Use of carboxymethylcellulose/polyethylene oxide gel in microdiscectomy with interlaminectomy: a case series comparison with long-term follow-up.

STUDY DESIGN

A consecutive, case series comparison.

OBJECTIVE

To compare safety, long-term pain, and disability scores with and without use of carboxymethylcellulose/polyethylene oxide (CMC/PEO) gel after microdiscectomy with interlaminectomy.

SUMMARY OF BACKGROUND DATA

Patient outcomes after microdiscectomy for lumbar disc herniation are frequently complicated by adhesions and fibrotic scars. Present management is controlled by good surgical technique as adhesion-reduction agents to date, have either proved ineffective or toxic. In 2002 a 100% synthetic combination of CMC/PEO, which reduces adhesions and fibrosis, became available across Europe as a gel application, (OXIPLEX/SP adhesion barrier gel FzioMed, Inc., San Luis Obispo, CA) and distributed under the trade names OXIPLEX/SP adhesion barrier gel (DePuy International, Ltd., Leeds, United Kingdom) and MEDISHIELD adhesion barrier gel (Medtronic International Trading SARL, Tolochenaz, Switzerland).

METHODS

A consecutive series of 70 patients with lumbar disc herniation undergoing microdiscectomy with interlaminectomy by the same surgeon were treated at the end of surgery with either CMC/PEO gel (N = 35) or no gel (N = 35). Treatments were allocated by an independent investigator. At presurgery and regular intervals over 3 years postsurgery, Oswestry disability index (ODI) and leg and back pain scores determined by visual analog scales (VAS), were assessed by a member of the surgical team blinded to the initial treatment allocation.

RESULTS

Three years postsurgery reduction in disability as measured by the decrease in ODI compared with presurgery (mean +/- SD) was significantly (P < 0.05) greater with CMC/PEO than controls (-49.4 +/- 12.7 vs. -41 +/- 17.8). CMC/PEO treatment also resulted in significantly more patients having no disability as measured by reaching 0% ODI scores (15 CMC/PEO [43%] vs. 0 control group [0%]) (P < 0.01). Leg and back pain as measured by the decrease in VAS scores 3 years postsurgery were reduced with CMC/PEO compared with controls(leg -6.8 +/- 1.7 vs. -5.6 +/- 1.6, back -0.4 +/- 1.5 vs. -0.1 +/- 2.0), P < 0.05 for leg pain. Importantly there were no safety issues and no differences in complications between the 2 treatment groups during the 30 day postoperative period.

CONCLUSION

CMC/PEO gel after microdiscectomy with interlaminectomy appears safe to use and in a 3-year follow-up significantly reduces disability and leg pain scores compared with our conventional treatment.