New artificial disc may offer real pain relief
Lazaro Puerto, 45, of Kendale Lakes, Fla., is a tough guy. He spent 13 years driving a concrete truck, wheeling it into position, climbing up the ladder in back, slinging the chute back and forth to distribute the wet concrete, 22 tons to a load.
All that hard work contributed to a herniated disc in his neck, a debilitating condition that resulted in crippling pain.
On Aug. 2, Puerto became one of the first dozen patients in the country to receive a stainless steel replacement disc that could offer hope to hundreds of thousands of people nationwide who suffer from neck pain.
Puerto realized he had a herniated disc three months ago, when the pain in his neck got so bad he could no longer drive or even play in the yard with his daughter, Lexa Victoria, 10, and his dogs Princess and Titan.
“And I don’t take pain relievers for it, because I don’t want to damage my liver,” he said.
In a two-hour operation at Miami’s Baptist Hospital, he received the replacement disc, which is designed to ease pain and, unlike old procedures, restore a greater range of motion in his neck.
The FDA approved the Prestige Cervical Disc, by Medtronic Sofamor Danek of Memphis, on July 17. It became available August 1, and South Florida doctors got right to work with it.
The implant could replace many of the 200,000 traditional cervical operations performed each year in the United States in which a damaged disc is removed and the vertebrae above and below it are fused with bone grafts, the company said.
In the new procedure, an apparatus screwed into the vertebrae above and below the removed disc rotates on a “ball-and-trough” system to restore motion.
“It’s very slick,” said neurosurgeon Sergio Gonzalez-Arias, medical director of Baptist Hospital’s Neuroscience Center, who led Puerto’s surgery. “It makes a real difference that instead of creating fusion, we’re preserving motion.”
In the neck, the spinal cord and nerves are surrounded by bony vertebrae, which are separated from each other by discs that allow the neck to rotate and bend.
A disc is like a jelly doughnut, made of tough cartilage on the outside and softer material inside, Gonzalez-Arias said. If the disc is damaged, degraded or herniated by disease or injury, some of the “stuffing” comes out, and the disc no longer properly cushions the vertebrae. It leads to intense pain and loss of motion.
Until now, the “gold standard” operation has been to remove the damaged disc and fuse the two vertebrae together with bone grafts and titanium plates. It could stop the pain, but with loss of motion.
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With the new procedure, the disc is replaced by the Prestige Cervical Disc. Attached to the vertebrae with six surgical screws, it restores the neck’s motion in all directions.
“You can bend, rotate, flex, whatever you need to do,” Gonzalez-Arias said.
The new disc is not for every patient, neurosurgeons and Medtronic officials said. It should not be used for:
* Smokers and people with diabetes, who can have problems healing.
* Patients not yet 18, whose bone structure has not fully matured, and elderly patients with fragile bones. No specific ages are precluded, said Medtronic spokesman Bert Kelly, but prospective patients should consult their doctors about bone strength.
* Patients who lack mobility because of arthritis or other reasons.
* Patients whose injuries involve several cervical discs, since the artificial disc must be attached to intact vertebrae.
The FDA, in approving the disc, classifies it as a “high-risk” operation, since it involves surgery so close to the spinal cord, Kelly said. The procedure costs $32,000 to $34,000, about the same as traditional spinal fusion, and some insurance companies are paying for it, he said.
In the two-year clinical trial at 37 hospitals and medical centers that lead to FDA approval, Medtronic inserted the artificial disc in 276 patients selected randomly and performed traditional bone fusion in 265 others. It said the patients who got the artificial disc experienced less neck and arm pain, saw range of motion restored faster and were able to return to work and other activities sooner.
The FDA will require Medtronic to do a seven-year follow-up, reporting yearly.
Neurosurgeons at hospitals not involved in developing the disc expressed general approval of it.
“This is a good procedure, a moderate step forward in treating diseases of the cervical spine,” said Dr. Eric Nottmeier, neurosurgeon and assistant professor of neurosurgery at the Mayo Clinic in Jacksonville, Fla.
Mayo is training its doctors now to use the procedure, Nottmeier said. He estimated the artificial disc could be used in 30 percent to 40 percent of cases previously dealt with by disc fusion.
Medtronic spokesman Kelly said patients in the company’s clinical trials typically got back the range of motion they had before the surgery — not the greater motion of their youth. Most were able to return to old levels of activity — even downhill skiing or truck driving.
Puerto, on the eve of the operation, said he hopes to take advantage of that — up to a point. He has given up the concrete truck. He now hauls groceries for Wal-Mart.