TRUST

Re-evaluation of low intensity pulsed ultrasound in treatment of tibial fractures (TRUST): randomized clinical trial

Busse JW, Bhandari M, Einhorn TA, et al. BMJ (Clinical research ed.) 2016 · PMID 27797787 · doi:10.1136/bmj.i5351

Question

Does low-intensity pulsed ultrasound (LIPUS) accelerate functional recovery and radiographic healing after intramedullary nailing of tibial shaft fractures?

Design

Multicentre, concealed, sham-controlled, blinded RCT in North American academic trauma centres.

Patients

Adults with tibial shaft fractures treated with intramedullary nailing.

Intervention

Daily self-administered LIPUS

Comparison

Identical sham device

Primary outcome

Time to radiographic healing within 1 year, with SF-36 physical component score as a key functional outcome

Key result

LIPUS did not improve functional recovery or speed radiographic healing compared with sham; the trial was stopped early for futility.

Limitations

Limited to nailed tibial shaft fractures; adherence to daily device use was imperfect.

Impact on practice

Strong evidence against routine LIPUS for fresh tibial fractures; prompted a BMJ Rapid Recommendation against its use, and NHS use is limited to selected delayed or nonunions.