An 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. The trial at sites in Canada and the United States involved 501 patients who had surgical repair of fractures of the tibia. It found that patients treated with “low-intensity pulsed ultrasound” healed at the same rate as those given a sham treatment. Their healing was assessed by x-rays and by how quickly they could bear full weight and return to normal activities.
The device, known as Exogen, is the leading brand in a roughly $300 million annual U.S. market for this type of ultrasound treatment. It was by far the largest randomized, controlled clinical study of the technology. And it raised questions about how rigorously the device was vetted before going on the market. Earlier trials showing some benefit were methodologically suspect, said Jason Busse, a researcher at McMaster University in Hamilton, Ontario. Some of those studies were co-authored by the inventor of the device.
Source: Charles Piller, STAT [10/25/16]
Brought to you by Dr. John A. Hardy, Toronto foot clinic, Academy Foot and Orthotic Clinics.