Implantable strain sensor to monitor fracture healing with standard radiography.

Current orthopaedic clinical methods do not provide an objective measure of fracture healing or weight bearing for lower extremity fractures. The following report describes a novel approach involving in-situ strain sensors to objectively measure fracture healing. The sensor uses a cantilevered indicator pin that responds to plate bending and an internal scale to demonstrate changes in the pin position on plain film radiographs. The long lever arm amplifies pin movement compared to interfragmentary motion, and the scale enables more accurate measurement of position changes. Testing with a human cadaver comminuted metaphyseal tibia fracture specimen demonstrated over 2.25 mm of reproducible sensor displacement on radiographs with as little as 100 N of axial compressive loading. Finite element simulations determined that pin displacement decreases as the fracture callus stiffens and that pin motion is linearly related to the strain in the callus. These results indicate that an implanted strain sensor is an effective tool to help assess bone healing after internal fixation and could provide an objective clinical measure for return to weight bearing.