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: 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.
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.
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