Mechanical performance of the standard Orthofix external fixator.

Static and fatigue tests of the standard Orthofix unilateral external fixator (Orthofix SRL, Verona, Italy) were performed. Under similar fixation configurations, the Orthofix device offered higher bending stiffness in both directions, equal torsional stiffness, and lower axial stiffness when compared to the Hoffmann-Vidal quadrilateral frame with full pins. The bending resistance of the Orthofix ball joint was found to be proportional to its locking cam tightening torque. After applying 2 million loading cycles to the bone ends fixed by the device, the overall stiffness characteristics of the frame did not change significantly. Repetitive manual tightening and loosening of the ball joint caused abrasive wear on the cam and bushing surfaces. The locking position of the cam migrated for a mean of 45 degrees. After 50 cycles of tightening and bending to failure, the ball joint locking strength was reduced by 20% to 25%, but the stiffness did not change. Wear and stripping of the seat of the fixator body locking screw and the pin fixation screw threads were also noted. Based on the test results, the standard Orthofix device could be re-used, but certain fixator components must be inspected and replaced. The ball joint locking cam and fixation screws required periodic tightening during clinical application to prevent loss of frame stiffness under repetitive loading. Modifications of the fixator design are recommended to improve its mechanical performance.