Surgical outcomes of patients with degenerative lumbar disc disease post-IntraSPINE® device fixation: Three-year prospective study

Abstract

Background: Lumbar degenerative disc disease is one of the most common conditions associated with chronic low back pain. IntraSPINE® is a novel inter-laminar device that allows more physiological rocking-type movements in flexion and extension. Aim: To evaluate the results of patients with symptomatic Lumbar degenerative disc disease treated with an IntraSPINE® device and followed up over a 3-year period. Materials and Methods: A Prospective longitudinal research study involving patients with imaging-confirmed Lumbar degenerative disc disease in whom conservative treatment was unsuccessful. Outcome measures were changes over baseline score on the Oswestry Disability Index (ODI), and low back and radicular pain assessed at 6, 12, 24 and 36 months postoperatively. Overall success, a composite outcome that included key safety and clinical considerations, was assessed. Secondary outcomes included satisfaction with symptoms, employment status and post-surgery medical interventions. To compare differences in longitudinal clinical score patterns over 36 months, a mixed-effect model ANCOVA with repeated measurements was performed, with adjustment for low back and radicular pain score and ODI score at baseline. Results: 231 patients were recruited and 180 completed the study. A significant improvement in ODI score (p=0.0597), as well as in VAS (Visual Analogue Scale) scores for back (p= 0.0228) and leg pain (p<0.0001) was observed during the follow-up. For ODI score, the mean percentage decrease from inclusion to month 36 was 64.5%. These scores were respectively 66.2% for radicular pain and 46.4% for low back pain. In 73% of cases, surgery was considered successful. 89% of working patients returned to work and 68% of patients were very satisfied at month 12. Only four patients presented intraoperative complications.