As a fracture or fusion heals, a hematoma is formed at the fracture site and fibrocartilaginous tissue bridges the gap. At the intermediate state of repair, new bone cells proliferate within the callus and calcify the fibrocartilage. When the gap has been completely bridged, mechanical stresses gradually remodel and strengthen the new bone tissue and the normal anatomy is restored. In as many as one in twenty of long bone fractures and as much as a third of spinal fusions, the normal healing pattern slows or ceases. The fibrocartilage fails to calcify, resulting in persistent soft tissue in the gap. In ‘high risk’ patients such as diabetic, sufferers of disease causing vascular restriction, tobacco users and alcohol/drug dependents, these ratios can be considerably higher, however data may be skewed here because many spinal surgeons may avoid surgical fusion in the classic high risk patient. By triggering the cellular response that brings about gap tissue mineralization, electrical stimulation helps reestablish the pattern of normal healing.
With effectiveness and safety established through extensive laboratory and clinical studies and practical application history, PEMF plays a major role in fracture and fusion management in the United States and Europe where it is often considered a first line treatment for failed arthrodeses or as added insurance, an adjunct, to primary treatment of high risk patients.
The following is a brief chronological history of the healing power of electricity resulting in the evolution of electrical bone growth stimulation:
- In 1780, Luigi Galvani, an Italian surgeon, observes the effect of electrical current on animal tissue and with subsequent experimentation produces a paper in 1791 entitled “The Effects of Artificial Electricity on Muscular Motion”.
- Michael Faraday in England, in 1831, discovers that magnetism can be used to produce electricity. This fundamental principle lead to development of electric machines, generators, telegraph and induction coil and was also the basis for the discovery of radio waves, X-rays and the electron.
- In 1841, Edward Hartshorne describes the use of electrical stimulation by John Birch, a London Surgeon, to treat a tibial non-union.
- W. Lente in 1850 presents a series of case reports describing electricity’s effect on fracture non-unions and pseudoarthroses.
- In 1853, the British journal, Medical Times and Gazette, publishes “Galvanism to the Un-united Fracture”, describing the use of electrically charged needles inserted into a fracture site to cause healing at York County Hospital.
- By the late 1920’s, commercial interests have so abused claims regarding electrotherapy benefit that the medical community disavowed its medicinal uses, however by the ‘50’s widespread interest was renewed.
- In 1957 Fukada and Yasuda of Japan demonstrate that bone has piezoelectric properties, generating electric potentials in response to mechanical stresses.
- Andrew Bassett and Robert Becker in a 1962 collaborative study further prove the Japanese claim and confirm bone is negatively charged in areas of compression and positively charged in areas of tension.
- In 1970, Alan Dwyer of Australia uses an implanted bone growth stimulator to successfully treat failed posterior lumbrosacral fusions, and a longstanding tibial non-union.
- In 1974, Andrew Basset publishes his research on a totally non-invasive system to produce fracture healing using pulsed electromagnetic fields.
- In 1979, the FDA approves the first PEMF stimulation device for treatment of non-unions. The semi-portable device runs on AC current from a standard household receptacle.
- In the past four decades, there is an abundance, literally hundreds, of clinical studies and trials published internationally demonstrating low-level pulsed electrical/electromagnetic fields to be effective in healing recalcitrant fractures and fusions.
- Once such study, authored by noted electrical fracture stimulation researcher Carl Brighton (et al), Signal Transduction in Electrically Stimulated Bone Cells, demonstrates that capacitive coupling as a method of getting the signal to bone cells is superior, by a significant margin to other methods such as coil induction or inductive coupling. It also demonstrates that in capacitive coupling, 2 hours per day of induction is as effective as 6 hours or even 24 hours.
- We estimate the present day individual PEMF unit sales in the US alone to be in the order of more than 100,000 annually.
Our family has been in the business of providing bone growth stimulation devices, (along with surgical products to hospitals), to patients in Canada for nearly 15 years. We distributed both a capacitive coupled device and coil induction devices during that time. In our own practical experience with patient results, we knew that there were distinct advantages to the capacitive coupled device as we definitely saw faster results in accelerating healing times. It is a one-size-fits-all device with no real limitations on application. And unlike the coil-induction devices (which have many different models specific to different physical locations), or the ultrasound device which employs a small transducer to target a specific area, the capacitive coupled device can treat an entire long bone (or full set of vertebrae) with two electrodes spaced out to either end. Thus it forms a circuit with the bones or column and can effectively treat multiple fractures or segmental fractures. It forms the circuit at a very effective low level pulse which means that it can operate with quality common 9 volt batteries for 75-90 hours of treatments. Most patients get 25-30 treatments out of a single battery. The other devices are often bulky and cumbersome to operate, while the electrodes and lead wire are low-profile and comfortable. They can be casted over or inserted under a shoe or clothing and the single battery and micro circuit board can be enclosed in a compact case that can be inserted into a pocket or clipped to clothing. Avoiding the ‘wow factor’ of displays that mostly just count down the minutes, it gives off a simple audible signal to initiate treatment and to let you know when your treatment is complete. A green LED indicates treatment in progress and a red led indicates treatment completion or low battery. Our lightweight compact power unit casing measures only 4.15” x 2.4” x .85” and weighs in at less than 5 ounces (132 gm) with battery installed!
Our device is Canadian! The printed circuit board is made in Canada and the quality components are sourced primarily from Canadian suppliers. Our competitors make their products in the US, Europe, Japan and China.
Some products, such as the CMF and ultrasound devices, promote shorter treatment times – but when using those devices, you must remain stationary. Read the fine print – some of those devices are not compatible with certain types of metal implantation, and there are Cautions and Warnings about their use. There are also promoters of devices for rental, even though the ‘rental’ often works out to the same cost as a purchase. These devices are generally single-patient use for good reason, often non-union patients are infected and ‘sanitized’ does not mean ‘sterilized’.