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.

Lumbar spinal stenosis is one of the degenerative diseases which have increasingly grown, as the nation is transitioning to an aging society. Even though medication is readily available as treatment for lumbar spinal stenosis, surgical treatments can be considered if symptoms are severe. The most basic operation, laminectomy and decompression, alone, can bring about improvements of symptoms by alleviating the pressure of the nerve root, however if instability is evident on the radiograph or during surgery, spinal fusion will be performed, and will yield favorable results. On the contrary, it is also common knowledge that spinal fusion can give rise to a variety of complications afterwards. New surgical procedures and apparatuses have been developed and used in clinical practices in order to overcome these complications. One of these new concepts is posterior dynamic stabilization. The purpose of posterior dynamic stabilization is to enable the spine to adjust so that, by limiting the movement to the direction which causes the pain, patients can feel at ease. Until recently, interspinous devices have been developed and applied in clinical practices in order to improve the symptoms of patients. The device is inserted after decompression of the nerve root in between the spinous processes of the lumbar part, where the symptom is present. By doing so, it not only limits the extension (without impacting flexion, axial rotation, and lateral bending) but also, alleviates the load on the facet joint by playing a role as a shock absorber. However, it is also true that the practice of this surgery has been limited due to the reports showing that; halo formed between the contact surface of the bone and the metal device might be the cause of pain; and according to a follow-up survey, fractures of the spinous process, breakaway of apparatus and post-operative complication such as kyphosis may be present. This paper will investigate the usefulness of these devices again by looking at the fundamental biomechanical effect of interspinous devices and analyzing the thesis which has been previously published.