Description
Electrical Bone Growth Stimulators
Both invasive and noninvasive electrical bone growth stimulators have been investigated as an adjunct to spinal fusion surgery, with or without associated instrumentation, to enhance the probability of obtaining a solid spinal fusion. Noninvasive devices have also been investigated to treat a failed fusion.
Electrical and electromagnetic fields can be generated and applied to bones through surgical, noninvasive, and semi-invasive methods.
Invasive Stimulators
Invasive devices require surgical implantation of a current generator in an intramuscular or subcutaneous space, with an accompanying electrode implanted within the fragments of bone graft at the fusion site. The implantable device typically remains functional for six to nine months after implantation, and although the current generator is removed in a second surgical procedure when stimulation is completed , the electrode may or may not be removed . Implantable electrodes provide constant stimulation at the nonunion or fracture site but carry increased risks associated with implantable leads.
Noninvasive Stimulators
Noninvasive electrical bone growth stimulators generate a weak electrical current within the target site using either pulsed electromagnetic fields, capacitive coupling, or combined magnetic fields. In capacitive coupling, small skin pads/electrodes are placed on either side of the fusion site and are worn for 24 hours a day until healing occurs, or for up to nine (9) months. In contrast, pulsed electromagnetic fields are delivered via treatment coils that are placed into a back brace or directly onto the skin and are worn for six to eight hours a day for three to six months. Combined magnetic fields deliver a time-varying magnetic field by superimposing the time-varying field onto an additional static magnetic field. This device involves 30 minutes of treatment daily for nine (9) months. Individual compliance may be an issue with externally worn devices.
Semi-Invasive Stimulators
Semi-invasive (semi-implantable) stimulators use percutaneous electrodes and an external power supply, obviating the need for a surgical procedure to remove the generator when treatment is finished .
Summary of Evidence
For individuals who are at high-risk of lumbar spinal fusion surgery failure who receive invasive or noninvasive electrical bone growth stimulation, the evidence includes systematic reviews, a TEC Assessment, and randomized controlled trials. Relevant outcomes are symptoms, change in disease status, and functional outcomes. Results from these trials have indicated that in individuals with risk factors for failed fusion surgery, either invasive or noninvasive electrical bone stimulation increases the fusion rate. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.
For individuals who have failed lumbar spinal fusion surgery who receive noninvasive electrical bone growth stimulation, the evidence includes a TEC Assessment and studies with individuals serving as their own controls. Relevant outcomes are symptoms, change in disease status, and functional outcomes. Data have shown that noninvasive electrical stimulation improves fusion rates in this population. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.
For individuals who are undergoing cervical spinal fusion surgery or have failed cervical spine fusion who receive invasive or noninvasive electrical bone growth stimulation, the evidence includes a randomized controlled trial. Relevant outcomes are symptoms, change in disease status, and functional outcomes. The only controlled trial published to date had methodologic limitations, and the efficacy of electrical stimulation in the cervical spine has not been established. An open-label multicenter cohort study provided evidence to demonstrate that individuals at high-risk for arthrodesis following anterior cervical discectomy and fusion procedures reported statistically significant improvements in fusion rates with pulsed electromagnetic field stimulation. However, limitations in the study design, including use of a historical control group, lack of blinding, and no restrictions on surgical methods used by surgeons, preclude definitive assessments of treatment efficacy. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.
