L4-5 Charite ADR Stenum

[Terry Allen Blackburn]

I had the opportunity to have the Charite Disc installed inside of my spine by a local surgeon. The surgeon I have a lot of respect for but I did do research on the Charite Disc. I would never have agreed to have this disc installed in side of my spine as the design scared the hell out of me. To have a free floating core never made sense to me when we are designed to move and have range of motion preserved with this new disc technology. I also Googled the Charite Disc and got many sites for lawyers representing people in the United States that had the Charite installed in their spine. I also came upon this article that caused me to have some serious pause over having my local surgeon install this disc:
FREQUENTLY ASKED QUESTIONS:

This recent article examines 75 patients who had poor outcomes with this disc:
Complications and reoperations of the SB Charité lumbar disc prosthesis: experience in 75 patients

Charite Artificial Disc Generating Controversy - Medgadget - www.medgadget.com

And the list goes on and on.

I chose to get the Maverick discs installed in my spine and had a good outcome going through Stenum in November 2006. I had 4 discs implanted and went with the Prestige discs/cervical and Maverick discs/lumbar.

I am very sorry for your friend's loss. I can only imagine how much pain he was in prior to his death. My only hope is that they continue to research what is best for the treatment of spinal diseases. As it stands, we are the guinea pigs for the surgeons, unfortunately. I only hope his death was not in vain and that this serves as a lesson to all to research, research, and research. Even then, the decisions we all make may not be the best ones, and we are ultimately responsible for the chances we take.

Terry Newton

[mmglobal]

H, thanks for posting. I agree, these stories are long overdue.

Yes, all surgeons have many failures and many successes. Those who have worked with me know that I do not sugar coat anything and I offer to introduce my clients to failed patients, including failed patients for the doctor that they are going to. There is no getting around the fact that spine surgery is dangerous. However, there is a difference between this type of case and the type of failure that we all fear as we go into surgery. There are many reasons to fail. You can have undiagnosed pain generators so that you have the surgery, recover, yet still have your pain. You can already have permanent damage that will not get better from surgery. You can have a case that is so complex or severe so the chance of resolving the pain generators is unrealistic. You can have a configuration that is impossible to know about, that may cause damage in the surgery that cannot be avoided. (Something like tissue that is adhering to a nerve that may damage the nerve when removed, like removing tape from a wall and taking the paint with it.) There is also the general risk of surgery that will go along with any surgery. I’m sure there are many, many more issues, but you get the point.

For the most part, failures as described above are going to happen to every surgeon. I don’t believe the studies that get into the 90’s percentage for success. I believe that there is at least a 10 or 15% chance of failure for ADR surgery for reasons that cannot be avoided.

I knew John well. We’d only met after his ADR surgery and I had the pleasure of meeting him in person a few times. His ADR failure is completely different than the other types of failures that are experienced everywhere that ADR surgeries are performed. Let me shed a little light on his case.

First, notice the angulation of the Charite’ plates on the first picture. The implant is not centered well. This is causing the upper plate to ‘fall off’, lower on the left side of the image. This demonstrates one of the problems with mobile core devices. When this occurs, the core is pushed to the extreme right and stays there. That increases the angulation and increases the forces that push the core more off center in the wrong direction. This is why the Activ-L eliminated the lateral movement of the core. Every mobile core device I’ve seen will do this. Properly implanted it’s much less of an issue. I’ve had 2 clients with M6 cervical discs explanted, one for problems much like I just described, another one for serious complications that may have been exacerbated for these reasons. (Yes, they were both Stenum patients. I know of a third, but I was not involved in the case. I did get to examine the explanted disc though.)

That brings us to the second picture. Notice how far the back of the upper plate is from the back of the vertebral body. Notice how the teeth of the plate are literally on top of the anterior margin of the vertebral body. There is the appearance of more vertebra because of an anterior osteophytes. This kind of alignment increases the risk of migration by many orders of magnitude. I see these types of films presented at the conferences as if they are a device issue, but this is not a device issue. The picture of the configuration before migration is one of a disaster waiting to happen. The surgeon should know that and be focused on proper placement. The doctors at Stenum say that there are anatomical reasons that may make it impossible to get the disc further back. That is absolute BS. I have NEVER seen this type of failure from any of the other surgeons I work with because they take care to get it right. Accepting sloppy work because you are lazy, hurried or just not careful may not cause problems most of the time. However, when the stakes are soooooo very high, accepting sloppy work may doom patients that would have otherwise been successful, to lives of pain, meds, revision surgeries and more.

