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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-30

Study Completion Date

2025-04-30

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.

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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.

Conditions

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Herniated Disk Lumbar

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Polydioxanone membrane

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.

Group Type ACTIVE_COMPARATOR

Plenum® Tissue ortho membrane (polydioxanone membrane)

Intervention Type DEVICE

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

Control

The microdiscectomy procedure will be performed routinely, without the addition of any device over the dura mater.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Plenum® Tissue ortho membrane (polydioxanone membrane)

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

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No