Choosing ADR or fusion

sharman · #1 (**permalink**) 10-30-2007, 12:42 AM

Thank you all so much for the invaluable input and, of course, kind words. I'm looking forward to thinking about what you've said, googling a bit, and then talking to you all more specifically. (Mariaa, I've followed your story. I've been just where you are right now, so often in the course of my gimphood. We could talk forever.)

Right now, I'm most focused on the risks of adjacent level degeneration and nerve damage. Certainly, fusion has the rap for adjacent segment syndrome. The statistics are grim, but I would like to see the stats for single level L5/S1. Sure enough, without much google effort, I found a pro-fusion guy confidently asserting that, at L5/S1, "there is minimal motion, so fusing does not significantly change the biomechanics of the segment."

Nerve damage I have a lot of questions about. Both procedures involve distracting the disc space during the surgery. And--this I've never understood--both also proudly claim to permanently "jack up" the disc, "restore disc height." Now, from the pictures it appears to me that both fusion cages and ADRs stretch the space, not just more than pre-surgery, but more than normal. This is a good thing? Why do I want to grow an inch after surgery? That just seems awfully brutal on the nerve roots. I could understand if a patient has radicular pain due to a disc space so flat, there was impingement on the nerve roots. But that's not my case. I don't have any leg pain.

So which is worse for nerve damage, fusion or ADR? It seems to me I never heard of "distraction pain" before ADR. But nerve damage is considered a not uncommon complication of fusion. And there are so many variations on the fusion theme, who knows what outcomes correlate to what flavor? Perhaps some of the new procedures succeed in minimizing the trauma.

Finally, this is a weird factor to ponder. I've somewhat suspected that fusion is for patients with great loss of disc height, and ADR for patients who still have good height. And that's not just because the other option is ruled out, but because those respective symptoms work best with the two respective procedures. Now, in the same article from the pro-fusion guy I quoted above, very strong confirmation: "The two findings on the MRI that correlate best with a successful postoperative outcome is the presence of disc space collapse and cartiliginous endplate erosion. Findings such as disc bulge, disc dessication or an annular tear do not correlate well with a successful outcome." Isn't that weird?

To be continued.

ans · #2 (**permalink**) 10-30-2007, 07:28 AM

Yes, weird and disturbing.

Good work!

sharman · #3 (**permalink**) 11-03-2007, 06:53 PM

ans

Wouldn't you know, I had to google to find your thoughtful posts, a few months ago, on the subject I'm pondering now.

For what it's worth, here are my thoughts about one of your options, fusion at 5/1 and ADR at 4/5.

I've found no specifics yet in my google searches, to confirm that fusion increases the risk of adjacent segment degeneration, even in the case of fusion at 5/1. But I would argue we have one very significant statistic already: Is it not true that 5/1 is the level that most frequently fails? And what is 5/1, but the disc that has solid bone, not another shock-absorbing disc, beneath it. So, isn't 5/1 analogous to the level adjacent a fusion: any level that does not have a shock-absorbing disc adjacent (especially below) is going to get more stress and be vulnerable.

However, let's think about fusion at 5/1 with ADR at 4/5. The vulnerable level is 4/5; that's the level that meets solid bone. But your 4/5 will be plastic and metal, able to stand up to the abuse (and no innervated annulus to complain). So, that would be an ideal situation in which to have 5/1 fused, if fusion appears the best option at that level.

That's my first thought. My second has to do with your statement that you have a lot of DDD. Do you have vulnerable levels in addition to 5/1 and 4/5? It is my current hope that borderline discs can be saved with one of the biological therapies just now coming available. Especially combined with ADR, we might be the first generation of back sufferers to need major back surgery only once in our lives.

Blairsara · #4 (**permalink**) 11-04-2007, 12:38 AM

I had Charite ADR in 2004 @ L5/S1. A few months later my facets started to go. First one side than the other. Than things started at L4/L5. The same facet problems as L5/S1 and also bulge. The longer time went on, the more "destruction" to the facets at L5/S1 and at L4/L5 it became bilateral. If that doesn't show a domino effect, I don't know what does. Things were just going to get worse if the Charite didnt come out. And so it did.. and now I don't have the pain I did pre-revision.

Blair

sharman · #5 (**permalink**) 11-14-2007, 02:11 AM

This is really interesting, and I sure would appreciate hearing your reactions.

