Cochrane in CORR ®: Ultrasound and Shockwave Therapy for Acute Fractures in Adults (Review)

Importance of the Topic Fractures cause considerable morbidity and often result in pain, loss of function, and decreased productivity [8]. Delayed union and nonunion complicate approximately 5% to 10% of fractures and often require further surgical or nonsurgical intervention [7]. A number of adjunct methods have been proposed to accelerate fracture healing, including low-intensity pulsed ultrasound (LIPUS). Ultrasound therapy delivers noninvasive soundwaves, which are believed to induce low-level micromechanical forces at the fracture site, stimulating the molecular and cellular responses in fracture healing [5, 13]. The first successful application of LIPUS for human nonunions was demonstrated in 1983 in a study that reported healing in 70% of 26 fractures [15]. In 1994 and 2000, the FDA approved ultrasound for accelerating the healing of acute fractures and existing nonunions [11]. This Cochrane Review systematically reviewed the best available evidence on LIPUS, high-intensity pulsed ultrasound, and extracorporeal shockwave therapy for acute fractures in adults. After evaluating 12 studies that enrolled a total of 622 patients with 648 fractures, no meaningful reductions with LIPUS in time to union of acute fractures, fractures with delayed unions, or nonunions were found when compared to controls. Upon Closer Inspection Heterogeneity in systematic reviews should be explored and explained. Exploration may reveal poor study design, inconsistent reporting, or reliability of outcome measures or “real” sources of variation related to patient or fracture characteristics, interventions, and outcome measures [6]. The authors reported considerable statistical heterogeneity (I2 = 90%) for the outcome of fracture healing with LIPUS, which was explored but not explained by two subgroup analyses a priori: Upper- versus lower-limb fractures and smoking status. An additional subgroup analysis comparing nonoperatively with surgically-treated fractures likewise found no benefit to LIPUS. Posthoc sensitivity analyses, in which outlier studies were excluded, also did not explain heterogeneity. The authors did not explore the assessment of fracture union, a potentially important source of heterogeneity in fracture studies. Although adjudication of outcomes has been shown to provide a more reliable and valid outcome assessment in fracture healing [12], only one of the included studies [10] used a blinded panel to adjudicate outcomes. Furthermore, the method and timing of assessing radiographic union varied widely, with no consistent measure of radiographic union used across studies. Standardized assessments of union, such as the Radiographic Union Scale for Tibial (RUST) fractures [14] or the Radiographic Union Score for Hip [4] have been shown to substantially improve agreement of fracture-healing assessment [1, 9]. Take-home Messages Despite the apparent lack of benefit, a survey of 450 Canadian trauma surgeons in 2008 [3] (response rate: 79%) showed that 45% of surgeons used either LIPUS or electrical stimulators as part of their treatment strategies for managing acute tibial fractures in adults, divided almost equally between electrical stimulators and ultrasound therapy. Most respondents (80%) considered a reduction in healing time due to a bone stimulator of 6 weeks to be clinically important. The current available evidence, however, does not support this practice. The Trial to Re-evaluate UltraSound in the treatment of Tibial (TRUST) fractures [2] is a concealed, blinded randomized trial engaging 25 trauma centers comparing LIPUS versus placebo for operatively treated tibial fractures using primarily patient-important functional outcomes (Physical Component Summary Score of the SF-36). Radiographic assessment of healing is assessed using the RUST score, which was found to exhibit improvements in reliability compared to previously published scores [14]. By addressing many of the methodological issues inherent in previous trials, particularly issues of clinical heterogeneity, small sample size, risk of bias, and limited assessment of patient-important outcomes, TRUST aims to definitively elucidate the role of ultrasound therapy in fracture healing.

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