And it raised questions about how rigorously the device was vetted before going on the market. It was by far the largest randomized, controlled clinical study of the technology. (Their healing was assessed by X-rays and by how quickly they could bear full weight and return to normal activities.) It found that patients treated with “low-intensity pulsed ultrasound” healed at the same rate as those given a sham treatment. The trial at sites in Canada and the United States involved 501 patients who had surgical repair of fractures of the tibia - the larger of two leg bones between the knee and ankle. Exclusive analysis of biotech, pharma, and the life sciences Learn MoreĪn ultrasound device meant to speed healing of bone fractures is ineffective, according to a new clinical trial - though it has been on the market for 22 years and has rung up hundreds of millions of dollars in sales.
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