NCT05776628

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: M3 Health · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

• Herniated Disk Lumbar

Interventions

Type	Name	Description
DEVICE	Plenum® Tissue ortho membrane (polydioxanone membrane)	Membrane addition after flavectomy and spinal nerve and dura mater manipulation.

Timeline

• Start date: 2024-04-01
• Primary completion: 2024-10-01
• Completion: 2025-04-01
• First posted: 2023-03-20
• Last updated: 2024-03-12

Locations

1 site across 1 country: Brazil