Strain response of an instrumented intramedullary nail to three-point bending.

Objectives: An experimental biomechanical evaluation of an instrumented intramedullary nail (TriGen® META Nail, Smith&Nephew®) was undertaken. The objectives were two-fold. The first was to identify the most sensitive strain gauge positions and orientations on the nail, and the second was to demonstrate that the nail was capable of detecting changes in stiffness of the nail-bone composite. The function of the instrumented nail is to quantify fracture healing objectively and directly, and so to predict delayed repair or non-union 2 months before current methods.

Methods: Eight flat pockets were machined onto the surface of the nail and three strain gauges attached in each pocket. The instrumented nail was inserted into fourth generation biomechanical grade Sawbones® tibiae with three different fracture configurations as well as into a non-fractured bone. The nail-bone composite was loaded in three-point bending at five positions to determine the strain changes in each of the eight strain gauge pockets located along the length of the nail. To simulate callus in the simplest way and to increase the stiffness of the nail-bone composite, loops of duct tape in multiples of four were applied over the fracture locus. A three-point loading jig was used to obtain the change in strain with increasing stiffness. Relative displacement of the bone ends was quantified using radiostereometric analysis.

Results: There was no single position of greatest strain sensitivity for all fracture types. The greatest change in strain occurred when the strain gauge pocket and fracture line were closest. Applying the loading moment directly over the strain gauge pocket also maximised its sensitivity. The duct tape callus simulation showed that the instrumented nail was able to detect a change in stiffness of less than 4.1 Nm/°.

Conclusions: It has been shown that the instrumented nail can detect physiologically relevant changes in stiffness, and so to provide a useful function as an objective monitor of fracture repair.