3am here and have to pack and leave at 4:30 for a 6am flight. I'm giving up on sleeping, so I'll take a few minutes to respond to this.
It is frustrating for me to watch some discussions go on without having the ability to weigh in on them.
This study reminds me of the 50% HO with ProDisc-C experience that was recently published in ESJ (I think... not checking up on minor detail.) You all remember the study.
It's interesting data, but there is one take home message from that study. DON'T GO TO THOSE GUYS FOR CERVICAL ADR... ESPECIALLY IF YOU ARE INTERESTED IF PRODISC-C!!! Is there a more important message buried in there? Are they exposing a dirty little secret and the thousands of PD-C procedures are getting done with massive HO rates somehow being hidden? Or, do THEY just get lousy results?
Wednesday morning, Delamarter reported his results with 1, 2, and 3 level PD-C procedures at his site only. He discussed site specific data. There were 14 sites in the PD-C clinical. 10 of the 14 sites had ZERO HO. His center had the lion's share of the cohort and has ZERO HO.
Does this mean that HO doesn't exist or is not an issue? Absolutely not! As we've been seeing from day one with lumbar ADR... it's about getting a good job done more than the device used. All of the prostheses have serious potential issues that may be amplified by poor technique. Unfortunately, we'll continue to see disasters.
I've seen several studies over the years by the same group that Justin posted on ADR support... similar data with outcome numbers that is way worse than reported elsewhere. The presented a mini-paper at SAS-7 on Friday that reported horrible results with Charite' and Prodisc... different paper, same horrible numbers. Look at the number of surgeons listed... is it 10? How many are on their learning curve... just to make up some numbers call it 1/2. Learning curve with ProDisc and Charite???? that's 5 each, times 2 discs, time 5 surgeons... 50 learning curve patients included? Obviously, I'm making up these numbers and I could be 100% off base with this.
However, just because a study reports almost 50% HO with PD-C or a mini-paper reports "52% failed to meet success criteria" does not mean that the sky is falling.
Data is not the holy grail. Much of it unreliable for a whole variety of different reasons. I find it astounding that I see data presented on devices that are clearly inferior... so inferior that most industry people that I know expects it to ever be FDA approved... yet they show results that are similar to approved devices. These studies present some good info... they advance the science. Often bad numbers studies are dishonest anti-science designed to reduce the attractiveness of competitors products. (I'm not suggesting that in this case.)
Bitan presented a paper on hybrid surgeries with combined fusion and ADR.
Much more interesting stuff this year... This was the most interesting SAS with some real innovative products... very cool stuff. More later.
Allan... I have your name on one of the lending library Abstract book... you'll get it after I get home.
Please consider changing the title of your post to something that will describe the content. Titles like these make searching difficult, because you get hits on things you should look at, but the title doesn't give you a clue about what's inside.
All the best...
Mark
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