Lumbar Spinal StenosisPhase 4NCT01082159
MiDAS II (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study
A Phase 4 study testing lumbar decompression in people with Lumbar Spinal Stenosis, run by Vertos Medical, Inc. at 8 sites in United States.
Trial summary
This is a multi-center, prospective, patient outcomes assessment of Minimally Invasive Lumbar Decompression with the Mild® devices in patients with symptomatic central canal spinal stenosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Spinal Stenosis
- What is being tested?
- lumbar decompression
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 8 sitesUnited States
- Study dates
- Feb 2010to Jan 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic lumbar spinal stenosis (LSS) primarily caused by dorsal element hypertrophy.
- Prior failure of conservative therapy and Oswestry Disability Index (ODI) score > 20%.
- Radiologic evidence of lumbar spinal stenosis (LSS), ligamentum flavum hypertrophy (typically > 2.5 mm), confirmed by pre-op MRI and/or CT.
- Central canal cross sectional area clearly reduced per MRI/CT report.
- If present, anterior listhesis preferred ≤ 5.0mm and deemed stable by Investigator.
- Able to walk at least 10 feet unaided before being limited by pain.
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- Available to complete 26 weeks of follow-up.
- A signed Informed Consent Form is obtained from the patient.
- Adults at least 18 years of age.
Who cannot join
- Prior surgery at intended treatment level.
- Compound fracture with interspinal retropulsion contributing to spinal stenosis.
- Disabling back or leg pain from causes other than LSS (e.g. acute compression fracture, metabolic neuropathy, or vascular claudication symptoms, etc.).
- Disc protrusion or osteophyte formation severe enough to confound study outcome.
- Facet hypertrophy severe enough to confound study outcome.
- Bleeding disorders and/or current use of anti-coagulants.
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- Use of acetylsalicylic acid (ASA) and/or non-steroidal anti-inflammatory drug (NSAID) within 5 days of treatment.
- Epidural steroid administration within prior three weeks (of procedure).
- Inability of the patient to lie prone for any reason with anesthesia support (e.g.chronic obstructive pulmonary disease (COPD), obesity, etc.).
- Metabolic wound healing pathologies deemed by Investigator to compromise study outcomes.
- Dementia and/or inability to give informed consent.
- Pregnant and/or breastfeeding.
- On Workman's Compensation or considering litigation associated with back pain.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
The Spine Center
Baltimore, Maryland, 21211
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Occupational and Pain Management Professionals
Festus, Missouri, 63028
Kenneth Alo, MD, PA-TX
Houston, Texas, 77090
The Center for Pain Relief Tri-State, PLLC
Huntington, West Virginia, 25702
Lab2Marche, LLC
Las Vegas, Nevada, 89149
MedCentral Health System
Mansfield, Ohio, 44903
Space Coast Pain Institute
Merritt Island, Florida, 32953
About this study
This is a multi-center, prospective, patient outcomes assessment of Minimally Invasive Lumbar Decompression with the Mild® devices in patients with symptomatic central canal spinal stenosis.
- Conditions
- Lumbar Spinal Stenosis
- Being tested
- lumbar decompression
- Keywords
- Spinal Stenosis, Lumbar Spinal Stenosis
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lumbar decompressionProcedure or surgery
Also called The mild® Device Kit
The mild® devices used in this study are specialized surgical instruments intended to be used to perform percutaneous lumbar decompressive procedures for the treatment of various spinal conditions.
| Study group | Role | What they receive |
|---|---|---|
| lumbar decompression | Other | Percutaneous lumbar decompression with mild® Device Kit. Receives: Procedure: lumbar decompression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Back Pain as Measured by a 10-point Visual Analog Scale (VAS).
The 10-point Visual Analog Scale (VAS)rates 'no pain' as zero and 'worst pain imaginable' as ten. VAS mean improvement greater than or equal to 2 points is considered clinically relevant.
The change from baseline to Month 6 is presented below where a positive value represents the baseline value minus the 6 month value.
Measured: Baseline and Month 6
Function as Measured Subjectively by the Oswestry Disability Index Questionnaire
Oswestry Disability Index (ODI) measures permanent functional disability using questions regarding activities of daily living (ADL), specifically disturbance of ADL related to chronic back pain. Higher scores indicate a 'more limited' life. The ten topics of the ODI are rated from zero (no pain/limitation) to five (high pain/very limited physically). The worst possible score is 50 (100% disability) with the best score being zero (0% disability).Change from baseline to 6 months is presented below, where a positive value represents the baseline value minus the 6 month value.
Measured: Baseline and Month 6
Quality of Life Changes as Determined by Short Form 12-question (SF-12) Survey Specifically Related to Physical Component Score (PCS).
The SF-12 is a validated norm-based scoring tool used to determine treatment outcomes. The PCS summary measure shows the impact of the treatment on the patients abilities to conduct their usual physical activities. Clinical relevance of PCS is established by baseline to post-treatment improvement of 2 to 3 points. Norm-based scoring is used so that each scale has the same mean (50 points) and the same standard deviation (10 points) as the general US population in 1998. Scores below 50 indicate a decline in health status, with lower scores representing worse health status. Minimally Important Difference (MID) is a measure of true clinical relevance of a difference, with suggested MID for the Physical Component Summary (PCS) being 2 to 3 points. Change from baseline to 6 months is presented, where a positive value represents the 6 month value minus the baseline value.
