Abstract
BackgroundWe compared the healing response of tibial delayed unions between subjects treated with low-intensity pulsed ultrasound (LIPUS) (n = 51) and subjects treated with a sham device (n = 50). Fracture age was ≥ 4 months in all cases. Study personnel and participants were blinded to random treatment assignment throughout the study.MethodsThis multi-center randomized sham-controlled trial was undertaken at six hospitals in Germany. Adult patients who had sustained a tibial shaft fracture that subsequently showed inadequate progress toward healing (i.e., delayed union) were enrolled and randomized to receive either LIPUS (Exogen 2000/2000+, Smith & Nephew GmbH, Schenefeld, Germany) or an identical nonoperative sham device. The daily treatment duration was 20 minutes, for a period of 16 weeks. Subjects randomly assigned to active treatment had the ultrasound pressure wave signal set at the following parameters: 1.5 MHz frequency, 1 kHz repetition rate, 200 μs pulse duration, 30 mW/cm2 spatial intensity. Progress toward healing was estimated from changes in bone mineral density (BMD) and gap area as determined from computed tomography scans. Intention-to-treat analysis was conducted using a multiple imputation methodology.ResultsBased on log-transformed data, mean improvement in BMD was 1.34 (90% confidence interval (CI) 1.14 to 1.57) times greater for LIPUS-treated subjects compared to sham (p = 0.002). A mean reduction in bone gap area also favored LIPUS treatment (p = 0.014).ConclusionsThese findings demonstrate significantly greater progress toward bone healing after LIPUS treatment compared to no LIPUS treatment in subjects with established delayed unions of the tibia.
Highlights
We compared the healing response of tibial delayed unions between subjects treated with lowintensity pulsed ultrasound (LIPUS) (n = 51) and subjects treated with a sham device (n = 50)
We found that bone mineral density (BMD) could be validly analyzed with or without log transformation, but that valid inference required log transformation for gap area
There was a larger percentage of LIPUS-treated subjects with time since fracture ≥ 48 weeks (41% vs. 24%) and a smaller percentage with < 24 weeks (14% vs. 30%), this comparison did not achieve statistical significance (p = 0.08)
Summary
Low-intensity pulsed ultrasound (LIPUS) is a safe, noninvasive treatment option that has been proven to enhance the healing of fresh closed tibial fractures in a Level-I randomized sham-controlled trial [1]. These results have been corroborated in studies of complex open fractures, prone to delayed union or nonunion [2,3]. Using quantitative histomorphometric analysis of biopsy samples from fibular delayed unions, Rutten et al [7] reported that use of LIPUS accelerates fracture healing by directly increasing bone formation through increased osteoblastic activity These authors showed a demonstrable increase, compared to shamtreated control patients, in osteoid thickness, mineral apposition rate and bone volume at the leading edge of new bony callus formation. Due to ethical considerations and difficulty in recruiting subjects, randomized sham-controlled trials in this setting to definitively demonstrate the value of LIPUS have been absent [6]
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