Comparison of a standardized four-point bending test to an implant system test of an osteosynthetic system under static and dynamic load condition

Abstract

Current test standards of osteosynthetic implants examine the bone plate and screw separately leading to unrealistic load scenarios and unknown performance of the system as a whole, which prevents the identification of characteristic failures in clinical use. A standardized static and dynamic four-point bending test (ASTM F382) was performed on a bone plate. Based on that standard, an advanced implant system test (IST) was designed and performed to test a mechanical construct consisting of a bone plate, screws and an artificial bone substitute out of Polyoxymethylene (POM). The test object was an osteosynthetic system to treat fractured ulna bones. Both results of the conventional and advanced test method were analyzed and compared to one another. The static results show a similar yield point (YP) relative to the bending moment with just 9% difference. Dynamic results show a bi-phasic behavior of the displacement vs. cycle data for the IST. The secondary phase can be defined as a constantly increasing plastic deflection or ratcheting effect quantified by its slope in mm per one million cycles, leading to a 10 times higher slope for the IST than the conventional test. The IST has a high impact on the test results and the resultant interpretation of the mechanical behavior of the osteosynthetic system. A constantly increasing plastic deflection might lead to fatigue failures and to a loss of the mechanical durability. The development of new standardizations referring to the whole system within reasonable boundary conditions of individual biomechanical applications is crucial for high quality mechanical analysis.

Keywords: ASTM F382; bone-plate-screw construct; implant system; implant testing; osteosynthesis.