Herniated Disk LumbarNCT05776628
Evaluation of Plenum® Tissue Ortho to Prevent Epidural Fibrosis and Post-laminectomy Syndrome.
A study testing Plenum® Tissue ortho membrane (polydioxanone membrane) in people with Herniated Disk Lumbar, run by M3 Health at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Herniated Disk Lumbar
- What is being tested?
- Plenum® Tissue ortho membrane (polydioxanone membrane)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2024to Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
M3 Health
Jundiaí, São Paulo, 13212213
Sybele Saska Specian, PhD, +5511934742419, sybele.saska@plenum.bio
Lívia Silva, PhD, +551131099068, pesquisa@plenum.bio
About this study
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
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.
Read the 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.
- Conditions
- Herniated Disk Lumbar
- Being tested
- Plenum® Tissue ortho membrane (polydioxanone membrane)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plenum® Tissue ortho membrane (polydioxanone membrane)Device
Membrane addition after flavectomy and spinal nerve and dura mater manipulation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Plenum® Tissue ortho membrane (polydioxanone membrane) |
| Control | No intervention | The microdiscectomy procedure will be performed routinely, without the addition of any device over the dura mater. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's quality of life
Assessed by the Oswestry Questionnaire for lumbar evaluation (The low back pain disability Oswestry questionnaire).
Measured: Change from the baseline, to immediate potostoperative period (14 days) and to late postoperative period (6 months).
Secondary outcomes (4)
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).
Measured: 6 months postoperatively.
Patient's quality of life
SF-36 Questionnaire
Measured: 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)
Measured: Before the procedure, in the immediate postoperative period (14 days) and in the late postoperative period (6 months).
Intervention safety
Adverse events occurrence
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study startApr 2024 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herniated Disk LumbarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M3 Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Irmandade da Santa Casa de Misericordia de Sao Paulo
- Responsible party
- Sponsor
- Investigators
- Sybele Saska Specian, PhD, Study director, M3 Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05776628
- Sponsor's protocol ID
- Regenerative membrane
- Other IDs
- U1111-1302-0033
- Status last verified
- Nov 2023
- First submitted
- 27 Feb 2023
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05776628
- Acronym / sponsor ID
- Regenerative membrane
- Conditions
- Herniated Disk Lumbar
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- M3 HealthIndustry (pharma, biotech, devices)
- Collaborators
- Irmandade da Santa Casa de Misericordia de Sao Paulo
- Study start
- Apr 2024 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 20 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polydioxanone membrane | Active comparator | Device: Plenum® Tissue ortho membrane (polydioxanone membrane)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. |
| Control | No intervention | –The microdiscectomy procedure will be performed routinely, without the addition of any device over the dura mater. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plenum® Tissue ortho membrane (polydioxanone membrane)Membrane addition after flavectomy and spinal nerve and dura mater manipulation. | Device | Polydioxanone membrane |
Primary outcome
Patient's quality of life
Time frame: 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).
4 secondary outcomes
Epidural fibrosis
Time frame: 6 months postoperatively.
Patient's quality of life
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
Time frame: Before the procedure, in the immediate postoperative period (14 days) and in the late postoperative period (6 months).
Intervention safety
Time frame: Through study completion, an average of 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sybele Saska Specian, PhD study director
M3 Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plenum® Tissue ortho membrane (polydioxanone membrane) in people with Herniated Disk Lumbar, run by M3 Health at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert Meves, PhD (+55112176-1525, robertmeves@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient's quality of life (time frame: Change from the baseline, to immediate potostoperative period (14 days) and to late postoperative period (6 months).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.