Comparative cost effectiveness of Coflex® interlaminar stabilization versus instrumented posterolateral lumbar fusion for the treatment of lumbar spinal stenosis and spondylolisthesis.

Introduction: Symptomatic chronic low back and leg pain resulting from lumbar spinal stenosis is expensive to treat and manage. A randomized, controlled, multicenter US Food and Drug Administration Investigational Device Exemption clinical trial assessed treatment-related patient outcomes comparing the Coflex® Interlaminar Stabilization Device, an interlaminar stabilization implant inserted following decompressive surgical laminotomy in the lumbar spine, to instrumented posterolateral fusion among patients with moderate to severe spinal stenosis. This study uses patient-reported outcomes and clinical events from the trial along with costs and expected resource utilization to determine cost effectiveness.

Mitigating adverse event reporting bias in spine surgery.

Background: Recent articles in the lay press and literature have raised concerns about the ability to report honest adverse event data from industry-sponsored spine surgery studies. To address this, clinical trials may utilize an independent Clinical Events Committee (CEC) to review adverse events and readjudicate the severity and relatedness accordingly. We are aware of no prior study that has quantified either the degree to which investigator bias is present in adverse event reporting or the effect that an independent CEC has on mitigating this potential bias.