Considering ADR...

[MRLucky]

I'm new here... first post but have been lurking for some time while dealing with my back issues. I have a very large central herniation (7mm) at L4/L5 that I have been offered a microdiscectomy on. Doc says it will do nothing for my back pain which is about 50% of it. I have terrible sciatica in the left leg and moderate sciatica in the right leg. I'm considering an M6L in the UK but I'm scared to bits by the nightmare 1st and 2nd generation failure stories. I know many are successful but the thought of ending up worse sounds terrible! My life isn't much right now and I guess I can wait for it to get better or do something before it gets worse.

I have done PT for months, accupuncture, pilates, swimming, chiro, PLDD, among other things. Each one helped slightly but the second I try to go back to living a somewhat normal life (ie. sitting or walking) I get slammed with back and leg pain. It's been like this for about a year now.

Any advice on what questions to ask or what direction to go would be appreciated! The stories I have read so far are inspiring!

[Azhure]

Hi MRLucky,
I'm relatively new myself! About 3 weeks post-ADR using the Freedom (which, I believe, is already approved in Europe).

I have friends and family who have had microdiscectomies that have later gone on to have more intensive surgeries, like ADR. When my doc told me what was going on with my back, I just immediately jumped for ADR instead of trying a dozen less-intensive (but also less-effective) options.

I can tell you that the sciatic nerve pain and numbness in my leg has not been back since the day I had surgery. I have new pain, but that should heal with time. The moment I woke up from anesthesia, I was shocked that that dreaded tingling was gone in my leg and foot.

Do your research, first and foremost. Make yourself an educated patient. Don't let any doctor "sell" you on something you're not certain of. The commitment to ADR is a commitment to a multi-month recovery and acceptance that your spine will be different afterwards. I'm still having trouble with that acceptance.

Make sure you research doctors. If it means traveling to find the right surgeon for you, then do it. I was fortunate to live only an hour or so from one of the best in the industry (Dr. Ken Pettine).

Only you can make the decision for whats best for you, your family, and your health. I have found this forum to be a great resource of support when I get frustrated, knowledge of what to expect, and sort of a roadmap of what life "on the other side" is like.

Good luck!

Melissa

[Harrison]

Melissa, really well said!

Mr Lucky, thanks for finding us, sorry you are here. Let me know if you need any help finding your way around the online community. People here are really wonderful, I hope they can help you!

They are

[MRLucky]

Melissa,
Thanks for the kind words and advice. I am realizing that it's not a back to it in a few weeks surgery like the micro but I also want to do the best thing long term for a healthy spine.
Everyone says your back will "never be the same" about any spinal surgery, what does that mean? Right now I can't sit, travel, walk much, do anything athletic, etc. So I guess improvement would be good but I don't want to stop living.
What are the real outcome studies of ADR? Is there any gold standard clinical trial that has been done? I'm still considering fusion but everyone says no way! From the studies I've seen it's still a close call and I've heard the lumbar region is a harsh environment so you need something that will hold up over time.
I'm so confused!!! Is there a spine patient advocacy consultant that could help me make these decisions. I feel like being in this much pain and making these decisions is not smart.

[annapurna]

Laura or Rich are probably some of better examples of successful ADR surgeries. Rich (aka Harrison) can speak for himself but Laura's limitations post-ADR are really mild at this point. Her SI joint is still really PO'ed at her and probably will be for the rest of her life but L5S1 is a mild problem controlled by heat every night and no pain medication otherwise. She's limited more by knee problems than by lumbar spine or SI joint problems and those limitations means she can bike century rides without problem but can't easily hike five miles, even without a pack.

That said, she can tell in little ways that everything isn't as care-free as it was before her spine went bad, some twenty-five years ago. Of course, she might be forgetting that her spine has been bad since her teens and some of that happy-go-lucky memory might have been from being a teenager.

Basically, at the very best end of outcomes, you'll know that you had surgery if you're athletic and push your body but that knowledge will come with the ability to come pretty darn close to the levels you could do before your back started going bad. The very worst outcomes are horror stories that should be read in their own words here and on other boards. Fusion can match the worst of the horror stories and come very close to matching the very best of the best outcomes. It's really a matter of matching the technique used to the degree of damage you have in your spine.

I don't know of many outcome studies that weren't funded by one or more groups that had a serious stake in getting "correct" results to prove or disprove this or that device's life. Overall, if you want a cheap, quick summary: don't put an ADR into a spine with facet problems; spend the money to go with a doctor you trust and has a good record and experience;and get a doctor who's office staff will work with you to get information to and from you pre-op and post-op. If you subtract those factors from the outcome studies available, you'll likely not see any strong trends for or against any device.

There are spine patient advocates. I know of at least one who's work can vary from very good to somewhat bad. Unfortunately, all of the "buyer beware" caveats that apply to doctors apply to advocates as well. Posting here and learning as much as you can will help. Rich will take phone calls and offer help. Should you need a second layperson's opinion, feel free to PM us and we can set up a time to talk.

[Azhure]

"Never be the same", in my eyes, means:
- I won't ever be a power lifter, and will probably never lift anything over 50 pounds again in my life.
- I will always have to be cautious about the amount of pressure I put on my lumbar spine. This means I also have to maintain a healthy weight because every 10 pounds of weight = 100 pounds of pressure on your spine.
- You may have complications. Those complications may be better or worse than your current situation. Accepting spinal surgery means accepting that the benefits outweigh the risks as far as clinical trials have shown.
- I won't ever be an Olympic athlete.

