OrthoBuzz occasionally receives posts from guest bloggers. This guest post comes from E. Scott Paxton, MD, in response to a recent “Rapid Recommendation” in The BMJ.
An international panel convened by The BMJ recently issued a “Rapid Recommendation” that strongly recommends against using low-intensity pulsed ultrasound (LIPUS) in patients with fracture or osteotomy because the treatment doesn’t improve functional recovery or pain.1
The systematic review on which the recommendation was based reviewed 26 trials of nearly 1600 patients with fracture or osteotomy who were randomized to either LIPUS or sham/no device.2 The authors concluded with moderate to high levels of certainty that the treatment had little effect on the time patients could return to work, time to full weight-bearing activity, pain levels, future operations, or time to radiographic healing.
In 2009, Busse et al. performed a similar meta-analysis, concluding that “evidence for the effect of low intensity pulsed ultrasonography on healing of fractures is moderate to very low in quality and provides conflicting results.”3 This analysis only included 13 trials, however. Then, in 2016, Busse et al. published results from the TRUST study,4 a blinded, randomized controlled trial of 501 patients from 43 North American academic trauma centers who had a fresh tibial shaft fracture treated with intramedullary nailing. The authors based their sample size calculations on the minimal clinically important difference on the SF-36 PCS, as this was a co-primary outcome. The authors found no improvement in radiographic healing time or functional recovery with the use of LIPUS. However, the authors noted that only 1 nonunion occurred among 195 sham-treated patients, demonstrating that this group was at extremely low risk for nonunion at baseline.
Including the TRUST trial in the 2017 meta-analysis of LIPUS led Schandelmaier et al. to the aforementioned conclusions and informed the strong BMJ Rapid Recommendation against the use of LIPUS for patients with any bone fracture or osteotomy. However, this recommendation was based in large part on the TRUST trial, which was unable to directly assess the effectiveness of LIPUS on reducing nonunion rates because of the almost universal healing of the fractures studied.
The BMJ Rapid Recommendation states “there was high quality evidence showing a lack of benefit in accelerating healing for fresh fractures; thus it is unlikely that LIPUS would improve outcomes in patients with non-union.” However, the effect of LIPUS on preventing nonunions in fractures known to have high nonunion rates or on treating established nonunions will require further high-quality studies looking at those patients specifically.
Scott Paxton, MD is an assistant professor in the Department of Orthopaedic Surgery at the Warren Alpert Medical School at Brown University and a fellowship-trained shoulder and elbow surgeon at University Orthopedics in Providence, Rhode Island.
- Poolman RW, Agoritsas T, Siemieniuk RAC, et al. Low intensity pulsed ultrasound (LIPUS) for bone healing: a clinical practice guideline. BMJ. February 2017:j576-j576. doi:10.1136/bmj.j576.
- Schandelmaier S, Kaushal A, Lytvyn L, et al. Low intensity pulsed ultrasound for bone healing: systematic review of randomized controlled trials. BMJ. 2017;356:j656. doi:10.1136/bmj.j656.
- Busse JW, Kaur J, Mollon B, et al. Low intensity pulsed ultrasonography for fractures: systematic review of randomised controlled trials. BMJ. 2009;338:b351. doi:10.1136/bmj.b351.
- TRUST Investigators writing group, Busse JW, Bhandari M, et al. Re-evaluation of low intensity pulsed ultrasound in treatment of tibial fractures (TRUST): randomized clinical trial. BMJ. 2016;355:i5351. doi:10.1136/bmj.i5351.
BMJ recently published two studies of interest to orthopaedists:
- After analyzing data from more than 200 cardiovascular, orthopaedic, and neurologic devices approved in both the US and European Union (EU), Hwang et al. found that those approved in the EU first were nearly three times as likely to trigger a safety alert or experience a recall than those first approved in the US. Finding further that trial results were published for fewer than half of approved devices considered “major innovations,” the authors call for “greater regulatory transparency” so physicians and patients can make better-informed decisions. Interestingly, Figure 2 in this study showed that the FDA approval time for orthopaedic devices was faster than ortho-device approval times in the EU. However, a JBJS study earlier this year found that devices approved via the FDA’s “quick” 510(k) process were 11.5 times more likely to be recalled than those cleared through the longer and more stringent FDA pathway.
- In the second BMJ article, a registry-based case-control study, Abrahamsen et al. found that the long-term use of the bisphosphonate alendronate does not increase the risk for atypical femoral fractures (either subtrochanteric or femoral shaft), while protecting against hip fractures. After applying some sophisticated statistical analyses, the authors estimated that 38 patients with ≥5 years of alendronate adherence would need to be treated for an additional 5 years to prevent one hip fracture, while 1449 similar patients would need to be treated to cause an atypical femoral fracture. Click here for more OrthoBuzz coverage of the relationship between bisphosphonates and atypical femoral fractures.