Lumbar Spinal Stenosis
Conditions
Keywords
Spinal Stenosis, Lumbar Spinal Stenosis, Laminotomy, Laminectomy, Spine Surgery
Brief summary
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.
Interventions
DEVICEMILD® (Minimally Invasive Lumbar Decompression)
Image guided minimally-invasive lumbar decompression performed with arthroscopic devices.
An Epidural Steroid Injection is injected into the space around the spinal cord and nerve roots called epidural space.
Sponsors
Vertos Medical, Inc.
Coastal Orthopedics & Sports Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Symptomatic Lumbar Spinal Stenosis (LSS) primarily caused by dorsal element hypertrophy. * Prior failure of conservative therapy and ODI Score \>20%. * Radiologic evidence of LSS (L3-L5), Ligamentum flavum \>2.5mm, confirmed by pre-op MRI and/or CT. * Central canal cross sectional area ≤ 100 square mm. * Anterior listhesis ≤ 5.0mm. * Able to walk at least 10 feet unaided before being limited by pain. * 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.
Exclusion criteria
* Prior surgery at intended treatment level. * History of recent spinal fractures with concurrent pain symptoms. * Disabling back or leg pain from causes other than LSS (e.g. acute compression fracture, metabolic neuropathy, or vascular claudication symptoms, etc.) * Significant / symptomatic disc protrusion or osteophyte formation. * Excessive / symptomatic facet hypertrophy. * Bleeding disorders and/or current use of anti-coagulants. * Use of ASA and/or NSAID within 5 days of treatment. * Pregnant and/or breastfeeding. * Epidural steroids previously administered (not ESI naive) * Wound healing pathologies deemed to compromise outcomes, including: diabetes, excessive smoking history, cancer, connective tissue diseases, recent spine radiation and severe COPD. * Dementia and/or inability to give informed consent. * Inability of the patient to lie prone for any reason with anesthesia support (e.g. COPD, obesity, etc.). * On Workman's Compensation or considering litigation associated with back pain.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in VAS | Baseline and 6 weeks prior to cross-over | 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. |
| Mean Change in ODI | Baseline and 6 weeks prior to cross-over | 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 |
Countries
United States
Participant flow
Recruitment details
Patients were enrolled through one site (Coastal Orthopedics) between September 2009 and January 2011.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 21 |
| 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. | 17 |
| Total | 38 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| After ESI Cross-over to Mild, 26 Weeks | Withdrawal by Subject | 5 | 5 |
Baseline characteristics
| Characteristic | Epidural Steroid Injection | Vertos Mild® Minimally-Invasive Lumbar Decompression (Mild) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 16 Participants | 16 Participants | 32 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 5 Participants | 6 Participants |
| Age Continuous | 78.71 years STANDARD_DEVIATION 7.11 | 74.24 years STANDARD_DEVIATION 10.12 | 76.26 years STANDARD_DEVIATION 9.18 |
| Region of Enrollment United States | 17 participants | 21 participants | 38 participants |
| Sex: Female, Male Female | 9 Participants | 8 Participants | 17 Participants |
| Sex: Female, Male Male | 8 Participants | 13 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 21 | 0 / 17 | 0 / 17 |
| serious Total, serious adverse events | 0 / 21 | 0 / 17 | 0 / 17 |
Outcome results
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
Time frame: Baseline and 6 weeks prior to cross-over
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Vertos Mild® Minimally-Invasive Lumbar Decompression (Mild) | Mean Change in ODI | 11.33 units on a scale |
| Epidural Steroid Injection Prior to Cross-Over | Mean Change in ODI | 5.65 units on a scale |
Comparison: The mean change from baseline was assessed for ODI 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.p-value: >0.0595% CI: [-4.12, 15.41]t-test, 2 sided
Comparison: The mean change from baseline was assessed for ODI 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.p-value: <0.0595% CI: [3.35, 19.31]t-test, 2 sided
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
Time frame: Baseline and 26 weeks After ESI to mild cross-over
Population: Participants who reported Week 26 outcomes. All findings reported below for the ESI group are after cross-over to mild.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Vertos Mild® Minimally-Invasive Lumbar Decompression (Mild) | Mean Change in ODI | 16.13 units on a scale |
| Epidural Steroid Injection Prior to Cross-Over | Mean Change in ODI | 6.17 units on a scale |
Comparison: The mean change from baseline was assessed for ODI 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.p-value: <0.0595% CI: [7.43, 24.83]t-test, 2 sided
Comparison: The mean change from baseline was assessed for ODI 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.p-value: >0.0595% CI: [-1.24, 13.58]t-test, 2 sided
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.
Time frame: Baseline and 6 weeks prior to cross-over
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Vertos Mild® Minimally-Invasive Lumbar Decompression (Mild) | Mean Change in VAS | 2.52 units on a scale |
| Epidural Steroid Injection Prior to Cross-Over | Mean Change in VAS | 0.06 units on a scale |
Comparison: 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.p-value: <0.0595% CI: [1.09, 3.96]t-test, 2 sided
Comparison: 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.p-value: >0.0595% CI: [-1.43, 1.55]t-test, 2 sided
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.
Time frame: Baseline and 26 weeks After ESI to mild cross-over
Population: Participants who reported Week 26 outcomes. All findings reported below for the ESI group are after cross-over to mild.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Vertos Mild® Minimally-Invasive Lumbar Decompression (Mild) | Mean Change in VAS | 2.19 units on a scale |
| Epidural Steroid Injection Prior to Cross-Over | Mean Change in VAS | 1.00 units on a scale |
Comparison: 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.p-value: <0.0595% CI: [0.61, 3.77]t-test, 2 sided
Comparison: 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.p-value: >0.0595% CI: [-0.66, 2.66]t-test, 2 sided