ADRSupport Community  

Go Back   ADRSupport Community > General Discussion > New Member Introductions

New Member Introductions If you just joined, please introduce yourself here. Please add a signature describing your spinal history (use the "User CP) and ask us how we can help you get started.


Reply
 
Thread Tools
  #1  
Old 02-12-2014, 06:24 PM
dieter dieter is offline
Junior Member
 
Join Date: Feb 2014
Posts: 9
Default New Member introduction - Robustness of M6C ?

Good day to everybody,

I am a 53year old male from Germany who had a M6c implanted (C5/C6) on 17-01-14 in Germany Markgröningen.

My operation was done as an emergency after 40 hours of severe pain, loss of strength and a numbness sensation in my right hand arm after a normal jogging session. Due to the emergency there was no time to get information prior to the operation - neither about the operation itself nor about the available prostheses.
All I knew was that the operation had to be done immediately to avoid permanent damage to the pinched nerve and that a prosthesis would be implanted instead of conducting a fusion.

Now, after the operation, I searched the net for information on the procedure and what actually is a M6c prosthesis. The more I read the more new questions are coming up.

My intention with this posting is to share my questions and some information I found in the net and to be able to discuss the issues openly without generating uncertainty.


How good is the M6c in real life use?
There does not seem to be enough long term information available to judge the effectiveness of the M6c to answer questions like:
Does the movement of the prostheses remain for ever?
Does it prevent overload to the adjacent cervical discs?
Does it prevent fusion?

What I found:
An article from Professor Dr. med. W. I. Steudel from the Universitätskliniken des Saarlandes who conducted a study in 2008 concluded that there is no statistically significant difference between Fusion or prostheses as there is not enough long term data available. (You find the article if you Google for "Bewegungsanalyse bei zervikalen Bandscheibenprothesen"). http://scidok.sulb.uni-saarland.de/v...del_Nabhan.pdf He concludes that according to his study a prostheses is only an interesting alternative to fusion. On the other hand did I also find articles claiming the opposite.

Fusion does not necessarily seem to be a bad alternative. It is incredible how much movement remains despite fusion e.g. from C3toC7. Have a look at this video on YouTube. (search for "spineant C3C7") CW C3C7 ACDF 2 months postop - YouTube

Robustness of the M6c?
To mimic the complex movements of a natural disc, as the M6c is supposed to do, requires a complex mechanical design. Complex mechanical designs usually take years to become robust enough to work without failure in real life situations. Very seldom do complex designs work without failure first time every time.

Collapse of a M6c in Germany
In a German Cervical Disc Forum (similar to this one) there is an unfortunate story about a M6c that actually broke after six years. Subsequently the nucleus of the M6c pushed right into the patient's spine channel (2013) causing serious complications and a very risky and delicate removal. (See posting from 17-01-2014). (The posting is found if you Google for "Prothesen-KERN (M6-C) im Spinalkanal gelandet..., Fusion wegen Implantatversagen (c5/c6)"). Bandscheiben-Forum - Hilfe rund um die Uhr
The reaction by Spinal Kinetics according to the posting was that this can not happen with the latest M6 designs. What would that mean? (OP with M6c that failed seems to have been conducted in Jul 2007).

My conclusion to this is to go for a regular check up to confirm that there are no visual changes to the prosthesis. Currently I don't know what is the most suitable method. MRT?

Comparison of cervical disc prostheses?
Is there a study that compares the various available cervical disc prostheses with respect to robustness, advantages and disadvantages?

Is there a study on cervical disc prostheses for a time period longer than 10 years proving robustness over time?


I am looking forward to your answers and comments. Best regards
__________________
Pain and Right hand numness 16-01-14 during jogging
Loss of strength in right arm
Emergency OP cervical vertebra 5/6 M6-C Spinal Kinetic 17-01-2014 Clinic Markgröningen Germany
Pain vanished - Numness remains - Strength in right arm not fully recovered
Reply With Quote
  #2  
Old 02-12-2014, 10:51 PM
Harrison's Avatar
Harrison Harrison is offline
Administrator
 
Join Date: Oct 2004
Posts: 7,010
Default

Hi Dieter,

Many people here have had implants with the M6 in the past 3 years. Most have done very well. In general, most patients do very well with cervical disc replacements.

If complications do occur, it's because of surgeon error(s), including:

- imprecise placement;
- failure to diagnose localized vertebral osteoporosis;
- failure to diagnose sub-clinical infections.

