Study Supports Titan Spine’s Interbody Cage for Lumbar Fusion

Titan Spine LLC, a medical device surface technology company headquartered in Mequon, Wis., has gathered clinical data to support the use of its Endoskeleton titanium interbody cage for achieving rapid lumbar fusion and improving treatment. The prospective study was presented at the 13th Annual Meeting of the International Society for the Advancement of Spine Surgery (ISASS), recently held in Vancouver, British Columbia, Canada.

“Titan Spine is focused on optimizing the surface of interbody implants so that they can play an active role in facilitating bone integration and promoting fusion,” said Andrew Shepherd, vice president of marketing for Titan Spine. “This prospective study, which echoes similar clinical experiences from other surgeons in the United States and abroad, included patients of varying ages and degenerative conditions who all successfully fused and experienced excellent clinical improvement with our device. We look forward to continued research into the application of our proprietary technology and its impact on fusion outcomes.”

The study looked at 77 patients with a mean age of 46 years who underwent an ALIF (anterior lumbar interbody fusion) procedure using the Endoskeleton interbody device. A total of 138 spinal segment levels were treated, and radiographic analysis by two independent radiologists revealed a 100 percent fusion rate between six and 12 months, with no appreciable subsidence and an interobserver reliability (rate of agreement between participating clinician observers) rate of 95 percent. Researchers also noted that clinical outcomes as determined by ODI and VNS scores improved significantly by six months, with the improvement sustained at 12 and 24 months follow-up. They concluded this was likely due to early bone incorporation at the implant surface and lack of subsidence.

Titan Spine’s Endoskeleton implants feature a proprietary acid-etched surface that is textured at the macro, micro and cellular levels to support bone purchase and new bone growth. According to the company, cellular research has demonstrated the surface promotes a superior bone-forming response as compared to smooth titanium and PEEK (polyetheretherketone) implants.

“This study supports the use of the Endoskeleton device for safe, effective and rapid spinal fusion,” said lead author Paul Slosar, M.D., of Spinecare Medical Group and the San Francisco Spine Institute in San Francisco, Calif. “It is also important to note that fusion status was determined in all patients due to the design of the implant, which is in contrast to the difficulty in assessing fusion in historical titanium threaded devices. The Endoskeleton’s unique surface has been shown in published cellular research to stimulate improved osteoblast differentiation to support fusion. Our clinical data further substantiates those findings, and demonstrates the notable positive impact on patient outcomes.”

Titan Spine focuses on the design and manufacture of spinal interbody fusion devices.