Newbie could use some input/feedback on Lumbar ADR

[Tatonka_usn]

Greetings everyone!

I'm a new arrival to this group, though a back pain sufferer for a number of years. It appears as though ADR may now be an option in my case, and after doing some recent research of the up's/down's/pro's/con's I figured I would seek out the sage wisdom of those who are knowledgable and/or have lived through it.

Let me try to give you a semi-abridged version of my situation:

- Fell off a motorcycle while learning to ride in 1991 (at age 19). LBP and right side symptoms presented due to bulge & stenosis at L4/L5. Conservative treatment (to include botched ESI). After several years the issue gradually resolved itself (with occasional flareups).
- Involved in significant MVA in Dec 03 (at age 31). Walked away with whiplash, but though everything ok otherwise.....until:
- April 2007 (age 35). Sudden onset LBP and pain/loss of sensation down left leg (into outer half of foot) coupled with loss of S1 reflex in achilles tendon. MRI reveals HUGE herniation at L5-S1 (likely delayed onset from car wreck). Several months conservative treatment (PT, ESIs & accupuncture) unsuccessful.
- Forced into MICRO-D/hemi-laminectomy at L5-S1 in July 2007 by Navy (conducted at Walter Reed). Was advised herniation was one of the largest surgeon had ever seen (the size of his thumb!). Initial results promising, with 6 months improvement and increased cardio routine....:-)
- Residual effects return by early 2008. MRI reveals reherniation at same level, coupled with severe bilateral recess narrowing and scar tissue (not to mention changes from L3-L5). Symptoms progress bilaterally by mid 2008, and conservative treatment does little (PT, acupunture, massage, 3 X ESI, 1 X Lysis of Adhesion for scarring, and Chiro --> bad move). Consult with civilian N/S --> recommends holding off on surgery, but advises will likely need fusion down the road. Consult with Navy N/S (Dec 08)--> can probably decompress with bilateral foraminotomies as a quality of life issue (no need for fusion,etc).
- Continued symptoms, accompanied by increased LBP (first time, or first time noticed??) and anterior thigh pain in both legs (feels like groin pain running from crotch to knee, worse on right). Navy Ortho Surgeon (my "third opinion", June 09) reiterates what Navy N/S said earlier --> avoid ANY surgery as long as possible.
- Repeat MRI's in June 08 and April/Sept 09 reveal no "significant" changes, though pain increasing (particularly in right buttock and leg)
- F/U with Navy N/S today (Oct 09). Concerned over increase in LBP, which calls into question new pain generator. Careful review of MRI's reveals L5/S1 disc space decreasing in height and water content since June 08 MRI. Guess I shouldn't be surprised given the size of the fragment removed --> textbook example of DDD. N/S discusses means of increasing disc space height and broaches both Fusion and ADR. Says the former is not applicable for me as I'm too young (at 37) and there is no noticable instability. Believes I can go with either foraminotomy or ADR, when/if I opt for surgery. I have obviously concerns with BOTH: forminotomy appears a short term fix (given the decreasing disc height) and ADR is still a "new" technology (certainly no guarenteed results). Unfortunately, I'll be leaving the Navy early next year and my goal is to have any necessary surgery BEFORE I depart (which rules out holding off too long)

Ok, so here's where my question comes into play. The Navy N/S believes I am a viable candidate for the ADR, given my apparent post-diskectomy syndrome (as he calls it). There is no instability in my spine, and contrary to earlier radiology readouts, there is no facet hypertrophy at L5-S1, something I'd been concerned about (though there is some at L4-L5). Unlike the Neuro folks at Walter Reed (who used the Charite --> sp?), this guy uses the Prodisc-L. We discussed the issue in great length, to include pro's, con's and what it means in the larger perspective. I obviously have concerns about such a significant surgery, particularly when the clinic at this particular Navy hospital has only done 27 ADRs total. He advised that all but one have had positive results (one needed an S1 decompression shortly thereafter), with one guy running the Navy PT test within 3 months. Here are my questions:

1. What are the pro's/con's of the Prodisc-L, in a nutshell? I know that surgeons tend to recommend/use techniques within their "comfort zone", but he really seemed to hype up this one. I've read some of the reviews of the equipment, but I prefer to hear the unvarnished truth from some of you who may have had it implanted. I know they're using newer generation ADR's in Europe, but can't afford the cash outlay right now (especially when the Navy will do it for "free")

2. Should I be concerned that this clinic has only done a grand total of 27 procedures (a number Stenum and others probably do in less than a month)? Remember, being a military member I'm pretty restricted on my ability to pick/chose providers.

