Wednesday, January 27, 2010

Zero Profile Cervical Devices: Boom or Bust?

Recently, TSB was speaking with a few surgeons about their experience with the STALIF-C and it seems that this device is not as easy to implant as is claimed by Centinel Spine. Implantation of the PEEK device is not the difficult part of the procedure, its a bear getting the screws into the vertebral body. So the question must be asked, are these implants a viable option for the spine surgeon if it complicates the procedure? How much bigger does the incision have to be to accommodate screw placement? In addition, TSB has heard that surgeons have been concerned about the complexity of inserting the LDR Vertebridge ROI-C. Surgeons have reported they do not like the way it feels upon insertion and that it is destructive to the endplates.

If any of our surgeon readers or industry professionals have had any experience with these devices, TSB and our readers welcomes your feedback. It seems that everyone has jumped on the bandwagon in developing these products, yet, the reality may be that an old-fashioned cervical plate and interbody device may be the way to go. TSB wants to know what our readers think?

30 comments:

  1. I havent used these yet mostly because of the cost compared to an anterior plate + allograft. Looking at the size of the devices and the screw location, the surface area for fusion is pretty small. They seem nice for a level adjacent to a prior plate but otherwise there are easier, cheaper options.

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  2. TSB
    Is this your way of black mailing VB for a job?

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  3. Word on the street is that Zero-P from Synthes continues to receive positive surgeon feedback.

    Anyone heard anything about this particular device?

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  4. though it is not a zero profile. Has anyone had experience with the C-Jaws from Medicrea?

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  5. I just did a Zero P about an hour ago; no bigger incision, no frustration in screw placement, and went a lot faster then a regular plate placement.

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  6. One major problem with the Zero-P (and similar zero-profile cervical devices)is that you can't bill for an additional anterior instrumentation code (22845)because there is not a separate construct placed across the vertebral segment. MSD officially published that guideline for their similar Prevail device.

    So there goes $1000 per procedure out the window for a procedure that's arguably less stable than a plate plus cage and trickier to implant. No thanks. I don't know why any surgeon gives a $1000 donation to the payor for every ACF in order to use one of these!

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    1. Might not be the case, but you come across as thous you're more worried about $ than your patients.

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  7. I don't think surgeons want to use these for every case, just revisions, at least that's what we use them for. The nice thing about Zero profile systems is that you don't have to dissect through scar tissue to remove the plate. As for payments, docs will forgo a loss in pay to do what's the best option for the patient once in awhile.

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  8. The Mosaic from Spinal Elements takes about half the time once surgeons are experienced with it because it has only 2 screws and the device. You don't have to bend or size the plate. The screws are clearly anterior instrumentation-no coding issues. Adjacent level fusions are easy because there is no need to revise the existing level. The device has nearly 3 years of clinical history. OK--this is a shameless plug but still true.

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  9. With regards to the "Mosaic", I have never seen a surgeon use just two screws. Never saw a single level plate bent yet as well. As for sizing, that may take, oh 30 seconds(?)

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  10. NASS has issued a formal position that 22845 is not applicable to stand-alone IBFs. Insurers are starting to get savvy and not paying for this code. The risk of doing so falls on the surgeons that bill 845 with these devices, as NASS has made its formal position known. RSB's Interplate is the only device that complies with the code because it is truely two separate devices - one cleared as a cervical plate the other used with a separate IBD. It is flush-fit and in order to get a zero-profile with other devices you have to use Peek. According to poll by Dr. Alex Vaccaro at CSRS '10, allograft is still the gold standard in anterior cervical spine fusion and is used by over 75% of attendees polled. Interplate is the only devices that does not box you in to Peek. STALIF C, Zero-P, Coalition, Prevail, and Vertebridge are Peek IBDs only, and are not cleared as anterior fixation. Kudos to RSB for innovating while others imitate!

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  11. Yes, RSB -- The Ultimate in Innovation!

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  12. Probably not the "ultimate", but sure gives my surgeons a lot of choices they don't have with some of the other implants. I don't think the perfect implant has been invented yet! I heard RSB just got their spacers approved that fit with their titanium version. Pretty nifty.

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  13. Pretty rediculous if you ask me. I can't tell you how many surgeons have told me that they hate all of these low profile anterior lumbar devices that require you to have a 6-inch incision in order to accomodate the drill / driver docking at a steep angle on the implant in order to drive the screws into the ajacent bodies. Cervical? Maybe, but good luck making a living off of that alone!

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  14. Funny, we have seen a decrease in the incision size since using these products for the lumbar spine.

