The challenge that this organization has had is to overcome the reimbursement issues surrounding AxiaLIF. This is the third quarter that there has been a decrease in revenue and performance. A full court press is being employed by Rick Randall, and his team is fervently educating and training their surgeon users. But with that said, the real question is how is the integration with Life Spine's MIS progressing? Supposedly this relationship was fostered to aid the company in securing additional pull-thru business?
A leaner sales force means a greater onus on the those people to ramp up their efforts while the CEO maps out a virtual strategic plan. Sounds a bit like the early stages of the Afghan war. Like any campaign, the burden can only be exercised with the addition of complimentary products/weapons and troops that offset the reimbursement challenges with AxiaLIF. But that is going to take additional capital, and until the reimbursement issue is resolved, TSB just does not see an escalation in troops. Given that the integration with Life Spine was recently announced, Trans 1 will be given the benefit of doubt this time, but the analysts will be closely watching the 2010 QI results.
The company also announced that its CFO, Michael Luetkemeyer will be stepping down on March 31st to pursue other opportunities. The only observation that TSB will make is that it's always interesting as to why someone that has been an integral part in financially building this company is looking to leave? Interestingly enough, it was reported late last year that Trans 1 had scaled back its sales force, and was having difficulty in making decisions about hiring engineers. So as Trans 1 moves into a new fiscal calendar, it will be interesting to see whether there will be a change in strategy in order survive the many challenges this company is facing.
TSB wants to know what our readers have heard on the street? Tick, Tock, Tick, Tock Trans 1 is on the Clock.
Maybe the days of building a company based on "working" the coding system are coming to and end? Lanx, NuVasive, are you next?
ReplyDeleteThe reimbursement issue is the least of Trans1's problems. The main issue is that the technology is not being readily accepted by surgeons. There is little if any clean data that demonstrates superiority to conventional anterior or posterior fixation methods. There is a long learning curve to the device and revisions are very difficult.
ReplyDeleteI have to wonder how many of the implantations performed were done by surgeons that had some sort of working relationship with the company. It is hard to imagine a surgeon using this technology of his free will, when there are many better MIS fixation options out there.
How do you consider Nuvasive and Lanx to be "working the coding system" If the end result is still achieved but the time it takes a surgeon is less, do we then consider this to be "working" the coding system. Over time companies will develop less invasive and less time consuming procedures with the same outcomes. Do we then not pay, or pay the surgeon less money. I would consider Nuvasive a pioneer of MAS and Lanx has done a great job with an alternative to pedicle screws for "some" cases.
ReplyDeleteI imagine it is very difficult to decide upon which engineer(s) to hire, when you are in a romote location, have well known financial and reimbursement challenges, and your technology, while novel, seems to be JUST that.
ReplyDeleteI have heard that there will be a mass exodus. The morale is low, reimbursement is a bitch, and contrary to the spin from the CEO, some of their best and more experienced people have been let go. The management is questionable at best, terrible at worst.
ReplyDeleteToo bad, because the technology is pretty sweet. SpineDoc1, have you ever done an AxiaLIF? I have seen several, as well as a couple revisions, and I tell you that it is too damn simple for the curve to be that steep. It is a good procedure, and I hear that the patients do pretty well. It would be a great addition to a full line porfolio, which is where I am sure it will ultimately land.
I'm not sure if you can lump Lanx in with Trans1. Lanx got their start by having surgeons invest $50,000 (for a .33 block) to become shareholders. They solicited many of the "shareholders" to sell back their blocks for about $200K. Many suspect in order for the principles to gain shares before possibly selling or going IPO. They're just another story in our world.....
ReplyDeleteTwo words - gram negative. You won't find me anywhere near that device. Ever.
ReplyDeleteGram negative? Can you elaborate please.
ReplyDeleteGram negative, as in, an infection. Beware the colon.
ReplyDeleteI have been thinking about trying this procedure. Is there a higher infection rate for AxiaLIF vs other fusion procedures? From the research I have done its actually safer and there is almost zero risk of nerve injury. I would rather have a treatable infection than a non treatable nerve injury? Yes, I too hear that the patients do very well.
ReplyDeleteSo here is a follow-up question to our readers, why is it that these emerging companies seem to have so many issues with reimbursement? Understanding that each venture has its own challenges, is Trans 1 experiencing the same challenges that a company like Hydrocision is, where they put the cart before the horse? Is this a by-product of inventing a product without understanding the overall landscape? And if so, what does it say about the qualifications of the people that are running these ventures? Could it be that we are so driven by the potential financial rewards that we overlook the obstacles that challenge many of these new procedures? How many of these procedures are stand-alone? How many are augmented by facet screws? How many are augmented with pedicle screws?
