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| Name | Class |
|---|---|
| Vertos Medical, Inc. | INDUSTRY |
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This is a single-center, randomized, prospective, double-blind clinical study to assess the clinical application and outcomes with MILD® devices versus epidural steroid injection in patients with symptomatic moderate to severe central canal spinal stenosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vertos mild® Minimally-Invasive Lumbar Decompression | Active Comparator | Patients in the Vertos mild® treatment group will be treated by appropriately trained physicians in accordance with the product labeling and indications for use. |
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| Epidural Steroid Injection | Active Comparator | Patients in the Epidural Steroid Injection (ESI) group will have ESI performed by appropriately trained physicians in accordance with product labeling and indications for use. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MILD® (Minimally Invasive Lumbar Decompression) | Device | Image guided minimally-invasive lumbar decompression performed with arthroscopic devices. |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in VAS | Visual Analog Scale (VAS) - a validated ten point scale where ten is the worst possible pain and zero represents complete lack of pain. The change from baseline to 6 weeks for all participants is presented below, where a positive value represents the baseline value minus the 6 week value. | Baseline and 6 weeks prior to cross-over |
| Mean Change in ODI | Oswestry Disability Index (ODI) measures permanent functional disability using questions regarding activities of daily living (ADL), specifically disturbance in ADL related to chronic back pain. Higher score 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). Calculated values range from zero (0% disability) to 100 (100% disability). The change from baseline to 6 weeks for all participants is presented below, where a positive value represents the baseline value minus the 6 week value | Baseline and 6 weeks prior to cross-over |
| Mean Change in VAS | Visual Analog Scale (VAS) - a validated ten point scale where ten is the worst possible pain and zero represents complete lack of pain. The change from baseline to 26 weeks for all participants is presented below, where a positive value represents the baseline value minus the 26 week value. | Baseline and 26 weeks After ESI to mild cross-over |
| Mean Change in ODI | Oswestry Disability Index (ODI) measures permanent functional disability using questions regarding activities of daily living (ADL), specifically disturbance in ADL related to chronic back pain. Higher score 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). Calculated values range from zero (0% disability) to 100 (100% disability). The change from baseline to 6 weeks for all participants is presented below, where a positive value represents the baseline value minus the 26 week value |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lora Brown, MD | Coastal Orthopedics & Sports Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coastal Orthopedics & Sports Medicine | Bradenton | Florida | 34209 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22272730 | Derived | Brown LL. A double-blind, randomized, prospective study of epidural steroid injection vs. the mild(R) procedure in patients with symptomatic lumbar spinal stenosis. Pain Pract. 2012 Jun;12(5):333-41. doi: 10.1111/j.1533-2500.2011.00518.x. Epub 2012 Jan 25. |
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Randomization occurred in blocks of four. After Week 6 post-treatment and prior to 4 months, ESI arm participants were allowed to cross over to mild if they chose to have it.
Patients were enrolled through one site (Coastal Orthopedics) between September 2009 and January 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vertos Mild® Minimally-Invasive Lumbar Decompression (Mild) | Group 1: Patients in the Vertos mild treatment group will be treated by appropriately trained physicians in accordance with the product labeling and indications for use. |
| FG001 | Epidural Steroid Injection Then Lumbar Decompression With Mild |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Prior to ESI Cross-over, 6 Weeks |
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| Epidural Steroid Injection | Drug | An Epidural Steroid Injection is injected into the space around the spinal cord and nerve roots called epidural space. |
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| Baseline and 26 weeks After ESI to mild cross-over |
Group 2: After post-treatment Week 6 and prior to 4 months patients in ESI procedure arm, when unblinded, were given option to cross-over to and receive the mild procedure using the mild device kit |
| COMPLETED |
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| NOT COMPLETED |
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| After ESI Cross-over to Mild, 26 Weeks |
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ITT analysis includes all patients at weeks 6 post-treatment. Week 26 cohort analysis includes 16 mild patients who reported outcomes at Week 26 and the 12 ESI patients who reported outcomes at Week 26 after cross-over to mild.
