Wednesday, April 21, 2010

Facet Fusion Technology: Does it really Work?

Recently one of our readers e-mailed TSB and inquired whether there was any existing literature/white papers pertaining to facet fusion devices. This post pertains solely to machined allograft products that have been in use for two to three years. This alternative treatment to fusion is relatively new, so, TSB went in search of data that would potentially substantiate the clinical efficacy of these products, address the many concerns that have been raised implanting a cortical allograft within the facet joint, and whether there was a selection criteria that would make orthopaedic and neuro-spine surgeons, interventional radiologists and pain management physicians comfortable with these products as an alternative modality of treatment to traditional fusion techniques.

So what did we find?

The first clarification that must be made is that bone dowels or wedges are not as new as some marketing platforms claim. Bone dowels and wedges of different shapes and sizes have been around for many years, especially in orthopaedics. To claim that the allograft will "eliminate" facet pain is a bit disingenuous. Maybe, if the primary source of pain is facet degeneration, but, back pain can be and is usually accompanied by secondary, and at times, even tertiary drivers. Therefore the key to any successful surgery is patient profiling, in addition to pre-operative planning. In many respects, it's similar to laser surgery. Yet, before any of this is considered, the majority of patients prefer to be treated conservatively. This runs the gamut from administering pain medication, "hand grenading" the facet joint with a combination steroid/anesthetic injection, PT, and a good old fashion facet rhizotomy where a needle or catheter is inserted into the area where the sensory nerves meet the joint sending an electric current utilizing heat to stun or ablate the nerves utilizing fluoroscopy. So by the time the patient is desperate for surgery, the physician has extinguished conservative therapies.

But what about the osteogenic characteristic of the allograft used to manufacture these implants? Most orthopaedic surgeons are skeptics using a cortical graft, and in all likelihood will never be proponents, or, advocates of this procedure, unless they are a paid consultant. Neurosurgeons seem to like this product, yet, one must question the philosophical difference between these two disciplines. So the question must be raised, where is the retrospective data substantiating facet fusion using a cortical allograft? Considering that it is nearly impossible to develop a cancellous graft for facet fusion applications, yes, TSB knows that some will argue that it can be done, but at what cost? And, where will one harvest from? The industry would love to see the published data in addition to what financial interest these physicians have in driving the revenue for some of these companies. With the Spine Technology Summit in NOLA next week, this would have been a perfect forum to showcase results.

But the biggest challenge that any of these companies have is the selection criteria. Not one of these companies can specifically provide an established criteria as far as patient selection. Facet pain is a broad generalization. So, in the spirit of debate, have any of our readers had success selling these products? What have been some of the clinical indications? And, which specialist seem to like the use of this device? Sometimes, it's not just about the money, at the end of the day it comes down to outcomes. TSB wants to know if our readers can shed a little light on this topic.

You know the old expression that if one cannot get one's way, one must adjust to the inevitable. Therefore, if the mountain cannot come to Mohammed, Mohammed must go to the mountain.

26 comments:

  1. I have reviewed several of these products from different manufacturers as well as searched for any articles, posters or presentations. There is not much supporting data out there. Found an ASRA abstract, fall 2009, retrospective review. The 1 year data on 25 patients showed 70% had a reduction in pain of 60-100%. It did not discuss fusion. Some of these patients may experience pain relief from stabilizing the facet, but be at risk for gross instability if the graft never incorporates and comes out.

    I know several surgeons who used these in their TLIF cases as an adjunct to ped. screws. More than a couple of the smooth taper lock designed dowels in these cases didn't fuse and retropulsed. I have discussed the techology with both ortho and neuro surgeon customers and pain physicians. Pain physicians seem to be more jazzed about it than the surgeons, but not for the most obvious benefit....billing a fusion. They have expressed an interest in the technology as an MIS option for patients who have diagnosed facet pain, who have had repeated short term relief facet injections and are one of the 20-50% reported who fail rf ablation. The only other option for these patients are more of the same, which they have failed, or potentially a fusion, which isn't necessarily a great option for facet mediated pain.

    The best device I have seen yet to address the cortical graft incorporation issue has a surface demineralization treatment like many of the cortical structural allografts in spine. The surface demin is a proven technology in the interbody space (OTI, MTF). If it aids graft incorporation in the facet, it could help to make a strong case. It has circumferential ridges to help hold in place and also increased surface area.

