Choosing ADR or fusion

[WayDownInCoCrMo]

Dear Diane & Dale,

Congratulations on your successes (including families, children, friends and puppies.) I would love to have a puppy myself, but for Anastasia - with a destroyed leg and weakened back, having a boisterous puppy is probably not a good idea - no matter how much I beg.

Thanks for the concern about me ... but trust me, feeling sorry for me is the last thing anyone should do. I have no pain and a full life.

My point here is to emphasis that I did a hell of a lot of research ... only to find out later that it was all lies. I heard this from several German surgeons too.

I'm not beating myself up on our ADR decision ... we were sure we chose the best surgeon with the best device ... given everything we read, studies, comparisons, wear rates, ... everything. If I could have done more, (like I didnt do with the knee surgery), then I would be distraught with guilt.

What I'm disturbed about, is that no-one even discussed fusion. Maybe it was our pure bad-luck to be living in Germany. Maybe its was our dumb luck to have read through ADRsupport at all the oozing praise of these surgeons. I studied everything, and eventually came up with the conclusions that:

1) The Prodisc has a 94% success rate in 60 year olds, 98.2% success in single-levels with average ages in the 45+ range, and no bad outcomes - compared to much worse results with the Charite. According to Dr. B. My 31 year-old wife had 1 level (l4/5) DDD, everything else perfect ... (but that was according to images from nearly 1 year before the ADR surgery.) Now I know those Prodisc numbers are not class I data. Not that it is relevant to our situation - since my wife was not a candidate at all. If she was a perfect candidate, I think everyone would agree that choosing a device with 98.2% success is better than something with 64% success, versus 58% for (BAK) fusion. Or maybe we should revisit, and look at the Charite vs. Prodisc, with 93.9% (Charite) vs 83.3% (Prodisc). In any case, the FDA's results on the Prodisc were more like 53% ... but I didnt know that at the time.

2.) The AK and Sten'm are financially driven institutions, according to several German doctors. However, Dr. B. appeared as an academic. I like professors - they are only interested in improving humanity. They dont care about money. They will take a special interest in every patient. That is what I thought. Too bad they ignored our begging for a review session ... since 5 months before, and 3 months after the surgery. The surgeon Never even visited for a moment. Now I suspect he is probably more financially involved than all the rest combined.

3) I believed that the other institutions were assembly machines. We had already seen how the knee surgeon at AK never even saw us ... even after 4 extremely painful trips. He was too busy in his assembly line. We were foolish enough to trust the salesman, that they were going to do as written - check for a torn medial meniscus. They lied. We have written reports from many surgeons (including German), that her Patella was perfectly healthy. But, in any case, I was totally stricken when the ADR surgeon never even visited once afterwards. We were in the hospital 7 days, and in a hotel nearby 2 weeks. We begged ... and were totally ignored.

4) I read that fusion is horrible compared to ADR. That there is a 9% chance of revision surgery with fusion, lots of blood loss, an extremely long recovery period, a need for posterior screws, a high rate of morbidity with ICB (iliac crest bone), you will be stiff as a grandma, and the rest of your discs will blow sequentially. That, as I recall it, was my honest perception. You will note, none of the ADR kliniks tell you about the modern versions of fusion with 99% fusion rates, no need for ICB due to rhBMP-2 (bone morphogenic protein), the new PEEK cages which are MRI translucent, the minimally invasive (MAST) fusion techniques ... or even the micro-invasive techniques of injecting BMP into the disc which has been shown to stimulation regeneration. Even those damned trials compare ADR against failed fusion techniques (BAK). Its Criminal.

5) I was told that, in the case of failure of the Prodisc, it would be simple to revise it to either a different device or a fusion. I was not told that every surgeon in Germany would refuse to revise, because the scarring over of the veins would make it impossible to remove except laterally. It was not revealed that lateral explantation would require a huge osteotomy (remove of vertebral bone) ... and severing of the sympathetic nerves running through the psoas - leading to horrors that you dont want to hear about. I found this all out later. Of course, you cant expect your surgeon to tell you all those details ... but you can expect someone (i.e. Synthes) to have addressed the concern ... since we can in fact expect a lot of them to fail.

6) I was not told that, the Prodisc only comes in 3 sizes (10, 12, 14mm), while the Charite has a lot more - down to 6.5mm in height. Also, the Prodisc has a minimum lordosis of 6 degrees, so if your natural segmental lordosis is very small, they will jam this thing in you, bending you backwards into hyperlordosis, permanently. If your natural disc height is small, then the Prodisc will jack you up ... and guess what ... its not just about distraction. Its your whole spinal unit. Its designed to fit perfectly ... which means the facet joints are only designed to work with an exact height of the disc. Its like a gate. If you mess up the hinge's height, the latch completely misses. Except, in spines, the missing causes tearing and crushing of facet cartilage. This probably explains the 32% facet degeneration reported post ADR.

