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

Not Applicable

Not yet recruiting

• Conditions: Herniated Disk Lumbar
• Interventions: Device: Plenum® Tissue ortho membrane (polydioxanone membrane)

• Registration Number: NCT05776628
• Lead Sponsor: M3 Health

Brief 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.

Study Timeline

• Study First Submitted: 2023-02-27
• Study First Submitted QC: 2023-03-08
• Study First Posted: 2023-03-20
• Status Verified: 2023-11
• Last Update Submitted: 2024-03-11
• Last Update Posted: 2024-03-12
• Study Start: 2024-04
• Primary Completion: 2024-10
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Polydioxanone membrane	Plenum® Tissue ortho membrane (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.

Primary Outcome Measures

Name	Time	Method
Patient's quality of life	Change from the baseline, to immediate potostoperative period (14 days) and to late postoperative period (6 months).	Assessed by the Oswestry Questionnaire for lumbar evaluation (The low back pain disability Oswestry questionnaire).

Secondary Outcome Measures

Name	Time	Method
Patient's quality of life	Before the procedure, in the immediate postoperative period (14 days) and in the late postoperative period (6 months).	SF-36 Questionnaire
Intervention safety	Through study completion, an average of 6 months	Adverse events occurrence
Epidural fibrosis	6 months postoperatively.	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).
Low back and leg pain	Before the procedure, in the immediate postoperative period (14 days) and in the late postoperative period (6 months).	Pain change will be measured by a Visual Analogue Scale (VAS)

Trial Locations

Locations (1)

M3 Health; 🇧🇷 Jundiaí, São Paulo, Brazil