The Spine Journal accepted a new study based on in-vitro research titled "Does Impaction of Titanium-Coated Interbody Fusion Cages into the Disc Space Cause Wear Debris and/or Delamination?"
The study subjected spine devices to a simulated biomechanical impaction process into the disc space, showing 26 percent of the teeth on titanium-coated PEEK implants lost coating material ranging from one micron to 191 microns.
The study's author, Professor Hans-Joachim Wilke, PhD, found more than half the particles were a size range that allows for phagocytosis, an osteolytic process that occurs when macrophage cells are unable to safely digest foreign material.
"We undertook this study to investigate the possibility of impaction-generated debris since the FDA currently does not require interbody fusion devices to be tested in this fashion prior to regulatory clearances," said Dr. Wilke. "Our findings suggest that different surface manufacturing processes have a large effect on whether the material stays bound during impaction or not."
The study examined PEEK implants and compared them to Titan Spine's Endoskeleton, a titanium interbody fusion device. The Endoskeleton titanium device didn't show signs of impaction whereas the PEEK implants were susceptible to generating debris particles during impaction.
The Endoskeleton device includes proprietary implant surface technology — a combination of roughened topographies at the macro, micro and cellular levels created by a subtractive process. The implant promotes the upregulation of osteogenic and angiogenic factors necessary for bone growth.