Low-intensity pulsed ultrasound as a useful adjuvant during distraction osteogenesis: a prospective, randomized controlled trial.

Background: Low-intensity pulsed ultrasound (LIPUS) was proven to have a positive impact on bone healing in animal and clinical studies.

Methods: In this prospective, randomized controlled trial the effect of LIPUS during distraction osteogenesis was investigated. Thirty-six patients who underwent distraction osteogenesis (>2 cm) were enrolled. Sixteen patients in the treatment group received LIPUS, and 20 patients as control group did not. Ultrasound treatment device was transcutaneously applied at the distraction gap for 20 minutes daily (frequency 1.5 MHz, signal burst with 200 μs, signal repetition frequency 1.0 kHz, intensity 30 mW/cm(2)). Evaluation of patients was performed by standard radiographs every 3 weeks to 4 weeks.

Results: Average transport distance was 7.0 cm in the ultrasound group and 6.3 cm in the control group. Mean Paley index for the ultrasound group was 1.09 mo/cm and 1.49 mo/cm for the control group. Mean distraction consolidation index for the ultrasound group was 32.8 d/cm and 44.6 d/cm for the control group. The calculated indices indicated no significant statistical difference between the two groups (p < 0.116) but the fixator gestation period could be decreased for 43.6 days in the treatment group.

Conclusions: Therapeutic application of LIPUS during callus distraction constitutes a useful adjuvant treatment during distraction osteogenesis and has a positive effect on healing time with no negative effects.