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.
Keywords: Degenerative disease; interspinous devices; interspinous spacers; lumbar spinal stenosis; medical devices; neurogenic intermittent claudication; percutaneous interspinous device; spinal surgery; vertebral canal.
© The Author(s) 2016.