Measured: Baseline and Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2010 (estimated)
- Study startFeb 2010
- Primary completionOct 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lumbar Spinal StenosisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vertos Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David L Caraway, MD, PhD, Principal investigator, The Center for Pain Relief Tri-State, PLLCBohdan W Chopko, MD, Principal investigator, MedCentral Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01082159
- Sponsor's protocol ID
- MiDAS II
- Status last verified
- Feb 2013
- First submitted
- 4 Mar 2010
- Last updated
- 1 Apr 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MiDAS II (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study
- ClinicalTrials.gov ID
- NCT01082159
- Acronym / sponsor ID
- MiDAS II
- Conditions
- Lumbar Spinal Stenosis
- Keywords
- Spinal Stenosis, Lumbar Spinal Stenosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Vertos Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 8 Mar 2010 (estimated)
- Results
- Posted 1 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-center, prospective, patient outcomes assessment of Minimally Invasive Lumbar Decompression with the Mild® devices in patients with symptomatic central canal spinal stenosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lumbar decompression | Other | Procedure: lumbar decompressionPercutaneous lumbar decompression with mild® Device Kit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Symptomatic lumbar spinal stenosis (LSS) primarily caused by dorsal element hypertrophy.
- Prior failure of conservative therapy and Oswestry Disability Index (ODI) score > 20%.
- Radiologic evidence of lumbar spinal stenosis (LSS), ligamentum flavum hypertrophy (typically > 2.5 mm), confirmed by pre-op MRI and/or CT.
- Central canal cross sectional area clearly reduced per MRI/CT report.
- If present, anterior listhesis preferred ≤ 5.0mm and deemed stable by Investigator.
Key exclusion criteria (13 listed)
- Prior surgery at intended treatment level.
- Compound fracture with interspinal retropulsion contributing to spinal stenosis.
- Disabling back or leg pain from causes other than LSS (e.g. acute compression fracture, metabolic neuropathy, or vascular claudication symptoms, etc.).
- Disc protrusion or osteophyte formation severe enough to confound study outcome.
- Facet hypertrophy severe enough to confound study outcome.
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 |
|---|---|---|
| lumbar decompressionAlso: The mild® Device KitThe mild® devices used in this study are specialized surgical instruments intended to be used to perform percutaneous lumbar decompressive procedures for the treatment of various spinal conditions. | Procedure or surgery | lumbar decompression |
Primary outcome
Changes in Back Pain as Measured by a 10-point Visual Analog Scale (VAS).
Time frame: Baseline and Month 6
The 10-point Visual Analog Scale (VAS)rates 'no pain' as zero and 'worst pain imaginable' as ten. VAS mean improvement greater than or equal to 2 points is considered clinically relevant. The change from baseline to Month 6 is presented below where a positive value represents the baseline value minus the 6 month value.
Function as Measured Subjectively by the Oswestry Disability Index Questionnaire
Time frame: Baseline and Month 6
Oswestry Disability Index (ODI) measures permanent functional disability using questions regarding activities of daily living (ADL), specifically disturbance of ADL related to chronic back pain. Higher scores indicate a 'more limited' life. The ten topics of the ODI are rated from zero (no pain/limitation) to five (high pain/very limited physically). The worst possible score is 50 (100% disability) with the best score being zero (0% disability).Change from baseline to 6 months is presented below, where a positive value represents the baseline value minus the 6 month value.
Quality of Life Changes as Determined by Short Form 12-question (SF-12) Survey Specifically Related to Physical Component Score (PCS).
Time frame: Baseline and Month 6
The SF-12 is a validated norm-based scoring tool used to determine treatment outcomes. The PCS summary measure shows the impact of the treatment on the patients abilities to conduct their usual physical activities. Clinical relevance of PCS is established by baseline to post-treatment improvement of 2 to 3 points. Norm-based scoring is used so that each scale has the same mean (50 points) and the same standard deviation (10 points) as the general US population in 1998. Scores below 50 indicate a decline in health status, with lower scores representing worse health status. Minimally Important Difference (MID) is a measure of true clinical relevance of a difference, with suggested MID for the Physical Component Summary (PCS) being 2 to 3 points. Change from baseline to 6 months is presented, where a positive value represents the 6 month value minus the baseline value.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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LUMBAR STENOSIS
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.
David L Caraway, MD, PhD principal investigator
The Center for Pain Relief Tri-State, PLLC
Bohdan W Chopko, MD principal investigator
MedCentral Health System
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing lumbar decompression in people with Lumbar Spinal Stenosis, run by Vertos Medical, Inc. at 8 sites in United States.
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 9 inclusion and 13 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: finished, as of the sponsor's last update on 1 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Back Pain as Measured by a 10-point Visual Analog Scale (VAS). (time frame: Baseline and Month 6). The study lists 3 primary outcomes in all. 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 1 Apr 2013.