Limb Lengthening Forum
Limb Lengthening Surgery => Limb Lengthening Discussions => Topic started by: Erkan on January 27, 2021, 07:49:21 AM
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Hey,
just got an information, that NuVasive doesnt ship any new Stryde Nails, because they do new internal quality control checks.
This is very bad news for anyone, who wants to do the surgery this year because nobody knows how long it will take.
Anyone heard about it yet?
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Who told you they are not shipping any new Stryde nails? Regarding the quality checks are you saying that previously nuvasive did not do internal quality checks?
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Who told you they are not shipping any new Stryde nails? Regarding the quality checks are you saying that previously nuvasive did not do internal quality checks?
Of course I assume that there were quality controls in the first place, but apparently after 10,000 operations a few cases have now emerged that are being investigated
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Of course I assume that there were quality controls in the first place, but apparently after 10,000 operations a few cases have now emerged that are being investigated
I heard the same in November last year. Stryde was put on hold by the NHS in the UK pending some investigations - but the older non-weight bearing precise nail is still available.
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It's probably same reason in India - Dr. Parihar had mentioned some "company audit" for Stryde.
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Does this mean the production of stryde will be put on hold for several months? That is very hard to imagine.
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This is true NuVasive put Stryde nail on hold for quality check .I knew it in October 2020.
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I heard the same in November last year. Stryde was put on hold by the NHS in the UK pending some investigations - but the older non-weight bearing precise nail is still available.
Precice was also on hold. they released precice in November 2020. lets see when they will release Stryde again .
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How long should that take?
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how long was precise 2 on hold?
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well thats fked up. i hope people did not die.
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Details can be found here - note it's a PDF file: https://www.boa.ac.uk/uploads/assets/552dea10-c795-4c9f-b1a08177bf9151c1/NuVasive-MHRA-notice.pdf (https://www.boa.ac.uk/uploads/assets/552dea10-c795-4c9f-b1a08177bf9151c1/NuVasive-MHRA-notice.pdf)
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Is it worldwide or just the UK? Sorry if it's a dumb question after reading the document, I have bad English
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Is it worldwide or just the UK? Sorry if it's a dumb question after reading the document, I have bad English
Well that document only talks about the UK so I don't know. But assuming the exact same product is being marketed everywhere then surely we can expect the same issue to be present regardless of where it is used.
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Why is it that only Styde has been suspended and not precise 2?
Did Stryde have negative effects that Precise 2 did not have?
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Why is it that only Styde has been suspended and not precise 2?
Did Stryde have negative effects that Precise 2 did not have?
They have all been suspended.
It specifically says Stryde patients have had issues of "pain and bony abnormalities" at the site of the telescoping mechanism, but the Brits have other, more general concerns about the whole family of products.
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They have all been suspended.
It specifically says Stryde patients have had issues of "pain and bony abnormalities" at the site of the telescoping mechanism, but the Brits have other, more general concerns about the whole family of products.
its not telescopic only , many cases of screws breaking too.
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I have read many diaries regarding that bony thing regarding stryde. It's like a bone outgrowth or something and Dr. M tells patients to press on it consistently and eventually it subsides. No one knows what it is. Didn't really do anything negative as far as I'm aware of.
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How can they say it is full weight bearing , what does it meaning full weight bearing??
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Giotikas did told me about that bony thing, but said it was nothing to really worry about
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I hope it turns out that Nuvasive is simply doing its due diligence to keep people safe. It would be not nearly as "fun" to learn that there are serious concerns with these intramedullary nails still.
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I have read many diaries regarding that bony thing regarding stryde. It's like a bone outgrowth or something and Dr. M tells patients to press on it consistently and eventually it subsides. No one knows what it is. Didn't really do anything negative as far as I'm aware of.
What diaries had this? And how much do u press
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There are still other nails (or even externals for tibia), but I hope that this problem is solved soon, because there are a lot of people who need this surgery, for cosmetic or medical reasons. Stryde was a great improvement to the procedure.
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Let's hope it gets solved soon
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this is worrying. if the NHS bans stryde nail that is breaking news. was stryde hurried ? is good old external frames the king after all this? how did FDA approve this if there were such major concerns?
can any Paley or dr. Debiparshad patients ask them about this? They have a great relationship with Nuvasive (first and second to implant stryde respectively). They have both been vocal about stryde being the best, so we should know what they have to say.
I like how dr. Rozburch was a little cautious from the beginning to his patients. He said stryde is still new, lets wait awhile before implanting it.
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Before all of this happened Giotikas told me about that bony thing, but said that it has no bad effects: it just happens and they don't know why, so they have to look into it. I'm hopeful it gets solved soon
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Here it is from Nuvasive: https://www.boa.ac.uk/uploads/assets/1b8d2c68-b020-4c0c-bdf4cbb66b23d583/NuVasive-Field-Safety-Notice.pdf
My English is bad, but I think it says Q2 2021 (Quarter two I guess?).
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This is really bad news. So now if someone wants to do an LL surgery and was counting on Stryde, what other options/surgeons are there for a weight bearing nail?
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If it's solved in quarter 2 2021, I think it's better to just wait a few months
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i have enquired with dr. koehne, who is in direct contact with nuvasive. they say it will take till quarter 3, which basically means it could take till quarter 4. so everybody who was planning on doing stryde this year, better put your plans on hold or check alternatives surgery method. this could be the covid-19 of ll.
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If it's solved in quarter 2 2021, I think it's better to just wait a few months
Yes, this is probably a good idea. It just sucks that I was really planning to have the surgery during the pandemic (so before June, July). After the pandemic it will be harder since I will be working.
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I have mine booked for July 7th... First month of airbnb would not be refundable, fk
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I have mine booked for July 7th... First month of airbnb would not be refundable, fk
Have you asked Giotikas if he still offers stryde or if he was asked to send the nails back?
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Lol I texted his secretary and she said this:
"Hello,
Do not worry, we do not anticipate any problems with the supply in July in Greece"
I don't understand anything, they seem like they are not worried at all about the supply.
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I asked for further information and they said this.
"We constantly have stock for the next 2-3 months. Our current stock does not cover July. Based on our information, we confidently anticipate the issue will have been resolved by May 2021.
Kind regards
Anta"
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I have mine booked for July 7th... First month of airbnb would not be refundable, fk
Why not just do precise 2? I mean stryde is way more convenient but might as well
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I think the document says that ALL Precice instruments are under audit. In case I'm wrong... Well, I would wait a few months for Stryde, but if was not possible Stryde this year, I would do Precise in July, yeah
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I asked for further information and they said this.
"We constantly have stock for the next 2-3 months. Our current stock does not cover July. Based on our information, we confidently anticipate the issue will have been resolved by May 2021.
Kind regards
Anta"
Isn't that a bit of a problem though. I would expect a doctor who is responsible to at least stop doing stryde surgeries as long as the stryde nail is being reexamined. I don't know, that pdf document was even saying about carcinogenic.
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The main focus of the document is the bony thing. Giotikas told me about it in our appointment and said that it has no bad effects, the problems is that they don't know the reason and they have to figure it out just in case. The medicine field is like that, they must be careful. So there are not really huge concerns about Stryde being dangerous or anything like that. The issue is that something is happening that they can't explain, and it must be figured out just in case it could cause issues.
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Hey guys,
So I have my surgery booked for March 10th and have been in contact with Dr G’s office today. My surgery is still going ahead as my nails are already in Athens, I just need to do another consult with Dr G for informed consent purposes. I was really worried myself but am a bit more relieved now. Not a good situation at all.
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I understand Paley and others continue to use Stryde and Precise in the US all these months without problems or restrictions, don't they?
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I don't know, I will contact with Paley and Mahboubian as well. Giotikas seems quite confident that all of this will be solved by May... Let's hope
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Weird things.
Lets hope that "bony" thing is safe and the only concern about stryde.
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What happened with Stryde? :(
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This has been known for several months, it isn't clear why it has taken so long to be recalled.
This sounds like it could be an inflammatory reaction to bits coming off the nail.
Precise and stryde are different materials and are used at different stresses so could react quite different in the body
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Does someone have a paper related to that side effect?
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Does someone have a paper related to that side effect?
Here is a diary of one instance of an LLvet on this forum having that side effect. Dr. Mahboubian patient. I read this about 9 months ago and commented. MarkE is the LL person. Bone leakage is how he described it.
XRAYS PIC OF INCIDENT ATTACHED
http://www.limblengtheningforum.com/index.php?topic=64978.msg173454#msg173454
He pressed on it and it slowly dissipated, I think lol. No problems
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which doctor will STOP doing procedures with stryde now? he is the most ethical doctor out there, mark my words!!
Im concerned what dr. Mahboubian would do now since his business is mostly cosmetic leg lengthening. 6 months is a long time without business. dr Kevin has his profitable spine surgery business, dr Paley has his deformity correction business, well pretty much every one has other business.
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I was also planning on having the surgery soon. I’m not too sure if surgeon in America will continue to use the precise products but I will refrain from it at the moment. Seems like there are some serious health risks.
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which doctor will STOP doing procedures with stryde now? he is the most ethical doctor out there, mark my words!!
Im concerned what dr. Mahboubian would do now since his business is mostly cosmetic leg lengthening. 6 months is a long time without business. dr Kevin has his profitable spine surgery business, dr Paley has his deformity correction business, well pretty much every one has other business.
Interesting. Dr. Paley himself has said don't go to a doc who only does CLL. Funny how it comes full circle now.
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Here is a diary of one instance of an LLvet on this forum having that side effect. Dr. Mahboubian patient. I read this about 9 months ago and commented. MarkE is the LL person. Bone leakage is how he described it.
XRAYS PIC OF INCIDENT ATTACHED
http://www.limblengtheningforum.com/index.php?topic=64978.msg173454#msg173454
He pressed on it and it slowly dissipated, I think lol. No problems
I just commented about this on another thread so you can ignore than now. Thanks for linking this! Always providing the best info...
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Man this sucks !! I wanted to have the surgery during the pandemic. Does anyone have any new information about this situation
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The document also mentioned wanting to do more study of "biological endpoints", which means microscopic pieces of the nails are breaking off and they don't know where all of them are going inside the body.
I wonder what it's made of.
