Back to resultsEvaluation of Plenum® Tissue Ortho to Prevent Epidural Fibrosis and Post-laminectomy Syndrome.
Primary Purpose
Herniated Disk Lumbar
Status
Not yet recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Plenum® Tissue ortho membrane (polydioxanone membrane)
Sponsored by
About this trial
This is an interventional prevention trial for Herniated Disk Lumbar
Eligibility Criteria
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.
Sites / Locations
- M3 Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Polydioxanone membrane
Control
Arm Description
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.
The microdiscectomy procedure will be performed routinely, without the addition of any device over the dura mater.
Outcomes
Primary Outcome Measures
Patient's quality of life
Assessed by the Oswestry Questionnaire for lumbar evaluation (The low back pain disability Oswestry questionnaire).
Secondary Outcome Measures
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).
Patient's quality of life
SF-36 Questionnaire
Low back and leg pain
Pain change will be measured by a Visual Analogue Scale (VAS)
Intervention safety
Adverse events occurrence
Full Information
NCT ID
NCT05776628
First Posted
February 27, 2023
Last Updated
October 18, 2023
Sponsor
M3 Health
Collaborators
Irmandade da Santa Casa de Misericordia de Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT05776628
Brief Title
Evaluation of Plenum® Tissue Ortho to Prevent Epidural Fibrosis and Post-laminectomy Syndrome.
Official Title
Evaluation of the Performance and Safety of Plenum® Tissue Ortho for the Prevention of Epidural Fibrosis and Post-laminectomy Syndrome After Microdiscectomy, for the Treatment of Disc Herniation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M3 Health
Collaborators
Irmandade da Santa Casa de Misericordia de Sao Paulo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herniated Disk Lumbar
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Polydioxanone membrane
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The microdiscectomy procedure will be performed routinely, without the addition of any device over the dura mater.
Intervention Type
Device
Intervention Name(s)
Plenum® Tissue ortho membrane (polydioxanone membrane)
Intervention Description
Membrane addition after flavectomy and spinal nerve and dura mater manipulation.
Primary Outcome Measure Information:
Title
Patient's quality of life
Description
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).
Secondary Outcome Measure Information:
Title
Epidural fibrosis
Description
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.
Title
Patient's quality of life
Description
SF-36 Questionnaire
Time Frame
Before the procedure, in the immediate postoperative period (14 days) and in the late postoperative period (6 months).
Title
Low back and leg pain
Description
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).
Title
Intervention safety
Description
Adverse events occurrence
Time Frame
Through study completion, an average of 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robert Meves, PhD
Phone
+55112176-1525
Email
robertmeves@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sybele Saska Specian, PhD
Phone
+551131099068
Email
pesquisa@plenum.bio
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sybele Saska Specian, PhD
Organizational Affiliation
M3 Health
Official's Role
Study Director
Facility Information:
Facility Name
M3 Health
City
Jundiaí
State/Province
São Paulo
ZIP/Postal Code
13212213
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sybele Saska Specian, PhD
Phone
+5511934742419
Email
sybele.saska@plenum.bio
First Name & Middle Initial & Last Name & Degree
Lívia Silva, PhD
Phone
+551131099068
Email
pesquisa@plenum.bio
First Name & Middle Initial & Last Name & Degree
Robert Meves, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of Plenum® Tissue Ortho to Prevent Epidural Fibrosis and Post-laminectomy Syndrome.
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