Stryde is dead and won't be back without a full redesign. Alternatives?

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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.

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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.

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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.

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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.

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Quote from: RB on March 13, 2021, 03:23:48 AMI 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.

Wow dude that must be so exciting. I kind of wish I was in your shoes right now. Hope you're enjoying the pain meds. Good luck! I hope it goes well for you. Imagine how happy you'll be to be taller in just a few months.

Are you from Germany originally? How long are you staying in Germany for?

How quickly has Dr. Betz suggested you distract? Has he said much about his strategy for controlling the rate of distraction to prevent nonunion? Ie. Do you just go at a standard rate and then he will tell you to slow or speed up based on the serial x-rays?

Since the device is weight bearing, my thought would be going slower would probably be safer to avoid the risk of nonunion. It shouldn't slow you down too much in terms of your walking either way since the nail can take your weight fully. ie. Unlike PRECICE you don't need to "rush" the expansion or consolidation, since you can walk with or without consolidation.

I wonder if you can get a chance to ask before you leave his facility what he thinks of the article posted in the OP here. One of those PEMF devices like the OssaTec could theoretically cut your healing time by 25% according to that study and cut the risk of nonunion considerably too.

Congrats again on taking the plunge. I hope you will keep letting us know how it all goes. Everyone's experience is helpful.

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Quote from: KiloKAHN on March 13, 2021, 04:07:45 AMThe problem with the Albizzia nails and variants is that there's no way to reverse lengthening and it's possible to get accidental clicks that keep you distracting when you shouldn't. Unicorn's case with the Guichet nail was particularly bad.

The Ilizarov frame hasn't gone anywhere and it's tried and true. Tibia lengthening can still be done just fine, and for femur lengthening Precice 1 can still be used.

KiloKAHN it's good to see you still active around here. I read your journal and followed your progress back when you had your frame on. Your calmness and perseverance through it despite challenges were honestly inspiring. It showed me the value and importance of just staying steady if you're doing LL.

How has life been the past 5-6 years now as a taller man? Has it just become so normal that it's boring now? Or are you still enjoying it? What's been your experience with women (eg. dating) after getting taller? Any negatives all these years later?

The idea of accidental clicks is terrifying. Unicorn's journal was removed so can't see it anymore. That would presumably represent a faulty device right? Or is it more because your bones become loose so the ankle might accidentally twist on you? Or both?

Either way, perhaps you could prevent it with a brace to keep the leg straight. If you wore something like this I presume it couldn't accidentally click (can't twist, can't click) and you could still get around:

https://www.aliexpress.com/item/32863033836.html

Would not be subtle in public unless you wear super baggie jeans over top. But I imagine it's only some rare faulty devices or "loose" people that might have this issue so most people would never have to worry about it. That sort of brace could just be a "backup" if you prove prone to the issue or get a bad nail that is.

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Quote from: E Z on March 13, 2021, 07:11:40 AMWhat health issues could this cause? As a stryde patient, I’m extremely worried right now. My nails are still in and it has been almost 1.5 years post-op

I honestly wouldn't worry much at all. You may have actually gotten extremely lucky. You got to use the otherwise best nail out there before it got pulled from the market for reworking. Now the rest of us no longer have the choice.

I presume you had no nonunions or other serious issues. No nail breaking/failure. No manual clicking to deal with. And now you're taller and can get it out in 6 months or so.

If I was you, I would get some blood tests for metal levels. Someone posted in another thread about their chromium levels being high from the Stryde which is part of why this recall is happening. Unless it's insanely high I wouldn't worry though.

Even seeing these cases and issues, if I had the choice today between the Guichet/Betz mechanical nail and the Stryde I might still pick the Stryde and accept the corrosion and metal leaching if it happens.

Maybe the Stryde 2 when it comes out will be the perfect nail for everyone. But currently as we can see from this discussion so far, there exists no perfect nail in 2021 and if you want to get it done and not wait for who knows how long, every option still comes with compromises.

I wouldn't regret the Stryde if I was you because it was the best option at the time. And even with these issues it still might be the best option out there now (if it was still an option). If you avoided the known major risks like nonunion or becoming crippled, perhaps focus on considering yourself lucky and being happy for your new height.

On the other hand if you want to stress yourself out you can read about chromium toxicity. But if you're going to do that at least check your levels first.

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Quote from: Christopherbulder on March 13, 2021, 10:39:25 AMthe guichet  albizzia nail is a super sturdy nail no breakage or problem the only problem actually the twisting for the cliks can be painful twisting the leg 21 times a day from the start is torture

Hey man, how are you feeling all these years later? You had a pretty incredible/fast recovery, likely from your incredible muscle genetics (lucky you) and good training background. I think you used to work with Guichet right? Do you still?

What's your perspective on the subject of accidental clicks or the risk of nonunion since those mechanical devices can't telescope down? Do you think this can be adequately controlled by going slow enough with distraction and watching for callus bridging (eg. distend to 1 cm, wait for callus, then proceed, etc.)? Or what do you think?

My guess is if you know you can't go backwards you shouldn't keep expanding until you're SURE there is callus there at every 1 cm increment, but perhaps on the other hand waiting for callus might make "clicking" too hard so that's why people rush it.

If the nail is sturdy nonunion is the biggest risk probably. So if the device can't go back down you need a very good universal plant to prevent it. I think it would be crazy to rapidly and blindly distract to 7-10 cm and then just hope for the best, although it seems that's what many people do. Sounds like Russian Roulette.

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Quote from: PANDA:BEAR.. on March 15, 2021, 05:35:33 PM

Looks like I wasn't far off. Except I would have never guessed their primary solution is to coat or encapsulate the device. That's creative.

To summarize, the main point is at 14:30. He says of 122 implants that they followed up in a year on:

- 36% of the bones were totally normal
- 64% total of the bones had abnormal changes

Of those 64% with abnormal bone reactions, it was broken down into:

- 40% had extra bone thickening (hypertrophy)
- 3% bone breakdown (lysis).
- 21% had combination of hypertrophy and lysis.

The issue seems to develop at 6-12 months once the distraction is done. There have been no fractures so far from lysis, but that would be the main threat. He didn't talk about what you'd need to do if you got bad lysis (as none have had it so far that bad), but I presume you might need a permanent nail or grafting if it fractured and wouldn't thicken back up.

Then at ~51 min he talks about two possible solutions NuVasive is working on:

- Coat the junction in polyethylene (plastic)
- Add a sleeve over it to seal it the junction

He guesses if they try to fix the problem (rather than just re-release it) it will most likely happen by 10 months from now and maybe longer.