I personally do not like the myriad parts and materials in the M6 and have been vocal about this for years. Hopefully, my opinion doesn't matter much.

We don't have any long term data on outcomes on the M6; so if anyone can translate Dieter's referenced posts that would be appreciated. I could do this if I had more time, but I do not presently.

Dieter, back to you: are you taking/did you take any NSAIDs at all to manage any overgrowth of the bone (auto-fusion or HO)? How are you feeling now?

Ich wünsche Ihnen Gesundheit hoog immer mein Freund!
__________________
"Harrison" - info (at) adrsupport.org
Fell on my ***winter 2003, Canceled fusion April 6 2004
Reborn June 25th, 2004, L5-S1 ADR Charite in Boston
Founder & moderator of ADRSupport - 2004
Founder Arthroplasty Patient Foundation a 501(c)(3) - 2006
Creator & producer, Why Am I Still Sick? - 2012
Donate www.arthropatient.org/about/donate
Reply With Quote
  #3  
Old 02-12-2014, 10:56 PM
Harrison's Avatar
Harrison Harrison is offline
Administrator
 
Join Date: Oct 2004
Posts: 7,010
Default Additional References

Dieter:

http://www.adrsupport.org/forums/f55...etics-m6-9508/

and post-op patients with M6:

http://www.adrsupport.org/forums/f47/

Please note that in this post-op forum, there are hundred and hundreds of patients who have received spinal artificial discs.

The advanced search works well:

ADRSupport Community - Search Forums
__________________
"Harrison" - info (at) adrsupport.org
Fell on my ***winter 2003, Canceled fusion April 6 2004
Reborn June 25th, 2004, L5-S1 ADR Charite in Boston
Founder & moderator of ADRSupport - 2004
Founder Arthroplasty Patient Foundation a 501(c)(3) - 2006
Creator & producer, Why Am I Still Sick? - 2012
Donate www.arthropatient.org/about/donate
Reply With Quote
  #4  
Old 02-12-2014, 10:58 PM
annapurna annapurna is offline
Senior Member
 
Join Date: Dec 2004
Posts: 1,668
Default

There isn't long-term data on anything beyond the Charite lumbar ADR. The Prodisc-C is just getting old enough for realistic long-term data to be coming out. To tackle some of your other questions though:

1) Does the motion remain? First, you have to assume that you will not fuse around or have the ADR subside. With that assumption, Prodiscs, Charites, Mavericks, and pretty all mobile core ADRs will retain motion so long as the wear doesn't cause problems. The M6 doesn't have a mobile core so it will depend on the long-term behavior of the polymer and that's been discussed elsewhere. Without belaboring a discussion held elsewhere, I do not trust that long-term behavior.

2) Does it prevent adjacent level overload? Well, depending on who you believe ADR either does or it doesn't and fusion either does or doesn't either. Basically, pick something that mimics natural loading, not motion, and hope for the best. It might be worth pointing out that loading and motion are similar but bones respond to loads. The M6 ideal is actually better in that the loads seem to be intended to match the loads placed on the boney structures and not use the facets, for instance, as hard stops the way the Prodisc does.

3) Fusion? First, get a fusion if you need it. You can seriously screw up your life if you insist on an ADR when your damage is such that a fusion is necessary. Second, a lot might be dependent on why you need spinal surgery at all. A single failed disk due to discrete trauma might work well with fusion. General DDD at multiple levels with the disks failing in an ever-hastening cascade probably needs ADR and fusion hybrid solutions. I've never seen a study to this effect but I'd consider how well my adjacent disks and facets are doing before settling the fusion vs. ADR question.

4) Robustness of the M6? This is actually my greatest complaint with the M6. It works great on paper. It works great at the start of its life. It has so many ways in which it can fail, I worry that it's going to fail easily. That was also discussed in another thread.

5) Non-destructive evaluation of an aged M6? An MRI isn't going to answer the questions you want answered. There are techniques we use for NDE of materials and structure; they just happen to be so nasty they'd kill the patient we'd use them on. Best bet is flexion/extension x-rays and check for changes in the way your neck bends over time. Sharply increased bend angles suggest problems with the ADR.

6) Studies? No study that I know exists for comparing across multiple cervical ADRs or for longer than about 10 to 15 years. Cervical ADR simply hasn't existed that long.
__________________
Laura - L5S1 Charitee
C5/6 and 6/7 Prodisc C
Facet problems L4-S1
General joint hypermobility

Jim - C4/5, C5/6, L4/5 disk bulges and facet damage, L4/5 disk tears, currently using regenerative medicine to address

"There are many Annapurnas in the lives of men" Maurice Herzog
Reply With Quote
  #5  
Old 02-16-2014, 02:46 AM
dieter dieter is offline
Junior Member
 
Join Date: Feb 2014
Posts: 9
Default

Hi Harrison, Annapurna,

First of all thank you very much for such a detailed and quick reply.