ReplyDeleteLow infection rate, in fact, low complication rate overall, >1%. It is safe, and if the surgeon takes the time to look, a bowel injury can be found and treated before an infection occurs. MM, I think you hit the nail on the head regarding reimbursement: They put the cart before the horse. Contraindicated as a stand alone, requires posterior fixation, mainly to prevent axial rotation.
ReplyDeleteI think the reimbursement system is broken. There needs to be way for new products to get paid- before they have millions of dollars in clinical data. Maybe it's not a premium price before that data is in hand, but something. I certainly see the argument for wanting to pay only for 'proven' technologies but what is the appropriate level of proof. On the flip side, even companies that have invested in the clinical studies have still had issues with payment. How are we going to get these new products, which may be real improvements, to market when all the cards are stacked against innovation. It's bigger than trans1 or charite and deserves it's own top level post.
ReplyDeleteLet's see, let's run our our implant through the absolute dirtiest part of the body before placement. Think we'll get any infections? Every surgeon I've spoken with thinks this is absolutely crazy? Many surgeons are experiencing infection rates of zero by using "completely closed" channels like Medtronic's Metrx tubes or SpineSelect's Marquise tubes to do fusions. Let's be clear - infections matter and they are easy to avoid...
ReplyDelete4:22, you clearly do not understand the procedure. You do not run the implant THROUGH the bowel...You create access between the bowel and the sacrum. The dissection is merely through a pad of fat. You are no more on the inside of the bowel, than you are during an ALIF. There is a risk of perforating the bowel during the dissection, but it is low. There is a risk of bowel injury, nerve injury, vascular injury or muscle injury with other approaches. No surgery carries zero risk as you state. You should try educating yourself, before you interject nonsense, and misinformation. I agree that if the implant actually passed through the anus and rectum, it would be crazy, and in your case might cause brain trauma.
ReplyDeleteDear Doctor:
ReplyDeleteThank you for clarifying 4:22 proctological concerns, I guess this plugs up any questions or concerns that they have. The beauty of our blog is that it allows us to educate while humoring ourselves.
6:22 - I don't know if you are a consultant to TS1 or just an investor, but we'll let the market speak for itself. I didn't invent the term "ButtLIF" but we all know that's how many surgeons refer to this procedure. My understanding is that's not an endearing term...
ReplyDeleteThe question should not be a matter of whether or not a product/procedure is reminiscent of some doggy-style dominatrix sideshow but rather, whether or not it is clinically efficactive, and surgeons can get paid.
ReplyDelete"it goes near your BUTT! (tee hee)"
Get your head(s) out of the gutter.
Efficactive??? That one is obviously not just a typo. From what I have seen, the procedure is effective. The data says it is effective, and, yes, I have heard all of the nicknames for the procedure, some are much funnier, and much more creative than buttLIF. The issue about reimbursement is real, and potentially devastating. They do need more data, and better studies, but there are lots of technologies that are widely accepted with less. We mock what we do not understand.
ReplyDeleteAnybody know published fusion rates for this procedure?
ReplyDelete92.3% at 2 year, CT confirmed fusion.
ReplyDeleteAnd for those concerned with complication rates. I have personally done just over 100 of these and have had no complications and 95% fusion rate at 18months. My patients do very well and are typically back to ADL in 3 weeks. If you follow the protocol this is the safest fusion procedure! I have also had the opportunity to speak with a colorectal expert in detail about the procedure and he assured me it is a very safe space (presacral space) to work in. I can do a 360 fusion procedure in 90 minutes or less and my reimbursement is very positive. The hospital makes a nice profit on it as well.
ReplyDelete1:37: what posterior fixation are you using to get the 360 fusion?
ReplyDeleteI usually do a facet fusion and deliver bone graft in the joint after I drill across it. Don't go there! It's a totally legit fusion. Just ask any hand or foot surgeon how they do fusions. It's a posterior fusion and i will defend it against anyone!
ReplyDeleteDefensive much?
ReplyDeleteSpine Doc,
ReplyDeleteGet a clue. Long learning curve? Little data? You obviously have never given AxiaLIF a chance. And to imply that the implant is being dragged through the bowel is just plain nonsense. I think all those bashing it are just hoping surgeons out there will continue to never give it a chance. If they do, then those that sell against it will see their surgeons make the shift to an easy, effective, and safe fusion procedure. .2% infection and .6% bowel injury - hmmmm is this a good safety profile? Has a patient ever died or had permanent nerve damage from AxiaLIF?
