Efficacy of low-intensity pulsed ultrasound in surgically managed lower limb fractures: a randomised controlled trial

Although there have been improvements in surgical fixation techniques, the process of fracture healing continues to pose challenges, especially for patients with additional health issues. Low-intensity pulsed ultrasound (LIPUS) has been proposed as a non-invasive method to facilitate faster bone recovery; however, its effectiveness in clinical settings remains unclear. This study aimed to assess the impact of LIPUS on the healing of lower limb fractures. A double-blinded, prospective, randomised controlled trial was conducted in two hospitals in Gauteng, South Africa. The study was approved by the University of the Witwatersrand (M150236). Ninety-four individuals aged 18 years and older with lower limb fractures were consecutively recruited and randomly assigned to either the LIPUS or control group. The intervention group underwent 20-minute LIPUS sessions every alternate day for a duration of 20 days during their hospitalisation, followed by follow-up after discharge. Callus formation, cortical bridging, fracture gap, and overall radiographic healing were evaluated at 6, 12, and 18 weeks. An intention-to- treat analysis was performed to accommodate missing radiographs and loss to follow-up. No statistically significant differences were found between the intervention and control groups concerning callus formation, cortical bridging, fracture gap, or overall healing at any assessment time. A high rate of loss to follow-up and unavailability of radiographs diminished the analysis's power. LIPUS did not show a notable improvement in fracture healing when compared to standard care. Its clinical use may need to be reevaluated, especially in low- and middle-income countries, where cost-effectiveness is a crucial factor.