Clarifications about the Stryde recall

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Thanks for the response. Another quick question - how long can a Precice patient expect to be using a wheelchair/assistance?

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How do Precise 2 patients get in and out of a vehicle? Since they have to use wheelchair and have to get in a car to go to a physical therapy place.

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Quote from: silverlining on March 15, 2021, 04:49:27 AMHow do Precise 2 patients get in and out of a vehicle? Since they have to use wheelchair and have to get in a car to go to a physical therapy place.

I used Precice 2.2 in my femurs.  The femur rods can handle at least a combined 150lbs (75lbs times 2 legs), so unless you are heavy you can probably stand up on both feet.  As such, you can essentially rotate your feet out of the car, put both on the ground, and stand up, and then use the walker from there.  Similar procedure to get back in.  You can hold onto the car if needed.

Note that the tibia nails have a lower weight bearing capacity, so that might differ.

Quote from: BreaktoGrow on March 14, 2021, 11:58:40 PMThanks for the response. Another quick question - how long can a Precice patient expect to be using a wheelchair/assistance?

I never used my wheelchair, but I did have to use the walker for several months.

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Thanks for the response. How many cm's did you gain and how long was "several months"? How long was it until you could was unassisted?

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Thank @FomerKidd.  I'm planning to do Precise 2 with Dr. Depiparshad this June. Do you have any pro tips for the surgery & recovery? How long did it take you to walk without assistance? How long did it take you to recover to normal walking gait? There aren't as many Precise 2 diaries out there comparing to Stryde. I appreciate your response.

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I forget the exact time, but maybe 5-6 months until I was cleared to walk unassisted.  The rule of thumb they give is that, however long you spend lengthening, you probably need about the same of time to be consolidated.  You cannot walk unassisted until that time.

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Dr Paley... recall of Stryde interview

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Quote from: PANDA:BEAR.. on March 15, 2021, 05:29:30 PMDr Paley... recall of Stryde interview

Thanks for posting. The main point is at 14:30. He says of 122 implants that they followed up in a year on:

- 36% of the bones were totally normal
- 64% total of the bones had abnormal changes

Of those 64% with abnormal bone reactions, it was broken down into:

- 40% had extra bone thickening (hypertrophy)
- 3% bone breakdown (lysis).
- 21% had combination of hypertrophy and lysis.

The issue seems to develop at 6-12 months once the distraction is done. There have been no fractures so far from lysis, but that would be the main threat. He didn't talk about what you'd need to do if you got bad lysis (as none have had it so far that bad), but I presume you might need a permanent nail or grafting if it fractured and wouldn't thicken back up.

Then at ~51 min he talks about two possible solutions NuVasive is working on:

- Coat the junction in polyethylene (plastic)
- Add a sleeve over it to seal it the junction

He guesses if they try to fix the problem (rather than just re-release it) it will most likely happen by 10 months from now and maybe longer.

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Very well summarized maximize!

It also wasn't clear what the actual cause of lysis was, and whether it happens with other nails like Precice as well.

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Quote from: 2020hope on March 15, 2021, 07:20:35 PMVery well summarized maximize!

It also wasn't clear what the actual cause of lysis was, and whether it happens with other nails like Precice as well.

He'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.