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AKactivemom
03-02-2015, 02:50 AM
Hi, I'm a 37 year old active mother, wife, and occupational therapist. My husband is a physical therapist. We have been researching relentlessly (mainly me and passing on info. to my husband) since my spine surgery (2 level ADR at L3/L4, L4/L5 or hybrid (ADR and fusion) was cancelled on Jan. 15, 2015 when the very final nurse caught that I had a possible nickel allergy (b/c I break out to cheap jewelry and rivets on waist of jeans) to the fact that the ProDisc might have nickel in it (0.03% as an alloy). I was NOT screened for metal allergies at the surgeon's office.

I had formal metal implant patch allergy testing 2 weeks ago and I have confirmed allergies to: Nickel (2+), Pallidium Chloride, Tungsten, & Silvre Nitrate (1+). The ProDisc is automatically out and so is the MobyDisc (all fda approved in the US lumbar ADR's have nickel is my understanding). The only lumbar ADR I have found compatible with my allergies is the M6 made by spinal kinetics which is not fda approved yet in the U.S. & there are not any clinical trials that will be started in the next three years (straight from a rep. at Spinal Kinetics two days ago) in the U.S. for the Lumbar spine. Dr. Bierstedt at the ONZ spine surgical group in Germany has reviewed my case & says I'm an excellent candidate for the 2 level ADR procedure. Dr. Bertagnoli primarily uses the Prodisc as far as I know so I have ruled him out.

Some people may have found this blog early on in their journey but I'm much farther along in this journey and ready to make a decision and been doing extensive research, pouring over approx. 40 research studies (PubMed, etc.). I've been trying conservative treatments for the past 3 years with minimal success and ever since May, 2014 (perhaps an annular tear? while working at my parents farm laboring to scrape the old buildings to prepare to paint them) I have chronic pain with bending, prolonged standing, sitting, and walking and my quality of life has been greatly affected and I have to take daily ibuprofen, e.s. tylenol, tramodyl, & muscle relaxers to manage the pain every day. In the US, the spine surgeon wants to do a 2 level spine fusion since I am not a candidate for the ADR b/c of my nickel allergy.

I am waiting on a 2nd spine surgeon's opinion on March 20th (in my home state, Alaska) and then I'll also be uploading my files and contacting Dr. Clavelle for a 2nd opinion in Europe. If you are wondering about the shape of my facet joints, there is not osteoarthritis noted on the MRI's or CT scans and I'm not a candidate for facet steroid injections b/c there is no noted problems there, they are said to be in good shape and Dr. Bierstedt says my lumbar lordosis curve is intact as well, although the MRI report says it is slightly straightened.

Any feedback/advice for me? Thanks so much, this is an amazing online community to be a part of. I have watched the ADR video.

My pain is considered to be discogenic and mechanical/axial and I have minimal (if any) nerve impingement.

Also, I have heard a couple people say on the discussion boards that 2 level ADR's are not paid for by insurance companies in the U.S. I just wanted to mention that I read that 2 level ADR's were approved starting in the fall of 2013/early 2014 and I was approved in January, 2015 for a 2 level ADR (prodisc) at L3-L5. The first request was denied but it was approved when my Spine surgeon's office requested a "peer review by a Dr. and consulted directly with a Dr." and then it was approved-my surgeon was pretty much shocked it was approved for two levels. WE have ModaHealth insurance & live in Alaska. Having said that, he told me not to count on a 2 level ADR b/c there was a good chance he might decide to do a fusion at L4/L5 depending on how my anatomy was and how much height I had in that disc space (I think he said).

Anyhow, I would like to upload a pix. of my MRI so everyone can see it but I can't figure out how to do that, can someone help me with that?

AKactivemom
03-02-2015, 03:33 AM
I know this is a long post but with as busy as I am with my family, work, etc., I barely have time for this so here goes another question...
Re: Dr. Clavel at the Barcelona Spain Institute. I've heard excellent things about this Dr. as well and I plan to get a 2nd opinion from him (European 2nd opinion). My Liason, Ken Hiebert, to the ONZ spinesolutions group of Dr. Bierstedt said that Dr. Clavel is or was associated with Dr. Ritter-lang and then broke out on his own or branched out on his own (not sure exactly what he said here) BUT then I talked with another 2 level ADR cervical pt. and he said that Dr. Clavel used to be with the ONZ group until 2009 until he split out on his own. Can someone enlighten me as to how and whom Dr. Clavel is affiliated with or was? I know Sternum hospital and Dr. Ritter-lang have quite a bit of negative publicity and I'm trying to figure our who is who. Thank you.

