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Reply With QuoteThere's a lot of really good information and suggestions in this Kathy. Thanks so very much for posting. It's given me some more ideas
This is a discussion on How Many of You Would Consider Being in a Trial? within the Spine Patient Support: Body, Mind & Spirit forums, part of the Social and Support Forums category; Ughh, I was just adding to my response when my computer battery died. So, here it is... On the trials, ...
Ughh, I was just adding to my response when my computer battery died.
So, here it is... On the trials, the big thing to consider is that these are usually devices that are approved in other countries. There are people on these boards who have went to Germany and received these exact same devices, and paid for it. They do this because they can't get the device here and feel it is better, more advanced, etc. than what is on the market here. I received the Active L, it has been in Germany for quite some time, it is just not approved here yet because the FDA process is slow. So, I don't really see a difference in going to Germany and paying for device A or getting it for free in a clinical trial in the US??? To me, the only difference is one person paid for it and the other didn't.
As far as doctors doing these surgeries, most of them are the top doctors in the US. TBI does many of these trials, Dr. Bitan has done trials, Dr. Yue, Dr. Garcia, and many of the other top doctors in the ADR world. You can pick which doctor does your surgery, that is not something the trial determines. I had 10 different doctors and locations I could go to for my trial and after some research it came down to Dr. Yue or Dr. Garcia, were equally great surgeons. I chose Dr. Garcia, because of his sunny Florida location. It's not like you get some quack doing it. The makers of these discs want the disc to get approval, thus they will make lots of money. So, they are going to make sure that the participants are good canidates for surgery, that the surgeons are top notch and will do an excellent job and etc. In my opinion, you go through more rigorous clinical criteria to get into the trial (thus avoiding potential overlooked issues that some have after ADR), you get a great surgeon, who is probably also financially invested in the device being tested, so who is going to do the best surgery they can to ensure a great result. In the end, I think a trial is a lot more safe than just going to a doctor and trusting them and doing a surgery, because they say so.
Last edited by KBear; 10-31-2009 at 12:39 AM.
31 years old- 1/06- In wreck with 18 wheeler at 25 years old; 6/06- Head on collision on Interstate, both wrecks other drivers fault. Numerous MRI's, PT, chiropractic, acupuncture, TENS therapy, massage therapy, facet injections, epidural injections, Nerve study, Discogram, confirms pain in L4/5, IDET, decompression, Bi-lateral neurotomy L3/4/5, denied by insurance twice, in Active L clinical trial, had surgery March 17, 2009 in Miami, FL- received Active L disc at 29 years old. Pain and medication free as of October 2010!Mommy to Emma- 8 years, Ava- 6 years & had baby Eli after ADR, via c-section on March 25, 2011, completely pain free still!
There's a lot of really good information and suggestions in this Kathy. Thanks so very much for posting. It's given me some more ideas
Severe compression of spinal cord, flaval ligament, etc. at C4/5 & 5/6.
Herniation and compression, at L3/4 to L5/S1 plus spondylosis at the latter level. Severe allergy to most metals.
Three level surgery in Brazil with Dr. Luiz Pimenta on March 17/2010 using non-metal appliances. L5/S1-PEEK cage, ALIF; L4/5-PEEK cage, XLIF; C5/6-NuVasive NeoDisc. Three separate approaches, two minimally invasive. Currently minor residual back pain, from SI ligament and still overdoing things. Therapy and chiropractic treatments helping immensely. Gone from being almost bedridden to near normal activities including gardening. Life is gooooood!
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