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 — the larger of two leg bones between the knee and ankle. 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.)
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 coauthored by the inventor of the device.
“The device industry perhaps needs to be held to a higher standard before approval is given by regulatory bodies for marketing,” said Busse, a coauthor of the study, published Tuesday in the BMJ.
The study was launched in 2008 with funding from Smith & Nephew, which made the leading hand-held device for delivering low-intensity pulsed ultrasound. Smith & Nephew later spun off that division into a separate company, Bioventus.
In 2012, the year the last patients were enrolled, Bioventus conducted an unplanned early review of the data. Upon learning that the treatment had no apparent benefits, the company yanked funding for the trial, Busse said.
“They didn’t see an obvious reason to continue to support a study that would not be supportive of their product,” Busse said. Bioventus said the funding was pulled to prevent inconvenience to patients and to reduce their exposure to X-rays.
Researchers continued to follow up with patients and analyze the data. Then, in 2015, Bioventus retroactively inserted a new condition into the study protocol, according to ClinicalTrials.gov, the National Institutes of Health database of trial information. 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.
As it turned out, just 43 percent of patients met that standard.
Dr. Peter Heeckt, chief medical officer of Bioventus, said that “dismal compliance” rate invalidated the study. He said internal company data and findings from an unpublished study show good results when patients use the device regularly. 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. (One-third of the participants were active smokers and 6 percent had diabetes.)
Busse, however, rejected the criticism. He said the trial was meant to mimic the real-world patient experience for compliance. 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. Yet they didn’t heal faster than those who got a sham treatment.
“We would have expected to see something — some sort of evidence of a benefit,” Busse said. “Yet we saw nothing.”
He said other, smaller studies with better compliance results also found no benefits from the ultrasound.
In an accompanying editorial in the BMJ, Dr. X.L. Griffin of the University of Oxford called for doctors to “abandon this ineffective treatment” for surgically treated tibia fractures.
The device, known as Exogen, is the leading brand in a roughly $300 million annual US market for this type of ultrasound treatment.
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I’ve used the device and it appeared to accelerate healing. I was very compliant in the recommended daily treatment of 20 minutes.
I am currently using this treatment for distal fractures of the tibia that does not seem to heal. I had a bone graft done 6 months ago on the femur and tibia. The tibia seems to be stubborn in its healing. So now we are trying this. My first question was why didn’t we try this first? Non invasive and easy to administer. It now has a money back guarantee so I’m encouraged by that. My problem is trying to stay off the leg and losing 50 lbs. What did the test patients do to enhance healing? I am encouraged. I didn’t want another surgery that might not work.
“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.” However, the non replaceable, non reachargable lithium battery only works for 150 times as per the product documents. Also, the company does not stand behind its product. Try calling to get a unit fixed, the company is too busy going to the bank to deposit its profits. Insurance companies will not pay for any reimbursement. That tells you something right there, that the product is faulty.
I wish I had read this article before my doctor had me do this treatment. After $500 and 3 months of time wasted, my broken foot felt worse than before. I went to a different doctor to get a second opinion and he said that the ultrasound treatment was a sham. Given my experience, I agree with him. I’m very disappointed that my initial doctor would prescribe this in the first place. Hopefully other people do their research and find your article. I mistakenly trusted my doctor blindly.
There are other brands of bone growth stimulators on the market that do not use Ultrasound as their method to encourage bone growth. I would highly suggest researching capacity coupling and PEMF technology.
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.
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.
I came to the conclusion myself early on in my experience that it did not seem to help in tibial fractures treated surgically (usually with an IM nail) and do not use it in that setting currently, but it can be used in other settings – wrist or distal tibial fractures are two where it has worked well for my patients.
Don’t throw the baby out with the bathwater!
FYI, I have no financial interest in Smith Nephew, Bioventus or any connection to this device and I have worked with Jason Busse on research studies in Hamilton, Ontario where I used to practice at the level 1 trauma centre (Hamilton General Hospital). I find I use it (Exogen) much less now at the community hospital where I currently work, than when I was seeing more complex and challenging fractures at the tertiary referral trauma centre.
I usually research things before I buy. I am using the exogen by bioventus for a meditarsal fusion which is generally non bearing for 10-12 weeks. I have been using it religiously for for 10 weeks hoping to heal faster and get back to walking again. I use this twice a day at 20 minutes each interval. I am very discouraged to hear these discussions. I hope this is not a scam that lots of people are making money off of.
I have had a shattered clavicle in my left arm for 18 years now that has refused to heal. The original doctor put in a plate, 4 screws and 4 cables to tie it all together and it just never grew at all, but there was a space between the bones. Eventually, the plate and screws came out and the plate started bulging out my arm and I had to have it removed and a new hardware put in just last month. The surgeon had to remove some bone on each end that was dead and actually shaved one down enough to shove it into the other and added 2 plates with 6 screws in each. My arm is 3 inches shorter but semi stabilized for now. He said if this doesn’t work I might lose my arm and he recommended that I use this ultrasound system and showed me where exactly to apply it. I had to have 2 surgeries, one to remove the other hardware and put in a temporary plate until the infection was taken care of, and then the other hardware put in 3 weeks later. My arm was sore for so long but the swelling has now gone and I’ve been using this device for 2 weeks. I’m hoping it works, but with all that metal in there I’m kind of wondering that will be used for an excuse of why it didn’t work. If it doesn’t work I may lose my arm because those plates won’t stay forever. He said my bone is very brittle and the screws weren’t in as tight as they would be in good.healthy bone.
He notified this company himself and they called and talked to me and tell me that it had a 90% success rate on stubborn bone growth such as my doctor described do them. He told me it was $500 but when I told him I didn’t have that at one time they said I could pay it out over the next 2 years. I haven’t paid anything on it yet, I just now received my first bill. Not really sure what to do now, but I really don’t want to lose my arm.
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