Sixty-seven closed or grade-I open fractures of the tibial shaft were
examined in a prospective, randomized, double-blind evaluation of use of a
new ultrasound stimulating device as an adjunct to conventional treatment
with a cast. Thirty-three fractures were treated with the active device and
thirty-four, with a placebo control device. At the end of the treatment,
there was a statistically significant decrease in the time to clinical
healing (86 +/- 5.8 days in the active-treatment group compared with 114
+/- 10.4 days in the control group) (p = 0.01) and also a significant
decrease in the time to over-all (clinical and radiographic) healing (96
+/- 4.9 days in the active-treatment group compared with 154 +/- 13.7 days
in the control group) (p = 0.0001). The patients' compliance with the use
of the device was excellent, and there were no serious complications
related to its use. This study confirms earlier animal and clinical studies
that demonstrated the efficacy of low-intensity ultrasound stimulation in
the acceleration of the normal fracture-repair process.