Purpose of study: The objective of this retrospective clinical study was to investigate the potential benefits of using the Collagen Dural Matrix as an adhesion barrier following spine surgerin order to avoid periradicular lumbar fibrosis.

Method: Retrospective patient data was used 500patients. The study cohort (collagen matrix group) consisted of consecutive patients (250 patients) who were treated with collagen Dural matrix. Patients in the standard procedure group (250 patients in all) were operated on prior to the adoption of collagen dural matrix use by the surgeon. Patients underwent spinal surgery and completed follow-up evaluations at no less than 3 years post-operation

Study Design: Following surgery, pain was assessed at various times post operation (0 to 6 months, 6 to 12 months, and 12 to 48 months- 60 months). A post-operative MRI scan was performed on patients experiencing excessive pain to assess extent of peridural scarring and adhesions.

Summary of findings:

Post-operative Pain Assessment. Mean post-operative pain scores for the collagen matrix group at all time points were lower than those for the standard procedure group and were statistically lower at 3 to 6 months.

Comparison of Post-operative and Pre-operative MRI. Of the patients that received post-operative MRI, 43% of the standard procedure group showed adhesion formation, whereas 23% of the collagen matrix group showed adhesions.

Re-operation Rate. The difference in re-operation rate between the collagen matrix group and the standard procedure group is statistically significant (p< 0.01).

Relationship between findings and existing knowledge. Dural adhesions resulting from peridural fibrosis can cause persistent pain and may lead to re-operation. The need exists for treatments to prevent dural adhesions and minimize the impact of peridural fibrosis on post-operative outcome of spine surgery. Collagen Dural Matrix has traditionally been used for the repair of dural defects in both cranial and spinal procedures. Because of collagen dural matrix excellent clinical profile, it may be useful as an adhesion barrier.

Overall significance of findings: Findings in this study (reduced pain and lower incidence of adhesions) are consistent with the Collagen Dural Matrix acting as an effective adhesion barrier it is likely that the Collagen Dural Matrix may be used in other regions of the spine to prevent peridural fibrosis and associated sequelae. Ultimately the use of the collagen dural matrix prophylactically to prevent adhesions may result in improved patient outcomes.