After I went to Stenum with MrBee, I made excuses for them, saying that they are probably doing the surgery the way they were taught to do it years ago. The reply from one of my favorite surgeons was, “If you are a bricklayer or a librarian, that may be OK. But if you are an astronaut, an airline pilot, race care driver or a surgeon, you have to be learning all the time. That is not an excuse.”

Here is a picture that I extracted from the original Stenum-and-back website. This picture stayed up there for many years until the patient community got wise to what it really showed.



I want everyone to keep in mind that this is the image of a successful surgery. The author of the website may even be in better shape than me. They point to images like this as if it’s evidence that it’s OK to do surgery this way. However, you do NOT want any ADR implanted this way. If the patient’s disc was his pain generator and they took it out, he experiences success. If he gets away with the horrible placement, that is dumb luck, not appropriate surgical technique. At the conferences they discuss the sequelae of configurations like this: increased risk of complications like migration and subsidence. In addition, there is the expectation of accelerated wear and degeneration of posterior elements, possibly adjacent levels (due to inappropriate kinematics), AND of the prosthesis itself. It’s like driving with your tires out of alignment.

Does this mean it WILL happen? Absolutely not! All it does is increase your risk. Poor surgery does not guarantee failure just as perfect surgery does not guarantee success. If anyone wants to have poor surgery because it’s OK most of the time, I would suggest that they don’t fully understand the issues.

Back to the pictures. Look at the plates in the successful surgery. Look at the plates in John’s. He was shocked when I told him this because he’d shown the films to a dozen spine surgeons and none of them had noticed it. The disc is installed upside-down. In this configuration, the upside-down disc INCREASES the sheer forces that lead to migration. My guess is that the configuration may have been able to tolerate the terrible placement. I doubt it would have migrated if it was upside-down, but properly placed. But poorly placed AND upside-down is too much. He asked for an explanation for why the disc was installed upside-down and the question was always ignored.

(continued)

[mmglobal]

(continued from previous post)

If you think that this is a Charite’ issue, you are mistaken. While the failure mode of the Charite’ seems to be worse, you avoid the failure mode by getting the surgery done properly. Poorly located or poorly sized discs are a problem no matter which disc you use. I see similar problems with other designs. You can’t put any of them in improperly and not have disasters. I will say again and again… there is a difference between the unavoidable failure that all spine surgeons experience and a failure that absolutely would not have happened if the surgery was done properly.

Here is another case that is similar. Look at the pre-migration picture for the placement of the plates. The prosthesis is right-side-up, but it’s so anteriorly located that the cleats are literally riding on the anterior ridge. Unfortunately, the post-migration xray is oblique and of poor quality, but you can see the lower plate has migrated out and rotated 90 degrees as it migrated out and like John, the core was expulsed. Do you think it is a coincidence that the plate that was hanging off the front of the body is the one that expulse.



Any experienced ADR surgeon should look at the interoperative images and see that while this MIGHT stay put, this is just as likely, a disaster waiting to happen. In every ADR surgery I’ve observed (with the exception of one), there are literally dozens of xrays taken to insure proper positioning. None of the surgeons I’ve seen doing ADR (with the exception of one), would look at an image like this and consider the job of placing the prosthesis to be done – time to close. (I’ve seen close to 200 arthroplasty procedures in more than a dozen centers, more than a dozen implants.)

This patient was told that the reason for the expulsion was because of the fusion below. I have MANY clients with similar configurations. That placement is problematic without regard to the adjacent disc. ADR adjacent to fusion is not problematic when properly placed, properly sized, etc.

I really appreciate that kc0iet and Havanna have come forward and started this discussion. This is NOT about the design of the Charite’. This is NOT about the general risk of ADR surgery. The two cases that I have written about in this post are 100% carelessness, poor implantation that should NEVER HAVE HAPPENED. Both of these patients had every reason to look for success or at least a chance of success because they were going to a surgeon with a great deal of ADR experience. Sadly, what they got was something completely different.

