How many ADRs performed worldwide?

[Trish]

Has anyone heard a current figure for the number of ADR recepients worldwide?

Authorities in Norway still considered ADRs as experimental treatment! And they have even gone so far as to state that it will continue to be experimental until a Norwegian study gets its long-term data finished in 2009, I believe.

A local newspaper is doing an article on me next week and I want to point out how ridiculous it is for the people in Norway to have to wait.

The latest numbers I read were around 60,000 (vague memory) but I believe that was as of 2005.

Any reliabe figures out there?

Thanks in advance for you help.

[tmont]

Trish,

I have no idea of the actual figures and understand your frustration, but I have to agree with the authorities in Norway: until it has been PROVEN that ADR is a valid, LONG TERM treatment solution for DDD and associated spine pathologies, it merits the appellation 'experimental'. There is too much which remains unknown and unmastered regarding ADR for it to be considered overwhelmingly reliable at this date. Many studies seeking to establish the superiority/inferiority of ADR over fusion have failed to unequivocally establish this fact; most agree more long-term results are needed. Problems, when they arrive, are often serious and the medical community is hard-pressed to effectively deal with all the issues surrounding 'failed' ADR.

However, this doesn't automatically mean ADR shouldn't be made available to informed patients based on the often-promising results we have so far. I agree with you that patients who want to assume the risks should have access to the treatment.

But IMHO, at the end of the day ADR is still 'experimental' by my perception of the word--and the technique.

Trace

[Trish]

You touched on the core of the problem here, as I see it.
That informed patients should be given the right to choose. Currently the only choices are:[LIST]Learn to live with the pain or
Fusion

The reason the "experimental" classification is so important here in Norway is that any treatment bearing that name is not paid for. In other words, they can get fusions for free, but must pay about $21,500 for ADR.

Regards,
Trish

[Lisibug]

I have no idea, but Dr. Bertagnoli has performed over 8,000 of them in over 20 years.

[Harrison]

Lisa, are you sure about the 8000 surgeries? I believe it’s far less, about ¼ of that number. I’ll work on confirming this (though it’s still an impressive number of surgeries). Trace, “experimental?” That’s music to the ears of insurance actuaries here in the states! Let’s look at a few definitions of experimental:

Experiment - noun

1 : a procedure carried out under controlled conditions in order to discover an unknown effect or law, to test or establish a hypothesis, or to illustrate a known law 2. To try something new, especially in order to gain experience.

The FDA trials get a bad wrap here, for many reasons. But the purpose of the trial is to ensure that new technologies can be properly moved out of the lab, and commercialized safely to improve or correct a medical condition. The Charite was approved in 2004 and ProDisc in 2006 for lumbar indications.

The Charite has been around now for 25 years, and the ProDisc followed thereafter. In my mind, the technology is proven. The only variable – and it’s a big one that you allude to – is the huge variety of spine pathologies that afflict patients.

As we’ve seen on this board, the number and complexity of spine pathologies is the #1 problem here. That is to say:

1. If more careful patient selection disqualifies patients from ADR, then some of the “negative outcomes” would go away. That’s why some doctors “cherry pick” patients, leaving them stranded or choosing “experiments” elsewhere.

2. The depth of diagnostics to assess spine pathologies (at this time) is usually limited to imaging. As a result of this shortcoming, systemic problems that contribute to “spine pathologies” are usually missed. IMHO, this is the weakest link, and ironically an integral link in the diagnostic process.

3. Take a look at the qualifications from various device manufacturers, and even the differences between them. I’ve written about this before, but it underscores point #2, that the screening and qualification for ADR needs more work; and that means for patients, doctors and professional organizations!

OK, I’ll get off my soapbox now. I have to get back to preparing for patient video interviews, which start next weekend in NYC.

[tmont]

You make some very valid points, Harrison, especially on patient selection and the need for more careful screening prior to surgery. And don't forget surgeon error and ambition either; the desire to keep pace with and ride the wave of technology I believe puts patients at risk in the hands of some surgeons who might not be overly qualified and/or entirely prudent/ethical in their approach at times.

We agree on much surrounding ADR, but according to your own definition: 'to test or establish a hypothesis', ADR fits in my mind for the time being, as it has yet to be proven as equal or superior to fusion in the long term. Then again, I'm cherry- picking that part of the definition myself and the rest of it can be argued based on individual perception, as pretty much everything else involving ADR. That's one of the reasons the 'experimental' tab sticks in my mind.

I still believe there are enough promising results for carefully- informed patients to be able to elect to have the surgery--and have it paid for!!--by insurance companies. The question we (and they) should be studying is: 'does one perception of the word 'experimental' automatically preclude the right to the most advanced technology science has yet to offer patients, especially when they pay handsomely for coverage regardless of whether they will ever actually need it?' Another battle...

Happy prepping. I've got to go back to dosage calculations and ortho-rheumato-traumato chapters.

[Lisibug]

Harrison, I spent some time online yesterday trying to find where I'd read that Dr. B had performed that many ADR surgeries, but couldn't find it. Soon, I will be sending Dr. F-M my 6 month post-op x-rays and will ask her that question and hopefully, get a reliable response that I can post for everyone.