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
We conducted a multicentre two arm double blind randomised controlled trial to assess efficacy of pulsed ultrasound for accelerating the rate of bone healing. Sixty-two skeletally mature adults undergoing limb lengthening, of between 2.5cm to 10cm by distraction osteogenesis, at the proximal tibia using an Ilizarov frame were randomised to either an active or a placebo (control) ultrasound device. 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) patients. The time at which the frame was removed was determined by the maturation of the regenerate bone. Secondary outcomes were return to weight bearing and covariates affecting time to frame removal. The baseline characteristics of the two groups were well balanced, and 90% of patients were managed and followed up as PP. There was no difference in the time to frame removal between the two groups for the ITT (5.0days/cm, p=0.23) or the PP (10.1days/cm, p=0.054). There was no difference in return to weight bearing between the two groups, after adjusting for distraction length, for the ITT or PP patients (p>0.5). Smoking was the only covariate identified to increase the frame removal time (hazard ratio 0.46, 95% confidence interval 0.22 to 0.96; p=0.04). This trial demonstrated no difference in bone healing between those who underwent pulsed ultrasound and those who did not. Smoking was observed to have a significant inhibitory effect on bone healing.
To assess efficacy of pulsed ultrasound for accelerating regenerate consolidation. A multicentre two arm patient and assessor double blind RCTObjective:
Design:
