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Author Topic: Clarifications about the Stryde recall  (Read 6906 times)

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silverlining

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Re: Clarifications about the Stryde recall
« Reply #31 on: March 15, 2021, 04:49:27 AM »

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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FormerKidd

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Re: Clarifications about the Stryde recall
« Reply #32 on: March 15, 2021, 08:57:52 AM »

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.

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.

Thanks 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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BreaktoGrow

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Re: Clarifications about the Stryde recall
« Reply #33 on: March 15, 2021, 02:19:09 PM »

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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silverlining

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Re: Clarifications about the Stryde recall
« Reply #34 on: March 15, 2021, 03:14:45 PM »

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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FormerKidd

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Re: Clarifications about the Stryde recall
« Reply #35 on: March 15, 2021, 04:34:17 PM »

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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PANDA:BEAR..

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Re: Clarifications about the Stryde recall
« Reply #36 on: March 15, 2021, 05:29:30 PM »

Dr Paley... recall of Stryde interview

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maximize

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Re: Clarifications about the Stryde recall
« Reply #37 on: March 15, 2021, 07:13:10 PM »

Dr 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.

2020hope

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Re: Clarifications about the Stryde recall
« Reply #38 on: March 15, 2021, 07:20:35 PM »

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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maximize

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Re: Clarifications about the Stryde recall
« Reply #39 on: March 15, 2021, 07:31:45 PM »

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.

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.

2020hope

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Re: Clarifications about the Stryde recall
« Reply #40 on: March 16, 2021, 09:52:49 AM »

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.

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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maximize

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Re: Clarifications about the Stryde recall
« Reply #41 on: March 16, 2021, 04:07:51 PM »

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.

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.

Nestor

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Re: Clarifications about the Stryde recall
« Reply #42 on: March 16, 2021, 04:29:04 PM »

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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more

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Re: Clarifications about the Stryde recall
« Reply #43 on: March 16, 2021, 04:59:20 PM »

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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Arcon

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Re: Clarifications about the Stryde recall
« Reply #44 on: March 16, 2021, 07:42:45 PM »

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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RB

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Re: Clarifications about the Stryde recall
« Reply #45 on: March 16, 2021, 08:08:07 PM »

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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Femurs with Dr. Betz - March 2021
5'4" > 5'7.5"
Status: Consolidation phase
Diary: http://www.limblengtheningforum.com/index.php?topic=66296.0

DutchGiant

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Re: Clarifications about the Stryde recall
« Reply #46 on: March 16, 2021, 09:06:22 PM »

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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FormerKidd

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Re: Clarifications about the Stryde recall
« Reply #47 on: March 16, 2021, 10:41:44 PM »

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.

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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maximize

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Re: Clarifications about the Stryde recall
« Reply #48 on: March 17, 2021, 01:47:55 AM »

Would the hypertrophy or lysis show up in an x-ray?

Yeah, x-ray should show it. That's how they were assessing it.
« Last Edit: March 17, 2021, 02:26:03 AM by maximize »
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Nestor

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Re: Clarifications about the Stryde recall
« Reply #49 on: March 17, 2021, 12:06:05 PM »

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?
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RealLostSoul

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Re: Clarifications about the Stryde recall
« Reply #50 on: March 17, 2021, 01:10:55 PM »

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.

I am interested in doing precice as well. How much did you lengthen, how much did you weight and when where you able to use crutches?
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maximize

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Re: Clarifications about the Stryde recall
« Reply #51 on: March 17, 2021, 03:04:44 PM »

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?
I would expect it's likely permanent. Once the bones heal that is just the way they are. Sometimes bones can remodel a bit after healing. Like if you fixate a bone with a slight misalignment and there is a jagged point sticking out at either end usually that will smooth over with time. But generally the way it heals is the way it remains.

If Paley is right, as long as you aren't showing obvious lysis or weak points that thickening will do you no harm. He says he believes this hypertrophic bone should be stronger than normal bone.

Serilium

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Re: Clarifications about the Stryde recall
« Reply #52 on: March 17, 2021, 03:12:16 PM »

Definitely not permanent. Bones always remodel.

Remodeling is always going to happen. A hole from corrosion will be filled in. hypertrophy will go back to normal. Lysis will go back to normal.
Active corrosion from the nail is what causes this to occur. Once it is removed, remodeling happens

Email Paley if you don't believe me. Also emailed giotikas and he confirmed, removal causes this to eventually remodel and go away

If it's permanent, what's the point of removal then? You're already screwed for forever? Our bones are amazing. They remodel everything.

It will go back to normal. Bones are amazing.
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Nestor

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Re: Clarifications about the Stryde recall
« Reply #53 on: March 17, 2021, 03:20:22 PM »

Thanks guys. I've just had time to watch the whole thing there. I think at 25 mins Paley mentions that the thickening goes away after a couple of years, hope this is true.