Reimbursement is the real problem for TranS1. You gotta have sympathy for the company--they create something new and beneficial, and insurance companies want nothing to do with it. The more surgeries an insurance company can deny, the happier they are. Look at NuVasive; was there still really a debate over XLIF being experimental and untested? No, but 4 of the biggest insurers were unwilling to pay for XLIFs as of last Thursday. If NuVasive is having trouble with reimbursement, every company with a novel spine device will. I agree with the commenter who said newer devices shouldn't necessarily command a premium, but there should be some reimbursement as they prove out their relative value.
ReplyDeleteTo introduce a reverse herbert screw into the intradiscal space with distraction only stress shields the graft and leads to poor quality fusion at best--the best hope is for the screw to actually subside and load the bone properly---fundamentally this idea never had any merit as a biomechanical solution for recreating the anterior load path, despite all the trappings and marketing.
ReplyDeleteWhy anyone would want to implant this device, even if you could implant it without complication, and even if you could get paid for it, and even if it didn't have a long learning curve, is a mystery that violates Wolfe's laws completely.
That's very insightful about your load theory. But it doesn't seem to hold much validity when they have confirmed fusion rates in the mid 90%. You mention high complication rates when I'm told they are >1% and a very short learning curve. Also, I know my surgeon says he gets paid for it. They don't have enough market share to need to bash them. I think those that have seen AxiaLIF and used it believe it's a good technology.
ReplyDeleteInfo about the possiblities that can to your toosh. copy and paste
ReplyDeletehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/results.cfm?start_search=1&searchyear=&productcode=&productproblem=&devicename=&knumber=K&pmanumber=P&manufacturer=&brandname=AxiaLIF&eventtype=&reportdatefrom=01%2F01%2F2008&reportdateto=01%2F31%2F2010&pagenum=10&key_count=0
"that can happen"
ReplyDeleteFirst, regarding Wolfe's Law, we all know that because of the concavity of most vertebral body endplates, a cage packed with graft is not necessarily under load, and that it is the cage, not the graft material that carries the load. With AxiaLIF, most of the distraction can be attained by packing the bone graft into the space...if done properly, minimal distraction is gained by the thread differential.
ReplyDeleteSecond, as far as the Maude Database goes, I think that 47 events in two years (about 6000 cases done) is a good rate...<1%. Obviously, no injury is good for the patient, and it is simply an unfortunate part of surgery, no matter what the procedure or part of the anatomy. I wonder if Medtronic, DePuy or any of the others lost a patient in the last 2 years?
Fear will always play a role in evaluating a new or different technology, and it is certainly a factor in the adoption of AxiaLIF. The reality is that there has never been a death, and never been a permanent colostomy. It is still the safest way to get a reproducible, >90% rate of fusion at L5-S1. It also provides the most robust, stable interbody implant on the market...the only interbody that offers resistance to sheer (spondylolisthesis), and the only interbody that MAY provide stress shielding for S1 screws for a long fusion (deformity surgery) that may negate the need for S2 screws or illac bolts.
Haters, keep on hating, but you cannot stop the wheels of progress.
The Wheels of progress?? You have to be kidding or you simply do not understand progress.
ReplyDelete20 years ago, Wiltze, Harms, Mets, Brantigan, et. al, pioneered anterior support and got fusion rates of 92% to 99.4%--against posterior only at %60, and anterior only at 60-83%.
The challenge was to establish an approach modality that was reproduceable for the average surgeon-ALIF,PLIF, TLIF--and one that could be used at all levels if possible to streamline education and technique.
Outcomes have not improved since then---20+ years, yet you seem to think that more specific procedures, in this case a 1 level solution that DOESN'T IMPROVE FUSION RATES should be added to the mix----why? (because you want to make money for it)
The patient doesn't need it, a surgeon doesn't need to learn this, it is always wrong not to load share in the intradiscal space if you want to reconstruct the load path----but in this case, you just want to sell an expensive "alternative" to what already works---right?
Have you seen better fusion rates produced by any device versus a simple bone graft and tension band? (No, you haven't)
Reimbursements for hospitals---Down
Reimbursements for Surgeons----Down
Fusion Rates-----------------Exactly The Same
Outcomes---------------------Exactly the Same
Income for Implants-----------Up 1260%
Do you think there is a reason for this?
Not to mention this... is this better for the patient? Does the patient recover faster?
ReplyDeleteWell, let's watch the surgery video on Trans1's website. What's that Dr. Lieberman? You hope to get these AxiaLIF patients out of the hospital in two days?
Two days?!? Is that MIS? There are plenty of surgeons getting patients out the door the next day after lumbar fusion. Some are even consistently doing same-day discharge fusions.
There should be some rule about what we can and can't call MIS...
