Similar results seen with use of interspinous process device vs decompression for lumbar spinal stenosis
CHICAGO — Insertion of standalone percutaneous interspinous process devices is safe and shows outcomes similar to decompressive surgery for patients with degenerative lumbar spinal stenosis with neurogenic intermittent claudication, according to data presented at the American Association of Neurological Surgeons Annual Meeting, here.
“Aperius is not inferior to standard decompression after 24 months. Surgery is significantly less invasive and shorter, but you do have a higher reoperation rate at 24 months,” Bernhard Meyer, MD, said.
In the multicenter prospective clinical trial, 163 patients were randomized to either the percutaneous insertion of interspinous process devices (IPDs) or decompression groups. Patients were gathered from 19 sites in Europe. Mean patient age was 65±11 years. Physical function, symptom severity and patient satisfaction were assessed until 24 months. The researchers assessed leg, buttock/groin and back pain with VAS scores and determined quality of life with SF-36 version 2 questionnaires.
Meyer said mean physical function change from baseline to 12 months decreased equally in both groups and was stable at 24-month follow-up. Patients in the IPD group had shorter surgical time and less blood loss compared with patients in the decompression group. Symptom severity and VAS leg pain scores improved equally in both groups. Reoperation occurred in 18% of the IPD group and in 11% of the decompression group.
Meyer said results of this study confirm those of three other randomized clinical trials conducted in Europe, which showed identical results. However, he said the consequences are unclear. – by Kristine Houck, MA, ELS
Meyer B, et al. Paper #622. Presented at: American Association of Neurological Surgeons Annual Meeting. April 30-May 4, 2016; Chicago.
Disclosure: Meyer reports no relevant financial disclosures.