Measuring Orthopedic Plate Strain to Track Bone Healing Using a Fluidic Sensor Read via Plain Radiography

We describe a fluidic X-ray visualized strain indicator under applied load (X-VISUAL) to quantify orthopedic plate strain and inform rehabilitative care. This sensor uses a liquid-level gauge with hydro-mechanical amplification and is visualized in plain radiographs which are routinely acquired during patient recovery to find pathologies but are usually insufficient to quantify fracture stiffness. The sensor has two components: a stainless-steel lever which attaches to the plate, and an acrylic fluidic component which sits between the plate and lever. The fluidic component has a reservoir filled with radio-dense solution and an adjoining capillary wherein the fluid level is measured. When the plate bends under load, the lever squeezes the reservoir, which pushes the fluid along the channel. A tibial osteotomy model (5 mm gap) was used to simulate an unstable fracture, and allograft repair used to simulate a stiffer healed fracture. A cadaveric tibia and a mechanically equivalent composite tibia mimic were cyclically loaded five times (0 – 400 N axial force) while fluid displacement was measured from radiographs. The sensor displayed reversible and repeatable behavior with a slope of 0.096 mm/kg and fluid level noise of 50 to 80 micrometers (equivalent to 5-10 N). The allograft-repaired composite fracture was 13 times stiffer than the unstable fracture. An analysis of prior external fracture fixation studies and fatigue curves for internal plates indicates that the threshold for safe weight bearing should be 1/5th −1/10th of the initial bending for an unstable fracture. The precision of our device (<2% body weight) should thus be sufficient to track fracture healing from unstable through safe weight bearing.