The NeXt Stop: One small metal invention saves time and money while fixing a common back ailment of the elderly
Sam Whiting
Sunday February 26,2006
The X Stop titanium spreader makes an attractive fob on the key ring of Dr. James Zucherman, medical director of the Spine Center at St. Mary's in San Francisco.
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But the more practical way to carry it, given its $5,500 cost, is implanted in the lower back as it enlarges the spinal canal. This is what Victoria von Colditz was waiting for at 7:45 the other morning as she lay awake in an operating room. At age 87, she was lucky to be there because the X Stop, which resembles a miniature bicycle part or rock-climbing tool, just got FDA approval in November, and she's having the work done by the man who invented it -- Zucherman, at the place it was pioneered -- St. Mary's Medical Center on the eastern edge of Golden Gate Park, just north of the Haight.
The device is patented by St. Francis Medical Technologies as a pleasant alternative to surgery for lumbar spinal stenosis, a degenerative disease that usually affects the elderly.
"The most common problem people over 50 have in their backs is that the hole in the spine gets too tight," Zucherman says. "The typical symptom is that people have trouble standing up and walking because as you stand up and walk, the hole gets smaller."
The spinal canal shrinks because of natural thickening in the ligament and bone that protects it. The thickening pinches nerve fibers, which react by shooting pain down the legs, along with a dull ache in the lower back. It's why old people hunch over as they walk.
The traditional treatment, either a laminotomy or laminectomy, is moderate to major surgery that takes at least two hours and leaves one in the hospital for five days. Bone is removed and often vertebrae are fused. "You remove tissue, like you do a Roto-Rooter, cleaning out the pipe from the inside," Zucherman says.
The X Stop, conversely "acts like a stent from the outside," he says. "It pulls the pipe apart so the area is indirectly opened up without having to remove any tissue." The device is implanted between the spinous processes, or the bony bumps that stick out when you run your hand down your spine. Because the X Stop is placed just under the surface close to the skin, the procedure is done under local anesthesia. This is of great benefit for anybody who has experienced coming out of general anesthesia, which can be worse than the recovery from the operation.
This was the case with a stenosis patient of Zucherman's. He never got his mind fully back from the anesthesia, so Zucherman, along with partner Ken Hsu, started looking for another way. Noticing that lumbar stenosis patients are at ease while sitting and in pain while standing, they started making custom versions so that the spine would stay locked in the seated position. The finished product is called X Stop because it stops the extension motion that causes the pain.
"We ran it on 10 patients who were going to have the regular, big surgery and it worked in nine of them," Zucherman says. "To our surprise, the pain was negligible from the device."
The first X Stop was implanted in 1997 as a pilot study, and Zucherman and Hsu have since done about 120 of them.
"If you look at the spine as like a Christmas tree," Zucherman says, "the X Stop pulls the branches apart from each other and leaves more room for the ornaments."
Zucherman, an orthopedic surgeon, does up to five a day, and he could probably do 20, moving from room to room, because he has it down to half an hour, tops, from incision to stitchery, as he demonstrated on von Colditz.
For about a year she has had pain getting up and constant griping pain in her leg. She went to see a neurosurgeon, who said her best chance was the laminectomy. "He said he could fix me up, but it would take five hours for the operation and the recovery is a year," she recalls. "At my age I thought that would be truly ridiculous.''
A search for relief brought her to a pain center in Alameda, where she lives. There she was told about the X Stop.
"We thought it hadn't been passed by Medicare," she says, "but it has so here I am."
To be precise, she is lying on her right side when Zucherman, who resembles Dennis the Menace's father, enters the surgical room.
She is sedated and her lower back numbed. The incision, 2 inches long, is made at 8:27. He cuts through the skin, the fatty layer and a layer of fascia. Then the muscles are pulled to the side to reveal the vertebrae.
From time to time he asks for an X-ray, then gets up and walks over to a TV monitor to see precisely where to put the X Stop. The X Stop to be used is not the one in his pocket, nor the one "I can pull out of my sleeve," he says.
It comes in five sizes. To measure von Colditz's need, he ask her to "curl up into the smallest ball you can," so she is in a symptom-free position with the gap between bones as large as possible. Then he calls for a size. The X Stop is still sealed in the manufacturer's box, along with assembly instructions. But he ignores them. The device comes in two parts, and both are dipped in an antibiotic solution. (The little hole for the key ring is standard.)
As Zucherman starts to assemble it he calls over to the nurse to begin preparing the next patient. It won't be long now. "It's straightforward when you know all the subtleties about it," he says.
At 8:47, just 20 minutes after the incision, he starts screwing the keeper wing into the main body, which looks like a silver bullet. It is held in place by the anatomy of the bones and is not attached.
Zucherman calls for another X ray, then gives it one final adjustment. "That's it," he says, and at 8:54 von Colditz is being sewed back up.
"Everything was so quick and easy," von Colditz says from a bed upstairs, just four hours later. The next day she got up and didn't feel the old pain, just the new pain from the incision. She is walking and expects to soon lose the cane she's depended on for a year. The cost, including one night in the hospital, is $10,000, about half the cost of a laminectomy.
The waiting list at St. Mary's is more than a hundred people. Patients are coming from across the country.
Asked if he'll get rich off this, Zucherman says, "Maybe someday." So why didn't other orthopedic surgeons think of this?
"I've heard that quite a few times," he says with a laugh.
E-mail Sam Whiting at .