I, personally, don't care about being an Olympian or working in a warehouse that involves 50 pound lifting. I want to be able to go shopping with my girlfriends and not limp after 2-3 hours, I want to be able to run 10Ks, even if I'm not in the first 5% of finishers, I want to be able to play Frisbee at the park with my son. ADR has high probability to give me this life.

The problem with ADR is that it is new. It does not have the long-term research that fusion surgeries have because it has not been in existence for more than a decade. There are also multiple "generations" of discs (I believe we're on the second generation now, which is what I have, the "Freedom" by AxioMed). The advantages to the second generation are a lower risk of vertebral fracture due to the "teeth" on the Freedom versus the keel on the ProDisc-L, for example; also, the second generation discs have shock-absorbing polymers, versus ball-and-socket (rigid) construction. I was hoping to receive the second-generation disc, but as a study participant, I could have received either. I got the one I wanted thought. My mother, age 54, has multiple fusions and at almost every fused level, after two decades, the hardware has failed. There is, supposedly, a much, much lower risk of device failure. The cases I've read about so far where there's a major post-op problem are a result of vertebral fracture, not device failure. There's a discussion about that in my post-op thread right now, actually.

At the end of the day, fusions were a total non-option, and I wasn't willing to waste my time on steroid injections. The only other options were "live with it" or ADR. I'm still early in recovery, but all signs are positive.

As for patient advocates - I honestly think this forum is 10x more honest and informative than any patient advocate would be.

[annapurna]

Originally Posted by Azhure

The problem with ADR is that it is new. It does not have the long-term research that fusion surgeries have because it has not been in existence for more than a decade.

I have two disagreements with Azhure and only one of which is serious. The Charite has been in existence for something close to thirty years, not ten. That in itself is a serious outcome study if you wish to take it that way. The newer disks have all been developed within the last ten years but the Charite has been around Europe for quite a while. If you do choose a newer ADR, you can take reassurance from the fact that ADRs have been doing well for a while.

The minor disagreement is an engineer's dislike of the new bonded ADRs. Speaking as a materials engineer who regularly works with bonded joints, we don't know as much about the long term behavior of those in fatigue loading. The ADRs have all been tested for longevity and done well but I worry a bit if the testing was valid if we don't really know how bonded joints fail due to fatigue.

[Azhure]

Thank you for correcting my misinformation.
The second generation bonded materials have shown promise in holding up over time (I'm only 24 and would dread ever havIng to have it replaced.

[Hooch]

Originally Posted by annapurna

. Speaking as a materials engineer who regularly works with bonded joints

Jim,

Do you have any insights into the long term behaviour of elastomers in general? eg do they eventually tear or tend just tend to continually compress? Once I reached this point of my research I had well and truly exhausted my knowledge. Then I chose the surgeon based on my impression, not on the device. The only adr I didn't want was a charite, I just don't trust unconstrained transverse motion like that.

I have no doubt that the surgeons have absolutely no clue about how these things will go long term. Their expertise lies in surgery. When I asked my surgeon how do you think a plastic will go in 10 or 20 years time, he responded that those Wallis implant thingoes were still going well 5 years later. Which wasn't much of an endorsement imo.

Fingers crossed it never becomes an issue. I was 28 when I had it put in so longetivity is a concern. Better than being disabled by pain tho, by a long long way.

Mr Lucky, I echo the others in get multiple opinions and go for the most indicated op, be that fusion or adr.

Chris.

[JEVE19]

I have the same worries. I don't know if you read my post but this is what Dr. Zigler said about the M6 (copy and pasted from his email to me) :
THE M6 MAY TURN OUT TO BE GREAT, BUT SINCE IT
HASN'T GONE THROUGH AN FDA STUDY WITH 98%
FOLLOW- UP LIKE THE PRODISC, NO ONE CAN BE AS
CONFIDENT ABOUT IT. THE EUROPEAN GUYS LIKE TO USE
THE NEWEST DEVICES , AND WAIT FOR PROBLEMS TO
DEVELOP. AS I MENTIONED, DR. BERTAGNOLI TOLD ME HE
HAS REVISED SEVERAL M6 PROBLEMS, AND HE PREFERS
PRODISC.

It seems that each doctor prefers one disc over another.
My fear is that the M6 is liked by some because the concept is newer and sounds better. The question I asked myself is do I want to "try" it anyway and see if it holds up in the long term?
What if it doesn't? When something goes awry, I'll be in the US and my doctor will be in another country. Will I be able to make the plane ride back for plan B?

I have sat and read for days through all of surgical outcome posts. I know that lumbar is a whole different ballgame than cervical. Dr. Zigler told me that the success rate of cervical is higher than lumbar. I've read a lot and seen some people didn't have success with different kinds of discs.
Was that the doctor they chose or disc? or both?

As soon as you make up your mind about what you're going to do, that doubt always wants to creep back in.

I'm going to talk to Dr. Boeree next week. I figure it's worth it to get the opinions before I've done anything.
I figure he is going to say that he likes the M6 and Dr. Zigler and Dr. Bertagnoli don't. Then, I have to decide which opinion to listen to.

It's not an easy decision to make.
The forum is so great because we can all learn from everyone's experiences thus far and the support while trying to figure out a decision is wonderful..