I Just saw this thread which clearly answers why there is a recall on Stryde:
http://www.limblengtheningforum.com/index.php?topic=66325.0
You cannot have a medical device that rusts within the human body after only 6-18 months. This is likely unsolvable without requiring them to redesign the entire unit from new materials. That means unless you want to be the first guinea pig for the new one, or the redesign goes very very fast, this is a dead option for at least 1-2 years.
What are our options if we want a weight-bearing solution? I know there is the Albizzia nail in Europe with Dr. Guichet. That has the disadvantage of needing ratcheting which I think might disturbs the callus in an unideal way (although who knows - perhaps it actually stimulates the callus in a way like accordion maneuvers do). Is this option with Dr. Guichet still considered a good one?
Then there is the BetzBone with Dr. Betz in Germany. Is he the only one who uses it? Any perspectives on the quality?
As far as I can see there is no weight-bearing option in North America now. Is that correct?
Thanks.
Stryde is dead and won't be back without a full redesign. Alternatives?
SYNOSTE Nitinail Study completion estimated December 2022
Stryde honestly will probably be back before that, since even 2023 is very far away
Or, nuvasive can focus their efforts on resigning the specific telescopic junction, that is an area most likely to corrode or strip material due to how the lengthening works and amount of force needed from magnetic inside rod lengthening. The material itself is likely not the cause, just the design of the telescopic junction. If the material itself was the cause, then the whole nail would errode. Keep in mind this is stainless steel with like 20% chromium, it's not going to corrode without something actively grinding it or damaging it (hence the telescopic section). Having that much friction in a tight area (telescoping section) while still needing to be strong enough to be weight bearing and be tight (causing friction) and not break is tough design. Even in Precice material the telescopic junction area released ions and stuff like that.
Quote from: Serilium on March 12, 2021, 11:24:31 PMSYNOSTE Nitinail Study completion estimated December 2022
Stryde honestly will probably be back before that, since even 2023 is very far away
Or, nuvasive can focus their efforts on resigning the specific telescopic junction, that is an area most likely to corrode or strip material due to how the lengthening works and amount of force needed from magnetic inside rod lengthening. The material itself is likely not the cause, just the design of the telescopic junction. Having that much friction in a tight area while still needing to be strong enough to be weight bearing and be tight (causing friction) and not break is tough design. Even in Precice material the telescopic junction area released ions and stuff like that.
Yeah that makes sense but the telescopic junction is probably the most complex and fundamental part of the whole design. If they fked up the mechanics of it that basically means going back to the drawing board. They will have to figure out how to make it so it can handle the weight, magnetically telescope on demand, and not strip or fail, which is why this was a hard design challenge in the first place. It took them years of making Precice nails before they even tried this and it looks like the design has now failed. I would guess 1-2 years to redesign it. Of course that's just my speculation.
Quote from: maximize on March 12, 2021, 11:16:21 PMI Just saw this thread which clearly answers why there is a recall on Stryde:
http://www.limblengtheningforum.com/index.php?topic=66325.0
You cannot have a medical device that rusts within the human body after only 6-18 months. This is likely unsolvable without requiring them to redesign the entire unit from new materials. That means unless you want to be the first guinea pig for the new one, or the redesign goes very very fast, this is a dead option for at least 1-2 years.
What are our options if we want a weight-bearing solution? I know there is the Albizzia nail in Europe with Dr. Guichet. That has the disadvantage of needing ratcheting which I think might disturbs the callus in an unideal way (although who knows - perhaps it actually stimulates the callus in a way like accordion maneuvers do). Is this option with Dr. Guichet still considered a good one?
Then there is the BetzBone with Dr. Betz in Germany. Is he the only one who uses it? Any perspectives on the quality?
As far as I can see there is no weight-bearing option in North America now. Is that correct?
Thanks.
Both nails you mentioned and generally any full weight bearing nail except stryde is garbage.
Better to use precise 2 and wait some months till you can bear weight otherwise do external tibias.
That said, I doubt that stryde will be redesigned. Corrosion is very problematic and dangerous but I believe they'll find a solution without redesign the nail. We'll see.
It's a pity though that the best nail we had for LL have so major problems and is really a risk for anyone who used it. I really hope that at least LLers who used it won't face any health issues.
Quote from: Body Builder on March 12, 2021, 11:43:12 PMBoth nails you mentioned and generally any full weight bearing nail except stryde is garbage.
Better to use precise 2 and wait some months till you can bear weight otherwise do external tibias.
