Degenerative lumbar spinal stenosis treatment with Aperius™ PerCLID™ system and Falena® interspinous spacers: 1-year follow-up of clinical outcome and quality of life

Abstract

Purpose Evaluation of the efficacy of the Falena® and Aperius™ PerCLID™ interspinous devices in the treatment of degenerative lumbar spinal stenosis with neurogenic intermittent claudication refractory to conservative treatment. Materials and methods We retrospectively analyzed data from 24 patients (20 male and 4 female patients; 61 ± 7 years old), treated with an implantation of the AperiusTM PerCLID™ system, and from 35 patients (29 male and 6 female patients; 65 ± 9 years old) treated with the Falena® interspinous device. Patient pain intensity was evaluated by a 10-point visual analog scale (VAS), with a score (ranging from 0 = no pain to 10 = unbearable pain) that was collected before the procedure, at baseline; and at months 1, 6 and 12 after the interventional procedure. The assessment of quality of life (QOL) impairment was evaluated by the Oswestry Disability Index (ODI) questionnaire, which was administered beforehand at baseline; and at months 1, 6 and 12 after the interventional procedure. The vertebral canal area was measured by magnetic resonance imaging (MRI) scans before the treatment and at the one-year follow-up. Results All patients completed the study with no complications. Both the Falena group and Aperius group of surgery patients showed a statistically significant reduction of their VAS and ODI scores at the 6- and 12-month follow-up ( p < 0.0001). A statistically significant increase in the vertebral canal area was observed both in the group that received Falena ( p < 0.0001) and in the group that received Aperius ( p = 0.0003). At the 1-year follow-up, we observed that there was a higher increase of vertebral canal area in those patients whom were treated with the Falena device ( p < 0.001). Conclusions The implantation of Falena® and Aperius™ PerCLID™ interspinous devices is an effective and safe procedure, in the medium term.