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Dr. Giotikas is really confident that the issue will be solved before summer. I'm sending emails to Nuvasive and another doctors in order to know their opinions, but no answer yet
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Dr. Giotikas is really confident that the issue will be solved before summer. I'm sending emails to Nuvasive and another doctors in order to know their opinions, but no answer yet
Giotikas is the biggest LL centre in Europe so he might have some priviledged inside information. The truth is nobody really knows.
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Yeah, that's what I hope. My surgery is in July and I told him twice that my airbnb is not refundable if I don't cancel it right now, and he told me that they "confidently anticipate" that the issue will be solved in May, so no need for cancelation. I want to believe that he is quite sure about it, but of course, I'm really worried lol. I will try to contact nuvasive and other doctors in order to know their estimations
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Nuvasive says the issue will be solved in the second quarter of this year (april, may, june). If that's true I would be quite relieved
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My surgery is in 5 days with Dr. Giotikas.
Not what you wanna see days before your surgery lol
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My surgery is in 5 days with Dr. Giotikas.
Not what you wanna see days before your surgery lol
Don't worry, it's not a mayor problem. In fact I envy you, I'm not even sure I will be able to have Stryde in July¡¡ Congrats man, everything will be perfectly fine
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Yeah, that's what I hope. My surgery is in July and I told him twice that my airbnb is not refundable if I don't cancel it right now, and he told me that they "confidently anticipate" that the issue will be solved in May, so no need for cancelation. I want to believe that he is quite sure about it, but of course, I'm really worried lol. I will try to contact nuvasive and other doctors in order to know their estimations
Yeah he might say that, but to me it seems more like "yeah, come to me so I can take your money, it's safe". But could he commit to have in written form (which would legally bind him) that he is certain that that nail doesn't cause any weird side effects on the body or even cancer? Probably not. The Field safety notice the company has produced is stating even carcinogenic, they wouldn't put that on paper lightly. Just my opinion.
I don't want to bash that doctor specifically, I would say any doctor doing stryde while the investigation is going on would seem irresponsible to me. I came in contact with Dr. Donghoon Lee few days ago, and he had retired the stryde nails, as an example. That doctor I would trust 10x more.
In fact for you it might be ok, since your surgery is in July and they might have already cleared this out by then. But how many others will have done the procedure until then?
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Yeah he might say that, but to me it seems more like "yeah, come to me so I can take your money, it's safe". But could he commit to have in written form (which would legally bind him) that he is certain that that nail doesn't cause any weird side effects on the body or even cancer? Probably not. The Field safety notice the company has produced is stating even carcinogenic, they wouldn't put that on paper lightly. Just my opinion.
I don't want to bash that doctor specifically, I would say any doctor doing stryde while the investigation is going on would seem irresponsible to me. I came in contact with Dr. Donghoon Lee few days ago, and he had retired the stryde nails, as an example. That doctor I would trust 10x more.
In fact for you it might be ok, since your surgery is in July and they might have already cleared this out by then. But how many others will have done the procedure until then?
I thing you are wrong...All top doctors in the US and Europe have kept using Stryde nails all these months even in non-cosmetic cases. I don't think that they would do that if they had serious concerns.
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What he told me during our appointment is that the "bony" thing has happened in some cases. However, regarding cancer, it's not that it has happened: it's that there have not been enough tests in order to clinically assure the nail's safety. So I think people are blowing things out of proportions. Of course it is concerning, but it's not like people have been getting cancer or anything. It's that they must pass some safety tests that they didn't pass before. Anyway, to be honest and I may seem dumb, I have been suffering from severe height dysphoria for 4 years, in which I almost have not left my house. At this point, I'm willing to take any risks so... my only true concern is getting the surgery in July and getting my life back. I'm terrified about having to postpone lol
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Regarding his honesty as a doctor... of course you never know. But he did told me about these abnormalities BEFORE all of this happened, so I think that's a good sign
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By the way, Nuvasive told me this:
In response to your email below, I will attempt to answer your questions as best as possible. You are correct in both the following ways:
The document you read, titled Precice Field Safety Notice, states, “The generation of evidence, to bridge the current gaps are ongoing with expected completion in Q2 2021 for all NSO devices.”
It is not possible for NSO to 100% guarantee this timeline.
However, completion in the second quarter of 2021 is what our internal team is anticipating.
Whether or not to maintain the arrangements and accommodations you have made in preparation for your July surgery, that is a question best answered by yourself and Dr. Giotikas
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Yeah he might say that, but to me it seems more like "yeah, come to me so I can take your money, it's safe". But could he commit to have in written form (which would legally bind him) that he is certain that that nail doesn't cause any weird side effects on the body or even cancer? Probably not. The Field safety notice the company has produced is stating even carcinogenic, they wouldn't put that on paper lightly. Just my opinion.
I don't want to bash that doctor specifically, I would say any doctor doing stryde while the investigation is going on would seem irresponsible to me. I came in contact with Dr. Donghoon Lee few days ago, and he had retired the stryde nails, as an example. That doctor I would trust 10x more.
I think this is a very good take on the situation. It makes sense that they suspended it for a reason, a corporation wants to make money, and the fact that they voluntarily suspended a whole family of products must mean there is at least some type of serious risk. If it was "no big deal", I don't believe they would take such drastic actions. MHRA report said "Unknown long-term biological safety profile", so I don't believe this is just stupid empty action.
Do you know specifically why Dr. Donghoon retired the STRYDE nail? Did he find problems himself or is it because of the report?
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I don't think there are serious risks as 99% of doctors are going on with the surgeries
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I don't think there are serious risks as 99% of doctors are going on with the surgeries
I agree.
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I think this is a very good take on the situation. It makes sense that they suspended it for a reason, a corporation wants to make money, and the fact that they voluntarily suspended a whole family of products must mean there is at least some type of serious risk. If it was "no big deal", I don't believe they would take such drastic actions. MHRA report said "Unknown long-term biological safety profile", so I don't believe this is just stupid empty action.
Do you know specifically why Dr. Donghoon retired the STRYDE nail? Did he find problems himself or is it because of the report?
Seconding this. Why did Dr. Lee do this? That seems very telling..
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I went to my pre-op today, my surgery was supposed to be in two days but Dr. Giotikas cancelled it because NuVasive are recalling all nails as of today.
Honestly I'm devastated. All my plans are ruined and I spent a lot of money to get to Greece and prepare everything. I even met someone on this forum and we are sharing an apartment together, he already had his surgery 3 weeks ago so it's ruined it for both of us.
I just can't believe I came this far and now I can't do it until the summer. And I'll potentially have to do it alone rather than doing it with someone. Ah I'm just so upset.
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I went to my pre-op today, my surgery was supposed to be in two days but Dr. Giotikas cancelled it because NuVasive are recalling all nails as of today.
Honestly I'm devastated. All my plans are ruined and I spent a lot of money to get to Greece and prepare everything. I even met someone on this forum and we are sharing an apartment together, he already had his surgery 3 weeks ago so it's ruined it for both of us.
I just can't believe I came this far and now I can't do it until the summer. And I'll potentially have to do it alone rather than doing it with someone. Ah I'm just so upset.
Didn't Giotikas have stock nails as he said?
I really hope there is not something really dangerous going on with that nail that led doctors to stop using it asap and in a few days things will get back to normal.
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I went to my pre-op today, my surgery was supposed to be in two days but Dr. Giotikas cancelled it because NuVasive are recalling all nails as of today.
Honestly I'm devastated. All my plans are ruined and I spent a lot of money to get to Greece and prepare everything. I even met someone on this forum and we are sharing an apartment together, he already had his surgery 3 weeks ago so it's ruined it for both of us.
I just can't believe I came this far and now I can't do it until the summer. And I'll potentially have to do it alone rather than doing it with someone. Ah I'm just so upset.
WOW dude. I am so sorry that happened to you man. That f**king sucks. Words cannot describe how angry I am at what happened to you.
I'm sorry dude.
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Didn't Giotikas have stock nails as he said?
I really hope there is not something really dangerous going on with that nail that led doctors to stop using it asap and in a few days things will get back to normal.
Giotikas told me that he has stock for like 3 months, and that all doctors (Paley, etc) were going on with their surgeries too. However, it seems that Nuvasive recalled all devices today... That sucks, you can't cancel somebody's surgery like that, lots of money and planning involved. He does say that the issue will be solved before summer, and that his sources in Nuvasive say that around May, but of course, how could you not be worried after a cancelation like this?
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Didn't Giotikas have stock nails as he said?
I really hope there is not something really dangerous going on with that nail that led doctors to stop using it asap and in a few days things will get back to normal.
He does have stock, and we even had a call on Saturday discussing the problems and if I wanted to go ahead anyway. He said the problems with the nail aren't serious at all and agreed that I should go ahead with it. But today Nuvasive has officially recalled the nails, so he can't even use the ones he has in stock
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WOW dude. I am so sorry that happened to you man. That f**king sucks. Words cannot describe how angry I am at what happened to you.
I'm sorry dude.
Thanks man. I'm devastated. I planned so much and now I have to fly back to my country. I just can't believe it
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Giotikas told me that he has stock for like 3 months, and that all doctors (Paley, etc) were going on with their surgeries too. However, it seems that Nuvasive recalled all devices today... That sucks, you can't cancel somebody's surgery like that, lots of money and planning involved. He does say that the issue will be solved before summer, and that his sources in Nuvasive say that around May, but of course, how could you not be worried after a cancelation like this?
I wasn't too worried about the problems because they aren't serious. Dr. Giotikas said the company cares about their image, and their stock price, so they decided to take no chances and just recall all the nails
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I went to my pre-op today, my surgery was supposed to be in two days but Dr. Giotikas cancelled it because NuVasive are recalling all nails as of today.
Honestly I'm devastated. All my plans are ruined and I spent a lot of money to get to Greece and prepare everything. I even met someone on this forum and we are sharing an apartment together, he already had his surgery 3 weeks ago so it's ruined it for both of us.
I just can't believe I came this far and now I can't do it until the summer. And I'll potentially have to do it alone rather than doing it with someone. Ah I'm just so upset.
Hi, thanks a lot for the update, and I think it really sucks what happened. I honestly hope the whole thing is solved quickly, but let's see. This has also changed my plans, but better safe and do it a bit later than sorry.
