Herniated Disk Lumbar
Conditions
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.
Interventions
DEVICEPlenum® Tissue ortho membrane (polydioxanone membrane)
Membrane addition after flavectomy and spinal nerve and dura mater manipulation.
Sponsors
Irmandade da Santa Casa de Misericordia de Sao Paulo
M3 Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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 |
| 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) |
| Intervention safety | Through study completion, an average of 6 months | Adverse events occurrence |
Countries
Brazil
Contacts
Primary ContactRobert Meves, PhD
Backup ContactSybele Saska Specian, PhD
Outcome results
None listed