October 21, 2010
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Low-intensity pulsed ultrasound aids tibial fracture healing vs. sham in recent study

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A team of German investigators found 34% greater bone mineral density in patients with slow-healing tibial fractures after 16 weeks of treatment with a low-intensity pulsed ultrasound device compared to those who received a sham treatment, according to results of a recent study.

“These findings demonstrate significantly greater progress toward bone healing after low-intensity pulsed ultrasound treatment compared to no low-intensity pulsed ultrasound in subjects with established delayed unions of the tibia,” investigator Jon E. Block, PhD, stated in a press release from BioMed Central.

Level 1 study

Block and investigators from Germany’s University Hospital Marburg and the University of Ulm tested the ultrasound technology in a multicenter, randomized controlled study that appeared in the journal BioMed Central Musculoskeletal Disorders.

The 51 patients randomized to the treatment arm of the study placed a small handheld ultrasound-emitting device over the site of their tibial shaft fractures for 20 minutes daily for 16 weeks. The 50 patients in the control group did the same practice for the same duration, but used a nonfunctional device. Everyone involved in the study was blinded to the randomization.

The patients in both groups had fractures that were at least 4 months old.

The operational low-intensity pulsed ultrasound units worked at 1.5 MHz frequency with a 1 kHz repetition rate, 200 ultrasound pulse duration and 30 mW/cm2 spatial intensity, according to the study abstract.

Results

“Progress toward healing was estimated from changes in bone mineral density (BMD) and gap area as determined from computed tomography scans,” Block and colleagues wrote in their abstract. They found 1.34 times greater BMD in the treatment group compared to the control group.

Measurements of the reduction in the size of the fracture gaps also favored the active treatment group, Block and colleagues noted.

“This is the first study to offer level-1 evidence of this effect in a single fracture type,” Block stated in the release.

He is a consultant to Smith & Nephew, manufacturer of the device studied, which supported the research.

Reference:

Schofer MD, Block JE, Aigner J, et al. Improved healing response in delayed unions of the tibia with low-intensity pulsed ultrasound: results of a randomized sham-controlled trial. BMC Musculoskelet Disord.2010;11(1):229. doi:10.1186/1471-2474-11-229.

Perspective

Low-intensity pulsed ultrasound has been reported to accelerate the cortical and cancellous bone repair process in fractures and nonunions. We perform ultrasonographic augmentation by treatment of complex fractures suffered from severe high-energy injuries to limbs (high-velocity gun-shot blast injuries, road and work accidents). All patients had extensive soft tissue damage. Adjunct ultrasonographic stimulation was initiated after a median delay in osteogenesis of 6 months (range 4–18 months). No local or systemic side effects ensued, even in cases of multiple metal foreign bodies (bullets, shells) at the facture zone. Results of our study indicate that pulsed low-intensity ultrasound is an effective supplementary treatment method when delayed union of complex, high-energy compound fractures develops and is an adjunct for limb salvage.

— Alexander Lerner, MD, PhD
Department of Orthopedic Surgery, Rambam Medical Center
Haifa, Israel

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