Evaluation of Plenum® Tissue Ortho to Prevent Epidural Fibrosis and Post-laminectomy Syndrome.

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.

Inclusion Criteria:

• Pain radiating to one of the legs confirmed with an MRI scan;
• Patients who have already undergone conservative treatment (treatment with medication and physiotherapy) for at least 6 weeks, but have not shown improvement;
• Non-pregnant women or women of childbearing age who use contraceptive methods;
• Having signed the free and informed consent form (TCLE).

Exclusion Criteria:

• Patients with concomitant pathologies (eg infection or tumor and segmental instability or vertebral fractures);
• Cauda equina syndrome;
• Strength deficit characterized by strength equal to or less than III/V;
• Previous surgery of the lumbar spine;
• Patientes who have wound healing disorders;
• Patients with contraindications for evaluating MRI with the use of contrast;
• More than 1 herniated disk.