Radiographs show Charité discs still mobile

[Harrison]

All, interesting study results below (I can't believe I almost missed these!). Any way, these numbers seem positive; and as I mentioned previously, seem to gel with my previously assumptive (from unscientific surveys) conclusions.
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Radiographs show Charité discs still mobile after 10 years

Patients who received the Charité TDR had fewer long-term adjacent level problems than fusion patients.

By Susan M. Rapp
1st on the web (June 19, 2006)

June 2006

BERGEN, Norway — A retrospective, multicenter study showed 78.8% of 226 patients implanted with Charité total disc replacement prostheses maintained good or excellent clinical outcomes at over 10 years’ follow-up.

Investigators Thierry David, MD, of Bernard, France, and Jean-Philippe Lemaire, MD, of Dijon, France, submitted cases for the review. They implanted 301 prostheses with noncoated endplates primarily at the L4-5 and L5-S1 levels. Surgeons performed 154 one-level and 72 two-level procedures, and only one three-level procedure, according to the study abstract.

Fabien Bitan, MD, an orthopedic surgeon at Lenox Hill Hospital, New York, presented the study results at the International Society for the Study of the Lumbar Spine 33rd Annual Meeting, here.

Patients had a mean age of 37 years. Of David’s patients, 93% reported excellent or good outcomes at the last follow-up.

Overall, dynamic radiographs showed that 263 implants (87.4%) remained mobile, with flexion/extension averaging 10.2° at the L4-5 level and 7.4° at the L5-S1 level.

The researchers found good to excellent clinical outcomes for 178 of the 226 patients (78.8%). Additionally, 196 of 210 patients (93.3%) who worked prior to surgery had returned to work postoperatively and continued working at last follow-up, according to the study.

Subsidence of undersized implants represented a problem for early investigators. But, “We know now how to avoid this,” Bitan said.

Six patients (2.7%) had adjacent-level disease requiring revision and three patients (1.3%) had immediate subluxation that required revision. Additionally, 19 patients (8.4%) required posterior instrumentation and fusion for continued pain, according to the study.

Other complications included 10 patients (2.3%) who developed facet arthrosis at the implant level. And four patients developed late polyethylene core breakdown at over nine years postop, two of whom surgeons revised to a new prosthesis.

Overall, the results demonstrate the safety and efficacy of Charité TDR, Bitan said.

For more information:

* David T, Lemaire J-P, Moreno P, Bitan F. A long-term multi-center retrospective study of 226 patients with the Charité artificial disc: Minimum 10-year follow-up. #27. Presented at the International Society for the Study of the Lumbar Spine 33rd Annual Meeting. June 14-17, 2006. Bergen, Norway.

Courtesy: OrthoSupersite:

http://www.orthosupersite.com/defaul...view&rid=17634

[letteski]

Another positive publication on the Charite and ADR. Too bad the insurance companies won’t look at European studies this is a good one. 93% reported excellent or good outcomes is the best result I have ever seen for the Charite.

[Harrison]

And four patients developed late polyethylene core breakdown at over nine years postop, two of whom surgeons revised to a new prosthesis.

I'd like to see more information on these outcomes, wouldn't you Charite' owners be a bit curious!? That being said, I think 1% core issues ( 4/ 226) after NINE YEARS is not bad -- but perhaps not if you are one of the four?!

Paulette, ditto on your comment. I have no idea why "studies have borders." What's up with that?!

[luvmysibe]

Yeah!! I am pleased to report that my flexibility is continuing to increase. This study gives me cause to be even more enthusiastic about my future outcomes.

[tmont]

Killjoy yet again (sigh, I was honestly looking to see if I could find some European study data for you), but lest we forget--there's also this from August 11, 2006 :

"In 2002 alone, the FDA received more than 111,000 reports of adverse events involving medical devices.

That number has increased since the Charite artificial spinal disc was approved for use in the US in October 2004. As of July 2006, there have been more than 130 serious adverse events reported to the FDA associated with its use. "

http://www.yubanet.com/artman/publis...le_40413.shtml

Van Ooij (outspoken against ADR from what I've read) is cited again, and the source is investigative journalism rather than pure medical publication, but if the questions are out there then let's at least hear them is my take...questions are as usual impossible to answer: from human error, device design error, or both?

[Harrison]

BTW: I did some checking on this article you linked to and have interesting information for you to consider. The author was paid to research & write this article -- by a legal marketing firm. As well, the "adverse" events reported to the FDA range from subsidence to infections (and more), but issues already broached and discussed on this forum.

[tmont]

I know--I mentioned the source was investigative journalism and like everything else, motivations have to be considered. But while spin can be put on info, conjuring data out of thin air is unlikely (and can result in prosecution). My point is that less-than-positive outcomes are also out there, so let the buyer beware. For now, there's no one to be held responsible if your outcome isn't what you were told or expected.

[fl man]

I was told that there was a chance I could end up in more pain. I was to of a chance that i could end up sexually impotent. I was also told I was responsible for my decision on what to do about my health care.

Everyone wants the best outcome but the reality is this procedure, like all others is not 100% and the competition is spending the money to distort the facts. JNJ has no incentive to keep promoting a faulty device. In today’s world of litigation, it would be far cheaper for JNJ to drop the program than to try to endure future law suits for defect and malicious intent. It is the competition who is the major sponsor of these "independent" reports. Their reporting Dr.s get paid well for "conjuring" up the needed results.

I bet the incidents of poor out comes will remain the same as other disc designs get approved, and that you will now see them get attacked with negative reports and talk of litigation until Medtronic's Maverick disc gets approved. Any takers?

Pat

[tmont]

Everyone wants the best outcome but the reality is this procedure, like all others is not 100% and the competition is spending the money to distort the facts

Yes, that the bottom line. There is going to be a lot of spun press out there, negative and positive, simply because there is so much money to be made in ADR and manufacturers and some docs are going to want the biggest piece of pie possible. It's already started. Greed is a powerful motivator and easy to mask behind a humanitarian front.

If patients are informed by their doctors of the real risks involved and make their decisions accordingly, then hey, responsibility has been fulfilled by my standards.

I have no problems with presenting ADR as a promising technique, but people can't count on the disc manufacturers and their advertising to give you the full story--you'll only see the best possible outcomes in the magazine ads or in those 30 second TV spots and they can be powerful influencers of desperate people in pain.

While ADR may be the Holy Grail for some--and that's what we all hope--you won't see the failures being filmed for prime time, much less any responsibility being taken for them. You only have one spine; please make your decision based on your own extensive research and doctor's evaluation of your case and prognosis, rather than on other people's experiences or the effects of high-tech marketing.

That's all.