Clarifications about the Stryde recall

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Quote from: maximize on March 15, 2021, 07:31:45 PMHe's saying the lysis is occurring due to the corrosion (rusting), same as the hypertrophy. The corrosion (rust) is irritating the bone and it is reacting either with overgrowth (hypertrophy), breakdown (lysis) or some combo thereof. It's not happening with Precice because Precice is titanium which won't corrode. Stryde is steel (which is mostly iron) and steel/iron can more easily rust.

The only significant issue that has been raised on the forum he did not address is whether NuVasive is testing people's blood for chromium or other metal levels. We had one person post here saying he had 2-3 times the chromium of normal and the NuVasive rep was in the room when he was told (so they are aware).

He said there are no cases of proven cancer from a corroded implant, but realistically that would almost be impossible to prove causality on, unless it was happening in massive numbers. I agree it's unlikely to be an issue for anyone. You've only got the device for 1-2 years and it's probably a minimal amount. But if you want to be technically correct, chromium-6 is defined by government agencies as a potential carcinogen (if that's the type of chromium used in the alloy). I would expect NuVasive to want to do blood tests on people as well, and maybe they are, and those numbers will be reassuring. Or maybe they don't want to stir that potential hornet's nest of "technicalities" so they're just ignoring it.

Either way if they can coat or seal the joint that should solve it, but as he said that's probably going to take about a year.

Well the part I don't get is how the same corrosion can have completely opposite effects of hypertrophy and lysis. I think it's just a hypothesis at this point.

One more scary thing from the interview was the rare Earth magnet which is sealed but the seal can theoretically break as time passes. No one knows the impact of that event. I hope that the seal is a tried and tested thing in implants and that there is no debate about that.

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Quote from: 2020hope on March 16, 2021, 09:52:49 AMWell the part I don't get is how the same corrosion can have completely opposite effects of hypertrophy and lysis. I think it's just a hypothesis at this point.

One more scary thing from the interview was the rare Earth magnet which is sealed but the seal can theoretically break as time passes. No one knows the impact of that event. I hope that the seal is a tried and tested thing in implants and that there is no debate about that.

I don't think anyone could give you a good answer for that. The body can react to damage in varied and unpredictable ways. An example would be skin scarring. Some people are prone to hypertrophic scars (big overgrown scars). Some people are prone to atrophic scars (underdeveloped scars). Often it has nothing to do with the skin cut or how it was stitched. It's just how that person reacts as an individual.

Probably in the cases of combined lysis and hypertrophy you could theoretically find that there is a difference between whether those spots are being differentially loaded by standing or in different contact with the rust itself vs. the metal leaching from the rusted spots. But this would be very hard to verify and no one is going to bother because it doesn't really matter except for curiosity. Either way they need to stop the rust or seal it off so that's what they're doing.

I doubt the magnet is an issue at all. He was just pointing out that sealing something off as a solution works in principle and using that as an example.

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64% with abnormal bone reactions? That's a high number. Would the hypertrophy or lysis show up in an x-ray?

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The best part of interview is cyborg put lipstick and dr. Paley had background of his Institute. LOL . too much hypocrisy

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Paley said that he doesn't want to "downplay" the whole thing etc, but to compare 5months in a wheelchair with going back to using iphone6 is the definition of downplaying imo.

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Paley has an incentive to downplay the precise experience and it’s easy for him to say it’s no big deal as he isn’t the one in a wheelchair for months. He is acting like there isn’t a major difference between stryde and precise when he and other surgeons have been on record multiple times saying how much better stryde is. But now all of a sudden it’s “almost the same”. Paley is obviously at the top of his field but it’s not fair to patients when a doctor downplays just how tough of a recovery experience it will be. There is a significant difference and Paley knows this. But I can understand as he is running and business but at the same time he should be more transparent about the differences and not just say “oh the only difference is that it’s not fully weight bearing” when that is literally what made stryde such a revolutionary device for LL. At least Dr. Assayag is up front with the lack of weight bearing.

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Looks like dr. Assayag and Giotkas (judging from the text on his website) are more optimistic about a swift return.
I was planning to do surgery end of year.

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Quote from: RB on March 16, 2021, 08:08:07 PMPaley has an incentive to downplay the precise experience and it’s easy for him to say it’s no big deal as he isn’t the one in a wheelchair for months.

You may not be able to walk but you're not wheelchair bound.  I used a walker for the duration of my Precice lengthening and consolidation (on femurs), but I had to essentially had to hop around -- both feet on the ground at the same time, or neither of them.

Obviously, being able to walk is better, but moving around with a walker is far better than a wheelchair.

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Quote from: Nestor on March 16, 2021, 04:29:04 PMWould the hypertrophy or lysis show up in an x-ray?

Yeah, x-ray should show it. That's how they were assessing it.

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Thanks maximize. I've just looked again at my last x-ray and the bones are swollen at the points where the corrosion is occurring. I wonder does this go away after the rods are removed or is it permanent?