Choosing ADR or fusion

Job13 · #1 (**permalink**) 05-21-2008, 12:27 PM

RIP Freedom of Speech

dshobbies · #2 (**permalink**) 05-21-2008, 03:50 PM

Job13,

If anything, our medical community is known for it's secrecy. Finding a doctor today that is more concerned with a patient's welfare instead of their own self serving needs is rare today, especially for specialties.

I was amazed that my neuro, knowing that other procedures existed, failed to tell me about them because he didn't perform them and because it had not yet passed FDA trials, was not legally bound. However, he was more than happy to perform another diso/lami knowing, yet failing to tell me, that the success rate was drastically reduced and would more than likely lead to further DDD. This is only 1 example of why it is so necessary for patients to become educated, not to believe everything they're told, and get more than 1opinion.

Even on this forum, some sing the praises of doctors with whom others have had negative experiences. Even medications, designed to help have been known to kill and only after the fact does the truth come out that these dangers were known all along. Manufacturing warnings are meant more to protect the manufacturer than the public. In today's day, legalities and rightousness have little to do with each other.

Bottom line, read, learn, ask questions, make up your own mind. It's your body, your suffering and your possible relief.

Diane · #3 (**permalink**) 05-21-2008, 10:38 PM

One of the interesting exchanges I observed at SAS in Miami was during a Q&A panel discussion after one of the lumbar ADR session. A surgeon came up to the microphone and while framing a question about retrograde ejaculation said something like, "What do you tell your patients regarding retrograde ejaculation? Do you have them use a sperm bank? My experience is that if you tell them a 2% chance exists, they will NOT believe it can happen to them. I tell them, 'What if you are in the 2%'?" This was more of a lesson for the audience than a question. He was trying to let everyone know that they should actively try to get males who may want children in the future, to take seriously the risk of RE and use a sperm bank. 2% is not never.

Risks can be small, but they can still happen to you. As a nurse, working on a busy surgical floor for many years, I've seen many post-op complications - some small, some major - and NOT always in the patients with the highest risk factors. We wish we never had to have surgery, but sometimes it's necessary, in spite of the risks that we must accept.

Diane

WayDownInCoCrMo · #4 (**permalink**) 05-24-2008, 05:52 PM

Quite a confusing conversation. Especially if your a suffering patient just looking for clues on what is better: fusion/ADR ... and in what cases.

What I read here: Do your homework, read, learn, question ... and simultaneously ... do not trust published data (i.e., what you read), do not trust your surgeon's answers to your questions, and much of what you learn (especially on the internet ...like on forums) is apparently garbage or dangerously misleading. One person says - decide on your procedure, then find a doctor who agrees. In other words, you must be smarter and more knowledgeable than the surgeons themselves. How can you do this? Attend conferences? No, of course not. You can barely move. Ask multiple doctors? Of course not ... again, you can barely breath, much less sit for hours in a waiting room. Send email? Forget it. No doctor is going to give medical advice except in person. Count the happy people vs. sad people post surgery on forums? Not after seeing the misrepresentation, defamation, censorship and banning of failure case we see on sites like ADRsupport. In any case, we can easily see in the member lists that the successful people's posts of 'encouragement' outnumber the failure warnings 1000 to 1.

Believe it or not, I studied like mad (on ADR) before leading my wife into this hell. EVERYTHING said ADR was supperior in every respect. Now, I feel like a Joseph Fritzl ... going to work, stores, sleeping free of pain ... while my wife is facing FIFTY years at least of hell. A destroyed leg, and the consequences of a late lateral explantation of a Prodisc. Hard to believe this was my wife only 3 years ago ... before we were tricked into 'volunteering' for someone's sick experiment ... for data that no one believes.

So, as Mark said on ADRsupport long ago: "This is a dangerous landscape. We can't trust the studies... we can't trust the statistics... we can't trust the anectodal evidence... we can't trust the doctors to always know what's right, or to always tell us the truth... and on and on."

I doubt you will be able to find that quote on ADRsupport ... as H has locked the doors, so to speak. By invitation only.

So, this begs the question: Who/What do you trust? Obviously, the first to exclude are those who have a financial conflict of interest. Next would be data which is not double-blind class I controlled (i.e., basically everything from Europe is self-monitored). Third would be, anyone who suggests that a selected set of success stories from forum members is justification for ignoring the generally accepted practices (rules).

