Part I. Evaluation of Pedcile Screw Pullout Strength
OBJECTIVE: To determine the pullout strength of a Turkish-made pedicle screw (Tıpsan Posterior Instrumentation System, Tıpsan Tıbbi Aletler, İzmir, Turkey) compared to another well-known system (VSP System, DePuy AcroMed, Raynham, MA, USA).
METHODS: A series of pedicle screw axial pullout tests were performed in 14-week-old calf vertebrae. A sample size of 8 for both screw types was used to quantify pullout performance determined by peak load and stiffness.
RESULTS: The mean peak loads were 1892 ± 554 N for Tıpsan and 1959 ± 594 N for VSP screws. The difference was statistically insignificant (p>0.05). The mean stiffness values were also similar for the two screw types: 1063 ± 192 N for Tıpsan and 1126 ± 155.8 N for VSP screws (p>0.05). The mean insertional torque of the Tıpsan screw (3.89 ± 0.66 Nm) was significantly greater than those of VSP screws (2.68 ± 0.57 Nm) (p=0.0016).
CONCLUSION: Tıpsan screws provided sufficient pullout strength when compared to another well-known system as demonstrated by the similar peak load and stiffness results. The authors therefore consider the Tıpsan screw to be equal to its imported counterpart for use in a pedicle fixation system.