Self-adapting washer system for lag screw fixation of mandibular fractures. Part II: In vitro mechanical characterization of 2.3 and 2.7 mm lag screw prototypes and in vivo removal torque after healing.

The aim of this study was to mechanically characterize self-tapping 2.3 and 2.7 mm titanium lag screw prototypes which are part of the newly developed 'self-adapting washer' maxillofacial lag screw osteosynthesis system. In vitro in a screw testing machine the insertion torque, maximum locking torque and axial force and the ultimate torsional strength were assessed. In vivo in six miniature pigs using a mandibular symphyseal fracture model, the removal torques after 3 and 6 months of healing were measured. Additionally the bone-metal contact (BMC) of the screws was assessed histometrically. The maximum insertion torque (0.185 Nm) was far below the mechanical limits of the screws (2.3 mm = 0.96 Nm, 2.7 mm = 1.6 Nm). A tightening of the 2.7 mm screw with an axial force of 1000 N and of the 2.3 mm screw with 500-550 N leaves a safety margin of approximately one-third on the ultimate torsional strength. Clinically these values permit the use of two 2.3 mm lag screws or one 2.7 mm lag screw in mandibular symphysis fractures since 1000 N tensile axial force are required in this indication. During screw removal after 6 months healing, torque levels close to the mechanical limits of the screws were recorded and screw failures were observed. This failure rate may have been due to the BMC of 49.8% which was in the range of titanium dental implants. Accordingly the screw heads were reinforced to prevent fractures.