Low-magnitude high-frequency mechanical signals accelerate and augment endochondral bone repair: Preliminary evidence of efficacy

Fracture healing can be enhanced by load bearing, but the specific components of the mechanical environment which can augment or accelerate the process remain unknown. The ability of low-magnitude, high-frequency mechanical signals, anabolic in bone tissue, are evaluated here for their ability to influence fracture healing. The potential for short duration (17 min), extremely low-magnitude (25 mm), high-frequency (30 Hz) interfragmentary displacements to enhance fracture healing was evaluated in a mid-diaphyseal, 3-mm osteotomy of the sheep tibia. In a pilot study of proof of concept and clinical relevance, healing in osteotomies stabilized with rigid external fixation (Control: n = 4), were compared to the healing status of osteotomies with the same stiffness of fixation, but supplemented with daily mechanical loading (Experimental: n = 4). These 25-mm displacements, induced by a ferroactive shape-memory alloy ("smart" material) incorporated into the body of the external fixator, were less than 1% of the 3-mm fracture gap, and less than 6% of the 0.45-mm displacement measured at the site during ambulation (p < 0.001). At 10-weeks post-op, the callus in the Experimental group was 3.6-fold stiffer (p < 0.03), 2.5-fold stronger (p = 0.05), and 29% larger (p < 0.01) than Controls. Bone mineral content was 52% greater in the Experimental group (p < 0.02), with a 2.6-fold increase in bone mineral content (BMC) in the region of the periosteum (p < 0.001). These data reinforce the critical role of mechanical factors in the enhancement of fracture healing, and emphasize that the signals need not be large to be influential and potentially clinically advantageous to the restoration of function.