NJ Gene
03-02-2015, 07:51 AM
Ken, from ONZ, works for Dr. Bierstedt. Many of Dr. Bierstedt's team members are former employees/patients of Dr. Ritter-Lang. They are correct, at least from what I've heard, that Dr. Ritter-Lang and Stenum are not good. However, they will say anything to prevent you from going to a surgeon outside of ONZ. Let's face it, they are sales people too.

Dr. Clavel is only associated with Dr. Bierstedt for marketing purposes. If you tried to get an appointment with Dr. Clavel through Dr. Ritter-Lang's website, they would push you to go with Dr. Ritter-Lang. Dr. Clavel has his own site. Here is a link to it: Barcelona Spine Center (http://www.doctorclavel.com/en-us)

Btw, I believe the physicians at ONZ are very good. However, IMO, it is very shady of Ken and the team leaders to say that Dr. Clavel is associated with Dr. Ritter-Lang, when he has nothing to do with him except for appearing on his website. These people (i.e. Ken, Malte, Kelli) on the ONZ team are more closely related to Ritter-Lang and Stenum than Dr. Clavel ever was or will be.

Good luck!!
Gene

Boxer78
03-02-2015, 03:06 PM
i was told by a patient that he had a 4 level done by ritter Lang in Spain with the assistance of clavel . I see nothing wrong w these guys sharing techniques etc I also understand clavel studied at Hopkins with neurosurgeon dr Lee Dellon.

Jerry5
03-02-2015, 08:02 PM
Hello, First, sorry to see you here, but now that you are, hope you can find some answers.

The FDA in the USA is in the hands of a few big corporate types, much like the Internet will be if the 'Net Neutrality' goes through.

That said, I could recommend, Ilherhaus and Bierstedt, but I could not NOT recommend Ritter Lang, I did talk to his Rep here in the USA, and had a favorable talk with him.

If I had one piece of advice, get a good MRI, and have at least TWO evaluations from a Doctor in Europe, and another, maybe two more in the USA.

If the L45 is bad, better take a look at the L51.

All the Best,

AKactivemom
03-08-2015, 04:52 AM
I appreciate your comments. My L5/S1 has a good disc signal and looks good on the MRI which is why they didn't test it on the provocative discography (I think).The surgeon thinks my L3/L4 is in such bad shape from an old trauma 15 to 20 yrs. ago that then began to accelerate the DDD at a more rapid rate & then the L4/5 probably took up the slack right under it but I might also have a genetic disposition as well, hard to know.
Anyways, thanks for all your feedback. Take care and I'll keep everyone posted as to how my 2nd spine surgeon opinion (in the US) goes in the next two weeks and I'll also be trying to connect online with Dr. Clavel from Spain in the meantime.
Thanks!

AKactivemom
03-08-2015, 04:53 AM
I completely agree. Makes sense to me.

AKactivemom
03-08-2015, 04:57 AM
When I asked Ken (liason from ONZ group) directly via email, he ended up telling me that Dr. Clavel was never affiliated with the ONZ grop and that he wasn't sure if Dr. Clavel was affiliated with Dr Ritter-lang but he had "heard" he might be...Oh well, I got an excellent feeling from Dr. Bierstedt on the phone so I don't think I'll hold it against Ken if he wants me to stick with his group I guess.
Politics, politics, wherever you go, even across the ocean.

Cynlite
03-08-2015, 01:37 PM
I'm so sorry you had to cancel your ADR in the states! I can imagine how frustrating that must have been :(

Since we are following the same path (I think I'm just a little behind you,) I thought I would introduce myself. I'm a 50 plus year old looking at Europe for cervical ADR (probably two levels) because I don't think I can wait through a lengthy appeal process with the insurance company. Also, Europe is so far ahead of the U.S., I feel like if I'm going to have surgery again, I want to make sure I give myself the best shot at a recovery. I haven't ruled out the U.S. yet but, am not confident the surgeons will tell me what I want to hear. I am adamantly against fusion.

In an email last week, Malte said that Dr. Bierstedt stopped using the ProDisc "some 8 years ago." I just got my package to them on Friday and am waiting for a consult with the surgeon still.

