Posted on 11/22/2005 9:02:50 PM PST by neverdem
WASHINGTON -- People who suffer from a spinal problem that can cause back and leg pain have an alternative to difficult surgery with a newly approved device that requires a much less invasive procedure to implant.
The Food and Drug Administration authorized use of the "X-stop" - a thumb of titanium on a mount that fits to a vertebra in the lower back - to reduces pain from lumbar spinal stenosis. The FDA's approval was announced Tuesday by the St. Mary's Spine Center in San Francisco, which developed the device.
The condition is the most common cause of back surgery in people over 50. It occurs when the tube for nerves in the spine becomes constricted as a person ages. Pain, numbness and weakness usually manifest by standing up; it is often relieved when sitting down.
Previously, the condition could be treated with physical therapy, anti-inflammatory drugs and injections, or by a laminectomy, a difficult surgery that involves full anesthesia and the removal of parts of bone and tissue to open up the canal in the spine.
The X-stop achieves a similar effect by pressing against parts of either side of a vertebra, pushing open the tube without removing any of it.
"By wedging those bones apart, the tube is indirectly opened up," said Dr. James Zucherman, who invented the device. He is the medical director of the St. Mary's Spine Center. "The bones don't collapse on the nerves like they did before. The patient doesn't have to bend over to protect the nerves."
Because it is implanted so close to the surface of the skin, it usually requires only local anesthesia to insert. People may have up to two of the devices implanted on vertebrae in the lower spine.
Zucherman, who has overseen the implantation of more than 100 of the devices during trials, said he will recommend it to most people with the condition who don't benefit from physical therapy and drug treatments. He will only recommend a laminectomy if the device doesn't help.
However, FDA documents released last year before a public hearing on the product raise concerns that the X-stop's effectiveness decreases over time, saying studies found that about 15 percent of patients who had the implant reported symptoms returning.
"It appears that the X-stop is effective to about a year and then begins to decline," the FDA said.
Dr. Zucherman disputed those figures, saying the percentage of implant patients reporting a dropoff was about half that - and that people who received only therapy and drug treatments reported a much greater rate of symptoms returning.
The documents also say roughly 50 percent of people who received the implant said they had a significant relief of all symptoms related to stenosis, as opposed to 5 percent who reported relief from nonsurgical treatment.
Zucherman pointed to another figure provided to the FDA - that 73 percent of patients who received the implant reported being satisfied with it after two years. People who underwent laminectomies report similar success rates, he said.
The treatment is also less expensive than the more invasive alternative. Implanting a single X-stop costs about $17,000; implanting two costs $24,000, he said. A laminectomy is about $50,000.
About 4,000 X-stop devices have been implanted around the world, he said. Versions of the device are already available in Europe and Japan. About 400,000 Americans are affected annually by lumbar spinal stenosis.
Zucherman said he invented the device in 1997 after watching a patient who received a successful laminectomy become mentally disabled - he couldn't remember where he was moment to moment - because of the full anesthesia used.
I think I'll go with my limp.
Wow, what a timely post to pass to an uncle contemplating surgery. Thanks for posting it.
Mildly Depressed People More Perceptive Than Others
This Is Your Brain Under Hypnosis
William Duke
Don Hogan Charles/The New York Times
SEEING RED Dr. Amir Raz, rear, and Miguel Moeno demonstrate the hypnosis test.
FReepmail me if you want on or off my health and science ping list. Anyone can post any unposted, unrelated link as they see fit.
What will you do when you can't even limp sit, stand, lay down, bend down, take a crap?
If your problem is managable, certainly, avoid surgery. It's risky. But if your condition gets worse, you have to do something about it if you want to have any sort of life worth living. Trust me, it isn't pleasant to be in that much pain 24 hrs a day. (thank God for oxycontin!!)
I hope you never degenerate to the point where you need surgery, but at least you know it's available, and now a less risky one is an option as well. I'll have to ask my Doc about this, as i'm long overdue for a third operation.
How often does that occur with general anesthesia, or is full anesthesia different from general anesthesia, and what is the term for it besides amnesia?
These are some really good articles. Thanks! My undergraduate degree is in psych, so I love this stuff.
I guess we're all sort of arm chair psychologists anyway.
You're welcome!
I'm not discounting the benefit. I'm just being cranky.
I know what you mean. I had back surgery twice with good results. Having a bulging disc and sciatica is a horrible experience even with prescription pain medication.
LoL! I understand completely. One the bright side, the surgery (if it's successful) will pay for itself in a couple years with the money you save on meds.
I figured you would. Anyone with chronic pain usually does. Thanks for the info (All - neverdem)
Sidenote: I remember going to hockey games with my littlest angel whose feet stuck straight out from her chair. Everytime she moved, her feet nudged the seat in front of her. One night, the lady who sat in that chair turned around and said, "Would you PLEASE keep your daughter still?" I thought the lady was a real beatch...I understood a lot more when I started having problems. (I would like to think I'd be more pleasant than that lady was, though).
I've has 2 on my back so far, plus others on my legs.
No matter haw many surgeries a person has, each one is just as worrysome as the first. I guess it because in the back of your mind, you know you are playing the odds.
You are right, a person can develop permanent nerve damage and other serious problems if it isn't watched and treated properly.
Glad your brother is doing well.
About 4,000 X-stop devices have been implanted around the world, he said. Versions of the device are already available in Europe and Japan. About 400,000 Americans are affected annually by lumbar spinal stenosis.
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Thanks FDA for finally allowing us citizens to finally use this if we so choose. /s
Can you please add me to your health/science ping.
Remember the Stroop test? That was fun. It says a lot about perception.
"A laminectomy is about $50,000."
That seems a bit steep. I had a four level lumbar spinal fusion done with two rods and eight screws three years ago, and it ran just over 75 grand. (where they removed bone fom hip for graft has given the most pain)
Had two laminectomies done about five years apart back in the 80's. They helped for a few years, then things deteriorated to the fusion thingy.
How are you feeling now?
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