In summary, we have been run over by the loco of ADR, its financially conflicted proponents who publish outlandishly high rates of success, zeolots who present only the positives on ADR ... and not the litany of dangers. We have naively thought that certain surgeons are only academically driven, when it turns out that they have a huge financial interest. We were fooled into thinking the surgeon would make a thorough review beforehand, choose the best possible solution out of all available, and that he would give every bit of concern and compassion in follow-up ... not treat us as a legal nuisance.


So, anyway. Sharman is asking for advice about ADR vs. Fusion ... and everyone is saying - you need to educate yourself ... or praising the thoroughness on his questions... or talking on some other subject (uh, me included). But no one will address the questions directly ... we are basically saying go find your information elsewhere - while also saying that info is bogus. We all believe that ADR is better than fusion ... at least in the short run ... if all the patient selection criteria are met ... and the surgeon is highly trained and skilled ... and the surgeon is not financially biased to use an inappropriate device or technique ... and the patient has a thorough understanding of the risks and expectations (15% pain reduction = success), and the surgeon is going to openly and honestly take responsibility for whatever results instead of trying to cover up a major blunder and just hope the patient goes away ... like all the others.

I leave you with a few key quotations:

"Disk replacement is appropriate during the narrow time window when degeneration is limited only to the disc and signs of instability or degeneration of the posterior elements have not yet appeared. Limited by this time window and the inclusion criteria dictated by the US Food and Drug Administration (FDA) for disk replacement, only 7.7% of patients admitted for lumbar spine fusion during the study period were found suitable for disk replacement. "
http://www.orthosupersite.com/print.asp?rID=25668

"the FDA and DePuy Spine recognize the limitations of the available data. They restrict use to a relatively narrow indication" medscape

"Disc Arthroplasty changed my practice completely: Today, after 6 years experience, Disc Arthroplasty has replaced ~ 90% of my Fusion Procedures!" Dr. B.

"Reoperation Rate After Instrumented Posterior Lumbar Interbody Fusion: In the present study of 1680 patients, the revision rate amounts to 13.2%"

"Suboptimal patient selection and/or surgical technique accounted for the majority of failed disc arthroplasties." spine

Article which debunks adjacent segment degen with fusion

[B13s]

Originally Posted by WayDownInCoCrMo

What I'm disturbed about, is that no-one even discussed fusion. Maybe it was our pure bad-luck to be living in Germany. Maybe its was our dumb luck to have read through ADRsupport at all the oozing praise of these surgeons.

As you can see I also live in Germany - and out of 4 different clinics/hospitals only one recommended ADR - and it was Alphaklinik. Two others suggested fusion in a coming years and one - microdiscectomy. You cannot really solely relay on the internet only...

[Maria]

The only thing I have to add here is in response to the puppy idea. I got Lola and the thing that used to bother me so much was walking yet now I can walk and walk. I thank Lola for that. She gave me a reason to walk as well as the daily motivation. She's not a well trained dog and in fact she's terribly spoiled and has a mind of her own as mini schnauzers do but thanks to Lola I'm quite the walker now and even lost the excess 10 plus pounds I had been carrying around for years.

BTW, Taffy is a really sweet dog. Lola's companion, Leila is a nearly 8 y.o. lab (my stepson's) and she is so well trained and great to walk as well. In fact she doesn't need the leash at all.

Should anyone get a dog to walk, make sure that the dog isn't walking you. That can lead to problems with tugging of one's own body parts which may lead to flare ups of injured parts.

While I can pretty easily walk Lola alone, walking Lei and Lo together has lead to flare ups with my c-spine.

This is a bit off topic re what's better, ADR or fusion. I say dog walking in my own case for now is better than either since I've not yet had further surgery....

[ans]

I never researched the most recent fusion modalities success rates. An other forum is filled with the emotional debris of failed fusions. I have extensive DDD (L -2 to L-5), questionable facets acc'd to MRIs, and adjacent segment syndrome's a concern. Nice summarization job but sorry you had to do it.

+ +

There's substantial literature on "pet therapy" and how this helps people heal better and diminishes depression. Even hardened prisoners love caring for animals. Remember how Koko mourned (warning: hokey music):

http://diabellalovescats.com/koko.htm

[WayDownInCoCrMo]

"Maybe it was our pure bad-luck to be living in Germany" ...

Meaning, in the USA, with the Prodisc not approved, we probably would not have had so much access to so many clinics (Stenum, AK, Pro_Spine) ... which specialize in ADR. Of course, we thought it was amazingly good luck at the time, that we lived only 1 hour from Straubing, and 30 minutes from AK. Of course, if we were natives, we may have had more success finding other Orthopaedic clinics.