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I contacted Debiparshad and his office said this: There are no confirmed biological safety issues with these products.
Release was issued in UK and Ireland for a. Gaps in material testing b. Lack of testing in pediatric use. Their MRA like our FDA - requested more testing. The company is trying to resolve that issue. We have not had a recall here in the States. We have continued to do the leg lengthening procedure.
I can check on the precice 2 nail. You would have to stay here the whole duration of the distraction using that nail.
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This is madness. I have My Surgery scheduled for next week with Köhne. Gonna find out tmr if we can go through with it I guess.
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This is madness. I have My Surgery scheduled for next week with Köhne. Gonna find out tmr if we can go through with it I guess.
It seems like we Europeans will have to wait until summer..
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I went to my pre-op today, my surgery was supposed to be in two days but Dr. Giotikas cancelled it because NuVasive are recalling all nails as of today.
Honestly I'm devastated. All my plans are ruined and I spent a lot of money to get to Greece and prepare everything. I even met someone on this forum and we are sharing an apartment together, he already had his surgery 3 weeks ago so it's ruined it for both of us.
I just can't believe I came this far and now I can't do it until the summer. And I'll potentially have to do it alone rather than doing it with someone. Ah I'm just so upset.
That's horrible man. Really fked up, especially since you had already flown into Greece. I had a call with Giotikas yesterday and we decided to go ahead but now that Nuvasive has recalled all nails, I assume I will get notice that my surgery in March has been cancelled too.
Does anyone know if the US doctors will continue to be able to use stryde? I assume Nuvasive will recall nails globally.
Are there any other alternatives to stryde at the moment that are good options? I had planned my entire life/job around doing surgery in March and now I'm screwed.
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I have just gotten a reply from Koehne regarding My Surgery next week. Its cancleed and according to him nuvasive will widraw the nails globally. I’ll be honest here, this is absolutely crushing. As a person of short stature your used to experiencing a lot of speedbumbs and things being out of your line of control, but this takes it to a another level. I’m very disappointed to say the least. Nuvasive did say the nail might be ready by may/ June, but I’ll take that with a grain of salt as of right now.
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I have just gotten a reply from Koehne regarding My Surgery next week. Its cancleed and according to him nuvasive will widraw the nails globally. I’ll be honest here, this is absolutely crushing. As a person of short stature your used to experiencing a lot of speedbumbs and things being out of your line of control, but this takes it to a another level. I’m very disappointed to say the least. Nuvasive did say the nail might be ready by may/ June, but I’ll take that with a grain of salt as of right now.
Damn sorry to hear man.
I contacted Dr Mahboubian and they said they are waiting to hear an update from Nuvasive's internal audit and will hear from them next week but I am unsure of what this means for future use of the nail over the next few weeks.
This is devastating, it just seems like its setback after setback. I am really unsure of what to do.
The May / June timeline is probably best case scenario. It could even be July / August till stryde is available again.
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It seems Nuvasive is telling all doctors the issue will be solved by May/June, but it seems hard to trust them after this. My surgery is for July 7. I think I will try to move it to late July, also changing the dates for my Airbnb, I think that way I will have more margin... The thing is, worst case scenario, does anyone know if Precice 2 is available?
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To the guys who want to do it with Giotikas this summer... If you want to you can PM and I will give my Whatsapp number so we can share information. This is such a mess
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It seems Nuvasive is telling all doctors the issue will be solved by May/June, but it seems hard to trust them after this. My surgery is for July 7. I think I will try to move it to late July, also changing the dates for my Airbnb, I think that way I will have more margin... The thing is, worst case scenario, does anyone know if Precice 2 is available?
Precise-2 isn't available either. The whole Precise family has been recalled. Dr. Giotikas offered me to do external tibias but I just don't want to do that
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Precise-2 isn't available either. The whole Precise family has been recalled. Dr. Giotikas offered me to do external tibias but I just don't want to do that
Oh f**k. Then I really do expect their timelines are true and this doesn't take longer than summer. I can wait until september at worst...
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This is good and bad, but above all safety is the number #1 priority.
I’ll text Chris Yunker tomorrow afternoon and see if he has any updates or possible timeline.
For the meantime, let’s pray it’s just as simple as Dr. G informed.
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I wrote to him and he said that they can't guarantee anything. but they are expecting it to be solved during quarter 2
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This is terrifying. I haven't had any of the bony issues mentioned but the idea of microscopic pieces of the nails breaking off and potentially causing cancer scares the sh*t out of me! I have no idea when I'll be able to get the nails removed yet due to covid. How can a company that big be allowed to sell medical devices that haven't been fully tested? I'm really stressing out after reading all of this, I hope me and others dont end up as some horror report of cases gone wrong
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This is terrifying. I haven't had any of the bony issues mentioned but the idea of microscopic pieces of the nails breaking off and potentially causing cancer scares the sh*t out of me! I have no idea when I'll be able to get the nails removed yet due to covid. How can a company that big be allowed to sell medical devices that haven't been fully tested? I'm really stressing out after reading all of this, I hope me and others dont end up as some horror report of cases gone wrong
I hear ya bro. even though the contents of that NHS letter are grim sounding nuvasive is like "ok dont worry, be good in 3 months". How the hell are they gonna prove in 3 months that it does NOT cause cancer or that weird bone thing is no big deal?
we gotta wait for the NHS to approve this nail again. UK has got one thing right the NHS, God bless it. they really care for their country citizens and I hope they will thouroughly scrutinize nuvasive before unbannin the nail.
nuvasive is the best nail company so far, but I wouldnt take a corporate's word as the truth. big pharma will do anything to make big bucks.
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Another doctor has just told me that Nuvasive will meet with the FDA next week, and that will determine if Stryde is allowed to be used during this months in the States. He also states that is realistic to expect this to be solved by summer and, in the worst case, to have at least Precice 2. I think that this meeting with the FDA will be really telling.
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I thought Stryde was already FDA approved?
This is all just really confusing at the moment. Like las vegas said how are they going to prove or disprove anything in the space of just a few months, especially in terms of device toxicity. Really hope this was something that was blown out of proportion but its worrying that these questions are even being raised at all. This isn't like some consumer product with a flaw that gets taken off the shelves, peoples lives could be at risk.
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You can be FDA approved and then have that approval revoked. Happens all the time. ISKD was an FDA approved nail that kept lengthening and was not accurate in distraction.
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I had a consultation with Mahoubian a few days ago. He says that he definitely does not believe that the Stryde nail could be chipping off and causing cancer. He mentioned that he is waiting to hear back from the FDA - and should in two weeks. He has halted all new Stryde patients until then.
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Just a question here: how much worse of an alternative is betzbone v2?
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Betzbone break allot
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What about fitbone? Some doctors are considering it
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What about fitbone? Some doctors are considering it
Eh it’s kinda stupid tbh, everyone needs to just calm down and wait. I’m sure within 3-6 months max stryde will be back. If not they will develop something else before the year ends I’m sure. I’ll be fkdd if I’m expected to pay the same price as stryde for a crappier product, betz/fit bone is trash compared to stryde, they’re not terrible but definitely not worth the same price
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One of Paley's papers about the development of stryde states that they avoided a cobalt chrome based due to the potential for toxicity.
Stryde is stainless steel, precise titanium which are used in lots of implants but I don't know if the lengthening mechanism is different between the two nails and their components. If it is different then hopefully the issue won't be across both nails.
Most components should have gone through toxicity testing, I would imagine the tests will be looking at what forces release what quantities of components which should be fairly quick to perform to see if they reach potential toxic levels
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One of Paley's papers about the development of stryde states that they avoided a cobalt chrome based due to the potential for toxicity.
Stryde is stainless steel, precise titanium which are used in lots of implants but I don't know if the lengthening mechanism is different between the two nails and their components. If it is different then hopefully the issue won't be across both nails.
Most components should have gone through toxicity testing, I would imagine the tests will be looking at what forces release what quantities of components which should be fairly quick to perform to see if they reach potential toxic levels
Awesome post, really appreciate your insight.
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Eh it’s kinda stupid tbh, everyone needs to just calm down and wait. I’m sure within 3-6 months max stryde will be back. If not they will develop something else before the year ends I’m sure. I’ll be fkdd if I’m expected to pay the same price as stryde for a crappier product, betz/fit bone is trash compared to stryde, they’re not terrible but definitely not worth the same price
I'm not so sure to be honest.
They will test the toxicity of the product (which they are testing as they obviously had certain allegations, patients having adverse issues with them otherwise they wouldn't have recalled their devices), but what about the weird callus formation, which if I'm not mistaken is formed around the telescopic area of the stryde nail? I don't think that them saying "it's no biggie" would be good enough. And I don't think then that them changing their product so that it doesn't form the weird callus only takes 3-4 months. They would probably have to redesign quite some stuff.
Just my opinion/assumptions.
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If everything goes well, they are not going to modify anything. They just will run test to "prove" there are not biological risks involved.
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What about fitbone? Some doctors are considering it
Fitbone has alot of problems. I don't know what problems, but it has alot
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Fitbone has alot of problems. I don't know what problems, but it has alot
It is very unreliable as too many stopped working and needed a new surgery to put a new one in.
Also it has almost zero weight bearing capabilities which means that even standing is almost impossible.
It ia a very bad nail, I wouldn't use it no matter what.
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It is very unreliable as too many stopped working and needed a new surgery to put a new one in.
Also it has almost zero weight bearing capabilities which means that even standing is almost impossible.
It ia a very bad nail, I wouldn't use it no matter what.
Thanks for the info, I really did not know much about Fitbone. I expect Stryde to be available in summer, but I just wanted to know about other options. Worst case scenario, Precice 2 then
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In case anyone wants to know how much other nails s*cks :
https://youtu.be/asqHiqNgVwI
Regards
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Is anyone familiar with the Lot numbers, Serial numbers, or date-of-production for the series of Stryde nails which are in question? This is definitely not good news. Thanks to anyone who may respond to this question, much appreciation.
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Anyone who seriously considers anything less than Precise 2 is asking for a world of pain and complications.
Just wait. The sun will still shine tomorrow. They will become approved again in no time.
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Is anyone familiar with the Lot numbers, Serial numbers, or date-of-production for the series of Stryde nails which are in question? This is definitely not good news. Thanks to anyone who may respond to this question, much appreciation.
