Wednesday, October 13, 2010

The Great Debate: Whose Is Bigger and Better?

The recent guidelines that were published by the AAOS on the use of vertebroplasty or kyphoplasty for spinal compression fractures (SCFx) has raised many questions as to efficacy and cost.  Sources estimate that $17 billion is spent annually on the universal treatment of SCFx .   Those figures probably reflect universal treatment.  Annually, 1.5 million fractures are diagnosed with an estimated 200 to 300 thousand patients undergoing some type of vertebro/kypho procedure.  The cost per procedure can be as low as $2,400 and as high as $4,000.  In order to minimize cost per procedure, it may behoove the industry to have this procedure performed in an ambulatory surgery center.  Yet, the biggest question that is being debated is whether surgical intervention should take precedents over conservative care?  And, what is the rationale behind the AAOS' findings?

To recap the players, we have Kyphoplasty (MSD), Osseoplasty (Osseon w/DePuy Distribution), No Confidence (DePuy), RF Kyphoplasty (DFINE Be Fine), Parallex EZ Flow (Arthrocare), CDV/LP2 (Biomet), Stryker, and  Cortoss (Orthovita).  TSB apologizes if there have been any omissions.  Considering that many of these systems have their own features and benefits, TSB though it would be interesting to table these products and offer the industry a unique forum to discuss the pro's and con's of each system.  Some of the questions that we have heard include the following;

Do surgeons choose cost over retrospective data, intra-operative performance and post-op results?

Why one system over another?

Which system has provided the industry with a revolutionary or evolutionary advancement and why?

Which cement has the best workability, viscosity, and settling characteristics?

Is an articulating tip for unipedicular access an advantage or disadvantage, and why?

Is mimicking the physiological properties of bone important, if so then who has the best material?

Can one product legitimately minimize the potential for adjacent vertebral body fracture (ALFx), and does a lack of interdigitation contribute to ALFx?

Is thermal necrosis of nerve endings in the affected level a bad thing?

Is there a mechanical and chemical advantage of Cortoss over PMMA?

Considering that this is a hot market and that there has been some serious capital invested into some of these companies, TSB wants to know what our readers think?


  1. castrol gtx. that has high viscosity.

  2. I always thought that it was Valvoline?

  3. TSB asks "Which system has provided the industry with a revolutionary or evolutionary advancement and why?"

    The material (not system) that is the most revolutionary is Cortoss by Orthovita. They are putting emphasis on the material that walks away inside the patient, rather than widgets to combat the inherent issues with PMMA. The Cortoss IDE Study (largest Level 1 study for vertebroplasty...or kyphoplasty available) comparing outcomes between Cortoss and PMMA proved greater pain relief at 3 months and greater long term function at 24 months in the Cortoss group over PMMA. Considering Cortoss does not reach the high temperatures that PMMA does, I believe that proves that the thermal necrosis of nerve endings that happens with PMMA does not improve pain...

  4. who ultimately cares about Osseon's cement, or Orthovita for that matter? this is by and large a palliative procedure conducted on the elderly.

    long term bone growth on an 85 year old with co-morbidities means squat. these people just want to be out of pain.

    my choice in a vacuum (ie no price issue and if not sold by a marketing team of dipshits): Confidence

    my choice with real world considerations: CareFusion w curved needle

  5. Who claims long term bone growth in 85 year olds?

  6. Hmm, I guess it would also depend on which way reimbursement goes. A system that runs in the $4k range, but is reimbursed as a VCF will never take significant market share.

    "Not all devices are indicated equal"

  7. Please let's not forget of Benvenue medical, Spine wave, Osseofix from Alphatec and Vexim. Please comment.

  8. Really, Who cares?

  9. Confidence sold by dipshits...Amen

    What, you mean I can't sell cement at list price for 3500 dollars?

    Has anyone at JnJ taken a re-imbursement class? Know the difference between in/out patient costs etc.

    Had one of my customers say the Confidence rep asked him to use his cement and my balloon?

    Keep up the good work DePoo

  10. Will this really matter if "the man" is actively trying to eliminate the procedure all together. I believe the number of VCF surgical treatments are going down. all of the negative press and studies that are being displayed are ammo for the government or insurance companies who have to pay for the procedures. They are trying to cut cost and this will be an easy target.

  11. I lost a vetebroplasty case last week. Insurer denied payment for procedure. It is the beginning of rationed care....

    The future lies in the free market...if you can pay.

