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 overall (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 lowintensity ultrasound stimulation in the acceleration of the normal fracture-repair process. Ultrasound has many medical applications, including therapeutic, operative, and diagnostic procedures '. Both ultrasound therapy and operative ultrasound subject tissue to power levels that are capable of causing ACCELERATION OF TIBIAL FRACTURE-HEALING BY NON-INVASIVE. LOW-INTENSITY PULSED ULTRASOUND 27 VOL. 76.A, NO.
Positive-outcome bias was present during peer review. A fabricated manuscript with a positive outcome was more likely to be recommended for publication than was an otherwise identical no-difference manuscript.
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