Expanded polytetrafluoroethylene membrane for the prevention of peridural fibrosis after spinal surgery: a clinical study.

Peridural fibrosis developing after laminectomy may cause pain that can necessitate reoperation. Many materials have been used as a barrier to invasion of fibrous tissue into the vertebral canal, but the ideal material has not been found. Various studies in animals have achieved favourable results with an expanded polytetrafluoroethylene (ePTFE) membrane. In a prospective, randomized study, we compared postoperative results in 33 patients who had an ePTFE membrane implanted to cover the defect caused by laminectomy during lumbar spine decompression with the results in 33 patients in whom no material was implanted. At operation, an ePTFE membrane was placed after the decompression procedure to cover the laminectomy defect completely. Systematic clinical and MRI follow-up evaluations of patients with and without the membrane were conducted 3, 6, 12, and 24 months postoperatively. The effect of ePTFE membrane implantation over laminectomy sites on postoperative peridural fibrosis, pain and neurological claudication was assessed. The ePTFE-membrane group had a significantly lower rate of epidural fibrosis on MRI (P<0.0001) and of clinical manifestations of radiculalgia (P = 0.002) compared with the no-material group. Epidural fibrosis that occurred in the ePTFE group was generally less extensive than that in the no-material group. There was no significant difference in the rate of postoperative claudication in the two groups. Significantly more seromas occurred in the ePTFE group (P = 0.0002). There were no infections or other complications in either group. The results showed that placement of an ePTFE spinal membrane over the laminectomy defect produced by lumbar spine surgery provided a physical barrier to invasion of fibrous tissue into the vertebral canal, and patients with the membrane had less postoperative radicular pain.

RCT Entities:   Population Interventions Outcomes