For the record, I do not work for TranS1.
ReplyDeleteSorry if you want everything simplified, so that you don't have to learn anything new, or a variety of approaches to best serve your patients. You sound sort of lazy. Judging by your pomposity, you probably have 100% fusion rates, as do ALL spine surgeons right? You never see a patient for a revision of one of your surgeries, right? Guess what, I wouldn't return to the hack that screwed-up my first surgery either.
It is completely unrealistic to think that you can have a single approach for all levels of the spine. A cardio-thoracic surgeon needs to know several approaches to remove a lung tumor, depending on where the pathology resides...a general surgeon needs to learn various approaches depending on which organ, or which part of the bowel they wish to access. So all of the hoopla from 20 years ago, is sort of irrellevant. Sometimes progress requires expanding the knowledge base, and specificity. Furthermore, any spine surgeon that knows anything about biomechanics, knows that the lumbosacral junction is not like any other level of the spine. If you are honest, and if you do any deformity surgery (I am assuming you are a surgeon) you will admit that L5-S1 is a very difficult level to treat as compared to other common levels. So yes, a different solution is warranted.
As for the economics and benefits, sure, every device manufacturer is looking to maximize revenue. There is a reason that no other company has created another version of AxiaLIF, it is because the IP is so well protected that they can't. You can fool yourself into thinking it is because they don't want to, but you would be wrong. The market will determine what the appropriate price for AxiaLIF is, and in the meantime, TranS1 SHOULD (fiduciary responsibility to their investors) try to maximize the revenue per case.
As for the recovery time, 2 days on a single level AxiaLIF with facet screws is certainly a long hospital stay. Check out the ABC World News segment on AxiaLIF from 11/08. The patient went home 6 hours after surgery. Show me how that compares to your TLIF's or ALIF's. The benefits range further than that: Shorter operative times (saves/makes hospitals $ if they can adapt to the available OR time), shorter recovery times, HIGHER improvement in VAS and ODI scores than other modalities, and faster return to work or ADL.
If a 2cm incision that doesn't even create a muscular defect, doesn't qualify as minimally invasive spine surgery, I can't imagine what would.
If you don't like the free market associated with healthcare in this country, get behind the socialists running the country now, before they are shown the door, or better yet, move to France (I know that is a tired retort, but it is so fitting). Or, maybe you could climb out of your cave, recognize good technology, and invest a little in the companies that are changing surgery. TranS1 stock is cheap, and you might get lucky. If you had bought NUVA last Thursday (you were probably laughing because you think XLIF is a crock too), you would have seen a nice return overnight. Get on board with progress and forward looking companies, or get out of the way. If you dig in like you have, you WILL get run over.
Those of you who do not fully understand biomechanics, Wolfe's Law, modulus of elasticity, please take some time to learn. Do you really think that a 5cm screw can fully support the spinal column. It is a proven fact that no implant placed into the intradiscal space will prevent a small amount of subsidence.
ReplyDeleteAs for outcomes, over half of my AxiaLIF patients go home the same day and many of them don't even realize they have an incision near their tailbone. Initially I was very sceptical of the reimbursent but I have seen this as a very profitable procedure for my practice but more importantly a very successful treatment for my patients.
I don't think that a 5cm screw can completely support the spinal column, but I do think that a 5cm screw (AxiaLIF), with appropriate bone graft material, and pedicle screws with rods provides the most stable construct available for L5-S1.
ReplyDelete"There is a reason that no other company has created another version of AxiaLIF, it is because the IP is so well protected that they can't." --> That is comical. You think Medtronic, J&J, or even Nuvasive is scared of some tiny company with a rapidly vanishing pool of cash, while they knock off everyone else? Thanks for the laugh.
ReplyDeleteAnd, "I do not work for Trans1" --> I'd bet my last dollar you have some relationship with them - consulting agreement, investment, kickback... what is it? let's be honest.
I never said they couldn't buy the IP, or steal it and fight lawsuits until TranS1 is broke, but as you say, the company is in decline, so why not wait for the price to drop further? There is no hurry to have a competitive product to AxiaLIF, since they are not making a real dent in marketshare, or revenue. TranS1 made a couple of mistakes in their long term plan, and they are paying the price. They may make it out of the quagmire, but their best option may be to sell. We shall see what their management is made of.
