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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Herniated Disk Lumbar

Intervention / Treatment
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* Device: Plenum® Tissue ortho membrane (polydioxanone membrane)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Polydioxanone membrane<br>After flavectomy and manipulation of the spinal nerve and dura mater to resect the herniated intervertebral disk, the membrane will be placed on top of the dura mater. | Device: Plenum® Tissue ortho membrane (polydioxanone membrane)<br>* Membrane addition after flavectomy and spinal nerve and dura mater manipulation.<br>|
| No Intervention: Control<br>The microdiscectomy procedure will be performed routinely, without the addition of any device over the dura mater. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's quality of life | Assessed by the Oswestry Questionnaire for lumbar evaluation (The low back pain disability Oswestry questionnaire). | Change from the baseline, to immediate potostoperative period (14 days) and to late postoperative period (6 months). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epidural fibrosis | Evaluation of epidural fibrosis using Magnetic Resonance Imaging (IMR) will grade the scar from 0 to 4 for 5 contiguous axial slices centered around the intervertebral disc. The scar will be graded as none (0) (no scar on the dural surface), mild (1) (scar on less than 25% of the surface), mild-moderate (2) (scar on 25-50 % of the surface), (3) moderate-extensive (scarring on 50-75% of the surface), or extensive (4) (scarring on more than 75% of the surface). | 6 months postoperatively. | 
| Patient's quality of life | SF-36 Questionnaire | Before the procedure, in the immediate postoperative period (14 days) and in the late postoperative period (6 months). | 
| Low back and leg pain | Pain change will be measured by a Visual Analogue Scale (VAS) | Before the procedure, in the immediate postoperative period (14 days) and in the late postoperative period (6 months). | 
| Intervention safety | Adverse events occurrence | Through study completion, an average of 6 months |