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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lumbar decompression | Other | Percutaneous lumbar decompression with mild® Device Kit. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lumbar decompression | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Baseline and Month 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David L Caraway, MD, PhD | The Center for Pain Relief Tri-State, PLLC | Principal Investigator |
| Bohdan W Chopko, MD | MedCentral Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Space Coast Pain Institute | Merritt Island | Florida | 32953 | United States | ||
| The Spine Center |
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Patients were enrolled from July 2008 through January 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lumbar Decompression | Single arm cohort having percutaneous decompression using the mild Device Kit |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Baltimore |
| Maryland |
| 21211 |
| United States |
| Occupational and Pain Management Professionals | Festus | Missouri | 63028 | United States |
| Lab2Marche, LLC | Las Vegas | Nevada | 89149 | United States |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| MedCentral Health System | Mansfield | Ohio | 44903 | United States |
| Kenneth Alo, MD, PA-TX | Houston | Texas | 77090 | United States |
| The Center for Pain Relief Tri-State, PLLC | Huntington | West Virginia | 25702 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Lumbar Decompression | Single arm cohort having percutaneous decompression using the mild Device Kit |
| 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 | ||||||||||||||
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| Age, Categorical | Count of Participants | 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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| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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. | All available participants who reported Month 6 outcomes are included in this analysis. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and Month 6 |
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| Primary | 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. | All available patients at 6 months are reported below. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and Month 6 |
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| Primary | 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. | All participants at month 6 who completed all questionnaire fields necessary to analyze PCS data according to guidelines. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and Month 6 |
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Adverse events were collected from time of treatment through study period of six months.
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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 | Lumbar Decompression | Single arm cohort having percutaneous decompression using the mild Device Kit | 0 | 55 | 0 | 55 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP Clinical Research | Vertos Medical | 949-349-0008 | 216 | cmyers@vertosmed.com |
| ID | Term |
|---|---|
| D013130 | Spinal Stenosis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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