Let me balance my criticism: Over half of the FDA Prodisc trial surgeons in the USA had financial conflicts of interest. They should be fined at least - for the amount invested. The Prodisc FDA approve must, by Federal law, be thrown out. That's not from me, its from the Senate Finance Committee, headed by Senator Grassley. I do not subscribe to the line that the surgeon must invest in a company in order to improve the technology. They should put themselves above it - its their oath.

Please note, we did get a lot of inputs from German neurosurgeons AFTER the ADR ... but that was only because I found a site listing ever Prodisc specialist in Germany ... and emailed to every one of them.

It would be great if you could post the names of the surgeons/kliniken who have more conservative views on ADR.

Thanks! Best Regards,
Matt

[ans]

Matt: given all the (perhaps rightful) criticisms of ADR/ProDisc, there have been some outstanding successes (and w/Charite). I wonder, given both of these ADR's shortcomings, what happens to make a sucessful ADR? I'm thinking of excellent placement, no pain relief from facet injections, etc. I hope I don't seem insensitive, I'm not. Maybe there's some factors that have not been fully recognized. (As I'm in the middle area of MRIs showing facet "arthroses", the nuances of this maze confuse me). With Regards ~ Allan

[fuzzy]

I did go to AlphaKlink. Many reasons for that. Dr. Z. did a fusion on my L5/S1 even though he originally offered ADR. He did not charge me extra for the fusion, which normally goes for 3000 euros more, which he did using my own bone, again, for a very good reason. After taking double xrays he spotted a minute shift in my L5 vertabrae on flexion. He said it was not worth to risk putting ADR there but to do fusion instead so now I have 1 fusion and 1 adr, with no complications. The improvement was immediate. Ask Mark, I met him there and he saw me walking better then in 7 years, after only 1 month. This shows that they will not just do ADR no matter what. They do reject patients as well. I know of several.

I have researched this since 2000 and read a lot of the negative stuff. In US they told me don't have surgery, its bad news, its too risky, the word "guinea pig" came up. Live with it. Go home. PT, pain killers what ever. I read and read and read. Everytime I had another level 10 episode I read again. So when I finally showed up in Germany it all fell in place with everything I knew and read. Yes, I personally felt that there was more "money" behind Bertagnoli" then with Zeegers *EVEN* though the Alpha is so darn flashy that all one can think is whoah, there is a lot of money in this place. I went there 4 month before I actually had the surgery so I had time to think. But then if they did bad operations all the time there would not be there anymore with that big sign on the front. So I know I was taking a big risk when I walked in the back door and layed down on that stretcher and prayed when they stuffed the IV in that all the bad stuff I had read about would not happen to ME because it probably would and I don't like gambles, I never go to casinos and I did it anyway, even with all the concerns. I guess I hurt long enough and knew that was the only way it could get better. Mind you 10+ years of this backpain sh*t, getting worse every year.


ADR vs fusion. The STALIF fusion that Z. did to me worked fine out the door. Yes, the hip site hurt, real good. But if you need to decide weather to have fusion at L5/S1 don't rule it out. It seems like it worked just fine, just as good as the ADR above so I am somewhat glad I only have 1 ADR...

[WayDownInCoCrMo]

Hi Ans: Please note, I have not criticized ADR/Prodisc. IF the stats were true, (as I believed), I would be all for it. That's why we chose it. If your conditions indicated ADR strictly (as nearly ALL surgeons state ... including Dr. B.) then you will fit those high stats. If a surgeon disregards the indications, then you no longer benefit from the stats. The trials used highly selected patients - perfect candidates. If your facets are half-blown, then forget about the stats.

My points were:

1) The success stats highly correlate with the degree of financial investment of some surgeons
2) No one even discussed fusion - ever. My wife was absolutely contraindicated. I got this from numerous US/UK/FR/NL/DE surgeons afterwards.
3) We were told revision would be easy. We were very concerned about the keels. We were not told that everyone in Germany would refused to do it.
4) We were appalled that the surgeon never even visited ... even though it had been 5 months since our original visit - where our images were already 5 months old. He never even said hi ... until 3 months later ... with a legal team.

Fuzzy: We agree that Dr. Zeegers is incredibly nice and accessible. Our beef is with the knee surgeon ... who did not show up for any of the 4 visits we made specifically to see him. In any case, AK did say 'ADR' for us ... and nothing else. I didnt mean to imply that AK or Stenum or ProSpine never do fusion. The question is really: Do they ignore the rules when desired ... although following them strictly in their stat gathering trials? Some here say that facet arthrosis is NOT a contraindication, and that a collapsed disc is also not. I say that is crazy.

Cheers,
Matt

[ans]

Thanks for clarifying M. I have a bad chest cold and am not quite "here". My sense is to beware re: facet arthropathy and ADR - 'tho I wonder if others e.g. Active - L might be better.

Again, my sentiments - I'm sorry you two have to go through all this. I hope that A continues to mend and regain her spirited life.

Best, Allan