Study of Epidural Steroid Injection (ESI) Versus Minimally Invasive Lumbar Decompression (Mild®) in Patients With Symptomatic Lumbar Central Canal Stenosis

Study Overview
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Brief Summary
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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.

Official Title
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Comparative Study of Epidural Steroid Injection Versus Mild® (Minimally Invasive Lumbar Decompression) Procedure in Patients Diagnosed With Symptomatic Moderate to Severe Lumbar Central Canal Stenosis

Conditions
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Lumbar Spinal Stenosis

Intervention / Treatment
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* Device: MILD® (Minimally Invasive Lumbar Decompression)
* Drug: Epidural Steroid Injection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vertos mild® Minimally-Invasive Lumbar Decompression<br>Patients in the Vertos mild® treatment group will be treated by appropriately trained physicians in accordance with the product labeling and indications for use. | Device: MILD® (Minimally Invasive Lumbar Decompression)<br>* Image guided minimally-invasive lumbar decompression performed with arthroscopic devices.<br>|
| Active Comparator: Epidural Steroid Injection<br>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. | Drug: Epidural Steroid Injection<br>* An Epidural Steroid Injection is injected into the space around the spinal cord and nerve roots called epidural space.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | Baseline and 26 weeks After ESI to mild cross-over | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal Stenosis, Lumbar Spinal Stenosis, Laminotomy, Laminectomy, Spine Surgery