    I, and the physicians I work with, would like to see more studies and a more clearly defined patient population. Otherwise, we will see pain physicians billing fusions, expanding their patient selection and using devices that are known to pop out. This will upset the surgeon market, as they have to "fix the problem" and the surgeons will dismiss it entirely as a sham procedure.

    ReplyDelete
  2. The philosophical difference you refer to between orthopedic surgeons and neurosurgeons is based in the fundamentally different educational background we come from. There is comparatively very little educational emphasis on mechanics and bone biology in neurosurgery training compared to orthopedics. Just as there is very little vascular education in orthopedics compared to neurosurgery.

    This information gap explains the relatively quick adoption of unproven mechanical systems (peek rods, dynamic stabilization) and unproven biological products. The bone dowels you describe are the perfect, unsound combination of poor mechanics and poor biologics. Not surprising to see a difference of opinion then.

    ReplyDelete
  3. Everyone is looking for the next spectrum approach to back pain. A wedge of bone that is surface demineralized and placed in the facet space may be the answer for a select patient profile, but not for a very high percentage. You are not the first to note the retropulsing of the round plugs out there.

    ReplyDelete
  4. This is a very interesting topic and I am glad to see you pursue it once again. I have performed a lot of online research to try and find any information on studies of bone dowel products. I was not successful in finding one with any real clinical data. What I did find were a few biomechanical papers from at least two companies that, of course, state that their respective products should work. The interesting thing is, when I compared these two papers, that the same phd had a hand in engineering both products. Even more interesting was this guy's paper that compared the two products. In my opinion, the spine community is looking for actual clinical data to support these products and not biomechanical studies.

    I keep in touch with with my other spine buddies across the US on a regular basis and hear that those two products, along with a host of others, seem to be having problems.

    I just do not see how a cortical graft is going to fuse a joint. TSB, keep digging until you find the low-down on these companies.

    ReplyDelete
  5. The round dowels are known to retropulse, but not all of the implants are round. We have implanted around 120 implants, mainly during a lami decompression and the patient has a large central stenosis and so far none have popped out. I did revise 2 of the morse taper round dowels I put in before I switched technology. The patients are doing well and I haven't burned any bridges for pedicle screws down the road. Does the patient feel better from the stabilization of the joint, the fusion, or the decompression? All I know is that my patients are doing well. I prob average 1, 1 level case per week and I am very selective who I do the procedure on. I pull on the spinous process with a towel clamp and see if the patient has movement and go from there. There has been a handful of patients that I planned to do a facet fusion on but they were stable intra-operatively so I just did the decompression. It is actually very impressive how stable it makes the joint!

    ReplyDelete
  6. The purpose of surgical intervention is to heal the patient. Is their back pain gone after this procedure. If the patient selections and indications are correct our surgeons are enjoying excellent outcomes. As stated by 10:48am the stability achieved in a decompression procedure is most impressive. The better question is not "did it fuse" but is the patient healed and free from pain? I've seen CT scans at 6 months that indicate fusion but I realize this is anecdotal evidence. For the 4:46 comment cortical allograft has been used for many years and will fuse in most cases, it just takes longer to incorporate. We experienced poor outcomes due to expulsions with round and round conical designs as well. We've settled on the rectangular wedge with teeth with very good feedback from our surgeons so far.

    ReplyDelete
  7. I heard today that stand alone percutaneous facet fusion got a T Code? Can anyone verify or dismiss this information? I looked and couldn't find anything.

    Thanks.

    ReplyDelete
  8. Surface demineralization does squat. Pure smoke and mirrors.

    ReplyDelete
  9. Excellent topics, I like your topic very much. After long searching I found this online that, HealthSource Chiropractic and Progessive Rehab Rye Brook, NY their commitment to their patients has led them to develop a center consisting of state of the art treatment using the revolutionary FDA cleared DRX spinal decompression equipment. You may visit their website to learn more.
    chiropractor westchester ny

    ReplyDelete
  10. I sell one of these products, but I am not running through town extolling it's greatness because I am not sure if it works or not. Most surgeons using it have come to me because for certain patients it makes intuitive sense to them. There have been some really good posts above regarding these products and the proper patient selection and I will not regurgitate their comments, except that I will say that the TruFuse dowels have had consistently high expulsion rates.

