Objective: The aim of this report was to evaluate the long-term effectiveness and safety of mild lumbar decompression for the treatment of neurogenic claudication associated with lumbar spinal stenosis. This technique uses a percutaneous dorsal approach to remove small portions of ligament and lamina, thereby restoring space and decompressing the spinal canal.
Materials and Methods: Two-year data are reported for 45 patients treated with mild decompression at 11 US sites. Outcome measures included the Visual Analog Scale (VAS), Oswestry Disability Index, and Zurich Claudication Questionnaire. Safety was monitored throughout the procedural and follow-up period for all patients. Interim data are included for these patients at 1 week, 6 months, and 1-year follow-up.
Results: Seventy-one percent of patients reported improvement in VAS at the end of the reporting period. At 2 years, patients demonstrated a statistically significant reduction of pain as measured by VAS, and improvement in physical function and mobility was significant as measured by Zurich Claudication Questionnaire and Oswestry Disability Index. Tukey honestly significant different test found significant improvement in all outcome measures from baseline to each follow-up interval. Further, major improvement occurred by 1-week follow-up and showed no difference between each subsequent follow-up, signifying considerable stability and durability of the initial result over time. No major device or intraprocedural adverse events were reported.
Discussion: In this report of 2-year follow-up on 45 patients treated with mild percutaneous lumbar decompression, patients experienced statistically significant pain relief and improved functionality.
Department of Anatomy and Neurobiology, Northeast Ohio Medical University, Rootstown, OH
B.W.C. is a consultant to Vertos Medical. B.W.C.’s relationship with Vertos includes financial compensation. Independent data management services, conducted by PharmaPros Corporation in Cambridge, MA, and statistical analysis provided by ICRC Inc. in Reno, Nevada, were funded by Vertos Medical, Aliso Viejo, CA. Manuscript assistance was provided by Karen Davis, an independent contractor.
Reprints: Bohdan W. Chopko, PhD, MD, Department of Anatomy and Neurobiology, Northeast Ohio Medical University, Rootstown, 39 Wood Street, Mansfield, OH 44903 (e-mail: firstname.lastname@example.org).
Received July 30, 2012
Accepted November 25, 2012