Please note that the patient with the fusion was done on the same day as the MrBee disaster in August 2004. That is also the same day as the Carmont disaster. One would think that they would have learned that such anterior placement is a bad idea. We have to ask, why are they still making the same avoidable mistakes in October 2005? The surgeon gets to choose when the prosthesis is appropriately placed. They look and say, "yeah, that's good", or "no, it needs to go further back." With the Charite' they have the option taking it out and starting again. (I've seen that done many times.) It is a choice they make to close the patient when they feel that it's appropriately placed. These cases are NOT, "all surgeons have problems!"

I'm sorry this is so strong. I get very agitated when I have to discuss Stenum because I've seen so many of these unnecessary, avoidable disasters that result in lives ruined. I apologize to all the happy Stenum patients who had a wonderful experience and love them. I know a lot of happy Stenum patients. Some of them are happy campers in spite of poor implantations. Some have success with good work done. But, what I've seen as the steady stream of avoidable disasters is unforgivable. As my friend said, if you are an airline pilot or a surgeon, you have to keep learning and improving. Sadly, for the complacency shown in these cases and so many others, the patients paid such a severe price.

All the best,

Mark

[New-disc]

Mark,

I'd like to take this time to thank you for helping all of us understand what went wrong.

Todd

[Kathy]

Mark,
I have a question for you.... Dr. Garcia told me that the reason I can not bend backwards was for this very reason. He said that (in theory at least) by bending backward it could push the disc out (forward, think that is anterior?). He said that until my bone grows into the implant that I should not bend backward, to thus avoid the chance of this hapening. My question is, is there any chance that any of these patients were one of the very unlucky ones that this happened to? I am in no way defending Stenum, like I said, I know absolutely nothing about them or any of the other overseas clinics; but am trying to better understand what happened? Is there one surgeon at Stenum that has more of these outcomes than others? Or is it across the board? I just can't wrap my mind around how if they are being this careless, that they are still in business and there are people who swear by them? Just trying to understand....
PS. Not trying to offend anyone, I am neutral on this issue, just trying to 'get it'

[phylly]

Havanna,
I just read you post and am deeply sorry for your loss. I am glad that there is so much discussion here about what can happen with poor surgery and bad outcomes. Even the best surgeons can have problems but this sounds like it should never have happened. I guess I have just been stunned reading these posts and realizing the chances we all take in getting ADR surgery.
Phylly

[wilsonrob]

Thanks for your excellent take on this. I will just keep praying for all that continue to struggle in pain. I will pray for wisdom and comfort. As well I will pray for the surgeons that they take care to do the best surgery possible.

[treefrog]

Yes, thanks Havanna for bringing John's story to this site. I am deeply sorry for John's family and friends, at their loss.

And Mark, thanks so much for explaining how these surgeries may have gone wrong. It really is inexcusable that a surgeon would be so careless with someone's life.

I do have a question, as I remember in one of Dr. J's posts, that showed his disc as being placed upside down by Dr. Bertagnoli. How is that different, and could Dr. J's current problems be caused by this configuration?

[mmglobal]

Cathy, go back and read the explanations on Justin's thread and this thread. See if you can get your head wrapped around the angles, forces, etc. I don't believe that being upside-down in John's case would have had this result if the prosthesis was placed appropraitely, towards the back of the disc space.

The Prodisc is very different from the Charite, with much better 'primary fixation', that is the fixation that occurs upon implantion, as opposed to secondary fixation that occurs after bony ingrowth into the coating. The keel provides much more surface area for primary and secondary fixation and since it's a press-fit, it's also very tight and resists migration. Even so, it too should be implanted towards the rear of the disc space, as shown in Justin's images.

On my last client with Dr. Zeegers, he explained why the discs will not move. It went somethin like:

Picture working on the wheel of a truck. You jack it up and place a large stone under the suspension and then lower the jack. You can try to pull out the stone but there is no way to pull it out.

