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  #31  
Old 02-21-2014, 12:34 PM
dieter dieter is offline
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Join Date: Feb 2014
Posts: 9
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Quote:
Originally Posted by bwink23 View Post
In my eyes, the forces in your spine would keep that failed annulus in place, but wouldn't move in the on the nucleus and impede it's work. This many moving parts thing is really just the annulus isn't it?


...it's possible to convert a failed ADR to a fusion, but a fusion is there for life, the absolute last ditch effort.

Hi bwink23,

in a German forum a situation is described where the M6C nucleus actually did not stay in its position.

Yes an ADR can be turned into a fusion but a failed ADR will most probably go along with undesirable side effects which can make things very complicated.

Regards Dieter
__________________
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

Last edited by dieter; 02-21-2014 at 12:43 PM. Reason: Not wanting to elaborate too much
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  #32  
Old 02-21-2014, 03:12 PM
bwink23 bwink23 is offline
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Join Date: Nov 2013
Posts: 263
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I agree, no one would want to undergo another spinal surgery to convert an ADR to a fusion. There are cases on here where people were having problems a with certain disc i won't mention, and they tried leaving the disc in place and fusing around it. That NEVER goes over well. In the very rare case that should ever be necessary, find a quality surgeon who will get it out first. Dr. Clavel said he's needed to explant an M6 only 2 times that were not his patients, he claims he's done close to 2,000 M6's. One of the cases he was able to swap the M6 for another one. The other case he had to take it out and fuse because the disc space was too large to put another one back in...Neither case was due to failure of the disc, it was surgical error. Take that as you will.

All discs have a possibility for mechanical failure if enough forces are applied to the area, like say a real bad car accident. There are MRI's of discs(ball and sockets) that came completely off the nucleus. Can the nucleus shift under the right, extreme circumstances? Sure, just like any other disc out there. My point was if the annulus lost it's bond, i don't see that would interfere with the function of the nucleus, unless it's the woven annulus that's keeping the nucleus in place. Could be a good question to call SpinalKinetics about and ask them. If you have a fear about certain disc implants, by all means call them grill them about it. The more you know the better off you are. If you do, please post your findings here as many of us would love to know what new information you come up with.

__________________
2013 - MRI and CT scan....DDD L4-S1
left side (where my pain is) interarticularis pars fracture/defect with Spondylolithesis L5 over S1 with 2MM anterior displacement

Feb. 2014 - Hybrid lumbar fusion(l5/S1), ADR(L4/L5)...2-level cervical ADR (C5/C6, C6/C7). Dr. Pablo Clavel of Quiron Hospital in Barcelona, Spain. All M6 implants (PEEK cage and plate from Medtronic at fusion level in lumbar.) SAME DAY OPERATION for both areas of the spine.
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  #33  
Old 02-21-2014, 03:16 PM
bwink23 bwink23 is offline
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Join Date: Nov 2013
Posts: 263
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Quote:
Originally Posted by dieter View Post
Hi bwink23,

in a German forum a situation is described where the M6C nucleus actually did not stay in its position.

Yes an ADR can be turned into a fusion but a failed ADR will most probably go along with undesirable side effects which can make things very complicated.

Regards Dieter


He did mention, one of those patients was German. Which one was which, i don't know.
__________________
2013 - MRI and CT scan....DDD L4-S1
left side (where my pain is) interarticularis pars fracture/defect with Spondylolithesis L5 over S1 with 2MM anterior displacement

Feb. 2014 - Hybrid lumbar fusion(l5/S1), ADR(L4/L5)...2-level cervical ADR (C5/C6, C6/C7). Dr. Pablo Clavel of Quiron Hospital in Barcelona, Spain. All M6 implants (PEEK cage and plate from Medtronic at fusion level in lumbar.) SAME DAY OPERATION for both areas of the spine.
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  #34  
Old 02-24-2014, 03:40 PM
dieter dieter is offline
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Join Date: Feb 2014
Posts: 9
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Sorry if I caused a confusion. I am referring to a German patient in Germany. (See first post in this thread)
__________________
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

Last edited by dieter; 02-24-2014 at 03:41 PM. Reason: Bigger letters
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  #35  
Old 03-12-2014, 06:10 PM
dieter dieter is offline
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Join Date: Feb 2014
Posts: 9
Default Summary - Robustness M6C

To summarize my thread, querying the M6C Robustness, I have studied the WEB quite intensively on ADR's and therefore postulate, without addressing surgical issues, the following:

1) Reliability of the M6C:
There are no clinical studies available that prove the reliability of the M6C even though it is in use since 2005 (may be earlier) and 25 000 discs have apparently been implanted to date.

Hopefully my M6C will last the intended 40 years (Info Spinal Kinetics). The dilemma is that nobody can tell before hand and only time will tell.

