Thursday, May 10, 2012

A Generation of Regeneration

Recently, while working on a project, TSB began to wonder about the advent and evolution of synthetic bone graft materials, and the many claims that exist regarding the efficacy of one product or one's science that has been utilized to exceed a competitors claims.  It would be interesting to hear the opinions of our readers. As regenerative therapies gain momentum and revolutionize preferential modalities of treatment. What is it about one product that truly differentiates itself as the leader, as a game changer, or is some of the science that exists behind the curtain regarding the science, more smoke than mirrors?  Questions that still abound are:

Is it the Science?
Is it the Structural Composition?
Is it the Chemistry?
Is it the Porosity?
Is it the Resorption Rate?
Is it the Sintering Technique?
Is it the Silicate?

The industry is enamored with marketing nomenclature. "Does it taste great, but is it less filling?" Is there one product that is really that much better? When will we see commercials reenacting an incident whereby someone benefits from a specific bone grafting material? Maybe someone falling out of the bathtub after a Cialis moment? The industry throws around words like osteoconductive, osteoinductive (BMP), osteostimulative (Actifuse/Novabone), bioactive, osteoinductive potential (Alphatec WTF), platelet derived growth factors, Bone Morphogenic Proteins, and last but not least, the latest and greatest craze stem cells. It's a wonder no one has trademarked the line "osteoproductive." It does produce bone, doesn't it?  Granted, some of these fall into distinct yet separate categories, but they are all engineered in one shape or manner. Do some of these products work better than others? Which ones? TSB is sure that the public would love to hear our readers take on this segment of the industry.  Is one product safer than another, if used properly? If the intent is bone remodeling, how does one substantiate that one material recruits mesenchymal/osteoprogenitor cells faster, differentiating into osteoblast which secrete the matrix for the onset of bone formation? How fast is fast?  Is it nanoseconds,  is it a matter of minutes, of hours?  And if in the end, bone remodeling does take place, meaning a successful outcome, does it really matter what magic dust is used?  How do some of these companies substantiate their claims?

The AIDS epidemic of the 80's created tremendous opportunities for pull thru revenue that many have taken advantage of.  It also let the marketing boogeyman out of the closet.  But what is it about one product that makes it so unique in comparison to another?  Is it truly science? Is it marketing? Is it about relationships?  Are surgeons basing their decision making on science or on relationships? TSB wants to know what our readers think?

78 comments:

  1. The differentiation between the products is nominal. It is the relationship with the surgeon.

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    1. ^ very true. 95% of the fusions in my territory, the doc is going to use the synthetic extender that the hardware rep has in his bag (be it Healos, Mastergraft, Chronos, Formagraft, Conduct, etc). Very few guys using a biologic or a synthetic from another company

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    2. 7:16 again..and thats why I would hate to work for Orthovita

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    3. I had a synthetic graft (obviously supplied by the company i work for). The surgeon actually pointed out on the xrays a one of the follow up visits why he was so happy with it, showing how the previous synthetic he was using had a different x-ray appearance and how happy he was with the speed that my fusion was occuring. There may not be that much between them - but there are differences...

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    4. was the previous biologic Actifuse?

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    5. Any product that has a large percentage of HA will look great on xrays, even two weeks after surgery! Does that mean it is fused?

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    6. @10:53 Absolutely right, HA lasts for a while.

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    7. 7:39 rick rolls in with the most ignorant post of the day, kudos to you sir/ma'am.

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    8. reply to 7:39 AM
      You could see that on a plain x-ray - Boy your good

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    9. Its 7:39 again, 8:09 yes you are totally right the previous product was Actifuse. He was saying Actifuse had a granular appearance and couldnt be sure of the fusion for quite a long time afterwards...

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  2. Why dont you ask baxter how its going since they took actifuse direct! LMAO case in point.

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  3. HA shows up great on X-rays.

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  4. 7:17 you might want to check yourself and the facts. Stryker purchased Orthovita last June. I agree that surgeon relationships are crucial, but don't always drive the product over science/ marketing. Many surgeons in my terrirory continue to use Vitoss and have never touched a Stryker implant. Level 1 human data, as minimal as it is on Vitoss, is Level 1 human data. As far as I know, Vitoss is the only synthetic on the market that backs up claims with real data(sans BMP). Been tough to overcome with certain surgeons.

