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Low-intensity pulsed ultrasound (LIPUS) is an FDA-approved intervention that is often used after fracture surgery to accelerate fracture healing and avert nonunion. However, scant evidence supports this practice. In this industry-sponsored trial, investigators enrolled 501 adults with open or closed tibial fractures who underwent intramedullary nail fixation. Patients were then were randomized to self-administer LIPUS or to use a sham device once daily for 20 minutes until their fractures showed radiographic healing or until 1 year after fixation.
The study was terminated early following an interim analysis that showed no between-group differences in treatment effects. However, the investigators continued to gather follow-up data. At 1 year,…