New member considering 2-level Cervical ADR: M6, NeoDisc, ProDisc, Mobi-C ...?
 

Hello everyone,

After a cycling accident this Spring, an MRI revealed degeneration at two cervical discs (C5-6 and C6-7) with nerve impingement causing arm pain and weakness.

I’ve looked into two very different new discs that claim to provide shock absorbing capability:
- M6 - used in Europe at Stenum and other locations
- NeoDisc - just completed clinical trials in the U.S.

Would really appreciate any feedback from folks who have had these or know about them. Thanks!

Best,
Tyler

re: NeoDisc
 

Unlike almost all other artificial discs on the market, it looks like NeoDisc is designed to promote tissue ingrowth - although it's described as 'fibrous tissue.'

What I don't understand is why this would not end up promoting heterotopic ossification or "HO" (development of bony tissue outside of existing bones) - which most artificial discs are trying to avoid. If it ends up as a fusion, wouldn't it be better to have a strong fusion in the first place...?

Does anyone have any knowledge of medium to longer-term results?
http://www.ellisdev.co.uk/neodisc2.jpg

A few links for you...
 

Ty,

The US clinical trial site, which shows it “active” but not recruiting:
Evaluating The Safety and Effectiveness of The NeoDisc™ Versus ACDF in Subjects With Single-Level Cervical Disc Disease - Full Text View - ClinicalTrials.gov

The clinical study site, Nuvasive locator:
NeoDisc - Find a Study Site

British Scoliosis Society
Liverpool – 2–4 March, 2005 President – Mr Frank Dowling
NEODISC – PRELIMINARY CLINICAL EXPERIENCE WITH AN ELASTOMERIC CERVICAL TOTAL DISC REPLACEMENT
Jackowski 88-B (2): 232 -- The Journal of Bone and Joint Surgery (Proceedings)[/url]

A mish-mash of other links:

Neodisc Cervical Disc Replacement * Motion Preservation * Minimally Invasive Spine Surgery * Spine Education * Los Angeles, California

http://www.rmsas.com/documents/NeoDiscPosterLake2..pdf

NuVasive Treats First Patient With NeoDisc(TM)

You can find a good chapter on NeoDisc in Google books too. And you may have seen this on the AAOS site already:

2009 Annual Meeting Poster Presentations
NeoDisc Cervical TDR: Correlation between Disc Height Increase and Clinical/Radiographic Success
Poster Presentation Number: P370
Location: Venetian/Sands EXPO Hall D

Ty,

A while back, someone brought up the question of silicon use in the NeoDisc, relating it to concerns with breast implants. This is a complex issue to sort through…

You may recall that I’ve been intensively researching bacterial biofilms for several years now. I am sharing my research with the public on the biofilmcommunity.org site; Dr. Tom Webster’s video interview is in the ADRSupport Cutting Edge forum, where our interview explored the material aspects of implant materials/design…focusing on bacterial biofilms and their role in implant failure.

To be fair, every material out there for implants is not completely biofilm-resistant. At least that’s my conclusion based on interviews with some of the top biofilm scientists. Some are just “better” than others. And believe it or not, this is still a new area of science.

That said, I would be concerned about silicon products. Picking up on Sahuaro’s comment from 2006, I dug up this article on diagnostics performed on failed breast implants. Read it carefully. Bear in mind:

- Culturing technology for bugs is 150 years old. Far superior molecular diagnostics are available now and practically negate the possibility of false negatives; this problem is touched on within this article below.

- All materials are susceptible to biofilm formation(s), but that doesn’t mean every instance will lead to failure. Our bodies are loaded with biofilms of “commensal” or friendly bacteria. As far as we know, the long-term infection rates for disc replacements are very, very low. The acute cases are more obvious and some are (very personally) described here in this community.

- Note also that biofilm-based infections can be “sub-clinical,” and chronic. This compares starkly to “acute” infections which are more apt to be diagnosed & treated.

See these articles and links:

Detection of subclinical infection in significant breast implant capsules.
Detection of subclinical infection in significant ... [Plast Reconstr Surg. 2003] - PubMed result

Subclinical infection as a possible cause of significant breast capsules.
Netscher DT.
Plast Reconstr Surg. 2005 Apr 15;115(5):1426-7; author reply 1427-8.
(No abstract!)

OK, is this too much information?! G’night for now. :sleeping:

Do you have neck pain too or just radiating pain?

Thanks for the additional info Harrison. I think it'll be interesting to see how NeoDisc develops once their clinical trial results are described - but I've got some hesitation.

Radiating Arm Pain vs. Neck Pain
 

Jet - the question you raise is one that I've become really focused on.

The short answer is that I mostly notice the radiating arm pain; but I do have some amount of neck pain. The key issue seems to be whether the neck pain is arising from the same apparent source (i.e. very clear foraminal narrowing at C5-6 and C6-7) - or whether there's something else going on at the level of the two thin discs.

Having met with 5 surgeons and received several different potential solutions, this has become a central focus in trying to figure out what to do. In particular, if the neck pain is basically just arising from foraminal narrowing and impingement of the C6 and C7 nerves (which can also give rise to some amount of neck pain in addition to the arms), then a foraminotomy (a slight increase of space to provide additional room where the nerves are exiting) could cure both problems and allow me to hold onto the discs for a longer period of time, while technologies countinue to advance.

On the other hand, if the neck pain is coming from something else, then the foraminotomy might fix the radiating arm pain but leave me with substantial neck pain - suggesting I should have gone ahead with discectomy.

I'm now trying to figure out if there's any way to help better diagnose the source of the neck pain to help predict which pathway would be better.

Any thoughts welcome!

I am having the same problem. Since my pain is mostly in my neck, I am worried that surgery will not fix that pain. I think discectomies usually take care of radiating pain but I am not sure about the neck pain. The possibilities I have been given concerning the neck pain are: facet problems, the disc bulge pushing on something, the disc bulge and facet overload causing inflammation, etc. No one seems to know what the answer is. I have had severe pain on the sides of my neck for about 2-3 years. I also have frequent episodes where my neck locks up (almost like a crick in the neck) and stays very painful and locked for about a week each time. This makes dealing with 3 small children very difficult. I am tired of saying "Mom's neck hurts". I am seeing a new surgeon on Wed. so hopefully I will have more answers.

What have the surgeons been recommending so far?
Keep me posted!

Have you considered a discogram?
 

Tyler,

Everyone is correct in that a discectomy or foraminotomy will correct radiating arm pain (which comes from the nerves being pinched) but probably will not correct neck pain if that is coming from the discs themselves. The best way to find out may be a discogram, where they inject dye into the discs and pressurize them to see if that replicates your neck pain. If it does, that indicates that the discs are the cause of the pain and not the nerves. In addition, they take a CT scan after the procedure (while the dye is still in the discs) and that allows them to better visualize the discs---if they are leaking dye that suggests they are degenerated and probably need to be replaced.

Most surgeons will not do an ADR or fusion surgery without doing a discogram first, to verify the source of the pain. It seems to me that this would allow you to find out if your neck pain was from your nerves being impinged or from the discs being degenerated.