ABSTRACT ASTM F543-23-A2, Standard Specification and Test Methods for Metallic Medical Bone Screws, provides critical experiential data on the torque required by surgeons when securing screws in clinical settings. This study aimed to evaluate the universal applicability of ASTM standard default testing parameters in assessing a wide variety of screws. A total of 131 screws, spanning 24 types, were selected and tested following ASTM F543-23-A2 guidelines, with the insertion state of the screws observed during the tests. The results indicated that 19 screws (average rate per group was 12 %) failed to complete the test successfully, whereas only 20 screws (average rate per group was 17 %) required no pretapping to facilitate threadform insertion. Furthermore, factors such as smaller diameter, lower thread pitch angle, and usage in cancellous bone positively influenced (based on pretapping angle inputs) screw insertion under uniform testing conditions. In conclusion, ASTM F543-A2-23 demonstrates certain applicability for the completion of testing; however, it cannot guarantee optimal screw insertion performance for all screws. Reassessment for default axial force or further clarifying its role (to overcome self-tapping resistance and ensure proper insertion) would be beneficial for enhancing the standard’s applicability.
Hua et al. (Tue,) studied this question.