    I would like to comment on the suggestion from many bloggers that cortical bone will not fuse. It seems to me and I think there are some studies that bear this out, that cortical bone takes a very long time to fully remodel. Large grafts may never fully remodel. But historically, they have been used successfully for decades in the spine for cervical grafting, lumbar interbody grafts and for corpectomies. So I am not sure how people can simply dismiss the use of cortical graft as ineffective.

    I would like to see more data on this before I can commit to selling it with any enthusiasm. I was just as skeptical of PEEK rods, dynamic rods and resorbable cervical plates. Some of these technologies will survive the test of time and others won't. It will be interesting.

    ReplyDelete
  11. "The patients are doing well and I haven't burned any bridges for pedicle screws down the road." The patients are doing well and I haven't burned any bridges for discectomy down the road. The latter was the argument for IDET, member that? Spine, the gift that keeps on giving......

    ReplyDelete
  12. I am a Neurosurgeon who has used several of the facet bone implants available on the market. The one we finally decided was the most appealing was an oval implant with additional "wings" that fit into the facet joint. Concern over fusion rates with cortical allograft is a real issue and we do not put these in as stand alone devices, rather back-up a PLIF or similar procedure or place after wide laminotomies for decompression paired with an interspinous plate/fusion. What I would like to know is if this procedure is being done by non-spine surgeons (pain management etc), who is managing the complications such as graft migration, instability etc and should this exclude those that are not formally trained in spine fusion from performing this procedure. We do not call this a pain procedure, rather a supplement to spine fusion. I agree with the orthopod statement that historically there has been an imbalance in terms of bone biology and joint fusion teaching during residency, however, I expect that over the last decade this has largely become a minor difference with the main difference in training being microneural technique near eloquent structures.

    ReplyDelete
  13. Has anyone heard that the facet fusion procedure utilizing MIS instruments was patented at USTPO in D.C. by MINSURG/TRUFUSE? It was my understanding that this occured in March of 2010? Can anyone comment or affirm? What does it mean to the market?

    ReplyDelete
  14. I was looking there and there appears to be some dispute.

    ReplyDelete
  15. RFC Case Number: P-M10-1589N
    Court Case Number: 8:10-cv-01589-VMC-EAJ
    File Date: Monday, July 19, 2010
    Plaintiff: Minsurg International, Inc.
    Plaintiff Counsel: Frank R. Jakes, Zachary David Messa of Johnson, Pope, Bokor, Ruppel & Burns, LLP
    M. Roy Goldberg, Darren M. Franklin of Sheppard, Mullin, Richter & Hampton, LLP
    Defendant: Nuvasive, Inc.
    Frontier Devices, Inc.
    Osteotech, Inc.
    NuTech Medical, Inc.
    NuFix, Inc.
    Kenneth Horton
    VG Innovations, LLC
    Danny Wayne Grayson
    Bacterin International, Inc.
    Facet Fusion Technologies, LLC
    Does 1 through 35
    Cause: 28:1338 Patent Infringement
    Court: Florida Middle District Court
    Judge: Judge Virginia M. Hernandez Covington
    Referred To: Magistrate Judge Elizabeth A. Jenkins
    Notes:

    ReplyDelete
  16. Apparently the patent is expressly for percutaneous facet fusion only, which is bad news for Minsurg if the T-Code is for percutaneous procedures only (they don't get approved or paid most of the time). Minsurg thinks the patent covers all facet fusions, but the patent clearly makes the claim for minimally invasive facet fusions only. Most of the companies listed above have coutersued Minsurg because Minsurg reps went around running the mouths to customers that they couldn't use the other companies anymore and interfered with their business. This may well be the end of Minsurg, word is they don't have much cash to pay the lawyers. The funny thing is, of all of the companies listed, the TruFuse product is the least innovative and the instruments are terrible.

    ReplyDelete
  17. Well I had a Facet Fusion Item placed in my back , and it wasn't even approved by the FDA. Guess What They are going to lose too.