This means we have to trust the manufacturers which is not always good. For example the Galileo disc from Signus had to be recalled and the implants had to be removed.

This brings me to the next point.

2) ADR or Fusion?
The most emphasized selling point of the ADR versus fusion is that it is supposed to reduce or prevent ASD. There are many articles comparing the effects of ADR and Fusion. All articles conclude that there was no statistically significant difference in the reduction or elimination of ASD.
e.g. http://www.surgicalneurologyint.com/...707_093217.pdf

So I asked myself, which decision will reduce the likelihood of a second operation?

3) Likelihood of Revision / second surgery
Due to ASD a 2nd surgery might be required both after fusion or ADR.
An additional risk is the unknown mechanical reliability of the ADR which might call for a premature revision operation.

If there is a risk of mechanical failure, which ADR is the best?

4) Which ADR?
From the mechanical loading point of view the M6C seems to mimic the loading of a natural disc better than other devices. This also makes the M6C quite complex and for that reason more vulnerable to wear and tear.

Now I am back to square one, robustness....


My Conclusion:
There are no clear answers with respect to the mechanical reliability of ADR's. Only time will tell which is not a comfortable secure feeling.
This makes the decision with respect to fusion versus ADR very tough.
This is why this Forum and similar are so valuable to the users and future patients of ADR's.

This article (July 2012) I feel elaborates the pros and cons of ADR's quite well.
Cervical disc arthroplasty: Pros and cons Moatz B, Tortolani P J - Surg Neurol Int


@Harrison
There is plenty information on good surgeons in this forum. (A good surgery I also value as the most important factor for a successful ADR operation).

May I suggest to start a sub-forum where everybody can post experiences of ADR's with respect to mechanical failures. Over time this will be a helpful data base for newcomers on the various ADR's.


I wish everybody in the forum all the best.
Thank you for such a great job on the forum.
By the way, tomorrow will be my follow up visit at the hospital (post 8 weeks).
__________________
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
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  #36  
Old 03-12-2014, 11:16 PM
CDW321 CDW321 is offline
Member
 
Join Date: Aug 2013
Posts: 69
Default FDA trials did prove next to no ASD

Hi Dieter

I am going to jump in here. The US FDA clinical trials on the Prodisc actually did prove that an ADR is substantially less likely to cause ASD than fusion. I believe that after 5 years the fusion and Prodisc patients were compared. Approx. 25% of the fusion patients were starting to show ASD on MRIs. Only 2% of the Prodisc recipients showed signs of ASD.
For all the FDA bashing done on this site, it is nice to have some genuine facts backed up by a legitimate, multicenter trial.
You can find these results on the FDA website under clinical trials.
__________________
Healthy and athletic for 51+ years until:
Dog yanked on leash & low back went, can't sit, stand, walk W/O pain.
10 mos. PT, Shots, meds, alternative stuff; nothing
Microdiscectomy at L5S1 at HSS - failed
Lost successful business, went on disability; more "conservative" treatments
At 3 years fed up and deciding upon ADR or Fusion
Scared and uncertain
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  #37  
Old 04-06-2016, 04:05 PM
Sukhre Sukhre is offline
Member
 
Join Date: Jul 2015
Posts: 33
Default Lack of data

One of the main issues, I find in deciding surgeries is the lack of data. Mc6 has been around from 2005. So there should do at least 100+ patients who has had this surgery for 9 or 10 years. There is no data to how these patients are doing. One of the reason is that there are privacy laws to protect patient privacy. Patients do not get any benefits from those laws ( like a patient information could be kept without name, date of birth or any identity... so there can be a map between a patient's identity to non-private data from which identity has been stripped out).

People used to believe that 90% or so fusion patients are doing really well. Dr. Pettine published a paper showing its around 60% or so who are doing really well. Propublica surgeon scorecard published complication rates of individual surgeons (its far from perfect), but it helps a lot.

Also statistics is used such an improper way. I have had these symptoms 14 years back. A surgeon told me that it could be my cervical discs. My PCP told me studies show physical therapy patients are doing better than patient who went through surgeries and he denied me to do an MRI. I had PPO insurance. I went to physical therapy and it hurt like crazy. He kept on saying its all in my head because I did not improve by physical therapy. The truth is I would be better off doing MRI, knowing where my problems were and live a life with precaution. Most surgeons know physical therapy might do worse for patients with stenosis.

Nothing should prevent FDA to collect data as in how many people had fusion/laminectomy/ADR, and what their current thoughts are. Would it be 100% fair? no. Say studies show 80% patients are happy with their surgery decision (like Mobic ADR 4 yr followup), it would be greatly helpful.
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46 yr old male/ USA
May 2015 MRI: Cervical Stenosis at C4/5, C5/6 and C6/7
Surgeon asked to do Fusion C4-C6
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