Bone plate-screw constructs for osteosynthesis - recommendations for standardized mechanical torsion and bending tests.

This paper follows up on a recent systematic review of test methods and parameters for biomechanical testing of bone plates and it is the first study that contains recommendations for standardized mechanical testing of bone plate-screw constructs for osteosynthesis. Following the testing philosophy of ASTM F382 and ISO 9585, we have developed standardized quasi-static and dynamic testing methods for straight linear and anatomically shaped plates, including locked type and conventional systems. The test specification comprises torsion and bending tests along the implant axis and therefore modifies and extends the methods proposed by ASTM F382. We present specific test setups in order to determine product-specific characteristics of the mechanical construct, consisting of the bone plate with corresponding screws (such as construct stiffness, yield strength, ultimate strength and fatigue properties) under the condition that it is rigidly fixed to "healthy bone". We also address specific testing requirements that are important for the purpose of standardization, such as the positioning of the construct for testing or the number of screws in the diaphysis and metaphysis. Finally, we define the outcome parameters and associated failure criteria related to quasi-static and dynamic testing for comparative purposes. This paper does not intend to replace biomechanical testing of those devices under physiological loading conditions.