This is for everything in existence. They recalled pretty must everything in Europe thus far.
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I'm not so sure to be honest.
They will test the toxicity of the product (which they are testing as they obviously had certain allegations, patients having adverse issues with them otherwise they wouldn't have recalled their devices), but what about the weird callus formation, which if I'm not mistaken is formed around the telescopic area of the stryde nail? I don't think that them saying "it's no biggie" would be good enough. And I don't think then that them changing their product so that it doesn't form the weird callus only takes 3-4 months. They would probably have to redesign quite some stuff.
Just my opinion/assumptions.
But within a year I think for sure it will be resolved worst case scenario if it is really that bad
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are you sure the precice is still available?
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I contacted nuvasive and they said the precice is not available
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No, all Precice products were recalled in Europe.
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I can only agree with Giotikas2021 here. This seems absolutely terrible. I have had it all planned for July as well. I really hope this doesn‘t terminate everything. I wouldn‘t want to take it anymore longer honestly because It‘s really unpleasant to live with the neurological effects of this mental illness. I have had this since kindergarden and life is worse than ever. I won‘t be able to leave my house anymore too, especially after lockdown.. I can only pray that quarantine goes on forever which isn‘t realistic since it‘s gonna be over in may or june when we are all vaccined here (more or less at least).
E:/ plus having to do it later would fk my university schedules so hard. It‘s close to impossible then without cancelling which I never ever want to do.
But then, imagine you do the surgery just to get cancer in the end... fk that has to be just an assumption by health services right? I can‘t imagine this actually being true, it would be terrible, just think about all the people that have already done it! fk life man makes me wondering if maybe it‘s just better to kill myself honestly, then I won‘t have to think about this crap anymore anyways...
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I can only agree with Giotikas2021 here. This seems absolutely terrible. I have had it all planned for July as well. I really hope this doesn‘t terminate everything. I wouldn‘t want to take it anymore longer honestly because It‘s really unpleasant to live with the neurological effects of this mental illness. I have had this since kindergarden and life is worse than ever. I won‘t be able to leave my house anymore too, especially after lockdown.. I can only pray that quarantine goes on forever which isn‘t realistic since it‘s gonna be over in may or june when we are all vaccined here (more or less at least).
E:/ plus having to do it later would fk my university schedules so hard. It‘s close to impossible then without cancelling which I never ever want to do.
But then, imagine you do the surgery just to get cancer in the end... fk that has to be just an assumption by health services right? I can‘t imagine this actually being true, it would be terrible, just think about all the people that have already done it! fk life man makes me wondering if maybe it‘s just better to kill myself honestly, then I won‘t have to think about this crap anymore anyways...
You should honestly do LL, then really get some help with a cognitive behavioral therapy. There's some trauma in here that goes beyond height that the surgery won't fix, I can tell.
And no one's getting cancer... At least Not in the way you're thinking about it.
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Giotikas right now
Following the recent, temporary, global recall of all Precise/Stryde family products by the manufacturer,
We announce:
All surgeries with Stryde nail, scheduled for anytime sooner than 18th August 2021, are postponed until further notice.
Precise-2 nail is expected to be available for clinical use again in our Centre in the second half of March 2021. The first available date for surgery with Precise-2 nail in our centre is the 23rd March 2021. The longer track of satisfactory clinical performance of Precise-2 since 2012 allowed for this early resolution of the matter for the Precise-2.
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Giotikas right now
Following the recent, temporary, global recall of all Precise/Stryde family products by the manufacturer,
We announce:
All surgeries with Stryde nail, scheduled for anytime sooner than 18th August 2021, are postponed until further notice.
Precise-2 nail is expected to be available for clinical use again in our Centre in the second half of March 2021. The first available date for surgery with Precise-2 nail in our centre is the 23rd March 2021. The longer track of satisfactory clinical performance of Precise-2 since 2012 allowed for this early resolution of the matter for the Precise-2.
Great news! I got this in my email too: https://www.athensbjr.com/announcement-about-stryde-and-precise-nails-availability/ (https://www.athensbjr.com/announcement-about-stryde-and-precise-nails-availability/)
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Great news! I got this in my email too: https://www.athensbjr.com/announcement-about-stryde-and-precise-nails-availability/ (https://www.athensbjr.com/announcement-about-stryde-and-precise-nails-availability/)
Well, it depends on accuracy... it says Precice 2 will be ready in March, but nothing sure about Stryde. If it is available in late August great, but it does not confirm anything.... My surgery was booked for July 7th, changing it means losing 1000 euros. If I change it to August and Stryde is still not available what happens? More money lost? Lol. I hope he gives me more info about those timelines
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Great news! I got this in my email too: https://www.athensbjr.com/announcement-about-stryde-and-precise-nails-availability/ (https://www.athensbjr.com/announcement-about-stryde-and-precise-nails-availability/)
thank you for pasting that link! It is a bit CONCERNING to read that. it says people who have nails and have aches and pains should consult Dr. Giotakis. It says people who have nails since 14 months should get it removed asap.
something is not right here. Stryde is probably not comin back anytime soon (and probably shouldnt with all these concerns).
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Assayag says that the last report from Nuvasive says July, but of course, they can't guarantee it 100%
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Alright!
So here is the news.
Further biocompatibility testing is needed for all of NuVasive's stainless steel implants, including STRYDE.
Until further notice (Nuvasive quotes July, possibly later) Stryde nail is completely unavailable and all inventory needs to be returned. IN the past few months we were still allowed to use our inventory ,however we are not allowed to implant any further STRYDE at this time.
We thankfully can continue using PRECICE titanium implants , which have a 10 year track record of success and accuracy. We are also continuing lengthening over nails (LON) Lengthening and then Nailing (LATN) and circular fixator lengthenings
On the bright side, a lot of people are still going forward with PRECICE lengthenings which represent a considerable cost saving.
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Alright!
So here is the news.
Further biocompatibility testing is needed for all of NuVasive's stainless steel implants, including STRYDE.
Until further notice (Nuvasive quotes July, possibly later) Stryde nail is completely unavailable and all inventory needs to be returned. IN the past few months we were still allowed to use our inventory ,however we are not allowed to implant any further STRYDE at this time.
We thankfully can continue using PRECICE titanium implants , which have a 10 year track record of success and accuracy. We are also continuing lengthening over nails (LON) Lengthening and then Nailing (LATN) and circular fixator lengthenings
On the bright side, a lot of people are still going forward with PRECICE lengthenings which represent a considerable cost saving.
Thanks for the news, you definitely are one of doctors who are more involved with patients. Many of us just want to have some certainty and information in order to make a choice about our treatment, so thank you again for the information you provided.
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The British NHS... has found problems regarding the Stryde nail. what is puzzling that the American FDA.. did not do the correct checks.. let's see what happens.. as the NHS.. will make sure patients safety.. comes 1st
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The issue is that they said may/june, now july.... It's hard to trust. I could wait for Stryde until September, but this makes me consider taking Precice 2 in July
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Hey guys, I got new from Paley and he says that talking about cancer is nonsense, that all of this is due to corrosion at the junction of telescopic ends and it can cause an extra thickening of the bone. He said it happens in half or more of the cases, but he is not concerned because it goes away when removing the rods and it does not cause any serious issues.
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Hey guys, I got new from Paley and he says that talking about cancer is nonsense, that all of this is due to corrosion at the junction of telescopic ends and it can cause an extra thickening of the bone. He said it happens in half or more of the cases, but he is not concerned because it goes away when removing the rods and it does not cause any serious issues.
Let's wait and see what the FDA or NHS will say, not Paley who has an obvious incentive for it to get back in the market.
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Hey guys, I got new from Paley and he says that talking about cancer is nonsense, that all of this is due to corrosion at the junction of telescopic ends and it can cause an extra thickening of the bone. He said it happens in half or more of the cases, but he is not concerned because it goes away when removing the rods and it does not cause any serious issues.
Similarly to LON, is it possible to keep the stryde nail or is it mandatory to remove it?
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You should remove it, but you can keep it in if you want. I don't know why you would want to besides not wanting to pay the removal surgery fee. Especially with this whole "unproved biological safety profile" controversy going on now with nuvasive nails.
The timing is not very important, which allows some freedom to choose when to remove it. some people get their nails removed in a year, some in 5 years. Sooner (given full consolidation) is obviously better, as there's just less chance of material going into your body, but it's not like if you don't remove within 2 years you'll get metal poisining or something. It's just over time, material may get absorbed into your body which is no bueno
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You should remove it, but you can keep it in if you want. I don't know why you would want to besides not wanting to pay the removal surgery fee. Especially with this whole "unproved biological safety profile" controversy going on now with nuvasive nails.
The timing is not very important, which allows some freedom to choose when to remove it. some people get their nails removed in a year, some in 5 years. Sooner (given full consolidation) is obviously better, as there's just less chance of material going into your body, but it's not like if you don't remove within 2 years you'll get metal poisining or something. It's just over time, material may get absorbed into your body which is no bueno
Im planning to keep it. Simple titanium rod that many people live with all their lives. I honestly don't mind it and I would also be saving myself from another surgery.
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Yeah, there's a guy on here called Sweden who has his nails in for like 7 or 8 years already with no plans to remove it and he's doing fine apparently. I would probably just take a heavy metal blood test some years down the line in your life to see if the metals are leaking or if it's fine. Otherwise it's whatever and you should be okay (although I would definitely remove it if I had LL and advocate everyone to remove)
Keep in mind the surgery for removal is far easier than the insertion one, it's outpatient (usually) and people get back to full recovery within a week or two. And you might be a little lighter and swifter on your legs after removal ;) reasons to remove
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I see you haven’t mentally recovered from the pain caused by the surgery yet. Hang in there it’s almost done!!!
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There are many reasons to get rid of them. Not mandatory very soon, but plan to do it.
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The most important reasons to remove your internal rods.
1) If you get into an accident and damage your femurs, the rods can break and toxic fluids can spill into your body.
2) Accident again, but the orthopedic surgeon does not do CLL and will create a great obstacle in the emergency surgery.
3) You cannot get an MRI scan because of the magnetic properties.
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The most important reasons to remove your internal rods.
1) If you get into an accident and damage your femurs, the rods can break and toxic fluids can spill into your body.
