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bmills 06-13-2005 01:55 PM

Article from Fort Collins Colorado news paper. Here is the link if you want it:

http://www.coloradoan.com/apps/pbcs.dll/article?AID=/20...rchID=73211042708442

In the three years since Christin Boothe was hit by a drunken driver, her back has carried the pain.

Walking hurt. Sitting more than 15 minutes was a chore. Doing any given activity for more than a half-hour was unbearable.

Last week, Boothe took a step toward eliminating that pain. As part of a Federal Drug Administration study, she was among the first in the nation to receive a new artificial disc - the Kineflex - designed to relieve pain and restore motion.

Dr. Kenneth Pettine, a Loveland surgeon, installed the artificial disc.

Days after the surgery, Boothe was walking, albeit tenderly, a victory for the 31-year-old, who shunned spinal fusion surgery after the March 2002 accident in which a drunken driver rear-ended her car, causing her to hit the car in front of her.

"I just hoped that something better would come along," Boothe said. "I was thrilled there was another option."

Current fusion techniques essentially freeze a portion of the spine. The procedure is designed torelieve pain but also eliminates motion in the fused area. That puts pressure on nearby areas of the spine, which can degrade faster than normal.

Nearly 200,000 spinal fusion surgeries are performed in the United States each year. About 70 percent of fusion patients report some sort of relief for two years or more after the surgery.

The Kineflex, the artificial disc Pettine installed in Boothe�s back, looks like a hybrid of a model released in the United States last fall by Johnson & Johnson, called the Charite, and one Pettine designed in the early 1990s that Medtronic is developing.

Pettine�s disc, called the Maverick, is nearing the end of FDA trials. Thirty-six Pettine patients got the Maverick in 2003 and 2004 and are being monitored during their recovery. Pettine expects the Maverick to get approval in fall 2006.

If approved, the Kineflex, developed by Spinal Motin, and the Maverick would join the Charite on a market that seems to be moving away from the restrictive fusion and toward artificial discs that allow more normal back movement.

The first patient to get the Kineflex disc underwent the surgery on Monday and drove himself home Tuesday. All six patients who got the Kineflex and two who got the Charite last week went home the next day, Pettine said.

�I�ve never had anybody with fusion do that,� said Pettine, who estimates he�s done about 1,000 back fusion surgeries.
Artificial discs aren�t for everybody, however. Patients older than 50 need a bone-density test to see if their spine is strong enough to support the prosthetics that surgeons pound in.

Some are concerned the plastic discs in the Charite will wear out or slip out of place. A 52-year-old Indianapolis woman nearly died earlier this year when the plastic discs in her Charite, which had been installed in January, slipped out.

Unlike fusion surgery, which is typically done from the back, artificial disc surgery is done through the abdomen. Critics of the Charite and similar devices say replacing the device puts patients at risk because surgeons have to move major blood vessels. Scar tissue from the first surgery also can make it difficult to navigate later surgeries.

Opponents also point out that patients who got the Charite during the FDA study had about the same pain success rates as those who underwent fusion.

Increased mobility comes largely from pain relief, meaning disc replacement benefits could be limited relative to potential complications, said Dr. Donn Turner, a neurosurgeon at Front Range Center for Brain and Spine Surgery in Fort Collins.

Turner estimated that about 10 percent of fusion candidates are good candidates for disc replacement. He called the procedure an equivalent to spinal fusion.

If doctors can figure out how to do the procedure without going through the abdomen, its benefits will increase, Turner said.

�It�ll be a slam dunk if somebody can do it,� he said.

Few insurance companies will pay for the Charite, calling it an experimental procedure.

Pettine predicted that within a few years, insurance companies would favor artificial discs to fusion.

�It�s taken awhile to realize that�s as good as fusion will get,� Pettine said.


Originally published June 12, 2005


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