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71 Executive Briefing Each type of bone stimulation is backed by different levels of ev- idence in the literature. A 2009 study that examined 13 random- ized trials evaluating low intensity pulsed ultrasound, published in The BMJ, 1 found that the evidence for the effect of low-intensi- ty pulsed ultrasonography on bone fracture healing "is moderate to very low in quality and provides conflicting results." Dr. Bhandari and his colleagues conducted the largest random- ized trial of low intensity pulsed ultrasound (called TRUST) that enrolled 501 patients, some of which were smokers. 2 The study aimed to evaluate the use of low-intensity ultrasound in the treatment of tibial fractures. Enrolled patients had an average age of 38 years with a mix of closed and open fractures. The study found that there was no difference in patient function or time to radiographic healing at final follow up (SF36). Howev- er, compliance challenges did exist with the ultrasound devices that may have contributed to this lack of difference, although the investigators did not believe this was a major contributor. Meta-analysis shows positive results In 2015, Dr. Bhandari and his colleagues conducted a study 3 of randomized sham-controlled trials testing the efficacy of electrical stimulators for bone healing in patients with fracture nonunions and spinal fusions. The meta-analysis examined pa- tient-important outcomes, such as pain and function as well as bone healing. The researchers compared active treatment with an electrical stimulator to a control. "When we look at the hierarchy of evidence, we find that ran- domized clinical trials top that hierarchy," says Dr. Bhandari. "So we focused only on randomized clinical trials, which we found to be the most valid and least biased of the approaches in healthcare research that we could use." Dr. Bhandari and his colleagues included 15 randomized clin- ical trials and 1,247 patients. The researchers found electrical stimulation was associated with a 35 percent risk reduction in the development of nonunions. "For every seven patients treated with an electrical stimulator, one non-union, or persistent non-union, can be prevented," says Dr. Bhandari. "That is an NNT (number needed to treat) of seven which is extremely, extremely small. This means that the benefit associated with an electrical stimulator is pretty high." The researchers were also able to identify a significant pain reduction, which was "most novel in the area of bone stimula- tion," says Dr. Bhandari. Pain management is a measure that is particularly important be- cause pain is a measure of healing, overall function and patient satisfaction. The study also showed radiographic benefit with electrical stimulation, which suggests a biological effect, and correlated that clinically with a patient-reported benefit — pain. "Even if you look outside of fracture care, if you look at knee os- teoarthritis, for example, overall patient satisfaction is correlat- ed with pain," says Dr. Bhandari. "Pain is limiting." Further research needed Further evidence is required to differentiate between the spe- cific types of bone stimulation. There isn't enough evidence to point to one type over another, as each one is different with respect to application and potential benefits. There have been some small network meta-analyses that have focused on an in- direct comparison between the types of bone stimulation, says Dr. Bhandari. For example, one small meta-analysis 4 compared electrical bone stimulation to a placebo and then compared low-inten- sity pulsed ultrasound to a placebo to treat fractures. Through indirect mathematical assessment, the researchers determined electrical bone stimulation compared more favorably to low-in- tensity pulsed ultrasound in the management of nonunions. "But this data was based on a small study set and is hypothe- sis-generating," says Dr. Bhandari. "It is not definitive." Going forward, orthopedic industry stakeholders will need to spend more time trying to understand what types of bone stim- ulators cause differentiating factors. Clinicians and researchers also need to understand how bone stimulators fit in the context of other bone healing technologies to provide the best care in a cost-effective manner. "When we talk of the use of high-quality evidence, we look at randomized clinical trials. When we don't have single large clinical trials, we look to meta-analysis," he adds. "Until a large clinical trial is conducted, looking at more than 1,000 patients, these types of meta-analyses that combine smaller randomized trials are important. These types of studies can impact clinical care guidelines as well as policy." n 1 Jason W. Busse, Jagdeep Kaur, Brent Mollon, Mohit Bhandari, Paul Tornetta, Holger J Schünemann, Gordon H Guyatt (2009). Low intensity pulsed ultrasonography for fractures: systematic review of randomised controlled trials, BMJ 2009;338:b351 http://www.bmj.com/content/338/bmj.b351 2 Jason W. Busse, Mohit Bhandari, Thomas A. Einhorn, James D. heck- man, Kwok-Sui-Leung, Emil Schemitsch, Paul Tornetta III, Stephen D. Walter, Gordon H. Guyatt (2014). Trial to re-evaluate ultrasound in the treatment of tibial fractures (TRUST): a multicenter randomized pilot study, Busse et al. Trials 2014, 15:206 http://www.trialsjournal.com/content/15/1/206 3 Ilyas Aleem, MD, Idris Aleem, MSc, Nathan Evaniew, MD, Michael J. Yaszemski, MD, PhD, Thomas A. Einhorn, MD, Mohit Bhandari, MD, FRCSC, PhD. Efficacy of Electrical Stimulators for Bone Healing: A Me- ta-Analysis of Sham-Controlled Randomized Trials, Presented at AAOS, 2016 4 Shanil Ebrahim, MSc, PhD,Brent Mollon, MD,Sheena Bance, MSc, MA, Jason W. Busse, DC, PhD, and Mohit Bhandari, MD, PhD*,** Low-inten- sity pulsed ultrasonography versus electrical stimulation for fracture healing: a systematic review and network meta-analysis, Can J Surg. 2014 Jun; 57(3): E105–E118. DJO Global is a leading global provider of medical technologies designed to get and keep people moving. The Company's products address the continuum of patient care from injury prevention to rehabilitation after surgery, injury or from degenerative disease, enabling people to regain or maintain their natural motion. For additional information on the Company, please visit DJOglobal.com or djoglobal.com/cmf to learn more about our bone growth stimulators.