2) Accident again, but the orthopedic surgeon does not do CLL and will create a great obstacle in the emergency surgery.
3) You cannot get an MRI scan because of the magnetic properties.
Titanium is a paramagnetic material that is not affected by the magnetic field of MRI. The risk of implant-based complications is very low, and MRI can be safely used in patients with implants and the rods in my legs are indeed titanium.
2. I have a relative with rods after an accident and I can assure you it has never been a problem.
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Im planning to keep it. Simple titanium rod that many people live with all their lives. I honestly don't mind it and I would also be saving myself from another surgery.
Stryde is stainless steel, not titanium.
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Stryde is stainless steel, not titanium.
Jamesy998 is not doing Stryde.
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The titanium part is MRI compatible. Precise 2 is not MRI compatible
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What are the cons of using Precise 2 instead of Stryde? What y‘all think?
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What are the cons of using Precise 2 instead of Stryde? What y‘all think?
You won't walk until consolidation, it may take time
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You won't walk until consolidation, it may take time
Wheelchair or just crutches? And how long do you think does it take after the end of lengthening phase?
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Wheelchair or just crutches? And how long do you think does it take after the end of lengthening phase?
It depends also on the nail size... About time, at least two months post lenghtening as far as I know
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@RealDamagedLostSoul:
Not sure what the WB recommendations are for Precise 2.2 these days. This was my own experience in 2014 with Precise 2.0 at 22 years old...
1) Was 147 lbs (66/67 Kg) on operation day and went down to 129 lbs (58.5 Kg) over the course on lengthening.
2) From 3 days post-op, I never used a wheelchair again, walking everywhere with a walker.
3) I lengthened 6 Cm and switched from walker to one crutch at about 5 months, and full weight-bearing at 5.5 months.
4) At around the 7-month mark I was routinely walking long distances with a pretty normal gait.
5) By 8/9 months I had pretty much forgotten that I had ever done LL, even though my high-level athletism wasn't back to normal, daily functions were back to 100%.
I hear that 2.2 is stronger than 2.0 because they worked out a lot of the problems with the design. However, if a lot of P2's have broken they may have modified weight-bearing restrictions. Remember under 75 lbs per leg can easily be achieved if you are really conscious about shifting weight onto walker or crutches. I probably could have used crutches earlier, but I chose to use walker because of balance and to mitigate the risk of falling. I also started driving about 3.5 months post-op, and because I was well under 150 lbs after atrophy, I could stand up on my 2 feet and pump gas, transfer in and out of car, and perform basic functions like that.
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@RealDamagedLostSoul:
Not sure what the WB recommendations are for Precise 2.2 these days. This was my own experience in 2014 with Precise 2.0 at 22 years old...
1) Was 147 lbs (66/67 Kg) on operation day and went down to 129 lbs (58.5 Kg) over the course on lengthening.
2) From 3 days post-op, I never used a wheelchair again, walking everywhere with a walker.
3) I lengthened 6 Cm and switched from walker to one crutch at about 5 months, and full weight-bearing at 5.5 months.
4) At around the 7-month mark I was routinely walking long distances with a pretty normal gait.
5) By 8/9 months I had pretty much forgotten that I had ever done LL, even though my high-level athletism wasn't back to normal, daily functions were back to 100%.
I hear that 2.2 is stronger than 2.0 because they worked out a lot of the problems with the design. However, if a lot of P2's have broken they may have modified weight-bearing restrictions. Remember under 75 lbs per leg can easily be achieved if you are really conscious about shifting weight onto walker or crutches. I probably could have used crutches earlier, but I chose to use walker because of balance and to mitigate the risk of falling. I also started driving about 3.5 months post-op, and because I was well under 150 lbs after atrophy, I could stand up on my 2 feet and pump gas, transfer in and out of car, and perform basic functions like that.
Do you think that using crutches for the entire distraction phase with precise is possible?
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Do you think that using crutches for the entire distraction phase with precise is possible?
You have to ask your surgeon. Not sure what the restrictions are these days. I was one of the first people ever to use precise 2. I am sure there has been a lot of trial and error since then.
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Crutches is not a good idea because you are still weightbearing significantly. I mean it should be comparable, but a walker is also not a good idea. Any amount of standing will be pressure towards the fragile small precice nail. Non weightbearing nail is just no bueno to even stand. Sure you can do it but do it over and over again and you might risk bad things. The best thing is a wheelchair, unfortunately. Sadly stryde is just levels above the precice nail so it really sucks that they took it off the market.
I have my suspicions that Stryde will return very soon after determining that it's safe. Sooner then you would expect. I feel bad for everyone who planned on Stryde... It Is so sad. But I believe nuvasive lobbyists will get this back on the market asap
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MARKE credits (https://i.ibb.co/TKZkgwr/BE61-C746-7-B2-F-485-F-BF27-FB2-E4741-E730.jpg)
MARKE credits
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I'm not sure about timelines man. Paley says there is corrosion in the telescopic ends, causing thicker bone. It does not cause issues, but they are freaked out because that should not be happening. They say July now, but 20 days ago they said may/june... I can wait to september but man, it's hard to trust
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The most important reasons to remove your internal rods.
1) If you get into an accident and damage your femurs, the rods can break and toxic fluids can spill into your body.
2) Accident again, but the orthopedic surgeon does not do CLL and will create a great obstacle in the emergency surgery.
3) You cannot get an MRI scan because of the magnetic properties.
These are the points
Crutches is not a good idea because you are still weightbearing significantly. I mean it should be comparable, but a walker is also not a good idea. Any amount of standing will be pressure towards the fragile small precice nail. Non weightbearing nail is just no bueno to even stand. Sure you can do it but do it over and over again and you might risk bad things. The best thing is a wheelchair, unfortunately. Sadly stryde is just levels above the precice nail so it really sucks that they took it off the market.
I have my suspicions that Stryde will return very soon after determining that it's safe. Sooner then you would expect. I feel bad for everyone who planned on Stryde... It Is so sad. But I believe nuvasive lobbyists will get this back on the market asap
It's really up to which nail size you fit and which and your weight, even the nail lenght is quite important. Every case is different.
Titanium is a paramagnetic material that is not affected by the magnetic field of MRI. The risk of implant-based complications is very low, and MRI can be safely used in patients with implants and the rods in my legs are indeed titanium.
2. I have a relative with rods after an accident and I can assure you it has never been a problem.
That's true titanium is not ferromagnetic but precice 2 is not fully titanium, Nuvasive expressly forbids any MRI exam for any patient with both precice 2 and stryde implants.
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@RealDamagedLostSoul:
Not sure what the WB recommendations are for Precise 2.2 these days. This was my own experience in 2014 with Precise 2.0 at 22 years old...
1) Was 147 lbs (66/67 Kg) on operation day and went down to 129 lbs (58.5 Kg) over the course on lengthening.
2) From 3 days post-op, I never used a wheelchair again, walking everywhere with a walker.
3) I lengthened 6 Cm and switched from walker to one crutch at about 5 months, and full weight-bearing at 5.5 months.
4) At around the 7-month mark I was routinely walking long distances with a pretty normal gait.
5) By 8/9 months I had pretty much forgotten that I had ever done LL, even though my high-level athletism wasn't back to normal, daily functions were back to 100%.
I hear that 2.2 is stronger than 2.0 because they worked out a lot of the problems with the design. However, if a lot of P2's have broken they may have modified weight-bearing restrictions. Remember under 75 lbs per leg can easily be achieved if you are really conscious about shifting weight onto walker or crutches. I probably could have used crutches earlier, but I chose to use walker because of balance and to mitigate the risk of falling. I also started driving about 3.5 months post-op, and because I was well under 150 lbs after atrophy, I could stand up on my 2 feet and pump gas, transfer in and out of car, and perform basic functions like that.
Thanks for the insights! I will discuss it with my doctor in about 2 weeks. I will see what he has to say about P2.2, thank god I am a very low weight guy, might come in handy after all.
They say July now, but 20 days ago they said may/june... I can wait to september but man, it's hard to trust
Well I drop all hopes for Stryde now, it‘s such a fate that it gets down exactly when I was finally able to do it. Postponing for me isn‘t possible, early July is the last date I could possibly do it, so I guess I have to take it up the butt and go with Precise.
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So do we have any news from the FDA's meeting with Nuvasive?
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So do we have any news from the FDA's meeting with Nuvasive?
Offical update will be tomorrow according to Debiparshad after my consult with him a few days ago. He said it’s likely going to be officially recalled but their not sure of timelines so the update tomorrow should provide some info on that. Stryde in Europe is likely to come back in August or later and the US will be the first country to get it back he suspects.
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Offical update will be tomorrow according to Debiparshad after my consult with him a few days ago. He said it’s likely going to be officially recalled but their not sure of timelines so the update tomorrow should provide some info on that. Stryde in Europe is likely to come back in August or later and the US will be the first country to get it back he suspects.
inb4 stryde gets delayed for even longer.
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My husband and I talked to the regional Sales Rep about Stryde. He said the independent company is doing testing and it is time consuming. He told us it will most likely be available by July 2021.
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Hi guys long time lurker, I was scheduled to have surgery next week, but my doctor just informed me that they are officially pulling Stryde from the market. It's a complete international recall according to him. No one will legally be able to use Stryde starting this Monday. He expects it to be longer than a year until changes are made and Stryde can come back to the market.
The recall is due to a small amount of corrosion that may occur with the nail while implanted.
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Jesus, can we please get some clarity on this matter. I really Hope it won’t take a full year and they’ll get done by the end of the year at least. my surgery also got cancelled 1 week beforehand because of this mess.
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Well said, Siegfried. What a mess! I was hoping to pull the trigger in March but hadn’t actually scheduled anything yet. Sorry about your cancellation and all the other LLers who had their surgeries actually cancelled. That sucks!
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Are there any official statements? I can't find any...
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FDA is jammed baked with new covid tech, its the only reason why the review assessment is taking so long.
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I don’t think the fda has any role to play here. This seems to be an internal testing study, which they failed to deliver in the past and which got uncovered by the nhs. As far as I understand there is no external agency involved here. The fda does also not play a role in Europe. But this is all speculation, since nuvasive has failed to deliver an official press statement to this day.
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Are there any official statements? I can't find any...
