BACKGROUND: The objective of this prospective, randomized, controlled trial was to investigate the potential benefits of using Collagen Dural Matrix Plus (DuraGen Plus) as an adhesion barrier in order to prevent periradicular lumbar fibrosis following spine surgery.

MATERIAL and METHODS: The trial was conducted by the investigator at a single site from 2006 to 2008 (DuraGen Plus, 200 cases with 2 years follow-up). Outcome measures Clinical follow-up intervals were fixed at 1 month, 6 months, 1 year and 2 years. Gadolinium enhanced MRI (Gad-MRI) was administered to patients suffering pain. Results from the DuraGen Plus Group were assessed independently. Post-surgical fibrosis was found in 2% of cases, against 8% in the control group. Pain Outcomes Results from the Control Group, subjected to the standard procedure, showed that patients with higher fibrosis levels (indicated with arrows) displayed more significant symptoms. Mean post-operative pain scores for the DuraGen Group were lower during all intervals and statistically lowest at 6 to 12 months. The difference in reoperation rate between the DuraGen Group and the Standard Procedure group is statistically significant (p<0.001).

CONCLUSION: The use of DuraGen Plus resulted in statistically significant (2% vs. 8%) surgical results. None of the 100 patients from the DuraGgen Group required re-operation due to clinical symptoms. Collagen Graft Matrix Plus was easy to apply to exposed tissues (thecal sac and nerve root) and reduced pain from fibrosis by forming a physical barrier.