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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
First received
Last updated
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
Health authority
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.

Study Design


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
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