Here’s the official documentation regarding the recall.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?start_search=1&event_id=86150
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Here’s the official documentation regarding the recall.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?start_search=1&event_id=86150
That is not the correct recall documentation or link. That is not the stryde or precice stature lengthening nail. That is a recall for a limb Salvage nail called a bone transport nail. (Which was actually also recalled along with stryde this month as well) Different and was months ago in October . Unrelated am sorry
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Toxicity assessments is expected to be completed in Q2 2021. Stryde may be put on market after this tests . s . Really sorry to everyone who want suregery
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Stryde is product pulled because of report of bony abnormality on side of extending (telescoping) part of the nail . Perhaps risk no good need further test t.
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Nuvasive personal recall document 200+ pages only first few are relevant
https://mhra-gov.filecamp.com/s/pz82Q5uAZowsRb7s/d
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Toxicity assessments is expected to be completed in Q2 2021. Stryde may be put on market after this tests . s . Really sorry to everyone who want suregery
Even Nuvasive is saying now July at the earliest, so definitely no quarter 2 :(
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I don’t think the fda has any role to play here. This seems to be an internal testing study, which they failed to deliver in the past and which got uncovered by the nhs. As far as I understand there is no external agency involved here. The fda does also not play a role in Europe. But this is all speculation, since nuvasive has failed to deliver an official press statement to this day.
You are true. That's just negligence by the company.
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worst part is no communication even now!!
there needs to be a PRESS RELEASE with a public apology at this point!!
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Even Nuvasive is saying now July at the earliest, so definitely no quarter 2 :(
End of June is considered q2
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Yah FDA did not issue a recall this is nuvasive themself
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Hi all-I had the Stryde nail implanted in Sept 2019 and removed in October 2020. I heard about the pause recently so came on here to see what news I could find. Like a lot of you on here, I’m not 100% clear on the issue. I will say, I remember some of my early xrays looking like the one on this thread...my doctor never said anything about it not being normal...like everyone else here, I’ve looked at my fair share of xrays but am by no means an expert...that’s why we have doctors! With my lengthening (not CLL, was an LLD)...I literally had 0 complications with it. So, I certainly hope they work out the issues quickly for all of your waiting for your surgery.
The other thing I will add...not sure if it’s psychological or physiological but I felt an immediate improvement after the rod was removed...it’s very heavy (I actually got to keep my rod after removal) so not sure if that’s it or if it’s just in my head lol...but I strongly recommend getting it out. The recovery is longer than 1-2 weeks...it’s more like 4 weeks but worth it. You can look at my patient experience story on this forum for more info or I have a youtube channel “Pulling my leg” that should be easy to find.
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Is anyone considering moving forward with Precice 2 in the second half of March?
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Hi all-I had the Stryde nail implanted in Sept 2019 and removed in October 2020. I heard about the pause recently so came on here to see what news I could find. Like a lot of you on here, I’m not 100% clear on the issue. I will say, I remember some of my early xrays looking like the one on this thread...my doctor never said anything about it not being normal...like everyone else here, I’ve looked at my fair share of xrays but am by no means an expert...that’s why we have doctors! With my lengthening (not CLL, was an LLD)...I literally had 0 complications with it. So, I certainly hope they work out the issues quickly for all of your waiting for your surgery.
The other thing I will add...not sure if it’s psychological or physiological but I felt an immediate improvement after the rod was removed...it’s very heavy (I actually got to keep my rod after removal) so not sure if that’s it or if it’s just in my head lol...but I strongly recommend getting it out. The recovery is longer than 1-2 weeks...it’s more like 4 weeks but worth it. You can look at my patient experience story on this forum for more info or I have a youtube channel “Pulling my leg” that should be easy to find.
Thanks man for your anecdote. Helps relieve some fear. Glad you're doing good man
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There is probably a good reasoning to call back the nails and re-test it. However, there is also a need to check the functionality of the electromagnetic controllers as well. I have seen or heard it fail and give unexpected errors on a few patients, which required replacement or intervention from the company
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what is surgery date
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Hi all-I had the Stryde nail implanted in Sept 2019 and removed in October 2020. I heard about the pause recently so came on here to see what news I could find. Like a lot of you on here, I’m not 100% clear on the issue. I will say, I remember some of my early xrays looking like the one on this thread...my doctor never said anything about it not being normal...like everyone else here, I’ve looked at my fair share of xrays but am by no means an expert...that’s why we have doctors! With my lengthening (not CLL, was an LLD)...I literally had 0 complications with it. So, I certainly hope they work out the issues quickly for all of your waiting for your surgery.
The other thing I will add...not sure if it’s psychological or physiological but I felt an immediate improvement after the rod was removed...it’s very heavy (I actually got to keep my rod after removal) so not sure if that’s it or if it’s just in my head lol...but I strongly recommend getting it out. The recovery is longer than 1-2 weeks...it’s more like 4 weeks but worth it. You can look at my patient experience story on this forum for more info or I have a youtube channel “Pulling my leg” that should be easy to find.
Hi, how did you feel when you still had the rod inside? Were there more pains? And how was the sleep while you had the rod?
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Hello, first post. I am a 51 y/o male who did the stryde and gained the full 8cm on both femurs; consolidation began 1 month ago. What has precipitated this post is the "recall" and my doctor asking me to get a cobalt and chrome blood test. Any insight on these two elements in relation to the recall? thanks!
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How come the FDA.. did not pick up.. on this matter? But the UK ... NHS did..
It's just shows poor patient care ... The UK.. NHS has a stricter policy.. It will put the UK Patients 1st.. the Stryde will have to pass a very tough test.. with the UK.. before it can go out on the Market for patients!!!!!
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... I may go with the precise 2.. I'm not sure if I can wait for another year.. I feel sorry for the patients who were have recently booked with the Stryde.. I hope this matter is sorted out quickly
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Hello, first post. I am a 51 y/o male who did the stryde and gained the full 8cm on both femurs; consolidation began 1 month ago. What has precipitated this post is the "recall" and my doctor asking me to get a cobalt and chrome blood test. Any insight on these two elements in relation to the recall? thanks!
Who is your Doctor... and where did you get your surgery done.. and how do you feel.. with the new height? Was it worth it ?
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Avoid precice method surgery till Nuvasive makes a second official statement.
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Avoid precice method surgery till Nuvasive makes a second official statement.
Can you please ... tell me. why I should Avoid the Precice ?
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Most of the people on this forum know very well that in the last 1 year, many cases of breakage from Precice nails have been reported. The production of the nails was therefore stopped several times by the FDA and the nails were recalled. Some doctors use previously purchased nails, although they are life-threatening.
Here’s the official documentation regarding the recall.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?start_search=1&event_id=86150
Here's the another threat about some precice user doctors (b*tchers)
http://www.limblengtheningforum.com/index.php?topic=66254.0
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I cannot believe the amount of misinformation you're spreading Jcoreleone. If you don't know about something then just shut up. It's honestly stunning when people post links that they haven't even read at all and make up random bullshït to sound credible.
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Precice use has been aproved by the FDA. The document linked is not even related to this matter lol
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Hello, first post. I am a 51 y/o male who did the stryde and gained the full 8cm on both femurs; consolidation began 1 month ago. What has precipitated this post is the "recall" and my doctor asking me to get a cobalt and chrome blood test. Any insight on these two elements in relation to the recall? thanks!
Semi-informed speculation here: Stryde uses metals that are more corrosive than Precice. Those metals can in theory enter your bloodstream. Also I think we have the same doc; feel free to PM :)
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Dr. Janet Conway Baltimore MD. She is best described as a brilliant sweetheart; her bedside is palpable/cannot more highly recommend. I had a screw loose....ha....but true. She found it early, was nearly all the way out. She replaced screw with a different manufacturer part b/c the styrde screws have too little threads. Jury still out on full results of course b/c it really is too soon. I'm walking without assist or device but with a prominent limp. Consolidation was Jan 15th, 2021. I made it to 8cm despite my advanced age due to flexibility (was a gymnast) and even at 51 y/o I could still do a split to the floor right before the surgery. I think that's the only way I made it to 8cm. Dr. Conway was beyond cautious the whole way. She would have preferred 65-70mm.
Worth it? Well I have lost feeling on the front of my left tibia (saphneous nerve) and it's not getting better. But that is just a sensory nerve/doesn't do much anyway. I can live w/o that. Is it worth losing the ability to play some sports that I did previously? IDK about that b/c if I can't play basketball again I will be very disappointed. But quite honestly I can't even dream of that at the moment. I would just like to walk like I haven't been riding a horse for a week straight. But 3" taller? That goes a long long way. No more shoe lifts etc...I definitely feel more confident. Sounds shallow and it is really but thus far i do not regret.
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Dr. Janet Conway Baltimore MD. She is best described as a brilliant sweetheart; her bedside is palpable/cannot more highly recommend. I had a screw loose....ha....but true. She found it early, was nearly all the way out. She replaced screw with a different manufacturer part b/c the styrde screws have too little threads. Jury still out on full results of course b/c it really is too soon. I'm walking without assist or device but with a prominent limp. Consolidation was Jan 15th, 2021. I made it to 8cm despite my advanced age due to flexibility (was a gymnast) and even at 51 y/o I could still do a split to the floor right before the surgery. I think that's the only way I made it to 8cm. Dr. Conway was beyond cautious the whole way. She would have preferred 65-70mm.
Worth it? Well I have lost feeling on the front of my left tibia (saphneous nerve) and it's not getting better. But that is just a sensory nerve/doesn't do much anyway. I can live w/o that. Is it worth losing the ability to play some sports that I did previously? IDK about that b/c if I can't play basketball again I will be very disappointed. But quite honestly I can't even dream of that at the moment. I would just like to walk like I haven't been riding a horse for a week straight. But 3" taller? That goes a long long way. No more shoe lifts etc...I definitely feel more confident. Sounds shallow and it is really but thus far i do not regret.
Still early for numbness so don't worry it'll get better eventually. Very impressive you did 8cm considering your age and I am glad you are hapy 😀
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I'm in the same situation as a few others...had surgery coming up and then got the news about the recall. Heavily considering going with the Precice 2.2 as I will be doing around a 5cm-6cm tibia lengthening first followed by a 5cm-6cm femur lengthening a month later to get the best proportions. I am fairly thin and young so hopefully my recovery time is not too much longer. I have also heard from my doctor the same news as some others reported, that a new Stryde nail will not be available until a year from now. Don't want to wait that long for surgery when I could already be walking normally with the Precice by then.
