Current state of ADR ???

[kennethhoff]

I looked into ADR back in 2003. At that point, it was barely new. Everything three years ago were clinical trials. What has changed? Which ADR products are now FDA approved and available? Are mutliple levels now being accepted? Does health coverage now accept it. Are the waiting lists stillas long? Any getting started info would be great!

Thanks,
Ken

[Alastair]

Hi Ken,
your query of course is about ADR in the USA -- -- -- Europe has been doing it from many years I had ADR in 2002 which is highly successful with Dr Zeegers.

There's loads of information about ADR in the USA especially in surgical outcomes. It's a bit unfortunate that this is the second board because I think we lost some stuff in the previous one
Best,
Alastair

[annapurna]

The Charite lumbar ADR has a better than 20 year history in Europe. Other disks are newer, many as young as you suggest but were based on the early work done with ADR. To paraphrase a European doctor, US companies generally start ideas (not true in this case), send them to Europe to see if they work, then try to get them accepted in the US.

[Harrison]

The Charite’ artificial disc was approved in October of 2004 by the FDA for one levels at L4-5 or L5-S1. For “compassionate” cases (also called off label by docs), doctors can get approval for a 2 level Charite disc replacements. Many members in this community have had 2 level Charites’; even more have had 2,3, 4 or even 5 level ADR – most with the ProDisc and performed overseas.

Approval for the Synthes ProDisc is said to be “right around the corner,” as we’ve discussed elsewhere. Meanwhile, most insurance companies are dragging their feet and not covering ADR. Oddly, there are substantive differences among carriers in terms of the appeal processes, but there are more insights & resources on this complex issue in the Big Bucket forum.

One commonly discussed (and strangely, not often contentiously) topic is the overall success rates of ADR. Many of us define “success” as the return of a quality of life and being pain-free after surgery. My informal short survey from last year shows quality of life and pain reduction indicators quite high for patients’ surveyed (83+% far less or less pain after ADR).

In the meantime, other surveys from Charite’ patients indicate a satisfaction rating of 89%, which gels with what we’ve seen across the many patients’ postings in the past 18 months.

I hope this helps, we can talk if you’d like more information. Just email or PM me!

[ans]

I think if you have multiple levels replaced by ADR and if you wait long, your chances of no pain afterwards are diminished. Good luck, Allan

[livjoyful]

I know Dr. Gurr has been doing them here in Canada for at least 10 years. Why do all the Americans go to Europe and not up here? Just curious. Wouldnt it be cheaper?

[kennethhoff]

Have there been clinical studies and research on the success rate after someone has recieved the Charite', ProDisc, or other ADR product? AND, have any of those studies been from independent organizations without any connections to the manufacturers, or others who would not profit from successful study outcomes?

[annapurna]

Within the US, generally no. There are various studies quoted but many devolve down to a some device manufacturer. either a fusion maker wanting to discredit, an ADR maker wanting to show success, or an opposing ADR maker wanting discredit any design other than their own. The FDA study is out for Charite ADR, that might meet your need.

In Europe, and possibly Canada, the devices have been out for longer and more general study has taken place, but even then you might find a more honest answer if you read through papers discussing complications or solutions to other problems. They'll give you a better feel for how often things happen and what the general response to them might be. For a really good, scientifically and statistically valid comparison between fusion and ADR, you're probably out of luck. My wife and I are both engineers and trying to decipher somone else's games with statistics is a large portion of our normal daily work. You'll find a whole lot of bad statistics and lousy conclusions in this field in particular and medicine in general.