An experimental study of the biomechanical stability of ultrasound-activated pinned (SonicWeld Rx+Resorb-X) and screwed fixed (Resorb-X) resorbable materials for osteosynthesis in the treatment of simulated craniosynostosis in sheep.

We compared a conventional resorbable screw osteosynthesis with a resorbable, ultrasound-activated pin osteosynthesis, and studied mechanical load capacity and operative handling. This new form of osteosynthesis aims to reduce operation times, and to avoid torque loads and screw fractures to achieve stability. A sheep craniotomy model simulated an operation for dysmorphia on an infant skull. Two rectangular craniotomies of equal size were created in 13 lamb skulls, and each refixed by different means: the first by mesh and 20 screws, and the second by mesh with 20 pins inserted with ultrasound activation. All osteosynthesis material consisted of resorbable amorphous poly-(d,l)-lactide (PDLLA) (Resorb-X, KLS Martin, Tuttlingen, Germany). The insertion time was recorded. The animals were killed at different times, and areas of the healing skull including the plates and pins or screws were removed and divided into sections, which were then tested. In total 74 pin-fixed and 77 screw-fixed samples were obtained. Bending and tensile tests were used to simulate different forms of loading. The time required for the insertion of pins was significantly shorter than for screws. The mechanical tests showed differences in the stability of the bond between the osteosynthesis plate and bone that depended on the osteosynthesis system and the length of time it was in the animal. The pin osteosynthesis gave a stable mechanical load capacity, which was significantly different from that of screw osteosynthesis. Advantages of ultrasound-assisted, resorbable, pin osteosynthesis, include optimum operative handling, reduced insertion time, avoidance of fractures of the fixation elements and higher three-dimensional load capacity.