Purpose of study: The purpose of this study is to understand the biomechanics of interspinous devices in lumbar spinal surgery and to review the effectiveness of the devices for lumbar spinal stenosis through recent related articles.
Materials and Methods Medical databases were searched for the key words of interspinous device and lumbar spinal stenosis using PubMed from 2010 to the present.
Results Several studies have shown sustained symptomatic improvements after interspinous device insertion.
However, most of the prospective, randomized, double-blinded studies have shown that it is not superior to conventional laminectomy from a statistical perspective. Furthermore, interspinous device insertion has been shown to have a higher reoperation rate and to be less cost effective.
Conclusions A large prospective cohort study with a longer follow-up period comparing decompressive surgery alone versus interspinous device insertion for the treatment of lumbar spinal stenosis is needed to conclusively determine whether the interspinous device is beneficial.
Objective Peridural fibrosis may cause failed back syndrome and the presence of fibrosis renders reoperations risky.
Therefore, preventing the adhesion of scar tissue to the dura and nerve root is one of the issues in spinal surgery.
Thus, the purpose of this study is to evaluate and compare the efficacy and the safety between two anti-adhesive agents, BNCH-202 (Korea BNC Inc, Daegu, Korea) and Guardix-SOL (Hanmi, Seoul, Korea).
Methods Sixty eight patients were enrolled in this study. To evaluate and compare the efficacy in preventing epidural adhesion formation and the safety in human laminotomy models, the two barriers tested were either BNCH-202 or Guardix-SOL (gel/film combination). Clinical evaluation was performed at 0, 6 and 12 weeks to assess pain and functional outcome. The patients were also assessed radiographically with postoperative magnetic resonance imaging (MRI) to evaluate the presence of perinueral scar and adhesion.
Results There was no statistically significant difference between two biologic barriers in terms of the safety issue, clinical and radiological efficacy. There were no significant differences between the BNCH-202 group and the control group on the preoperative ODI and VAS scores. In general, the ODI and VAS scores decreased in both groups at all the time points. At the 6 week and 12 week time point, the VAS scores for back pain/ leg pain and the ODI scores in both groups were lower than the preoperative score in each group (P<0.01). And at the 12-week time point, the peridural scar scores were assessed in both groups. The mean value of the peridural scar score in BNCH-202 group was not inferior to the mean value of that in Guardix-SOL group.
Conclusion The results demonstrated that BNCH-202 gel is as effective as Guardix-SOL in reducing posterior dural adhesions in the spine with no apparent safety issues. It can improve patients’ postoperative clinical outcome.