Analysis of alternate material Onyx™ for total knee arthroplasty instrumentation sets.

CONTEXT: A 25-pound weight limit is currently set on containerized instrumentation sets by the Association of periOperative Registered Nurses (AORN) and the Association for the Advancement of Medical Instrumentation (AAMI), in order to reduce strain on the staff and ensure that the sets are not too crowded in order to preserve sterilization and drying of the instruments. This is pushing companies to reduce the weight and number of instrumentation sets for the operating room. One solution has been to explore the viability of new, lighter materials such as Onyx.

OBJECTIVES

The goal of this study is to evaluate the novel material Onyx as a viable material utilized in reusable total knee arthroplasty (TKA) instrumentation sets utilizing traditional steam sterilization as the sterilization method.

METHODS

Mechanical and biocompatibility tests according to the American Society for Testing Materials (ASTM) and International Organization for Standardization (ISO) 10,993 were run to evaluate the Onyx Material to see if it would be a viable alternative to the stainless and martensitic steel that is currently being utilized.

RESULTS

Gross warping and cracking after 10 rounds of sterilization was observed. This was qualitatively worse in the Onyx without a carbon fiber component. The Onyx material did not meet biocompatibility standards for its application.

CONCLUSIONS

Onyx was determined to not be a viable material for TKA instruments regarding multiple high-pressure and -temperature sterilizations and cytotoxic cell testing.