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Hey guys, could you elaborate on the info given by your doctors? I must decide between Precice 2 on June or waiting until september. Giotikas says Stryde may be back on september, but some doctor seem to be talking about a year from now lol. In that case Precice no doubt, I just want to de 5.5 cm femur, it's not THAT bad
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Dr. Janet Conway Baltimore MD. She is best described as a brilliant sweetheart; her bedside is palpable/cannot more highly recommend. I had a screw loose....ha....but true. She found it early, was nearly all the way out. She replaced screw with a different manufacturer part b/c the styrde screws have too little threads. Jury still out on full results of course b/c it really is too soon. I'm walking without assist or device but with a prominent limp. Consolidation was Jan 15th, 2021. I made it to 8cm despite my advanced age due to flexibility (was a gymnast) and even at 51 y/o I could still do a split to the floor right before the surgery. I think that's the only way I made it to 8cm. Dr. Conway was beyond cautious the whole way. She would have preferred 65-70mm.
Worth it? Well I have lost feeling on the front of my left tibia (saphneous nerve) and it's not getting better. But that is just a sensory nerve/doesn't do much anyway. I can live w/o that. Is it worth losing the ability to play some sports that I did previously? IDK about that b/c if I can't play basketball again I will be very disappointed. But quite honestly I can't even dream of that at the moment. I would just like to walk like I haven't been riding a horse for a week straight. But 3" taller? That goes a long long way. No more shoe lifts etc...I definitely feel more confident. Sounds shallow and it is really but thus far i do not regret.
Check your private messages
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Dr. Janet Conway Baltimore MD. She is best described as a brilliant sweetheart; her bedside is palpable/cannot more highly recommend. I had a screw loose....ha....but true. She found it early, was nearly all the way out. She replaced screw with a different manufacturer part b/c the styrde screws have too little threads. Jury still out on full results of course b/c it really is too soon. I'm walking without assist or device but with a prominent limp. Consolidation was Jan 15th, 2021. I made it to 8cm despite my advanced age due to flexibility (was a gymnast) and even at 51 y/o I could still do a split to the floor right before the surgery. I think that's the only way I made it to 8cm. Dr. Conway was beyond cautious the whole way. She would have preferred 65-70mm.
Worth it? Well I have lost feeling on the front of my left tibia (saphneous nerve) and it's not getting better. But that is just a sensory nerve/doesn't do much anyway. I can live w/o that. Is it worth losing the ability to play some sports that I did previously? IDK about that b/c if I can't play basketball again I will be very disappointed. But quite honestly I can't even dream of that at the moment. I would just like to walk like I haven't been riding a horse for a week straight. But 3" taller? That goes a long long way. No more shoe lifts etc...I definitely feel more confident. Sounds shallow and it is really but thus far i do not regret.
Hi Shhh...I'm very happy for you... just give it time.. the nerve feeling should come back.
The new height is well worth it ... Panda
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Dr. Janet Conway Baltimore MD. She is best described as a brilliant sweetheart; her bedside is palpable/cannot more highly recommend. I had a screw loose....ha....but true. She found it early, was nearly all the way out. She replaced screw with a different manufacturer part b/c the styrde screws have too little threads. Jury still out on full results of course b/c it really is too soon. I'm walking without assist or device but with a prominent limp. Consolidation was Jan 15th, 2021. I made it to 8cm despite my advanced age due to flexibility (was a gymnast) and even at 51 y/o I could still do a split to the floor right before the surgery. I think that's the only way I made it to 8cm. Dr. Conway was beyond cautious the whole way. She would have preferred 65-70mm.
Worth it? Well I have lost feeling on the front of my left tibia (saphneous nerve) and it's not getting better. But that is just a sensory nerve/doesn't do much anyway. I can live w/o that. Is it worth losing the ability to play some sports that I did previously? IDK about that b/c if I can't play basketball again I will be very disappointed. But quite honestly I can't even dream of that at the moment. I would just like to walk like I haven't been riding a horse for a week straight. But 3" taller? That goes a long long way. No more shoe lifts etc...I definitely feel more confident. Sounds shallow and it is really but thus far i do not regret.
didn't you ask her why she wants you to get cobalt blood test?
and great to have you here big bro! you HAVE to show us your recovery state as videos being the eldest of the clan ;)
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My doctor is in direct contact with nuvasive On a daily basis and he is confident stryde will be finished by June/July 2021.
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I contacted several doctors and was told that they're expecting precice test results to be ready by april but no estimate on stryde. Note they mentioned "test results" so I assume actual resolution i.e. resumption of nail shipment and fda approval is a whole other thing.
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nothing like good ole ilizarov lads. do it once, endure the pins, stop early due to pain and fear, recover well and never look back.
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The nail does not have to be approved by the fda since it was never disaproved. It was recalled by nuvasive on their own agenda.
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nothing like good ole ilizarov lads. do it once, endure the pins, stop early due to pain and fear, recover well and never look back.
Truly, nothing is more painless, cheap and safe compared to pure external on tibias.
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My doctor is in direct contact with nuvasive On a daily basis and he is confident stryde will be finished by June/July 2021.
I don't understand these different opinions. Giotikas says maybe late August at the earliest, but Rozbruch and Debiparshad say next year
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Truly, nothing is more painless, cheap and safe compared to pure external on tibias.
All doctors disagree with you. Even most patients disagree with you. even u didnt have a "perfect" experience right? Femur lengthening using internal nails is best tolerated. look at the patients today, walking around during distraction, going to work and doing sports as early as 6 months.
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I don't understand these different opinions. Giotikas says maybe late August at the earliest, but Rozbruch and Debiparshad say next year
Debiparshad said next year? So hes effectively paused all surgeries for a year? we wont see any media articles this whole year then?
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Debiparshad said next year? So hes effectively paused all surgeries for a year? we wont see any media articles this whole year then?
No more Stryde for now, but Precice will still be used. I'm doing Precice 2.2 it seems lol
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All doctors disagree with you. Even most patients disagree with you. even u didnt have a "perfect" experience right? Femur lengthening using internal nails is best tolerated. look at the patients today, walking around during distraction, going to work and doing sports as early as 6 months.
I used monorails. If I used hexapod I would never have had any problem. But then we didn't have the knowledge we have now about what is the best choice.
Still after a fix surgery I am very good.
Almost everyone agrees that external tibias are far more painless than internals.
And after all I have a personal experience which was 100% painless after the first week while almost all that use internals need heavy painkillers to tolerate it.
And finally, the.doctors that disagree with me are some merchants like D who could promote invisible lengthening and not some bulky fixators that people are afraid of, have much less money for him and needs much better skills than just puting an internal nail.
Doing everyday works at 6 months is important and I am not against stryde. I always say that it is the biggest innovation in LL in the last 30+ years.
But still internals needs 2 major surgeries to put on and.out, have more significant risks like embolism, can cause knee pain and are much more expensive than externals.
Of course, for femurs they are the only way. But for tibias they are not the best way except someone who care more about time and having something invisible than longterm risks, having another major surgery in the future and at least 20-30k euros more to spend.
Everyone can choose the best for his needs. But it isna fact that at least in terms of pain and longterm risks pure externals are superior.
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Yes you can walk anytime with internal femur but then there are people with bend/broken nail, or maybe they can end up with bow femurs due to bending. It's not a walking in the park because there are many risks and it's way more difficult and invasive to fix if you mess it. The great thing of internals is not the weight bearing itself but the fact you can have a proper rehab avoiding externals old devices that leads in big scarring. Then if the nail is big enough you can even walk without worries.
If I had done tibias I would have chosen external for sure. They are safer and they allow a good assured weight bearing (I'm not sure about how much).
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I think what puts people off for externals in the long àss time in frames. Just feels so long, 7.5 months to 10 months in frames for only 5cm. I would do it but it is just longer than my patience and probably becomes very depressing fast
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No more Stryde for now, but Precice will still be used. I'm doing Precice 2.2 it seems lol
with Kevin Debiparshad?
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I used monorails. If I used hexapod I would never have had any problem. But then we didn't have the knowledge we have now about what is the best choice.
Still after a fix surgery I am very good.
Almost everyone agrees that external tibias are far more painless than internals.
And after all I have a personal experience which was 100% painless after the first week while almost all that use internals need heavy painkillers to tolerate it.
And finally, the.doctors that disagree with me are some merchants like D who could promote invisible lengthening and not some bulky fixators that people are afraid of, have much less money for him and needs much better skills than just puting an internal nail.
Doing everyday works at 6 months is important and I am not against stryde. I always say that it is the biggest innovation in LL in the last 30+ years.
But still internals needs 2 major surgeries to put on and.out, have more significant risks like embolism, can cause knee pain and are much more expensive than externals.
Of course, for femurs they are the only way. But for tibias they are not the best way except someone who care more about time and having something invisible than longterm risks, having another major surgery in the future and at least 20-30k euros more to spend.
Everyone can choose the best for his needs. But it isna fact that at least in terms of pain and longterm risks pure externals are superior.
I seen no tibia patient recover like movie or that stryde nail challenge dude. I think longer tibia just arent good for athleticism. also they dont look good. people can tell theyre too long.
yea yea I hear ya on how its 2 surgeries with internals and risk of embolism. Thats true. But all said and done people who do femur internals seem to just do damn well compared to tibial people.
ALL doctors I Know prefer doing internal femur lengthening if a patient wants to grow taller. See cyborg4life's channel. Not just "Mr Merchant" as you call him ;D
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guys, please keep this thread about the nuvasive mess
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sorry my bad.
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I seen no tibia patient recover like movie or that stryde nail challenge dude. I think longer tibia just arent good for athleticism. also they dont look good. people can tell theyre too long.
yea yea I hear ya on how its 2 surgeries with internals and risk of embolism. Thats true. But all said and done people who do femur internals seem to just do damn well compared to tibial people.
ALL doctors I Know prefer doing internal femur lengthening if a patient wants to grow taller. See cyborg4life's channel. Not just "Mr Merchant" as you call him ;D
All the doctors you mention earn much more money with intrernals and the surgery is way easier so yes, they prefer it.
