Low-intensity pulsed ultrasound does not influence bone healing by distraction osteogenesis: a multicentre double blind randomised control trial

Aim:
To assess efficacy of low intensity pulsed ultrasound (LIPUS) to accelerate or enhance the rate of bone healing in adult patients.

Patients and Methods:
Sixty-two skeletally mature adults undergoing limb lengthening or bone transport by distraction osteogenesis were randomised to either an active (n=32) or a placebo (n=30) ultrasound device. A standardised corticotomy was performed in the proximal tibial metaphysis and a circular frame (Ilizarov) was used in all patients. The rate of distraction was also standardised. Primary outcome measure was time ready for removal of frame after adjusting for distraction length (days/cm) for both intension to treat (ITT) and per protocol (PP). The assessor was blind to treatment group. Secondary outcome was to identify covariates affecting time to frame removal.

Results:
There was no difference in the time to frame removal between the two groups for the ITT (difference 5.0days/cm, 95% CI −8.2 to 18.21; p=0.226) or the PP (difference in favour of the control group was 10.1days/cm, 95% CI −3.2 to 23.4; p=0.054). Current smoking status was the only covariate identified to increase the frame removal time (hazard ratio 0.47, 95% CI 0.22 to 0.97; p=0.042).

Conclusions:
LIPUS does not influence the rate of bone healing.