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The efficacy of electrical bone stimulators & ultrasound for bone healing — Dr. Mohit Bhandari weighs in with new evidence Featured

Written by  Megan Wood | Tuesday, 21 June 2016 00:00
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In a DJO Global-sponsored webinar, Mohit Bhandari, MD, MSc, PhD, FRSC, discussed new evidence surrounding electrical stimulators' efficacy for bone healing. Dr. Bhandari serves as a professor in the department of surgery at McMaster University in Hamilton, Canada, where he is also the academic division head of orthopedic surgery.

For 15 years, Dr. Bhandari has focused on evidence-based decisions, clinical trials and meta-analysis as well as evidence-driven strategy.

 

To enhance orthopedic patient care, Dr. Bhandari believes orthopedic surgeons need to focus on decision making.

 

"What separates a good surgeon from a great surgeon is the ability and sound clinical judgment that is absolutely essential to ensure the highest standards of patient safety and care," he said.

 

Why evidence-based medicine matters
Evidence-based practice trumps eminence-based practice if the evidence is high quality, said Dr. Bhandari.

 

The hierarchy of evidence involves five levels:

 

  • Level 1: Randomized trials (least bias)
  • Level 2: Prospective cohort studies
  • Level 3: Case control studies 
  • Level 4: Retrospective case series
  • Level 5: Opinion (most bias)

 

"Randomization is a very powerful tool that ensures, in many ways, that we have a balance of prognosis across groups, and ultimately, if there are differences between treatments we should be able to detect them," explained Dr. Bhandari. A meta-analysis involves analyzing many randomized trials of high quality results.

 

Bone healing players
The orthopedic field has been seeking adjunctive systemically applied minimally invasive biological enhancement of healing.

 

Fracture healing has utilized various agents throughout the years, from bone morphogenic proteins to platelet-derived growth factor to platelet-rich plasma. The industry has been tough on BMPs, as some require a significant invasive operation, while others have not existed beyond a Phase II trial. Ultimately, both BMPs and PRPs lack high quality evidence.

 

However, bone stimulators have been around for decades, as other biologics have entered and left the space. "When we think about the reality, although there are many products that appear to be available, the reality is there aren't that many that have remained consistent throughout this period of time," said Dr. Bhandari. It is imperative to think of bone stimulators as devices that may possess a biological action, said Dr. Bhandari.

 

"We have some real challenges," said Dr. Bhandari. “What we have on the market doesn't necessarily mean that we have good evidence-based behind these products." He noted the industry does not have the bone healing "game-changer" right now.

 

Electrical stimulation evidence
A bone stimulator is an externally applied, non-invasive device intended to "stimulate healing of damaged tissue." Key areas include extracorporeal shock waves, electrical stimulation and low-intensity pulsed ultrasound.

 

"We still think of extracorporeal shock waves therapy as being fairly preliminary, and although there are randomized trials, that suggest there is benefit, there's not enough of them," said Dr. Bhandari. More evidence supports ultrasound than ECSW, he noted, and it can aid in patient decision-making. Dr. Bhandari said electrical stimulation contains the most supporting evidence.

 

As a class, bone stimulation is heterogeneous — "There's a lot of noise and through the noise, we are trying to find a signal," said Dr. Bhandari.

 

Within electrical stimulation, subareas include:

 

  • Capacitive coupling: Involves the use of metal electrodes applied to the skin to deliver current 
  • Pulsed electromagnetic field: Involves devices utilizing externally applied coils to deliver current, which may be pulsed on and off
  • Combined magnetic field: Involves devices utilizing external coil systems with a combination of direct and alternating current, resulting in static and alternating magnetic fields

 

Still, all of these areas and subareas have a "lack of effect on clinically important outcomes," said Dr. Bhandari. Patients care more about their pain levels than how their X-rays look.

 

New ultrasound and electrical stimulation data
Dr. Bhandari and colleagues evaluated ultrasound in the treatment of tibial fractures, with the primary outcome as function. The study, titled TRUST, involved a randomized clinical trial and was 10 times larger than any comparable trial, involving 501 patients, some of which were smokers. Enrolled patients had an average age of 38 years with a mix of closed and open fractures.

 

"First, we learned that there was no difference in function as it relates to the SF36," said Dr. Bhandari. "We also learned that there was no statistically significant difference in the health utility index." He noted compliance challenges exist with ultrasound devices.

 

In 2015, Dr. Bhandari and colleagues conducted a meta-analysis of randomized sham-controlled trials testing the "efficacy of electrical stimulators for bone healing." The study involved 15 randomized clinical trials and 1,247 patients.

 

Within nonunion, the study found electrical stimulation devices compared to controls resulted in a 35 percent risk reduction.

 

"We're seeing for the first time, in review of electrical stimulation, enough study power and enough robust data to begin a pretty compelling argument for reduction in pain," said Dr. Bhandari. Additionally, electrical stimulation demonstrated efficacy in radiographic healing.

 

The data surrounding bone stimulators is evolving, and it's critical to continue updating data because "data changes things," said Dr. Bhandari.

 

Equipped with more information, Dr. Bhandari said the field will be able to better compare the efficacy of ultrasound versus electrical stimulation.

 

"The ultimate hope is, for knowledge translation, is that we have to rally together to use best evidence and share it with the world and as many people as we can," said Dr. Bhandari. "Because that is ultimately the way we are going to be able to change practice and help patients with better decisions."

 

To view the webinar recording, click here

 

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Last modified on Tuesday, 21 June 2016 19:06
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