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| ID | Title | Description |
|---|---|---|
| BG000 | Vertos Mild® Minimally-Invasive Lumbar Decompression (Mild) | Group 1: Patients in the Vertos mild treatment group will be treated by appropriately trained physicians in accordance with the product labeling and indications for use. |
| BG001 | Epidural Steroid Injection | Group 2: Patients in the Epidural Steroid Injection (ESI) group will be treated by the physicians in accordance with product labeling and indications for use. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change in VAS | Visual Analog Scale (VAS) - a validated ten point scale where ten is the worst possible pain and zero represents complete lack of pain. The change from baseline to 6 weeks for all participants is presented below, where a positive value represents the baseline value minus the 6 week value. | All 38 participants (21 in mild and 17 in ESI arm) reported VAS at Week 6 post-treatment. All measurements for the ESI group occurred prior to cross-over to the mild procedure. This is Intent to Treat (ITT) analysis. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and 6 weeks prior to cross-over |
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| Primary | Mean Change in ODI | Oswestry Disability Index (ODI) measures permanent functional disability using questions regarding activities of daily living (ADL), specifically disturbance in ADL related to chronic back pain. Higher score 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). Calculated values range from zero (0% disability) to 100 (100% disability). The change from baseline to 6 weeks for all participants is presented below, where a positive value represents the baseline value minus the 6 week value | All 38 participants (21 in mild and 17 in ESI arm) reported ODI at Week 6 post-treatment. All measurements for the ESI group occurred prior to cross-over to the mild procedure. This is Intent to Treat (ITT) analysis. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and 6 weeks prior to cross-over |
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| Primary | Mean Change in VAS | Visual Analog Scale (VAS) - a validated ten point scale where ten is the worst possible pain and zero represents complete lack of pain. The change from baseline to 26 weeks for all participants is presented below, where a positive value represents the baseline value minus the 26 week value. | Participants who reported Week 26 outcomes. All findings reported below for the ESI group are after cross-over to mild. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and 26 weeks After ESI to mild cross-over |
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| Primary | Mean Change in ODI | Oswestry Disability Index (ODI) measures permanent functional disability using questions regarding activities of daily living (ADL), specifically disturbance in ADL related to chronic back pain. Higher score 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). Calculated values range from zero (0% disability) to 100 (100% disability). The change from baseline to 6 weeks for all participants is presented below, where a positive value represents the baseline value minus the 26 week value | Participants who reported Week 26 outcomes. All findings reported below for the ESI group are after cross-over to mild. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and 26 weeks After ESI to mild cross-over |
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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 | Vertos Mild® Minimally-Invasive Lumbar Decompression | Group 1: Patients in the Vertos mild® treatment group will be treated by appropriately trained physicians in accordance with the product labeling and indications for use. | 0 | 21 | 0 | 21 | ||
| EG001 | Epidural Steroid Injection | Group 2: Patients in the Epidural Steroid Injection (ESI) group will be treated by the physicians in accordance with product labeling and indications for use. The ESI group analyzed crossed over to receive the mild procedure after being unblinded. The results are up to 26 weeks post-mild procedure | 0 | 17 | 0 | 17 | ||
| EG002 | ESI Cross-over to Lumbar Decompression With Mild | Group 3: Patients in the Epidural Steroid Injection (ESI) group treated by the physicians in accordance with product labeling and indications for use, crossed over to receive the mild procedure after being unblinded. The results are up to 26 weeks post-mild procedure | 0 | 17 | 0 | 17 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lois A. Davis | Coastal Orthopedics & Sports Medicine | 941-782-1353 | ldavis@coastalorthopedics.com |
| ID | Term |
|---|---|
| D013130 | Spinal Stenosis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| >=65 years |
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| Male |
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The mean change from baseline was assessed for VAS using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used.
| t-test, 2 sided |
| >0.05 |
| Mean Difference (Final Values) |
| 0.06 |
| 2-Sided |
| 95 |
| -1.43 |
| 1.55 |
| No |
| Superiority or Other |
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