The other surgeons I have on my list to contact now are Dr. Clavel (Spain), Dr. Dare (UK) and Dr. Zeegers (Germany). I contacted Dr. Bertagnoli's U.S. liaison but, have ruled them out since he is using a Prodisc-C Novas. I didn't feel like they would be a good fit for me. I'm not sure if I have metal allergies so, will have to get that checked. Sorry you had to be the one to bring that to my attention...but, THANK YOU! I'm extremely sensitive to medications, anesthesia and adhesives so, it's definitely worth checking out!

One of my questions for the surgeons is re data on the HO rate for the M6-C as I have not found any. Perhaps it's too new? Here is some information I have in my notes:
Heterotopic Ossification:
http://dev-journals.lww.com/spinejournal/Abstract/2010/07150/Difference_in_Occurrence_of_Heterotopic.11.aspx
Results. Each prosthesis group included patients as follows: Bryan disc, 81 patients; Mobi-C, 61 patients; and ProDisc-C, 28 patients. Overall HO rate was 40.6% (69 of 170 patients). Each HO occurrence rate by prosthesis was as follows:
Bryan disc group, 21.0%;
Mobi-C group, 52.5%;
ProDisc-C group, 71.4%.
The surgeons are using wax or something like that now to help mitigate the problem.

Romakis seems to also be at about the same place we are in this process. I'm following your posts and hoping you both find your solutions soon!

AKactivemom
03-09-2015, 03:43 AM
Wow! I just read that abstract from the journal "Spine" you gave the link to and that is fascinating...I am not very familiar with the cervical ADR research as I've focused primarily on the lumbar spine. Have you read much on the HO in the lumbar spine? I would agree about Dr. Bertagnoli, b/c he fathered the prodisc, I understand he primarily puts that in patients and so I have ruled him out as well b/c of my metal allergies. I would highly recommend!! getting a patch allergy test to test for allergies if you a highly sensitive person (if it was me and I had to do this all over again, I would do it no matter what, it only was about $300 out of pocket with my 20% co-pay to find out what I can and can't tolerate in my body). My surgery was probably going to cost about $150k US (with insurance paying most of it) so somehow $300 doesn't seem like much compared to that...not to mention the prodisc can be VERY difficult I've read to remove from the spine or Dr. Bierstedt said even NOT possible b/c of it wide keel, etc. which doesn't bode well if you are allergic to something in it and its been anchored in your spine....Let me know how your consult goes with the ONZ surgeons if you will. I also need to make contact with Dr. Clavel but haven't heard back via email yet, I guess I need to call. I heard from another forum post that Dr. Zeegers is on the edge of retirement but I have no idea, maybe he works part-time now, I've heard he's also very good. I can tell you that I have emailed with 2 patients that have had the cervical spine ADR and also been able to talk with one lady that is 43 and also lives in Alaska (and had nickel allergies) who went to Germany for a 2 level ADR (cervical) with the ONZ group and all 3 of them have given me excellent reports on the ONZ group. One thing you may want to ask when you call these places is if they have a rehabilitation/massage/etc component following your surgery/hospital stay. One of the primary reasons that the lady I talked with in Alaska chose Dr. B___ over Dr. Clavel in Spain was b/c of Medicos, the rehab facility that is all paid for (one week) with your two week package and includes PT, OT, a Rehabilitation Doctor, wound care/check-ups, oh and massage therapy too. Keep me posted and yes it does seem Romakis is about at the same decision making process we are..nice to know there are others out there. This is hard time for me and I CAN'T WAIT to make a decision on WHEN I'm going. My 2nd opinion in the US March 20th and I hope to decide that following weekend where I'm headed. Also, did you know that Spinal Kinetics has a clinical trial right now on the M6 for the cervical spine but I'm not sure if its only single level.

Cynlite
03-09-2015, 11:09 AM
Yes, I checked into the trial but, because of my prior surgeries, I was not a candidate. Besides, I am fairly certain I will hear back that I need more than one level plus, my insurance didn't cover them either. That was a bummer but, worth a shot.

I'm sorry, my research has all been focused on the cervical spine so, I have nothing to share regarding the Lumbar spine.

I did read about the massage/rehab component of Dr. B's approach and that really caught my attention. I think its an important part of the equation. I paid out of pocket for a neuromuscular massage therapist after my prior surgeries but, had to wait a month before I was released to use her. It seems so counter intuitive to me to wait. Many years ago, I had an ACL knee surgery. My surgeon had me in PT prior to the surgery. Muscle has memory so it's a good idea to be in as good of shape as possible prior and then jumping right back into PT after the surgery is wonderful. I'm having such a hard time moving now that all I can do is focus on my diet and try to lose the extra weight I put on sitting around being in pain. Juicing has been a great addition to my life BTW. I think it helps to replenish and heal the body from what it loses dealing with the drugs we take to manage pain. I walked until I couldn't walk and lifted light weights until my pain got too bad. Now, all I have left is that I stretch every day and focus on trying to keep a good posture when I sit and walk. Stretching helps with the muscle spasms.

