[Deborah]

I'm not a professional but I know my husband has had a wonderful recovery after surgery in the US. He wasn't part of any clinical trial, but used FDA approved hardware (which certainly doesn't mean 'perfect' but at least it's finished trials).

I can't speak on Stenum but know that in general, when in a foreign country it can be easier to misunderstand what is going on and of course, also easier to be misled. I do think clinical trials in general are misunderstood (and those done outside the US are using entirely different standards so need to be examined in that light).

I think it's critically important any patient *minimally* first researches exactly what phase a trial is in and what that means - each phase is dramatically different in providing solid data which might help one determine the best options. Of course doctors will explain their preference but anywhere you go, if they are involved in clinical trials, they are quite likely to 'promote' whatever they are currently trying to test... yes, making you a lab rat. That may be necessary or preferable in some cases, but certainly not in all cases. But it is, after all, a *trial*. One should think very long and hard before jumping into any Phase I trial (with the exception of those with a prognosis of death in a short time, as in many cancer trials). The other side of that argument is that, of course, you could miss out on the best of the best (but no one has proven it yet) or you may be a special case that really requires whatever is unique about this new device and feel personally confident of that choice.

In the end, many drugs and pieces of surgical hardware have gone through trials well and ended up trashed because they were nowhere as good as whatever else is out there. Trials can be somewhat misleading and statistics often depend upon the surgeon and their handling of that particular device and your particular problem. So it's always a bit of a gamble. As I recall, when my husband had his surgery, the prognosis in general was that '80% of the patients had a 15% or better reduction in pain' meaning the other 20% had none or got worse... and among the 80% it ranged from 15% improvement to close to 100%. He was blessed with very close to 100% (it's been one year since surgery and he felt the improvement by month 4 post surgery). He was, however, a 42 year old otherwise healthy man (except the damage caused by 8 years of being in bed and on drugs of all kinds with various attempts at therapies and surgeries to help reduce pain).

Still, there's no denying - he's well. Period. Dr. Hu worked a miracle with her petite hands and the help of other surgeons (vascular, etc) and a wonderful device. He considers it a success even if he does get worse again - he frankly was at the point of giving up on life altogether. Even I didn't realize how horribly the medication was affecting him - until he no longer was on it. It didn't matter then, without the meds, he was completely unable to function.

Bottom line on surgeons and facilities, I think it's important to consider why a surgeon may be motivated to make a certain recommendation (including the massive problem with conflict of interest in making those decisions at most locations; the exception generally being large top quality teaching hospitals). It should be noted that the vast majority, if not all surgeons 'well known' are privately invested in many device manufacturers, own the facility for the surgery as well as PT, etc, and therefore have an obvious vested interest in doing the surgery, particularly if it's in a trial area they are involved in. That doesn't make them bad, it's a fair argument to say they're also 'betting their lives' on what they're doing. But it can feel uncomfortable, for sure (as a patient).

In some cases it can be affected, even unintentionally, by ongoing trials or studies. This (back surgery) is a very imperfect science - they don't even have conclusive proof of how to diagnose the problems in many cases requiring (possibly) ADR. But what investigation you can do on your own, should be done.

In our case, we went out of state to find who we felt was the very best doctor in my husband's case. We were lucky enough to be able to discuss doctors with the North American head of the manufacturers company, as well as many insurance companies, and researching many studies. In the end, CMS knew the doctor by name purely based on reputation and I do think that affected his ability to get preapproved for the surgery normally denied.

Everyone needs to go about making those choices in their own way. In the end, the reality is the outcome can be any of a broad range of possibilities so you're only going to feel satisfied if you've investigated as impartially as possible. Just reading the 'good' stories from other patients isn't a practical way to compare - although they definitely can head you in the right direction. We did investigate Stenum among many others and had personal reasons it felt wrong for my husband's case.

God bless all of you still hunting help for back pain - it's incredibly debilitating, misunderstood, and not yet even diagnosed 'well'. The most I can suggest is to follow your instincts and NOT make any quick decisions.