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

Herniated Disk Lumbar Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05776628
• Other study ID #: Regenerative membrane
• Secondary ID: U1111-1302-0033
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: April 2025

Study information

• Verified date: November 2023
• Source: M3 Health
• Contact: Robert Meves, PhD
• Phone: +55112176-1525
• Email: robertmeves[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: April 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Herniated Disk Lumbar
• Intervertebral Disc Displacement

Intervention

Device:
• Plenum® Tissue ortho membrane (polydioxanone membrane)
Membrane addition after flavectomy and spinal nerve and dura mater manipulation.

Locations

Country	Name	City	State
Brazil	M3 Health	Jundiaí	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
M3 Health	Irmandade da Santa Casa de Misericordia de Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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).
Secondary	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).
Secondary	Intervention safety	Adverse events occurrence	Through study completion, an average of 6 months