What made you so sure ADR was the right decision?

[laid up doc]

saw the allergy derm guy today - said he'd be happy to write a letter on my behalf should i show metal issues on the patch testing. said he doesn't think LTT is helpful - he also said he doesn't believe in true "titanium" allergy - but obviously ppl can have issues w/ aluminum and vanadium which are part of the alloy. pure titanium is too soft for surgical use.

so i now have like 90 patched plastered on my back... guess i'll know every damn thing in the world that pisses off my skin after this!

had a phone chat w/ Dr Coric today - he does lots of ADR's and he said he couldn't look me in the face and tell me that either choice was clearly better. said he has sent ppl w/ unusual cases like mine overseas, specifically mentioned Germany and someone else in the UK - name starts w/ F? not Boeree. also said given my metal issues, best thing may be to have a fusion knowing the screws could always come out. was surprised to hear that Aetna wasn't covering fusion - apparently they've been fighting a similar battle w/ BCBS-NC as far as not covering fusions.

he also said he thinks the M6 is a good disc, and clearly has advantages for people w/ metal allergies. said the next disc on the market will probably be Flexicore, but that's a CrCo alloy too. didn't think there was anyway in Freedom trial to get around randomization since I likely can't have a prodisc. wouldn't commit to "following" me after out of country ADR, but would look at my xrays. thinks it's fairly risky to go overseas.

and so it goes... patches are on til wed. not allowed to sweat and can't lay too much on my back. and i'm supposed to move friday.... this will be interesting! bumped my thermostat down to 70 and i guess i'm stuck indoors during the day!

[Slackwater]

Originally Posted by laid up doc

saw the allergy derm guy today - said he'd be happy to write a letter on my behalf should i show metal issues on the patch testing. (Nice Gesture, Thumbs Up)

had a phone chat w/ Dr Coric today - he does lots of ADR's and he said he couldn't look me in the face and tell me that either choice was clearly better. (Understand) said he has sent ppl w/ unusual cases like mine overseas, specifically mentioned Germany and someone else in the UK - name starts w/ F? (SEE BELOW) not Boeree.

also said given my metal issues, best thing may be to have a fusion knowing the screws could always come out. was surprised to hear that Aetna wasn't covering fusion - apparently they've been fighting a similar battle w/ BCBS-NC as far as not covering fusions.(Insurance companies have more data than the doctors on results, follow-ups, total costs and possible revision(s) over a patient's lifetime. ref also: Deyo and Mirza, University of WA )

and so it goes... patches are on til wed. not allowed to sweat and can't lay too much on my back. and i'm supposed to move friday.... this will be interesting! bumped my thermostat down to 70 and i guess i'm stuck indoors during the day!

Glad you got the patches, I hope your patches get off without trauma and the household move goes OK+.

You mentioned a possible orhopaedic surgeon in England. I am fuzzy on the UK. May I suggest ?


ISASS 2011 Annual Meeting (LINK)

Abstract 276
An Association between the Center of Rotation and Clinical Outcome in Patients Implanted with a Viscoelastic Lumbar Total Disc Replacement
B. Rischke1, E.R. Ross2, B. Jollenbeck 3, J.A. Hipp 4, K.B. Zimmers5
1 Spine-Center-Rischke, Center of Orthopaedic and Spine Surgery, Zurich, Switzerland,
2 Spire Hospital, Manchester, United Kingdom,
3 Otto-Von-Guericke University, Magdeburg, Germany,
4 Medical Metrics, Inc., Houston, TX, United States,
5 AxioMed Spine Corp., Garfield Heights, OH, United States

Freedom Lumbar Disc above: similar on Anterior-Posterior positioning models done in biomechanics. EuroSpine abstracts may have them online (see Heuer, Schmidt, HJ Wilke Univ.Ulm ? ). Surgeons' hands make a difference. See also Metzger/Lotz UCSF-UC Berkeley ORS Annual Meeting 54.#1336.PDF Pettine comments on facets as being 46% of the reason for sub-optimal ADR/TDR results elsewhere in 2011.ISASS Abstract 468

532
Three Level Lumbar Disc Replacement - A 2 Year Follow up
J.C. Sutcliffe1, H.S. Bhatti1, A. Dadds1, P. Ankers1
1 London Spine Clinic, London, United Kingdom

Abstract 463

Does Reconstruction of the Anterior Longitudinal Ligament (ALL) Improve the Results of Lumbar Artificial Disc Replacement (ADR)?
K.A. Pettine1
1The Spine Institute, Loveland, CO, United States

Yes, short answer for Maverick, Charite' and ProDisc. Journal of Biomechanics has the long answer. Not sure on viscoelastic models.

