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.