Titan Spine has announced that data presented at the annual meeting of the International Society for the Advancement of Spine Surgery (ISASS; 3–5 April 2013, Vancouver, Canada) indicates that its Endoskeleton interbody cage is associated with a 100% fusion rate in lumbar surgeries.
According to a company press release, the study looked at 77 patients with a mean age of 46 years who underwent an anterior lumbar interbody fusion (ALIF) using the Endoskeleton device. The press release reported that a total of 138 spinal segment levels were treated and that radiographic analysis by two independent radiologists revealed a 100% fusion rate between six and 12 month, with no appreciable subsidence and an interobserver reliability rate of 95%. It added that researchers also noted that clinical outcomes, as determined by Oswestry Disability Index (ODI) and verbal numeric scale (VNS) scores, improved significantly by six months (ODI≥15 and VNS≥3) 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.
Lead author Paul Slosar, of SpineCare Medical Group and the San Francisco Spine Institute in San Francisco, USA, said, “This study supports the use of the Endoskeleton device for safe, effective and rapid spinal fusion. It is also important to note that fusion status was able to be 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.”
The press release explained that the Endoskeleton device features a proprietary acid-etched surface that is textured at the macro, micro and cellular levels to support bone purchase and new bone growth.