The aim of this double-blind prospective randomised controlled
trial was to assess whether low intensity pulsed ultrasound (LIPUS)
accelerated or enhanced the rate of bone healing in adult patients
undergoing distraction osteogenesis. A total of 62 adult patients undergoing limb lengthening or bone
transport by distraction osteogenesis were randomised to treatment
with 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 Ilizarov frame was used in all
patients. The rate of distraction was also standardised. The primary
outcome measure was the time to removal of the frame after adjusting
for the length of distraction in days/cm for both the per protocol
(PP) and the intention-to-treat (ITT) groups. The assessor was blinded
to the form of treatment. A secondary outcome was to identify covariates affecting
the time to removal of the frame.Aims
Patients and Methods