3. Most importantly, what is the unvarnished truth about the ADR process itself (I want it all....good, bad and ugly)? I still consider myself to be functional, but with the pain increasing I get the feeling this is a function of living on borrowed time and don't want to forgo life (especially having two young daughters). Being a "glass is half EMPTY" type of person, I'm trying to lay out all the worst case scenarios (particuarly with some of the horrible results I've read). The Navy is concerned with getting me "fit for full duty" as quickly as possible, but this doesn't inherently coincide with MY best interests. The most important thing for me is to get my life back and remain that way down the long term.

Okay...enough babbling for the moment. Thanks again for taking the time to humor me, and I look forward to learning more from you all!!

Best regards!
Alan

[Tatonka_usn]

This may sound like a strange question, but maybe someone might be able to set me on the right path. Given that there is no specific long-term data indicating how long the lifespan of a Prodisc ADR actually is/could be, I was curious if there is any capability to replace the plastic insert if/when it wears down? Can't imagine the metal itself would break down, but figure that wearing in the join material is ultimately one of the long term concerns. Is there any literature on this?


Alan

[Harrison]

Alan, sorry for the delay and welcome again! Yes, the core(s) of most devices are made to be replaced...

Perhaps others will comment on your intro questions too. Hope you are OK these days!

[Tatonka_usn]

Thanks Harrison. I'm doing fair to middling, though increasingly frustrated with my back (I'm sure that's a common sentiment around these parts). Thanks for following up on my 2nd question on this thread. Sadly, I meant to post it as a separate topic, and must blame my faux pax on either 1) early onset senilty or 2) being Monday, pre coffee.... Either way, certainly appreciate your feedback, and look forward to interacting with the folks around these parts....

[Slackwater]

Originally Posted by Tatonka_usn

Greetings everyone!

3. Most importantly, what is the unvarnished truth about the ADR process itself (I want it all....good, bad and ugly)?
Best regards!
Alan

You have valid issues, good thinking. The range of outcomes goes from good to bad. I learned about ADR from a fellow sailor. He had a two-level Lumbar ADR (L4/5, L5/S1) in Germany and he returned to an "active" lifestyle < sixty (60) days after surgery with no symptoms.

The reported data trend is Lumbar ADR gives better results than fusion over the two (2) year results measured in the U.S.-based FDA and other studies. My limited recall is the five (5) year Lumbar ADR report(s) show similar, although the difference gets smaller over time between fusion and ADR.

It's hard for me personally to measure the outcomes as there are no digital read-outs on the human body, although I reasonably understand the metrics of VAS, ODI and MCID. My limited perspective is the doctors, surgeons' creed of do no harm is really strong (thank you) and the shift to ADR from Fusion will be generational (?). I suggest 5 , 10 and 20 year results, international, national and regional, are needed to sway (XX %) surgeons, plus training and iterative improvements, in the direction of a procedure.

Most patients do not have twenty (20) years to wait for clinical results.


My suggestion for the "unvarnished truth":

Listen to your surgeon.
Get a second opinon.

I met with four (4) surgeons, all with different options.


Read both the good and not good outcomes on this forum. There is no magic wand.

Correct placement of the device trumps device design and many factors. Mis-placed devices cause issues. Individuals' anatomy of the facets ( angle from center measured in the x-y plane ) may affect results.

Any surgery will be significant. Re-operation is complicated and you can consider a surgeon who attempts that as "heroic".


Plastic wearing out is not the issue for Prodisc (short of impingement). Polyethylene wear debris might or can be an issue for some patients and it has been reported, just like seen in the decades of knee and hip replacements. Individuals respond differently.


Read the packaging on the Prodisc-L - FDA documents, see below:

http://www.accessdata.fda.gov/cdrh_docs/pdf5/P050010b.pdf
SUMMARY OF SAFETY AND EFFECTIVENESS DATA
see => VIII. POTENTIAL ADVERSE EFFECTS OF THE DEVICE ON HEALTH

http://www.accessdata.fda.gov/cdrh_d...5/P050010c.pdf
PRODISC®-L Total Disc Replacement PACKAGE INSERT

http://www.accessdata.fda.gov/cdrh_d...5/P050010d.pdf
PRODISC®-L TOTAL DISC REPLACEMENT PATIENT INFORMATION


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slackwater_sf