Print

Please login or register.
1 Hour 1 Day 1 Week 1 Month Forever
Login with username, password and session length

[Highest]

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.

[Super-JR]

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.

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.

[zaozari]

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.

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).

[Highest]

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).

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.

[zaozari]

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".

[Highest]

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".

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.

[Body Builder]

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".

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.

[zaozari]

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.

[init1alove]

Osteomyelitis happens more often on tibia lenghening. Most of patients on the forum just did femur lengthening.

[Body Builder]

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.

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.

[zaozari]

I wonder why Stryde is out of market. Please be a little humble about medical and specialist certitudes. Where are the peer review articles stating that magnetic nails are definitely superior?
You are wrong several times and for respect for those in the forum you should better research: for example G-nail is full weight bearing.
Please also learn that 2 years of market use of a medicine or medical device is a period allmost irrelevant for safety  guaranty.
Many times, "old" is not bad in medicine. I haven't put aside for example externals in the tibias with an experienced doctor. It has its risks, inconveniences and pain. But it has been "tested" and improved since 80 years ago in cosmetic or related LL. Doctors know much better how to avoid and handle any complications. Besides it's cheaper than the "ultra modern" magnetic nails.

[zaozari]

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.

Many patients, maybe the majority, don't come to the forum.
Here you have unfortunately about Stryde (just 2 articles as examples)

https://online.boneandjoint.org.uk/doi/full/10.1302/0301-620X.103B.BJJ-2021-0549.R1?utm_source=TrendMD&utm_medium=cpc&utm_campaign=The_Bone_%2526_Joint_Journal_TrendMD_0

and

https://online.boneandjoint.org.uk/doi/abs/10.1302/0301-620X.103B6.BJJ-2020-2165.R1?utm_source=TrendMD&utm_medium=cpc&utm_campaign=The_Bone_%2526_Joint_Journal_TrendMD_0

[ask.me]

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.

In STRYDE's case it was found by some special panel to be substantially equivalent to devices that are already in the market (previous iterations of PRECICE).
https://www.accessdata.fda.gov/cdrh_docs/pdf18/K180503.pdf

[ask.me]

Stryde caused osteomyelitis in 2 out of 3 patients.

Osteomyelitis is an infection of the bone. From what I can tell, the cause has more to do with the osteotomy to insert the device than the device itself. Most studies have found that internal nails actually have significantly lesser rates of infection compared to external fixators, which is why a lot of surgeons are gung ho about internal fixators.
https://www.hopkinsmedicine.org/health/conditions-and-diseases/osteomyelitis

[zaozari]

""In STRYDE's case it was found by some special panel to be substantially equivalent to devices that are already in the market (previous iterations of PRECICE).
https://www.accessdata.fda.gov/cdrh_docs/pdf18/K180503.pdf   ""


And here you have the result of the "assessment"! It only makes the matter worse. Can we really trust the panel of the agency.? The decision (like in Europe) is fundamentally based on documentation provided by the company itself, rarely or never additional independent tests are made.
That's why we should maybe be more conservative in the choice of method. It is a wiser decision, more scientifically and medically tested and known/practiced by doctors.

[zaozari]

Osteomyelitis is an infection of the bone. From what I can tell, the cause has more to do with the osteotomy to insert the device than the device itself. Most studies have found that internal nails actually have significantly lesser rates of infection compared to external fixators, which is why a lot of surgeons are gung ho about internal fixators.
https://www.hopkinsmedicine.org/health/conditions-and-diseases/osteomyelitis

Yes, it seems true for infection issues alone, and for internals DIFFERENT than Stryde,  not Stryde itself.
It's true that infections in the pins of externals are frequent but not as frequent as the complications in this trial with Stryde (77%!), and externals' pin infections are generally always external and manageable. Also, externals have their own advantages, like in Ilizarov's 70 years of real use, testing and improvment, being more stable when done by competent doctors and being cheaper.

But there are other options to Stryde (other than pure externals). However my point is not to "promote" or "attack" any method specifically ( I am not competent for that and it also allways depend on each patient).

I am just trying to send a message of caution with Stryde.