ReplyDeleteMy background was in product development for decades (none with TranS1), but now I am a private investor and investment consultant with a focus on healthcare. I have no specific connection to TranS1, but I have followed them closely, and lost money on my investment, simply because of the reimbursement issue (poor foresight). I am keeping a watchful eye on the clinical performance of the product, because the second I see a clinical reason to bail, I will. I haven't seen anything but positive clinical results. I have averaged my investment down, because I think the clinical benefits will ultimately win over surgeons, payors and patients. I am hopeful for any increase in the stock price because I would like to minimize my losses, or even see a small gain. I hesitate to make my identity known, because I have lots of far reaching relationships in the industry, but let's just say, I have a decent breadth of understanding.
I like this blog because I think there are some thoughtful people contributing, but there are obvious meatheads too. I remember what the reps for my old companies were all about, and I can see you guys coming from miles away. Some were excellent, some (even some of the top performers) were obnoxious and immature. A little knowledge is a dangerous thing.
12:00PM,
ReplyDeleteMy point behind the statement that a 5cm rod cannot support the spinal column was in effect stating that nothing can without a small amount of subsidence. How much load (Wolfe's Law) is needed to initiate bone growth and ultimate fusion? Nobody knows! These implants are there to stabilize the segment until it fuses, after that they serve no function.
So, what were Trans1's strategic mistakes? What could they have done differently? You're clearly saying this isn't a product issue, so why are they where they are now?
ReplyDeleteI am not sure that they had a strategic path planned out when they went public. Meaning: Did they plan to become a full-line company, or were they going to position themselves for acquisition? I think the indecision hurt them.
ReplyDeleteThey also did not foresee (not sure if it was possible) the reimbursement issues. In hindsight, they would have been wise to begin the accumulation of data, or development of studies necessary to avoid a tracking code, and designation of investigational. I have not seen a letter from NASS to insurers on behalf of AxiaLIF like we did with XLIF. Maybe they didn't do their homework or have the proper relationships with whomever they needed to at NASS or any of the insurers. Maybe there were studies that could have been done, that would have helped them position AxiaLIF as an anterior approach...I don't know exactly what they knew, or what decisions were made. It is easy to Monday Morning QB. Maybe they should have employed a different distribution model or sales strategy...All I do know, is that the surgeons I talk to, and whose comments I read, seem to like the procedure. Patients seem to do well.
I cannot offer much more than that, it is purely speculation because I don't know what factors, or what priorities went into the decisions. All I know is that the market cap reflects the companies cash position, which is not a great place to be, especially as cash is flowing the wrong way. TranS1 is becoming a bargain for potential acquisition, unless they can turn the tide.
This comment has been removed by the author.
ReplyDeleteSome excellent posts by our readers. As TSB has always stated, this is your blogsite and it behooves us to have an intelligent discussion about the pro's and con's of products that are considered novel or emerging technology. This is why we started this blog. No other site is willing to cross the line to challenge or be challenged. Hopefully, Trans 1 will see better days, until then, it's a marathon and not a sprint.
ReplyDeleteAny person who quotes ABC News Hour as a reliable source for education and/or affirmation for product usage is the perfect candidate to use this product.
ReplyDeleteHater. OK, ignore the ABC piece, just look at the feedback from the surgeon above that says half of his AxiaLIF patients go home the same day. I feel like I am banging my head against a concrete wall...some people are just too thick skulled to get it. I can only imagine what the reps out there have to go through with all of the misinformation and ignorance surrounding a decent technology. Go ahead and stay in your cocoon, I couldn't really care less.
ReplyDeleteYours truly,
Open Minded Advocate
Open Minded Advocate,
ReplyDeleteIt seems when someone offers a different opinion you are the first to call names and "bang your head against a wall"--only a thick skulled person can do that.
In this case you advocate change to this modality, and yet you do not want to discuss the modality.
Once the cartigenious endlplate has been removed, most grafts work pretty well. The first consideration for grafting is material, surface area, and how these relate to load sharing and fusion potential, and then the secondary consideration of which approach provides the least morbidity for the procedure----give and take in all these decisions.
There is no reason I have seen in any literature to make me want to distract in the intra-discal space, and there is no reason I would want the device to occupy a central portion of the graft space itself----only rarely in longer cervical strut fusions would I want to even put screws into the graft but sometimes it is necessary to stablilze the graft itself.
That being said, the technique is slick, but I don't believe the graft itself is a better option primarily----the fact that it can work well doesn't mean it's the best choice, and is a testament to the healing characteristics of a good fusion itself that it does so in spite of the intrusion of this device. Remember that all the devices have not improved outcomes greater than a smith robinson bone graft (with no cage) and supplemental fixation.
Also you may probably already know that the surgeon who pioneered the approach has never used this device, and as he has put it "why would I want to?"
