Ultrasound therapy following surgery to repair a fractured tibia is not beneficial, according to an analysis published today.
Dr Jason Busse, of McMaster University, Ontario, Canada, and colleagues explain that tibial fractures are a prime target for interventions to aid recovery, including electromagnetic stimulation, drug treatments such as bone morphogenetic proteins, and low intensity pulsed ultrasound. Low intensity pulsed ultrasound (LIPUS) was approved for fracture healing by the US Food and Drug Administration in 1994.
Its effectiveness remains uncertain because previous trials have been limited by focusing on radiographic fracture healing, which is "a surrogate for functional recovery", they write in the BMJ today (26 October).
The researchers compared the impact of LIPUS versus sham treatment on functional recovery and radiographic healing after operations on straightforward tibial fractures, in 501 male and female patients at 43 North American academic trauma centres.
At random, patients were asked to self-administer daily LIPUS or use a sham device until their tibial fracture showed radiographic healing or until for a year, whichever was soonest. Results showed no significant differences in time to radiographic healing, or on a self-reported survey of physical health between the two groups. There were also no differences in safety outcomes.
The authors conclude: "Postoperative use of LIPUS after tibial fracture fixation does not accelerate radiographic healing and fails to improve functional recovery."
Researcher Professor Mohit Bhandari said: "LIPUS was approved for fracture healing on the basis of small trials that had important limitations, and they focussed on radiographic healing instead of patient important outcomes," said Bhandari, who also holds the Canada Research Chair in Evidence-Based Orthopaedic Surgery.
"The new trial results establish that LIPUS has no role in managing patients with surgically repaired fractures."
A linked editorial by Dr Xavier Griffin of Oxford University, UK, recommends that this "ineffective treatment" should now be abandoned. Dr Griffin also highlights difficulties faced by the researchers behind the scenes of this trial cause by interference from The US Food and Drug Administration and the industry sponsor.
"Fortunately for patients, clinicians, and future clinical guideline groups the results were eventually clear, despite the influence of outside agencies," he states.
Busse, J. W. et al. Re-evaluation of low intensity pulsed ultrasound nography in treatment of tibial fractures (TRUST): randomized clinical trial. BMJ 26 October 2016; doi: 10.1136/bmj.i5351 [abstract]
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