," said Nockels. "This permanent fusion of bone eliminates normal movement and adds stress on the vertebrae above and below the fusion.
"Although anecdotal, several disc recipients in the clinical trial have been involved in serious motor vehicle accidents," said Nockels. "One was a front-end crash; another occurred 10 weeks after the disc surgery. Some patients were subject to air bag deployment.
In spite of this, follow-up X-rays of these patients show continued normal function and no device-related problems," Nockels reported.
Nockels noted that the artificial cervical disk is not for everyone. You have to have some ability to move, so someone with severe arthritis is not a candidate. In addition, the cervical disc disease must be only in one level of the neck, not throughout.
Nockels also is the chief of Loyola's division of neurological spinal disorder and director of the spinal cord injury repair laboratory.
The department of neurological surgery is actively involved in research on complex neurological pathologies and its spinal cord injury repair lab is investigating novel treatments for repair of the injured spinal cord.
For information, visit www.LoyolaMedicine.org or weekdays, call (888) LUHS-888 and ask for extension 60005.