So keep banging your head against the wall, but until you address or create a primary reason why this device is a better grafting choice, why would anyone want to take a new road to get there?(and please note I did not use some of the more colorful descriptions for that journey)
In any event, no sale for you, you are lost in the change for changes sake argument propaganda
and refuse to acknowledge that the inherent biomechanical needs of this space don't care how well you articulate your marketing based messages----the body wants what the body wants, it doesn't want a metal fusion blocker and the dole pineapple ring of poor bone around it.
I'm confused. Don't all interbody cages take up space in the disc space. And thusly produce whatever shapes of bone in relation to whatever shape the cage? And why would the bone quality be poor?
ReplyDeleteYes you are.
ReplyDeleteNot all cages take up space(like the original Harms)but most promote growth through them and around them in any event----but those are only the ones put in under compression packed with scaffold material(bone,biologics, synthetic or natural), not distraction like the reverse herbert screw from Trans 1.
Some Devices like Spineology's are all surface area and distract and load at the same time, and then there is the standard---just bone, which fuses just as well and more thoroughly than cages---but you don't make any money on that, do you?
The bone quality is poor because it is stress shielded by the device----are you in elementary school?
Dr. 3:18, what interbody do you use? What approach do you use? As you have stated (I think it was you, sorry if I am wrong), the fusion rates are equivalent to other modalities, so from that stantpoint, AxiaLIF is just as good, but now you are saying that even though it is fused, it is not fused as well? Is there proof of that, or is that just your theory? If there is a track record of these fusions breaking down, or becoming unstable over time, I would love to know about it. As an investor (not a rep), that is the clinical "straw that (would) break the camel's back." I just have not heard of that or seen any data to confirm that. I get what you are saying about the distraction from the implant unloading/stress shielding the graft, but as another poster mentioned, it doesn't seem to matter with regard to fusion rates. You seem to want to pick and choose when you base your opinion on true science or when you base it on theory...show me the data.
ReplyDeleteFurthermore, you consistently minimize the benefits to the minimally invasive nature of the approach, as well as the short operative time, and short recovery time. You also have not addressed the structural support that the rod offers in flex/ex, and lateral bending, as well as the resistance to shear. I am willing to listen...I don't claim to have all the answers, but I don't think you are being completely objective.
The pioneer of the approach was an interventional radiologist (Andrew Cragg), so I am not that surprised that he hasn't done any AxiaLIF's.
What is the footprint ratio of bone vs cage with implants other than bone struts or FRA spacers? AxiaLIF is about 10%?
Changing approach and method for surgeons is a big step, and you guys can be anywhere on the spectrum of adoption: some early, some late, some never. I get that changing, is almost like admitting on some level that what you were doing before wasn't the best mode of treatment, and it takes someone with some, if not lots, of humility to make a change. I have seen ego get in the way of a lot of progress. There is no shortage of ego among surgeons. I don't expect that you will change your mind on AxiaLIF, which is fine, no problem. I wanted to bang my head against a wall, because I kept reading the same misinformation.
Points like yours, that MAY have a scientific, evidence based basis, are what I come to this blog for. Please cite the evidence that the fusion attained via AxiaLIF is inferior, or the quality of the bone is poor, and I will agree that the approach is change for the sake of change. I just think that with the data I have seen, it provides a better solution.
I understand your frustration, but for those of us who have seen things come and go--based on false premises--(
ReplyDeleteStarting with the original Harrington rod, fixature Interne, threaded fusion cages,bone dowels, etc all the way to the Charite)---you can't change the laws of biomechanics with marketing dreams.
Bone remodels under load---more load = more density, less load = less density. You have to tell me you understand this?
Distraction in the interbody space to recreate anterior column height is not a new concept---unless you are doing it with the bone graft itself, you are off-loading the graft, and setting yourself up for poor quality bone---period.
The worse case scenario were implants that created defects in doing this and as you know osteoblasts are good crawlers but terrible jumpers.
In any event, at the end of the day, I will first look to put in a graft with 100% surface area or as close as I can get, with as much bone on bone affrontation as the carpentry and shape of the space will allow, and then load this space under compression to resist extension.
No matter how cool and minimally invasive you want to get to this space, if the graft itself sucks as an option, why would anyone do it?
If you can get a good graft via this method, than we have the basis for a forward conversation, but I am not looking to throw everything we have learned about this procedure and disregard the entire learning curve of instrumenting the lumbar spine, as well as believe that Wolfe's law no longer exists, because some share-holders want to create some buzz with an "advancement in spine."
This implant can't help recreate the load path by what it is---a distracting agent---and the marketers can't change that, but that's not gonna stop them is it?
I get your theory...I just want to know if there is proof of that theory. I am not challenging the theory so much as I am looking at things from a different perspective.