Currently I am taking NSAID's but will stop taking them by the end of the week. Are they meant to be taken for a longer time period to prevent auto-fusion?

I am physically feeling very well. No pain. I never felt any pain in my neck, also not prior to the operation. The terrible pain I had in my shoulder and arm was immediately gone after the operation.
Just the numbness in the right hand thumb / lower arm remained. The right arm is still weaker compared to the left arm and the doctor tells me not to worry. It is supposed to cure over time. (regeneration of the pinched nerve)
In 2-4 weeks I will go for rehabilitation to strengthen and train my muscles in such way that I stand up straight and reduce the wear / forces on the neck. (This is how I understood it)
Currently I am still at home to assure that the ADR grows on well to the bone. I do some daily exercises with my hand and arm and take a 8-10km walk to keep my body going.


@Annapurna
Yes you are right the M6C mimics the loading, not only the movement.

I tried the extended search but found no posting regarding a failed M6C that had to be removed. (Like the one I found in a German forum). Is there any experience in this forum for failed M6C's that I missed, where the M6C prosthesis actually broke after some years?

Thank you for the information on the non-destructive evaluation of the ADR. My orthopaedic gave a similar answer and advised a yearly check up by X-ray.
__________________
Pain and Right hand numness 16-01-14 during jogging
Loss of strength in right arm
Emergency OP cervical vertebra 5/6 M6-C Spinal Kinetic 17-01-2014 Clinic Markgröningen Germany
Pain vanished - Numness remains - Strength in right arm not fully recovered
Reply With Quote
  #6  
Old 02-16-2014, 07:35 PM
drewrad drewrad is offline
Senior Member
 
Join Date: Jan 2014
Posts: 629
Default

Quote:
Originally Posted by Harrison View Post

I personally do not like the myriad parts and materials in the M6 and have been vocal about this for years. Hopefully, my opinion doesn't matter much.

I just read this from Dr. Zeegers website and will have to ask him for further clarification, however, I wonder if anyone here already knows why Zeegers prefers the L Activ over the M6. Is it a fiscal decision, I doubt it, but you never know. Here's Dr. Zeegers quote below.

Quote:
Nowadays he is using of one of the best implant on the market, the Activ L Lumbar Artificial Disc. Rarely I am using M6-L artificial disc replacement in the lumbar area.
So then... what gives?

I like the facet protection of the M 6, however, I too am wary of the complexity of the device. I have no problem with polymers themselves, the actual substance. Its very hardy stuff. If anyone doubts that look up 'Glock 26 torture test' online. Polymers have been in handguns for years with fantastic success and they are durable.
__________________
Weightlifter since 12 years old, now mid-40's and figuring out this wasn't such a good idea.

Chronic back pain started in 2010 while shrugging weights that a 40 yr. old shouldn't even try.

MRI in 2012 showing L4/L5, L5/S1 herniations and L2/L3 bulge.

L5/S1 taking on new shape, chronic sciatica, etc.

DEXA bone scan performed 5/7/14 showing mild osteopenia.

Surgery performed July 9th, 2014, Dr Clavel, hybrid three level lumbar.
Reply With Quote
  #7  
Old 02-16-2014, 09:51 PM
Harrison's Avatar
Harrison Harrison is offline
Administrator
 
Join Date: Oct 2004
Posts: 7,010
Default

For new folks, for what it's worth...I really respect Annapurnas' posts. Annapurna is two people -- Jim and Laura -- both of whom are engineers who have literally worked on different systems in the space shuttle. If anyone understands engineering and material science, it's these two.
__________________
"Harrison" - info (at) adrsupport.org
Fell on my ***winter 2003, Canceled fusion April 6 2004
Reborn June 25th, 2004, L5-S1 ADR Charite in Boston
Founder & moderator of ADRSupport - 2004
Founder Arthroplasty Patient Foundation a 501(c)(3) - 2006
Creator & producer, Why Am I Still Sick? - 2012
Donate www.arthropatient.org/about/donate
Reply With Quote
  #8  
Old 02-16-2014, 09:53 PM
annapurna annapurna is offline
Senior Member
 
