[Toebin]

Tango Man,

Very tough choices involved with your case.

Harrison brings up some of the issues to consider that are vital to your individual case. And I would just bring up one other issue related to the clinical trial itself.

I am a "control" patient in a randomized ADR clinical trial (2 level). I went in knowing I may not get the devices and was also told up front that I would not know what I had been randomized FOR until I actually got into the OR... Lots to consider there knowing you might not be given the devices you entered the trial to get, and you have to really be sure your ok with whatever course of treatment is decided "for" you.

In my case I figured I either get the new devices OR I get the "gold standard" fusion and I felt I had nothing to loose.. HOWEVER, in my ignorant bliss I was not aware that the "standard" fusion contained some limitations on the type of fusion materials my surgeon was allowed to use. Which with 20/20 hindsight may have affected my outcomes post operatively.

I got wonderful care and have no issues with not getting the ADR's I had hoped for. As a matter of fact it was probably the best scenario for me. However there were some materials available that could have made me heal faster/better that my surgeon was not allowed to consider because of the clinical trials rigid definition of how the fusion would be performed (also very understandably).

Had I not gone for the trial my surgeon would have been free to use any material he felt "best" for my individual case. And in my ignorance I didn't know there were options related to that area of the process.

Insurance coverage was not an issue for me as the ADR's would have been provided as part of the trial , and my insurance would cover the underlying costs of the basic exposure of my spine to what ever type of repair was finally done.

So when considering becoming involved with a trial just make sure you address the "devil in the detail" aspects... on top of everything else.