Why do you think the Albizzia is garbage? It's one of the oldest weight bearing nails with few failures I'm aware of. The ratcheting may or may not be a good thing actually when I think about it (when people don't consolidate the surgeons make you "accordion" to stimulate callus - maybe that's not much different from racheting). Given that it is just mechanical and no magnetic telescope it seems improbable to fail.
It's a shame Guichet doesn't license it and let anyone else use it. I think he's the only one that has it right?
I know the Betzbone used to be prone to bending but according to recent diaries Betz has redesigned it to fix those issues so that may not be the case anymore.
Man the psychological burden of being in a wheelchair for 6 months - to not even be able to get on/off the toilet without worrying you're going to snap the nail - I don't know if I could handle that. I'm impressed by anyone who can.
Quote from: maximize on March 13, 2021, 12:02:33 AMWhy do you think the Albizzia is garbage? It's one of the oldest weight bearing nails with few failures I'm aware of. The ratcheting may or may not be a good thing actually when I think about it (when people don't consolidate the surgeons make you "accordion" to stimulate callus - maybe that's not much different from racheting). Given that it is just mechanical and no magnetic telescope it seems improbable to fail.
It's a shame Guichet doesn't license it and let anyone else use it. I think he's the only one that has it right?
I know the Betzbone used to be prone to bending but according to recent diaries Betz has redesigned it to fix those issues so that may not be the case anymore.
Man the psychological burden of being in a wheelchair for 6 months - to not even be able to get on/off the toilet without worrying you're going to snap the nail - I don't know if I could handle that. I'm impressed by anyone who can.
lose a lot of bodyweight beforehand ideas...
no seriously.. I think waiting for STRYDE is obsolete but if you really want to you can and should ditch the forum, focus on something else and do it in a couple of years. I doubt anyone who seriously is down with the topic would be online here if they plan to do it in 2023 or even later though.
That being said I agree with @Body Builder, the best and safest option probably is precice. Some here recommend Betz though and it definitely has it's pros but if it's worth it, one has to evaluate it for themselves.
Quote from: maximize on March 13, 2021, 12:02:33 AMWhy do you think the Albizzia is garbage? It's one of the oldest weight bearing nails with few failures I'm aware of. The ratcheting may or may not be a good thing actually when I think about it (when people don't consolidate the surgeons make you "accordion" to stimulate callus - maybe that's not much different from racheting). Given that it is just mechanical and no magnetic telescope it seems improbable to fail.
It's a shame Guichet doesn't license it and let anyone else use it. I think he's the only one that has it right?
I know the Betzbone used to be prone to bending but according to recent diaries Betz has redesigned it to fix those issues so that may not be the case anymore.
Man the psychological burden of being in a wheelchair for 6 months - to not even be able to get on/off the toilet without worrying you're going to snap the nail - I don't know if I could handle that. I'm impressed by anyone who can.
Guichetnail and Betznail are obsolete mechanical nails with few differences between them.
Mechanical nails make rehabilitation much longer and lengthening too painful. Also there were many cases of the nails lengthen with very small movements without the will of patient so they are dangerous too.
Precise 2 is.partially weight bearing so I don't believe.you will be more than 3.months in the wheelchair.
The best though is for someone who wants internals to wait until there is a clear decision about stryde. In a few months we will know if it is safe and back to market or no.
Till then noone should make its final decision.
Quote from: Body Builder on March 13, 2021, 01:23:20 AMGuichetnail and Betznail are obsolete mechanical nails with few differences between them.
Mechanical nails make rehabilitation much longer and lengthening too painful. Also there were many cases of the nails lengthen with very small movements without the will of patient so they are dangerous too.
Precise 2 is.partially weight bearing so I don't believe.you will be more than 3.months in the wheelchair.
The best though is for someone who wants internals to wait until there is a clear decision about stryde. In a few months we will know if it is safe and back to market or no.
Till then noone should make its final decision.
Hey mate you seem to have some knowledge, what is your opinion on being lighter than precice max weight limit? for example if I would be able to fit the 12.5mm precice nail I am 30lbs down the maximum weight limit. I know I probably won't weight bear but maybe I can stay on crutches most of the time? I asked paley already but they told me they can't tell in advance. so I am only able to speculate.
About the decision, I'd recommend that too (if you are not bound to a time window like me), however, I'd not be too optimistic. the best case of stryde returning would be end of the year ish
Quote from: Body Builder on March 13, 2021, 01:23:20 AMGuichetnail and Betznail are obsolete mechanical nails with few differences between them.
