Bone Growth Stimulators Help Spinal Fusion Patients Recover

Two new medical devices use a low-level pulsed electromagnetic field (PEMF) to activate and augment the body's natural healing process, promoting post-operative spinal fusion.

The Orthofix CervicalStim and SpinalStim bone growth stimulators are lightweight, all-in-one devices intended as a post-operative adjunct to lumbar and cervical fusion surgical procedures, providing a PEMF signal that covers 360 degrees and up to five levels of fusion. The Spinal-Stim device is indicated as a adjunct to spinal fusion to increase the probability of fusion success and as a nonoperative treatment of salvage of failed spinal fusion, where a minimum of nine months has elapsed since the last surgery.

The Cervical-Stim device is indicated as an adjunct to cervical fusion surgery in patients at high risk for non-fusion; there are no known contraindications. Both the devices work effectively even when worn over clothing or bracing, and have no power cords, thus allowing for unrestricted patient mobility during the treatment. They also include several patient enhancements aimed at improving fit, comfort, and ease of use. Adverse effects may include increased pain, numbness and tingling, headache, migraines and nausea, which may or may not be directly related to use of the device.

Both systems are available with Stim onTrack, an interactive app designed for smartphones and other mobile devices to help patients follow their treatment plan that includes daily reminders and a device usage calendar. The mobile app also includes a feature that enables physicians to receive real-time data on how their patients are adhering to their prescribed treatment protocol. The Stim onTrack app is free of charge and available through the iTunes App Store and Google Play.

“Patient recovery is often dependent on how well they follow the prescription for the device,” said James Ryaby, PhD, chief scientific officer at Orthofix. “Equipping patients with a mobile app to help them adhere to their prescription is an excellent addition to this system while simultaneously enhancing post-surgical care by giving physicians additional data to help personalize follow-up protocols.”

Electricity’s potential to aid bone healing was reported as early as 1841, but it was not until the 1950’s that serious study began. During the 1970s, a new approach for the treatment of delayed fractures was introduced, which employed a very specific biphasic low frequency signal that was applied for non-union/delayed fractures. The first use of electrical stimulation in the lumbosacral region was reported by Alan Dwyer of Australia in 1974.