Objective: To evaluate the clinical outcomes of Biofelx dynamic stabilization system in the treatment of lumbar degenerative disease (LDD).
Methods: A total of 29 patients (16 males, 13 females) received the treatment of Bioflex between June 2011 and April 2013 were recruited. There were with lumbar spinal stenosis (n = 15), lumbar disc herniation (n = 10) and lumbar spondylolisthesis (n = 4). And they underwent one-segment (n = 14), two-segment (n = 10), three-segment (n = 3) and four-segment (n = 2) implantations. Mean age was 52.3 (38-62) years. Visual analogue scale (VAS) and Oswestry Disability Index (ODI) were used to evaluate the clinical outcomes. And lumbar radiography was used to observe disc height (DH) and range of motion (ROM) in fixed segment and cranial adjacent segment before and after operation.
Results: The mean follow-up period was 22.6 ± 2.1 (8-32) months. The mean ODI score decreased from 39.96 ± 2.58 preoperatively to 11.26 ± 1.76 at 3 months postoperatively (P < 0.05) and 3.97 ± 1.30 at the last follow-up (P < 0.05). The mean VAS score for low back pain dropped from 7.34 ± 0.80 preoperatively to 2.63 ± 1.01 at 3 months postoperatively (P < 0.05) and 0.91 ± 0.32 at the last follow-up (P < 0.05). The mean VAS score for leg pain deceased from 8.63 ± 0.95 preoperatively to 2.13 ± 0.62 at 3 months postoperatively and 0.58 ± 0.65 at the last follow-up (P < 0.05). The implanted segment preserved some ROM at the last follow-up. Compared to preoperative, no statistically significance existed in postoperative DH and ROM (P > 0.05).
Conclusion: The clinical outcomes of Bioflex system are excellent in the treatment of LDD. As an effective therapy for non-fusion of LDD, it may preserve some ROM of fixed segment and prevent increased range of motion in adjacent segment.