What I don't understand is why the bone is thickening at the corrosion sites. I get why it would thicken at the screw sites due to adapting to stress load but I'm confused as to why it thickens in an area where there is no direct load placed on the bone. It seems like the bone is almost reacting to the rust in the same way a tissue would to inflammation caused by an infection or likes, I hope I'm completely wrong about this.
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Serilium

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Re: Clarifications about the Stryde recall
« Reply #54 on: March 17, 2021, 03:34:32 PM »

It seems like the bone is almost reacting to the rust in the same way a tissue would to inflammation caused by an infection or likes, I hope I'm completely wrong about this.

You're absolutely right. He even said it in the video. I recommend watching the whole video in detail. Paley specifically acknowledges this. He's not hiding anything, and he tells us that this corrosion is directly causing the bone adjacent to react. He concurs everything you said, in the video.
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PANDA:BEAR..

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Re: Clarifications about the Stryde recall
« Reply #55 on: March 17, 2021, 04:53:00 PM »

update ...

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FormerKidd

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Re: Clarifications about the Stryde recall
« Reply #56 on: March 17, 2021, 07:42:00 PM »

I am interested in doing precice as well. How much did you lengthen, how much did you weight and when where you able to use crutches?

My experience was very similar to Purushrottam's.  I do recommend giving his diary a read.
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Nestor

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Re: Clarifications about the Stryde recall
« Reply #57 on: March 18, 2021, 12:32:03 PM »

You're absolutely right. He even said it in the video. I recommend watching the whole video in detail. Paley specifically acknowledges this. He's not hiding anything, and he tells us that this corrosion is directly causing the bone adjacent to react. He concurs everything you said, in the video.

My only worry is that, although Paley says the bones are thicker and stronger, it's the reason why they became thicker that worries me. If the hypertrophy occurred due to load bearing exercise or similar then in all probability the bone will be healthy, if it enlarges due to inflammation caused by corrosion then surely it's reasonable to assume there might be something wrong. I'm just curious if a sample of the bone tissue was examined at a cellular level would it be as healthy as normal bone?
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Serilium

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Re: Clarifications about the Stryde recall
« Reply #58 on: March 18, 2021, 04:43:08 PM »

My only worry is that, although Paley says the bones are thicker and stronger, it's the reason why they became thicker that worries me. If the hypertrophy occurred due to load bearing exercise or similar then in all probability the bone will be healthy, if it enlarges due to inflammation caused by corrosion then surely it's reasonable to assume there might be something wrong. I'm just curious if a sample of the bone tissue was examined at a cellular level would it be as healthy as normal bone?

Yes, it's not ideal obviously and they are going to find a solution to this to prevent corrosion from affecting the bone. It can and has burned holes through the bone so it's not a good thing and hopefully Nuvasive fixed this soon so people can do CLL!
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Nestor

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Re: Clarifications about the Stryde recall
« Reply #59 on: March 18, 2021, 07:35:55 PM »

Yes, it's not ideal obviously and they are going to find a solution to this to prevent corrosion from affecting the bone. It can and has burned holes through the bone so it's not a good thing and hopefully Nuvasive fixed this soon so people can do CLL!

Not ideal, little bit of an understatement ;D If there was some clarification as to whether or not the thickened bone at the corrosion site is normal, healthy bone then I think it would put a lot of people's minds at ease. The only way they could test that though is by taking a sample and analyzing it.
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Jamesy998

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Re: Clarifications about the Stryde recall
« Reply #60 on: March 18, 2021, 08:48:44 PM »

My only worry is that, although Paley says the bones are thicker and stronger, it's the reason why they became thicker that worries me. If the hypertrophy occurred due to load bearing exercise or similar then in all probability the bone will be healthy, if it enlarges due to inflammation caused by corrosion then surely it's reasonable to assume there might be something wrong. I'm just curious if a sample of the bone tissue was examined at a cellular level would it be as healthy as normal bone?

Does the thicker bone not develop in some external patients?
Personally I have seen some thicker bones on LON femur patients using titanium rods which do not corrode as far as I am aware, well they do not corrode as easily anyway.
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LON method | Dr. Halil Buldu | 2021
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Serilium

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Re: Clarifications about the Stryde recall
« Reply #61 on: March 18, 2021, 09:40:22 PM »

Not ideal, little bit of an understatement ;D If there was some clarification as to whether or not the thickened bone at the corrosion site is normal, healthy bone then I think it would put a lot of people's minds at ease. The only way they could test that though is by taking a sample and analyzing it.

They are doing biocompatibility test. If you even watched a second of the Victor and Paley video you would know. Just watch it. It's not long. All your questions are quite literally answered by the video.

And yes, it quite literally burned a goddamn hole in the bone. It's not ideal to have a hole in your bone.
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