Choosing ADR or fusion

[sharman]

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]

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]

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?)

[dshobbies]

Wendy,

There are doctors and then there are doctors! Some that are very sure of their skill may very well implant an ADR with less than 50% disc space left. I was supposed to have a fusion at S1/L5 but Dr. B decided on an ADR.

A problem could be distracting the disc space to implant the ADR. I gained 1 1/2" with my 3 level. I also sustained a lot of nerve damage that now appears to be permanant.

As for outcomes, some great candidates don't do well and some poor ones do great. Which one is best for you? Get educated and get opinions, more than one. Then YOU decide.

Dale

[ans]

Dr. Regan won't consider an ADR at one level b/c it's such a mess.

Sharman, I'm sorry I missed your response but glad I found you again. I was just talking about adjacent segment syndrome, if it could be stopped 'half-way", and voila, I saw this important post. Thanks all for the info.

[wendy]

thanks for the info and advice, i dont seem to get many replys on this site and this was encouraging.
i now have an app on the 4th of june to discuss which operation i will be having although still waiting on date for the op itself!!!!!!!!!!
but as soon as he said he'd op i mentioned adr and he said no out right so dont think this will be an option, he seemed quite keen on dynesys will open new thread when i get go ahead and hopefully get some advice from you all then? its hard here in the uk as for the time diff but have found this site really helpful just reading other peoples experiences.

thanks again x

[mmglobal]

Wendy... I'm looking foward to hearing what your doc has to say. Dale's point is well taken, that the recommendation for or against ADR often has to do with many factors, including comfort level of the surgeon, what his/her hospital will allow, how different procedures are reimbursed, etc...

As for no ADR w/less than 50% disc height... that sounds like a hard and fast rule in a place where each case is different. Here are my wife's pre and post-op pics... she's only 7 weeks out of 2-level ADR, but the severe prior disc collapse was no issue.

[ans]

"As for no ADR w/less than 50% disc height... that sounds like a hard and fast rule".

Thank you; I never heard that. Very impt.

Best to you Wendy.

[Michelle]

That "50% disc height' rule doesn't sound right. My disc was down to 4 mm, when it should've been 21mm. Another member had his bone-on-bone, and starting to fuse when the disc was implanted. Was that the surgeon's opinion? Something from the implant manufacturer? I'd ask a whole bunch of questions about that, if I were you.

[Maria]

What would be criteria or parameters for allowing autofusion to continue or to intervene with implant or fusion (if this is done).