502 patients with an acute open or closed tibial fracture undergoing treatment with intramedullary (IM) nails were randomly assigned to receive either active or sham low-intensity pulse ultrasound (LIPUS) to determine whether the use of LIPUS demonstrated a significantly beneficial effect on functional recovery. The results of this study indicated that LIPUS treatment did not result in significantly improved functional outcome over the first 52 postoperative weeks, and demonstrated no significant effect on time to union when compared to sham LIPUS treatment.