A large international clinical trial conducted by McMaster University uncovered that a technology that generates about $250 million per year is not effective. Low-intensity pulsed ultrasound (LIPUS) is commonly used to improve recovery after bone fracture surgery, but that may change.

The randomized, controlled trial involved 501 patients at 43 academic trauma centers in North America who underwent surgery to repair a fractured tibia from 2008 to 2012. Each patient was assigned 20-minute daily treatment with either LIPUS or a placebo device that looked the same.

The physicians, data collectors, data analysts and patients were not aware of which treatment was used. The patients were then tracked for 12 months or until X-ray images showed that their fracture was healed.

The researchers found that there was no difference in recovery time whether the patients were treated with the LIPUS or placebo device. In addition, there was no difference in quality of life, time until they returned to work, leisure activities and weight-bearing.

LIPUS was approved by the FDA in 1994 for fracture healing. The approval was based upon small trials that had limitations and focused on radiographic healing instead of patient outcomes, according to one of the researchers.

In an accompanying article published in The BMJ, Xavier Griffin, associate professor of trauma surgery at the University of Oxford, wrote that “it is time to abandon this ineffective treatment,” because there is strong evidence that it doesn’t work.

The trial was funded by the Canadian Institutes of Health Research and Smith & Nephew, a British-based multinational medical equipment manufacturing company.

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