If trial is for 2 levels, can trial site decide to do only 1?

[spacemusic]

According to info posted on clinicaltrials.gov, the Discover disk made by DePuy is in clinical trials for one and 2 levels on C-spine. I contacted a hospital in my area participating in the trial. They said they're not doing 2 levels.

What does this mean? Could another hospital in the trial use the same artificial disk on 2 levels? I know the surgeon in the Boston hospital I contacted, and he's participated in other trials (Charite, I think).

[Angel]

I am not exactly sure of the answer to your q, but I am trying to get into a clinical trial too and I'm going to tell you what I think it is.
The study requires a certain number of participants for each study. I am looking at the Mobi-C study, which was also one and 2 level. When it first opened every doctor participating need to get a the certain number of patients for the study. When they reach the quota it closes. The Mobi-C study for 1 level is closed in Tulsa OK, they are only doing 2 level now. The docs in Plano TX are still doing 2 also, which is where I'm going.
You can try to see if another doctor is in that study and doing 2 levels or look for a different trial doing 1 level, which most of the studies are only 1 level. Hope this helps. Angel

[LBP]

Yes yes yes, If you want to get into a 2 level trial, call around to all the centers.

I'm not up on the cervical trials but I banged my head against the wall a few times trying to get accurate information at the end of the prodisc 2 level lumbar trials. It was almost impossible to get a knowledgeable person on the phone to help you - and explain how it works, and then equally impossible to get the same story twice between different offices. It was very frustrating and suspicious how some people got in and others didn't at the end. I am still VERY bitter about the wall I hit trying to get straight answers.... the lack of open full disclosure from dr offices, manufactuers and the fda is overwhelmingly frustrating.

Sometimes if certain spots go unsued at one center, they might be transfered to another center but it's unclear how and when that might happen and which center might get them!

Try hard to get into the trial because I need a 2 level lumbar and because I missed out on the clinical trials, I am still waiting years later. And the FDA still hasn't approved Prodisc for 2 levels even though 1 level has been a approved for over a year.

IF this is what you want, fight for it. It could be forever before the FDA gets around to approving 2 levels and another decade before insurance companies are on board!

[Liz]

There is also something called "compassionate exemptions" where centers in participating trials can request a "compassionate exemption" from the FDA for a patient once the trial has closed or filled all the spots. I was offered this a few yrs ago for a 2 level Prodisc (sorry LBP) by my local ortho surgeon but at the time I wasn't ready to commit to ADR. He never filed it w/the FDA so I'm unsure how many of these are granted. Little did I know that I should have tried for the exemption b/c 3 yrs later after unsuccessfully fighting my insurance company for over a year for approval I had to pay out of pocket for a 2 level with a different surgeon. I could have saved a lot of money, time and suffering! I'm having a difficult recovery but I'm told that is due in part to my waiting so long to have surgery.
My local surgeon had treated me for many years so perhaps that comes into play for compassionate exemptions.

Even if you get into a trial or receive a compassionate exemption, if your insurance company does not authorize it they will likely not pay for any complications or add'l surgeries.

Good luck!

[LBP]

The story I got was that there was a different criteria for those who could qualify for a compassionate use exemption (possibly even a limit to the number of compassionate use exemptions as well). If I remember correctly, it was explained to me that if you met the criteria for the original trial you were disqualified for what's called "compassionate use." In Liz's signature above, it states she had scolosis. I'm pretty sure that would have disqualified her for the original clinical trial which is why she might have been offered a "compassionate use" exemption.

I do think certain centers were/are awarded more spots in the trial. I got the distinct impression Dr. Delamarter got more spots in the ProDisc trials than the trial surgeon I was working with but supposedly by the time I learned about this stuff it was too late.

[spacemusic]

Thank you all for your replies. I saw my neurologist yesterday who I hadn't seen in over a year. I asked her what she knew about ADR. She said "it's not for you, you have ossified ligaments and degenerative joints [or something like that], and replacement disks won't help you. In other words, you have very bad arthritis in your neck." I asked about the disks causing some of my problems and she said no, it's probably bony protrusions and my spinal cord may be affected.

She ordered another MRI, so I'll wait and see what that shows before I pursue more ADR research. I've been consistently diagnosed with cervical radiculopathy, among other things, but she thinks my neck pain is from arthritis.

[Harrison]

Spacemusic, email or call some time! I live in your neck of the woods and would be happy to help.