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-   -   fda trial followup visits, how many? (https://www.adrsupport.org/forums/showthread.php?t=5313)

myprodisc 01-09-2005 07:17 PM

Are you in an fda trial? How many follow up visits are you required to make? Before surgery I was told 4 visits over 2 years. The latest schedule I received has me scheduled for 7 visits, over 3 years.

Scott

florihupf 01-09-2005 08:46 PM

i got:

6 weeks
3 month
6 month
1 year
18 month
24 month

-> six follow ups

ie. that's for the single level prodisc trail

gary 01-09-2005 09:10 PM

for me,and my surgery was 07/2002,as stated in my
"consent to participate as a subject in a research
project" contract is as follows:
2weeks(remove staples/stitches)
6weeks
6mos
12mos
18mos
24mos
and my surgeon wants to see me every 12mos just to monitor my situation.

Harrison 01-10-2005 10:19 AM

Ditto, from this Charite' boy -- it would seem that the FDA studies are similar among disc mfr's...

Linda 01-22-2005 01:09 AM

I had a 2 level at L4/L5 and L5/S1 in October, 2002. I was asked to participate for 2 years. I had 2 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 18 months and 24 months. I just recently had my 24 month and they asked me to participate for at least another year. I just had 2 level C5/C6 and a C6/C7 prodisc implants put in my neck in Germany on Wednesday the 12th of January, 2005. The German doctor got my email address and also wants me to participate in answering the questionaires for them too. So far I am doing great and it really isn't that big of a hassle to participate.

Linda
l.roberts@comcast.net

myprodisc 01-24-2005 03:10 AM

Thanks all, I havn't looked over the paperwork to see if the info was there. I'm usually very through with that kind of stuff. I could have missed it. I talked to the trial coordinator about it. They offered to work with me to keep me in the trial. It is a pretty big impact to my savings acct, 1000$/visit, travel, hotel, car etc. The docs schedule, fri aft and mondays off, plus the sat night stay make it a scheduling pain. I'm just grumbling. I look forward to the visits. Maybe I can talk the doc into coming up for a guided fishing trip, save me one and earn alittle of my money back ;-)

Linda 01-24-2005 09:09 AM

FYI,

I live in the Dallas area and Dr. Rashbaum did my surgery for prodiscs at L4/L5 and L5/S1. He and Jennifer Carson, who coordinates the FDA studies told me recently, that if people could not afford to stay in the program, that TBI would now pick up the costs of travel for out of state clients. They really are needing people to stay in the study. I will be going in Wednesday to see Dr. Guyer to follow up on my new neck implants that Dr. Bertagnoli did on January 12th.

Linda


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