And in particular, does any one know what the hell a "non-inferiority margin [of 10%/12%]" is?

Check out this link--it appears to be the package insert required by the FDA for the ProDisc, which includes the results of the trials, comparing fusion and ProDisc.

fda.gov/cdrh/pdf5/p050010c.pdf

Two things jump out at me:

On almost every criterion measure, the ProDisc scored quite well. It always scored higher than fusion, and its lowest score was a 67%. (E.g., 85.4% showing 15% or more ODI improvement.) Yet, in the "overall success" category, which differed from the other categories only in the addition of the mystery "non-inferiority margin," ProDisc got rated between 53% and 66.7%. (Fusion scored lower.)

First, does this explain the discrepancy between surgeons/Europeans who claim 75 - 85% success rate, and the official results of the trials: "About 60% success, similar to fusion"?

Second, as noted above, what the hell is "non-inferiority margin"?

Ok, a third thing. The nonrandomized ProDisc group did consistently better on every category than the randomized. I would think the non-randomized were a later group of patients--perhaps outcomes improving with surgeon experience? And you would think any placebo effect would be in the opposite direction, patients in a random trial being happy to have lucked out with the ProDisc.

wendy · #6 (**permalink**) 05-15-2008, 07:56 PM

hi

thought i would just add, i have ddd at l4/5 l5/s1 and i have only been given the option of fusion or dynesys, when i asked about adr i was told if the discs are more that 50% degenerated they cant give this option as there is nothing to fix them too?????????????
you really need to find a doc and get there opinion as usually they give you the best option and percentages of outcome.???

wendy x

good luck

mmglobal · #7 (**permalink**) 05-15-2008, 08:16 PM

There are some systems that took the great idea of Dynesys and resolved many of the problems while adding improvements. Modular systems that can combine flexible and fused segments. These modular systems will allow conversion of a flexible segment to fusion if needed with minimally invasive exchange of the spacer, using the screw system that is already in place.

DSS from paradigm spine has 510k approval in the US for fusion. (flexible system not yet approved?)

ans · #8 (**permalink**) 05-26-2008, 01:16 PM

Blair: By the grace of God (maybe surgeon too!) are you doing so well and I hope that this continues.

+ +

Sharman: Hola. Thank you for your advice. I like it! Never considered biologics as a later precaution (if there is one) against adjacent syndrome thingie. The DDD creeps me out.

Best of luck to both of you and have a nice holiday.

Allan, in LA

racergaldar · #9 (**permalink**) 08-24-2008, 02:49 AM

Thanks for all your comparison info. I've started the same thing, but waiting for diagnostic testing approval through WC.

I was told yesterday by my dr. office that if I get a fusion and if I need the disc replacement later (for example fusion failed), that I would not be able to get the ADR at the same level.

BTW: Aetna, Kaiser Permanente and CIGNA cover the procedure, as well as Blue Cross Blue Shield plans in AR, NJ and MT.

mmglobal · #10 (**permalink**) 08-24-2008, 04:50 PM

Racer, welcome to the forum. Thanks for your reply on KL's work com thread. Having someone with your HR knowledge here will be great.

Regarding your post (above). If one would be a candidate for ADR in the future at the operated level... then they must be a candidate for ADR now. I agree that it is safe to assume that attempting fusion will certainly burn many bridges for less invasive and less severe procedures. If a less invasive or less severe procedure is in play... that should be entertained before fusion.

Mark

racergaldar · #11 (**permalink**) 08-24-2008, 06:25 PM

Mark; thanks for the welcome.

My surgeon gave me 2 brochures: 1) fusion and 2) ADR. Without a discography, we can't tell whether I'm a candidate for ADR. Based on MRI, xrays and MRI, I could be, but the MRI doesn't give enough info to determine that. I just found out that the discography has been denied (WC) so now I'm starting that battle.

The PA tried to convince me that fusion wasn't going to limit my flexibility, but she didn't succeed. Since the dr. gave me info on those two options, then I'm assuming I may be a candidate for ADR. My best friend had fusion and everytime I hear him tell me what he can't do, the more I'm convinced that ADR is the best choice for my lifestyle. I'm too active of a person to get fused and I'm afraid of the future risks and limitations. I have faith in new technology and willing to accept the risks for ADR. After all, I use to race mortorcyles against a bunch of guys going 160mph into a turn, ADR is nothing compared to that!