Before being released to market are there human trials or are they released to see how it goes? With the issues that Stryde caused in a significant number of patients I tend to think it's the latter or the sample size for trials was incredibly small.
Quote from: Highest on October 22, 2021, 04:39:28 AMBefore being released to market are there human trials or are they released to see how it goes? With the issues that Stryde caused in a significant number of patients I tend to think it's the latter or the sample size for trials was incredibly small.
One of the reasons I have chosen Gnail is becuase it was created long before Stryde. Gnail was initially called Albizzia, internal nail that was invented by Dr Guichet. It was the first lengthening nail with weight bearing in the world, for over 30 years ago and was also the first weight bearing one used in the USA.
Dr Guichet gathered the complications of this technique from his statistics and of other surgeons and modified a lot of things in the nail. The current evolution from that is the Guichet nail (G-Nail) which allows weight bearing, sports and is secure for the gain with little complications.
In my experience the important thing is not only the nail, besides having a weight bearing one, but the rehab program for recovery. as well.
Quote from: Super-JR on October 22, 2021, 05:31:40 AMOne of the reasons I have chosen Gnail is becuase it was created long before Stryde. Gnail was initially called Albizzia, internal nail that was invented by Dr Guichet. It was the first lengthening nail with weight bearing in the world, for over 30 years ago and was also the first weight bearing one used in the USA.
Dr Guichet gathered the complications of this technique from his statistics and of other surgeons and modified a lot of things in the nail. The current evolution from that is the Guichet nail (G-Nail) which allows weight bearing, sports and is secure for the gain with little complications.
In my experience the important thing is not only the nail, besides having a weight bearing one, but the rehab program for recovery. as well.
I read somewhere that Stryde caused osteomyelitis in 2 out of 3 patients. Osteomyelitis is very serious and difficult to treat, and if that is true, it is simply incredible.
I am sure no real clinical tests were made in humans (it's easy to understand why...) but find very strange that trials in animals, especially mammals with long bones, didn't cause any alarm.
Were these trials seriously made? Or made at all, even in animals other than mice? At least in mice?
Although Stryde seems very effective other than ‘’that’’, modern, comfortable, weight bearing, etc. I don't think it’s wise to choose it, especially in the first 2 years following its reintroduction and, let's say, after at least 200 surgeries (and 1 year follow up) made by different doctors for different elongations in voluntary ‘’pioneer'' patients.
This issue should also make us all think again about the safety of LL surgery and all its context, especially regulation, ethics, industry, research, etc.
Maybe Precise is still the more available, cheaper (with some doctors) and safer method (besides external).
Quote from: zaozari on October 22, 2021, 02:31:45 PMI read somewhere that Stryde caused osteomyelitis in 2 out of 3 patients. Osteomyelitis is very serious and difficult to treat, and if that is true, it is simply incredible.
I am sure no real clinical tests were made in humans (it's easy to understand why...) but find very strange that trials in animals, especially mammals with long bones, didn't cause any alarm.
Were these trials seriously made? Or made at all, even in animals other than mice? At least in mice?
Although Stryde seems very effective other than ‘’that’’, modern, comfortable, weight bearing, etc. I don't think it’s wise to choose it, especially in the first 2 years following its reintroduction and, let's say, after at least 200 surgeries (and 1 year follow up) made by different doctors for different elongations in voluntary ‘’pioneer'' patients.
This issue should also make us all think again about the safety of LL surgery and all its context, especially regulation, ethics, industry, research, etc.
Maybe Precise is still the more available, cheaper (with some doctors) and safer method (besides external).
To test Stryde in mice you would have needed to make mouse size Stryde nails right? Lol. It has to be human trials like what synoste are doing now.
That's why I wrote "EVEN in mice?". Its an expression of mistrust since it's generally the first trial phase in pharmacology but of course not the ideal here. Anyway, we have already nanotechnology and much smaller apparatus are produced in other materials. By the way, is osteomyelitis, before even more severe problems, including amputation, the "good" bone is eaten by "bad bone" and infection. If the ratio of complications was 2/3, again, they didn't surely experiment it "EVEN in mice".
Quote from: zaozari on October 25, 2021, 06:21:13 AMThat's why I wrote "EVEN in mice?". Its an expression of mistrust since it's generally the first trial phase in pharmacology but of course not the ideal here. Anyway, we have already nanotechnology and much smaller apparatus are produced in other materials. By the way, is osteomyelitis, before even more severe problems, including amputation, the "good" bone is eaten by "bad bone" and infection. If the ratio of complications was 2/3, again, they didn't surely experiment it "EVEN in mice".
I misunderstood your expression. Yea that makes sense. What tests do they need to do then to get their product into the market? It's kind of concerning for when nuvasive do their relaunch of a weight bearing nail to know that problems won't occur again.
Quote from: zaozari on October 25, 2021, 06:21:13 AMThat's why I wrote "EVEN in mice?". Its an expression of mistrust since it's generally the first trial phase in pharmacology but of course not the ideal here. Anyway, we have already nanotechnology and much smaller apparatus are produced in other materials. By the way, is osteomyelitis, before even more severe problems, including amputation, the "good" bone is eaten by "bad bone" and infection. If the ratio of complications was 2/3, again, they didn't surely experiment it "EVEN in mice".
If stryde caused osteomyelitis in 2/3 of patients then for sure many of the people here that had LL with strydw would have had that complication or heard about it in some other patient.
And none of these happened. So of course it is not true. Stryde has sone problems with rusting which are not even sure if they cause any problem but of course it shouldn't have had that problem and thats why it is out of market right now. Period.
Also, gnail and all these kind of nails are obsolete craps which make LL much harder, painful and makes rehabilitation slower.
I hope that stryde or other fully weiggt bearing magnetic nails come back, completely safe that time, to get rid of gnail, betzbone and all these hillariously expensive bs that still exist only for the doctors who use them to earn more money.
I said IF the 2/3 were true and that I had read (from unknown source). We are here to learn from each other.
But you can do your own research and check the problem of osteomyelitis vs Stryde.
I don't know if you know better than doctors which nails are crap or not. This is not football, like each nail against the other. Obviously, this surely also depends a lot on each case.
Quote from: zaozari on October 25, 2021, 06:36:37 PMI said IF the 2/3 were true and that I had read (from unknown source). We are here to learn from each other.
But you can do your own research and check the problem of osteomyelitis vs Stryde.
I don't know if you know better than doctors which nails are crap or not. This is not football, like each nail against the other. Obviously, this surely also depends a lot on each case.
All doctors agree that mechanic nails are obsolete and have many disadvantages (no reverse lengthening, slower bone formation etc) compared to magnetic nails and also LL with them are much more painful compared to any other method (except from external femurs which of course is an unacceptable way of LL).
The only reason that are still being used is for some moneyhungry doctors like Guichet to earn even more money and now that Stryde is out of business in case someone wants a fully weight bearing nail at all costs.
But when stryde comes back or any other magnetic fully weight bearing nail (like synoste) then gnail would really have no reason to exist.
But I am sure that Guichet and Betz will still use them that crap nails to have a bigger profit than just the surgery fees.
And about osteomyelitis, which is a very significant complication, even a nail had a so big percentage (like 2/3 of cases) then it is sure that noone would have let it on the market and many patients would have had that complication and sue the company.
But as far as I know that never happened and noone from that forum who used stryde had that kind of complication.
So for sure there is no possibility that stryde have a so big complication rate with osteomyelitis. Even 1% would have been enough to withdraw it from the market for that reason but the reason was completely different.
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