ReplyDeleteMedicine is an evidence based discipline, but sometimes that is only a convenience. Physicians follow that premise, unless they have enough anecdotal experience to convince them otherwise. Or unless the theory they are so attached to doesn't have the empirical proof to back it up.
I just want to know if the theory that you have eloquently, and simply explained has any published proof...if the fusion is inadequate in any way, if the patients that undergo this operation do poorly. After all, isn't this really about treating the patient, not adhering the the theory, and dogma? If the patients do well, if they achieve fusion, and it doesn't ultimately break down, isn't that successful? Maybe it isn't the densest (is that even a word?) bone, but is it dense enough?
Are you just hesitant to admit that maybe it would work as well as what you are doing, but the patient may recover faster?
So, now I will throw some darts at the theory, some variables that you may not have included in your equation. Maybe some are negligible by themselves, but cumulatively, maybe they make a difference. If the disc space is packed with enough bone to increase it's height, before the reverse Herbert screw is impanted, then the screw is driven, which causes slightly more distraction, but at the same time radially displaces the bone material that was previously in it's path, and at the same time it retentions the annulus, drawing the walls in toward the center, isn't it possible that the volume of the discectomy is reduced, and the graft material is still under some load? Isn't it true, as another MD pointed out above, that there is no such thing as an interbody device that doesn't allow some subsidence? And if there is some subsidence, even 1/2 mm, isn't it possible that the graft is carrying at least some of the load? Aren't osteoblasts infact decent jumpers, I mean limbs are lengthened by constantly incrementally distracting a fracture which creates a bridge of bone as you go?
I am also wondering where in med school biomechanics is taught...is it in the first 2 or four years? Or does it come through a fellowship, or does it come from a few CEU courses? I am pretty sure that, not every spine surgeon has an M.S. in Mechanical Engineering, or even a B.S for that matter...just wondering where the exptertise comes from...certainly there are a lot of MD's that are experts in biomechanics, but I don't think that all are, are they?
Frankly, it is getting a bit repetitive for you to imply that every point of view other than yours, is motivated by greed. Maybe there are just some good ideas, even though they didn't come from you, or your mentors. Don't hate those that profit because they either thought them up, or recognized them.
VERY WELL SAID Open Minded Advocate!!!
ReplyDeleteAll grafts including AxiaLIF subside a little (Blake Rodgers studies).
OJD - Osteoblast Jumping Distance is a scientific fact that is used along with Ilizariv or TSF external frames to lengthen limbs up to 5cm or more.
AxiaLIF is here to stay! The fusion rates are there!
I guess I would have to agree. If there are confirmed fusion rates at 1 & 2 years, then it's not just marketing success.
ReplyDeleteWhat you will see with this device is radiolucencies greater than 2mm around the device, and poor egg shell bone in callous formation---this is not an improvement as an implant, but an improvement in the approach--arguably.
ReplyDeleteAny device that is more dense than the bone around it will subside--physics not opinion---why would the market take a step backward and use a more dense material after all this time? Why would it want a distracting device? It doesn't, it hasn't, and it won't---that is why Trans 1 has not and will not take off---those are facts supported by clinical unacceptance, based on the fact that surgeons who understand how to attempt to reconstruct the anterior column already know what empirically is an unsound solution device.
Now you can take shots and go back to villifying the messenger, but when you ask simple questions and get simple responses you don't want, you cry and call names like a child.
It is a flawed idea from the very first step--the modality of distracting and taking up the central portion of graft space with a piece of metal is unnecessary in light of the newer devices already out there and still doesn't even compare favourably to using simple bone strut solutions---bone is the same density of bone, it is the right matrix, and it offers the most surface area---if I choose a device it will be one that best mimics these qualities not one that has the furthest characteristics from the actual anatomy.
Load sharing is the answer, stress shielding will never gain acceptance. No matter how slick you articulate your childish wants and dreams for this device, you can't change the fact that it is a distraction screw, an old one at that, and it does not beloing in the anterior spine. Sorry for the message, but enough of the hogwash for now.
Just heard about another bowel injury - patient has been in hospital for a month. 0.6% complication rate... no way. Maybe with a select group of surgeons that did a small study for Trans1. But with all the jokers they trained on this technique, 0.6%... no way. Absolutely no way.
ReplyDelete12:21: Please educate yourself before making inacurate statements. Not only do you not understand what callus bone formation is but you don't even know how to spell it. Callus bone formation is stronger than trabecular (cancellous) bone. Most CT scans confirming fusion look for trabecular bone. If you truly see callus bone (typically seen in long bone fracture healing due to secondary bone formation - IM Nailing) than it's a very solid fusion.
