Herniated Disk Lumbar Clinical Trial
Official title:
Evaluation of the Performance and Safety of Plenum® Tissue Ortho for the Prevention of Epidural Fibrosis and Post-laminectomy Syndrome After Microdiscectomy, for the Treatment of Disc Herniation
The goal of this clinical trial is to compare if adding a polydioxanone membrane prevents epidural fibrosis and, consequently, the rate of occurrence of the post-laminectomy syndrome in participants undergoing microdiscectomy for treatment of disc herniation.
Participants will be submitted to microdiscectomy with the addition of a polydioxanone membrane over the dura mater in the test group and without in the control group. The groups will be compared regarding improving patients' quality of life, evaluation of epidural fibrosis, and device safety. ;
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