Guidelines for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 17: bone growth stimulators and lumbar fusion

Abstract

There have been a number of randomized studies supporting the use of ES for the promotion of bone healing following lumbar fusion. All of the published studies have methodological flaws that prevent the studies from providing Class I medical evidence. There is, however, Class II and III evidence to support the use of direct current stimulation or CCS for enhancing fusion rates in high-risk patients undergoing lumbar PLF. A beneficial effect on fusion rates in patients not at "high risk" has not been convincingly demonstrated, nor has an effect been shown for these modalities in patients treated with interbody fusion. There is limited evidence both for and against the use of PEMFS for enhancing fusion rates following PLE Class II and III medical evidence supports the use of PEMFS for promoting arthrodesis following interbody fusion. Although some studies have purported to demonstrate functional improvement in some patient subgroups, other studies have not detected differences. All of the reviewed studies are significantly flawed by the use of a four-point patient satisfaction scale as the primary outcome measure. This outcome measure is not validated. Because of the use of this flawed outcome measure and because of the conflicting results reported in the better-designed studies that assess functional outcome, there is no consistent medical evidence to support or refute use of these devices for improving patient outcomes.