Deviating from the Recommended Torque on Set Screws Can Reduce the Stability and Fatigue Life of Pedicle Screw Fixation Devices.

Background and Objectives: Using an appropriate torque to tighten set screws ensures the long-term stability of spinal posterior fixation devices. However, the recommended torque often varies between different devices and some devices do not state a recommended torque level. The purpose of this study is to evaluate the effect of set screw torque on the overall construct stability and fatigue life. Materials and Methods: Two commercial pedicle screw systems with different designs for the contact interface between the set screw and rod (Group A: plane contact, Group B: line contact) were assembled using torque wrenches provided with the devices to insert the set screws and tighten to the device specifications. The axial gipping capacity and dynamic mechanical stability of each bilateral construct were assessed in accordance with ASTM F1798 and ASTM F1717. Results: Increasing or decreasing the torque on the set screw by 1 Nm from the recommended level did not have a significant effect on the axial gripping capacity or fatigue strength of Group A (p > 0.05). For Group B, over-tightening the set screw by 1 Nm did cause a significant reduction in the fatigue strength. Conclusions: Excessive torque can damage the rod surface and cause premature failure. When insertion using a manual driver is preferred, a plane contact interface between the set screw and rod can reduce damage to the rod surface when the set screw is over-torqued.