  12. It is ironic that v/k is coming under so much fire. Is there a more successful spinal procedure?

  13. 6:16 - Is this a joke? Have you read the well done studies? Those NEJM papers get panned by people with serious COI. Lancet FREE = Fix it before it heals.

    These procedures make no sense. Where else do we treat fractures by filling the bone with a rock?

  14. Great time for CrossTrees to be looking for patients for their clinical trial

  15. Hey, 6:14 - We treat most every other fractured long bone with a cast, screw, plate or other hardware, so immobilization of fractured bones works. How else would you immobilize or reduce the fracture of a vertebral body? Put a cast around it? These procedures solve the problem from inside out in a minimally invasive way.

    Granted, there could be/will be improvements in the materials/implants use, but they have to get thru HUGE trials in the US to see the light of day. Take a look at how many orthobiologics options there are in the EU - far more than the US. What do they know that we don't?

  16. 6:14
    I would say the EU knows jack about using orthobiologics. Cortoss was launched in EU 2001 (9 years ago) - totals sales are less than a million. Vitoss too - total turnover over of VITA outside of US is about 5 million dollars.

  17. 11:11 Fixing a "long bone" with rigid plates and screws is hardly analogous to putting a rock inside a vertebral body. IF one could fill the ENTIRE cancellous body with a PERFECT rock, then maybe, but a balloon shaped rock? Nope. And healing a fracture in a cast is not analogous to an insufficiency fracture that occurs because the remodeling of the bone is screwed up in the first place.
    And no "minimally invasive" thanks - cement in the canal? yup, in the lungs? yup.
    Time, meds, vit d, forteo.
    Please inform me what osteobiologics that WORK they have that we don't. DBM is ridiculous - not quite graft, not quite BMP.

  18. Now that the VP/Kypho market has been shot by the media, fusions are their next target

  19. The backlash against vertebroplasty really bugs me. The real finding of the Kallmes paper, which started all this, seems ignored. The difference in cross-over rates between conservative care and vertebroplasty groups is the gem of that study. An intent to treat analysis breaks down if the voluntary cross-over rate is high- or markedly different between groups. This study had both. That difference in cross-over rates leads to flawed statistical conclusions- but strongly supports what doctors and patients say, mainly that vertebroplasty works very well.

    Orthovita's recent study was well done and actually showed that Cortoss was better than PMMA. That's meaningful. Today if I was paying to treat a compression fracture, I would opt for a vertebroplasty with Cortoss. I recently bought some shares of VITA because I believe in the efficacy of vertebroplasty, the value of randomized data, and products that save cost. We'll see if that was a good move. Kyphoplasty would be the procedure that I'd be denying without prejudice. Show me the large randomized study that justifies the premium price of kyphoplasty. Not that NASS is a powerhouse right now, but they should stand up to AAOS and tell them to stick to joint replacements.

    And seriously, why aren't the payors looking harder at fusion. Pretty easy to save a bunch of money on a procedure that has plenty of bad press.

  20. 11:18 - you're an idiot! Tell your mother who has a VCF to take meds, vit d, forteo while she lies in bed for 8 weeks or more. Then after she lays there and deteriorates, her bone and muscle quality become even worse, she'll attempt to become mobile again, and once again fracture. It's a downward spiral that takes years off of these patients lives. I've done over a thousand of these and most patients are mobile the day after surgery. This let's them get back to their normal lives. And of those 1000+ cases, I've never had a symptomatic complication. Yes some minor leakage in rare cases, but flour and slow injection minimize this tremendously. As to your comment about putting a rock in the body, learn how the system works before spewing your ignorance. The balloon moves the poor bone in the center of the vertebra to the periphery, autografting it, you then fill the created void with bone cement. The entire vertebral body is treated because of this and the patients pain almost always is eradicated quickly. Guidelines for fracture management include trying to restore anatomy, stabilization, and minimizing blood loss. Your brace, narcotics, and forteo do none of these while the procedural option accomplishes all of these inthe best fashion that medicine has to offer at this time. Did you learn something?

  21. 9:54 - Are you a physician (with a practice of 1000+ Vertebro/Kyphos)? Or a rep, who has sold 1000+ kits, and seen 0% followup?

    Thanks for the lesson on how the balloon "works" - prove it. With histology and not theory. LOTS of ortho theory has been disproven over time. Anything to prove your "wasting away" theory? FREE shows equivalent adverse events. I am not aware of any study that shows a difference in mortality, but I am happy to read one.

    Where are your guidelines for fracture management from? Not quite AO, and again, these are a very different beast from a femur.

    David- finally some insightful comments. Vertebro works as well as placebo, which is NOT the same as doing nothing.

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