In John's case, picture that you lower the jack so the suspension is resting on the very edge of the stone instead of on the middle of the stone. If you pull it in one direction it will be impossible to move it. However, if you pull it away from the side where it's resting on the edge, the forces will want to spit out the stone like a tiddley-wink or an olive pit. Putting the disc in upside-down (in this case) makes it like the truck is on a hill.


Not all implantations for ANY surgeon are all perfect. There are reasons that make some surgeries more difficult than others. However, looking at so, so many patient films, I see surgeons that have consistently excellent output and I see surgeons that have consistently mediocre output. I rarely see surgeons that have such a steady stream of cases that fall into this "should never have happened" category of complication that would have been avoided by a technically sound surgery.

All of this comes along with the appropriate "I'm not a doctor" qualifiers. However, I have observed many, many surgeries and have probably seen a wider variety and volume of spine arthroplasty cases done that 99% of the surgeon population in the world. (One of my favorite stories is the anecdote I tell just above the picture in the OR with Buetttner-Janz and Bitan in this post: Dr's Bitan and Buettner-Janz in the OR).

When I talk about observing surgeries, what do I mean? Here are pictures from Willie Beeson's book, in the OR at Stenum (I'm the tall one!):



Again, I'm sorry that all this comes out so strongly. It's hard for me as I become emotionally vested in so many cases, to see people suffer unnecessarily. Take everything I say with a grain of salt. Do your homework and make informed decisions.

Mark

[Terry Allen Blackburn]

You do make the appropriate disclaimer Mark about not being a doctor. Stenum will never be able to come on to the forums, nor will any other competent or, even questionable surgeon, be allowed to discuss any patient care, surgery, consultations, etc. due to patient confidentiality. So the only thing that we will ever get is your personal feelings, and we will never know the other side of any of these stories. Not to discount anything that you do here but your biases are very apparent.

I do hear you loud and clear, to do as others have suggested as well, which is research, research, research.

I could never draw any conclusions from any of this posting due to a lack of much information from many sources. As it is, we will never get any of this information, so we can all speculate what went wrong and never really know.

I am very sorry for the families loss.

Terry Newton

[james]

Charite’ polyethylene core 6.5 years after installation. From Complications and reoperations of the SB Charité lumbar disc prosthesis: experience in 75 patients

[mmglobal]

I just stumbled into this thread as I was updating kc0iet's thread on the surgical outcomes forum here:

L4-5 & L5-S1 Chartie Stenum - kc0iet

I'm bumping this one up for 2 reasons.... first because kc0iet's case and John's are related because they are part of the steady stream of truly unbelieveable Stenum errors.

Second, 3 years late, almost to the day, I have an anecdote related to the study posted by James, above.

In the past, when writing about the spine conferences, I have noted that there was an amazing number of papers from the same sources, that I characterized as anti-polyethylene anti-science. I coined the term anti-science to describe what Steven Kurtz and his organization were churning out. While there was likely some useful information developed in his studies, it truly seemed that Dr. Kurtz and Dr. Van Ooij received unlimited funding from medtronic to generate "polyethylene is bad" science. Much of what they reported on had to do with long-solved problems associated with early sterilization techniques and horrifically botched surgeries like the ones described above. I even asked him in the Q&A session after he presented a paper, "how is this relevant to what we are doing today" and his reply was, "it's not". (I'm paraphrasing)

IMHO, the spine societies seemed to give him a big platform in an effort to be fair, even though he got little respect. Last week, I sat next to a very prominent researcher (PhD biomechanics) and noted the absence of Dr. Kurtz. He told me about a conference in which a substantial percentage of the audience walked out as soon as Kurtz started to speak.

In any case, what I thought was amazing is that there was NO anti-polyethylene science presented (that I saw) and while Dr. Kurtz always had 5 or 6 papers to present at most of the previous conferences I attended, he was not here. Why? (IMHO) The Maverick was not FDA approved. Metal on metal joints are no longer in favor, so there is no longer any motivation for Medtronic to endlessly fund anti-poly anti-science. It seems that they were marketing pieces looking to create a competitive advantage.

It's truly amazing how the landscape changes... attending ISASS last week after missing the last 2 years... things were quite different. I'll be posting more about ISASS here:

ISASS 14, Miami Beach, April 30 - May 2 2014

Mark