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

NCT05776628 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-03-12

No results posted yet for this study

Summary

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.

Conditions

  • Herniated Disk Lumbar

Interventions

DEVICE

Plenum® Tissue ortho membrane (polydioxanone membrane)

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

Sponsors & Collaborators

  • Irmandade da Santa Casa de Misericordia de Sao Paulo

    collaborator OTHER

  • M3 Health

    lead INDUSTRY

Principal Investigators

  • Sybele Saska Specian, PhD · M3 Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-30
Primary Completion
2024-10-31
Completion
2025-04-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05776628 on ClinicalTrials.gov