An interventional study of Plenum® Tissue ortho membrane (polydioxanone membrane) in Herniated Disk Lumbar, sponsored by M3 Health. Not yet recruiting at 1 site in Brazil. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-03-12.
Sponsored by M3 Health · Not applicable, Interventional, and Prevention
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.
478 studies on the registry are indexed under Intervertebral Disc Displacement; 104 are open to participants now.
This study's planned enrollment of 36 is below the median of 63 across 344 interventional studies indexed under Intervertebral Disc Displacement.
Browse Intervertebral Disc Displacement studies →M3 Health is the lead sponsor of 4 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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)
The microdiscectomy procedure will be performed routinely, without the addition of any device over the dura mater.
Membrane addition after flavectomy and spinal nerve and dura mater manipulation.
Patient's quality of life
Assessed by the Oswestry Questionnaire for lumbar evaluation (The low back pain disability Oswestry questionnaire).
Time frame: Change from the baseline, to immediate potostoperative period (14 days) and to late postoperative period (6 months).
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).
Time frame: 6 months postoperatively.
Patient's quality of life
SF-36 Questionnaire
Time frame: 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)
Time frame: Before the procedure, in the immediate postoperative period (14 days) and in the late postoperative period (6 months).
Intervention safety
Adverse events occurrence
Time frame: Through study completion, an average of 6 months
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Intervertebral Disc Displacement→
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