Join Date: Dec 2004
Posts: 1,668
Default

Quote:
Originally Posted by drewrad View Post
I have no problem with polymers themselves, the actual substance. Its very hardy stuff. If anyone doubts that look up 'Glock 26 torture test' online. Polymers have been in handguns for years with fantastic success and they are durable.
The concern is that very few people use flexing polymers that are adhesively bonded to two non-flexible structures without any way to check them in-situ over their lifetime. It's putting a great deal of trust in materials and bonding techniques that we don't know that much about and doing it with the blind hope that it works. If there was better long-term fatigue testing of adhesive bonds in the materials engineering literature or a formal way to evaluate the ADRs to ensure problems were caught before they failed, then I'd be singing a different tune.
__________________
Laura - L5S1 Charitee
C5/6 and 6/7 Prodisc C
Facet problems L4-S1
General joint hypermobility

Jim - C4/5, C5/6, L4/5 disk bulges and facet damage, L4/5 disk tears, currently using regenerative medicine to address

"There are many Annapurnas in the lives of men" Maurice Herzog
Reply With Quote
  #9  
Old 02-17-2014, 01:00 AM
pittpete pittpete is offline
Senior Member
 
Join Date: Jan 2008
Posts: 307
Default

This is from Dr. Zeegers Facebook page
I suggest anyone who hasn't friend him, he's very knowledgeable
Quote:
The M6-L lumbar Artificial Disc design has advantages and disadvantages in relation to the Activ-L artificial disc implant. The indication for a lumbar M6 is very dependent on the individual anatomy and pathology to avoid malfunctioning and complications. An accurate judgement of the patient’s lumbar condition is mandatory. The final decision of the implant choice has to be made by an experienced artificial disc replacement surgeon. Be free to ask for more information about artificial disc replacements designs and your individual treatment alternatives via wzeegers@zeta.demon.nl or have a look at www.zeegersadr.com
__________________
Born 1970/1995-Hurt at work/1996-Right disc fragment L4-L5 discectomy-On/off back pain,no serious leg pain until/2007-Right herniation L5-S1,recurrent small herniation at L4-L5 with unbearable leg pain/6/08 discectomy L5-S1/leg pain relieved/occaisional mechanical pain/2012-Cymblata 60 mg,occasional aleve/2014-LB pain not debilitating but chronic,Rhizotomy relieves facet pain on right side/2015-L4-S1 facets shot/4/15 PLIF L4-S1 with facectomy
Reply With Quote
  #10  
Old 02-17-2014, 02:15 PM
Dema Dema is offline
Senior Member
 
Join Date: Jul 2013
Posts: 169
Default Adr & acdf!

Dear Dieter, first of all congratulation on the successful surgery, and getting some relief from pain. I too wish there are more studies/reports of long term comparisons of the artificial discs!
If you search for cervical ADR & Heterotopic ossification, you will find some studies that compare few ADR's in terms of post-op ossification. But I have not seen a comparison of the discs in terms of their reliability and long term durability! Attached is what the M6 company provided, and there are others.
In terms of ADR vs. ACDF, there are many studies, I like the following two, as they compare the results form several other studies, and both are consistent with your findings, the differences are not statistically significant:
For me personally, I prefer the ADR approach, because in case of future issues, it can be removed and replaced with ACFD, where with Fusion I do not think it is possible to revise it later to ADR!



Best wishes,
Dema
__________________
7/2007 Whiplash injury
11/2009 Cervical disc herniation C3-C6 (C5-C6 worse)
2010-2013 Conservative treatments (drugs, PT, epidurals, prolotherapy, acupuncture...etc)
, little effect on pain
Considering surgery (typical questions, which type & which surgeon!)
Reply With Quote
Reply

Bookmarks

Tags
failure m6c, m6c, m6c robustness, spinal kinetics failure

Thread Tools

Posting Rules
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Smilies are On
[IMG] code is On
HTML code is Off


Similar Threads
Thread Thread Starter Forum Replies Last Post
New member introduction ;-) aberge61 New Member Introductions 10 02-19-2014 12:43 AM
PRODISC C vs M6C Mirta New Member Introductions 3 05-26-2011 08:26 PM
mattbrand new member introduction mattbrand New Member Introductions 6 07-17-2010 02:55 PM
Introduction ADR Sugery - Ingrid (new member) Ingrid New Member Introductions 2 10-08-2008 11:02 AM


All times are GMT -4. The time now is 09:10 PM.


© Copyright 2006-2023 ADRSupport.org All rights reserved.