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  5. Vitoss has been on the market for over a decade. No one knows or cares about its data as it is an inert synthetic and should only be used as an extender anyway.

    One more vote for Distribution...

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  6. 8:28 yep!!! forever

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  7. TSB as one of my surgeons puts it "biologics is like walking down a cereal isel, so much to chose from and all full of crap".

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  8. SCAFFOLD-CELLS-Signal is all you need. Vitoss touts porosity but who can quantify that.

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  9. You guys are ALL so full of crap. You think you are scientist or truly know what you are talking about where you basically just regurgitate what some clinical specialist told you and they regurgitate what some product manger told them etc. etc. I just crack up how you all boast or defend your biologics until you lose / pick up another line and now, magically, you are selling the best shit in the world. God, i just want to punch you little shits in the face when I see you in the hall ways.

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    1. Another pompous ass doctor who belives he knows more about everything than everyone else. I've done cases with guys like you & your ability is much over rated, but not in your mind. I've had to talk guys like you through a new procedures, so for you to belive that reps add no value is just another of your samll minded delusions. Take a swing at me, and then see after you wake up from your coma (brain trauma) if that was an educated choice.

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    2. hmmm. should that reply be signed... "your local NUVA rep" ?

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    3. 2:36...brovo! If 2:04pm is "really" a medical professional than I call him/her out! Yes, biologics and some reps are full of shit, wont agrue with you there, roll up your sleeves and try and go a round or two with the rep you see in the hall way you dumb ass. If it were'nt for that rep in the hall way, you probably would have to wipe your own ass now.

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    4. 2:04 here. Funny. I'm not a doctor. Never said I was. Listen, some of you turds know your stuff (mostly centered on metal and PEEK). But you really don't know shit on the science other than want you have been told by your company. That is why everyone's product "is the best". You guys go around acting like docs. Just a bunch of fucking posers. I bet if yo neighbor kid got hurt, you rush over with some BS diagnosis like you are the MAN. With regards to 2:36...you are a fucking tard. Putting me in a coma with a little bit of brain trauma added in. That's priceless. In my post I was speaking metaphorically, Hard for you to understand that Roid Man.

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    5. WEll now, your intelligence, REPs, and Docs alike, really impresses me. I am a wife, and a mother of a man who has been fighting for his life for 10 years. He now has been told he needs a fusion and we just found out about these new products. So I come to research it, and boy do you all make me feel secure in these products. Thanks! Grow up all of you!

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    6. hey 9:26 if your not a doctor and thank GOD your not. I don't want you on this blog representing yourself has someone who knows what they are talking about. There are many people and patients out there on this blog looking for info and then you through your attitude around and your bad language all the while hiding your chicken shit ass behind the vale of anonymous. Now who is the tard!???

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    7. Well 6:17
      So we are all a bunch of jackasses. We know. But when the lights go on and surgery starts, and with a 50% chance after instrumented spine surgery that your husband is going to get better, what are you going to lose? Don't forget that if your husbands surgeon is in a POD, then he will likely get a few prophylactic levels fused as well. You know, since we are already there.

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    8. I must Agree that some of the lack of professionalism here has been appalling. I had 1st cervical fusion done in 1994 (anteriorly). Problems arose soon after a fall (leaking case at our local king soopers) in 2009 when leg started going numb, I then found out needed anterior cervical fusion in February 2010 and subsequent lumbar fusion l2-4 in March. Cervical went smoothly but after lumbar was unAble to walk so placed in rehab 12 days to relearn that and other fun things. Actifuse was used I believe in that surgery. I ended up having multiple revisions April, and June 2010 as had pseudo arthroses in cervical area. ActuAlly had to open and close me twice in June as surgeon who said surgery would be. Breeze so didn't need Any openended statements in consent in case there was problem. Of course they couldn't cut thru scar tissue and the. Couldn't get ahold of my lovely emergency contact ex husband, so had to abort surgery and reopen me next day. Fast forward 2 years after increasing pain Along with burning stabbing and every other pain imaginable in low back, left leg etc and finally get diagnosis of arachnoiditis with two major neurosurgeons saying thAt it came from lumbar fusion. My life has been profoundly changed and I have since had c3-t3 fused posteriorly (c3-6 anteriorly?) and am also 4 weeks post lSurgery, ALIF and PLIF l2-s1. Do you think the actifuse could have played a part in the arachnoiditis or in any of pseudoarthroses.

