Disc Drive

Chicago Sun Times - August 7, 2007

BY LORI RACKL Staff Reporter

Tom Nihill's neck was so stiff, he had to turn his body -- not his head -- to back the car out of his Wheaton home's driveway.

The pain in his neck made it tough to golf and even tougher to sleep. When he managed to doze off, the father of two would sometimes wake to a numb arm and fingertips. His hand felt so weak and shaky at times, he could barely pass the salt at dinner.

Nihill's neck and arm problems were traced to a ruptured disc in his cervical spine. He had the disc replaced with an artificial one -- an experimental treatment that was being tested at Loyola University
Medical Center in Maywood.

"When I came to after surgery, I could tell immediately that things were better," said Nihill, five years after that operation.

"All the pain associated with that disc problem is gone," the 46-year-old salesman said. "There's no more numbness. No more restricted motion in my neck."

And the treatment is no longer experimental, thanks to results like Nihill's. The Food and Drug Administration last month approved Medtronic's Prestige Cervical Disc, the first artificial disc made for
the segment of spine that runs through the neck.

The new device is a treatment for cervical degenerative disc disease -- a condition that sounds obscure but is actually one of the most common causes of neck and arm pain.

"We are now living in a new era where this is an option for patients," said Dr. Russ Nockels, Loyola's vice chair of neurological surgery. Nockels was an investigator in the clinical trial that led to Prestige's FDA approval.

A stack of seven bones, called vertebrae, make up the cervical spine. They're separated by discs. These shock-absorbing discs allow the neck to bend and twist. Aging or injury can damage the discs, putting pressure on the spinal cord and nearby nerves. That's when problems can crop up.

When drugs and other therapy don't work, patients may need surgery. For decades, this has meant taking out the troublesome disc, putting in a bone graft and fusing together two or more vertebrae.

More than 200,000 people in the U.S. each year undergo this fusion procedure. It can work well at relieving pressure and pain, but it's not without downsides. Patients' ability to move their neck can be somewhat restricted. It can also put stress on surrounding vertebrae, causing further degeneration. And people may spend up to three months wearing a neck brace while recovering from the operation.

The new treatment swaps out the bad disc with a stainless steel one that gets screwed into the adjacent vertebrae. Unlike fusion, "it replicates the normal motion of the spine," Nockels said.

A nationwide clinical trial of 541 patients compared fusion to the Prestige artificial disc. The disc patients had more mobility in their necks and appeared on X-rays to develop less arthritis near the operation site in relation to the fusion group. They showed better movement and feeling in their arms. They were less likely to need additional surgery, and they were back at work 26 percent sooner than those who had the traditional operation.

All of this sounded good to Jim Nangle, who will soon have the Prestige disc put in at the Chicago Institute of Neurosurgery and Neuroresearch.

"Initially we were going to do fusion, but the [FDA] approval happened," said Nangle, 57, a security supervisor. "I thought this was a much better idea."

Nangle's surgeon, Dr. Noam Stadlan, agreed. He said the Jefferson Park man is an ideal candidate for the artificial disc -- but many degenerative disc disease patients are not. It isn't for people whose arthritis has left them unable to move that part of their cervical spine. And it's not supposed to be used if more than one disc needs to be removed.

"There are a lot of problems that will still need to be treated with traditional fusion," Stadlan said.

Those who do qualify for the artificial disc might want to wait a little while before they get it. Health insurers haven't yet agreed to cover the Prestige device. But Loyola's Nockels thinks that will happen in the next month or two.

"I'm telling the patients who can wait to wait," Nockels said, "just so they don't have to fight the insurance companies."

Wait a few months longer, and there may be another artificial disc on the market. An FDA advisory panel last month recommended approval of Medtronic's Bryan Cervical Disc. It's made up of a polyurethane center surrounded by titanium.

"In my opinion, it more accurately reproduces the way an actual disc functions," said University of Chicago's Dr. Richard Fessler, who helped develop the Bryan model. While he waits for Bryan to get the green light from the FDA, he'll use Prestige.

"They're both good," he said. "I think they're both going to function very well."