[Harrison]

Good Lord, folks -- fusion is not an evil thing. Especially if you have concerns about the risks of metals, surgeons, costs etc. You all know this, I just want to point out the obvious.

That said, BMP in the cervical spine is still risky. See all the other posts and articles on the Medtronic BMP complications. Still, use NSAIDs if you use BMP products, IMHO. I am saying this as an information analyst and editor and nothing more than that.

Steve, Jeff, ML, Maddie, thanks for posting.

[Maddie]

patches are on til wed. not allowed to sweat and can't lay too much on my back. and i'm supposed to move friday....

Eeek! A blood test sounds so much easier

he also said he doesn't believe in true "titanium" allergy - but obviously ppl can have issues w/ aluminum and vanadium which are part of the alloy. pure titanium is too soft for surgical use.

I don't understand this opinion...yes, titanium is supposed to be much less of a reactant than other metals but as you say, the medical grade titanium IS an alloy, containing other metals to which we can be highly reactive. So why even raise this issue?

As far as going back out of country if there are problems, I don't see it being an issue really. I would have had to travel across this country to get help with surgeons in a different province, since no one here would help me. To me, one more stamp on my passport isn't a big deal. The hospital where I stayed for eight days in Brazil was the cleanest I've ever been in, and the surgeon and staff much more empathetic and willing to help than most others I've been to here at home. I would go back in a heartbeat if need be...fingers crossed that won't happen, 'cause I'm too broke now

[Maddie]

Just wanted to add that instead of titanium or stainless screws, I had carbon fiber ones used for my ADR.

While I had to have PEEK cages made of some sort of plastic for my fusions, I didn't have anything to keep them in place other than the pressure of the vertebrae themselves. No screws, rods, plates, etc., just the plastic discs and 'bone mash' made of my own bits mixed with a growth medium. Not sure if it is the BMP that you mention Harrison, but it beat the heck out of harvested bone from my hip or bovine/cadaver bone that are the only choices here for fusion.

[laid up doc]

Maddie,
the derm said that LTT results aren't widely accepted and it isn't totally clear how results translate into patient problems. i will decide on my own whether to do it after the patch tests.

Harrison,
I am absolutely not anti-fusion... but Aetna is. from their clinical policy bulletin (http://www.aetna.com/cpb/medical/dat...99/0743.html):

"Aetna considers lumbar spinal fusion experimental and investigational for degenerative disc disease and all other indications not listed above as medically necessary because of insufficient evidence of its effectiveness for these indications."

a guy on SPS (not sure he posts here) tried and failed to have Aetna cover a fusion - and he had spondy that was not severe enough under Aetna's criteria. i am not aware of anyone appealing based on having contra-indications to Charite'/Prodisc. if any of you know of someone, w/ any insurance... LET ME KNOW! it seems though, that Aetna and BCBS-NC are the only 2 major carriers who are trying to deny lots of fusions. many of you are fighting the opposite battle.

every surgeon i have talked to in the US thinks i should have a fusion - including ones who do ADR's. am awaiting word back from Boeree and Clavel, but i have serious reservations about having a reaction even to the M6 (though Boeree did say he isn't aware of any problems... but it is a new disc... argh!). fusion screws can always come out...

[nanfromsactown]

Wow, I am so glad I don't have any allergies after reading all that you're going through! Good luck to you.

You ask what made me decide ADR was best for me? A couple of reasons. One, I have not had any instability in my spine. The degeneration has been confined to L45 and L5S1. I was a work comp supervisor, and I saw so many failed fusions--people who were desperate to get pain relief and were promised a fusion was the answer. But for many it wasn't and they had failed surgeries. Since I have no instability, there is no reason for me to be fused. My discogram in 1999 was positive at the two levels and the IDET I had did provide a very short term relief of pain. All direct indications to me that my pain was discogenic. So for the past 10 years I've been researching ADR, a lot on this board, and taking breaks when other bigger life issues intruded. I consulted with both Bertagnoli and Zeegers in Germany, and UCSF here. I was stuck with horrible insurance--work comp and then medicare/empire bcbs once work comp was done. Work comp probably could have been forced to provide the two level pro-disc since I had a US surgeon's consult, paid for by them, saying I was a candidate, but I don't want a pro-disc. So then it became a matter of money and putting together what I need in order to go overseas to get the surgery done and get my life back. People have looked at my MRI (non medical personell) and stated that my MRI doesn't look so bad, people would kill to have my spine, etc, but these are people who are not educated in everything disc related and are not living with my daily pain. I have been forced by pain to go the route of pain management and I'm grateful for the years of support I've received from them, but I really, really need my life back. I cannot work, and I cannot do very much pleasurable or fun, and I am far too young (now 52) to be this disabled.