ReplyDeleteAlso, what does the density of a material have to do with anything? The implant is only there to maintain the disc space height (prevent foraminal stenosos) until fusion. By the way Titanium is an extremely biocompatable material used extensively in bone repair from the skull to the foot.
I have done almost 100 cases with no bowel injuries. If you know what you are doing you will be safe. Just ask a colorectal surgeon how safe the presacral space is.
11:17
ReplyDeleteNoone cares how safe the presacral space is,the presacral space is the vatican for all I care.
The questions which have not been answered posed by some of the surgeons above are simple;
1) Why would you ever distract with a stress shielding device when you don't have to?
2) Density of the graft should be the same as the levels above and below---it should look like one singular vertebral body once incorporated---do your elavator shafted fusions look this way?
3) What do you think the device does to the affected load path? Don't rigid distracting devices speed up degeneration at other levels as a result? (Every other rigid device in history did, but the reverse Herbert screw is magic right?)
Perhaps you should present your ideas on bone healing at the AAOS, everyone would love to hear how your magical screw is an advancement in spinal fusions--do you ever wonder why noone used a reverse herbert screw even though it has been around for 46 years?
Please educate all of us ignorant surgeons and engineers, evidently all of our research in the past 30 years was flawed. Wolfe got it all wrong too--I guess bone under load isn't more dense than non-loaded bone, despite what every piece of literature has shown us thus far.
I hope I used spellcheck, because I know you are a man of exacting details, seems the big details are lost on you though.
I will attempt to address your questions:
ReplyDelete1. If you can distract and decompress indirectly without disrupting the native muscular and cartilagenous anatomy would you? I really don't understand why so many of you believe this 5cm Ti screw is a stress shielding device??? Do you really think this AxiaLIF screw has the ability to support the spinal column without minimal subsidence?
2. Take a look at the fusion data. 90-95% fusion is hard to argue with. The CT fusions I have seen look the same as any other fusion. Trabecular bone formation. The device does not claim to be a dynamic system. Where is that data? Yes, adjacent levels will degenerate with any fusion system.
Please do me a favor and explain load on a graft in an open space? Other systems remove a portion of the anulus and therefore there is room for the graft to extrude under load correct? The graft that surrounds the AxiaLIF screw is loaded by axial compression and an intact annulus and therefore creates a favorable fusion cenario.
Working in the presacral space is perfectly safe. Also, crossing the Grand Canyon on a two-inch balance beam is perfectly safe, too... as long as you don't fall off.
ReplyDelete9:48
ReplyDeletePlease tell me in a degenerative segment that you are not counting on an intact annulus?
Did the annulus magically become resiliant again because you distracted it or is it still in the same degenerative condition? (ossification perhaps? no tears? bulges? it has kept its viscoelasticity all through the degeneration process? Why are you repairing it in the firstplace then??????)s
Ligamentotaxis didn't work 30 years ago, but somehow you have brought life back to a degenerated ligament?
How can the graft be loaded around the device if it distracts? Does the device fail to hold its height correction? Does it do both distraction and compression at the same time?
Was this device used in the Kennedy assisination? It is magic!!!
11:11
ReplyDeleteSomething must be working when multiple studies confirm 90-95% fusion rates!!!
You clearly do not understand biomechanics or disc degeration.
The nucleus propulsis is the degerating factor. Not the annulus.
Ligamentotaxis is used everyday to reduce intraarticular fractures.
Ligamentotaxis is used everyday to reduce intraarticlar fractures.
All interbody devices will subside slighly after being loaded unless you have an interbody that assumes the entire surface area of the disc.
Ligamentotaxis is used every day to reduce intraarticular fractures.
11:11
ReplyDeleteYour right---Then why not use a graft that assumes the entire surface of disc? And why not use a device that doesn't stress shield the graft?
I was at IMAST this past week and you should have seen the amount of surgeons at the Trans1 booth. Whatever your theories, when you see Dr. Boachie from NY talk about using AxiaLIF in his practice, everyone STOPS and listens.
ReplyDeleteThis company has caught a lot of attention (IMAST especially) and the surgeon I work with is getting trained on it next week. I'm a PA and have worked with three spine surgeons (within the practice) and all are looking for a solution for L5-S1. Well, it appears we may have one ladies and gentlemen.
I had this surgery done in 2006. No complications but never fused properly. Trans1 Axial Lif and 4 pedicle screws. Back pain and radicular symptoms worsening for past 5 years. I would recommend a more traditional approach that is tried and true. And if you ask me, I wouldn't invest in them. I predict an increase in law-suits for the ineffective fusion rates. Check Aetna website for studies on Axialif.
ReplyDelete