Questions about Balloon carpal tunnel plasty
Hi, while I was looking for info about cts surgery I came across balloon carpal tunnel plasty which seems to be by far the best surgical option BUT there is little to no other information about it. For something patented in 1993 it is still being called "experimental" and it seams only a handful of surgeons even do it. It's not even talked about as an option by the Dr.s I've spoken to or the sites I have visited. My question is why? Does anyone have info on the reasons? Has anyone had it done? Why is something that looks to be so much better not being talked about more? Looking for answers, thanks in advance.
Thank you for your response. I would have assumed a procedure (carpal tunnel release) that has been done sense the 1930s would have made more progress than just adding an endoscopic option. When I saw a procedure that saves the ligament and claims the same relief of other options I got very confused as to why it isn't the "bench mark" in the industry. Patented in 93, and from all accounts continuing glowing results, it is only performed by a handful of Doctors. How is that possible? There is nothing to indicate there are problems or issues with it that I could find so why hasn't it become more popular? If it isn't a better way, then why do these doctors perform it? I made a few calls and only found bits of information. The assistants I spoke with have heard of it in passing but don't know anything about it. The office that does do it says they do it regularly but a lot of the time insurance doesn't cover portions of the procedure. I just wish there was more info why it hasn't progressed into the main stream. It seems lack of information could indicate issues with it, but it also could be strictly a money thing. I can't find what it may be one way or the other. Apparently, for whatever reasons, it hasn't been the breakthrough it seems to be to become "the it procedure" in the industry. Seeing as this (balloon tunnel-plasty) has been around for over 20 years and is only done by a very small group of doctors says something I guess. That makes it a bit easier to go with the endoscopic release option.
It still scares me that the ligament will be cut and I am worried about permanent strength loss. This research was done for my wife, who got cts when she was pregnant and it never went away, that was about 10 years ago. It is not debilitating but she does have to sleep with braces and her hands give her problems during repeated activity. A few years ago the electrical nerve test made her pass out but she was not ready to get the surgery. Now she decided it's time so she goes in shortly. I got my hopes up for her when I started reading about it, too bad there isn't more to go on.
I think the main reason that it has not been widely adopted is simply that the people who developed it cannot be bothered to do a proper randomised clinical trial and publish it in a peer reviewed journal. We have been badly burnt by things like the latest trendy new hip prosthesis turning out to have much higher complication rates than the standard one and similar episodes so we try to practice 'evidence based medicine' nowadays and that means that we need properly conducted randomised studies, preferably replicated by several different groups, to convince us of the merits of a new drug or procedure.
If you subscribe to my view of the mechanics of the carpal tunnel then it probably doesn't matter how you do the operation, traditional open, endoscopic, multiple needle fenestration, balloon, utrasound guided thread-saw - the end result in all of them is, one way or another, disruption of the transverse carpal ligament. I don't see that it really matters whether you cut it, tear it apart or weaken it so much that it falls apart. I don't believe the people who say they can 'stretch' it though, either by external or internal manipulation - the mechanics of this just don't make very much sense and in any case if you did stretch it enough to lower the carpal tunnel pressure significantly that would probably have the same mechanical consequences for the wrist as cutting it in any case.
I think the big unresolved issues in CTS treatment at present are not exactly which operation to use but how to decide when surgery is actually necessary and what is the role of steroid injection. JB
Further to this I have just found a publication by Dr Berger in the somewhat obscure Pittsburgh Orthopaedic Journal in 2006. This describes the outcomes (SSS and FSS) in 45 hands treated with the open operation and 36 treated with the balloon. The outcomes over 24 weeks were broadly similar but it looks from the figures as though the SSS showed a sharp initial improvement with the balloon followed by a gradual deterioration between weeks 8 and 24, whereas the open group were slower to improve but were still getting better at 24 weeks. The FSS was better for the balloon procedure at 1 week but that is not too surprising as this is still in the acute recovery period for the traditional operation. By 24 weeks this difference had disappeared.
I remain unconvinced that Dr Berger is really stretching the ligament. I think it is equally plausible that he is simply squeezing water out of the tunnel. A group from the Cleveland clinic (Li 2009 and Li 2011) has carried out cadaver studies in which they applied forces up to 200N with a mechanical device or 200mmHg with a balloon within the carpal tunnel to try and stretch the ligament - they found that this did increase the cross sectional area of the carpal tunnel but it did this by making the tunnel more circular rather than elliptical. The length of the ligament stayed exactly the same, which just demonstrates how tough it is. Apart from seeing someone else repeat this work I think we also want to see some long term outcomes/recurrence rates. JB
It is indeed 'experimental'. I have seen no satisfactory scientific studies demonstrating that it is either more or less effective than the established procedures and there are some reasons to be cautious about it I think. If the balloon inflation really does generate a high enough pressure in the carpal tunnel to physically stretch the transverse carpal ligament, which is as strong as steel in tension, then pressures that high could possibly damage other structures in the tunnel, which would be exposed to the same or greater pressure, at the same time - most notably the nerve itself. It really needs a proper randomised trial doing. There is an uncontrolled series reported on a manufacturers website (Berger) by the doctor who I think probably holds the patent for the device used to perform the procedure but this does not seem to have been submitted to any peer reviewed journal - draw your own conclusions. JB