Thats the long answer! The short answer is that ADR protects my spinal motion and a fusion wouldn't. I cannot imagine taking away the motion I have, which like yours, is kinda freakishly good, I can touch fingertips to floor on a good day.

Have you consulted with Dr. Zeegers? He is the one I'm going with. My experience with him over the years has been very solid and never changing. My experience with Dr. Bertagnoli has been different--he went from very accessible to not really. Also, his price went up and he is strictly with Prodisc.

[laid up doc]

Nan - am more interested in going to UK or Spain. Need to follow up with Boeree and Clavel.

Decided to do the LTT - results should be ready in a week. The derm said there is a 10-15% risk of becoming allergic to chromium in anyone's life. I'm 33... come from a long-lived family... feel better about a titanium alloy if indeed LTT is ok. Need also to touch base w/ the surgeons who advised against the ADR's they have access to, and discuss the M6.

Household move has happened... gonna need serious help to set up the kitchen. Most of what I really need is unpacked, but I need to find my printer!!!

Am now ready to commence pre-surgery PT and conditioning. I don't have a job here which makes it so much easier to concentrate on my health and not have to worry about getting into too much pain prior to a shift.

[Slackwater]

Originally Posted by Harrison

Good Lord, folks -- fusion is not an evil thing. Especially if you have concerns about the risks of metals, surgeons, costs etc. You all know this, I just want to point out the obvious.

That said, BMP in the cervical spine is still risky. See all the other posts and articles on the Medtronic BMP complications. Still, use NSAIDs if you use BMP products, IMHO. I am saying this as an information analyst and editor and nothing more than that.

Steve, Jeff, ML, Maddie, thanks for posting.

Agree with you, fusion is not evil. The original question was what made you decide etc. I deferred the surgical decision.

The re-operation rates made me think a second and third time about having a two-level Fusion. Laid.Up.Doc was given a vauge reference above to Drs. Deyo and Mirza. The numbers, results, metrics and outcomes with percentages justify the procedure.

Deyo/Mirza wrote about lumbar surgical procedures in the state of WA n = 24,882 ( Pubmed, Adr.post ) and I noted the re-operation rate at eleven (11) years. I was fortunate to listen to Dr. Mirza speak at a UCSF spine conference. A more recent journal article was published on outcomes. I did not post it to the article library earlier this year (taking a break to ...).


~~~~~~~~~~~~~~~~~~~~~~~~~~~
LINK
Spine: 15 February 2011 - Volume 36 - Issue 4 - p 320–331
doi: 10.1097/BRS.0b013e3181ccc220
Epidemiology

Long-term Outcomes of Lumbar Fusion Among Workers’ Compensation Subjects: A Historical Cohort Study

Nguyen, Trang H. MD, PhD*; Randolph, David C. MD, MPH*; Talmage, James MD†; Succop, Paul PhD*; Travis, Russell MD‡

Study Design. Historical cohort study.

Objective.
To determine objective outcomes of return to work (RTW), permanent disability, postsurgical compli­cations, opiate utilization, and reoperation status for chronic low back pain subjects with lumbar fusion. Sim­ilarly, RTW status, permanent disability, and opiate utili­zation were also measured for nonsurgical controls.

Summary of Background Data.
A historical cohort study of workers’ compensation (WC) subjects with lum­bar arthrodesis and randomly selected controls to evalu­ate multiple objective outcomes has not been previously published.

Methods.
A total of 725 lumbar fusion cases were compared to 725 controls who were randomly selected from a pool of WC subjects with chronic low back pain diagnoses with dates of injury between January 1, 1999 and December 31, 2001. The study ended on January 31, 2006.

Main outcomes were reported as RTW status 2 years after the date of injury (for controls) or 2 years after date of surgery (for cases). Disability, reoperations, complications, opioid usage, and deaths were also deter­mined.

Results.
Two years after fusion surgery, 26% (n = 188) of fusion cases had RTW, while 67% (n = 483) of nonsur­gical controls had RTW (P ≤ 0.001) within 2 years from the date of injury.

The reoperation rate was 27% (n = 194) for surgical patients. Of the lumbar fusion subjects, 36% (n = 264) had complications. Permanent disability rates were 11% (n = 82) for cases and 2% (n = 11) for nonoperative controls (P ≤ 0.001). Seventeen surgical patients and 11 controls died by the end of the study (P = 0.26). For lumbar fusion subjects, daily opioid use increased 41% after surgery, with 76% (n = 550) of cases continuing opioid use after surgery. Total number of days off work was more prolonged for cases compared to controls, 1140 and 316 days, respectively (P < 0.001). Final multi­variate, logistic regression analysis indicated the number of days off before surgery odds ratio [OR], 0.94 (95% confidence interval [CI], 0.92–0.97); legal representation OR, 3.43 (95% CI, 1.58–7.41); daily morphine usage OR, 0.83 (95% CI, 0.71–0.98); reoperation OR, 0.42 (95% CI, 0.26–0.69); and complications OR, 0.25 (95% CI, 0.07–0.90), are significant predictors of RTW for lumbar fusion patients.

Conclusion.
This Lumbar fusion for the diagnoses of disc degeneration, disc herniation, and/or radiculopathy in a WC setting is associated with significant increase in disabil­ity, opiate use, prolonged work loss, and poor RTW status.

