Issue link: https://beckershealthcare.uberflip.com/i/571000
58 Executive Briefing: appears to be another attempt to confuse the spine community as they did successfully with their modulus of elasticity campaign. DB: In my view, these types of devices are an unnecessary compromise with significant limitations. They have a complex manufacturing process that was abandoned decades ago in the dental industry because of potential failures. Because the titanium coated PEEK joins two dissimilar materials, there will always be an increased risk of material failure and generation of particulate debris. Q: In researching titanium coated implants, I discovered at least one instructions for use (IFU) warned that "excessive insertion forces may cause damage to the implant," which seems to shift liability away from industry and the FDA to the surgeon. What are your thoughts on this? DB: I hadn't seen that in the IFU before and it worries me. When I look at that statement it makes me wonder what specifically constitutes excessive insertional force and how am I as a surgeon supposed to know how much that is. When there is a choice of implants, why would I want to use one prone to mechanical failure and has warnings? I would be putting myself and my patients at risk. DD: Similar to "off label use" this IFU shifts liability to the surgeon using the product. To my knowledge, "excessive insertion forces" is not even defined in the warning. "Excessive force" failure may be within the range of force required for routine intra-operative implantation. There have already been anecdotal cases of de-lamination during routine implantation. I am aware of a preliminary study that simulated interbody implantation stresses on titanium coated PEEK cages using a foam block model. Results demonstrated not only de-lamination of plasma sprayed titanium from the PEEK but also shear failure within the titanium layer itself. Surgeons using these implants need to be aware of the possible complications related to surface debris particles. Q: How are acid-etched titanium surfaces different than coated surfaces? KH: Acid etched titanium surfaces are much different because they use a subtractive technology, which leaves powerful molecular bonds that will not leave debris behind at insertion. This is very different than an additive surface. Coatings can come off and leave large debris or microscopic debris, and subsequent failures. This does not happen with implants that have utilized subtractive technology, because the titanium is still bonded to the adjacent titanium molecules by powerful bonds. RR: The acid-etched surfacing is a reduction technology. You're starting with a solid block of titanium and you are removing part of that titanium to create the macro, micro, and nano-scaled textures. The coated implant would be PEEK that is either sprayed or amalgamated with a titanium coating, so you have less accuracy as far as replicating the environment osteoblasts like and you have the uncertainty between the titanium coating and whatever material you are coating. The coating is subject to de-laminating, fracturing or creating debris during insertion that might be counterproductive to bony fusion. If the interface breaks and coating comes off, that could induce an osteolytic reaction that lessens the chance of arthrodesis. Q: How do you see surface technology continuing to evolve in the future? AB: I see further studies being done to see what can be done on this microscopic and nanoscopic level to further induce bone formation and fusion. In addition, there will likely be a focus in the biologic industry on developing complementary technologies to assist the fusion process. Many current biologics induce initial osteolysis or cause inflammation, both of which are counterproductive to the process that occurs when an appropriate handshake happens at the microscopic level between titanium and bone. RR: I think surface technology is going to be used more. It's apparent with everyone who is trying to coat their pre- existing implants with some kind of titanium surface that the device is trying to promote fusion and would benefit from nanotechnology that provides this microscopic architecture for bone growth. I foresee this might be utilized in surfacing titanium screws as well as cages and implants in the interbody space. It's possible they'll surface other devices used in fusion such as interspinous devices and anterior plates. It's something that derives a very friendly environment that all implants could benefit from if the goal is fusion. n Sponsored by: Titan Spine, LLC is a surface technology company focused on the design and manufacture of interbody fusion devices for the spine. The company is committed to advancing the science of surface engineering to enhance the treatment of various pathologies of the spine that require fusion. Titan Spine, located in Mequon, Wisconsin and Laichingen, Germany, markets a full line of Endoskeleton® interbody devices featuring its proprietary textured surface in the U.S. and portions of Europe through its sales force and a network of independent distributors. The company will be launching its next-generation nanoLOCK™ surface, the only FDA-cleared nanotechnology for the spine, in Q4 2015. To learn more, visit www. titanspine.com. Surface Technology Executive Roundtable: Surface Technology