Some of those people, even have the audacity to suggest that facet arthrosis is not a contraindication ... and then kick everyone who dissents off their board.

Question (back to Sharman's original question - regarding 'fit'): Does anyone know what the minimum height of the Prodisc-L is, and resultingly, what is then the minimum height of a person's natural disc?

Question 2: What grade of facet arthrosis is a contraindication to ADR?

Yours,
Matt

dshobbies · #5 (**permalink**) 05-24-2008, 08:14 PM

Matt,

Your pain in so evident in your post. What you and A have been through, are going through, will go through, no one should have to. I am sorry that you find yourself in this position.

I think your post demonstrates the need for educating oneself more than ever. If learned, studied doctors have differing opinions, how does anyone know which is the truth? Excellent question. And no, I don't believe someone should chart their own course and then find a doctor who agrees with them.

First, any surgery has it's own risk. When the spine in involved, this decision is multiplied too many times over. The best advice, which I still stand by, is the excellence and reputation of your doctor. A is the proof that even that criteria isn't fool proof. I too had a bad experience with a renowned surgeon. So what can someone do to insure this doesn't happen to them?

The truth is I don't think they can. Bad things happen even with the best advice/intentions. Bad things happen under the guise of basic medical care. I've no doubt, based on insurance approval and despite known contr-indications, I could have found 10 doctors who would have fused my 4 lumbar discs. Would this have been wrong? I honestly don't have the answer to that one.

In short, there is no cut and dry answer to too many medical questions. Everyone has to decide for themselves which information they find valuable and which to throw in the trash and the only way is to educate themselves. If an answer has leanings, go with the leanings. If 50/50, try to find examples. Are you wrong because you disagree? Are you right because others agree with you? I don't think, at least not in our lifetime, spinal procedures will progress to any definitive procedures. It's people like us that will pave the way. In the meantime and because of all the above, we owe it to ourselves to do the best we can with the best we have. I do believe that one day it will be simple but as to when is only in those evasive crystal balls.

I hope you and A find the relief you seek and this nightmare finally ends.

Dale

Diane · #6 (**permalink**) 05-25-2008, 05:32 AM

Matt,

I'm sorry that you are experiencing this spinal hell. Watching a loved one in pain is difficult and exhausting. It's been five years since Mark's chronic pain, and it's still difficult for me to think back to those days. Don't feel guilty about being able to live yourself. If I wasn't so busy with work, childcare and housework, I don't know if I would have made it. You need to take care of yourself so you can remain supportive. I was fortunate to have a best friend who would call me up and take me out even when I tried to decline.

Don't beat yourself up about the decision for ADR, sounds like you did your research. I'm sure it wasn't all your decision. As far as ADR vs fusion I don't have any magical answers. I'm happy the first ADR patient 24 years ago was willing to try the procedure. He still plays tennis and because of him I have a chance with my ADR.

Don't give up, recovery can be a long process. When Mark was at his lowest point, we got a puppy. I know that sounds crazy! Who needs the extra work, but it worked magic. Maybe an older dog would be easier, but they are great for companionship.

Diane

mmglobal · #7 (**permalink**) 05-25-2008, 04:19 PM

I don't think I can properly express how much of a difference getting Taffy made to me at a time when I was pretty severely disabled and depressed. Diane was brilliant in making this happen. After Taffy was older, the companionship was important, but right from the start, things were different. I suddenly had something I needed to care for, as opposed to the focus on my pain and my problems. I suddenly had something that made me laugh and smile a hundred times a day. Fortunately, Taffy was a service puppy, so she came with an instruction manual. (I wish our kids came with one!) We had a job to do... not only was it fun and rewarding training her, but it also made Taffy a well trained dog that is so much easier to handle.

I wish I could write more now... gottal run!

Mark

WayDownInCoCrMo · #8 (**permalink**) 05-25-2008, 06:27 PM

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

mmglobal · #9 (**permalink**) 05-21-2008, 06:51 PM

Quote:

Originally Posted by Job13

Mark, can you be more specific? Which information is harmful misleading?

.

