Tuttlingen, Germany-based Aesculap Implant Systems, LLC funded a multicenter sheep study which compared the osseointegration capabilities of the company’s porous titanium coated polyetheretherketone (PEEK) surface to uncoated polyetheretherketone. The study and resulting paper looked at both in vitro and in vivo analysis.
The paper, “Porous titanium-coated polyetheretherketone implants exhibit an improved bone–implant interface: an in vitro and in vivo biochemical, biomechanical, and histological study,” appears in the October 29, 2018 edition of Medical Devices: Evidence and Research.
“Although the benefits of surface porosity in bone formation have been widely accepted, the spine healthcare community is just beginning to understand that nanofeatures may also have a role to play in how best to optimize these surfaces at the bone-implant interface,” said author Boyle Cheng, Ph.D. (Allegheny Health Network Neuroscience Institute, Pittsburgh, Pennsylvania).
“Until now, there has been some confusion about whether the titanium plasma spray manufacturing process can actually create reproducible nanofeatures. This is the first peer-reviewed publication to confirm that this specific proprietary process does in fact produce unique surface features that are tens of nanometers in size.”
“This should be no surprise, as the PlasmaporeXP process has been well characterized over the past decades in large joint orthopedic implant applications. We continue to find ways to bring technologies to the spine field in hopes of improving better patient outcomes through science.”
Aesculap, supplier of PlasmaporeXP, said that the study’s “data reinforces decades of clinical experience with the Plasmapore technology, starting with the surface-enhanced BiContact hip implant over 30 years ago.”
“In addition to this study, clinical outcomes have been reported on over 1,000 spine and orthopedic patients treated with an Aesculap surface-enhanced implant; however, this is the first published study that provides a direct histological comparison between the PlasmaporeXP surface and uncoated polyetheretherketone (PEEK). Additionally, this is the first peer-reviewed publication to document the presence of nanofeatures created by Aesculap’s proprietary titanium plasma spray manufacturing process.”
Dr. Cheng told OTW, “The most intriguing result from this research was the significant increase in early bone-forming activity seen on the PlasmaporeXP surface, especially compared to uncoated PEEK. Clinical efficacy of a spinal implant can be linked to the device’s ability to support initial and long-term stability through spinal fusion. What this research found, both in cellular assays and in vivo ovine research, helps to explain the anecdotal clinical outcomes seen with this unique surface over the past 20 years.”
