Freedom Lumbar Disc Surgery - Anyone else?

[dbalkema]

Hey... My name is Dan.

I have just completed 1 week of surgery recovery. I had the Freedom Lumbar Disc inserted at the L5/S1 Level at Texas Back Institute with Dr. Richard Guyer.

I was interested if there was anyone else involved in the Axiomed Freedom Lumbar Disc / Pro-Disc Clinical Trial around the Country. I know the Texas Back Institute and a place in Durham, North Carolina are running the trial.

I'm just curious to see what you think. If you wouldn't mind filling out the form and letting us all know what you.

I'm looking forward to hearing from you.
Thanks,
Dan

NAME:
HAVE YOU HAD SURGERY YET?:
WHAT DISC DID YOU RECEIVE?
RECOVERY TIME?
WOULD YOU DO IT AGAIN IF YOU HAD THE OPPORTUNITY?

[Deborah]

I'm glad you appear to be doing well after surgery! Congratulations!

I checked on clinicaltrials.gov and it appears the third location for trial is in Berlin, Germany. My hub has a 2 level lumbar problem, so he wouldn't have qualified for the new disk. He's going to have a hybrid with fusion at L5/S1 and TDR Prodisc at L4/5.

I see the trial just started last September... I'm sure we'll all be interested in knowing how the Freedom disk fares in trials. Keep us posted!

D

[treefrog]

Darn my two levels . I live in Durham, NC - that would have been perfect. Oh well.

[trkdoc714]

Cathy,

You may want to inquire anyway. I remember in both the ProDisc and Charite trials they performed dual levels on a few patients. All they have to do is appeal to the FDA for permission.

Hope it helps,

Bob

[Deborah]

Cathy,

Be careful what you wish for... make sure you know all about the particular brand of disc replacement before seriously considering it. Please realize that doctors aren't your best source of information... they have to do what is needed, what is being tested, what conforms to their study. I do think you should be informed of all that's available... then you decide what makes sense for you specifically. I know all too many who were caught up in the goals of a doc at their own body's expense.

I assume everyone knows there are phases of trial, and early phases are generally .... well, it's untested (and foreign doesn't count for much because procedures and docs are differing. Plus, early phases tend to be random... is it really ok for you to have a random choice of one or another TDR unit?

All that said, for all who are 'at the end of their rope' ... anything looks good. But remember, within the scope of what's available there really are a lot of choices to be made.

Then there is the ever changing face of the insurance "hell' aspect. Many insurance companies are changing their opinions frequently. It's always ok to 'try' to get something approved for coverage. It takes a LOT of persistence, but with data and docs in hand, it can be done. It's exhausting (in our case, hub who is the worst pain patient really couldn't help with all that... it had to be me. So if you have someone on your side to fight the case... go for it! There is NO reason for insurance not to be covering these surgeries...

.... that is ONE level TDR (I think Prodisc L is about it for now, although it's not a bad choice, proven and track record). BUT there is also HYBRID available... if its the lowest levels of the spine... look at the data showing TDR v. fusion for L5/S1. Longer recovery for sure, but with L4/5 with a TDR it also means movement and should be longer lasting.

I know it sounds like talking through my hat, but I have it on good info that the multi level lumbar disk surgery did quite well... and final report was turned in June 2008, meaning the FDA has to give an answer within 18 months of that. SO... it is something that can happen. In my hub's case, it's just too far out... each week is hell and he needs to survive the wait. He's completely unable to live life at this point, and that's been for many many months.

So don't give up. PLUS fusion isn't a bad choice for many. If you KNOW disks are pain generators... and if there aren't other problems, oh my, I'd fight!

Good luck... and blessings!

D

[ctesch]

I am about to have a disc replacement (Charite) at L2-L3 at the Texas Back Clinic. I've done some research and fear that perhaps Charite is not the best choice.

Why would you choose the Freedom disc? Does it have a better center or rotation?

Cathy

[treefrog]

I wonder if we couldn't get a discussion going on the differences between the different discs that are available. Hmm, maybe I should start a new thread. But, not until I get some sleep.

[ssullivantx]

Hi Dan,

I just had TDR surgery at Texas Back Institute on 3/26/09, with Dr. Zigler. I am home now, and doing well in recovery. Pain is manageable, and no complications that I can tell so far. However, I am curious--you said that you were in the trial also and had the Freedom Disc implanted in February (I believe). When I woke up from surgery, I asked Dr. Zigler which disc they used with me, and he said that the study prevented them from telling patients for 2 years. (Thus, I know I had either the Prodisc or the Freedom Lumbar Disc). Can you tell me when you found out?? I was told before the surgery that I would know which disc I received when I woke up in recovery, so to later be told that it would be another 2 years before I got the information is disconcerting, to say the least.

Thanks!

Susanne
___________________
L5-S1 Rupture Oct 2007
TDR March 26 209 (Freedom Lumbar Disc Trial)

[kimmers]

Susanne,

Just to interject. You will probably figure it out if you see an x-ray of what is in your back. If you check out the different ADRs and what they look in the back, often you can tell which one you have.

k

[ssullivantx]

Thank you so much! That never occurred to me (although it makes perfect sense) and I really appreciate the advice