title: NFlex Dynamic Stabilization System : Two-Year Clinical Outcomes of Multi-Center Study.
abstract: OBJECTIVE
  Pedicle-based dynamic stabilization systems, in which semi-rigid rods or cords are used to restrict or control spinal segmental motion, aim to reduce or eliminate the drawbacks associated with rigid fusion. In this study, we analyzed the two-year clinical outcomes of patients treated with the NFlex (Synthes Spine, Inc.), a pedicle-based dynamic stabilization system.
  
  
  METHODS
  Five sites participated in a retrospective study of 72 consecutive patients who underwent NFlex stabilization. Of these 72 patients, 65 were available for 2-year follow-up. Patients were included based on the presence of degenerative disc disease (29 patients), degenerative spondylolisthesis (16 patients), lumbar stenosis (9 patients), adjacent segment degeneration (6 patients), and degenerative lumbar scoliosis (5 patients). The clinical outcome measures at each assessment were Visual Analogue Scale (VAS) to measure back pain, and Oswestry Disability Index (ODI) to measure functional status. Radiographic assessments included evidence of instrumentation failure or screw loosening.
  
  
  RESULTS
  Sixty-five patients (26 men and 39 women) with a mean age of 54.5 years were included. Mean follow-up was 25.6 months. The mean VAS score improved from 8.1 preoperatively to 3.8 postoperatively, representing a 53% improvement, and the ODI score from 44.5 to 21.8, representing a 51% improvement. Improvements in pain and disability scores were statistically significant. Three implant-related complications were observed.
  
  
  CONCLUSIONS
  Posterior pedicle-based dynamic stabilization using the NFlex system seems effective in improving pain and functional scores, with sustained clinical improvement after two years. With appropriate patient selection, it may be considered an effective alternative to rigid fusion.
authors.affiliation: Silicon Valley Spine Institute, Campbell, CA, USA.
authors.forename: Jeffrey D
authors.initials: JD
authors.lastname: Coe
authors.forename: Scott H
authors.initials: SH
authors.lastname: Kitchel
authors.forename: Hans Jörg
authors.initials: HJ
authors.lastname: Meisel
authors.forename: Charles H
authors.initials: CH
authors.lastname: Wingo
authors.forename: Soo Eon
authors.initials: SE
authors.lastname: Lee
authors.forename: Tae-Ahn
authors.initials: TA
authors.lastname: Jahng