Clinical Results of Interspinous Dynamic Stabilization with STENOFIX Device

Abstract

Introduction The objective of our study was to evaluate the efficacy of STENOFIX interspinous dynamic stabilization device in different spinal conditions including discectomies and central and foraminal spinal stenoses, with minimum of 1 year of patient follow-up. Materials and Methods We performed a prospective case series on 64 patients over a period of 3 years who underwent spinal surgeries in our institutions with a minimum of 1 year follow-up. Spinal procedures included discectomies, one or two level Stenofix implant insertions for patients with central spinal stenosis and one or two level Stenofix implant insertions for patients with lateral recess foraminal stenosis. Pre- and postoperatively disability and pain scores were measured using the Oswestry Disability Index (ODI), visual analogue scale (VAS), SF 36 scores, and EQ-5D-3L scores in conjunction with radiographic evaluation of disc height and sagittal alignment. Results All follow-up patients demonstrated significant improvement in ODI, VAS, SF 36, and EQ-5D-3L pain scores in comparison to those of preoperation ( p < 0.05). We observed no significant difference in sagittal alignment post-interspinous dynamic stabilization with Stenofix implant. No complications such as implant loosening, immigration, and spinal process fracture were observed. Conclusion The STENOFIX implant demonstrates significant improvement in clinical outcomes when used as the treatment of choice in patients with central and/or lateral recess lumbar spinal stenosis, as well as when used as a supplement to discectomies. Disclosure of Interest None declared