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 have managed 21 patients with a fracture of the tibia complicated by bone and soft-tissue loss as a result of an open fracture in 10, or following debridement of an infected nonunion in 11, by resection of all the devitalised tissues, acute limb shortening to close the defect, application of an external fixator and metaphyseal osteotomy for re-lengthening. The mean bone loss was 4.7 cm (3 to 11). The mean age of the patients was 28.8 years (12 to 54) and the mean follow-up was 34.8 months (24 to 75). All the fractures united with a well-aligned limb. The mean duration of treatment for the ten grade-III A+B open fractures (according to the Gustilo-Anderson classification) was 5.7 months (4.5 to 8) and for the nonunions, 7.6 months (5.5 to 12.5). Complications included one refracture, one transient palsy of the peroneal nerve and one equinus contracture of 10°.
