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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Herniated Disk Lumbar
• Intervention / Treatment: Device: Plenum® Tissue ortho membrane (polydioxanone membrane)

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.

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Robert Meves, PhD; Phone Number: +55112176-1525; Email: robertmeves@hotmail.com
• Study Contact Backup: Name: Sybele Saska Specian, PhD; Phone Number: +551131099068; Email: pesquisa@plenum.bio

Study Locations

• Brazil
  • São Paulo
    • Jundiaí, São Paulo, Brazil, 13212213
      • M3 Health
      • Contact: Sybele Saska Specian, PhD; Phone Number: +5511934742419; Email: sybele.saska@plenum.bio
      • Principal Investigator: Robert Meves, PhD
      • Contact: Lívia Silva, PhD; Phone Number: +551131099068; Email: pesquisa@plenum.bio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: Plenum® Tissue ortho membrane (polydioxanone membrane); Membrane addition after flavectomy and spinal nerve and dura mater manipulation.
No Intervention: Control; The microdiscectomy procedure will be performed routinely, without the addition of any device over the dura mater.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: M3 Health
• Collaborators: Irmandade da Santa Casa de Misericordia de Sao Paulo
• Investigators: Study Director: Sybele Saska Specian, PhD, M3 Health

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: February 27, 2023
• First Submitted That Met QC Criteria: March 8, 2023
• First Posted (Actual): March 20, 2023

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Intervertebral Disc Displacement
• Other Study ID Numbers: Regenerative membrane; U1111-1302-0033 (Registry Identifier: UTN)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No