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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1302-0033 | Registry Identifier | UTN |
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| Name | Class |
|---|---|
| Irmandade da Santa Casa de Misericordia de Sao Paulo | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Control | No Intervention | The microdiscectomy procedure will be performed routinely, without the addition of any device over the dura mater. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plenum® Tissue ortho membrane (polydioxanone membrane) | Device | Membrane addition after flavectomy and spinal nerve and dura mater manipulation. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Robert Meves, PhD | Contact | +55112176-1525 | robertmeves@hotmail.com | |
| Sybele Saska Specian, PhD | Contact | +551131099068 | pesquisa@plenum.bio |
| Name | Affiliation | Role |
|---|---|---|
| Sybele Saska Specian, PhD | M3 Health | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M3 Health | JundiaĂ | SĂŁo Paulo | 13212213 | Brazil |
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| 6 months postoperatively. |
| 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). |
| 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). |
| Intervention safety | Adverse events occurrence | Through study completion, an average of 6 months |