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.
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