Anastasia, that is a general statement about information on the internet. It was not specifically aimed at anything posted here. The patient community, like the medical community, continually discovers that what we thought we understood a year ago is not necessarily true. There is a steady stream of useful information that becomes misinformation as more knowledge is gained. There is also, flat out misinformation... sometimes mixed with good information... usually posted by people with good intentions. Often what one person considers to be harmful misinformation, another considers to be life-saving knowledge.

Quote:

Originally Posted by Job13

Do you disagree with a collapsed disc being a contraindication in the USA? (We know that anything goes in Germany).

Yes, I disagree. As I understand it from working with many of the most experienced surgeons in the US and overseas, each case is different. I've seen many people with completely collapsed disc spaces that were still very easy to remobilize and ADR was implanted with great results. (me and my wife both fit this profile.) It's not about a demographic or a measurement... it's about your spine. It may be the case that with more total collapse, the risk of surgery induced leg pain may be greater... but there are so many factors in that, I don't think there is a hard and fast rule... and THE PATIENT gets to decide.

I don't agree that anything goes in Germany. Just as in the US, there are careful surgeons and less than careful surgeons. There are surgeons willing to take on the tough cases and push the envelope, and there are surgeons who will stop at every 'hard and fast' rule and never take on a tough case.

If someone with a totally collapsed disc gets ADR and fails, they may look at what I've written here as harmful misinformation. If that person has a wonderful result, they may view what you've posted in that way. This is why it is foolhardy to base a medical decision upon what is found on the internet. Hopefully, what we find will be useful information. Hopefully, it will cause us to ask more questions, seek more options and be very careful about our decisions.

Quote:

Originally Posted by Job13

It is impossible for the general public to be informed on this subject enough to make good decisions. We have met many ortho doctors who know basically nothing about ADR. They love to gawk at my xrays. Thus, if 5 surgeons will give you 8 answers as you say, then the ONLY thing you can trust is the trial data, FDA rules used on the trials, and common sense.

I have discussed this at length with so many people (including Matt, and we don't agree on this.) Engineers and scientists tend to believe that the answer will be in the data. I disagree. I don't trust the data. On the last day of SAS in Miami, I was talking to Karin Buettner-Janz... she was seeking my input about the quality of the conference. As incoming president, she wants to make sure that SAS9 is even better than SAS8. I told her that I enjoy the presentations that present the clinical trial data less and less each year. (These are a huge percentage of the papers presented.) She asked me why. I told her, "Perhaps I'm becoming jaded. I just don't trust the data." Her reply was, "This is very wise."

So while some think that the answer will be in the data... I don't agree. Even if the answer is in the data... with success rates in the 80's, what does the data mean for the people who are on the wrong side of the equation? The useful information to glean from the data is the harsh reality of failed spine surgery. I believe that the success rates are overstated, that there are ways to manipulate the data, and that as long as the financial interests are so great, there will always be good reason to take it all with a grain of salt.

Quote:

Originally Posted by Job13

I have never seen a single web page that would show a failure case-all doctors, manufactures adverts are always showing only successes. (When I say "show", I mean to advertise on the first page).
Why not to advertise, lets say, 5 good outcomes and 5 bad to be fair? No one does it. Why? Because whoever advertising it has a financial interest in it. Everyone knows it but there are too many desperate people out there and they can swallow anything.

Sadly, the only reason that we have access to any of this technology is because of the money that is made on it. I don't think we'll see companies advertising to discourage business. This is supposed to addressed with an informed consent process. Sadly, that part of the process is severely lacking. I have seen surgeons who go way out of their way to present the scary possibilities in very real terms. I believe that the problem is that patients think that 70, 80 or 90% is a slam dunk and the results are automatic. That is what I think the real value of these patient forums are... a place that may give patients the understanding that 80% is not a slam dunk. The potential poor outcome from ANY spine surgery is not something that belongs in the boilerplate on the informed consent document... it doesn't belong with all the 1/4 of 1% complications.

I'll hold a patient conference and look over a room with 70 spine patients in it and think that 80% success means that 14 people out of this small group will not be successful. This is why we must ask the questions, discover the options, do our homework and make informed decisions... our lives depend upon it. The patient ultimately chooses and the patient must deal with the outcome.