Titan Spine Presents New Data on its Anterior Lumbar Interbody Fusion Device

During a podium presentation at the 15th annual meeting of the International Society for the Advancement of Spine Surgery (ISASS, April 15-17), in San Diego, Calif., officials for Titan Spine LLC presented results of a new study demonstrating “statistically reduced subsidence rate and overall subsidence amount” of its Endoskeleton TA interbody fusion device compared to a commercially available device made of polyether ether keytone (PEEK). 

The data was included in a presentation titled “Subsidence Following Dynamic Loading of Intervertebral Devices,” delivered by lead author Antonio Valdevit, Ph.D., during the general session on biomechanics.

According to the company, the findings, which come from a dynamic mechanical study assessing subsidence rates of spinal implants during continuous cyclic loading, demonstrate that Titan’s TA ALIF (anterior lumbar interbody fusion) interbody device provided for a 410 percent reduction in rate of subsidence and a 40 percent reduction in overall subsidence amount compared to a commercially available ALIF PEEK implant of similar footprint.¹ The parameters of the study were designed to reflect the three-month, post-operative period in which the incidence of subsidence is most likely to occur in-situ.

“Most mechanical subsidence studies for interbody fusion devices are performed statically according to ASTM testing standards. However, from a clinical standpoint, subsidence occurs dynamically under continuous cyclic loading,” said Valdevit, Ph.D., a professor in the Department of Chemical Engineering & Materials Sciences at Stevens Institute of Technology. “Our study replicated this clinical condition and demonstrated that Titan’s titanium TA implant resulted in a statistically slower and more gradual settling upon the endplate surface, producing a ‘soft landing,’ whereas the PEEK implant had a statistically increased settling rate and overall subsidence amount. The PEEK implant’s ‘hard landing’ may be the result of its anti-expulsion teeth that distributed the overall compressive force over a smaller contact area as compared to Titan’s roughened macro surface. This study distinctly shows that subsidence is a function of more than the implant’s material modulus, but also importantly involves device design, which may have meaningful clinical implications.”

Andrew Shepherd, vice president of marketing for Titan Spine said the importance of this study could not be overstated.

“The spinal community has long been led to believe that subsidence is purely a function of an interbody device’s material modulus and that PEEK implants will subside less than titanium devices since PEEK’s modulus is closer to that of the vertebral body,” said Shepherd. “Dr. Valdevit’s study directly refutes this myth and confirms what the biomechanical community has always known. Implant design plays a much larger role in subsidence than the implant’s modulus of elasticity. Titan will continue to design its implants based on scientific principles rather than marketing misconceptions to drive sales.”

The Endoskeleton line of devices features the company’s proprietary implant surface technology, consisting of a unique combination of roughened topographies at the macro, micro, and cellular levels. The unique combination of surface topographies is designed to create an optimal host-bone response and actively participate in the fusion process by promoting the upregulation of osteogenic and angiogenic factors necessary for bone growth, encouraging natural production of bone morphogenetic proteins, downregulating inflammatory factors, and creating the potential for a faster and more robust fusion.^2,3,4

Titan Spine is located in Mequon, Wis., and Laichingen, Germany.

References:

¹ Valdevit, A., Ullrich, P., Gallagher, M.B., Schneider, J.M. Subsidence Following Dynamic Loading of Intervertebral Devices. Abstract #224, Oral Podium Presentation; ISASS 2015.

² Olivares-Navarrete, R., Hyzy, S.L., Slosar, P.J., Schneider, J.M., Schwartz, Z., and Boyan, B.D. (2015). Implant materials generate different peri-implant inflammatory factors: PEEK promotes fibrosis and micro-textured titanium promotes osteogenic factors. Spine, Volume 40, Issue 6, 399–404.

³ Olivares-Navarrete, R., Gittens, R.A., Schneider, J.M., Hyzy, S.L., Haithcock, D.A., Ullrich, P.F., Schwartz, Z., Boyan, B.D. (2012). Osteoblasts exhibit a more differentiated phenotype and increased bone morphogenetic production on titanium alloy substrates than poly-ether-ether-ketone. The Spine Journal, 12, 265-272.

⁴ Olivares-Navarrete, R., Hyzy, S.L., Gittens, R.A., Schneider, J.M., Haithcock, D.A., Ullrich, P.F., Slosar, P. J., Schwartz, Z., Boyan, B.D. (2013). Rough titanium alloys regulate osteoblast production of angiogenic factors. The Spine Journal, 13, 1563-1570.