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This is a single-center, open label, prospective clinical study to assess the clinical application and functional outcomes of symptomatic patients undergoing the Minimally Invasive Lumbar Decompression (MILD™) treatment for lumbar spinal stenosis. In this study, patient-reported outcomes over a 3 month period following treatment will be collected by the investigator. Periodic surveys for each study subject's pain, functional status, quality of life and physical examination will track outcomes following MILD™ treatment.
The Vertos MILD™ devices are used for image-guided Minimally Invasive Lumbar Decompression, referred to as the MILD™ procedure. This percutaneous procedure is performed under fluoroscopic image guidance through a dorsal approach to the spine. Lumbar decompression is performed through the removal of tissue and bone, where indicated. All procedures are conducted in accordance with the product labeling and indications for use. A minimum of ten up to a maximum of twenty-five adult patients will be enrolled and followed for a period of up to 6 months. Patients with symptomatic lumbar spinal stenosis who meet the study enrollment criteria will be offered the MILD™ procedure as an alternative to surgery or continued standard non-surgical medical management.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Percutaneous Lumbar Decompression procedure | Other | mild percutaneous lumbar decompression procedure |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minimally Invasive Lumbar Decompression (MILD™) | Device | The arthroscopic devices in this study are specialized surgical instruments intended to be used to perform percutaneous lumbar decompressive procedures for the treatment of various spinal conditions. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Back Pain as Measured by a 10-point Visual Analog Scale (VAS). | Clinical relevance established by change of two points or more on a ten point scale where zero represents no pain and ten represents worst pain imaginable. Mean change from baseline to Month 6 was reported with a positive number representing the baseline value minus the 6 month value. | Baseline and Six Months |
| Function as Measured Subjectively by the Oswestry Disability Index Patient Questionnaire | Oswestry Disability Index (ODI) is used to measure permanent functional disability through a series of questions which characterize the disturbance of activities of daily living resulting from chronic back pain. The questionnaire is divided into 10 topics including pain intensity , personal care, lifting, walking, sitting, standing, sleeping, social life, traveling and employment/homemaking. Each topic is rated 0 (no pain or no limitation) to 5 (high pain or very limited physically). The worst possible score is 50 (100% disability) and best would be zero (0% disability), thus a higher ODI score indicates greater disability. | Baseline and Month 6 |
| Quality of Life as Measured by the PCS Subscale of the Short-form 12 Question (SF-12) Survey. | The 12-question SF-12v2 Health Survey is a validated generic measure of health status & outcomes, as opposed to one that targets a specific age, disease, or treatment group. The Physical Component Summary (PCS)takes into account the correlations among the Physical Functioning (PF), Role Physical (RP), Bodily Pain (BP), General Health (GH), and Vitality (VT)SF-12v2 Health Survey scales to show the broad impact on PCS. Norm-based scoring is used so 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. | Baseline and Six months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daryl R Fourney, MD, FRCSC, FACS | University of Saskatchewan, Royal University Hospital, Divison of Neurosurgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal University Hospital | Saskatoon | Saskatchewan | S7N 0W8 | Canada |
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Study enrolled between September 2008 and January 2009. Recruitment derived from patient pool of complex cases, all with confirmed presence of hypertrophic ligament, wait-listed for decompression laminectomy.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mild Percutaneous Lumbar Decompression | The single group in this pilot study included ten patients treated for lumbar spinal stenosis of the central canal using the mild device kit to perform minimally invasive percutaneous decompression. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Mild Percutaneous Lumbar Decompression | The single group in this pilot study included ten patients treated for lumbar spinal stenosis of the central canal using the mild device kit to perform minimally invasive percutaneous decompression. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes in Back Pain as Measured by a 10-point Visual Analog Scale (VAS). | Clinical relevance established by change of two points or more on a ten point scale where zero represents no pain and ten represents worst pain imaginable. Mean change from baseline to Month 6 was reported with a positive number representing the baseline value minus the 6 month value. | All available treated patients at six months post treatment. Mean change from baseline to Month 6 was reported. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Six Months |
|
Period of collection from enrollment through end of study (Month 6).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mild Percutaneous Lumbar Decompression | The single group in this pilot study included ten patients treated for lumbar spinal stenosis of the central canal using the mild device kit to perform minimally invasive percutaneous decompression. |
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Small pilot series with short follow-up. Procedure experience of investigator limited. Minimal information available regarding appropriate patient selection, thus patient pool confined to complex cases wait-listed for more aggressive laminectomy.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP Clinical, Regulatory, Quality | Vertos Medical | 9493490008 | 216 | cmyers@vertosmed.com |
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| ID | Term |
|---|---|
| D013130 | Spinal Stenosis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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|
| Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
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| Participants |
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| Primary | Function as Measured Subjectively by the Oswestry Disability Index Patient Questionnaire | Oswestry Disability Index (ODI) is used to measure permanent functional disability through a series of questions which characterize the disturbance of activities of daily living resulting from chronic back pain. The questionnaire is divided into 10 topics including pain intensity , personal care, lifting, walking, sitting, standing, sleeping, social life, traveling and employment/homemaking. Each topic is rated 0 (no pain or no limitation) to 5 (high pain or very limited physically). The worst possible score is 50 (100% disability) and best would be zero (0% disability), thus a higher ODI score indicates greater disability. | All treated patients having six month follow-up were included. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Month 6 |
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| Primary | Quality of Life as Measured by the PCS Subscale of the Short-form 12 Question (SF-12) Survey. | The 12-question SF-12v2 Health Survey is a validated generic measure of health status & outcomes, as opposed to one that targets a specific age, disease, or treatment group. The Physical Component Summary (PCS)takes into account the correlations among the Physical Functioning (PF), Role Physical (RP), Bodily Pain (BP), General Health (GH), and Vitality (VT)SF-12v2 Health Survey scales to show the broad impact on PCS. Norm-based scoring is used so 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. | All available treated patients with six month follow-up. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and Six months |
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