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  15. The problem with Mosaic is... no not the coding, but the gawd awful problem you have if the screws do not go in correctly if the anterior surface is not properly burred. Try backing those bad boys out..it pulls the entire implant up and out.

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  16. RSB Shill - ZeroP's PEEK is separate from the plate. 2 distinct items. Locking plate snaps easily on and off. I know the biomechanical date as it applies to ZeroP b/c I read it in Spine. However, I don't recall seeing this data for any of the other zero profile devices out on the market. Am I not looking in the right places?

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  17. Brian - Has Synthes biomechanically tested their Zero-P titanium plate vs a cervical plate? I don't believe so and I would assume that is why it is 510K cleared as an IBD only. If that is so, how can surgeons bill an IBD as a cervical plate and IBD. That is the exact point NASS is making and also MSD is printing in their literature. RSB's Interplate is the only device in this segment that is cleared as a plate and IBD - two seperate devices that can be used individulally. It is legitimate!

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  18. Yes they have. I think there was also a presentation at CSRS that looked at this device adjacent to previous fusion, but don't quote me on that.

    "A new stand-alone cervical anterior interbody fusion device: comparison with established anterior cervical fixation devices."

    Is the RSB a true zero profile device. Their technique guide mentions 'gardening' and problems with screw trajectories/stripping with prominent lip or lip osteophytes. Is gardening away cortical bone the best thing to be doing?

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  19. The Zero-P study at CSRS was Zero-P complete (Plate in PEEK), that is the titanium plate was inserted was into the PEEK cage. They did not do a study on the titanium plate alone. That would be interesting. Therefore, Zero-P is not two seperate devices, it one implant with three components (PEEK, PLATE, SCREWS + 1 implant).

    Although I am not a coding specialist, I believe 22845 cannot be billed as NASS states because it is one device under one IBD FDA 510K clearance. With that being said, the point of the discussion was whether you can code 22845 with zero-P. Companies claiming that their stand-alone devices have a "plate" are making bogus claims, especially when the PEEK and the plate are all one implant.

    Bony prep for this device is much less than a cervical plate and no more than other stand-alone devices. I saw recently that Interplate reported implantations in their 1000 patient. Not too shabby! I guess it must work fine.

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  20. The Synthes Zero P can be coded as two separate devices. The plate is removable from the spacer and could be used with allograft as I have done.

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  21. I have had an extensive experience with Stalif-C for over one year now, on both adjacent level cases and virgin fusions. Up to now, I have not had any issue with poor patient outcome (knock on wood...), and simply treat the patients as to how I would want to be treated. If it was me, I sure would not want a plate in my neck if I didn't have to have one ...
    The insertion time or "fiddle factor" is not an issue, and after a few times it actually takes less time than a plate construct.
    Once the coding issues are settled, I believe this SAD concept will be the wave of the future for degen c-spine cases.
    Just a thought ...

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  22. Can the zero profile device be used on patients with previous fusions? Would the previous plate need to come out or can the zero P be used with the other plate? What is the success rate with this device?

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  23. Old blog, but here you go, im a patient, c4,5,6 fusion with the roi-c, jan, 2011. ..surgery was a success until july, massive unusual pain, ran in to docs office, xray show one of the plates cracked in half. No apparent reason either.
    Still in horrible pain, personally, i want it out! I read on the fda site, 5 reported incients with this device. One pt is paralized, out of box failure. If u read this, what r yr thoughts?...typing on ph so excuse spelling

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    1. My husband had the same problem. Look up FDA Maude database and there are tons & tons of reports on failure, yet this company gets away with this garbage by blaming the doctor. He has had subsequent surgeries to remove backed out screws & his 4th surgery was to stand up the hardware that was failing. This LDR product is garbage.

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  24. looks like that comment killed this conversation. I was hoping to hear the answer to the question:
    What is the success rate with this device?

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  25. Had Synthes Zero P installed C4-5 about 9 weeks ago, adjacent to standard plate C5-6-7 from 10 years ago. Have had major radiating pain to shoulders since the Zero P installed, and now have just learned one of the screws has backed out. Help!!

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    1. IF the locking screw did back out that should have ZERO effect on ridicular pain. Maybe have a piece of disc spitting out the side you have the pain on but thats all posterior. Not anterior where the screws are.

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  26. if the doctor who installed the implant device also has a financial interest in the implant device how do you think you could get a fair evaluation on the product after having problems like fractures and screws backing out

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  27. I've had 2 of these devices in my neck since 12/10, and not a lick of problem, got to give the doc who did the surgery a lot of credit also.

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