How are nails tested and Stryde failure

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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.

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Quote from: Body Builder on October 25, 2021, 09:49:25 PMAll 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

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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.

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

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Quote from: zaozari on October 22, 2021, 02:31:45 PMStryde 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

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""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.

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Quote from: ask.me on November 05, 2021, 05:10:27 PMOsteomyelitis 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.