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Lumbar Artificial Disc Replacement: How Safe Are They?
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Posted on: 09/17/2005
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Consumers may think that FDA approval of artificial disc replacements (ADRs) is a big, green light. Some doctors advise caution before jumping on the bandwagon. This article akes a closer look at the results so far with this new device for back pain patients.
Only one ADR has been approved: the CHARITÉ™ Artificial Disc. And it's only for one kind of patient: chronic back pain from disc degeneration at one level. The good thing about these restrictions is that it makes research easier. The patients are fairly similar. Each surgeon must have extra training before doing ADR implants. The operation is close to the same from surgeon to surgeon.
But the success rate, according to this article, isn't that good. Almost one-third of all patients end up with five degrees or less of motion at the implant site. That's in the same range as a spinal fusion. Ads that say, "natural motion is back" are misleading. ADRs do not necessarily re-create a normal spine.
Among patients rated as a "success" more than half are still using strong painkillers two years later. Artificial joints don't last forever. There will be wear and tear, debris around the implant site, and the chance of the implant coming loose.
Accordingly, the ADR isn't a cure for back pain. Patients should approach this treatment option with caution.
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References:
Sohail K. Mirza, MD, MPH. Point of View: Commentary on the Research Reports that Led to Food and Drug Administration Approval of an Artificial Disc. In Spine. July 15, 2005. Vol. 30. No. 14. Pp. 1561-1564.
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