I'll be sure to stay in touch. Please stay in touch with me as well.

I'm off to get some tea and start making phone calls to surgeons LOL.

AKactivemom
04-01-2015, 07:05 PM
Sorry I've been off-line for awhile... I had a 2nd opinion by phone consult with Dr. Clavel Mid-March and he conferred with Dr. Bierstedt that I was an excellent candidate for the two-level lumbar ADR. He also said that the fact that I have Modic Type I/II reactive endplate changes has been shown clinically or in research that those patients do better than patients that don't with discogenic pain. I also had my 2nd opinion by Dr. Eule (Anchorage, Alaska) on Friday, March 20th. He thought I would be a good candidate for the two level ADR (art. disc replacement) and that I would do much better than with a fusion (he thought the fusion would also help but ultimately that I would do better with the ADR).....he also thought something was wrong with my neck b/c I had 5 positive neurological signs/reflexes that something was going on there....so he ordered an MRI of my neck which I had done Monday, March 23rd....... it all was within a normal range for someone my age and now its been ruled out..Dr. Eule has unfortunately been out of town and has not been able to personally look at the MRI but we decided given the normal reading by Dr. Kincaid and CPGH and by looking at the cervical MRI images ourselves to go ahead with surgery in Germany for the two -level ADR replacement.

I'm headed to Dusseldorf Airport in Germany and then onto Hattingen Hospital on April 21st with Dr. Bierstedt conducting the spine surgery with a vascular surgeon assisting (approx 2 hours total) and I'll stay in Germany for 16 days total plus travel time. My husband will stay with me for the first 5 to 6 days and then I'll go it alone from there on out at the rehab facility and fly home alone May 3rd, 2015. I'll overnight in Seattle for the long flight from Germany back to Alaska. Thank you all for your support on this journey! I am at complete peace with my decision and I will keep you posted once I have surgery.

Boxer78
04-01-2015, 07:26 PM
Good luck!!

Cynlite
04-04-2015, 04:51 PM
It must feel good to have your surgery planned! I hope your travels are uneventful and that you have a very successful surgery. I look forward to hearing about it and will keep you in my thoughts. Best of luck.

P.S. I've read of others here who got their insurance to pay for the surgery in Germany after the fact. Seems like you would be a good candidate since they approved it in the U.S. but, you had to cancel it because of your metal allergies. You might want to research what paperwork you will need from Dr. Bierstedt to make the claim; assuming you haven't already thought of this :)

Cheryl0331
04-04-2015, 06:42 PM
Even of Clavel was associated with Stenum; which he wasn't, it speaks volumes that he had the good sense to get away! ;o) The Hospital Quiron is JCI accredited and ISO 9001 compliant; so I trust that! :angel:

Stonewall_Boris
04-05-2015, 08:01 AM
When I was doing my research Dr. Clavel was associated with Dr. Ritter-Lang. I've personally met with Dr. Ritter-Lang patients and they doing well. Much like myself we are still doing post op treatment's. From my understanding Dr. Bierstedt also worked with Dr. Ritter-Lang.

Cheryl0331
04-05-2015, 09:20 AM
When I was doing my research Dr. Clavel was associated with Dr. Ritter-Lang. I've personally met with Dr. Ritter-Lang patients and they doing well. Much like myself we are still doing post op treatment's. From my understanding Dr. Bierstedt also worked with Dr. Ritter-Lang.
;) It was really the hospital's oversights not the doctors anyway...

Stonewall_Boris
04-05-2015, 09:39 PM
One of the reasons I went with Dr. B. was because of the hospital he was working from. It was just not a clinic but a full hospital. I've read posts here where people took tea with them to clean out there bowels before surgery. That was one of many things I didn't have to worry about, as soon as I was admitted I was instantly taken care of. And yes, they gave me something to drink to clear out my bowels before surgery. They pretty much kept track of me from the time I left on the airplane to Dusseldorf to now.
BTW. If anyone goes to see Dr. B. at Hattigen I was in room 4 on the sixth floor.