Effects of Smoking and Maturation on Long-Term Maintenance of Lumbar Spinal Fusion Success

Abstract

This is a follow-up study of a multicenter, randomized, placebo-controlled clinical trial conducted in accordance with the condition for Food and Drug Administration approval for pulsed electromagnetic fields. The purpose of this study was to evaluate the long-term efficacy and safety of pulsed electromagnetic fields for spinal fusion. An earlier clinical trial study was conducted to evaluate the efficacy of Pulsed Electromagnetic Fields to enhance fusion success at one year follow-up. In the original study, 195 patients undergoing interbody fusion were enrolled. Of the 195 patients, 98 were in the active group and 97 were in the placebo group. Study results showed a 92% successful fusion rate in the active group compared to 68% in the placebo group. For this long-term follow-up study, all patients who had healed in the original study were recalled for a follow-up radiograph. Radiographs were assessed by the attending surgeon for fusion assessment, when possible. The results of this long-term follow-up study showed that there was a reduction in maintenance of the fusion over time by 25%, but that the reduction was unrelated to treatment group and correlated statistically with whether the patient was a smoker.