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  10. Skye Orthobiologics and Osprey are taking over the biologic world as we speak....have you seen those hydrated spine structural bone grafts?

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    1. The biologics world must be in a parallel universe from our regular spine world. I looked at their website and products and nothing amazing to jerk off to. Joel, this would be a great line for you!

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    2. Skye? Osprey? Your joking right? Same shit, different company. There called commodities for a reason

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  11. Vitoss is a joke. All of the Vitoss users in my territory magically stopped using the product the minute Stryker picked it up. Its old, dead technology. It has zero osteoinductive properties, including the "fairy dust" sprinkled on. I've been in many a revision case where the Vitoss strips have been literally pulled out full intact with zero bony ingrowth. Same can be said for Actifuse. They dont work without local bone, so why not just go local bone? If it were me, I'd want local bone, cancellous chips and dbm

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  12. Anybody have any experience with Copios?

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  13. After years of publications and education this blog makes abudantly clear that nobody still knows the first thing about bone biology. Just like nobody knows anything about back pain. Pathetic, given how much money is wasted here. That includes your salaries and commissions.

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    1. @ 5:59; why dont you explain bone remolding amd then take a shot at back pain....

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  14. 6:18, after you take a GED English course. If you can still afford it.

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  15. LuLz, gut busting fun in here tonight boys!

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  16. 7:17 What level one "human" data does Orthovita/Stryker have? "Minimal" Level one scientific data kind of misses the definition of Level One Scientific Data. Just so you know all those studies with twenty patients don't really provide much Level One Data. You may have forgotten your statistics class (or you may have never taken one) but to have reliable and valid N (number of patients) your going to have to produce a study with more than 19 patients. Show me a study with six hundred plus patients studied for at least four years and you approach level one data. Infuse is the only product commercially available with Level One Scientific data. As many are questioning the accuracy of the Infuse data with the assertions that complications were under reported and that potentially a study or studies had falsified data, which leaves very little Level One Data available for the physicians to make informed decisions on products, which is exactly how the industry wants it. You see there is a tremendous risk involved in studying your product that your selling and making money on, it just may well be a dog, turd, or dud.

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    1. whats your email? Or anybody elses that wants to see the data. NOBODY has data to back their product like Orthovita / Stryker.

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    2. In other words... NOBODY had more paid consultants do their studies on Orthobiologics/synthetics than Orthovita. Interesting enough the vast majority of Vitoss's studies are from their consultant a Dr. Epstein..

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    3. 4:12, that's the most laughable statement yet. The fact that Stryker, while still under scrutiny of the DOJ, bought Orthovita after turning their back on at least 3 others is a strong indicator that Orthovita was probably the cleanest kid on the block. Certainly a lot cleaner than for example Apatech -ask Baxter-, or Danek -see registry-.

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  17. Zimmer's Copios is the only dicalcium phosphate on the mkt. Has 400x more calcium & phosphate than any other synthetic and its minerals are SOLUABLE which means the body can use them faster and easier to convert them to bone. If you look at the process of bone formation, DICAL occurs much sooner (just 1 step after monocalcium phosphate) vs much later in the process like the crystalized rocks that HA and BetraTricalcium Phosphate are. Body doesnt have to break down DICAL to use it. Makes a lot of sense to me.

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    1. The Zulu's have a saying which translates - The man who thinks he knows everything should be left alone to die quietly...

      Where do we send the flowers?

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    2. maybe Zimmer should just stick to selling biologics...seems that they can't sell spine hardware!

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    3. Zimmer's Copios is a JOKE. Another rep spewing crap that a product specialist told them. 8:10 Explain the whole Osteo-regenerative cascade, and why your product fits well within that process, and then I'll may an apprciataiton for your regurgitated words.

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  18. Sorry for the off topic comment - this issue was addressed a few blogs ago.

    I was sent the following link and I encourage all to read the article and, importantly, the comments. Start with the earliest ones.

    If nothing else, it will give you a glimpse into the mind of a typical patient....so very misinformed, so desperate. Read the summary of May 9, 2012 11:17 PM on the "Aching Back" entry. Sums it up pretty good.


    http://www.cbsnews.com/8301-3445_162-57428677/a-new-hope-for-back-pain-sufferers/?tag=contentBody;cbsCarousel

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  19. Most of you reps remind me of a Neti pot nose douche - I can breathe easier once I've gotten rid of you!