Now you do another vs except from internals-externals, you compare tibias vs femurs.
This is another big conversation and we are completely offtopic here.
However, if I could turn back time i would still do external tibias again but with hexapod to walk unaided from the first weeks and have perfectly aligned bones, without internal nails and all these bs.
But now, if I do another LL which is not in my final plans though, of course I would choose stryde for femurs as it is the best nail (unless there are safety reason) and internals is the only way for femurs.
As you see I don't disqualify internals and especially that nail but for my priorities , externals were the best and still I believe it is the safest and most painless way of LL.
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Q3 they say now:https://www.nuvasive.com/wp-content/uploads/2021/02/NSO-Precice-FSN-United-States-Biodur.pdf
It's hard to know if it's reasonable to wait for September... What do you think guys? I guess this is Q3 at best to end the tests, but it may take longer to come back? I'm thinking os just doing Precice 2 on June
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This is very bad news. I know testing needs to be extensive but Q3 to finish tests? In that case we'd be lucky to have stryde widely available by Q1 next year. I don't know about different countries rules but I'd imagine some sort of approval will have to happen as well. Can anyone confirm this for EU (Greece)? I know in Asia (Korea) they require a separate approval from their local FDA, this is according to my source who spoke with Dr Lee's office.
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This is very bad news. I know testing needs to be extensive but Q3 to finish tests? In that case we'd be lucky to have stryde widely available by Q1 next year. I don't know about different countries rules but I'd imagine some sort of approval will have to happen as well. Can anyone confirm this for EU (Greece)? I know in Asia (Korea) they require a separate approval from their local FDA, this is according to my source who spoke with Dr Lee's office.
That's my doubt. Since the recall was voluntary, I don't know if Stryde will be available after finishing tests, or if there must be permission. If the latter, it will take to end of year at least yeah
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Is it unrealistic to expect Stryde to be available in 2021?
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Nuvasive has stated that testing will be completed in Q3 - So yes it is realistic!
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If testing finishes in Q3, wouldn't development and distribution take several months?
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What needs to be developed? As far as i've understood, it's a formal and mandatory series of tests, which they seemingly missed out on. I dont think that the nail will be modified after the tests are completed. This is also what my doctor told me. Distribution should not take that long.
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Hm, my doctor informed me that they were experiences issues with material corroding and reports were anecdotally relating the depletion of material to pain in the thigh. If we assume this is the case, wouldn't they need to address that and therefore make adjustments?
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This is just speculation, but i think that might be another set of problems, which may not be directly related to the recall. Maybe they will address those problems after they complete the tests and resend the nails, since it appears to be a minor problem. But hey, i'm just trying to be optimistic here.
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I'm happy that you're being optimistic. Definitely helps justifying waiting as oppose to going forward with Precice. Any other information you have on hand that could shed light? By the way, if you had the choice of getting Precice tomorrow, or waiting it out for Stryde, what would you do?
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I think it depends on your need for it. In my case, it must be done before September. I would wait for september, but it seems very unlikely it would be available there. Then, I will do Precice in June. I think it's quite worse, but doable if you have someone to help you. Besides, I will try to buy things like pedals to exercise my legs while being on the ground. Also a big walker with wheels to walk every day without weight bearing.
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When do you imagine it returning? Also - what's your current height and how many cm's are you trying to achieve? Congrats, by the way.
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Maybe like november? All seems quite uncertain right now, that's the problem, no info a no communication. And I'm 172/173, I just want to do 5 cm so it's not that bad in my case to take precice.
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I think it's going to take a while. I would anticipate it getting modified and remanufactured. They're not going to risk future lawsuits (as evidenced by participating in a voluntary recall) just to get this out, especially when they already have alternate products on the market that do the same thing.
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On the opposing side, they're losing millions upon millions. They're team must be working around the clock to get this out.
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Had f/u appointment with Dr. conway. Company rep was at appointment too.
VERY interesting inferences I took from this. Dr. Conway is professional and cautiously guarded. She nor the rep would make any official statements; they're not stupid to stick their necks out.
But I inferred these opinions and was not corrected by either.
-Stryde is NOT coming back ANYTIME soon..... and here's the big one.... not coming back potentially EVER.
-my chromium levels were double almost triple what would be "normal". BUT I believe for poisoning you would need at least 20 times the normal amount.
-I believe she is looking in a completely different direction from anything Nuvasive.
-The rep was quiet but would neither confirm nor deny any of my polite questions. The rep recommended Precise for anybody else. I asked him if the implant is stainless steel why or how could it be leaching these other elements? He said yes it is stainless but it is still formulated with other metals. Interesting.
To reiterate I am a 51 y/o physical therapist and ex-gymnast who achieved 8 cm at 51 years old consolidating just this past January. IMHO IMHO IMHO ..... this kind of stuff has happened with hip replacement surgery. But with a partial or total hip replacement you have a constant movement or constant rubbing of the ball and socket joint so I could understand how a poorly formulated implant could leach metal over time. But after the lengthening phase of the stryde nail it's existence in your body is static. So by that analogy there should be less exposure to these metals leaching because there is simply no more movement. what is very slightly concerning to me is in a hip replacement surgery you have a titanium femoral head (ball) that is rotating in the acetabulum (socket). The acetabulum is always a plastic composite material so you really don't have Metal on metal whereas in the distraction phase of the stryde nail you do have metal rotating on metal.
Still in the long term I could see a hip implant corroding overtime due to constant movement. I'm hoping the saving grace for those that have these nails is that after consolidation there is no movement. But is it a frictional sloughing of metals or is it truly a corrosion. Because if the operative word is corrosion that can be a bit concerning.
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Had f/u appointment with Dr. conway. Company rep was at appointment too.
VERY interesting inferences I took from this. Dr. Conway is professional and cautiously guarded. She nor the rep would make any official statements; they're not stupid to stick their necks out.
But I inferred these opinions and was not corrected by either.
-Stryde is NOT coming back ANYTIME soon..... and here's the big one.... not coming back potentially EVER.
Very useful information and is what I feared. Looks like I will be going ahead with Precice.
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Had f/u appointment with Dr. conway. Company rep was at appointment too.
VERY interesting inferences I took from this. Dr. Conway is professional and cautiously guarded. She nor the rep would make any official statements; they're not stupid to stick their necks out.
But I inferred these opinions and was not corrected by either.
-Stryde is NOT coming back ANYTIME soon..... and here's the big one.... not coming back potentially EVER.
-my chromium levels were double almost triple what would be "normal". BUT I believe for poisoning you would need at least 20 times the normal amount.
-I believe she is looking in a completely different direction from anything Nuvasive.
-The rep was quiet but would neither confirm nor deny any of my polite questions. The rep recommended Precise for anybody else. I asked him if the implant is stainless steel why or how could it be leaching these other elements? He said yes it is stainless but it is still formulated with other metals. Interesting.
To reiterate I am a 51 y/o physical therapist and ex-gymnast who achieved 8 cm at 51 years old consolidating just this past January. IMHO IMHO IMHO ..... this kind of stuff has happened with hip replacement surgery. But with a partial or total hip replacement you have a constant movement or constant rubbing of the ball and socket joint so I could understand how a poorly formulated implant could leach metal over time. But after the lengthening phase of the stryde nail it's existence in your body is static. So by that analogy there should be less exposure to these metals leaching because there is simply no more movement. what is very slightly concerning to me is in a hip replacement surgery you have a titanium femoral head (ball) that is rotating in the acetabulum (socket). The acetabulum is always a plastic composite material so you really don't have Metal on metal whereas in the distraction phase of the stryde nail you do have metal rotating on metal.
Still in the long term I could see a hip implant corroding overtime due to constant movement. I'm hoping the saving grace for those that have these nails is that after consolidation there is no movement. But is it a frictional sloughing of metals or is it truly a corrosion. Because if the operative word is corrosion that can be a bit concerning.
Yeah thx for the info. Im nearly 40 days post surgery with stryde. I will try to get my chromium level checked.
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Talked with Paley, he says maybe STRYDE returns in August or September but only if you are optimistic. Probably till the end of this year :(. So I guess even when I start in summer with precice I will be done before stryde is back.
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And I guess he meant in the US, because it will be even longer in Europe. I'm in the same boat as you, Precice it is this summer...
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From reading all this, even if stryde got approved this year I would be vary of using it.
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And I guess he meant in the US, because it will be even longer in Europe. I'm in the same boat as you, Precice it is this summer...
Yep... Where are you doing it? and when? I'll travel to the US in early June.
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Talked with Paley, he says maybe STRYDE returns in August or September but only if you are optimistic. Probably till the end of this year :(. So I guess even when I start in summer with precice I will be done before stryde is back.
Did he seem concerned about the delay or did he clarify why it will take longer than expected?
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Hi... does anyone know.. what they have changed with the Precise.... Due to the Stryde recall problems.. Panda
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Did he seem concerned about the delay or did he clarify why it will take longer than expected?
No, he didn't seem concerned nor did his assistant surgeon. They told me it's just because of the extra bone growth abnormality.
Hi... does anyone know.. what they have changed with the Precise.... Due to the Stryde recall problems.. Panda
not 100% sure here but I doubt there is anything different. Paley told me he will use the same precice he did for years before stryde. he said it's a good nail and does its job but the weight-bearing thing is really not to be underestimated. They said something along the lines they will have to check if they can use the strongest diameter one for me because I have a relatively tall starting height but I am not sure since I am also very thin.
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Yep... Where are you doing it? and when? I'll travel to the US in early June.
Greece on July. I think I have big bones, so I'm getting X rays to see if at least I'm lucky enough for the big nail lol
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Greece on July. I think I have big bones, so I'm getting X rays to see if at least I'm lucky enough for the big nail lol
Good idea! good luck with that. Do you think you can weight bear, or at least use crutches for the majority of the time if you can use the big diameter P2.2? I mean if you are below 146 lbs it should work, shouldn't it?
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Update
https://youtu.be/AC-fkgM59mI
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Spoke to my doctor recently, he reiterated that this would take at least a year before STRYDE is back for CLL, possibly up to two years.
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Any sign of precise returning in September? My surgery for the 10. September was cancelled due to precise not having the appropriate certificate in Europe. 2021 has been quite the sihtshow for nuvasive to be honest