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

M3 Health36 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Herniated Disk Lumbar

Interventions

Plenum® Tissue ortho membrane (polydioxanone membrane)DEVICE

Membrane addition after flavectomy and spinal nerve and dura mater manipulation.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (1)

M3 Health

Jundiaí, São Paulo, Brazil

Outcomes

Primary Outcomes

Patient's quality of life

Assessed by the Oswestry Questionnaire for lumbar evaluation (The low back pain disability Oswestry questionnaire).

Time frame: Change from the baseline, to immediate potostoperative period (14 days) and to late postoperative period (6 months).

Secondary Outcomes

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).

Time frame: 6 months postoperatively.

Patient's quality of life

SF-36 Questionnaire

Time frame: 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)

Time frame: Before the procedure, in the immediate postoperative period (14 days) and in the late postoperative period (6 months).

Intervention safety

Adverse events occurrence

Time frame: Through study completion, an average of 6 months