RTI Surgical has announced the publication of a study evaluating the in-vivo material characteristics of 3D-printed Polyetherketoneketone (PEKK), TETRAfuse 3D spinal interbody implants compared to Polyetheretherketone (PEEK) and Titanium-coated PEEK (Ti-coated) technologies. ‘A comparative study of three biomaterials in an ovine bone defect model: A TETRAfuse PEKK study’ was published in The Spine Journal.
According to RTI, PEEK and more recently Ti-coated PEEK, have been used as conventional biomaterial design choices for spinal interbody implants. However, the company said in a press statement that shortcomings in these materials, such as surface delamination and lack of bone apposition, necessitated further research into additional interbody material constructs, such as TETRAfuse 3D Technology.
TETRAfuse 3D Technology is featured in RTI’s Fortilink Interbody Fusion Systems and has a nano-rough surface with antibacterial characteristics designed to participate in fusion without compromising mechanical integrity or radiographic visibility.
“This study provided evidence of the potential advantages of TETRAfuse 3D Technology related to bone growth characteristics without sacrificing structural integrity,” said Boyle C Cheng, director of research in neurosurgery at Allegheny General Hospital in Pittsburgh. “In the ovine model, histological review of TETRAfuse 3D Technology samples showed deeper implant osseointegration and more notable trabecular bone ingrowth. There is compelling evidence that PEKK offers preferable characteristics to the more conventional interbody materials.”
Implants were analysed post-implantation at eight and 16 weeks with respect to their osseointegrative capacities using a push-out method, histological staining and various radiographic tests. Study results showed TETRAfuse 3D Technology implants demonstrating bone ingrowth, no radiographic interference, no fibrotic tissue membrane formation, a significant increase in bony apposition over time, and a significantly higher push-out strength compared to standard PEEK, RTI said.
“The data from this hallmark ovine study in The Spine Journal indicate TETRAfuse 3D Technology’s unique potential to improve the effectiveness of spinal fusion procedures,” said Camille Farhat, president and CEO, RTI Surgical. “We believe there are significant opportunities for TETRAfuse to positively impact fusion, pain reduction and long-term performance. We continue to invest in the clinical data for this innovative interbody device material, including our ongoing FORTE study, to demonstrate its preferred characteristics and the positive impact it could have for spine patients.”