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

NCT05776628 | Unknown DMC

• 2 other identifiers: Regenerative membraneU1111-1302-0033
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Herniated Disk Lumbar

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Epidural fibrosis

  6 months postoperatively.

• Patient's quality of life

  Before the procedure, in the immediate postoperative period (14 days) and in the late postoperative period (6 months).

• Low back and leg pain

  Before the procedure, in the immediate postoperative period (14 days) and in the late postoperative period (6 months).

• Intervention safety

  Through study completion, an average of 6 months

Study Arms (2)

Polydioxanone membrane

ACTIVE COMPARATOR

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)

Control

NO INTERVENTION

The microdiscectomy procedure will be performed routinely, without the addition of any device over the dura mater.

Interventions

Plenum® Tissue ortho membrane (polydioxanone membrane) DEVICE

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

Polydioxanone membrane

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• M3 Health: lead
• Irmandade da Santa Casa de Misericordia de Sao Paulo: collaborator

Study Sites (1)

M3 Health

Jundiaí, São Paulo, 13212213, Brazil

Location

Study Officials

• Sybele Saska Specian, PhD

  M3 Health

  STUDY DIRECTOR

Central Study Contacts

Robert Meves, PhD

CONTACT

+55112176-1525; robertmeves@hotmail.com

Sybele Saska Specian, PhD

CONTACT

+551131099068; pesquisa@plenum.bio

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: March 20, 2023
• Study Start: April 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: April 1, 2025
• Last Updated: March 12, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)