Bone stimulator for foot5/15/2023 ![]() I have used this device as an orthopedic surgeon multiple times and there are very specific instances where it can (and has) worked very well in promoting healing and avoiding the need for further surgical procedures. It is important for your readers to understand that because it doesn’t work in this specific instance (surgically treated tibial fractures), does not mean that the device doesn’t work period. Yet they didn’t heal faster than those who got a sham treatment. And he pointed out that a sizable portion of the patients in the trial did, indeed, use the device as often as the company recommends. He said the trial was meant to mimic the real-world patient experience for compliance. (One-third of the participants were active smokers and 6 percent had diabetes.)īusse, however, rejected the criticism. Heeckt also criticized the patient population used by the researchers as relatively healthy - with few participants who had risk factors for slow bone healing, such as obesity, diabetes, and a history of smoking. He said internal company data and findings from an unpublished study show good results when patients use the device regularly. Peter Heeckt, chief medical officer of Bioventus, said that “dismal compliance” rate invalidated the study. The company said that for an adequate test, patients had to use the treatment at least 18 minutes a day, and they had to do that at least four out of every five days for a full year.Īs it turned out, just 43 percent of patients met that standard.ĭr. Then, in 2015, Bioventus retroactively inserted a new condition into the study protocol, according to, the National Institutes of Health database of trial information. Researchers continued to follow up with patients and analyze the data. The Exogen device was found to be no more effective at healing fractures than a sham treatment. Bioventus said the funding was pulled to prevent inconvenience to patients and to reduce their exposure to X-rays. ![]() “They didn’t see an obvious reason to continue to support a study that would not be supportive of their product,” Busse said. ![]() Upon learning that the treatment had no apparent benefits, the company yanked funding for the trial, Busse said. In 2012, the year the last patients were enrolled, Bioventus conducted an unplanned early review of the data. ĥ makeshift - and ingenious - ways to improve medical devices Some of those studies were coauthored by the inventor of the device. Earlier trials showing some benefit were methodologically suspect, said Jason Busse, a researcher at McMaster University in Hamilton, Ontario. 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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