The pink BIOLOX®delta large joint ceramic material is celebrating 20 years as an effective and successful material for articulating joint prosthesis.
Cheers to 20 Years of BIOLOX®delta!
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According to its manufacturer, CeramTec, BIOLOX®delta is a “highly biocompatible and hypoallergenic ceramic material,” which has demonstrated “superior physico-chemical properties leading to excellent wettability and a very high wear resistance.” Furthermore the materials “is safe in terms of metal ion release and pathogenic reactions to ceramic particles are highly unlikely.”
Other features of BIOLOX®delta ceramic, which led to its longevity as an implantable material is that it, again according to CeramTec, demonstrates “high chemical stability in physiological environments,” which is due to the “nature and strength of the covalent and ionic bonds of its structure.” When compared to other materials, BIOLOX®delta ceramic has “higher wettability, protein adsorption, and reduced incidence of bacterial adhesion.”
BIOLOX®delta was first introduced to the United States orthopedic market in 2003 under the FDA’s 510(k) clearance regulatory process. Since then, according to CeramTec, “millions of patients have been implanted with joint replacement components made of the BIOLOX®delta material. No other manufacturer’s ceramic material is used as often for hip bearing couples as the advanced pink BIOLOX®delta ceramics.”
CeramTec, which is based in Plochingen, Germany, manufacturers and supplies a full range of highly advanced technical ceramics.
CeramTec President Medical Katrin Sternberg, Ph.D. commented, “The excellent mechanical properties and biocompatibility of BIOLOX®delta have certainly contributed to the material’s great success. In times where metal sensitivities and multi-resistant germs continue to be on the rise, surgeons value our metal-free BIOLOX®delta material as a reliable option in arthroplasty.”
Dr. Sternberg continued, “The clinicians’ goal continuously to improve patient outcomes has significantly contributed to the great success of BIOLOX®delta. We look forward to partnering with surgeons across the globe also in the future, so that together we can help people to regain mobility.”
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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