U.S. limit on number of levels of ADR?

**Researcher** · 10-26-2010, 05:41 PM

I seem to recall seeing discussion regarding U.S. limitations on the number of levels of ADR that U.S. surgeons can perform. My pain medication warped memory must be distorted, since I spoke with a patient in Florida today that got a 3 level ProDisc-C in Orlando in August. What's the scoop on this?

Thanks,

Phil

**KBear** · 10-26-2010, 09:46 PM

Originally Posted by Researcher

I seem to recall seeing discussion regarding U.S. limitations on the number of levels of ADR that U.S. surgeons can perform. My pain medication warped memory must be distorted, since I spoke with a patient in Florida today that got a 3 level ProDisc-C in Orlando in August. What's the scoop on this?

Thanks,

Phil

I may be wrong on this, but I think they can get around that with a 'compassionate use' designation. Not sure that insurance would pay, probably just depend on insurer.

**scotto74** · 10-26-2010, 10:02 PM

Phil,

How is he doing with the 3-level ProDisc replacement? I am still trying to determine whether there's enough advantage in going with the M-6 over the ProDisc that its worth going overseas as opposed to staying closer to home.

However, my experience with the US surgeons that I've consulted with is that most will only do the ADR at one level -- so therefore, they propose a hybrid approach of fusion and ADR. This seems to be driven by the fact that most US insurance companies will only approve ADR at one level.

Scott

**Cindylou** · 10-26-2010, 10:19 PM

Phil, did you happen to ask if this person was in a trial? Or, they can also "work around" the system by doing things off label. Runagain gave me a great explanation on all this quite awhile back. I'll see if I can find it and repost it. CL

**Researcher** · 10-26-2010, 10:20 PM

The U.S. Surgeons I have communicated with won't go over one level. I agree with you that insurance is the primary driver. I got some recommendations of ADR at C6/7, with ACDF at C5/6. I'm looking at M6-C ADR at C5/6 and C6/7 with a potential ADR at C4/5, depending on what discography with contrast during surgery shows. If it shows significant fractures in the disc, it will be replaced too. Right now that's just a dream; big insurance battle to go.

I would not get a 3 level ADR in the U.S., since the FDA approved discs are too "loose". You need the graded resistance of the M6-C to emulate the natural disc resistance and the multiple axes of motion that the M6-C has. I have the detailed test reports for the M6-C and M6-L and the other discs can't come close. I just received today additional data describing testing that verified the vertebral body center of rotation characteristics of the M6-C and how it compares to the natural disc at each level. It's very, very good. Given the design of the other discs, there is no way that they could do what the M6-C does.

The patient I mentioned above indicated that he is doing very well in general. He said that he still has occasional pins and needles in his traps when he works at his desk too long. That was true for me long before I had DDD! He said that when he woke up from surgery, it was amazing. He had been working at his desk for months with a cervical traction strap keeping his neck under tension so he could make it through the day.

Phil

**Cindylou** · 10-26-2010, 10:39 PM

I know folks know this already, but I think it bears repeating, that first and foremost for success of ADR (either Lumbar or Cervical) it is the skills of the surgeon that are critical. Just a friendly reminder.

CL

**scotto74** · 10-26-2010, 10:45 PM

Phil -- Do you have a surgery date scheduled yet? You are planning to have surgery with Nick Boeree in the UK, right? I would love to see some of that research on the M-6 sometime.

Cindylou -- I couldn't agree with you more, and am hopeful that either of the two surgeons I am considering (Nick Boeree and Dr. Fabien Bitan in NYC) fall into that "skilled surgeon" category. My oldest brother has had three failed cervical fusion surgeries, and the first two, unfortunately, were largely attributed to lack of skill by the surgeon.

Scott

**Researcher** · 10-26-2010, 11:15 PM

Scott,

I am going to fight the insurance battle pre-surgery. I am working to get my appeal ready to go before I have Nick submit the request for pre-approval (or should I say request for pre-denial). Nick is the man for me. Everyone needs to listen to other patients, talk to several surgeons, read everything that you have time to on the internet, and maybe spend a little time on a forum.

In the end, you have to go with your gut. I knew the instant I completed my first phone call with Nick that he was the one. So smart. So humble. Cindylou is right - the surgeon deermines your success. It's the surgeon's skill that takes care of the oddball "stuff" they find that did not show on the X-Ray or MRI.

If you are interested in detailed M6 (C or L) test data, send me a PM.

Cheers (I'm practicing for a trip to Oz someday),

Phil

**Cindylou** · 10-26-2010, 11:53 PM

Phil, I look forward to continually following your posts all the way through surgery with Mr. Nick Boeree and your rehab to boot. You have done such a thorough job with your research and at the end of the day this will also serve you well. My very best to you.......Cindylou.......keep posting!

**mmarsh** · 10-27-2010, 08:09 PM

Phil

I just wanted to give you my experience. I have 2 fusions in my cervical spine and am still able to be very active. I have limited rotation and movement, but it does not impact my activities much. Can't hold a phone between my ear and shoulder! Anyway, If you need to have a hybrid, I don't think you will notice a huge change in your activity level. I know you are very concerned about activity after surgery. Best of luck.