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Max
12-14-2004, 06:00 PM
Spinal accord

Tuesday, December 7, 2004

By BOB IVRY
STAFF WRITER




Kyle Spooner is a good husband. When his wife asked him, at the end of a grueling day of moving into their new home, to shift the garden fountain a few inches, he agreed.

Whoops.

"I don't know if it was the wrong twist, bad form, or just being tired - something went," said Spooner, an IT manager in a Dallas suburb. "I was in horrible pain in my back and down both my legs."

After the injury, Spooner had what he called "bad days and worse days." Some mornings he'd get to work, close the door of his office and lie on the floor, trying to stretch the pain away.

The diagnosis: a herniated disc in his lower back. He tried physical therapy. Went to doctors. He popped pain pills. They helped, but his back wasn't getting better.

"I fought for two years before I agreed to have surgery," Spooner said.

His dad had undergone spinal fusion surgery, where doctors replace the herniated disc with bone to stabilize the vertebrae. But at 31, Spooner wanted a procedure that didn't limit his flexibility, as fusion would have.

So when his doctor suggested an experimental artificial disc, Spooner jumped. Or he would have, had his back allowed it.

"I was very excited," he said.

Thousands of patients in Europe have received the Charité implant, with encouraging results. In March 2000, Kyle Spooner became the first American to get the disc. In October, the U.S. Food and Drug Administration approved use of the Charité, making it the first artificial disc to get the green light in this country.

"This is the first major breakthrough in spine surgery since spinal fusion was developed in the 1940s," said Dr. Richard Guyer, a Texas spine surgeon who has implanted the disc in 150 patients. "It's restorative rather than salvage surgery. You don't lose range of motion like in fusion."

Not all doctors are as enthusiastic about the new technique.

Dr. Roy Vingan, a neurosurgeon with the North Jersey Brain & Spine Center, said he was concerned about the lack of a fall-back plan for patients who don't get positive results from the Charité.

The Charité is implanted through an incision just below the navel, an approach that's also common in fusion surgery, Vingan said. Typically, the back surgeon is assisted by a vascular surgeon who clears a path around blood vessels, muscles and organs, allowing for direct access to spinal discs.

After surgery, however, scar tissue causes blood vessels to become immobilized - almost glued to where they are, Vingan said - making additional surgical approaches from the patient's belly very risky.

"If a fusion doesn't work, you can try another fusion with another method," Vingan said. "With the Charité, what do you do? Taking it out from the front would be a [malpractice] lawyer's dream."

Bill Christianson, who directed the Charité's clinical trials for its manufacturer, DePuy Spine Inc., said the artificial disc would remain in place even if a patient required a second surgery.

"If the Charité is in its proper position and the patient still has significant pain, the surgeon would do a second surgery going in through the back," Christianson said. The surgeon would basically do a spinal fusion to correct the problem, and "the Charité would be left in as a placer."

In clinical trials, 5 percent of patients implanted with the Charité needed a second surgery; that number was 8 percent for fusion patients, Christianson said.

Despite his reservations, Vingan said he would learn the surgical techniques necessary to implant the Charité. The key to the success of the artificial disc, he said, was selecting the right patients for the procedure, a view shared by Christianson.

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