Nucleus Replacement

[sportsnut3007]

Hello, I was just curious how long does an fda trial usually take place for spinal products. I am greatly interested in nucleus replacement stuff as I fear one day I may need this because I am only 27 with a disc herniation and now suspected bulge on left side. I know the spinal wave nucore has been in fda trial I believe for 2 years. Also, if anyone can tell me a general idea if they think I will ever need nucleus replacement or adr bc i have had a herniation at l5-s1 measuring 6mm anto to posterior and 11mm in lateral dimension. I also know they have dascor out there with the balloon design in situ curing nucleus and replication medical has that expanding hydrogel one. Does anyone have any thoughts on which they think is best? Thanks for any help.

[KBear]

I can't say for sure how long they last, I know a few years. There are several stages of a trial, the first has a small enrollment and is alot about safety. Then there is a second phase and I believe a third phase. Either the second or third, usually last a couple of years, with the most people being treated in that time. You can on the FDA's website and read the exact procedures for trials and FDA approval. The legnth of time in the actual patient trial can vary, depending on how many patients are enrolled, how many dr's are participating and how quickly they recruit and operate on patients. I believe it is give or take 5 years from application to FDA approval. I would go on the website and read more, if I were you, because I am not positive on any of this, just a 'guesstimate'.

Also, on needing ADR or nucleus replacement, no one really knows why a small percentage of us fail conservative treatment and need more major intervention (it's like 10% of people with back problems who fit in this category.) My husband has a badly herniated disc, got an injection, and feels fine now. There are people with zero back pain, who have an MRI and have many herniations, DDD and other problem, yet feel fine. There is so much known, yet still so much unknown. I would suggest seeing several surgeons, when the time comes, and you have tried every conservative treatment possible and getting their opinions.

Last, back pain and problems doesn't discriminate based on age. I was injured at 25, lived in chronic pain for 3 years, and had ADR 12 days after my 29th birthday, earlier this year. Several people on here started having problems in their teens and early 20's. I believe Justin even had his first operation in his teens. Then, some people live to be 80 or 90 and never have any major back issues. I wish there were more certain answers for you (for all of us for that matter, there is no telling how long an ADR will even last... the first one implanted was just 20 years ago and he still has it; but beyond that, no one knows for sure)

[sportsnut3007]

Kbear, thank you for the information. I didnt mean to imply that back issues were only for older people. I am very sorry If I sounded like that Unfortunately with my situation and research I have discovered lots of young people with major back issues.

[Justin]

Hello, I was just curious how long does an fda trial usually take place for spinal products. I am greatly interested in nucleus replacement stuff as I fear one day I may need this because I am only 27 with a disc herniation and now suspected bulge on left side. I know the spinal wave nucore has been in fda trial I believe for 2 years. Also, if anyone can tell me a general idea if they think I will ever need nucleus replacement or adr bc i have had a herniation at l5-s1 measuring 6mm anto to posterior and 11mm in lateral dimension. I also know they have dascor out there with the balloon design in situ curing nucleus and replication medical has that expanding hydrogel one. Does anyone have any thoughts on which they think is best? Thanks for any help.

Hi SN,

FDA trials can take quite a while (many last over five years). There are also many post-approval studies that the FDA may require of a device or manufacturer of a spinal device.

It is hard to say if you need a nucleus replacement. Determining what a Spine Patient "needs" is based on many factors including but not limited to: patient trauma / injury, duration of injury, age, other comorbidities, past medical history (including alcohol, smoking and drug abuse), previous interventions (invasive and non-invasive), genetic predisposition, etc. There are also various contraindications for any given intervention.

I understand that you are trying to "feel things out" and "prepare for the worst / what ifs" in regard to your spine issues. I think the best advice I can give you is to get multiple opinions from well respected spine surgeons that have a lot of experience with many of the devices you are looking into. They will be up front with you regarding the specific indications for devices such as artificial disc replacement, nucleus replacement, fusion systems, etc. (My statements above make the assumption that you are, indeed, a surgical candidate.)

A lot of these technologies are too new to really know what is "best." At this point in the game, there is a lot of promising data but we are far from concrete pillars of evidence stating that these devices are truly efficacious in the way that many of them claim.

Good luck in your research and I wish you the very best.

[sportsnut3007]

Thanks for the advicie/input. I would like to pick your brain some more though and ask in your knowledgeable opion if you know some respected surgeons, besides of course bertangolini, who are experienced with nucleus replacement out of the usa who already do nucleus replacement of if you know any experienced ones in the usa who have done these things in trial besides the drs at the LOS Angeles Spine Institute. I ask for others bc i know he already does this from what I can tell on his site. If you know a few good other ones I would appreciate any info, if im being a pest lol I can do my own research. Thanks again for any insight.

[KBear]

Absolutely no offense taken, I did not take it at all like that. Unfortunately, many people and spine dr's act as if you have to be x amount of years old to have spine problems. I can't count how many times people have said "you are too young to have spine problems!" Like, I chose this. I even have had dr's say I was too young for an operation and one flat out told me they would not operate on me because I was too young. I just mentioned the ages and young people, so you would know that many on here know what that is like and we can empathize with you.

[Terry Newton]

Absolutely no offense taken, I did not take it at all like that. Unfortunately, many people and spine dr's act as if you have to be x amount of years old to have spine problems. I can't count how many times people have said "you are too young to have spine problems!" Like, I chose this. I even have had dr's say I was too young for an operation and one flat out told me they would not operate on me because I was too young. I just mentioned the ages and young people, so you would know that many on here know what that is like and we can empathize with you.

Kathy

I ruptured my first two discs from hard labor in the landscaping business in my early twenties. I wanted to own my own firm and received my first degree in landscape design. The discs rupturing put an end to that career and led me to a different, exciting profession. Maybe it was God's way of pointing me in a different pursuit. I do believe it helped me to understand others pain better. You have the same gift of empathy towards others as, you've been there. It's much easier listening to someone whose been there rather than just having read the book. I am sorry that you have had to deal with spinal problems for so long but, hopefully there is a gift in there for you as well. Empathy is a great gift.