Mechanical nails make rehabilitation much longer and lengthening too painful. Also there were many cases of the nails lengthen with very small movements without the will of patient so they are dangerous too.
Precise 2 is.partially weight bearing so I don't believe.you will be more than 3.months in the wheelchair.
The best though is for someone who wants internals to wait until there is a clear decision about stryde. In a few months we will know if it is safe and back to market or no.
Till then noone should make its final decision.
That's fair to say "wait to hear what happens with Stryde." But I am just very doubtful there will be a quick resolution to the problem. If they do a redesign or alter it in any way (which is inevitable - they must fix something in the design), they will then have to do trials on that to get it approved first as well before general use too, right? That could cost another 6-12 months just to get re-approval on their modifications. That's my guess anyway.
In the mean time, either way, on what basis are you so against the mechanical nails? Just because something uses simpler technology doesn't mean it's bad technology. You can see in his journal how incredible for example tallertree did with the Betzbone. He posts lots of videos of him walking around through his recovery which was smooth and uneventful:
http://www.limblengtheningforum.com/index.php?topic=6689.0
Obviously there will always be good and bad cases but I don't think it can be said a mechanical nail is certainly so poor or "obsolete" an option if it has the potential to give such a fantastic outcome and experience.
As far as I can tell the only major disadvantage of the mechanical nails is you can't ratchet them back down to close a gap in case of nonunion. But I presume that could be managed by just going slower and not progressing unless you see a good callus forming in the gap. If no callus, don't progress and instead work on PEMF/LIPUS bone stimulation until it forms.
I haven't heard of unintentional ratcheting - that would be no fun. But even the magnetic devices have a failure in their distraction method. In this study 2% of the PRECICE units failed for distraction. More importantly between 11% and 41% of the PRECICE nails bent/broke or had some other structural instability. Probably from people accidentally putting pressure on them or weight bearing too soon. That's a pretty big percentage.
I'm open to any perspectives and curious for your further thoughts. I am just reaching a point where I am ready to finally do this and I thought Stryde would be perfect - don't have to go to Europe, weight bearing in New York or Florida - and then this happened. Personally I'm not in the mood to wait another 2-3 years. I'm too old already.
If Stryde turns out to be dead for 1-2 years, I think on my current perspective I would likely go with a mechanical nail. Or if not that, just give up and never do it at all.
Quote from: maximize on March 13, 2021, 03:15:36 AMThat's fair to say "wait to hear what happens with Stryde." But I am just very doubtful there will be a quick resolution to the problem. If they do a redesign or alter it in any way (which is inevitable - they must fix something in the design), they will then have to do trials on that to get it approved first as well before general use too, right? That could cost another 6-12 months just to get re-approval on their modifications. That's my guess anyway.
In the mean time, either way, on what basis are you so against the mechanical nails? Just because something uses simpler technology doesn't mean it's bad technology. You can see in his journal how incredible for example tallertree did with the Betzbone. He posts lots of videos of him walking around through his recovery which was smooth and uneventful:
http://www.limblengtheningforum.com/index.php?topic=6689.0
Obviously there will always be good and bad cases but I don't think it can be said a mechanical nail is certainly so poor or "obsolete" an option if it has the potential to give such a fantastic outcome and experience.
As far as I can tell the only major disadvantage of the mechanical nails is you can't ratchet them back down to close a gap in case of nonunion. But I presume that could be managed by just going slower and not progressing unless you see a good callus forming in the gap. If no callus, don't progress and instead work on PEMF/LIPUS bone stimulation until it forms.
I haven't heard of unintentional ratcheting - that would be no fun. But even the magnetic devices have a failure in either direction (which they call "runaway" if it tries to expand too much).
I'm open to any perspectives and curious for your further thoughts. I am just reaching a point where I am ready to finally do this and I thought Stryde would be perfect - don't have to go to Europe, weight bearing in New York or Florida - and then this happened. Personally I'm not in the mood to wait another 2-3 years. I'm too old already.
If Stryde turns out to be dead for 1-2 years, I think on my current perspective I would likely go with a mechanical nail. Or if not that, just give up and never do it at all.
I am a current Betz patient who was originally scheduled with stryde (look at my old posts). I am only 4 days post op so haven’t begun distracting yet but to say this nail is obsolete isn’t true as it’s on of the few weight bearing nails on the market for the foreseeable future and stryde obviously isn’t as good as we initially thought if it causes rust issues like that. All nails have their limitations but feel free to check out my diary as I will update again when I begin lengthening. Precise is probably the safer nail with more research but you will be wheelchair and walker bound for months no matter what anyone tries to tell you.
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