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    1. No offense doc.... There are as many unsavory docs as there are reps. And, quite frankly, a bad surgeon is infinitely more dangerous to society than the worst sales rep I know. At the end of the day, we are all people that put our pants on the same way. And, last time I checked, just because you have an MD degree that apparently you earned from the Almighty himself doesn't make you any better than the guy that mops the OR hallways. Many (not all) surgeons lead lives that are completely defined by white "doctor" coats. Without it, many are shells of themselves with meager self confidence who are run over in their personal lives. In my humble opinion, that is a very sad existence, and I'd rather be the guy that mops floors. Before you throw stones my way, please check your own house......... cuz there is a lot of glass in the house where surgeons reside. Please re-douche your nose, b/c your post stinks and its ridiculous.

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    2. See May 10, 2:36 for my response.

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  20. 10:28 Your missing the point. I didn't suggest or say Orthovita/Stryker doesn't have a lot of studies. I said they don't have Level One Scientific Data. Level One Scientific Data is many peer reviewed, double blinded studies with a significant number of patients studied over a long period of time. Orthovita has none of them. Name your studies with more than fifty patients that has been published in a reputable journal and your number of studies shrinks considerably. Name your study with a 100+ patients that have been followed for more than two years published in a reputable journal and guess what you have none. Name your study with six or seven hundred patients and you probably don't have that in all your studies combined, which guess what you can't combine to achieve Level One Scientific Data.

    5:03 Most of you surgeons remind me of Automobile mechanics. I keep bringing my car in and you can't seem to fix the problem and when I get it back something else is broke. Perhaps you might try listening instead of being paid to use a product it might help your craft. Also, it might be the Neti pot or something else your doing causing your breathing to be so labored. There are many cases of Neti pots delivering tissue/brain eating organisms to patients sinuses and even some fatalities reported. I wouldn't want that to happen to you. What would the world do with one less egomaniac surgeon who I wouldn't let operate on my dog? Unless your one of my customers than of course you have the best hands I have ever seen, great job on the five hour single level PLIF.

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  21. My observations as a spine OR rat are that availability is key. You go it, the doc will use it. It's the "buddy putty" phenomenon.

    I heard from a surgeon than some synthetics upon revision appear to incorporate as well as saw dust.

    I believe that bone remodels best when the extender has a trabecular structure to function as a osteoconductive scaffold. Allograft with growth factors for me.

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  22. Vitoss for structure and autograft for osteoinductivity. That s what I would want. No HA or donor bone for me.

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  23. Most of the better synthetic products work well with the addition of BMA (havested properly). Product like NovaBone & ActiFuse are total junk! DBM's are junk with a carrier that provides no benifit at all..so junk with addtional junk! Local bone cleaned properly with a good synthetic with BMA best option! The truth about BmP continues to come out. The biggest development about BmP is how it promotes some cancer cells to grow wildly. Stay tuned for futher deveopments and class action lawsuits.

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  24. Nuvasive is promoting one of the biggest frauds yet. Osteocell is a horrible product. Doesn't work..very high price tag. It's a bigger fraud than ActiFuse!

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    1. Explain to me why Osteocell is a fraud or a horrible product......that's a big statement....

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    2. Because he sells against it. So its a fraud and a horrible product.

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    3. 8:50, Because living cells implanted in a dead space die within ~72 hours, that's why.

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    4. Also..no credible data! Explain why it's not a fraud for Nuvasive to promote dead tissue that amounts to allograft that is just "not so processed" dead tissue.

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    5. Explain to why all your companies are trying to copy Osteocell....just like you guys did with XLIF...I remember when guys said XLIF wouldn't last

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    6. Because companies in this field have no morals and no shame, just hunger for dollars....

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  25. Because the stem cells may not be viable upon delivery, may not be the right stem cells and may in fact cause inflammation and cancer all the while being one of the most expensive biologics on the market. There are much cheaper Cancellous Chips with a modicum of dbm available. If it is so great why not study it? I am not talking about ambiguous stem cell studies, I am asking for specific studies regarding the current version of Osteocell?

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    1. Studies are ongoing now. Stay tuned. My docs are seeing great fusion results. Several ortho and trauma docs are starting to use O+ in bigger defects, also with great results. I know you bozo's hate to admit it when NUVA does something right, but they have the best biologic on the market...bone forming cells on a bone scaffold. Sure it's $$ but results are on par with BMP, cheaper, without the side-effects. What's not to like?

