Titanium-Coated PEEK Interbody Cages & Delamination
Interbody fusion cages made of polyetheretherketone (PEEK) are spinal implants used to treat degenerative disc disease when non-surgical options have been unsuccessful.
Although these interbody fusion cases can be effective in the treatment of chronic back pain, new findings have indicated that some of these cages may be susceptible to wear and failure upon impaction, potentially increasing patients’ risk of developing complications.
Interbody Fusion Cages: What They Are & How They Work
Placed in the space between spinal discs, interbody fusion cages are porous devices that add space between compressed vertebrae while restricting their movement in order to relieve back pain. The permeable nature of these devices allows the bone to graft to and through them, facilitating the fusion of vertebrae and reducing the risk of implant rejection by the body.
Among the various types of interbody fusion cages currently available in the U.S. are titanium-coated cages, including surface-etched titanium cages and titanium-coated PEEK cages.
Titanium-Coated PEEK Interbody Cages: Potential for Delamination Discovered
Despite the efficacy of interbody cages, there has been some concern that these cages may be susceptible to erosion in the body via the wear that comes with impaction. Focused on evaluating this potential complication, researchers tested two different types of titanium interbody cages: the surface-etched titanium cages and the titanium-coated PEEK cages.
What they found was that:
- The surface-etched titanium cages did not display any signs of surface damage or delamination upon impact.
- The titanium-coated PEEK cages DID display signs of wear upon impact, with the detached wear particles ranging in size from 1 to 191 microns (µm). About half of these particles were reportedly larger than 10 µm, a size at which they cannot be safely absorbed by the body’s cells (i.e., phagocytosis). Although full delamination was not reportedly observed with these cages, about 26 percent of the implants’ teeth were eroded, and the lost coating was visible to the naked eye.
Delamination and phagocytosis can result in some potentially serious complications that may require at least one revision surgery. Some of these complications reportedly may include:
- Accelerated deterioration of the bone surrounding the implant
- Metallosis, the dangerous accumulation of metal particles (i.e., titanium particles in the body)
- Loosening of the implant
Commenting on these findings, which were published in The Spine Journal,1 Professor Hans-Joachim Wilke, Ph.D., an author of the study, explained that:
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 clearance. Our findings suggest that different surface manufacturing processes have a large effect on whether the material stays bound during impaction or not.
Regulators at the U.S. Food and Drug Administration (FDA) are reportedly conducting their own investigation into titanium interbody cages. When the results of their investigation become available, we will report the latest updates here and in our blogs.
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1: Study published in The Spine Journal