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| Name | Class |
|---|---|
| Vertos Medical, Inc. | INDUSTRY |
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This is a single-center study evaluating the outcomes of patients with painful lumbar spinal stenosis who were treated with the mild procedure (minimally invasive lumbar decompression. The patients will be followed for 6 months after the procedure.
Approximately 50 patients at a single center will be enrolled and followed for a period of up to 26 weeks. Adult patients with symptomatic lumbar spinal stenosis who meet the 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 |
|---|---|---|---|
| Minimally invasive lumbar decompression | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minimally Invasive Lumbar Decompression | Procedure | This minimally invasive procedure is performed under fluoroscopic image guidance through a dorsal approach to the spine. The patient is given local anesthesia and a sedative but needs to be responsive to the surgeon's questions for neurological monitoring. Under image guidance, the mild tools are inserted and positioned on the posterior spinal lamina, to the left or right of the spinous process. The tools are used to cut and remove tissue and bone from the posterior side of the lumbar spine to create a space inside the spine that can help decompress some of the spinal nerves. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain as Measured by Visual Analog Scale (VAS). | A validated ten point scale was used where ten is the worst possible pain and zero represents complete lack of pain. The change from baseline to six months is presented below, where a positive value represents the baseline value minus the 6 month value. | Baseline and six months |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Functional Mobility | Measured subjectively by the Oswestry Disability Index. Extent of disturbance in activities of daily living is subjectively reported using this validated instrument.Higher score indicate greater limitations in activity. The questionnaire is divided into 10 topics including pain intensity, personal care, lifting walking standing sitting, sleeping social life, traveling, employment/homemaking. Each topic is rated zero (no pain or no limitation) to 5 (high pain or very limited physically) based on typical pain and/or physical limitations. The worst possible score is 50 (100% disability) and the best score is zero (0% disability).Change from baseline to month 6 is reported below, where a positive value represents the baseline value minus the month 6 value. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy R Deer, MD | Center for Pain Relief, Inc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Center for Pain Relief, Inc. | Charleston | West Virginia | 25301 | United States | ||
| The Center for Pain Relief, Inc |
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Patients were enrolled through one site (Center for Pain Relief) between March 2010 to January 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Minimally Invasive Lumbar Decompression | Lumbar spinal stenosis patients exhibiting neurogenic claudication with predominance of ligamentum flavum hypertrophy were treated percutaneously using the mild Device Kit to decompress the target area. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Minimally Invasive Lumbar Decompression | Lumbar spinal stenosis patients exhibiting neurogenic claudication with predominance of ligamentum flavum hypertrophy were treated percutaneously using the mild Device Kit to decompress the target area. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Improvement in Functional Mobility | Measured subjectively by the Oswestry Disability Index. Extent of disturbance in activities of daily living is subjectively reported using this validated instrument.Higher score indicate greater limitations in activity. The questionnaire is divided into 10 topics including pain intensity, personal care, lifting walking standing sitting, sleeping social life, traveling, employment/homemaking. Each topic is rated zero (no pain or no limitation) to 5 (high pain or very limited physically) based on typical pain and/or physical limitations. The worst possible score is 50 (100% disability) and the best score is zero (0% disability).Change from baseline to month 6 is reported below, where a positive value represents the baseline value minus the month 6 value. | All available patients at six months were analyzed. | Posted | Mean | 95% Confidence Interval | units on a scale | baseline and month 6 |
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Continuous from enrollment through follow-up period.
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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 | Minimally Invasive Lumbar Decompression | Lumbar spinal stenosis patients exhibiting neurogenic claudication with predominance of ligamentum flavum hypertrophy were treated percutaneously using the mild Device Kit to decompress the target area. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Timothy Deer | Center for Pain Relief | (304) 347-6144 | Diana.tolentino@stfh.net |
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| ID | Term |
|---|---|
| D013130 | Spinal Stenosis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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|
| baseline and month 6 |
| Quality of Life as Measured by the Symptom Severity Scale of the Zurich Claudication Questionnaire (ZCQ). | As a validated patient outcome tool specific to lumbar spinal stenosis, Zurich Claudication Questionnaire (ZCQ) captures symptom severity as a quality of life indicator. A mean score of 1 is the best possible outcome representing 'no pain' in symptom severity, whereas higher mean scores up to a maximum of 5 indicate worse patient symptoms. The symptom severity outcomes are presented below as change from baseline to month 6 where a positive value represents the baseline value minus the 6 month value. Treatment is considered 'successful' or 'clinically relevant' if the patient population has at least a 0.5 improvement in symptom severity. | Baseline and month 6 |
| Quality of Life as Measured by Physical Function Scale of the Zurich Claudication Questionnaire (ZCQ). | For this ZCQ domain, a mean score of 1 is the best possible outcome representing 'no limitation' in physical function, whereas a mean score of 4 indicates worst physical function. Zurich Claudication physical function scale from this validated lumbar spine-specific measurement questionnaire are reported below as change from baseline to month 6. A positive value represents the baseline value minus the 6 month value. Treatment is considered clinically relevant when at least a 0.5 improvement is achieved. | Baseline and month 6 |
| Charleston |
| West Virginia |
| 25301 |
| United States |
| 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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Lumbar spinal stenosis patients exhibiting neurogenic claudication with predominance of ligamentum flavum hypertrophy were treated percutaneously using the mild Device Kit to decompress the target area. |
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| Secondary | Quality of Life as Measured by the Symptom Severity Scale of the Zurich Claudication Questionnaire (ZCQ). | As a validated patient outcome tool specific to lumbar spinal stenosis, Zurich Claudication Questionnaire (ZCQ) captures symptom severity as a quality of life indicator. A mean score of 1 is the best possible outcome representing 'no pain' in symptom severity, whereas higher mean scores up to a maximum of 5 indicate worse patient symptoms. The symptom severity outcomes are presented below as change from baseline to month 6 where a positive value represents the baseline value minus the 6 month value. Treatment is considered 'successful' or 'clinically relevant' if the patient population has at least a 0.5 improvement in symptom severity. | All patients having a month six report report were analyzed. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and month 6 |
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| Primary | Pain as Measured by Visual Analog Scale (VAS). | A validated ten point scale was used where ten is the worst possible pain and zero represents complete lack of pain. The change from baseline to six months is presented below, where a positive value represents the baseline value minus the 6 month value. | all available patients reporting at Month 6 | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and six months |
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| Secondary | Quality of Life as Measured by Physical Function Scale of the Zurich Claudication Questionnaire (ZCQ). | For this ZCQ domain, a mean score of 1 is the best possible outcome representing 'no limitation' in physical function, whereas a mean score of 4 indicates worst physical function. Zurich Claudication physical function scale from this validated lumbar spine-specific measurement questionnaire are reported below as change from baseline to month 6. A positive value represents the baseline value minus the 6 month value. Treatment is considered clinically relevant when at least a 0.5 improvement is achieved. | All available patients at the month 6 reporting period were analyzed. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and month 6 |
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