    ReplyDelete
  18. Everything was so hush hush and I had to threaten my doctor with a lawsuit for him to tell me what he placed in me and the device manufacturer. Mislabeled coding lying on the operative reports. So.... Some folks are in deep doo doo from the doc, to the supplier to these clowns. Because the wedge is a piece of garbage and I have to have it removed.

    http://www.kens5.com/news/health/SA-company-marketing-surgical-wedge-made-of-human-bone-69122742.html

    ReplyDelete
  19. I had an L5/S1 fusion and the fusion worked well. I am still have severe pain, especially after repetitive physical activity (Power walking, bicycling). The bone scans show the L4/L5 facets being the "hot" spots, probably from years of wear before the fusion. I have had two rhizotomys. While they work, it takes about 6 weeks before I feel relief and at 6 months the relief wears off. I know my problem is facet pain. I was wondering if the spinal fusion in any way excludes me from becoming a candidate for facet dowel fusion? Wouldn't the spinal fusion make the facets more stable and less likely to cause the dowel to "pop out"?

    ReplyDelete
  20. I had l4/l5 and l5/s1 facet fusion done minimally invasive on 12/20/2010. The product was the bacterin model. I'm still in early recovery and will post back later on with updates.

    ReplyDelete
  21. My doctor said he is now using a new product from MinSurg/TrueFuse -- the allograft bone dowels now have ridges that prevent them from slipping out (as opposed to other dowels that did not have ridges that were more likely to slip out). Does this make sense? Is this true?
    Also, he said if a dowel did slip out, it does not cause any problems for the patient. Is this accurate?
    What happens if it does not fuse?
    I feel that it is worth the risk. I'm not getting any better without the facet fusion. It will only worsen with time.
    Also, why is MinSurg being sued? Does it involve safety/health that would effect patients, or limited to business/sales side of things?

    ReplyDelete
  22. I do not know of any company that distributes facet fusion dowels that has sufficient clinical data showing their product actually works. But, I continue to hear that many of them pop out after surgery. If that is the case, then it appears this could just be a sham procedure to attain a fusion code, thus higher reimbursement.

    Dowels are commonly used to pin two non-moving surfaces together such as in woodworking. However, the facet joint are multi-directional, so a pin method probably would not work. If you believe in magic, then this type of procedure is probably one you would want to consider. But, if you believe in clinical science, then you should probably wait until there is actual documentation stating that it works.

    ReplyDelete
  23. Update. I still have some pelvis pain due to an actual leg length discrepancy, but my low back is much better. I'm almost 4 months post-op and feel better than I have in over 5 years. I've also lost 65lbs since surgery, which I'm sure is helping.

    ReplyDelete
  24. My ins company reject the spinal plug as experimental and my surgeon was pissed.

    ReplyDelete
  25. There are many spine fusion implants available on the market. Stay away from the Tru-fuse due to concerns about back-out. This is an adjunctive procedure for fusion and the conventional posterolateral fusion was basically sprinkling bone pixie dust between transverse processes. This is not magic technology as claimed by some but your surgeon needs to be smarter than the technology. The facet surfaces do not have a multidirectional range of motion--just look at the joint. Do not be misinformed. Consider this as an adjunctive procedure to a conventional fusion. Its not a pain procedure, its a fusion plain and simple. Backing up an IB Fusion with these, coupled with an aspen plate or Ilif plate is a nice procedure.

    ReplyDelete
  26. Since noone has posted here since 8/19/11, I figured Id throw out a few sentences, since this is something that my pain management doctor is recommending... It seems from the wording in most of the paragraphs that the only people that are for these tru-fuse things are the ones that are selling it or making money from it. The true folks out there word the paragraphs like I would--- someone that has seen little to no proof that they truly work. I am a patient that has had severe pain in my low back since i was a teenager. About 4 years ago, I had to start taking class 3 narcotics to lessen the pain. L4/L5 is deteriorating, L5/S1 is bulging and pinching my sciatic, S1/S2 is deteriorating. A lot of issues. A lot of pain. I am looking for something that is going to be a one-stop-shop... Though it may not exist, I dont want to go back in for repeat procedures just cause my doc wants his wallet to get fatter. I will be checking this post regularly to see if anyone else has any new news. Please dont reply if you are just selling this... you stick out like a sore thumb anyways.

    ReplyDelete