Study: Low-Intensity Ultrasonography Does Not Aid Fracture Healing
A new study from McMaster University researchers finds that although low-intensity ultrasonography (LIPUS) is commonly used to improve postsurgical bone fracture repair, it is not effective at doing so.
In an effort to determine whether LIPUS, when compared with sham treatment, accelerates functional recovery and radiographic healing in patients with operatively managed tibia fractures, the investigators conducted a concealed, randomized, blinded, sham-controlled clinical trial with a parallel group design of 501 patients who underwent surgical repair for a tibia fracture between 2008 and 2012 at 43 North American academic trauma centers. The researchers followed participants’ cases for 1 year.
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Individuals taking part in the study were skeletally mature men or women with an open or closed tibia fracture amenable to intramedullary nail fixation. Participants were assigned to self-administer a 20-minute daily treatment with either LIPUS or a placebo device until their tibia fracture showed radiographic healing or until 1 year after intramedullary fixation.
Overall, the results showed no difference between groups in time to functional recovery whether patients were treated with the active or placebo device. In addition, the authors saw no variance between groups in time to return to work, return to household and leisure activities, return to 80% or greater function before injury, time to full weight bearing, scores on the health utilities index, and adverse events related to the device.
Primary care practitioners tending to patients who have undergone surgical repair of a tibia fracture "should advise them that, despite marketing information to the contrary, low-intensity pulsed ultrasound will not accelerate recovery from their injury," said Jason Busse, BSc, an associate professor in the Department of Anesthesia at McMaster University in Hamilton, Ontario, Canada, and the study's principal investigator.
The goals of surgical repair for broken bones include limb realignment, timely healing of the bone ends, and a resultant return to prefracture function, added Mohit Bhandari, MD, MSc, PhD, FRCSC, a professor in the Department of Surgery at McMaster University, and co-principal investigator of the study.
Once a fracture has been surgically repaired, "the majority are likely to heal uneventfully with a return of function thereafter," Dr Bhandari said.
“[Primary care physicians] should be looking for signs and symptoms suggestive of delayed healing or nonunion, both of which represent potentially important complications and may necessitate further surgery and treatment," Dr Bhandari said, noting that the TRUST trial demonstrated that adjunctive use of a portable LIPUS device did not accelerate healing, nor did it prevent nonunions compared with a placebo device in patients treated surgically for a tibia shaft fracture.
"Given the trial results, the use of this technology is not a prudent use of limited health care resources for surgically treated fractures." Dr Bhandari said.
Busse JW, Bhandari M, Einhorn TA, et al; TRUST Investigators Writing Group. Re-evaluation of low intensity pulsed ultrasound in treatment of tibial fractures (TRUST): randomized clinical trial [published online October 25, 2016]. BMJ. doi:http://dx.doi.org/10.1136/bmj.i5351.