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  26. You now if Alex has his cheetahs selling it it must be good, goes to show you how much the analysts really know what their writing about and promoting

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    1. Analysts repeat the crap they hear on the company conferecne call without doing any credible research. If they did..they find out the smoke and miorrs of the purple people.

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    2. 2:51
      Please, please do not write a response without any thought to proper grammar. Your response shows a lack of attention to detail and perhaps a lack of education. Do you perform your job in the same manner?

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    3. 5:50..it is important for all of us to use the Queen's English language properly, but I belive you get the person's message even though it may be written in crayon. I did notice you did not bother to include your thoughts regarding the subject at hand. Care to chime in my good man?

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  27. Do I dare mention Etex? Is this stuff junk?

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  28. The grammar police are out in full force tonight, be careful or they will slap you down LMSAO

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  29. Just, cause u got right grammer dont make you smartar then any body?

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  30. Can someone enlighten me as to how a doctor can be convinced to use ActiFuse. What is the thought behind a product that is 99.2% HA... It pretty much just looks good on film, how can that stuff possibly incorporate or act as a scaffold.

    Not bashing the product, per se, just looking to understand how someone would even go about positioning it.

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    1. Most surgeons are easily fooled. ActiFuse looks great on x-ray & CT, but in reality it's one of the worst perfoming products ever. Shame on a surgeon that uses that product on a living patient!

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  31. All of these posts are laughable. The poster who comments on no one knowing what they're talking about is absolutely correct. In this post, I've seen the following products described as worthless: Vitoss, Actifuse, Novabone, DBM (none specific), Copios, Etex (none specific), InQu, Etc... If you haven't noticed, that's just about every product used commonly. If each of these products was indeed worthless, trust me, they wouldn't still be on the market.

    Synthetics will work fine in many situations as long as they are ultra porous (surface area), the body recognizes it as bone and sticks around long enough (provides a scaffold for bone growth). All of you saying that the above products don't work aren't paying attention the fundamentals. They all will work just fine for small constructs and healthy patients.

    The real trick is the train-wreck patients. In these cases, these products will not work the same. In older patients with a diminished number of growth factors, an inductive product will work best (Infuse). With a large construct, bone will take longer to bridge... so, you'll need a product that sticks around longer. Also, if you need a ton of product, the most expensive product isn't going to fly with the hospital.

    There's simply not one product for every patient. The product a Surgeon picks should be based on the patient he/she is treating. If there was a perfect product, there wouldn't be 150 of them on the market.

    Also, the only products with true level-1 data are Infuse and Grafton. Vitoss reps, stop touting that you do... it's misleading. You have data, but it's on the same level as the rest of em'

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    1. At last a sensible post on this forum... I completely agree with your point on grafts staying around long enough... So where do you stand on BTcP's like Vitoss BA (not a synthetic as it contains 20% Bovine) which has a fixed chemical dissolution rate and an HA like Actifise which has cell mediated absorption? And what are your thoughts on new Osteoinductive synthetics that are on the market?

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  32. 6:47 Thank You no need to say anymore

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  33. Is it true that the dieing cells from Osteocell and Trinity can cause a response that leads to local bone death and resorbtion and a failed surgery and patient suffering? Why has this "product " been unleashed upon unsuspecting patients without ANY human studies?!?

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    1. I would double check your information. That is a big leap. Osteocel is high priced snake oil, but I would be hesitant to make the bone death claim.
      I will say I would rather use osteocel or trinity over some acid washed DBM. Although, it appears the companies who carry these products try to position against BMP and price accordingly.

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    2. 7:17 - before you go jumping for joy for trinity - it also contains your "acid washed DBM" as well.

      You fail to understand that trinity is the epitome of the "kitchen sink" approach. You add in a few stem cells (I am sure a few make it down the gauntlet of 96 hours of processing to be frozen and then survive the thaw.) You retain some ground up cortical/cancellous bone chunks - say a hooray for some osteoconduction perhaps and then it also has some DBM of unknown quality added to the mix.

      there are proven osteoinductive DBMs out there with 20 year track records that when mixed with local bone and some bone marrow aspirate would be my first choice if other options are off the table (namely INFUSE and autograft) - INFUSE should only be used in certain situations and I would avoid autograft for the obvious reasons of comorbidity.

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