~~~~~~~~~~~~~~~~~~~~~~~~~~~


"Laid.Up.Doc" wrote about Aetna Policy Statement, Coverage Statement focused on ADR/TDR and not fusion. I suggest Aetna and other insurance companies have similar data, possibly better data on fusion outcomes.

A personal decision to defer 2-level fusion surgery was based partially on re-operation rate, two-year outcomes versus complications of adr v. fusion, narcotic use, RTW, ... I looked like a Work.Comp case with a lawsuit involving a motor vehicle accident. The prognostics on surgery for that situation looked below the 50th percentile. We still pursue the outcomes as measured by ~vas, ODI, SF-36 (PCS/MCS), MCID, etc.

[laid up doc]

My main issue w/ Aetna is that a Prodisc/ADR isn't the right disc or procedure for everyone with symptomatic DDD - and since nothing else is really available, they should have a less black and white policy... maybe mandate that pts have to be EVALUATED for indication for ADR, THEN evaluate if fusion is indicated.

In the end... I can't pay out of pocket for fusion and have come to be very comfortable w/ the idea of an M6L. No chromium, goes in as 1 pieces, no parts to fall out, way less wear debris, seems to be biomechanically the best thing available at this time.

I will also mention that no one can ever put to rest whether I injured my left SI joint during my initial injury, a horse fall... and fusion at L5/S1 could unmask an even harder to treat problem w/ my SI joint.

Slackwater - that study as you noted was in WC patients. At least 2 of the surgeons I saw said they won't operate on WC patients except in very select cases. My initial injury was reaggravated in an MVA - I have no guarantee of any payment, and honestly it's not even in my top 50 list of important things right now. It's hard to equate MVA and WC patients - some are similar and some are not. A lot of WC back injury claims are in laborers... it's best to pull the study and see how you compare to their patients. if they're a lot older, use more narcs, had very different ODI in either direction, or a host of other factors are different - it's hard to apply this study to your situation. that's a general rule of interpreting studies. also note that this wasn't a randomized control trial - they just looked back at how each group did. the decision to have surgery was made by the patient and doc, not randomized in a study.

I'm focused on preparing physically, mentally, and financially for surgery, doing everything I can to optimize my recovery, and being able to return to being the physician rather than the patient. It's hard to describe how rewarding (or frustrating!) the practice of medicine is to me - I work in an intense, chaotic environment where I can alleviate human suffering and change the course of people's lives every day. You can't ask for much more than that out of your work imho... and it breaks my heart every time I think of the amount of time/productivity/money/quality this stupid disc has cost me. I'm coming to get it back, very soon. Some say I look like a sweet, innocent angel, but inside I'm one of the most competitive and driven women you'll ever meet.